Titles of Regulations: 1VAC30-40. Regulations for the Certification of Laboratories Analyzing Drinking Water (repealing 1VAC30-40-10 through 1VAC30-40-370).

1VAC30-41. Regulation for the Certification of Laboratories Analyzing Drinking Water (adding 1VAC30-41-10 through 1VAC30-41-500).

Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.

Effective Date: May 1, 2014.

Agency Contact: Rhonda Bishton, Regulatory Coordinator, Department of General Services, 1100 Bank Street, Suite 420, Richmond, VA 23219, telephone (804) 786-3311, FAX (804) 371-8305, or email rhonda.bishton@dgs.virginia.gov.

Summary:

This regulatory action (i) updates the drinking water laboratory certification regulation to incorporate by reference the most recent Environmental Protection Agency (EPA) approved test methods and laboratory-specific requirements in the EPA's Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition (January 2005), Supplement 1 to the Fifth Edition (June 2008) and Code of Regulations (July 1, 2013); (ii) revises the fee provisions and requires local, state, and federal public laboratories, as well as private or commercial laboratories, to pay fees for certification; (iii) adds an alternative for drinking water laboratories to obtain certification by meeting the requirements of 1VAC30-46, Accreditation for Commercial Environmental Laboratories, as an alternative to meeting the drinking water laboratory certification regulation; and (iv) repeals existing regulation 1VAC30-40 and replaces it with new regulation 1VAC30-41, which sets out the requirements to certify laboratories that analyze drinking water samples and determine compliance with federal Safe Drinking Water Act (SDWA) contaminant limits.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

CHAPTER 41
REGULATION FOR THE CERTIFICATION OF LABORATORIES ANALYZING DRINKING WATER

Part I
General Provisions

1VAC30-41-10. Purpose.

A. This chapter establishes the requirements for certification of drinking water laboratories.

B. The federal Safe Drinking Water Act (SDWA) mandates the establishment of a national drinking water program to protect public health. The U.S. Environmental Protection Agency (EPA) at 40 CFR 141.28 requires that laboratories be certified to analyze samples of drinking water for compliance purposes. EPA at 40 CFR 142.10(b)(3)(i) requires states to establish and maintain programs for the certification of drinking water laboratories.

C. The Virginia Department of Health, Office of Drinking Water (VDH-ODW) maintains primary enforcement responsibility (primacy) under the SDWA and the federal SDWA regulations for the Commonwealth of Virginia. The VDH-ODW at 12VAC5-590-340 requires that all analyses done to demonstrate compliance with primary and secondary maximum contaminant levels or action levels be performed by the Division of Consolidated Laboratory Services of the Department of General Services (DCLS) or by laboratories certified by DCLS. VDH-ODW at 12VAC5-590-440 further requires that laboratories seeking certification to perform drinking water analyses shall comply with this chapter.

1VAC30-41-20. Applicability.

A. This chapter applies to the following:

1. Owners of drinking water laboratories in Virginia.

2. Owners of drinking water laboratories located outside Virginia who seek reciprocal certification under 1VAC30-41-90.

B. Covered contaminants.

1. This chapter covers the contaminants regulated in 40 CFR Parts 141 and 143 as specified in 12VAC5-590, Waterworks Regulations, of the Virginia Department of Health.

2. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

1VAC30-41-30. Alternative certification for drinking water laboratories.

Drinking water laboratories may become certified by meeting the requirements for accreditation set out in 1VAC30-46.

1VAC30-41-40. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context [ already clearly ] indicates otherwise:

"Analyst" means a chemist, microbiologist, physicist, or technician who actually performs a test. The analyst may carry out the complete test or participate jointly with other analysts.

"Certification officer" means a DCLS employee who has the responsibility for evaluating drinking water laboratories for certification.

"Contaminant" means any objectionable or hazardous physical, chemical, biological, or radiological substance or matter in water. Contaminants are the analytes for which drinking water laboratories test in the drinking water samples they analyze.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Drinking water laboratory" or "laboratory" means a laboratory that performs analyses to demonstrate compliance with primary or secondary maximum contaminant levels or action levels or any combination of these specified in 12VAC5-590.

"EPA" means the United States Environmental Protection Agency.

"Findings" means factual, objective statements that provide evidence of deficiencies in meeting the requirements of this chapter.

"Laboratory director" or "laboratory supervisor" means the person who directs the operation of the drinking water laboratory on a day-to-day basis.

"Manual" means the EPA Office of Water, Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

"Manual Supplement" means the EPA Office of Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

"Maximum contaminant level" or "MCL" means the maximum permissible level of a contaminant in [ pure ] water that is delivered to any user of a waterworks [ , except in the cases of turbidity and volatile organic compounds (VOCs), where the maximum permissible level is measured at each entry point to the distribution system. Contaminants added to the water under circumstances controlled by the user, except those resulting from corrosion of piping and plumbing caused by water quality, are excluded from this definition. MCLs are set as close to the MCLGs as feasible using the best available treatment technology. ] Maximum contaminant levels may be either "primary" (PMCL), meaning based on health considerations, or "secondary" (SMCL), meaning based on aesthetic considerations.

[ "Maximum contaminant level goal" or "MCLG" means the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

"National Environmental Laboratory Accreditation Program" or "NELAP" means the national program to establish and implement a program for the accreditation of environmental laboratories. NELAP relies on consensus standards representing the best professional practices in the industry to establish the requirements for this program, which is then implemented by state agencies recognized by the NELAC Institute (TNI) as accreditation bodies. ]

"Owner" means any person who owns, operates, leases, or controls a drinking water laboratory.

"Persistent" means to continue an activity without change in spite of opposition or warning.

"Private laboratory" means a laboratory that is, or is part of, a commercial entity.

"Proficiency testing sample" or "PT sample" means a sample, the composition of which is unknown to both the analyst and the laboratory. The PT sample tests whether the analyst or laboratory or both can produce analytical results within specified acceptance criteria.

"Public laboratory" means a laboratory that is, or is part of, a local, state, or U.S. governmental agency.

[ "Pure water" means water fit for human consumption and domestic use that is sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts for domestic usage in the area served and normally adequate in quantity and quality for the minimum health requirements of the persons served (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia). ]

"Quality assurance" means an integrated system of management activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.

"Quality assurance plan" or "QA plan" means a comprehensive plan detailing the aspects of quality assurance needed to adequately fulfill the data needs of a program.

"Quality control" means:

1. The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of the users.

2. The operational techniques and activities that are used to fulfill requirements for quality.

"SDWA" means the Safe Drinking Water Act (42 USC § 300f et seq.).

"VDH-ODW" means the Virginia Department of Health - Office of Drinking Water.

1VAC30-41-50. Incorporation by reference - EPA guidance documents.

A. The following EPA guidance documents are incorporated by reference into this chapter:

1. Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

2. Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

B. The federal regulatory requirements incorporated by reference into 1VAC30-41-55 shall govern if a conflict is found between the requirements of the Manual or the Manual Supplement and the requirements incorporated by reference into 1VAC30-41-55.

1VAC30-41-55. Incorporation by reference - Code of Federal Regulations.

A. The sampling, analytical methodology, and laboratory certification requirements of 40 CFR 141 and 143 in effect as of July 1, [ 2011 2013 ], are incorporated by reference into this chapter.

B. The specific sampling, analytical methodology, and laboratory certification requirements incorporated by reference are listed as follows by category for information purposes:

1. Inorganic chemistry: 40 CFR 141.23, 40 CFR 141.89, and 40 CFR 141.131.

2. Organic chemistry: 40 CFR 141.24 and 40 CFR 141.131.

3. Microbiology: 40 CFR 141.21, 40 CFR 141.74, 40 CFR 141.174, [ 40 CFR 141.402(c)(2), ] 40 CFR 141.704, and 40 CFR 141.705. 40 CFR 136.3(a) for E. coli requirements under 40 CFR 141.704.

4. Radiochemistry: 40 CFR 141.25.

5. Alternative testing methods: 40 CFR Part 141, Subpart C, Appendix A.

6. Test methods specified for secondary maximum contaminant levels: 40 CFR 143.4.

C. The exceptions to the requirements for laboratory certification in 40 CFR 141.28, 40 CFR 141.74(a), 40 CFR 141.89(a)(1), 40 CFR 141.131(b)(3), and 40 CFR 141.131(c)(3) are incorporated by reference into this chapter.

Part II
Certification of Laboratories - General Requirements

1VAC30-41-60. Categories of certification.

A. Laboratories may apply to be certified for inorganic chemistry, organic chemistry, microbiology, radiochemistry, or any combination of these four categories of certification.

B. Within each category, laboratories may be certified for specific contaminants or contaminant groups and for one or more methods used to determine the levels of these contaminants.

1VAC30-41-70. Initial certification application.

A. Application for initial certification. Drinking water laboratories applying under this chapter shall submit a completed Application for Certification, obtained by contacting the DCLS Laboratory Certification Office. A complete application contains:

1. Specific laboratory information, including name of organization, name of laboratory director, and contact information.

2. Identification of public water systems served by the laboratory.

3. Identification of the drinking water certification contaminants or contaminant groups and related methods for which the laboratory requests certification.

4. A quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2 as required by 1VAC30-41-120.

5. A satisfactory report of at least one proficiency test performed within the last 12 months for each method and contaminant for which the laboratory seeks certification.

6. Laboratory personnel list.

7. Requested laboratory data, including at a minimum:

a. For microbiology applications:

(1) Equipment and supply list.

(2) Sampling information and test results for at least 20 analyses for each method and contaminant for which the laboratory seeks certification.

b. For chemistry applications:

(1) Instrumentation and equipment list.

(2) Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

c. For radiochemistry applications:

(1) Instrumentation and equipment list.

(2) Minimum detectable activity (MDA) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

8. Payment of the fee required by 1VAC30-41-270.

B. DCLS review of application submittal.

1. DCLS shall administratively review the application submittal and respond to the applicant laboratory within 60 calendar days.

2. If DCLS finds that the application submittal is complete, a certification officer shall arrange a mutually agreeable time and date with the laboratory for an onsite assessment.

3. If DCLS finds that the application submittal is incomplete, a certification officer shall request the applicant laboratory to submit the additional information or documentation required within 90 days.

4. If the laboratory has not submitted the required additional information within 90 days of the DCLS request for information, DCLS may return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

1VAC30-41-80. Certification requirements.

To become certified, a laboratory shall meet or successfully complete the following:

1. Requirements for a quality assurance plan in 1VAC30-41-120.

2. Analysis of a proficiency testing sample for each contaminant and each method for which certification is sought. Proficiency testing requirements are set out in 1VAC30-41-130.

3. Specific requirements for chemistry, microbiology, or radiochemistry that are pertinent to the specific laboratory's application for certification. These requirements are set out in Part III (1VAC30-41-300 et seq.) through Part V (1VAC30-41-500) of this chapter.

4. Onsite assessment by DCLS certification officers at least once every three years. Onsite assessment requirements are set out in 1VAC30-41-150.

5. The laboratory ethics and fraud detection and deterrence requirements set out in 1VAC30-41-140.

6. Payment of the fee required by 1VAC30-41-270.

1VAC30-41-90. Reciprocity.

A. DCLS may grant reciprocal certification to a drinking water laboratory located outside Virginia, provided the laboratory demonstrates the need to serve customers in Virginia and is certified by EPA or another state under equivalent certification criteria.

B. To be considered for certification, the applicant laboratory shall send DCLS the following:

1. A copy of the certificate and scope of certification issued by the laboratory's primary certifying or accrediting authority.

2. A list of the methods and the contaminants tested under each method for which the laboratory is requesting certification.

3. The most recent proficiency testing report for each method and contaminant combination listed by the laboratory under subdivision 2 of this subsection.

4. The fee required under 1VAC30-41-270.

5. Confirmation that [ Virginia has been added to the proficiency testing provider's list of certifying authorities to whom the laboratory's proficiency testing the laboratory's proficiency test provider includes DCLS as a certifying authority to which the laboratory's proficiency test ] results will be reported.

C. Out-of-state laboratories holding National Environmental Laboratory Accreditation [ Conference (NELAC) Program (NELAP) ] accreditation for drinking water that seek reciprocal accreditation for drinking water in Virginia shall apply for that accreditation under 1VAC30-46.

1VAC30-41-100. Renewal of certification.

DCLS shall renew the certification for a drinking water laboratory if the laboratory maintains its certified status as required by 1VAC30-41-180, and pays the annual fee as required by 1VAC30-41-270.

1VAC30-41-110. Modification of certification.

A. To request the addition of contaminants or methods to its certification, the drinking water laboratory shall submit the following to DCLS:

1. A completed DCLS drinking water certification application form.

2. An acceptable proficiency testing report for each requested method and contaminant, performed within the last 12 months.

3. The standard operating procedures for the requested methods.

4. The current quality assurance plan, if requested.

5. For chemistry:

a. Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

b. Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

6. For microbiology, sampling information and test results for at least 20 analyses by the requested method and contaminant combination.

7. Applicable fees as required by 1VAC30-41-270.

B. To drop a contaminant or a method from the laboratory's certification, the laboratory shall submit a request in writing to the DCLS Laboratory Certification Office.

1VAC30-41-120. Quality assurance plan.

A drinking water laboratory shall develop and maintain a quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2.

1VAC30-41-130. Proficiency testing.

A. A drinking water laboratory shall meet the following requirements pertaining to proficiency testing (PT):

1. The requirements of this section.

2. The requirements of Chapter III, Section 13.1 of the Manual.

3. The specific requirements of the Manual for chemistry in Chapter IV, Section 7.2.1; for microbiology in Chapter V, Section 7.2; and for radiochemistry in Chapter VI, Section 7.4 that are pertinent to the laboratory.

[ 4. Proficiency testing requirements incorporated by reference in 1VAC30-41-55. ]

B. A drinking water laboratory shall successfully participate in at least one water supply (WS) PT study per calendar year for each contaminant and by each method for which the laboratory seeks or wants to maintain certification.

C. Drinking water laboratories shall obtain WS PT studies from PT providers approved by the American Association for Laboratory Accreditation utilizing the National Standards for Water Proficiency Testing Studies.

D. Drinking water laboratories shall instruct the PT providers to send the results of the WS PT studies to the DCLS Laboratory Certification Office.

E. WS PT study results.

1. DCLS shall certify or maintain certification for a drinking water laboratory for which WS PT study results are reported by the proficiency test provider as "acceptable."

2. A drinking water laboratory for which some or all WS PT study results are reported as "not acceptable" shall follow the procedure in subsection F of this section.

F. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall perform and document corrective action. The corrective action documentation shall be submitted to DCLS within 30 days of receiving the "not acceptable" PT study result.

2. Upon completion of the corrective action, the laboratory shall perform another PT study for each contaminant that had a "not acceptable" initial PT study result.

3. If the result of the laboratory's makeup PT study is "acceptable," DCLS shall not downgrade the laboratory.

4. If the laboratory fails the makeup PT study, DCLS shall downgrade the laboratory to provisionally certified status for the contaminant or contaminants for which the PT study was "not acceptable."

5. When DCLS becomes aware of a failure to comply with PT study requirements, DCLS shall notify the laboratory of its downgraded status within 14 days of the downgrade. DCLS shall send the notification by certified mail or an equivalent mailing service.

6. The laboratory shall correct the problems that caused the downgrade and satisfactorily analyze another PT study within three months. A laboratory may not be provisionally certified for more than three months.

7. If the result of the second makeup PT study is "acceptable," the laboratory can request DCLS in writing to restore its certified status.

8. If the result of the second makeup PT is "not acceptable," DCLS shall revoke certification for the contaminant or contaminants for which the PT study was unsuccessful.

9. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

1VAC30-41-140. Laboratory ethics and fraud detection and deterrence.

Drinking water laboratories shall meet the requirements of the Manual Supplement to Chapter III of the Manual concerning laboratory ethics and fraud detection and deterrence.

1VAC30-41-150. Onsite laboratory assessment.

A. Frequency of onsite laboratory assessments.

1. DCLS shall assess a drinking water laboratory when the laboratory owner initially applies for certification and at least once every three years after initial certification is granted.

2. DCLS may perform an onsite assessment if major changes in personnel or equipment occur at the laboratory or if the location of the laboratory changes.

3. DCLS may perform interim onsite assessments to confirm that a laboratory has carried out a corrective action plan.

4. DCLS may perform unannounced onsite assessments.

B. Action prior to a scheduled onsite assessment.

1. DCLS shall arrange a mutually agreeable date and time for the onsite assessment with the drinking water laboratory's management.

2. Prior to the onsite audit, DCLS shall request and the laboratory shall provide current records and information that are necessary to evaluate the laboratory. These records and information may include the following:

a. Quality manual.

b. Personnel list.

c. Instrument list or equipment list or both.

d. Standard operating procedure (SOP) for each method to be evaluated.

e. A data package specified by the certification officer.

f. For chemistry, the most recent method detection limit (MDL) study for each regulated contaminant to which the MDL requirement applies.

C. Opening conference. The DCLS onsite assessor or team shall begin the process of the onsite assessment by holding a conference to state the purpose of the assessment, identify the assessment team, and set out the tasks to be done during the assessment.

D. Assessment process.

1. The DCLS onsite assessment team shall evaluate laboratory personnel qualifications and training, operations, equipment, supplies, general laboratory practices, sample handling procedures, methodology, written procedures, and records. The team shall perform the assessment for those specific methods and contaminants for which the laboratory has requested certification.

2. DCLS may require a laboratory to demonstrate drinking water testing methods during the assessment.

3. The DCLS onsite assessment team shall perform a data audit on at least one sample and on one PT sample for at least one method.

4. The DCLS onsite assessment team shall discuss observed deviations at the time such deviations are observed.

5. Findings or deviations are considered preliminary until the final report is issued.

E. Closing conference.

1. The onsite assessment team shall conduct a closing conference to review the results of the assessment with laboratory staff and management.

2. The onsite assessment team shall discuss the following:

a. Any deviations in the observed procedures and records.

b. The time frame for any corrective actions needed and the response.

c. Recommendations, if necessary, for changes in equipment and supplies, staffing, and facility.

F. Notification. Within 30 calendar days after the onsite assessment, DCLS shall notify the laboratory of its certification status and send the laboratory the final onsite assessment report.

G. Final report. In its final onsite report, DCLS:

1. Shall list the certification status for each contaminant or, if applicable, each class of contaminants evaluated as determined by DCLS as a result of the onsite assessment.

2. Shall list and describe each finding, providing a reference to the underlying requirement.

3. May recommend changes to correct the problems described in the findings that have resulted in the laboratory not obtaining certification for a particular contaminant.

4. May recommend improvements to laboratory operation, recognize outstanding performance, and provide other information of use to the laboratory.

H. Results of the onsite assessment.

1. DCLS shall certify the laboratory when the onsite assessment shows that the laboratory has established or is maintaining the standards of quality required under this chapter.

2. When DCLS finds during the onsite assessment that the laboratory is not maintaining the standards of quality required under this chapter, the laboratory shall follow the procedure in subsection I of this section.

I. Procedures and requirements when findings are reported.

1. The laboratory shall respond with a corrective action plan for all findings issued in the report within 60 calendar days. This corrective action plan shall specify what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.

2. DCLS shall review the corrective action plan. If DCLS finds that any aspect of the laboratory's corrective action plan is inadequate, it shall notify the laboratory director in writing by certified mail or other equivalent mailing service of its intent to downgrade the laboratory.

3. The laboratory director shall respond within 30 calendar days with an additional corrective action plan. If the additional corrective action plan is still deficient, DCLS shall not issue a certificate for the initial application or shall downgrade the laboratory to provisionally certified status.

4. DCLS shall respond within 14 days of determining the laboratory's letter and corrective action plan are deficient.

5. The laboratory shall correct the problems cited in the initial notification letter within three months of the date the laboratory was downgraded.

6. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status.

7. DCLS shall revoke certification only for the contaminants and methods for which the laboratory was initially cited.

8. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

9. When DCLS reports a finding that had been identified in the previous triannual onsite assessment where the laboratory had not implemented corrective action, DCLS shall downgrade the laboratory to provisionally certified.

10. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

1VAC30-41-160. Levels of certification.

A. Certified. DCLS shall certify a laboratory that meets the criteria set out in this chapter.

B. Interim certification. DCLS may issue an interim certification when it finds that performing an onsite assessment is unnecessary or when the onsite assessment cannot be scheduled within a reasonable time. This may occur when DCLS reviews a laboratory application for an addition to its certification status or when a laboratory notifies DCLS that its location is changing. The laboratory shall maintain the requirements for certification while awaiting the onsite assessment. DCLS shall perform the onsite assessment as soon as possible. Interim certification status is equivalent to certified status.

C. Provisionally certified. DCLS shall provisionally certify a laboratory that has deficiencies as a preliminary stage prior to revocation. A provisionally certified laboratory may continue to analyze drinking water samples for compliance purposes. The laboratory shall notify its clients of the downgraded status in writing and indicate the status on reports. A laboratory may not be provisionally certified for more than three months.

D. Not certified. DCLS shall not certify a laboratory that possesses deficiencies and, in the opinion of DCLS, cannot consistently produce valid data. A laboratory that has had its certification revoked in whole or in part shall notify its clients of its revoked status in writing.

1VAC30-41-170. Term of certification.

DCLS shall certify drinking water laboratories for a period of one year.

1VAC30-41-180. Maintenance of certified status.

To maintain its certified status, a laboratory shall:

1. Continue to meet the requirements for certification listed in 1VAC30-41-80.

2. Successfully pass water supply proficiency testing studies annually as required by 1VAC30-41-130.

3. Notify DCLS in writing within 30 calendar days of major changes in personnel, equipment, or laboratory location as specified in 1VAC30-41-200.

4. Use approved methodology as required by this chapter and incorporated by reference into 1VAC30-41-55.

5. Comply with the reporting requirements specified in 1VAC30-41-190.

1VAC30-41-190. Reporting requirements.

A. To maintain certification, drinking water laboratories shall comply with the reporting requirements [ for compliance, monitoring, and exceedances ] set out in the VDH-ODW regulations [ specified as follows:

1. Compliance, monitoring, and exceedances, 12VAC5-590-530.

2. Public notices, 12VAC5-590-540 in 12VAC5-590-530 ].

B. Drinking water laboratories shall report the results of analyses to the VDH-ODW within three days of completion unless 12VAC5-590-530 [ or 12VAC5-590-540 ] requires a different time limit.

1VAC30-41-200. Major changes in personnel or equipment or a change of laboratory location.

A. Major change in personnel.

1. The drinking water laboratory shall notify DCLS of a major change in the laboratory's personnel in writing within 30 calendar days of the change.

2. A "major change in personnel" is defined as (i) the loss or replacement of the laboratory director or laboratory supervisor or (ii) the loss of all the trained and experienced analysts who had been available to analyze a particular contaminant for which certification has been granted.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of a major change in personnel.

B. Change of laboratory location.

1. The laboratory shall notify DCLS of a change in the laboratory's location in writing at least 30 calendar days prior to the location change.

2. DCLS may perform an onsite assessment of the new facility when a laboratory changes location.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS of a change in the laboratory's location at least 30 days prior to the location change.

C. Equipment.

1. A drinking water laboratory shall notify DCLS in writing within 30 calendar days of a major change in equipment.

2. A drinking water laboratory shall provide the following information to DCLS about new equipment:

a. Make and model of the new instrument.

b. Date of installation and training.

c. Initial demonstration of capability (IDC) and minimum detection limit (MDL).

d. Updated standard operating procedure (SOP).

e. Methods and contaminants for which the instrument will be used.

f. Successful proficiency testing analyzed on the new instrument.

g. Date the instrument was put into service analyzing compliance samples.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of any major change in equipment.

D. Laboratory action to address major changes to personnel or equipment or a change of location.

1. When a major change to laboratory personnel or equipment or a change of location occurs, the laboratory shall establish a schedule to address the change and provide the schedule in writing to DCLS. The laboratory shall submit the schedule to DCLS along with the notification of the change.

2. If DCLS determines that the laboratory can no longer produce valid data because of the major change in personnel or equipment or the change of location, DCLS shall follow the procedure in 1VAC30-41-240 to revoke certification for the contaminants in question.

1VAC30-41-210. Downgrading to provisionally certified status.

DCLS shall downgrade a certified drinking water laboratory's status to provisionally certified for each contaminant and by each method for any of the following reasons:

1. Failure to analyze a PT sample each calendar year during the period defined by DCLS and within the acceptance limits specified in the regulations incorporated by reference in 1VAC30-41-55.

2. Failure to successfully analyze a PT sample for a contaminant after participating in two successive PT studies.

3. Failure to notify DCLS within 30 calendar days of major changes in personnel or equipment or a change in laboratory location as required by 1VAC30-41-200.

4. Failure to satisfy DCLS that the laboratory is maintaining the required standard of quality based upon the onsite assessment requirements in 1VAC30-41-150.

5. Failure to comply with the reporting requirements of 1VAC30-41-190 in a timely manner.

1VAC30-41-220. Procedure to downgrade to provisionally certified status.

A. DCLS shall notify the laboratory director in writing that DCLS intends to downgrade the laboratory to provisionally certified status. DCLS shall send this notification within 14 days of becoming aware of the cause for the downgrade. DCLS shall send the notification by certified mail or other equivalent mailing service.

B. The laboratory director shall review the problems cited in the notice. Within 30 days of receiving the notice, the laboratory director shall send DCLS a letter specifying what immediate corrective actions are being taken and any proposed action that needs the concurrence of DCLS.

C. DCLS shall consider the adequacy of the laboratory's response and notify the laboratory director in writing by certified mail or other equivalent mailing service of the laboratory's certification status. DCLS shall respond within 14 days of receiving the laboratory's letter and corrective action plan.

D. The laboratory shall correct the problems cited in the initial notification letter from DCLS within three months of the date of the DCLS response to the laboratory's corrective action plan.

E. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status. This revocation shall apply only to the contaminants and methods for which the laboratory was initially cited in the DCLS downgrade notification.

F. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

G. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

1VAC30-41-230. Revocation of certified status.

DCLS shall downgrade a drinking water laboratory's status to not certified from certified or provisionally certified or interim certified status for each contaminant and by each method for any of the following reasons:

1. Falsification of data or use of other deceptive practices.

2. Reporting proficiency testing data from another laboratory as its own.

3. Failure to use the federally-approved methods incorporated by reference into this chapter at 1VAC30-41-55.

4. Refusal to participate in an onsite assessment conducted by DCLS.

5. Failure to pay the annual fee to DCLS.

6. For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the specified acceptance limits.

7. For provisionally certified laboratories, failure to satisfy DCLS that the laboratory has corrected identified deficiencies based on an onsite assessment.

8. For provisionally certified laboratories, persistent failure to comply with the reporting requirements specified in 1VAC30-41-190.

1VAC30-41-240. Procedure to revoke certification.

A. DCLS shall notify the laboratory owner in writing of its intent to revoke certification. DCLS shall describe in detail the reasons and circumstances that form the basis for revoking certified status in this notice. DCLS shall send the notification by certified mail or an equivalent mailing service.

B. DCLS shall provide an opportunity for an informal fact-finding conference pursuant to § 2.2-4019 of the Code of Virginia prior to making a final decision to revoke certification.

C. A drinking water laboratory that has had its certification revoked for methods and contaminants under the methods shall do the following:

1. Stop analyzing SDWA compliance samples for these contaminants and methods.

2. Send the samples to a laboratory that is certified to perform the analyses.

3. Notify its clients of its revoked status in writing.

1VAC30-41-250. Appeal procedure.

A laboratory may appeal a final decision to revoke certification by DCLS pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

1VAC30-41-260. Reinstatement of certification.

A. A drinking water laboratory may request in writing to have its certification status upgraded or reinstated.

B. DCLS shall upgrade or reinstate certification when the laboratory can demonstrate that it has corrected the deficiencies that produced the downgrading or revocation of certified status.

C. DCLS may require an onsite assessment or successful completion of a water supply proficiency testing study or both before upgrading or reinstating a drinking water laboratory. If the onsite assessment is necessary, the laboratory shall pay the fees set out in 1VAC30-41-270 H.

1VAC30-41-270. Fees.

A. DCLS shall charge a fee to certify drinking water laboratories. This fee shall be limited to the cost of administering the certification program.

B. Required fees.

1. Drinking water laboratories shall submit payment of the fee with the initial applications for certification.

2. Drinking water laboratories located out-of-state and applying for reciprocal certification shall submit payment of the fee with the initial applications.

3. Once certified under this chapter, drinking water laboratories shall pay the fee annually. DCLS shall send an invoice to the certified drinking water laboratory.

4. Additional fees may apply under subsection K of this section when changes to the laboratory's certification require DCLS staff time to administer the change.

C. DCLS shall not consider an application to be complete until the applicant laboratory submits payment of the certification fee.

D. All incomplete payments shall be deemed as nonpayment. Nonpayment of fees shall result in denial or revocation of certification.

E. Payment of fees shall be nonrefundable.

F. DCLS, under 1VAC30-41-230, may revoke the certification of any certified laboratory that does not pay its annual fee.

G. Fee computation.

1. Fees for certification of drinking water laboratories shall be applied on an annual basis.

2. Drinking water laboratories shall pay the total of the base year fees as required by subsections H and J of this section for the first 12 months following [ [insert the effective date of this chapter] May 1, 2014 ].

3. Beginning [ [insert the thirteenth month following the effective date of this chapter] May 1, 2015 ], drinking water laboratories shall pay the total of the base year fees required by subsection H and Table 1 of subsection J of this section as adjusted by the method set out in subsection I of this section.

H. Calculation of fees - base year fees [ [insert year of the effective date of this chapter] May 1, 2014 - April 30, 2015 ].

1. DCLS charges a fee for the review and certification of the drinking water laboratory's quality system. This includes a review of the test methods for which the drinking water laboratory requests or holds certification. The fees are based on the number of test methods for which the laboratory would be certified within each of the six testing categories set out in Table 1 of subsection J of this section.

2. DCLS shall calculate a laboratory's fees by adding the fees for the number of test methods in each category as set out in Table 1 of subsection J of this section for which the laboratory applies or is certified.

3. For example, a laboratory may be certified for three microbiological methods ($700); five inorganic chemistry, nonmetals methods ($850); two inorganic chemistry, metals methods ($1000); and two organic chemistry methods ($1050). The total annual fee would be $3600.

I. Calculation of fees - fees beginning [ [insert the thirteenth month following the effective date of this chapter] May 1, 2015 ].

1. DCLS shall revise the base year fees after the first 12 months following [ the effective date of this chapter May 1, 2014, ] and every 12-month period thereafter.

2. DCLS shall increase or decrease the fees set out in Table 1 of subsection J of this section using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year. (The CPI-U for all urban consumers is published by the U.S. Department of Labor, Bureau of Labor Statistics.)

3. DCLS shall revise each previous year's Table 1 of subsection J of this section so that the revisions will be cumulative, reflecting the changes in the CPI-U over time.

4. DCLS shall round the revised fees to the nearest whole dollar.

5. DCLS shall publish the revised fee table annually on its website for drinking water laboratory certification. This website can be found by going to the DCLS page of the Department of General Services' website at http://dgs.virginia.gov.

J. Fee tables.

1. Fees are calculated using the base year fees in Table 1.

2. Table 2 shows the relationship between the testing categories for fees and the drinking water laboratory certification categories.

K. Additional fees.

1. An additional fee shall be charged to a laboratory:

a. Applying for modification of certification under 1VAC30-41-110.

b. Moving its location when the move requires DCLS to perform an onsite assessment.

c. Requesting reinstatement of certification when DCLS requires an onsite assessment.

2. The fee charged shall be the sum of the total hourly charges for all reviewers plus any onsite assessment cost incurred.

a. An hourly charge per reviewer shall be $61 as of [ [insert the effective date of this chapter] May 1, 2014 ]. DCLS shall revise the hourly charge after the first 12 months following [ [insert the effective date of this chapter] May 1, 2014, ] and every 12-month period thereafter. The hourly charge shall increase or decrease using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year.

b. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

c. If an onsite review is required, travel time and onsite review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

L. Method of payment. Fees shall be paid by check, draft, or postal money order payable to the Treasurer, Commonwealth of Virginia, or submitted electronically, if available, and must be in U.S. currency, except that agencies and institutions of the Commonwealth of Virginia may submit interagency transfers for the amount of the fee. All fees shall be sent to the following address, or submitted electronically, if available: DCLS, Attn: Lab Certification, 600 North 5th Street, Richmond, VA 23219. Laboratories may also pay fees using credit cards. Laboratories shall fill out the DCLS Fee Payment Form for Virginia Laboratory Certification Programs and send the completed form with the fee.

1VAC30-41-280. (Reserved).

1VAC30-41-290. (Reserved).

Part III
Chemistry

1VAC30-41-300. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter IV, Section 1 of the Manual.

1VAC30-41-310. Laboratory facilities.

Drinking water laboratories shall meet the requirements of Chapter IV, Section 2 of the Manual.

1VAC30-41-320. Laboratory equipment and instrumentation.

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 3 of the Manual.

1VAC30-41-330. General laboratory practices.

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 4 of the Manual with the exception of Table IV-1.

1VAC30-41-340. Analytical methodology.

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Laboratories shall meet the requirements of Chapter IV, Section 5.1 of the Manual with the exception of Tables IV-2 through IV-5 [ and Table IV-11 ].

C. A drinking water laboratory shall perform a minimum of five water analyses monthly for each chemical contaminant for which the laboratory is certified in order to maintain certification status or qualify for initial certification.

D. Exceptions to laboratory certification requirements of 1VAC30-41-20 B 2.

1. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

2. This testing shall be performed using approved sampling and analytical methodology as incorporated by reference into 1VAC30-41-55 C.

3. Laboratories performing this testing shall meet the requirements of Chapter IV, Section 5.2 of the Manual, with the exception of Tables IV-2 through IV-5.

1VAC30-41-350. Sample collection, handling, and preservation.

A. Drinking water laboratories shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 6 of the Manual with the exception of Table IV-6, and the Manual Supplement to Chapter IV, Section 6 of the Manual.

C. Drinking water laboratories shall reject any sample not meeting the criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

1VAC30-41-360. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of [ both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include ] the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 of the Manual.

3. Chapter IV, Section 7 of the Manual with the exception of Tables IV-7 through IV-10.

4. The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-370. Recordkeeping and data reporting.

Drinking water laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter IV, Section 8 of the Manual.

1VAC30-41-380. Action response to laboratory results.

Drinking water laboratories shall meet the action response requirement of Chapter IV, Section 9 of the Manual and the requirements of 1VAC30-41-190.

1VAC30-41-390. (Reserved).

Part IV
Microbiology

1VAC30-41-400. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter V, Section 1 of the Manual.

1VAC30-41-410. Laboratory facilities.

A. Drinking water laboratories shall meet the requirements of Chapter V, Section 2 of the Manual.

B. The laboratory facilities shall include sufficient space to process and examine samples proportionate with the total work load.

C. The laboratory shall have provisions for decontamination and disposal of microbiological waste.

D. Office areas for clerical work and recordkeeping shall be segregated from laboratory work areas.

1VAC30-41-420. Laboratory equipment and supplies.

Drinking water laboratories shall meet the following requirements:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 3 of the Manual.

1VAC30-41-430. General laboratory practices.

Drinking water laboratories shall meet general laboratory practices of the following:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 4 of the Manual.

1VAC30-41-440. Analytical methodology.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements incorporated by reference into 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Drinking water laboratories shall meet the requirements of Chapter V, Section 5 of the Manual and the Manual Supplement to Chapter V, Section 5 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. A drinking water laboratory shall perform a minimum of 20 coliform analyses monthly by each coliform method for which it is certified in order to maintain certification status or qualify for initial certification. The minimum number of coliform analyses (20) may be performed on a variety of water sample types collected from different stages of the water treatment process, raw source water, and surface or ground water, as well as drinking water samples collected from a distribution system or private wells.

1VAC30-41-450. Sample collection, handling, and preservation.

A. Laboratories that perform sampling shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Laboratories that perform sampling shall meet the requirements of Chapter V, Section 6 of the Manual and the Manual Supplement to Chapter V, Section 6 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. Drinking water laboratories shall reject any sample not meeting the sampling criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

1VAC30-41-460. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of [ both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include ] the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 and Chapter V, Section 7 of the Manual.

3. The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-470. Recordkeeping and data reporting.

Laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter V, Section 8 of the Manual.

1VAC30-41-480. Action response to laboratory results.

Drinking water laboratories shall meet the requirements of Chapter V, Section 9 of the Manual and the requirements of 1VAC30-41-190.

1VAC30-41-490. (Reserved).

Part V
Radiochemistry

1VAC30-41-500. Radiochemistry.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements [ including the quality assurance and quality control requirements ] incorporated by reference into 1VAC30-41-55 for radiochemistry and alternative testing methods for radiochemistry.

B. Drinking water laboratories shall meet the requirements of Chapters III and VI of the Manual as follows:

1. Personnel: Chapter III, Section 10 and Chapter VI, Section 1.

2. Laboratory facilities: Chapter VI, Section 2.

3. Laboratory equipment and instrumentation: Chapter VI, Section 3.

4. General laboratory practices: Chapter VI, Section 4.

5. Analytical methods: Chapter VI, Section 5, with the exception of Table VI-1.

6. Sample collection, handling, and preservation: Chapter VI, Section 6, with the exception of Table VI-2.

7. Quality assurance: Chapter III, Section 11 and Chapter VI, Section 7.

8. Recordkeeping and data reporting: Chapter VI, Section 8.

9. Action response to laboratory results: Chapter VI, Section 9 and the requirements of 1VAC30-41-190.

FORMS (1VAC30-41)

Application for Virginia Certification Safe Drinking Water Program, DGS-21-109 (rev. 5/30/13)

Fee Payment Form for Virginia Laboratory Certification Programs, DGS-35-232 (rev. 1/14/11)

DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-41)

Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, January 2005 (EPA-815-R-05-004)

[ Chapters I through IV

Chapters V and VI

Appendices ]

Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, June 2008 (EPA 815-F-08-006)

Titles of Regulations: 1VAC30-40. Regulations for the Certification of Laboratories Analyzing Drinking Water (repealing 1VAC30-40-10 through 1VAC30-40-370).

1VAC30-41. Regulation for the Certification of Laboratories Analyzing Drinking Water (adding 1VAC30-41-10 through 1VAC30-41-500).

Statutory Authority: §§ 2.2-1102 and 2.2-1105 of the Code of Virginia; 42 USC § 300f et seq.

Effective Date: May 1, 2014.

Agency Contact: Rhonda Bishton, Regulatory Coordinator, Department of General Services, 1100 Bank Street, Suite 420, Richmond, VA 23219, telephone (804) 786-3311, FAX (804) 371-8305, or email rhonda.bishton@dgs.virginia.gov.

Summary:

This regulatory action (i) updates the drinking water laboratory certification regulation to incorporate by reference the most recent Environmental Protection Agency (EPA) approved test methods and laboratory-specific requirements in the EPA's Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition (January 2005), Supplement 1 to the Fifth Edition (June 2008) and Code of Regulations (July 1, 2013); (ii) revises the fee provisions and requires local, state, and federal public laboratories, as well as private or commercial laboratories, to pay fees for certification; (iii) adds an alternative for drinking water laboratories to obtain certification by meeting the requirements of 1VAC30-46, Accreditation for Commercial Environmental Laboratories, as an alternative to meeting the drinking water laboratory certification regulation; and (iv) repeals existing regulation 1VAC30-40 and replaces it with new regulation 1VAC30-41, which sets out the requirements to certify laboratories that analyze drinking water samples and determine compliance with federal Safe Drinking Water Act (SDWA) contaminant limits.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

CHAPTER 41
REGULATION FOR THE CERTIFICATION OF LABORATORIES ANALYZING DRINKING WATER

Part I
General Provisions

1VAC30-41-10. Purpose.

A. This chapter establishes the requirements for certification of drinking water laboratories.

B. The federal Safe Drinking Water Act (SDWA) mandates the establishment of a national drinking water program to protect public health. The U.S. Environmental Protection Agency (EPA) at 40 CFR 141.28 requires that laboratories be certified to analyze samples of drinking water for compliance purposes. EPA at 40 CFR 142.10(b)(3)(i) requires states to establish and maintain programs for the certification of drinking water laboratories.

C. The Virginia Department of Health, Office of Drinking Water (VDH-ODW) maintains primary enforcement responsibility (primacy) under the SDWA and the federal SDWA regulations for the Commonwealth of Virginia. The VDH-ODW at 12VAC5-590-340 requires that all analyses done to demonstrate compliance with primary and secondary maximum contaminant levels or action levels be performed by the Division of Consolidated Laboratory Services of the Department of General Services (DCLS) or by laboratories certified by DCLS. VDH-ODW at 12VAC5-590-440 further requires that laboratories seeking certification to perform drinking water analyses shall comply with this chapter.

1VAC30-41-20. Applicability.

A. This chapter applies to the following:

1. Owners of drinking water laboratories in Virginia.

2. Owners of drinking water laboratories located outside Virginia who seek reciprocal certification under 1VAC30-41-90.

B. Covered contaminants.

1. This chapter covers the contaminants regulated in 40 CFR Parts 141 and 143 as specified in 12VAC5-590, Waterworks Regulations, of the Virginia Department of Health.

2. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

1VAC30-41-30. Alternative certification for drinking water laboratories.

Drinking water laboratories may become certified by meeting the requirements for accreditation set out in 1VAC30-46.

1VAC30-41-40. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context [ already clearly ] indicates otherwise:

"Analyst" means a chemist, microbiologist, physicist, or technician who actually performs a test. The analyst may carry out the complete test or participate jointly with other analysts.

"Certification officer" means a DCLS employee who has the responsibility for evaluating drinking water laboratories for certification.

"Contaminant" means any objectionable or hazardous physical, chemical, biological, or radiological substance or matter in water. Contaminants are the analytes for which drinking water laboratories test in the drinking water samples they analyze.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Drinking water laboratory" or "laboratory" means a laboratory that performs analyses to demonstrate compliance with primary or secondary maximum contaminant levels or action levels or any combination of these specified in 12VAC5-590.

"EPA" means the United States Environmental Protection Agency.

"Findings" means factual, objective statements that provide evidence of deficiencies in meeting the requirements of this chapter.

"Laboratory director" or "laboratory supervisor" means the person who directs the operation of the drinking water laboratory on a day-to-day basis.

"Manual" means the EPA Office of Water, Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

"Manual Supplement" means the EPA Office of Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

"Maximum contaminant level" or "MCL" means the maximum permissible level of a contaminant in [ pure ] water that is delivered to any user of a waterworks [ , except in the cases of turbidity and volatile organic compounds (VOCs), where the maximum permissible level is measured at each entry point to the distribution system. Contaminants added to the water under circumstances controlled by the user, except those resulting from corrosion of piping and plumbing caused by water quality, are excluded from this definition. MCLs are set as close to the MCLGs as feasible using the best available treatment technology. ] Maximum contaminant levels may be either "primary" (PMCL), meaning based on health considerations, or "secondary" (SMCL), meaning based on aesthetic considerations.

[ "Maximum contaminant level goal" or "MCLG" means the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

"National Environmental Laboratory Accreditation Program" or "NELAP" means the national program to establish and implement a program for the accreditation of environmental laboratories. NELAP relies on consensus standards representing the best professional practices in the industry to establish the requirements for this program, which is then implemented by state agencies recognized by the NELAC Institute (TNI) as accreditation bodies. ]

"Owner" means any person who owns, operates, leases, or controls a drinking water laboratory.

"Persistent" means to continue an activity without change in spite of opposition or warning.

"Private laboratory" means a laboratory that is, or is part of, a commercial entity.

"Proficiency testing sample" or "PT sample" means a sample, the composition of which is unknown to both the analyst and the laboratory. The PT sample tests whether the analyst or laboratory or both can produce analytical results within specified acceptance criteria.

"Public laboratory" means a laboratory that is, or is part of, a local, state, or U.S. governmental agency.

[ "Pure water" means water fit for human consumption and domestic use that is sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts for domestic usage in the area served and normally adequate in quantity and quality for the minimum health requirements of the persons served (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia). ]

"Quality assurance" means an integrated system of management activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.

"Quality assurance plan" or "QA plan" means a comprehensive plan detailing the aspects of quality assurance needed to adequately fulfill the data needs of a program.

"Quality control" means:

1. The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of the users.

2. The operational techniques and activities that are used to fulfill requirements for quality.

"SDWA" means the Safe Drinking Water Act (42 USC § 300f et seq.).

"VDH-ODW" means the Virginia Department of Health - Office of Drinking Water.

1VAC30-41-50. Incorporation by reference - EPA guidance documents.

A. The following EPA guidance documents are incorporated by reference into this chapter:

1. Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

2. Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

B. The federal regulatory requirements incorporated by reference into 1VAC30-41-55 shall govern if a conflict is found between the requirements of the Manual or the Manual Supplement and the requirements incorporated by reference into 1VAC30-41-55.

1VAC30-41-55. Incorporation by reference - Code of Federal Regulations.

A. The sampling, analytical methodology, and laboratory certification requirements of 40 CFR 141 and 143 in effect as of July 1, [ 2011 2013 ], are incorporated by reference into this chapter.

B. The specific sampling, analytical methodology, and laboratory certification requirements incorporated by reference are listed as follows by category for information purposes:

1. Inorganic chemistry: 40 CFR 141.23, 40 CFR 141.89, and 40 CFR 141.131.

2. Organic chemistry: 40 CFR 141.24 and 40 CFR 141.131.

3. Microbiology: 40 CFR 141.21, 40 CFR 141.74, 40 CFR 141.174, [ 40 CFR 141.402(c)(2), ] 40 CFR 141.704, and 40 CFR 141.705. 40 CFR 136.3(a) for E. coli requirements under 40 CFR 141.704.

4. Radiochemistry: 40 CFR 141.25.

5. Alternative testing methods: 40 CFR Part 141, Subpart C, Appendix A.

6. Test methods specified for secondary maximum contaminant levels: 40 CFR 143.4.

C. The exceptions to the requirements for laboratory certification in 40 CFR 141.28, 40 CFR 141.74(a), 40 CFR 141.89(a)(1), 40 CFR 141.131(b)(3), and 40 CFR 141.131(c)(3) are incorporated by reference into this chapter.

Part II
Certification of Laboratories - General Requirements

1VAC30-41-60. Categories of certification.

A. Laboratories may apply to be certified for inorganic chemistry, organic chemistry, microbiology, radiochemistry, or any combination of these four categories of certification.

B. Within each category, laboratories may be certified for specific contaminants or contaminant groups and for one or more methods used to determine the levels of these contaminants.

1VAC30-41-70. Initial certification application.

A. Application for initial certification. Drinking water laboratories applying under this chapter shall submit a completed Application for Certification, obtained by contacting the DCLS Laboratory Certification Office. A complete application contains:

1. Specific laboratory information, including name of organization, name of laboratory director, and contact information.

2. Identification of public water systems served by the laboratory.

3. Identification of the drinking water certification contaminants or contaminant groups and related methods for which the laboratory requests certification.

4. A quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2 as required by 1VAC30-41-120.

5. A satisfactory report of at least one proficiency test performed within the last 12 months for each method and contaminant for which the laboratory seeks certification.

6. Laboratory personnel list.

7. Requested laboratory data, including at a minimum:

a. For microbiology applications:

(1) Equipment and supply list.

(2) Sampling information and test results for at least 20 analyses for each method and contaminant for which the laboratory seeks certification.

b. For chemistry applications:

(1) Instrumentation and equipment list.

(2) Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

c. For radiochemistry applications:

(1) Instrumentation and equipment list.

(2) Minimum detectable activity (MDA) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3) Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

8. Payment of the fee required by 1VAC30-41-270.

B. DCLS review of application submittal.

1. DCLS shall administratively review the application submittal and respond to the applicant laboratory within 60 calendar days.

2. If DCLS finds that the application submittal is complete, a certification officer shall arrange a mutually agreeable time and date with the laboratory for an onsite assessment.

3. If DCLS finds that the application submittal is incomplete, a certification officer shall request the applicant laboratory to submit the additional information or documentation required within 90 days.

4. If the laboratory has not submitted the required additional information within 90 days of the DCLS request for information, DCLS may return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

1VAC30-41-80. Certification requirements.

To become certified, a laboratory shall meet or successfully complete the following:

1. Requirements for a quality assurance plan in 1VAC30-41-120.

2. Analysis of a proficiency testing sample for each contaminant and each method for which certification is sought. Proficiency testing requirements are set out in 1VAC30-41-130.

3. Specific requirements for chemistry, microbiology, or radiochemistry that are pertinent to the specific laboratory's application for certification. These requirements are set out in Part III (1VAC30-41-300 et seq.) through Part V (1VAC30-41-500) of this chapter.

4. Onsite assessment by DCLS certification officers at least once every three years. Onsite assessment requirements are set out in 1VAC30-41-150.

5. The laboratory ethics and fraud detection and deterrence requirements set out in 1VAC30-41-140.

6. Payment of the fee required by 1VAC30-41-270.

1VAC30-41-90. Reciprocity.

A. DCLS may grant reciprocal certification to a drinking water laboratory located outside Virginia, provided the laboratory demonstrates the need to serve customers in Virginia and is certified by EPA or another state under equivalent certification criteria.

B. To be considered for certification, the applicant laboratory shall send DCLS the following:

1. A copy of the certificate and scope of certification issued by the laboratory's primary certifying or accrediting authority.

2. A list of the methods and the contaminants tested under each method for which the laboratory is requesting certification.

3. The most recent proficiency testing report for each method and contaminant combination listed by the laboratory under subdivision 2 of this subsection.

4. The fee required under 1VAC30-41-270.

5. Confirmation that [ Virginia has been added to the proficiency testing provider's list of certifying authorities to whom the laboratory's proficiency testing the laboratory's proficiency test provider includes DCLS as a certifying authority to which the laboratory's proficiency test ] results will be reported.

C. Out-of-state laboratories holding National Environmental Laboratory Accreditation [ Conference (NELAC) Program (NELAP) ] accreditation for drinking water that seek reciprocal accreditation for drinking water in Virginia shall apply for that accreditation under 1VAC30-46.

1VAC30-41-100. Renewal of certification.

DCLS shall renew the certification for a drinking water laboratory if the laboratory maintains its certified status as required by 1VAC30-41-180, and pays the annual fee as required by 1VAC30-41-270.

1VAC30-41-110. Modification of certification.

A. To request the addition of contaminants or methods to its certification, the drinking water laboratory shall submit the following to DCLS:

1. A completed DCLS drinking water certification application form.

2. An acceptable proficiency testing report for each requested method and contaminant, performed within the last 12 months.

3. The standard operating procedures for the requested methods.

4. The current quality assurance plan, if requested.

5. For chemistry:

a. Method detection limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

b. Initial demonstration of capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

6. For microbiology, sampling information and test results for at least 20 analyses by the requested method and contaminant combination.

7. Applicable fees as required by 1VAC30-41-270.

B. To drop a contaminant or a method from the laboratory's certification, the laboratory shall submit a request in writing to the DCLS Laboratory Certification Office.

1VAC30-41-120. Quality assurance plan.

A drinking water laboratory shall develop and maintain a quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2.

1VAC30-41-130. Proficiency testing.

A. A drinking water laboratory shall meet the following requirements pertaining to proficiency testing (PT):

1. The requirements of this section.

2. The requirements of Chapter III, Section 13.1 of the Manual.

3. The specific requirements of the Manual for chemistry in Chapter IV, Section 7.2.1; for microbiology in Chapter V, Section 7.2; and for radiochemistry in Chapter VI, Section 7.4 that are pertinent to the laboratory.

[ 4. Proficiency testing requirements incorporated by reference in 1VAC30-41-55. ]

B. A drinking water laboratory shall successfully participate in at least one water supply (WS) PT study per calendar year for each contaminant and by each method for which the laboratory seeks or wants to maintain certification.

C. Drinking water laboratories shall obtain WS PT studies from PT providers approved by the American Association for Laboratory Accreditation utilizing the National Standards for Water Proficiency Testing Studies.

D. Drinking water laboratories shall instruct the PT providers to send the results of the WS PT studies to the DCLS Laboratory Certification Office.

E. WS PT study results.

1. DCLS shall certify or maintain certification for a drinking water laboratory for which WS PT study results are reported by the proficiency test provider as "acceptable."

2. A drinking water laboratory for which some or all WS PT study results are reported as "not acceptable" shall follow the procedure in subsection F of this section.

F. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall perform and document corrective action. The corrective action documentation shall be submitted to DCLS within 30 days of receiving the "not acceptable" PT study result.

2. Upon completion of the corrective action, the laboratory shall perform another PT study for each contaminant that had a "not acceptable" initial PT study result.

3. If the result of the laboratory's makeup PT study is "acceptable," DCLS shall not downgrade the laboratory.

4. If the laboratory fails the makeup PT study, DCLS shall downgrade the laboratory to provisionally certified status for the contaminant or contaminants for which the PT study was "not acceptable."

5. When DCLS becomes aware of a failure to comply with PT study requirements, DCLS shall notify the laboratory of its downgraded status within 14 days of the downgrade. DCLS shall send the notification by certified mail or an equivalent mailing service.

6. The laboratory shall correct the problems that caused the downgrade and satisfactorily analyze another PT study within three months. A laboratory may not be provisionally certified for more than three months.

7. If the result of the second makeup PT study is "acceptable," the laboratory can request DCLS in writing to restore its certified status.

8. If the result of the second makeup PT is "not acceptable," DCLS shall revoke certification for the contaminant or contaminants for which the PT study was unsuccessful.

9. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

1VAC30-41-140. Laboratory ethics and fraud detection and deterrence.

Drinking water laboratories shall meet the requirements of the Manual Supplement to Chapter III of the Manual concerning laboratory ethics and fraud detection and deterrence.

1VAC30-41-150. Onsite laboratory assessment.

A. Frequency of onsite laboratory assessments.

1. DCLS shall assess a drinking water laboratory when the laboratory owner initially applies for certification and at least once every three years after initial certification is granted.

2. DCLS may perform an onsite assessment if major changes in personnel or equipment occur at the laboratory or if the location of the laboratory changes.

3. DCLS may perform interim onsite assessments to confirm that a laboratory has carried out a corrective action plan.

4. DCLS may perform unannounced onsite assessments.

B. Action prior to a scheduled onsite assessment.

1. DCLS shall arrange a mutually agreeable date and time for the onsite assessment with the drinking water laboratory's management.

2. Prior to the onsite audit, DCLS shall request and the laboratory shall provide current records and information that are necessary to evaluate the laboratory. These records and information may include the following:

a. Quality manual.

b. Personnel list.

c. Instrument list or equipment list or both.

d. Standard operating procedure (SOP) for each method to be evaluated.

e. A data package specified by the certification officer.

f. For chemistry, the most recent method detection limit (MDL) study for each regulated contaminant to which the MDL requirement applies.

C. Opening conference. The DCLS onsite assessor or team shall begin the process of the onsite assessment by holding a conference to state the purpose of the assessment, identify the assessment team, and set out the tasks to be done during the assessment.

D. Assessment process.

1. The DCLS onsite assessment team shall evaluate laboratory personnel qualifications and training, operations, equipment, supplies, general laboratory practices, sample handling procedures, methodology, written procedures, and records. The team shall perform the assessment for those specific methods and contaminants for which the laboratory has requested certification.

2. DCLS may require a laboratory to demonstrate drinking water testing methods during the assessment.

3. The DCLS onsite assessment team shall perform a data audit on at least one sample and on one PT sample for at least one method.

4. The DCLS onsite assessment team shall discuss observed deviations at the time such deviations are observed.

5. Findings or deviations are considered preliminary until the final report is issued.

E. Closing conference.

1. The onsite assessment team shall conduct a closing conference to review the results of the assessment with laboratory staff and management.

2. The onsite assessment team shall discuss the following:

a. Any deviations in the observed procedures and records.

b. The time frame for any corrective actions needed and the response.

c. Recommendations, if necessary, for changes in equipment and supplies, staffing, and facility.

F. Notification. Within 30 calendar days after the onsite assessment, DCLS shall notify the laboratory of its certification status and send the laboratory the final onsite assessment report.

G. Final report. In its final onsite report, DCLS:

1. Shall list the certification status for each contaminant or, if applicable, each class of contaminants evaluated as determined by DCLS as a result of the onsite assessment.

2. Shall list and describe each finding, providing a reference to the underlying requirement.

3. May recommend changes to correct the problems described in the findings that have resulted in the laboratory not obtaining certification for a particular contaminant.

4. May recommend improvements to laboratory operation, recognize outstanding performance, and provide other information of use to the laboratory.

H. Results of the onsite assessment.

1. DCLS shall certify the laboratory when the onsite assessment shows that the laboratory has established or is maintaining the standards of quality required under this chapter.

2. When DCLS finds during the onsite assessment that the laboratory is not maintaining the standards of quality required under this chapter, the laboratory shall follow the procedure in subsection I of this section.

I. Procedures and requirements when findings are reported.

1. The laboratory shall respond with a corrective action plan for all findings issued in the report within 60 calendar days. This corrective action plan shall specify what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.

2. DCLS shall review the corrective action plan. If DCLS finds that any aspect of the laboratory's corrective action plan is inadequate, it shall notify the laboratory director in writing by certified mail or other equivalent mailing service of its intent to downgrade the laboratory.

3. The laboratory director shall respond within 30 calendar days with an additional corrective action plan. If the additional corrective action plan is still deficient, DCLS shall not issue a certificate for the initial application or shall downgrade the laboratory to provisionally certified status.

4. DCLS shall respond within 14 days of determining the laboratory's letter and corrective action plan are deficient.

5. The laboratory shall correct the problems cited in the initial notification letter within three months of the date the laboratory was downgraded.

6. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status.

7. DCLS shall revoke certification only for the contaminants and methods for which the laboratory was initially cited.

8. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

9. When DCLS reports a finding that had been identified in the previous triannual onsite assessment where the laboratory had not implemented corrective action, DCLS shall downgrade the laboratory to provisionally certified.

10. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

1VAC30-41-160. Levels of certification.

A. Certified. DCLS shall certify a laboratory that meets the criteria set out in this chapter.

B. Interim certification. DCLS may issue an interim certification when it finds that performing an onsite assessment is unnecessary or when the onsite assessment cannot be scheduled within a reasonable time. This may occur when DCLS reviews a laboratory application for an addition to its certification status or when a laboratory notifies DCLS that its location is changing. The laboratory shall maintain the requirements for certification while awaiting the onsite assessment. DCLS shall perform the onsite assessment as soon as possible. Interim certification status is equivalent to certified status.

C. Provisionally certified. DCLS shall provisionally certify a laboratory that has deficiencies as a preliminary stage prior to revocation. A provisionally certified laboratory may continue to analyze drinking water samples for compliance purposes. The laboratory shall notify its clients of the downgraded status in writing and indicate the status on reports. A laboratory may not be provisionally certified for more than three months.

D. Not certified. DCLS shall not certify a laboratory that possesses deficiencies and, in the opinion of DCLS, cannot consistently produce valid data. A laboratory that has had its certification revoked in whole or in part shall notify its clients of its revoked status in writing.

1VAC30-41-170. Term of certification.

DCLS shall certify drinking water laboratories for a period of one year.

1VAC30-41-180. Maintenance of certified status.

To maintain its certified status, a laboratory shall:

1. Continue to meet the requirements for certification listed in 1VAC30-41-80.

2. Successfully pass water supply proficiency testing studies annually as required by 1VAC30-41-130.

3. Notify DCLS in writing within 30 calendar days of major changes in personnel, equipment, or laboratory location as specified in 1VAC30-41-200.

4. Use approved methodology as required by this chapter and incorporated by reference into 1VAC30-41-55.

5. Comply with the reporting requirements specified in 1VAC30-41-190.

1VAC30-41-190. Reporting requirements.

A. To maintain certification, drinking water laboratories shall comply with the reporting requirements [ for compliance, monitoring, and exceedances ] set out in the VDH-ODW regulations [ specified as follows:

1. Compliance, monitoring, and exceedances, 12VAC5-590-530.

2. Public notices, 12VAC5-590-540 in 12VAC5-590-530 ].

B. Drinking water laboratories shall report the results of analyses to the VDH-ODW within three days of completion unless 12VAC5-590-530 [ or 12VAC5-590-540 ] requires a different time limit.

1VAC30-41-200. Major changes in personnel or equipment or a change of laboratory location.

A. Major change in personnel.

1. The drinking water laboratory shall notify DCLS of a major change in the laboratory's personnel in writing within 30 calendar days of the change.

2. A "major change in personnel" is defined as (i) the loss or replacement of the laboratory director or laboratory supervisor or (ii) the loss of all the trained and experienced analysts who had been available to analyze a particular contaminant for which certification has been granted.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of a major change in personnel.

B. Change of laboratory location.

1. The laboratory shall notify DCLS of a change in the laboratory's location in writing at least 30 calendar days prior to the location change.

2. DCLS may perform an onsite assessment of the new facility when a laboratory changes location.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS of a change in the laboratory's location at least 30 days prior to the location change.

C. Equipment.

1. A drinking water laboratory shall notify DCLS in writing within 30 calendar days of a major change in equipment.

2. A drinking water laboratory shall provide the following information to DCLS about new equipment:

a. Make and model of the new instrument.

b. Date of installation and training.

c. Initial demonstration of capability (IDC) and minimum detection limit (MDL).

d. Updated standard operating procedure (SOP).

e. Methods and contaminants for which the instrument will be used.

f. Successful proficiency testing analyzed on the new instrument.

g. Date the instrument was put into service analyzing compliance samples.

3. DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of any major change in equipment.

D. Laboratory action to address major changes to personnel or equipment or a change of location.

1. When a major change to laboratory personnel or equipment or a change of location occurs, the laboratory shall establish a schedule to address the change and provide the schedule in writing to DCLS. The laboratory shall submit the schedule to DCLS along with the notification of the change.

2. If DCLS determines that the laboratory can no longer produce valid data because of the major change in personnel or equipment or the change of location, DCLS shall follow the procedure in 1VAC30-41-240 to revoke certification for the contaminants in question.

1VAC30-41-210. Downgrading to provisionally certified status.

DCLS shall downgrade a certified drinking water laboratory's status to provisionally certified for each contaminant and by each method for any of the following reasons:

1. Failure to analyze a PT sample each calendar year during the period defined by DCLS and within the acceptance limits specified in the regulations incorporated by reference in 1VAC30-41-55.

2. Failure to successfully analyze a PT sample for a contaminant after participating in two successive PT studies.

3. Failure to notify DCLS within 30 calendar days of major changes in personnel or equipment or a change in laboratory location as required by 1VAC30-41-200.

4. Failure to satisfy DCLS that the laboratory is maintaining the required standard of quality based upon the onsite assessment requirements in 1VAC30-41-150.

5. Failure to comply with the reporting requirements of 1VAC30-41-190 in a timely manner.

1VAC30-41-220. Procedure to downgrade to provisionally certified status.

A. DCLS shall notify the laboratory director in writing that DCLS intends to downgrade the laboratory to provisionally certified status. DCLS shall send this notification within 14 days of becoming aware of the cause for the downgrade. DCLS shall send the notification by certified mail or other equivalent mailing service.

B. The laboratory director shall review the problems cited in the notice. Within 30 days of receiving the notice, the laboratory director shall send DCLS a letter specifying what immediate corrective actions are being taken and any proposed action that needs the concurrence of DCLS.

C. DCLS shall consider the adequacy of the laboratory's response and notify the laboratory director in writing by certified mail or other equivalent mailing service of the laboratory's certification status. DCLS shall respond within 14 days of receiving the laboratory's letter and corrective action plan.

D. The laboratory shall correct the problems cited in the initial notification letter from DCLS within three months of the date of the DCLS response to the laboratory's corrective action plan.

E. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status. This revocation shall apply only to the contaminants and methods for which the laboratory was initially cited in the DCLS downgrade notification.

F. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

G. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.

1VAC30-41-230. Revocation of certified status.

DCLS shall downgrade a drinking water laboratory's status to not certified from certified or provisionally certified or interim certified status for each contaminant and by each method for any of the following reasons:

1. Falsification of data or use of other deceptive practices.

2. Reporting proficiency testing data from another laboratory as its own.

3. Failure to use the federally-approved methods incorporated by reference into this chapter at 1VAC30-41-55.

4. Refusal to participate in an onsite assessment conducted by DCLS.

5. Failure to pay the annual fee to DCLS.

6. For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the specified acceptance limits.

7. For provisionally certified laboratories, failure to satisfy DCLS that the laboratory has corrected identified deficiencies based on an onsite assessment.

8. For provisionally certified laboratories, persistent failure to comply with the reporting requirements specified in 1VAC30-41-190.

1VAC30-41-240. Procedure to revoke certification.

A. DCLS shall notify the laboratory owner in writing of its intent to revoke certification. DCLS shall describe in detail the reasons and circumstances that form the basis for revoking certified status in this notice. DCLS shall send the notification by certified mail or an equivalent mailing service.

B. DCLS shall provide an opportunity for an informal fact-finding conference pursuant to § 2.2-4019 of the Code of Virginia prior to making a final decision to revoke certification.

C. A drinking water laboratory that has had its certification revoked for methods and contaminants under the methods shall do the following:

1. Stop analyzing SDWA compliance samples for these contaminants and methods.

2. Send the samples to a laboratory that is certified to perform the analyses.

3. Notify its clients of its revoked status in writing.

1VAC30-41-250. Appeal procedure.

A laboratory may appeal a final decision to revoke certification by DCLS pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

1VAC30-41-260. Reinstatement of certification.

A. A drinking water laboratory may request in writing to have its certification status upgraded or reinstated.

B. DCLS shall upgrade or reinstate certification when the laboratory can demonstrate that it has corrected the deficiencies that produced the downgrading or revocation of certified status.

C. DCLS may require an onsite assessment or successful completion of a water supply proficiency testing study or both before upgrading or reinstating a drinking water laboratory. If the onsite assessment is necessary, the laboratory shall pay the fees set out in 1VAC30-41-270 H.

1VAC30-41-270. Fees.

A. DCLS shall charge a fee to certify drinking water laboratories. This fee shall be limited to the cost of administering the certification program.

B. Required fees.

1. Drinking water laboratories shall submit payment of the fee with the initial applications for certification.

2. Drinking water laboratories located out-of-state and applying for reciprocal certification shall submit payment of the fee with the initial applications.

3. Once certified under this chapter, drinking water laboratories shall pay the fee annually. DCLS shall send an invoice to the certified drinking water laboratory.

4. Additional fees may apply under subsection K of this section when changes to the laboratory's certification require DCLS staff time to administer the change.

C. DCLS shall not consider an application to be complete until the applicant laboratory submits payment of the certification fee.

D. All incomplete payments shall be deemed as nonpayment. Nonpayment of fees shall result in denial or revocation of certification.

E. Payment of fees shall be nonrefundable.

F. DCLS, under 1VAC30-41-230, may revoke the certification of any certified laboratory that does not pay its annual fee.

G. Fee computation.

1. Fees for certification of drinking water laboratories shall be applied on an annual basis.

2. Drinking water laboratories shall pay the total of the base year fees as required by subsections H and J of this section for the first 12 months following [ [insert the effective date of this chapter] May 1, 2014 ].

3. Beginning [ [insert the thirteenth month following the effective date of this chapter] May 1, 2015 ], drinking water laboratories shall pay the total of the base year fees required by subsection H and Table 1 of subsection J of this section as adjusted by the method set out in subsection I of this section.

H. Calculation of fees - base year fees [ [insert year of the effective date of this chapter] May 1, 2014 - April 30, 2015 ].

1. DCLS charges a fee for the review and certification of the drinking water laboratory's quality system. This includes a review of the test methods for which the drinking water laboratory requests or holds certification. The fees are based on the number of test methods for which the laboratory would be certified within each of the six testing categories set out in Table 1 of subsection J of this section.

2. DCLS shall calculate a laboratory's fees by adding the fees for the number of test methods in each category as set out in Table 1 of subsection J of this section for which the laboratory applies or is certified.

3. For example, a laboratory may be certified for three microbiological methods ($700); five inorganic chemistry, nonmetals methods ($850); two inorganic chemistry, metals methods ($1000); and two organic chemistry methods ($1050). The total annual fee would be $3600.

I. Calculation of fees - fees beginning [ [insert the thirteenth month following the effective date of this chapter] May 1, 2015 ].

1. DCLS shall revise the base year fees after the first 12 months following [ the effective date of this chapter May 1, 2014, ] and every 12-month period thereafter.

2. DCLS shall increase or decrease the fees set out in Table 1 of subsection J of this section using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year. (The CPI-U for all urban consumers is published by the U.S. Department of Labor, Bureau of Labor Statistics.)

3. DCLS shall revise each previous year's Table 1 of subsection J of this section so that the revisions will be cumulative, reflecting the changes in the CPI-U over time.

4. DCLS shall round the revised fees to the nearest whole dollar.

5. DCLS shall publish the revised fee table annually on its website for drinking water laboratory certification. This website can be found by going to the DCLS page of the Department of General Services' website at http://dgs.virginia.gov.

J. Fee tables.

1. Fees are calculated using the base year fees in Table 1.

2. Table 2 shows the relationship between the testing categories for fees and the drinking water laboratory certification categories.

K. Additional fees.

1. An additional fee shall be charged to a laboratory:

a. Applying for modification of certification under 1VAC30-41-110.

b. Moving its location when the move requires DCLS to perform an onsite assessment.

c. Requesting reinstatement of certification when DCLS requires an onsite assessment.

2. The fee charged shall be the sum of the total hourly charges for all reviewers plus any onsite assessment cost incurred.

a. An hourly charge per reviewer shall be $61 as of [ [insert the effective date of this chapter] May 1, 2014 ]. DCLS shall revise the hourly charge after the first 12 months following [ [insert the effective date of this chapter] May 1, 2014, ] and every 12-month period thereafter. The hourly charge shall increase or decrease using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year.

b. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

c. If an onsite review is required, travel time and onsite review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

L. Method of payment. Fees shall be paid by check, draft, or postal money order payable to the Treasurer, Commonwealth of Virginia, or submitted electronically, if available, and must be in U.S. currency, except that agencies and institutions of the Commonwealth of Virginia may submit interagency transfers for the amount of the fee. All fees shall be sent to the following address, or submitted electronically, if available: DCLS, Attn: Lab Certification, 600 North 5th Street, Richmond, VA 23219. Laboratories may also pay fees using credit cards. Laboratories shall fill out the DCLS Fee Payment Form for Virginia Laboratory Certification Programs and send the completed form with the fee.

1VAC30-41-280. (Reserved).

1VAC30-41-290. (Reserved).

Part III
Chemistry

1VAC30-41-300. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter IV, Section 1 of the Manual.

1VAC30-41-310. Laboratory facilities.

Drinking water laboratories shall meet the requirements of Chapter IV, Section 2 of the Manual.

1VAC30-41-320. Laboratory equipment and instrumentation.

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 3 of the Manual.

1VAC30-41-330. General laboratory practices.

A. Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 4 of the Manual with the exception of Table IV-1.

1VAC30-41-340. Analytical methodology.

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Laboratories shall meet the requirements of Chapter IV, Section 5.1 of the Manual with the exception of Tables IV-2 through IV-5 [ and Table IV-11 ].

C. A drinking water laboratory shall perform a minimum of five water analyses monthly for each chemical contaminant for which the laboratory is certified in order to maintain certification status or qualify for initial certification.

D. Exceptions to laboratory certification requirements of 1VAC30-41-20 B 2.

1. Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

2. This testing shall be performed using approved sampling and analytical methodology as incorporated by reference into 1VAC30-41-55 C.

3. Laboratories performing this testing shall meet the requirements of Chapter IV, Section 5.2 of the Manual, with the exception of Tables IV-2 through IV-5.

1VAC30-41-350. Sample collection, handling, and preservation.

A. Drinking water laboratories shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B. Drinking water laboratories shall meet the requirements of Chapter IV, Section 6 of the Manual with the exception of Table IV-6, and the Manual Supplement to Chapter IV, Section 6 of the Manual.

C. Drinking water laboratories shall reject any sample not meeting the criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

1VAC30-41-360. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of [ both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include ] the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 of the Manual.

3. Chapter IV, Section 7 of the Manual with the exception of Tables IV-7 through IV-10.

4. The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-370. Recordkeeping and data reporting.

Drinking water laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter IV, Section 8 of the Manual.

1VAC30-41-380. Action response to laboratory results.

Drinking water laboratories shall meet the action response requirement of Chapter IV, Section 9 of the Manual and the requirements of 1VAC30-41-190.

1VAC30-41-390. (Reserved).

Part IV
Microbiology

1VAC30-41-400. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter V, Section 1 of the Manual.

1VAC30-41-410. Laboratory facilities.

A. Drinking water laboratories shall meet the requirements of Chapter V, Section 2 of the Manual.

B. The laboratory facilities shall include sufficient space to process and examine samples proportionate with the total work load.

C. The laboratory shall have provisions for decontamination and disposal of microbiological waste.

D. Office areas for clerical work and recordkeeping shall be segregated from laboratory work areas.

1VAC30-41-420. Laboratory equipment and supplies.

Drinking water laboratories shall meet the following requirements:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 3 of the Manual.

1VAC30-41-430. General laboratory practices.

Drinking water laboratories shall meet general laboratory practices of the following:

1. The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2. The requirements of Chapter V, Section 4 of the Manual.

1VAC30-41-440. Analytical methodology.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements incorporated by reference into 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Drinking water laboratories shall meet the requirements of Chapter V, Section 5 of the Manual and the Manual Supplement to Chapter V, Section 5 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. A drinking water laboratory shall perform a minimum of 20 coliform analyses monthly by each coliform method for which it is certified in order to maintain certification status or qualify for initial certification. The minimum number of coliform analyses (20) may be performed on a variety of water sample types collected from different stages of the water treatment process, raw source water, and surface or ground water, as well as drinking water samples collected from a distribution system or private wells.

1VAC30-41-450. Sample collection, handling, and preservation.

A. Laboratories that perform sampling shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Laboratories that perform sampling shall meet the requirements of Chapter V, Section 6 of the Manual and the Manual Supplement to Chapter V, Section 6 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. Drinking water laboratories shall reject any sample not meeting the sampling criteria of this section and notify the system or individual requesting the analyses.

D. The laboratory shall have a written sample rejection policy covering samples that do not meet sampling requirements.

1VAC30-41-460. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of [ both the Manual and the required analytical methods incorporated by reference into 1VAC30-41-55. These requirements include ] the following:

1. The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2. Chapter III, Section 11 and Chapter V, Section 7 of the Manual.

3. The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-470. Recordkeeping and data reporting.

Laboratories shall meet the recordkeeping and data reporting requirements of the following:

1. The approved test methods incorporated by reference into 1VAC30-41-55.

2. Chapter V, Section 8 of the Manual.

1VAC30-41-480. Action response to laboratory results.

Drinking water laboratories shall meet the requirements of Chapter V, Section 9 of the Manual and the requirements of 1VAC30-41-190.

1VAC30-41-490. (Reserved).

Part V
Radiochemistry

1VAC30-41-500. Radiochemistry.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements [ including the quality assurance and quality control requirements ] incorporated by reference into 1VAC30-41-55 for radiochemistry and alternative testing methods for radiochemistry.

B. Drinking water laboratories shall meet the requirements of Chapters III and VI of the Manual as follows:

1. Personnel: Chapter III, Section 10 and Chapter VI, Section 1.

2. Laboratory facilities: Chapter VI, Section 2.

3. Laboratory equipment and instrumentation: Chapter VI, Section 3.

4. General laboratory practices: Chapter VI, Section 4.

5. Analytical methods: Chapter VI, Section 5, with the exception of Table VI-1.

6. Sample collection, handling, and preservation: Chapter VI, Section 6, with the exception of Table VI-2.

7. Quality assurance: Chapter III, Section 11 and Chapter VI, Section 7.

8. Recordkeeping and data reporting: Chapter VI, Section 8.

9. Action response to laboratory results: Chapter VI, Section 9 and the requirements of 1VAC30-41-190.

FORMS (1VAC30-41)

Application for Virginia Certification Safe Drinking Water Program, DGS-21-109 (rev. 5/30/13)

Fee Payment Form for Virginia Laboratory Certification Programs, DGS-35-232 (rev. 1/14/11)

DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-41)

Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, January 2005 (EPA-815-R-05-004)

[ Chapters I through IV

Chapters V and VI

Appendices ]

Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, June 2008 (EPA 815-F-08-006)

Title of Regulation: 1VAC55-20. Commonwealth of Virginia Health Benefits Program (amending 1VAC55-20-20, 1VAC55-20-90, 1VAC55-20-160, 1VAC55-20-230, 1VAC55-20-240, 1VAC55-20-280, 1VAC55-20-290, 1VAC55-20-320, 1VAC55-20-330, 1VAC55-20-350, 1VAC55-20-370 through 1VAC55-20-410, 1VAC55-20-430, 1VAC55-20-460; repealing 1VAC55-20-40).

Statutory Authority: § 2.2-2818 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 9, 2014.

Effective Date: April 24, 2014.

Agency Contact: Charles Reed, Associate Director, Department of Human Resource Management, 101 North 14th Street, 13th Floor, Richmond, VA 23219, telephone (804) 786-3124, FAX (804) 371-0231, or email charles.reed@dhrm.virginia.gov.

Basis: Section 2.2-2818 of the Code of Virginia authorizes the Department of Human Resource Management (DHRM) to establish and administer the health insurance plan for state employees.

Purpose: The amendments make certain technical corrections to definitions and remove the reference to the State Advisory Council because it is no longer authorized under the Code of Virginia.

Due to changes in the Health Insurance Portability and Accountability Act (HIPAA), the amendments allow an employee 60 days to add a newborn or an adopted child and allow new employees retroactive coverage, as long as they enroll within 30 days of their employment date. The employee's coverage will be effective the first of the month coinciding with or following the date of employment. IRS Section 125 had previously required this election to be on a prospective basis. The amendments provide greater access to health care for state employees thereby improving their health and welfare.

Furthermore, due to the uncertainty surrounding the number of hours required for benefits under the employer mandate of the Affordable Care Act, the amendment removes any reference to the number of hours required for full-time eligibility under the state plan. This information will be placed in DHRM's guidance documents.

Rationale for Using Fast-Track Process: The amendments only make technical corrections, liberalize eligibility rules, and make changes that are or will be required by the Code of Virginia or the Affordable Care Act.

Substance: The proposed amendments to this regulation make technical corrections and changes that are or will be required by the Code of Virginia or the Affordable Care Act. Additionally, due to changes in HIPAA, this amendment allows an employee 60 days to add a newborn or an adopted child. It also allows new employees retroactive coverage, as long as they enroll within 30 days of their employment date. IRS Section 125 had previously required this election to be on a prospective basis. The only substantive amendment to the existing regulation is the liberalization of coverage rules.

Issues: This regulatory action poses no disadvantage to the public or the Commonwealth. The primary advantage of the regulatory amendments to the public and the Commonwealth is that they bring the Commonwealth into compliance with the Affordable Care Act in order to avoid penalties.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Department of Human Resource Management (Department) proposes to amend language in the Commonwealth of Virginia Health Benefits Program regulations in order to make clarifications, update definitions, and bring consistency with the Code of Virginia and federal law.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The Department's proposed amendments do not change any requirements in practice. Thus, the proposed amendments will have no impact beyond providing a small benefit through a potential reduction in confusion concerning the requirements by readers of the regulations.

Businesses and Entities Affected. The regulations affect current and retired employees of the Commonwealth, and current and retired employees of local Virginia jurisdictions that participate in the Commonwealth of Virginia's The Local Choice health benefits program, as well as health insurance firms.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect small businesses.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget. The agency concurs with this analysis.

Summary:

The amendments (i) make technical corrections to definitions; (ii) remove the authority of the State Advisory Council to conform the regulations to the Code of Virginia; (iii) conform the regulations to changes in the Health Insurance Portability and Accountability Act (HIPPA), which include allowing an employee 60 days to add a newborn or an adopted child to his state health plan and allowing new employees retroactive coverage provided they enroll within 30 days of their employment date; and (iv) amend the definition of "full-time employee" by removing the number of work hours necessary for eligibility for participation in the state health plan.

Part I
General

1VAC55-20-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Accident or health plan" means a plan described in the Internal Revenue Code § 105.

"Administrative services arrangement" means an arrangement whereby a third party administrator agrees to administer all or part of the health benefits program.

"Adoption agreement" means an agreement executed between a local employer and the department specifying the terms and conditions of the local employer's participation in the health benefits program.

"Adverse experience adjustment" means the adjustment determined by the department, consistent with its actuarial practices, to premiums for the year in which a local employer withdraws from the plan.

"Alternative health benefits plans" means optional medical benefits plans, inclusive of but not limited to HMOs and PPOs, which are offered pursuant to the health benefits program in addition to the basic statewide plan(s) plan.

"Basic statewide plan(s)" plan" means the statewide hospitalization, medical and major medical plan health benefits plan for state employees offered at a uniform rate to all state employees pursuant to § 2.2-2818 of the Code of Virginia.

"Benefits administrator" or "group benefits administrator" means the person or office designated in the application and adoption agreement to be responsible for the day-to-day administration of the health benefits program at the local level. The benefits administrator is an employee of the agency or local employer that employs the benefits administrator. The benefits administrator is not an agent of the health insurance plan or the Department of Human Resource Management.

"Coordinated service" means a health care service or supply covered under both the program and another health plan. The coordinated service will be provided under the program only to the extent it is not excluded or limited under the program.

"Coordination of benefits" means the establishment of a priority between two or more underwriters which that provide health benefits protection covering the same claims incident.

"Department" means the Department of Human Resource Management.

"Dependent" means any person who is determined to be an eligible family member of an employee pursuant to subsection E of 1VAC55-20-320.

"Director" means the Director of the Department of Human Resource Management.

"Dual membership" means the coverage in the health benefits program of the employee and either the spouse or one dependent. This definition does not include coverage of retirees or employees or their spouses who are otherwise covered by Medicare.

"Effective date of coverage" means the date on which a participant is enrolled for benefits under a plan or plans elected under the health benefits program.

"Employee" means a person employed by an employer participating in the health benefits program or, where demanded by the context of this chapter, a retired employee of such an employer. The term "employee" shall include state employees and employees of local employers.

"Employee health insurance fund" or "health insurance funds" means accounts established by the state treasury and maintained by the department within which contributions to the plan shall be deposited.

"Employer" means the entity with whom a person maintains a common law employee-employer relationship. The term "employer" is inclusive of each state agency and of a local employer.

"Employer application" or "application" means the form, to be provided by the department, to be used by the local employer for applying to participate in the health benefits program.

"Enrollment action" means providing the information, which would otherwise be contained on an enrollment form, through an alternative means such as through the world wide web Internet or through an interactive voice response system, for the purpose of securing or changing membership or coverage in the employee health benefits program. Submitting a properly completed enrollment form and taking an enrollment action through an employee self-service system are used interchangeably to indicate equivalent actions.

"Enrollment form" means the form, to be provided by the department, to be used by participants to enroll in a plan or to indicate a change in coverage.

"Experience adjustment" means the adjustment determined by the department, consistent with its actuarial practices, to premiums for the year in which a local employer withdraws from the plan.

"Family membership" means the coverage in the health benefits program of the employee and two or more eligible dependents.

"Health benefits program" or "program" means, individually or collectively, the plan or plans the department may establish pursuant to §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.

"Health Maintenance Organization" or "HMO" means an entity created under federal law, "The Health Maintenance Organization Act of 1973" (Title XIII of the Public Health Service Act), as amended, or one defined under state law.

"Health benefits program" or "program" means, individually or collectively, the plan or plans the department may establish pursuant to §§ 2.2-1204 and 2.2-2818 of the Code of Virginia.

"Health plan" means:

1. A plan or program offering benefits for, or as a result of, any type of health care service when it is:

a. Group or blanket insurance (including school insurance programs); or

b. Blue Cross, Blue Shield, group practice (including HMOs and PPOs), individual practice (including IPAs), or any other prepayment arrangement (including this program) when;:

(1) An employer contributes any portion of the premium; or

(2) An employer contracts for the group coverage on behalf of employees; or

(3) It is any labor-management trustee plan, union welfare plan, employer organization plan, or employee benefit organization plan.

2. The term "health plan" refers to each plan or program separately. It also refers to any portion of a plan or program which that reserves the right to take into account benefits of other health plans when determining its own benefits. If a health plan has a coordination of benefits provision which that applies to only part of its services, the terms of this section will be applied separately to that part and to any other part.

3. A prepaid health care services contract or accident or health plan meeting all the following conditions is not a health plan:

a. One that is individually underwritten;

b. One that is individually issued;

c. One that provides only for accident and sickness benefits; and

d. One that is paid for entirely by the subscriber.

A contract or policy of the type described in this subdivision 3 of this definition is not subject to coordination of benefits.

"Independent hearing officer" means an individual requested by the director of the department from a list maintained by the Executive Secretary of the Supreme Court of Virginia to arbitrate disputes that may arise in conjunction with these regulations or the health benefits program.

"Impartial health entity" "Independent review organization" means an organization, which that, upon written request from the Department of Human Resource Management, examines the adverse health benefits claim decision made by the Commonwealth's Third Party Administrator (TPA). The impartial health entity independent review organization should determine whether the TPA's decision is objective, clinically valid, compatible with established principles of health care, and appropriate under the terms of the contractual obligations to the covered person.

"Insured arrangement" means an accident or health plan underwritten by an insurance company wherein the department's only obligation as it may relate to claims is the payment of insurance company premiums.

"Independent hearing officer" means an individual requested by the director of the department from a list maintained by the Executive Secretary of the Supreme Court to arbitrate disputes which may arise in conjunction with these regulations or the health benefits program.

"Local employees" or "employees of local governments" means all officers and employees of the governing body of any county, city, or town, and the directing or governing body of any political entity, subdivision, branch, or unit of the Commonwealth or of any commission or public authority or body corporate created by or under an act of the General Assembly specifying the power or powers, privileges or authority capable of exercise by the commission or public authority or body corporate, as distinguished from §§ 15.2-1300, or 15.2-1303 of the Code of Virginia, or similar statutes, provided that the officers and employees of a social services department, welfare board, mental health and mental retardation community services board, or behavioral health authority, or library board of a county, city, or town shall be deemed to be the employees of local government.

"Local employer" means any county, city, or town, school board, and the directing or governing body of any political entity, subdivision, branch or unit of the Commonwealth or of any commission or public authority or body corporate created by or under an act of the General Assembly specifying the power or powers, privileges or authority capable of exercise by the commission or public authority or body corporate, as distinguished from §§ 15.2-1300, or 15.2-1303 of the Code of Virginia, or similar statutes.

"Local officer" means the treasurer, registrar, commissioner of revenue, attorney for the Commonwealth, clerk of a circuit court, sheriff, or constable of any county or city or deputies or employees of any of the preceding local officers.

"Local retiree" means a former local employee who has met the terms and conditions for early, normal, or late retirement from a local employer.

"Open enrollment" means the period during which an employee may elect to commence, to waive, or to change membership or plans offered pursuant to the health benefits program.

"Part-time employee," as defined by each local employer, means an employee working less than full time but more than 20 hours per week whom a local employer has determined to be eligible to participate in the program. The conditions of participation for these employees shall be decided by the local employer in a nondiscriminatory manner.

"Participants" means individuals covered by the plan due to their relationship with the employer. They are not covered as dependents under the plan.

"Plan administrator" means the department.

"Preferred provider organization" or "PPO" means an entity through which a group of health care providers, such as doctors, hospitals and others, agree to provide specific medical and hospital care and some related services at a negotiated price.

"Preexisting condition" means a condition which that, in the opinion of the plan's medical advisors, displayed signs or symptoms before the participant's effective date of coverage. These signs or symptoms must be ones of which the participant was aware or should reasonably have been aware. The condition is considered preexisting whether or not the participant was seen or treated for the condition. It is also considered preexisting whether or not the signs and symptoms of the condition were correctly diagnosed.

"Preferred provider organization" or "PPO" means an entity through which a group of health care providers, such as doctors, hospitals, and others, agree to provide specific medical and hospital care and some related services at a negotiated price.

"Primary coverage" means the health plan which that will provide benefits first. It does not matter whether or not a claim has been filed for benefits with the primary health plan.

"Retiree" means any person who meets the definition of either a state retiree or a local retiree.

"Secondary coverage" means the health plan under which the benefits may be reduced to prevent duplicate or overlapping coverage.

"Self-funded arrangement" means a facility through which the plan sponsor agrees to assume the risk associated with the type of benefit provided without using an insurance company.

"Single membership" means coverage of the employee only under the health benefits program.

"State" means the Commonwealth of Virginia.

"State agency" means a court, department, institution, office, board, council, or other unit of state government located in the legislative, judicial, or executive departments or group of independent agencies, as shown in the Appropriation Act, and which is designated in the Appropriation Act by title and a three-digit agency code.

"State employee" means any person who is regularly employed full time on a salaried basis, whose tenure is not restricted as to temporary or provisional appointment, in the service of, and whose compensation is payable, no more often than biweekly, in whole or in part, by the Commonwealth or any department, institution, or agency thereof. "State employee" shall include the Governor, Lieutenant Governor, Attorney General, and members of the General Assembly. It includes "judge" as defined in § 51.1-301 of the Code of Virginia and judges, clerks, and deputy clerks of regional juvenile and domestic relations, county juvenile and domestic relations, and district courts of the Commonwealth.

"State retiree" means a former state employee who has met the terms and conditions for early, normal or late retirement from the Commonwealth.

"Teacher" means any employee of a county, city, or other local public school board.

1VAC55-20-40. State advisory council. (Repealed.)

In the administration of the health benefits program or any component plan or plans comprising such program, the department shall take into consideration the recommendations of the state human resource advisory council (the "council" or "advisory council"). The council is created pursuant to § 2.2-2675 of the Code of Virginia and operated in accordance therewith. Such advisory council will serve to advise the Secretary of Administration on among other things, issues and concerns of active and retired employees of the Commonwealth who are participating in the health benefits program, such as the type and amount of benefits provided by the program, the cost to employees to participate in the program and ways to effectively control claims experience. The department shall consider the findings and recommendations of the council in its decision-making process. Further, the department may request the council's guidance on other issues of concern to the department.

1VAC55-20-90. Appeals.

A. The director of the department shall be the final arbiter of any disputes arising under this chapter. The director may not redelegate this authority other than to an independent hearing officer except as provided under subsection C of this section.

All disputes arising under this chapter shall be submitted to the department, which shall have the responsibility for interpreting and administering this chapter. All disputes shall be made in writing in such manner as may be reasonably required by the department and shall set forth the facts which that the applicant believes to be sufficient to entitlement to relief hereunder. The department may adopt forms for such submissions in which case all appeals shall be filed on such forms.

B. Appeals not filed within the time frames established herein shall be denied.

Requests for review of procurements under the provisions of the VPPA Virginia Public Procurement Act (§ 2.2-4300 et seq. of the Code of Virginia) shall be filed within 10 days of the department's notice of intent to award a contract.

Requests for relief from local employers or state agencies with respect to any action of the department other than a procurement shall be filed within 30 days of the action grieving the applicant. Requests for relief from state or local employees with respect to any action of the department other than a procurement shall be filed within 60 days of the action grieving the employee.

C. Upon receipt by the department for a request for review under this section, it shall determine all facts which that are necessary to establish the right of an applicant for relief. The department shall approve, deny, or investigate any and all disputes arising hereunder. Upon request, the department will afford the applicant the right of a hearing with respect to any finding of fact or determination related to any claim under this section. In the event of an adverse decision by the department, the applicant shall be notified of such decision as hereinafter provided in this section. Reviews for treatment authorizations or medical claims that have been denied will be sent to an impartial health entity independent review organization. The impartial health entity independent review organization shall examine the final denial of claims or treatment authorizations to determine whether the decision is objective, clinically valid, and compatible with established principles of health care. The decision of the impartial health entity independent review organization shall (i) be in writing, (ii) contain findings of fact as to the material issues in the case and the basis for those findings, and (iii) be final and binding if consistent with law and policy.

D. The applicant shall be notified in writing of any adverse decision with respect to his claim within 90 days after its submission. The notice shall be written in a manner calculated to be understood by the applicant and shall include:

1. The specific reason or reasons for the denial;

2. Specific references to law, this chapter, contracts awarded pursuant to this chapter, or the Health Insurance Manual/Local Administrative Manual and related instructions on which the denial is based;

3. A description of any additional material or information necessary to the applicant to perfect the claim and an explanation why such material or information is necessary; and

4. An explanation of the review process.

If special circumstances require an extension of time for processing an initial application, the department shall furnish written notice of the extension and the reason therefore to the applicant before the end of the initial 90-day period. In no event shall such extension exceed 90 days.

E. Standards, credentials, and qualifications of the impartial health entity independent review organization.

1. In order to qualify to perform either standard or expedited external reviews pursuant to this chapter or the Code of Virginia, an impartial health entity independent review organization shall have and maintain written policies and procedures that govern all aspects of the standard and expedited external review processes that include, at a minimum, a quality assurance mechanism in place that ensures that:

a. External reviews are conducted within the specified time frames and required notices are provided in a timely manner;

b. Qualified and impartial clinical peer reviewers are selected to conduct external reviews on behalf of the impartial health entity and reviewers are suitably matched to specific cases; and

c. The confidentiality of medical records is maintained in accordance with the confidentiality and disclosure laws of the Commonwealth and/or or the Health Insurance Portability and Accountability Act.

2. All clinical peer reviewers assigned by an impartial health entity independent review organization to conduct external reviews shall be physicians or other appropriate health care providers who meet the following minimum qualifications:

a. Are expert in the treatment of the covered person's medical condition that is the subject of the external review;

b. Are knowledgeable about the recommended health care service or treatment through recent or current actual clinical experience treating patients with the same or similar medical conditions as the covered person's;

c. Hold a nonrestricted license in a state of the United States and, for physicians, a current certification by a recognized American medical specialty board in the area or areas appropriate to the subject of the external review; and

d. Have no history of disciplinary actions or sanctions, including loss of staff privileges or participation restrictions, that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body that raise a substantial question as to the clinical peer reviewer's physical, mental, or professional competence or moral character.

3. An impartial health entity independent review organization shall not be affiliated with or a subsidiary of nor be owned or controlled by a health plan, a trade association of health plans, or a professional association of health care providers.

4. In determining whether an independent review organization or a clinical peer reviewer of the impartial health entity independent review organization has a material, professional, familial, or financial conflict of interest, the director may take into consideration situations where the characteristics of that relationship or connection are such that they are not materially sufficient to disqualify the impartial health entity independent review organization or the clinical peer reviewer from conducting the external review.

1VAC55-20-160. Establishing contribution rates and accounting for contributions and claims.

A. The department shall establish one or more pools for establishing contribution rates and for accounting for claims and contributions for state employees and participating local employers. The plan for local employers shall be rated separately from the plan established for state employees. There are hereby authorized pools based on geographic and demographic characteristics and employment relationships. Such pools may include but shall not be limited to:

1. Active state employees, including retirees under age 65 and not eligible for Medicare;

2. Active local employees (excluding separately rated employees of public school systems);

3. Active employees of public school systems;

4. Retired state employees over age 65 and retired state employees eligible for Medicare;

5. Retired local employees (excluding separately rated employees of public school systems);

6. Retired employees of public school systems; and

7. Active employees whose employer does not sponsor a health insurance plan.

Participating employers shall make applicable contributions to the employee health insurance fund.

B. Such contributions may take into account the characteristics of the group, such as the demographics of employees, inclusive of age, sex, and dependent status of the employees of an employer; the geographic location of the employer or employees; claims experience of the employer; and the pool of the employers (for example, see subdivisions A 1 through 6 of 1VAC55-20-160 A) this section). Additionally, any such contributions may further be determined by spreading large losses, as determined by the department, across pools. Further, the department reserves the right to recognize, in its sole discretion, the claims experience of groups of sufficient size, regardless of their pool, where future claim levels can be predicted with an acceptable degree of credibility. The application of this rule by the department shall be exercised in a uniform and consistent manner.

C. The contribution rate in the aggregate will be composed of two factors; first, the current contribution and second, the amortization of experience adjustments. The current contributions will reflect the anticipated incurred claims and administrative expenses for the period; an experience adjustment will reflect gains and losses determined in accordance with an actuarial estimate. An experience adjustment will be part of the contributions for the succeeding year; however, the department may authorize the amortization of the experience adjustment for a period not to exceed three years.

D. The department will notify a terminating local employer of any adverse experience adjustment within six-calendar months of the time end of the plan year in which the local employer terminates participation in the program. Further the department reserves the right to modify the amount of the experience adjustment applicable to a terminating local employer for a period not to exceed 12 months from the end of the plan year in which such termination occurred. The experience adjustment shall be payable by the local employer in 12 equal monthly installments beginning 30 days after the date of notification by the department. In the event that a terminating local employer requests in writing an extension beyond a period of 12 months, the department may approve an extension up to 36 months provided the local employer agrees to pay interest at the statutory rate on any extended payments.

1VAC55-20-230. Entrance into the health benefits program.

A. Any local employer desiring to participate in the health benefits program shall complete an employer application provided by the department and execute an adoption agreement acknowledging the rights, duties, and responsibilities of the department and the local employer.

As a condition of participation, the department may require the local employer to complete the application in its entirety and deliver it to the department no less than 120 days prior to the effective date of coverage under the health benefits program. The application shall include the designation of a local administrator and include a list of other individuals whose responsibilities may be such that the department may have cause to contact them.

The application of a local employer may be withdrawn without penalty any time within the first 30 days after the department's delivery of rates to the employer. A 15-day extension will be available upon written request by the employer. Thereafter, the department may levy a processing charge not to exceed $500 to cover the cost of processing the application.

B. Except in unusual circumstances to be determined by the department, the completion of any waiting periods will not be required of employees of local employers joining the program at the time of a local employer's initial participation.

C. Local employers may include in the program their active employees, or their active employees and their retirees. Local employers may not elect to cover only retirees. If the local employer wishes to provide benefits to their Medicare-eligible retirees it must also provide coverage for non-Medicare retirees. The local employer's beneficiaries qualified under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) or similar legislation may also participate in the program. Coverage will not be available to a new employee unless the employee is on the payroll a minimum of 16 calendar days.

1VAC55-20-240. Payment of contributions.

A. Contributions due. It is the sole responsibility of the local employer to remit local employer and local employee contributions to the department or its designee. The local employer is may be responsible for remitting such contributions for active, retired, and COBRA-participating employees. Health benefits program contributions are to be made monthly, in advance, and are due at the department on the first of each month. If the first day of the month falls on a weekend or holiday, the payment is due at the department on the first business day of the month.

B. Nonpayment of contributions. A 10-day grace period for the nonpayment of contributions is hereby provided. If the full and complete payment of contributions is not received by the 10th of the month, a notice will be sent to the local employer by the department or its designee. Additionally, there shall be imposed an interest penalty of 12% per annum of the outstanding balance unpaid as of the 10th.

In the event that payment is not received by the 20th of the month, the department shall place a notice of nonpayment of contributions in a newspaper of general circulation in the locality of the local employer notifying the employees of such local employer that claims incurred after the end of the current month will not be paid until all outstanding contributions and interest have been paid.

Furthermore, the department reserves the right to collect from a local employer the greater of the monthly contribution or any amounts incurred for claims during a period of nonpayment as well as any other costs related thereto.

C. Nonpayment as breach. The nonpayment of contributions by a local employer shall constitute a breach of the adoption agreement and the local employer may be obligated to pay damages. In the event that the local employer terminates participation, such termination can only be prospective, and the employer shall be obligated to pay the greater of past contributions or actual claims incurred during such period and any interest and damages that may be associated with such nonpayment.

D. Coverage and contribution period. Except as noted here, coverage elections including those made by new employees are made on a prospective basis, that is, effective the first of the month coinciding with or following the receipt of the election form. However, if an election form is received from a new employee on the first business day of the month, coverage for the employee will commence on the first day of that month, (see 1VAC55-20-370). Coverage elections made for newborns, adoption, or placement for adoptions are effective the date the child is born, adopted, or placed for adoption, so long as the employee makes the coverage election within 31 60 days of the event. Coverage terminations are effective the end of the month following receipt of an election notice, except for terminations that are required by the plan. Coverage terminations required by the plan are effective the end of the month that the event takes place. Examples of coverage terminations required by the plan are such things as a divorce, termination of employment, or a dependent child losing eligibility.

Contributions shall always be for full calendar months. Local employees who terminate employment within a calendar month shall have coverage through the end of the month in which they terminate. In the event that a terminating local employee becomes covered under an accident or health plan of another employer prior to the end of the month in which the local employee terminates, this health benefits program shall be a secondary payor to the former local employee's new coverage.

1VAC55-20-280. Commencement of local employer participation.

Local employers may join initially at any time upon the timely submission of an employer application, but, thereafter, renewals must be as of July 1 of each year. Local school boards may have an October 1 renewal, if they so elect. Initial participation by a local employer at any time other than on July 1 (October 1) may be for the short plan year ending on the June 30 (September 30) following initial participation.

There shall be no specified time for local employee enrollment coincident with the local employer's initial participation in the health benefits program provided the department or its designee shall have knowledge of the local employee elections at least 30 days prior to the effective date of coverage. Thereafter the open enrollment period for local employees shall take place during the month of April or May of each year with the effective date of coverage then being July 1 of such year. Certain school groups may conduct their open enrollment in August and September.

1VAC55-20-290. Reparticipation of local employers.

Local employers having withdrawn from the health benefits program may reenter the program only with the consent of the department, and only on the July 1 (October 1 for school boards) following the timely submission of an employer application. The July 1 (October 1) effective date may be waived for local employers who have been away from the program for more than three years. Employees of local Local employers seeking reparticipation may be required to serve a waiting period.

Department consent shall not be granted until all pending contributions, penalties, and other assessments have been paid by a local employer and there is no outstanding litigation pending between the department and the local employer. A pending appeal will not prohibit a local employer from reparticipating in the health benefits program.

Part IV
Employee Participation

1VAC55-20-320. Eligible employees.

A. State employees.

1. Full-time salaried, classified employees as defined in 1VAC55-20-20 and faculty as defined in 1VAC55-20-20 are eligible for membership in the health benefits program. A full-time salaried employee is one who is scheduled to work at least 32 hours per week or carries a faculty teaching load considered to be full time at his institution.

2. Certain full-time employees in auxiliary enterprises (such as food services, bookstores, laundry services, etc.) at the University of Virginia, Virginia Military Institute, and the College of William and Mary as well as other state institutions of higher learning are also considered state employees even though they do not receive a salaried state paycheck. The Athletic Department of Virginia Polytechnic Institute and State University is an example of a local auxiliary whose members are eligible for the program.

3. Certain full-time employees of the Medical College of Virginia Hospital Authority are eligible for the program as long as they are on the authority's payroll and were enrolled in the program on November 1, 1996. They may have payroll deductions for health benefits premiums even if they rotate to the Veterans' Administration Hospital or other acute care facility.

4. Other employees identified in the Code of Virginia as eligible for the program.

5. Classified positions include employees who are fully covered by the Virginia Personnel Act, employees excluded from the Virginia Personnel Act by subdivision 16 of § 2.2-2905 of the Code of Virginia, and employees on a restricted appointment. A restricted appointment is a classified appointment to a position that is funded at least 10% from gifts, grants, donations, or other sources that are not identifiable as continuing in nature. An employee on a restricted appointment must receive a state paycheck in order to be eligible.

B. Local employees.

1. Full-time employees of participating local employers are eligible to participate in the program. A full-time employee is one who meets the definition set forth by the local employer in the employer application.

2. Part-time employees of local employers may participate in the plan if the local employer elects and the election does not discriminate among part-time employees. In order for the local employer to cover part-time employees, the local employer must provide to the department a definition of what constitutes a part-time employee.

The department reserves the right to establish a separate plan for part-time employees.

C. Unavailability of employer-sponsored coverage.

1. Employees, officers, and teachers without access to employer-sponsored health care coverage may participate in the plan. The employers of such employees, officers, and teachers must apply for participation and certify that other employer-sponsored health care coverage is not available. The employers shall collect contributions from such individuals and timely remit them to the department or its designee, act as a channel of communication with the covered employee and otherwise assist the department as may be necessary. The employer shall act as fiduciary with respect to such contributions and shall be responsible for any interest or other charges imposed by the department in accordance with these regulations.

2. Local employees living outside the service area of the plan offered by their local employer shall not be considered as local employees whose local employers do not offer a health benefits plan. For example, a local employee who lives in North Carolina and works in Virginia may live outside the service area of the HMO offered by his employer; however, he may not join the program individually.

3. Employer sponsorship of a health benefits plan will be broadly construed. For example, an employer will be deemed to sponsor health care coverage for purposes of this section and 1VAC55-20-260 if it utilizes § 125 of the Internal Revenue Code or any similar provision to allow employees, officers, or teachers to contribute their portion of the health care contribution on a pretax basis.

4. Individual employees and dependents who are eligible to join the program under the provisions of this subsection must meet all of the eligibility requirements pertaining to state employees except the identity of the employer.

D. Retirees.

1. Retirees are not eligible to enroll in the state retiree health benefits group outside of the opportunities provided in this section.

2. Retirees are eligible for membership in the state retiree group if a completed enrollment form is received within 31 days of separation for retirement. Retirees who remain in the health benefits group through a spouse's state employee membership may enroll in the retiree group at one of three later times: (i) future open enrollment, (ii) within 31 days of a qualifying mid-year event, or (iii) within 31 days of being removed from the active state employee spouse's membership.

3. Membership in the retiree group may be provided to an employee's spouse or dependents who were covered in the active employee group at the time of the employee's death in service.

4. Retirees who have attained the age of 65 or are otherwise covered or eligible for Medicare may enroll in certain plans as determined by the department provided that they apply for such coverage within 31 days of their separation from active service for retirement. Medicare will be the primary payor and the program shall serve as a supplement to Medicare's coverage.

5. Retirees who are ineligible for Medicare must apply for coverage within 31 days of their separation from active service for retirement. In order to receive coverage, the individual must meet the retirement requirements of his employer and receive an immediate annuity. For local employers, the immediate annuity requirement is not applicable as long as the retiree meets the age and service requirements imposed by the plan.

6. Local employers may offer retiree coverage at their option.

E. Dependents. 1. The following family members may be covered if the employee elects:

a. 1. The employee's spouse. The marriage must be recognized as legal in the Commonwealth of Virginia.

b. 2. Children. Under the health benefits program, the following eligible children may be covered to the end of the year in which they turn age 26 (age requirement is waived for adult incapacitated children):

(1) a. Natural children, adopted children, or children placed for adoption.

(2) b. Stepchildren. A stepchild is the natural or legally adopted child of the participant's legal spouse. Such marriage must be recognized by the Commonwealth of Virginia.

(3) c. Incapacitated children.

(1) Adult children who are incapacitated due to a physical or mental health condition, as long as the child was covered by the plan and the incapacitation existed prior to the termination of coverage due to the child attaining the limiting age. The employee must make written application, along with proof of incapacitation, prior to the child reaching the limiting age. Such extension of coverage must be approved by the plan and is subject to periodic review. Should the plan find that the child no longer meets the criteria for coverage as an incapacitated child, the child's coverage will be terminated at the end of the month following notification from the plan to the enrollee. The child must live with the employee as a member of the employee's household, be unmarried, and be dependent upon the employee for financial support. In the case of a divorce, living with the spouse will satisfy the condition of living with the employee. Furthermore, the support test is met if either the employee or spouse or combination of the employee and spouse provide over one half of the child's financial support.

(2) Adult incapacitated children of new employees may also be covered, provided that:

(a) The enrollment form is submitted within 31 30 days of hire;

(b) The child has been covered continuously by group employer coverage since the disability first occurred; and

(c) The disability commenced prior to the child attaining the limiting age of the plan.

The enrollment form must be accompanied by a letter from a physician explaining the nature of the incapacitation, providing the date of onset, and certifying that the dependent is not capable of self-support. This extension of coverage must be approved by the plan in which the employee is enrolled.

(4) d. Other children. A child in which for whom a court has ordered the employee to assume sole permanent custody.

Additionally, if the employee or spouse shares custody with the minor child who is the parent of the "other child," then the other child may be covered.

When a child loses eligibility, coverage terminates at the end of the month in which the event that causes the loss of eligibility occurs.

There are certain categories of persons who may not be covered as dependents under the program. These include dependent siblings, grandchildren, nieces, and nephews except where the criteria for "other children" are satisfied. Parents, grandparents, aunts, and uncles are not eligible for coverage regardless of dependency status.

1VAC55-20-330. Enrollment form or enrollment action.

A. No coverage is available unless an employee files an enrollment form or takes an equivalent enrollment action. No changes in coverage are effective unless an employee files an enrollment form or takes an equivalent enrollment action. Employees alone are responsible for knowing when an enrollment action is required, for taking the action, and for certifying that the information conveyed is complete and true.

B. The employer is responsible for checking that the employee fills in the form completely and accurately. The employer will certify each enrollment form in the space provided on the form.

C. The effective date of coverage shall be determined from the date the enrollment form is stamped as received by a designee of the department or the date of the equivalent enrollment action. This is generally the first of the month following receipt.

Except as noted here, coverage elections including those made by new employees are made on a prospective basis, that is, effective the first of the month following the receipt of the election form or enrollment action. However, if the receipt of the form or the date of the enrollment action is the first of the month, then the effective date will be the first of the month. Additionally, if an election form or enrollment action is received from a new employee on the first business day of the month, coverage for the new employee will commence on the first day of that month (see 1VAC55-20-370). Coverage elections made on account of a newborn, adoption, or placement for adoption are effective the date the child is born, adopted, or placed for adoption, as long as the employee makes the coverage election within 31 60 days of the event. Coverage terminations are effective the end of the month following receipt of an election notice, except for terminations that are required by the plan. Coverage terminations required by the plan are effective the end of the month that the event takes place. Examples of coverage terminations required by the plan are such things as a divorce, termination of employment, or a dependent child losing eligibility.

1VAC55-20-350. Membership.

A. Type of membership. Participants have a choice of three types of membership under the program:

1. Single (employee only). If a participant chooses employee only membership, the health benefits program does not cover the employee's dependents (spouse or children). A woman with single membership under the program does have maternity coverage. However, the newborn child is covered only for routine hospital nursery care, unless the mother changes to dual or family membership within 31 days of the date of birth.

2. Dual (employee and one eligible dependent).

3. Family membership (employee and two or more eligible dependents).

B. Changing type of membership.

1. Employees may change membership subject to 1VAC55-20-370.

a. During open enrollment.

b. Within 31 no more than 60 days of a qualifying mid-year event. Any such change in membership must be on account of and consistent with the event.

c. Within 31 no more than 60 days of a cost and coverage change, as acknowledged by the department.

2. All changes in membership must be made on a prospective basis except for the birth, adoption, or placement for adoption of a child.

3. If the change is from single to dual or family membership or vice versa because of a qualifying mid-year event, the employee must certify in the enrollment action the type of event and the date of the event.

1VAC55-20-370. Effective date of coverage.

A. General. Coverage and changes in coverage or membership are generally prospective, effective on the first day of the month following the month in which the enrollment action is received by the department's designee. Newly eligible employees. Newly eligible employees (new hires) have up to 30 calendar days to enroll in a health plan or flexible spending account offered by the state. The 30-day countdown period begins on the first day of employment and ends 30 calendar days later. If the enrollment action is received within the 30-calendar-day time frame, coverage will be effective the first of the month coinciding with or following the date of employment. There is no discretion allowed in this area. Coverage will always be effective in this manner. In no case will coverage begin before the eligible employee's first day of employment.

B. Date coverage begins. Coverage begins on the first day of the first full month of employment following the receipt of the employee's enrollment action. Employees who begin work on the first working day of the month are considered employed effective the first of the month. Thus, if an employee submits the completed enrollment action on or prior to the first working day of the month, coverage will be effective the first of the month in which employment commenced. Qualifying mid-year events. Employees who experience a qualifying mid-year event have 60 calendar days to make a consistent election change. The 60-day countdown period begins on the day of the event. Normally changes will be effective the first of the month following receipt of the enrollment action.

C. Exceptions. With prior approval from the department, coverage may be allowed to commence on an earlier date in limited circumstances when prior coverage is unavailable; for example, a new employee who has moved out of the service area of an HMO. Terminations required by the plan. Employees can only provide coverage for family members who meet the health plans' eligibility definition.

1VAC55-20-380. Leaves Leave of absence.

Note: This section addresses various aspects of employee leave and may or may not be applicable to a local employer.

A. Leave of absence with full pay. As long as an employee is still receiving full pay, health benefits coverage continues with the employer making its contribution. Nothing special must be done to maintain coverage. No action is required.

Local employers are not required to contribute toward coverage for any part-time employee granted any type of leave of absence.

B. Virginia Sickness and Disability Program, Long-Term Disability (VSDP-LTD).

1. LTD-working employees continue in active coverage until the end of the month in which the employee transitions to LTD-not working.

1. 2. Coverage with the employer contribution continues to the end of the month in which the LTD benefits begin, unless benefits begin on the first day of the month, in which case the employer contribution will end on the last day of the preceding month. Thereafter, employees may continue coverage by paying the entire cost of the coverage.

2. 3. Employees receiving LTD benefits may enroll in the State Retiree Health Benefits Program upon service retirement regardless of whether they have maintained health coverage in the state program provided that the individuals have been continuously covered and have had no break in long-term disability benefits prior to service retirement. The LTD participant has 31 days from the date of retirement to enroll in the State Retiree Health Benefits Program. Coverage in the retiree group begins on the first day of the first full month of retirement.

C. Educational leave -- full or partial pay. An official educational leave is a leave for educational reasons with partial or full pay maintained for the leave, not for work rendered. It is possible to maintain health coverage on an educational leave even when less than full pay is given provided that at least half pay is given. Coverage may continue for the duration of the leave up to 24 months.

D. Leave of absence without pay.

1. Coverage with the employer contribution continues to the end of the month in which the leave without pay begins provided the first day of the leave is after the first work day of the month. If the person returns from leave the following month and works at least half of the workdays in the month, coverage will be continuous. If the leave without pay begins on or before the first work day of the month, coverage and the employer contribution ceases on the last calendar day of the previous month.

2. Employees who do not want to continue coverage will be asked to sign a waiver.

E. Changing coverage while on leave. Coverage changes may be made while on leave in the same manner that changes may be made while actively employed. The same procedures and rules apply.

An employee enrolled in an alternative health benefits plan who moves out of the plan's service area while on a leave of absence may change to another plan offered by the department in his new location by taking an enrollment action within 31 60 days of the date of the move.

F. Returning from leave without pay.

1. Employees who have maintained coverage while on leave without pay. If the employee has maintained coverage while on leave, the employee's coverage in the health benefits program (with the employer making its contribution) will begin on the first of the month following the date the employee returns to full-time employment. However, if the return to work falls on the first day of the month then the employer contributions may begin immediately. It is not necessary for the employee to take a new enrollment action.

Employees may change from single to dual or family membership within 31 60 days of returning from leave without pay if the employee dropped dual or family membership during the leave or if there was a qualifying mid-year event during the leave. A new enrollment action must be taken. In the case of a qualifying mid-year event, the effective date would follow the rule on initiating dual or family membership at the time of the particular qualifying mid-year event.

2. Employees who have not maintained coverage while on leave will be treated in the same manner as new employees, unless they have exercised their rights under the Family Medical Leave Act. If these rights are exercised, they will have all rights that are required by law.

a. It shall be necessary to take a new enrollment action to receive coverage. The enrollment action shall indicate the date the employee returned to work as the date that the employee's continuous full-time employment commenced.

b. The employee has a choice of type of membership and plan.

c. The usual deadlines for filing apply. Coverage begins according to the rules and procedures for new employees.

3. Employees returning from military leave for active service. Employees returning from military leave of 30 days or more have the same choice of coverage as a new employee. If the employee returning from a military leave applies for coverage within 31 days of discharge, the coverage will begin on either the first day of the month of discharge or the first of the following month, whichever is necessary to effect continuous coverage.

4. Taking a second leave without pay. If an employee returns from a leave without pay and is employed full-time on every scheduled work day for at least one full calendar month before taking another leave without pay, the second leave will be treated as a new leave. If there is less than one calendar month of full-time employment between leaves without pay, the leaves will be treated as one, regardless of the types of leave. The length of time that coverage may be continued will depend on the current type of leave.

1VAC55-20-390. Termination of coverage.

A. Coverage ends at the end of the month in which an employee terminates the employment relationship, otherwise loses group eligibility, or on the last day of the month for which premiums are paid.

B. Coverage ends on the date of a participant's death. Coverage for family members of state employees continues until the end of the month following the month in which the participant died.

1. A surviving state beneficiary may enroll in the state retiree group if:

a. The state dependent is eligible for an annuity under the VRS Virginia Retirement System (VRS) death-in-service provision;

b. The employee had submitted a disability retirement application naming the dependent under the survivor option before his death and the employee died prior to achieving the retirement date; or

c. The death was job related.

To continue coverage, the family member must apply within 60 days of the date the coverage would otherwise end due to the death.

2. Survivors of deceased state employees who are not eligible for an annuity from VRS can nonetheless be covered under the State Health Benefits Program if they had coverage at the time the employee died. To continue coverage, the state family member must apply within 60 days of the employee's death.

C. In the event that an employee on leave without pay notifies the employer that he is terminating employment, coverage ends on the last day of the month in which the leave without pay ceases.

1VAC55-20-400. Termination of employment.

A. Coverage continues to the end of the month in which an employee terminates. Each terminating employee may elect continuation of coverage pursuant to Internal Revenue Code section 4980B and accompanying regulations.

B. Terminating employees may also have the option of converting to a non-group policy. The carrier will send the employee a letter offering non-group coverage. The employee will have 30 days after the date of the letter to reply in order for coverage to be continuous. All terminating employees will be given certificates of coverage as required by the Health Insurance Portability and Accountability Act.

1VAC55-20-410. Suspension and reinstatement of state employees.

A. General.

1. Coverage generally continues with the state contribution through the end of the month in which the suspension began. However, if the suspension was effective on or before the first work day of the month, there will be no coverage for that month unless the employee is reinstated in time to work half of the work days in the month. For example, if a suspension is effective on April 19, the employee will have coverage with the state contribution through the end of April. If the suspension is effective April 1, the employee will have no must pay the entire cost of coverage in for the month of April. By the same token, if the suspension is effective April 2 and the employee's first workday in April is April 3, the employee will not have coverage the state contribution in April. If the employee is reinstated in time to work half of the workdays in the month following the month in which the suspension began, there will be continuous coverage.

2. If the employee is suspended pending court action or pending an official investigation, the suspension may go beyond one pay period. In these cases, coverage will continue with the state contribution to the end of the month in which the suspension began. If the employee is reinstated in time to work half of the workdays of the month following the month in which the suspension began, there would be no break in coverage. Suspension beyond that period should be handled in the same way as a leave without pay with no employer contribution. The employee may waive coverage or remain in the group by paying the full monthly contributions contribution to the employer in advance. Group coverage may continue until a court decision is issued or the official investigation is completed, or up to a period of 12 months, whichever is less.

3. If the employee is reinstated with back benefits, the employer should refund the employee the amount of the employer contribution during the period the employee paid the full premium. Single membership should be reinstated retroactive to the date the employee was removed from the group up to a limit of 60 days. Retroactive dual or family membership will be available up to a maximum period of 60 days. Appropriate contributions must be made to cover the retroactive period. Alternatively, the family membership may begin the first full month of reinstatement if the employee applies within 31 days of reinstatement. Previous coverage elections, including dual and family memberships, will be reinstated retroactively.

B. Termination and grievance reinstatement.

1. Employees who are terminated and file a grievance shall be treated as terminated employees and may elect extended coverage or nongroup coverage. In the event such an employee is reinstated with back pay, he will be given single membership retroactive up to 60 days. Retroactive dual or family membership will be available up to a maximum period of 60 days. previous health and flexible spending account elections will be reinstated retroactively. Appropriate contributions must be made to cover the period.

2. If the employee is reinstated without full back pay, no retroactive coverage is available.

1VAC55-20-430. Coordination of benefits.

A. Employees are required to notify the plan administrator that they or a covered dependent are enrolled under another plan. If a plan participant is eligible for coverage under two or more plans, the plans involved will share the responsibility for the participant's benefits according to these rules. New employees will receive and be required to respond to a coordination of benefits (COB) inquiry letter following enrollment in the health plan. Employees should notify the plan administrator if coverage changes during employment for them or a covered dependent. If a plan participant is eligible for coverage under two or more plans, the plans involved will share the responsibility for the participant's benefits according to these rules.

1. If the other coverage does not have COB rules substantially similar to the participant's health plan's rules, the other coverage will be primary.

2. If a covered person is enrolled as the employee under one coverage and as a dependent under another, generally the one that covers him as the employee will be primary. The plan that covers a person as an active employee, that is an employee who is neither laid off nor retired, or as a dependent of an active employee is the primary plan. The plan covering that same person as a retired or laid-off employee or as a dependent of a retired or laid-off employee is the secondary plan.

3. If a covered person is the employee under both coverages, generally the one that covers him for the longer period of time will be primary.

4. If the dependent is covered as a dependent on his parent's or parents' plan and is also covered as a dependent on his spouse's plan, the spouse's plan is primary.

5. If the covered person is enrolled as a dependent child under both coverages (for example, when both parents cover their child), typically the coverage of the parent whose birthday falls earliest in the calendar year will be primary.

6. Special rules apply when a covered person is enrolled as a dependent child under two coverages and the child's parents are living apart. Generally, the coverage of the parent or step-parent with custody will be primary. However, if there is a court order that requires one parent to provide health care for the child, that parent's coverage will be primary. If there is a court order that states the parents share joint custody without designating that one parent is responsible for medical expenses, the parent whose birthday falls earliest in the plan year will be primary.

7. If a covered active employee or employee's dependent is also covered by Medicare, the coverage provided by the employer is primary, unless Medicare eligibility is due to end stage renal disease and the coordination period has been exhausted.

8. If a covered retiree, survivor, or long-term disability participant, or a covered dependent of any of these, is eligible for Medicare, the Medicare-eligible member is not eligible for active employee coverage under the member's health plan, except during an end stage renal disease coordination period.

B. If the other health benefit plan contains a coordination of benefits provision establishing the substantially same order of benefit determination rules as the ones in this section, the following will apply in the order of priority listed:

1. The plan that lists the person receiving services as the enrollee, insured or policyholder, not as a dependent, will provide primary coverage. There is one exception. If the person is also entitled to Medicare, and as a result of federal law Medicare is (i) secondary to the plan covering the person as a dependent; and (ii) primary to the plan covering the person as other than a dependent (e.g., a retired employee), then the benefits of the plan covering the person as a dependent are determined before those of the plan covering the person as other than a dependent.

2. Primary coverage for an enrolled child will be the plan which lists the parent whose month and day of birth occurs earliest in the calendar year as an enrollee, insured, or policyholder, except in the following circumstances:

a. When the parents are separated or divorced, primary coverage will be the plan that covers the child as a dependent of the parent with custody. The plan of the husband or wife of a remarried parent with custody may provide primary coverage if the remarried parent with custody does not have a plan that covers the child.

b. Despite subdivision 2 a of this subsection, if there is a court order that requires one parent to provide hospital or medical/surgical coverage for the child, primary coverage will be that parent's plan. If the specific terms of a court decree state that the parents will share joint custody and the court decree does not state that one of the parents is responsible for health care expenses of the child, then the rule set forth in the first sentence of subdivision 2 of this subsection, the birthday rule, will apply.

3. If subdivisions 1 and 2 of this subsection do not apply, primary coverage will be the plan that has covered the participant for the longest uninterrupted period of time. There are two exceptions to this rule:

a. The benefits of the plan that covers the person as a working employee (or the employee's dependent) will be determined before those of the plan that covers the person as a laid-off or retired employee (or the employee's dependent).

b. The benefits of the plan that covers the person as an employee (or the employee's dependent) will be determined before those of the plan that covers the person under a right of continuation pursuant to federal or state law.

B. When the participant's health plan is the primary coverage, it pays first. When the participant's health plan is the secondary coverage, it pays second as follows:

1. The plan administrator calculates the amount the participant's health plan would have paid if it had been primary coverage, then coordinates this amount with the primary plan's payment. The participant's health plan's payment in combination with the other plan's payment will never exceed the amount the participant's health plan would have paid if it had been the participant's primary coverage.

2. Some plans provide services rather than making a payment (i.e., a group model HMO). When such a plan is the primary coverage, the participant's health plan will assign a reasonable cash value for the services and that will be considered the plan's primary payment. The participant's health plan will then coordinate with the primary plan based on that value.

3. In no event will the participant's health plan pay more in benefits as secondary coverage than it would have paid as primary coverage.

C. If a plan does not have a coordination of benefits provision establishing substantially the same order of benefit determination rules as the ones in this section, that plan will be the primary coverage.

D. If, under the priority rules, the state plan is the primary coverage, participants will receive unreduced benefits for covered services to which they are entitled under this plan.

E. If the other plan is the primary coverage, the participant's benefits will be reduced so that the total benefit paid under this plan and the other plan will not exceed the benefits payable for covered services under this plan absent the other plan. In calculating benefits that would have been paid under this plan absent the other plan, any reduction in benefits for failure to receive a referral will not be considered. Benefits that would have been paid if the participant had filed a claim under the primary coverage will be counted and included as benefits provided. In a calendar year, benefits will be coordinated as claims are received.

F. When a health benefit plan provides benefits in the form of services, a reasonable cash value will be assigned to each covered service. This cash value will be considered a "benefit payment."

G. At the option of the plan administrator, payments may be made to anyone who paid for the coordinated services the participant received. These benefit payments by the administrator are ones that normally would have been made to the employee or on the employee's behalf to a facility or provider. The benefit payments made by the administrator will satisfy the obligation to provide benefits for covered services.

H. C. If the administrator provided primary coverage and discovers later that it should have provided secondary coverage, the administrator has the right to recover the excess payment from the employee or any other person or organization. If excess benefit payments are made on behalf of the employee, the employee must cooperate with the administrator in exercising its right of recovery.

I. D. Employees are obligated to supply the plan administrator all information needed to administer this coordination of benefits provision. This must be done before an employee is entitled to receive benefits under this plan. Further, the employees must agree that the administrator has the right to obtain or release information about covered services or benefits received. This right will be used only when working with another person or organization to settle payments for coordinated services. The employee's prior consent is not required.

1VAC55-20-460. Alternative health benefit plans.

The department also offers several health maintenance organization and preferred provider organization plans which that are available to participants residing in the service area of the HMO or PPO. A list of these plans is available upon request to the department.

Non-Medicare-eligible retirees have the same enrollment options as active employees.

Retirees must enroll in a plan within 31 days of separation for retirement. A separating state employee who defers retirement will not be eligible to enroll in a retiree medical plan when the former employee seeks retirement benefits.

FORMS (1VAC55-20)

Adoption Agreement.

Health Benefits Program Application.

Enrollment Application/Waiver Form SHBP (rev. 3/01).

Out of Area Exception Form.

Name/Address Change.

Claim Forms.

Extended Coverage.

Explanation of Benefits.

Interagency Transfer Invoice.

HIPAA Certificate.

Adoption Agreement, T20082 (R1/02)

Commonwealth of Virginia Health Benefits Program Application, T20445 (rev. 1/13)

Enrollment Form - The Local Choice Health Benefits Program, T20911 (1/14)

General Notice of Extended Coverage Rights (rev. 3/05)

Interagency Transfer Invoice, Department of Accounts DA-02-039 (rev. 7/86)

Commonwealth of Virginia Certificate of Group Health Plan Coverage and Statement of HIPAA Portability Rights (rev. 4/05).

State Health Benefits Program Appeal Form (rev. 5/11)

Title of Regulation: 12VAC30-120. Waivered Services (amending 12VAC30-120-700 through 12VAC30-120-776).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC § 1396.

Effective Date: April 10, 2014.

Agency Contact: Lois Gray, Regulatory Coordinator, Department of Medical Assistance Services, Policy and Research Division, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-4300, FAX (804) 786-1680, or email lois.gray@dmas.virginia.gov.

Summary:

The amendments (i) move the daily administrative responsibilities for the Individuals and Families with Developmental Disabilities Support (DD Waiver) from the Department of Medical Assistance Services to the Department of Behavioral Health and Developmental Services; (ii) change the term "mental retardation" to "intellectual disability"; (iii) update existing form names and numbers in regulation text; (iii) change references to "prior authorization" to "service authorization"; (iv) move existing requirements to more logical places in the text; (v) update state agency names; and (vi) remove references to the Medicaid AIDS waiver.

Part VIII
Individual and Family Developmental Disabilities Support Waiver

Article 1
General Requirements

12VAC30-120-700. Definitions.

"Activities of daily living (ADL)" or "ADL" means personal care tasks, e.g., bathing, dressing, toileting, transferring, and eating/feeding. An individual's degree of independence in performing these activities is a part of determining appropriate level of care and services.

"Appeal" means the process used to challenge adverse actions regarding services, benefits, and reimbursement provided by Medicaid pursuant to 12VAC30-110, Eligibility and Appeals, and 12VAC30-20-500 through 12VAC30-20-560.

"Assistive technology" means specialized medical equipment and supplies including those devices, controls, or appliances specified in the plan of care but not available under the State Plan for Medical Assistance that enable individuals to increase their abilities to perform activities of daily living, or to perceive, control, or communicate with the environment in which they live, or that are necessary to the proper functioning of the specialized equipment.

"Behavioral health authority" or "BHA" means the local agency, established by a city or county or a combination of counties or cities or cities and counties under Chapter 6 (§ 37.2-600 et seq.) of Title 37.2 of the Code of Virginia, that plans, provides, and evaluates mental health, mental retardation intellectual disability, and substance abuse services in the jurisdiction or jurisdictions it serves.

"CARF" means the Rehabilitation Accreditation Commission, formerly known as the Commission on Accreditation of Rehabilitation Facilities.

"Case management" means services as defined in 12VAC30-50-490.

"Case manager" means the provider of case management services as defined in 12VAC30-50-490.

"Centers for Medicare and Medicaid Services" or "CMS" means the unit of the federal Department of Health and Human Services that administers the Medicare and Medicaid programs.

"Community-based waiver services" or "waiver services" means a variety of home and community-based services paid for by DMAS as authorized under a § 1915(c) waiver designed to offer individuals an alternative to institutionalization. Individuals may be preauthorized to receive one or more of these services either solely or in combination, based on the documented need for the service or services to avoid ICF/MR ICF/IID placement.

"Community services board" or "CSB" means the local agency, established by a city or county or combination of counties or cities, or cities and counties, under Chapter 5 (§ 37.2-500 et seq.) of Title 37.2 of the Code of Virginia, that plans, provides, and evaluates mental health, mental retardation intellectual disability, and substance abuse services in the jurisdiction or jurisdictions it serves.

"Companion" means, for the purpose of these regulations, a person who provides companion services.

"Companion services" means nonmedical care, supervision, and socialization provided to an adult (age 18 and years or older). The provision of companion services does not entail hands-on care. It is provided in accordance with a therapeutic goal in the plan of care and is not purely diversional in nature.

"Consumer-directed employee" means, for purposes of these regulations, a person who provides consumer-directed services, personal care, companion services, and/or or respite care, who is also exempt from workers' compensation.

"Consumer-directed services" means personal care, companion services, and/or or respite care services where the individual or his family/caregiver, as appropriate, is responsible for hiring, training, supervising, and firing of the employee or employees.

"Consumer-directed (CD) services facilitator" means the provider enrolled with DMAS who is responsible for management training and review activities as required by DMAS for consumer-directed services.

"Crisis stabilization" means direct intervention for persons with related conditions who are experiencing serious psychiatric or behavioral challenges, or both, that jeopardize their current community living situation. This service must provide temporary intensive services and supports that avert emergency psychiatric hospitalization or institutional placement or prevent other out-of-home placement. This service shall be designed to stabilize individuals and strengthen the current living situations so that individuals may be maintained in the community during and beyond the crisis period.

"Current functional status" means an individual's degree of dependency in performing activities of daily living.

"DARS" means the Department for Aging and Rehabilitative Services.

"DBHDS" means the Department of Behavioral Health and Developmental Services.

"DBHDS staff" means employees of DBHDS who provide technical assistance and review individual level of care criteria.

"DMAS" means the Department of Medical Assistance Services.

"DMAS staff" means DMAS employees who perform utilization review, preauthorize service type and intensity, and provide technical assistance, and review of individual level of care criteria.

"DMHMRSAS" means the Department of Mental Health, Mental Retardation and Substance Abuse Services.

"DRS" means the Department of Rehabilitative Services.

"DSS" means the Department of Social Services.

"Day support" means training in intellectual, sensory, motor, and affective social development including awareness skills, sensory stimulation, use of appropriate behaviors and social skills, learning and problem solving, communication and self care, physical development, services and support activities. These services take place outside of the individual's home/residence.

"Direct marketing" means either (i) conducting directly or indirectly door-to-door, telephonic, or other "cold call" marketing of services at residences and provider sites; (ii) mailing directly; (iii) paying "finders' fees"; (iv) offering financial incentives, rewards, gifts, or special opportunities to eligible individuals or family/caregivers as inducements to use the providers' services; (v) continuous, periodic marketing activities to the same prospective individual or his family/caregiver, as appropriate, for example, monthly, quarterly, or annual giveaways as inducements to use the providers' services; or (vi) engaging in marketing activities that offer potential customers rebates or discounts in conjunction with the use of the providers' services or other benefits as a means of influencing the individual's or his family/caregiver's, as appropriate, use of the providers' services.

"Enroll" means that the individual has been determined by the IFDDS screening team to meet the eligibility requirements for the waiver, DMAS DBHDS has approved the individual's plan of care and has assigned an available slot to the individual, and DSS has determined the individual's Medicaid eligibility for home and community-based services.

"Entrepreneurial model" means a small business employing eight or fewer individuals with disabilities on a shift and may involve interactions with the public and coworkers with disabilities.

"Environmental modifications" means physical adaptations to a house, place of residence, primary vehicle or work site, when the work site modification exceeds reasonable accommodation requirements of the Americans with Disabilities Act, necessary to ensure individuals' health and safety or enable functioning with greater independence when the adaptation is not being used to bring a substandard dwelling up to minimum habitation standards and is of direct medical or remedial benefit to individuals.

"EPSDT" means the Early Periodic Screening, Diagnosis and Treatment program administered by DMAS for children under the age of 21 years according to federal guidelines that prescribe specific preventive and treatment services for Medicaid-eligible children as defined in 12VAC30-50-130.

"Face-to-face visit" means the case manager or service provider must meet with the individual in person and that the individual should be engaged in the visit to the maximum extent possible.

"Family/caregiver training" means training and counseling services provided to families or caregivers of individuals receiving services in the IFDDS Waiver.

"Fiscal agent" means an entity handling employment, payroll, and tax responsibilities on behalf of individuals who are receiving consumer-directed services.

"Home" means, for purposes of the IFDDS Waiver, an apartment or single family dwelling in which no more than four individuals who require services live, with the exception of siblings living in the same dwelling with family. This does not include an assisted living facility or group home.

"Home and community-based waiver services" means a variety of home and community-based services reimbursed by DMAS as authorized under a § 1915(c) waiver designed to offer individuals an alternative to institutionalization. Individuals may be preauthorized to receive one or more of these services either solely or in combination, based on the documented need for the service or services to avoid ICF/MR ICF/IID placement.

"ICF/MR" "ICF/IID" means a facility or distinct part of a facility certified as meeting the federal certification regulations for an Intermediate Care Facility for the Mentally Retarded Individuals with Intellectual Disabilities and persons with related conditions. These facilities must address the residents' total needs including physical, intellectual, social, emotional, and habilitation. An ICF/MR ICF/IID must provide active treatment, as that term is defined in 42 CFR 483.440(a).

"IDEA" means the federal Individuals with Disabilities Education Act of 2004, 20 USC § 1400 et seq.

"ID Waiver" means the Intellectual Disability waiver.

"IFDDS screening team" means the persons employed by the entity under contract with DMAS who are responsible for performing level of care screenings for the IFDDS Waiver.

"IFDDS Waiver," "IFDDS," or "DD" means the Individual and Family Developmental Disabilities Support Waiver.

"In-home residential support services" means support provided primarily in the individual's home, which includes training, assistance, and specialized supervision to enable the individual to maintain or improve his health; assisting in performing individual care tasks; training in activities of daily living; training and use of community resources; providing life skills training; and adapting behavior to community and home-like environments.

"Instrumental activities of daily living (IADL)" or "IADL" means meal preparation, shopping, housekeeping, laundry, and money management.

"Mental retardation" means a disability as defined by the American Association on Intellectual and Developmental Disabilities (AAIDD).

"MR Waiver" means the mental retardation waiver.

"Intellectual disability" or "ID" means a disability as defined by the American Association on Intellectual and Developmental Disabilities (AAIDD) in the Intellectual Disability: Definition, Classification, and Systems of Supports (11th edition, 2010).

"Participating provider" means an entity that meets the standards and requirements set forth by DMAS and has a current, signed provider participation agreement with DMAS.

"Pend" means delaying the consideration of an individual's request for authorization of services until all required information is received by DMAS or by its authorized agent.

"Person-centered planning" means a process, directed by the individual or his family/caregiver, as appropriate, intended to identify the strengths, capacities, preferences, needs and desired outcomes of the individual.

"Personal care provider" means a participating provider that renders services to prevent or reduce inappropriate institutional care by providing eligible individuals with personal care aides to provide personal care services.

"Personal care services" means long-term maintenance or support services necessary to enable individuals to remain in or return to the community rather than enter an Intermediate Care Facility for the Mentally Retarded Individuals with Intellectual Disabilities. Personal care services include assistance with activities of daily living, instrumental activities of daily living, access to the community, medication or other medical needs, and monitoring health status and physical condition. This does not include skilled nursing services with the exception of skilled nursing tasks that may be delegated in accordance with 18VAC90-20-420 through 18VAC90-20-460.

"Personal emergency response system (PERS)" or "PERS" is an electronic device that enables certain individuals to secure help in an emergency. PERS services are limited to those individuals who live alone or are alone for significant parts of the day and who have no regular caregiver for extended periods of time, and who would otherwise require extensive routine supervision.

"Plan of care" means a document developed by the individual or his family/caregiver, as appropriate, and the individual's case manager addressing all needs of individuals of home and community-based waiver services, in all life areas. Supporting documentation developed by waiver service providers is to be incorporated in the plan of care by the case manager. Factors to be considered when these plans are developed must include, but are not limited to, individuals' ages, levels of functioning, and preferences.

"Preauthorized" means the preauthorization service authorization agent has approved a service for initiation and reimbursement of the service by the service provider.

"Primary caregiver" means the primary person who consistently assumes the role of providing direct care and support of the individual to live successfully in the community without compensation for such care.

"Qualified developmental disabilities professional" or "QDDP" means a professional who (i) possesses at least one year of documented experience working directly with individuals who have related conditions; (ii) is one of the following: a doctor of medicine or osteopathy, a registered nurse, a provider holding at least a bachelor's degree in a human service field including, but not limited to, sociology, social work, special education, rehabilitation engineering, counseling or psychology, or a provider who has documented equivalent qualifications; and (iii) possesses the required Virginia or national license, registration, or certification in accordance with his profession, if applicable.

"Related conditions" means those persons who have autism or who have a severe chronic disability that meets all of the following conditions identified in 42 CFR 435.1009:

1. It is attributable to:

a. Cerebral palsy or epilepsy; or

b. Any other condition, other than mental illness, found to be closely related to mental retardation intellectual disability because this condition results in impairment of general intellectual functioning or adaptive behavior similar to that of persons with mental retardation intellectual disability, and requires treatment or services similar to those required for these persons.

2. It is manifested before the person reaches age 22 years.

3. It is likely to continue indefinitely.

4. It results in substantial functional limitations in three or more of the following areas of major life activity:

a. Self-care.

b. Understanding and use of language.

c. Learning.

d. Mobility.

e. Self-direction.

f. Capacity for independent living.

"Respite care" means services provided for unpaid caregivers of eligible individuals who are unable to care for themselves and are provided on an episodic or routine basis because of the absence of or need for relief of those unpaid persons who routinely provide the care.

"Respite care provider" means a participating provider that renders services designed to prevent or reduce inappropriate institutional care by providing respite care services for unpaid caregivers of eligible individuals.

"Screening" means the process conducted by the IFDDS screening team to evaluate the medical, nursing, and social needs of individuals referred for screening and to determine eligibility for an ICF/MR ICF/IID level of care.

"Skilled nursing services" means nursing services (i) listed in the plan of care that do not meet home health criteria, (ii) required to prevent institutionalization, (iii) not otherwise available under the State Plan for Medical Assistance, (iv) provided within the scope of the state's Nursing Act (§ 54.1-3000 et seq. of the Code of Virginia) and Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), and (v) provided by a registered professional nurse or by a licensed practical nurse under the supervision of a registered nurse who is licensed to practice in the state. Skilled nursing services are to be used to provide training, consultation, nurse delegation as appropriate, and oversight of direct care staff as appropriate.

"Slot" means an opening or vacancy of waiver services for an individual.

"Specialized supervision" means staff presence necessary for ongoing or intermittent intervention to ensure an individual's health and safety.

"State Plan for Medical Assistance" or "the State Plan" means the document containing the covered groups, covered services and their limitations, and provider reimbursement methodologies as provided for under Title XIX of the Social Security Act.

"Supporting documentation" means the specific plan of care developed by the individual and waiver service provider related solely to the specific tasks required of that service provider. Supporting documentation helps to comprise the overall plan of care for the individual, developed by the case manager and the individual.

"Supported employment" means work in settings in which persons without disabilities are typically employed. It includes training in specific skills related to paid employment and provision of ongoing or intermittent assistance and specialized supervision to enable an individual to maintain paid employment.

"Therapeutic consultation" means consultation provided by members of psychology, social work, rehabilitation engineering, behavioral analysis, speech therapy, occupational therapy, psychiatry, psychiatric clinical nursing, therapeutic recreation, or physical therapy or behavior consultation to assist individuals, parents, family members, in-home residential support, day support, and any other providers of support services in implementing a plan of care.

"Transition services" means set-up expenses for individuals who are transitioning from an institution or licensed or certified provider-operated living arrangement to a living arrangement in a private residence where the person is directly responsible for his or her own living expenses. 12VAC30-120-2010 provides the service description, criteria, service units and limitations, and provider requirements for this service.

"VDH" means the Virginia Department of Health.

12VAC30-120-710. General coverage and requirements for all home and community-based waiver services.

A. Waiver service populations. Home and community-based services shall be available through a § 1915(c) waiver. Coverage shall be provided under the waiver for individuals six years of age and or older with related conditions as defined in 12VAC30-120-700, including autism, who have been determined to require the level of care provided in an ICF/MR ICF/IID. The individual must not have a diagnosis of mental retardation intellectual disability as defined by the American Association on Intellectual and Developmental Disabilities (AAIDD). Mental Retardation (MR) Intellectual Disability Waiver recipients who are six years of age on or after October 1, 2002, who are determined to not have a diagnosis of mental retardation intellectual disability, and who meet all IFDDS Waiver eligibility criteria, shall be eligible for and shall transfer to the IFDDS Waiver effective with their sixth birthday. Psychological evaluations confirming diagnoses must be completed less than one year prior to the child's sixth birthday. These recipients transferring from the MR ID Waiver will automatically be assigned a slot in the IFDDS Waiver. Such slot shall be in addition to those slots available through the screening process described in 12VAC30-120-720 B and C.

B. Covered services.

1. Covered services shall include in-home residential supports, day support, prevocational services, supported employment, personal care (both agency-directed and consumer-directed), respite care (both agency-directed and consumer-directed), assistive technology, environmental modifications, skilled nursing services, therapeutic consultation, crisis stabilization, personal emergency response systems (PERS), family/caregiver training, companion services (both agency-directed and consumer-directed), and transition services.

2. These services shall be appropriate and medically necessary to maintain these individuals in the community. Federal waiver requirements provide that the average per capita fiscal year expenditures under the waiver must not exceed the average per capita expenditures for the level of care provided in ICFs/MR ICFs/IID under the State Plan that would have been made had the waiver not been granted.

3. Under this § 1915(c) waiver, DMAS waives subdivision (a)(10)(B) of § 1902 of the Social Security Act related to comparability.

C. Eligibility criteria for emergency access to the waiver.

1. Subject to available funding and a finding of eligibility under 12VAC30-120-720, individuals must meet at least one of the emergency criteria of this subdivision to be eligible for immediate access to waiver services without consideration to the length of time an individual has been waiting to access services. In the absence of waiver services, the individual would not be able to remain in his home. The criteria are as follows:

a. The primary caregiver has a serious illness, has been hospitalized, or has died;

b. The individual has been determined by the DSS to have been abused or neglected and is in need of immediate waiver services;

c. The individual demonstrates behaviors that present risk to personal or public safety;

d. The individual presents extreme physical, emotional, or financial burden at home, and the family or caregiver is unable to continue to provide care; or

e. The individual lives in an institutional setting and has a viable discharge plan in place.

2. When emergency slots become available:

a. All individuals who have been found eligible for the IFDDS Waiver but have not been enrolled shall be notified by either DMAS DBHDS or the individual's case manager.

b. Individuals and their family/caregivers shall be given 30 calendar days to request emergency consideration.

c. An interdisciplinary team of DMAS DBHDS professionals shall evaluate the requests for emergency consideration within 10 calendar days from the 30-calendar day deadline using the emergency criteria to determine who will be assigned an emergency slot. If DMAS DBHDS receives more requests than the number of available emergency slots, then the interdisciplinary team will make a decision on slot allocation based on need as documented in the request for emergency consideration. A waiting list of emergency cases will not be kept.

D. Appeals. Individual appeals shall be considered pursuant to 12VAC30-110-10 through 12VAC30-110-380 12VAC30-110-370. Provider appeals shall be considered pursuant to 12VAC30-10-1000 and 12VAC30-20-500 through 12VAC30-20-599 12VAC30-20-560.

12VAC30-120-720. Qualification and eligibility requirements; intake process.

A. Individuals receiving services under this waiver must meet the following requirements. Virginia will apply the financial eligibility criteria contained in the State Plan for the categorically needy. Virginia has elected to cover the optional categorically needy groups under 42 CFR 435.121 and 435.217. The income level used for 42 CFR 435.121 and 435.217 is 300% of the current Supplemental Security Income payment standard for one person.

1. Under this waiver, the coverage groups authorized under § 1902(a)(10)(A)(ii)(VI) of the Social Security Act will be considered as if they were institutionalized for the purpose of applying institutional deeming rules. All individuals under the waiver must meet the financial and nonfinancial Medicaid eligibility criteria and meet the institutional level of care criteria. The deeming rules are applied to waiver eligible individuals as if the individual were residing in an institution or would require that level of care.

2. Virginia shall reduce its payment for home and community-based waiver services provided to an individual who is eligible for Medicaid services under 42 CFR 435.217 by that amount of the individual's total income (including amounts disregarded in determining eligibility) that remains after allowable deductions for personal maintenance needs, deductions for other dependents, and medical needs have been made, according to the guidelines in 42 CFR 435.735 and § 1915(c)(3) of the Social Security Act as amended by the Consolidated Omnibus Budget Reconciliation Act of 1986. DMAS will reduce its payment for home and community-based waiver services by the amount that remains after the following deductions:

a. For individuals to whom § 1924(d) applies, and for whom Virginia waives the requirement for comparability pursuant to § 1902(a)(10)(B), deduct the following in the respective order:

(1) The basic maintenance needs for an individual, which is equal to 165% of the SSI payment for one person. Due to expenses of employment, a working individual shall have an additional income allowance. For an individual employed 20 hours or more per week, earned income shall be disregarded up to a maximum of 300% SSI; for an individual employed at least eight but less than 20 hours per week, earned income shall be disregarded up to a maximum of 200% of SSI. If the individual requires a guardian or conservator who charges a fee, the fee, not to exceed an amount greater than 5.0% of the individual's total monthly income, is added to the maintenance needs allowance. However, in no case shall the total amount of the maintenance needs allowance (basic allowance plus earned income allowance plus guardianship fees) for the individual exceed 300% of SSI.

(2) For an individual with a spouse at home, the community spousal income allowance determined in accordance with § 1924(d) of the Social Security Act.

(3) For an individual with a family at home, an additional amount for the maintenance needs of the family determined in accordance with § 1924(d) of the Social Security Act.

(4) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including Medicare and other health insurance premiums, deductibles, or coinsurance charges and necessary medical or remedial care recognized under state law but not covered under the State Plan.

b. For individuals to whom § 1924(d) does not apply and for whom Virginia waives the requirement for comparability pursuant to § 1902(a)(10)(B), deduct the following in the respective order:

(1) The basic maintenance needs for an individual, which is equal to 165% of the SSI payment for one person. Due to expenses of employment, a working individual shall have an additional income allowance. For an individual employed 20 hours or more per week, earned income shall be disregarded up to a maximum of 300% SSI; for an individual employed at least eight but less than 20 hours per week, earned income shall be disregarded up to a maximum of 200% of SSI. If the individual requires a guardian or conservator who charges a fee, the fee, not to exceed an amount greater than 5.0% of the individual's total monthly income, is added to the maintenance needs allowance. However, in no case shall the total amount of the maintenance needs allowance (basic allowance plus earned income allowance plus guardianship fees) for the individual exceed 300% of SSI.

(2) For an individual with a dependent child or children, an additional amount for the maintenance needs of the child or children, which shall be equal to the Title XIX medically needy income standard based on the number of dependent children.

(3) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including Medicare and other health insurance premiums, deductibles, or coinsurance charges and necessary medical or remedial care recognized under state law but not covered under the State Medical Assistance Plan.

B. Screening.

1. To ensure that Virginia's home and community-based waiver programs serve only individuals who would otherwise be placed in an ICF/MR ICF/IID, home and community-based waiver services shall be considered only for individuals who are eligible for admission to an ICF/MR ICF/IID, absent a diagnosis of mental retardation intellectual disability and are age six years or older. Home and community-based waiver services shall be the critical service that enables the individual to remain at home rather than being placed in an ICF/MR ICF/IID.

2. To be eligible for IFDDS Waiver services, the individual must:

a. Be determined to be eligible for the ICF/MR ICF/IID level of care;

b. Be six years of age or older;

c. Meet the related conditions definition as defined in 42 CFR 435.1009 or be diagnosed with autism; and

d. Not have a diagnosis of mental retardation intellectual disability as defined by the American Association on Mental Retardation (AAMR) Intellectual and Developmental Disabilities (AAIDD).

3. Children under A child younger than six years of age shall not be screened until three months prior to the month of their sixth birthday. Children under A child younger than six years of age shall not be added to the waiver or the wait list until the month in which their the child's sixth birthday occurs.

4. The IFDDS screening team shall gather relevant medical and social data and identify all services received by and supports available to the individual. The IFDDS screening team shall also gather psychological evaluations or refer the individual to a private or publicly funded psychologist for evaluation of the cognitive abilities of each screening applicant.

5. The individual's status as an individual in need of IFDDS home and community-based care waiver services shall be determined by the IFDDS screening team after completion of a thorough assessment of the individual's needs and available supports. Screening for home and community-based care waiver services by the IFDDS screening team or DMAS DBHDS staff is mandatory before Medicaid will assume payment responsibility of home and community-based care waiver services.

6. The IFDDS screening team determines the level of care by applying existing DMAS ICF/MR ICF/IID criteria (12VAC30-130-430).

7. The IFDDS screening team shall explore alternative settings and services to provide the care needed by the individual with the individual and his family/caregiver, as appropriate. If placement in an ICF/MR ICF/IID or a combination of other services is determined to be appropriate, the IFDDS screening team shall initiate a referral for service to DMAS DBHDS. If Medicaid-funded home and community-based waiver services are determined to be the critical service to delay or avoid placement in an ICF/MR ICF/IID or promote exiting from an institutional setting, the IFDDS screening team shall initiate a referral for service to a case manager of the individual's choice. Referrals are based on the individual choosing either ICF/MR ICF/IID placement or home and community-based waiver services.

8. Home and community-based waiver services shall not be provided to any individual who resides in a nursing facility, an ICF/MR ICF/IID, a hospital, an adult family care home approved by the DSS, a group home licensed by DMHMRSAS DBHDS, or an assisted living facility licensed by the DSS. However, an individual may be screened for the IFDDS Waiver and placed on the wait list while residing in one of the aforementioned facilities.

9. The IFDDS screening team must submit the results of the comprehensive assessment and a recommendation to DMAS DBHDS staff for final determination of ICF/MR ICF/IID level of care and authorization for home and community-based waiver services.

10. For children receiving MR ID Waiver services prior to age six to transfer to the IFDDS Waiver during their sixth year, the individual's MR ID Waiver case manager shall submit to DMAS DBHDS the child's most recent Level of Functioning form, the plan of care, and a psychological examination completed no more than one year prior to transferring. Such documentation must demonstrate that no diagnosis of mental retardation intellectual disability exists in order for this transfer to the IFDDS Waiver to be approved. The case manager shall be responsible for notifying DMAS, DMHMRSAS, DBHDS and DSS, via the DMAS-122 DMAS-225, when a child transfers from the MR ID Waiver to the IFDDS Waiver. Transfers must be completed prior to the child's seventh birthday.

C. Waiver approval process: available funding.

1. In order to ensure cost effectiveness of the IFDDS Waiver, the funding available for the waiver is allocated between two budget levels. The budget is the cost of waiver services only and does not include the costs of other Medicaid covered services. Other Medicaid services, however, must be counted toward cost effectiveness of the IFDDS Waiver. All services available under the waiver are available to both levels.

2. Level one is for individuals whose comprehensive plans of care cost less than $25,000 per fiscal year. Level two is for individuals whose plans of care costs are equal to or more than $25,000. There is no threshold for budget level two; however, if the actual cost of waiver services exceeds the average annual cost of ICF/MR ICF/IID care for an individual, the individual's care is case managed by DMAS DBHDS staff.

3. Fifty percent of available waiver funds are allocated to budget level one, and 40% of available waiver funds are allocated to level two in order to ensure that the waiver is cost effective. The remaining 10% of available waiver funds is allocated for emergencies as defined in 12VAC30-120-710. In order to transition an appropriate number of level one slots to emergency slots, every third level one slot that becomes available will convert to an emergency slot until the percentage of emergency slots reaches 10%. Half of emergency slots will be allocated for individuals in institutional settings who are discharge ready and have a viable discharge plan to transition into the community within 60 days. If there are no such individuals who choose to discharge into the community when emergency slots are available for institutionalized individuals, the emergency slot will be allocated to an individual residing in the community who meets emergency criteria.

D. Assessment and enrollment.

1. The IFDDS screening team shall determine if an individual meets the functional criteria within 45 calendar days of receiving the request for screening from the individual or his family/caregiver, as appropriate. Once the IFDDS screening team determines that an individual meets the eligibility criteria for IFDDS Waiver services and the individual has chosen this service, the IFDDS screening team shall provide the individual with a list of available case managers. The individual or his family/caregiver, as appropriate, shall choose a case manager within 10 calendar days of receiving the list of case managers and the IFDDS screening team shall forward the screening materials within 10 calendar days of the case manager's selection to the selected case manager.

2. The case manager shall contact the individual within 10 calendar days of receipt of screening materials. The case manager must meet face-to-face with the individual and his family/caregiver, as appropriate, within 30 calendar days to discuss the individual's needs, existing supports and to develop a preliminary plan of care identifying needed services and estimating the annual waiver cost of the individual's plan of care. If the individual's annual waiver services cost is expected to exceed the average annual cost of ICF/MR ICF/IID care for an individual, the individual's case management shall be provided by DMAS DBHDS.

3. Once the plan of care has been initially developed, the case manager shall contact DMAS DBHDS to request approval of the plan of care and to enroll the individual in the IFDDS Waiver. DMAS DBHDS shall, within 14 calendar days of receiving all supporting documentation, either approve for Medicaid coverage or deny for Medicaid coverage the plan of care.

4. Medicaid will not pay for any home and community-based waiver services delivered prior to the authorization date approved by DMAS. Any plan of care for home and community-based waiver services must be pre-approved by DMAS DBHDS prior to Medicaid reimbursement for waiver services.

5. The following five criteria shall apply to all IFDDS Waiver services:

a. Individuals qualifying for IFDDS Waiver services must have a demonstrated clinical need for the service resulting in significant functional limitations in major life activities. In order to be eligible, an individual must be six years of age or older, have a related condition as defined in these regulations, cannot have a diagnosis of mental retardation intellectual disability, and would, in the absence of waiver services, require the level of care provided in an ICF/MR ICF/IID facility, the cost of which would be reimbursed under the State Plan;

b. The plan of care and services that are delivered must be consistent with the Medicaid definition of each service;

c. Services must be approved by the case manager based on a current functional assessment tool approved by DMAS DBHDS or other DMAS-approved DBHDS-approved assessment and demonstrated need for each specific service;

d. Individuals qualifying for IFDDS Waiver services must meet the ICF/MR ICF/IID level of care criteria; and

e. The individual must be eligible for Medicaid as determined by the local office of DSS.

6. DMAS DBHDS shall only authorize a waiver slot for the individual if a slot is available. If DMAS DBHDS does not have a waiver slot for this individual, the individual shall be placed on the waiting list until such time as a waiver slot becomes available for the individual.

7. DMAS DBHDS will notify the case manager when a slot is available for the individual. The case manager shall also notify the local DSS by submitting a DMAS-122 DMAS-225 and IFDDS Level of Care Eligibility form. The case manager shall inform the individual so that the individual may apply for Medicaid if necessary and begin choosing waiver service providers for services listed in the plan of care.

8. The case manager forwards a copy of the completed DMAS-122 DMAS-225 to DMAS DBHDS. Upon receipt of the completed DMAS-122 DMAS-225, DMAS DBHDS shall enroll the individual into the IFDDS Waiver.

9. Once the individual has been determined to be Medicaid eligible and enrolled in the waiver, the individual or case manager shall contact the waiver service providers that the individual or his family/caregiver, as appropriate, chooses, who shall initiate waiver services within 60 calendar days. During this time, the individual, case manager, and waiver service providers shall meet to complete the provider's supporting documentation for the plan of care, implementing a person-centered planning process. The waiver service providers shall develop supporting documentation for each waiver service and shall submit a copy of this documentation to the case manager. If services are not initiated within 60 calendar days, the case manager must submit information to DMAS DBHDS demonstrating why more time is needed to initiate services and request in writing a 30-day 30-calendar-day extension, up to a maximum of four consecutive extensions, for the initiation of waiver services. DMAS DBHDS must receive the request for extension letter within the 30-day 30-calendar-day extension period being requested. DMAS DBHDS will review the request for extension and make a determination within 10 calendar days of receiving the request. DMAS DBHDS has authority to approve or deny the 30-day 30-calendar-day extension request. The waiver service providers shall develop supporting documentation for each waiver service and shall submit a copy of this documentation to the case manager.

10. The case manager shall monitor the waiver service providers' supporting documentation to ensure that all providers are working toward the identified goals of the individual. The case manager shall review and sign off on the supporting documentation. The case manager shall contact the preauthorization agent for prior service authorization of waiver services and shall notify the waiver service providers when waiver services are approved.

11. The case manager shall contact the individual at a minimum on a monthly basis and as needed to conduct case management activities as defined in 12VAC30-50-490. DMAS DBHDS shall conduct annual level of care reviews in which the individual is assessed to ensure continued waiver eligibility. DMAS DBHDS shall review individuals' plans of care and shall review the services provided by case managers and waiver service providers.

E. Reevaluation of service need and utilization review.

1. The plan of care.

a. The case manager shall develop the plan of care, implementing a person-centered planning process with the individual, his family/caregiver, as appropriate, other service providers, and other interested parties identified by the individual and/or or family/caregiver, based on relevant, current assessment data. The plan of care development process determines the services to be provided for individuals, the frequency of services, the type of service provided, and a description of the services to be offered. All plans of care written by the case managers must be approved by DMAS DBHDS prior to seeking authorization for services. DMAS is the single state authority responsible for the supervision of the administration of the home and community-based waiver.

b. The case manager is responsible for continuous monitoring of the appropriateness of the individual's services by reviewing supporting documentation and revisions to the plan of care as indicated by the changing needs of the individual. At a minimum, every three months the case manager must:

(1) Review the plan of care face-to-face with the individual and family/caregiver, as appropriate, using a person-centered planning approach;

(2) Review individual provider quarterly reports to ensure goals and objectives are being met; and

(3) Determine whether any modifications to the plan of care are necessary, based upon the needs of the individual.

c. At least once per plan of care year this review must be performed with the individual present, and his family/caregivers as appropriate, in the individual's home environment.

d. DMAS DBHDS staff shall review the plan of care every 12 months or more frequently as required to assure proper utilization of services. Any modification to the amount or type of services in the plan of care must be approved by DMAS DBHDS.

2. Annual reassessment.

a. The case manager or DMAS DBHDS, if DMAS DBHDS is acting as the individual's case manager, shall complete an annual comprehensive reassessment, in coordination with the individual, family family/caregiver, and service providers. If warranted, the case manager will coordinate a medical examination and a psychological evaluation for every waiver individual. The reassessment, completed in a person-centered planning manner, must include an update of the assessment instrument and any other appropriate assessment data.

b. A medical examination must be completed for adults 18 years of age and older based on need identified by the individual, his family/caregiver, as appropriate, providers, the case manager, or DMAS DBHDS staff. Medical examinations for children must be completed according to the recommended frequency and periodicity of the EPSDT program.

c. A psychological evaluation or standardized developmental assessment for children over older than six years of age and adults must reflect the current psychological status (diagnosis), adaptive level of functioning, and cognitive abilities. A new psychological evaluation is required whenever the individual's functioning has undergone significant change and the current evaluation no longer reflects the individual's current psychological status.

3. Documentation required.

a. The case management provider must maintain the following documentation for review by the DMAS DBHDS staff for each waiver individual:

(1) All assessment summaries and all plans of care completed for the individual are maintained for a period of not less than six years;

(2) All supporting documentation from any provider rendering waiver services for the individual;

(3) All supporting documentation related to any change in the plan of care;

(4) All related communication with the individual, his family/caregiver, as appropriate, providers, consultants, DMHMRSAS DBHDS, DMAS, DSS, DRS DARS, or other related parties;

(5) An ongoing log documenting all contacts related to the individual made by the case manager that relate to the individual;

(6) The individual's most recent, completed level of functioning;

(7) Psychologicals;

(8) Communications with DMAS DBHDS;

(9) Documentation of rejection or refusal of services and potential outcomes resulting from the refusal of services communicated to the individual; and

(10) Annual DMAS-122s DMAS-225.

b. The waiver service providers must maintain the following documentation for review by the DMAS or DBHDS staff for each waiver individual:

(1) All supporting documentation developed for that individual and maintained for a period of not less than six years;

(2) An attendance log documenting the date and times services were rendered and the amount and the type of services rendered;

(3) Appropriate progress notes reflecting the individual's status and, as appropriate, progress toward the identified goals on the supporting documentation;

(4) All communication relating to the individual. Any documentation or communication must be dated and signed by the provider;

(5) Prior Service authorization decisions;

(6) Plans of care specific to the service being provided; and

(7) Assessments/reassessments as required for the service being provided.

12VAC30-120-730. General requirements for home and community-based participating providers.

A. Providers approved for participation shall, at a minimum, perform the following activities:

1. Immediately notify DMAS, in writing, of any change in the information that the provider previously submitted to DMAS.

2. Assure freedom of choice for individuals seeking services from any institution, pharmacy, practitioner, or other provider qualified to perform the service or services required and participating in the Medicaid Program at the time the service or services were performed.

3. Assure the individual's freedom to reject medical care, treatment, and services, and document that potential adverse outcomes that may result from refusal of services were discussed with the individual.

4. Accept referrals for services only when staff is available to initiate services within 30 calendar days and perform such services on an ongoing basis.

5. Provide services and supplies for individuals in full compliance with Title VI of the Civil Rights Act of 1964, as amended (42 USC § 2000d et seq.), which prohibits discrimination on the grounds of race, color, or national origin; the Virginians with Disabilities Act (Title 51.5 (§ 51.5-1 et seq.) of the Code of Virginia); § 504 of the Rehabilitation Act of 1973, as amended (29 USC § 794), which prohibits discrimination on the basis of a disability; and the Americans with Disabilities Act, as amended (42 USC § 12101 et seq.), which provides comprehensive civil rights protections to individuals with disabilities in the areas of employment, public accommodations, state and local government services, and telecommunications.

6. Provide services and supplies to individuals of the same quality and in the same mode of delivery as provided to the general public.

7. Submit charges to DMAS for the provision of services and supplies for individuals in amounts not to exceed the provider's usual and customary charges to the general public and accept as payment in full the amount established by DMAS from the individual's authorization date for waiver services.

8. Use program-designated billing forms for submission of charges.

9. Maintain and retain business and professional records sufficient to document fully and accurately the nature, scope, and details of the care provided.

a. Such records shall be retained for at least six years from the last date of service or as provided by applicable state and federal laws, whichever period is longer. However, if an audit is initiated within the required retention period, the records shall be retained until the audit is completed and every exception resolved. Records of minors shall be kept for at least six years after such minor has reached the age of 18 years.

b. Policies regarding retention of records shall apply even if the provider discontinues operation. DMAS shall be notified in writing of storage, location, and procedures for obtaining records for review should the need arise. The location, agent, or trustee shall be within the Commonwealth of Virginia.

c. An attendance log or similar document must be maintained which that indicates the date services were rendered, type of services rendered, and number of hours/units provided (including specific time frame).

10. Agree Consistent with 12VAC30-120-1040, agree to furnish information on request and in the form requested to DMAS, DBHDS, the Attorney General of Virginia or his authorized representatives, federal personnel, and the State Medicaid Fraud Control Unit. The Commonwealth's right of access to provider premises and records shall survive any termination of the provider participation agreement.

11. Disclose, as requested by DMAS, all financial, beneficial, ownership, equity, surety, or other interests in any and all firms, corporations, partnerships, associations, business enterprises, joint ventures, agencies, institutions, or other legal entities providing any form of health care services to individuals enrolled in Medicaid.

B. Pursuant to 42 CFR Part 431, Subpart F, 12VAC30-20-90, and any other applicable federal or state law, all providers shall hold confidential and use for DMAS or DBHDS authorized purposes only all medical assistance information regarding individuals served. A provider shall disclose information in his possession only when the information is used in conjunction with a claim for health benefits or the data are necessary for the functioning of DMAS in conjunction with the cited laws. DMAS shall not disclose medical information to the public.

C. Change of ownership. When ownership of the provider changes, the provider must notify DMAS at least 15 calendar days before the date of change.

D. For (ICF/MR) (ICF/IID) facilities covered by § 1616(e) of the Social Security Act in which respite care as a home and community-based waiver service will be provided, the facilities shall be in compliance with applicable standards that meet the requirements for board and care facilities. Health and safety standards shall be monitored through the DBHDS' licensure standards or through DSS-approved standards for adult foster care providers.

E. Suspected abuse or neglect. Pursuant to §§ 63.2-1509 and 63.2-1606 of the Code of Virginia, if a participating provider knows or suspects that a home and community-based waiver service individual is being abused, neglected, or exploited, the party having knowledge or suspicion of the abuse, neglect, or exploitation shall report this immediately from first knowledge to the local DSS DARS adult or DSS child protective services agency, as applicable, as well as to DMAS, and, if applicable, to DBHDS Offices of Licensing and Human Rights.

F. Adherence to provider participation agreement and the DMAS provider manual. In addition to compliance with the general conditions and requirements, all providers enrolled by DMAS shall adhere to the conditions of participation outlined in their individual provider participation agreements and in the DMAS provider manual.

G. DMAS may terminate the provider's Medicaid provider agreement pursuant to § 32.1-325 of the Code of Virginia and as may be required for federal financial participation. Such provider agreement terminations shall conform to 12VAC30-10-690 and Part XII (12VAC30-20-500 et seq.) of 12VAC30-20. DMAS shall not reimburse for services that may be rendered subsequent to such terminations.

H. Direct marketing. Providers are prohibited from performing any type of direct marketing activities to Medicaid individuals or their family/caregivers.

12VAC30-120-740. Participation standards for home and community-based waiver services participating providers.

A. Requests for participation. Requests will be screened to determine whether the provider applicant meets the basic requirements for participation.

B. Provider participation standards. For DMAS to approve provider participation agreements with home and community-based waiver providers, the following standards shall be met:

1. For services that have licensure and certification requirements, licensure and certification requirements pursuant to 42 CFR 441.352.

2. Disclosure of ownership pursuant to 42 CFR 455.104 and 455.105.

3. The ability to document and maintain individual case records in accordance with state and federal requirements.

C. Adherence to provider participation agreements and special participation conditions. In addition to compliance with the general conditions and requirements, all providers enrolled by DMAS shall adhere to the conditions of participation outlined in their provider participation agreements.

D. Individual choice of provider entities. The individual will have the option of selecting the provider of his choice. The case manager must inform the individual of all available waiver service providers in the community in which he desires services, and he shall have the option of selecting the provider of his choice.

E. Review of provider participation standards and renewal of provider participation agreements. DMAS is responsible for assuring continued adherence to provider participation standards. DMAS shall conduct ongoing monitoring of compliance with provider participation standards and DMAS policies and recertify each provider for agreement renewal with DMAS to provide home and community-based waiver services. A provider's noncompliance with DMAS policies and procedures, as required in the provider's participation agreement, may result in a written request from DMAS for a corrective action plan which that details the steps the provider must take and the length of time permitted to achieve full compliance with the plan to correct the deficiencies which that have been cited.

F. Termination of provider participation. A participating provider may voluntarily terminate his participation in Medicaid by providing 30 calendar days' written notification. DMAS may terminate at will a provider's participation agreement on 30 calendar days' written notice as specified in the DMAS participation agreement. DMAS may also immediately terminate a provider's participation agreement if the provider is no longer eligible to participate in the program as determined by DMAS. Such action precludes further payment by DMAS for services provided for individuals subsequent to the date specified in the termination notice.

G. Reconsideration Appeals of adverse actions. A provider shall have the right to appeal adverse action taken by DMAS or its agent or DBHDS' decisions regarding the Medicaid IFDDS waiver. Provider appeals shall be considered pursuant to 12VAC30-10-1000 and 12VAC30-20-500 through 12VAC30-20-560.

H. Termination of a provider participation agreement upon conviction of a felony. Section 32.1-325 D 2 of the Code of Virginia mandates that "any such Medicaid agreement or contract shall terminate upon conviction of the provider of a felony." A provider convicted of a felony in Virginia or in any other of the 50 states or Washington, D.C., must, within 30 days, notify the Medicaid Program of this conviction and relinquish its provider agreement. In addition, termination of a provider participation agreement will occur as may be required for federal financial participation.

I. Case manager's responsibility for the Patient Information Form (DMAS-122) Medicaid Long Term Care Communication Form (DMAS-225). It is the responsibility of the case manager to notify DMAS, DBHDS, and DSS, in writing, when any of the following circumstances occur:

1. Home and community-based waiver services are implemented.

2. An individual dies.

3. An individual is discharged or terminated from services.

4. Any other circumstances (including hospitalization) that cause home and community-based waiver services to cease or be interrupted for more than 30 calendar days.

5. A selection by the individual or his family/caregiver, as appropriate, of a different case management provider.

J. Changes or termination of care. It is the DMAS DBHDS staff's responsibility to authorize any changes to supporting documentation of an individual's plan of care based on the recommendations of the case manager. Waiver service providers are responsible for modifying the supporting documentation with the involvement of the individual or his family/caregiver, as appropriate. The provider shall submit the supporting documentation to the case manager any time there is a change in the individual's condition or circumstances that may warrant a change in the amount or type of service rendered. The case manager shall review the need for a change and shall sign the supporting documentation if he agrees to the changes. The case manager shall submit the revised supporting documentation to the DMAS DBHDS staff to receive approval for that change. The DMAS staff or its agent or DBHDS has the final authority to approve or deny the requested change to individual's supporting documentation. DMAS DBHDS shall notify the individual or his family/caregiver, as appropriate, in writing of their the right to appeal the decision or decisions to reduce, terminate, suspend, or deny services pursuant to DMAS client appeals regulations, 12VAC30-110, Eligibility and Appeals.

1. Nonemergency termination of home and community-based waiver services by the participating provider. The participating provider shall give the individual, his family/caregiver, as appropriate, and case manager 10 calendar days' written notification of the intent to terminate services. The notification letter shall provide the reasons for and effective date of the termination. The effective date of services termination shall be at least 10 calendar days from the date of the termination notification letter.

2. Emergency termination of home and community-based waiver services by the participating provider. In an emergency situation when the health and safety of the individual or provider is endangered, the case manager and DMAS DBHDS must be notified prior to termination. The 10-day written notification period shall not be required. When appropriate, the local DSS adult protective services or child protective services agency must be notified immediately. DMHMRSAS DBHDS Offices of Licensing and Human Rights must also be notified as required under the provider's license.

3. The DMAS termination of eligibility to receive home and community-based waiver services. DMAS shall have the ultimate responsibility for assuring appropriate placement of the individual in home and community-based waiver services and the authority to terminate such services to the individual for the following reasons:

a. The home and community-based waiver service is not the critical alternative to prevent or delay institutional (ICF/MR) (ICF/IID) placement;

b. The individual no longer meets the institutional level of care criteria;

c. The individual's environment does not provide for his health, safety, and welfare; or

d. An appropriate and cost-effective plan of care cannot be developed.

4. In the case of termination of home and community-based waiver services by DMAS staff:

a. Individuals shall be notified of their appeal rights by DMAS pursuant to 12VAC30-110.

b. Individuals identified by the case manager who no longer meet the level of care criteria or for whom home and community-based waiver services are no longer appropriate must be referred by the case manager to DMAS for review.

Article 2
Covered Services and Limitations and Related Provider Requirements

12VAC30-120-750. In-home residential support services.

A. Service description. In-home residential support services shall be based primarily in the individual's home. The service shall be designed to enable individuals enrolled in the IFDDS Waiver to be maintained in their homes and shall include: (i) training in or engagement and interaction with functional skills and appropriate behavior related to an individual's health and safety, personal care, activities of daily living and use of community resources; (ii) assistance with medication management and monitoring the individual's health, nutrition, and physical condition (iii) life skills training; (iv) cognitive rehabilitation; (v) assistance with personal care activities of daily living and use of community resources; and (vi) specialized supervision to ensure the individual's health and safety. Service providers shall be reimbursed only for the amount and type of in-home residential support services included in the individual's approved plan of care. In-home residential support services shall not be authorized in the plan of care unless the individual requires these services and these services exceed services provided by the family or other caregiver. Services are not provided by paid staff of the in-home residential services provider for a continuous 24-hour period.

1. This service must be provided on an individual-specific basis according to the plan of care, supporting documentation, and service setting requirements.

2. Individuals may have in-home residential, personal care, and respite care in their plans of care but cannot receive these services simultaneously.

3. Room and board and general supervision shall not be components of this service.

4. This service shall not be used solely to provide routine or emergency respite care for the parent or parents or other unpaid caregivers with whom the individual lives.

B. Criteria.

1. All individuals must meet the following criteria in order for Medicaid to reimburse providers for in-home residential support services. The individual must meet the eligibility requirements for this waiver service as defined. The individual shall have a demonstrated need for supports to be provided by staff who are paid by the in-home residential support provider.

2. A functional assessment must be conducted to evaluate each individual in his home environment and community settings.

3. Routine supervision/oversight of direct care staff. To provide additional assurance for the protection or preservation of an individual's health and safety, there are specific requirements for the supervision and oversight of direct care staff providing in-home residential support as outlined below. For all in-home residential support services provided under a DMHMRSAS DBHDS license or CARF Rehabilitation Accreditation Commission accreditation:

a. An employee of the provider, typically by position, must be formally designated as the supervisor of each direct care staff person providing in-home residential support services.

b. The supervisor must have and document at least one supervisory contact with each direct care staff person per month regarding service delivery and direct care staff performance.

c. The supervisor must observe each direct care staff person delivering services at least semi-annually. Staff performance, service delivery in accordance with the plan of care, and evaluation of and evidence of the individual's satisfaction with service delivery by direct care staff must be documented.

d. The supervisor must complete and document at least one monthly contact with the individual or his family/caregiver, as appropriate, regarding satisfaction with services delivered by each direct care staff person.

4. The in-home residential support supporting documentation must indicate the necessary amount and type of activities required by the individual, the schedule of in-home residential support services, the total number of hours per day, and the total number of hours per week of in-home residential support. A formal, written behavioral program is required to address behaviors, including self-injury, aggression or self-stimulation.

5. Medicaid reimbursement is available only for in-home residential support services provided when the individual is present and when a qualified provider is providing the services.

C. Service units and service limitations. In-home residential supports shall be reimbursed on an hourly basis for time the in-home residential support direct care staff is working directly with the individual. Total monthly billing cannot exceed the total hours authorized in the plan of care. The provider must maintain documentation of the date, times, the services that were provided, and specific circumstances preventing the provision of any scheduled services.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, each in-home residential support service provider must be licensed by DMHMRSAS DBHDS as a provider of supportive residential services or have CARF Rehabilitation Accreditation Commission accreditation. The provider must also have training in the characteristics of individuals with related conditions and appropriate interventions, strategies, and support methods for individuals with related conditions and functional limitations.

1. For DMHMRSAS DBHDS licensed programs, a plan of care and ongoing documentation of service delivery must be consistent with licensing regulations.

2. Documentation must confirm attendance and the individuals' individual's amount of time in services and provide specific information regarding the individuals' individual's response to various settings and supports as agreed to in the supporting documentation objectives. Assessment results must be available in at least a daily note or a weekly summary. Data must be collected as described in the plan of care, analyzed, summarized, and then clearly addressed in the regular supporting documentation.

3. The supporting documentation must be reviewed by the provider with the individual, and this written review submitted to the case manager, at least semi-annually, with goals, objectives, and activities modified as appropriate.

4. Documentation must be maintained for routine supervision and oversight of all in-home residential support direct care staff. All significant contacts described in this section must be documented. A qualified developmental disabilities professional must provide supervision of direct service staff.

5. Documentation of supervision must be completed, signed by the staff person designated to perform the supervision and oversight, and include the following:

a. Date of contact or observation;

b. Person or persons contacted or observed;

c. A summary about direct care staff performance and service delivery for monthly contacts and semi-annual home visits;

d. Semi-annual observation documentation must also address individual satisfaction with service provision; and

e. Any action planned or taken to correct problems identified during supervision and oversight.; and

f. Copy of the most recently completed DMAS-122 DMAS-225 form. The provider must clearly document efforts to obtain the completed DMAS-122 DMAS-225 form from the case manager.

12VAC30-120-752. Day support services.

A. Service description. Day support services shall include a variety of training, assistance, support, and specialized supervision offered in a setting (other than the home or individual residence), which allows peer interactions and community integration for the acquisition, retention, or improvement of self-help, socialization, and adaptive skills. When services are provided through alternative payment sources, the plan of care shall not authorize them as a waiver funded expenditure. Service providers are reimbursed only for the amount and type of day support services included in the individual's approved plan of care based on the setting, intensity, and duration of the service to be delivered. This does not include prevocational services.

B. Criteria. For day support services, individual's the individual must demonstrate the need for functional training, assistance, and specialized supervision offered in settings other than the individual's own residence that allow an opportunity for being productive and contributing members of communities. In addition, day support services will be available for individuals who can benefit from supported employment services, but who need the services as an appropriate alternative or in addition to supported employment services.

1. A functional assessment must be conducted by the provider to evaluate each individual in his home environment and community settings.

2. Types and levels of day support. The amount and type of day support included in the individual's plan of care is determined according to the services required for that individual. There are two types of day support: center-based, which is provided primarily at one location/building, or noncenter-based, which is provided primarily in community settings. Both types of day support may be provided at either intensive or regular levels. To be authorized at the intensive level, the individual must meet at least one of the following criteria: (i) requires physical assistance to meet the basic personal care needs (toileting, feeding, etc.); (ii) has extensive disability-related difficulties and requires additional, ongoing support to fully participate in programming and to accomplish his service goals; or (iii) requires extensive constant supervision to reduce or eliminate behaviors that preclude full participation in the program. A formal, written behavioral program is required to address behaviors such as, but not limited to, withdrawal, self-injury, aggression, or self-stimulation.

C. Service units and service limitations. Day support cannot be regularly or temporarily provided in an individual's home or other residential setting (e.g., due to inclement weather or individual's illness) without prior written approval from DMAS DBHDS. Noncenter-based day support services must be separate and distinguishable from both in-home residential support services and personal care services. There must be separate supporting documentation for each service and each must be clearly differentiated in documentation and corresponding billing. The supporting documentation must provide an estimate of the amount of day support required by the individual. The maximum is 780 units per plan of care year. If this service is used in combination with prevocational and/or or supported employment services, the combined total units for these services can not exceed 780 units per plan of care year. Transportation shall not be billable as a day support service.

1. One unit shall be 1 to 3.99 hours of service a day.

2. Two units are 4 to 6.99 hours of service a day.

3. Three units are 7 or more hours of service a day.

Services shall normally be furnished four or more hours per day on a regularly scheduled basis for one or more days per week unless provided as an adjunct to other day activities included in an individual's plan of care.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, day support providers must meet the following requirements:

1. For DMHMRSAS DBHDS programs licensed as day support programs, the plan of care, supporting documentation, and ongoing documentation must be consistent with licensing regulations. For programs accredited by CARF as day support programs, there must be supporting documentation that contains, at a minimum, the following elements:

a. The individual's strengths, desired outcomes, required or desired supports and training needs;

b. The individual's goals and, for a training goal, a sequence of measurable objectives to meet the above identified outcomes;

c. Services to be rendered and the frequency of services to accomplish the above goals and objectives;

d. All entities that will provide the services specified in the statement of services;

e. A timetable for the accomplishment of the individual's goals and objectives;

f. The estimated duration of the individual's needs for services; and

g. The entities responsible for the overall coordination and integration of the services specified in the plan of care.

2. Documentation must confirm the individual's attendance, the amount of the individual's time in services, and provide specific information regarding the individual's response to various settings and supports as agreed to in the supporting documentation objectives. Assessment results must be available in at least a daily note or a weekly summary.

a. The provider must review the supporting documentation with the individual or his family/caregiver, as appropriate, and this written review submitted to the case manager at least semi-annually with goals, objectives, and activities modified as appropriate. For the annual review and anytime the supporting documentation is modified, the revised supporting documentation must be reviewed with the individual or his family/caregiver, as appropriate.

b. An attendance log or similar document must be maintained that indicates the date, type of services rendered, and the number of hours and units provided (including specific time frame).

c. Documentation must indicate whether the services were center-based or noncenter-based and regular or intensive level.

d. If intensive day support services are requested, in order to verify which of these criteria the individual met, documentation must be present in the individual's record to indicate the specific supports and the reasons they are needed. For reauthorization of intensive day support services, there must be clear documentation of the ongoing needs and associated staff supports.

e. In instances where day support staff are required to ride with the individual to and from day support, the day support staff time may be billed as day support, provided that the billing for this time does not exceed 25% of the total time spent in the day support activity for that day. Documentation must be maintained to verify that billing for day support staff coverage during transportation does not exceed 25% of the total time spent in the day support for that day.

f. Copy of the most recently completed DMAS-122 DMAS-225 form. The provider must clearly document efforts to obtain the completed DMAS-122 DMAS-225 form from the case manager.

3. Supervision of direct service staff must be provided by a qualified developmental disabilities professional.

12VAC30-120-753. Prevocational services.

A. Service description. Prevocational services are services aimed at preparing an individual for paid or unpaid employment, but are not job-task oriented. Prevocational services are provided for individuals who are not expected to be able to join the general work force without supports or to participate in a transitional, sheltered workshop within one year of beginning waiver services (excluding supported employment services or programs). Activities included in this service are not primarily directed at teaching specific job skills but at underlying rehabilitative goals such as accepting supervision, attendance, task completion, problem solving, and safety.

B. Criteria. In order to qualify for prevocational services, the individual shall have a demonstrated need for support in skills that are aimed toward preparation for paid employment that may be offered in a variety of community settings.

C. Service units and service limitations. Billing is for one unit of service. This service is limited to 780 units per plan of care year. If this service is used in combination with day support and/or or supported employment services, the combined total units for these services cannot exceed 780 units per plan of care year. Prevocational services may be provided in center or noncenter-based settings. There must be documentation about whether prevocational services are available in vocational rehabilitation agencies through § 110 of the Rehabilitation Act of 1973 or through the Individuals with Disabilities Education Act (IDEA). When services are provided through these sources to the individual, they will not be authorized as a waiver service. Prevocational services may only be provided when the individual's compensation is less than 50% of the minimum wage.

1. One unit shall be 1 to 3.99 hours of service a day.

2. Two units are 4 to 6.99 hours of service a day.

3. Three units are 7 or more hours of service a day.

Services shall normally be furnished four or more hours per day on a regularly scheduled basis for one or more days per week unless provided as an adjunct to other day activities included in an individual's plan of care.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based services participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, prevocational services providers must also meet the following requirements:

1. The prevocational services provider must be a vendor of extended employment services, long-term employment services, or supported employment services for DRS DARS, or be licensed by DMHMRSAS DBHDS as a day support services provider. Providers must ensure and document that persons providing prevocational services have training in the characteristics of related conditions, appropriate interventions, training strategies, and support methods for individuals with related conditions and functional limitations.

2. Required documentation in the individual's record. The provider must maintain a record for each individual receiving prevocational services. At a minimum, the record must contain the following:

a. A functional assessment conducted by the provider to evaluate each individual in the prevocational environment and community settings.

b. A plan of care containing, at a minimum, the following elements (new DMHMRSAS (DBHDS licensing regulations require the following for plans of care):

(1) The individual's needs and preferences;

(2) Relevant psychological, behavioral, medical, rehabilitation, and nursing needs as indicated by the assessment;

(3) Individualized strategies including the intensity of services needed;

(4) A communication plan for individuals with communication barriers including language barriers; and

(5) The behavior treatment plan, if applicable.

3. The plan of care must be reviewed by the provider quarterly, annually, and more often as needed, modified as appropriate, and with written results of these reviews submitted to the case manager. For the annual review and in cases where the plan of care is modified, the plan of care must be reviewed with the individual or his family/caregiver, as appropriate.

4. Documentation must confirm the individual's attendance, amount of time spent in services, type of services rendered, and provide specific information about the individual's response to various settings and supports as agreed to in the plan of care.

5. In instances where prevocational staff are required to ride with the individual to and from prevocational services, the prevocational staff time may be billed for prevocational services, provided that the billing for this time does not exceed 25% of the total time spent in prevocational services for that day. Documentation must be maintained to verify that billing for prevocational staff coverage during transportation does not exceed 25% of the total time spending the prevocational services for that day.

6. A copy of the most recently completed DMAS-122 DMAS-225. The provider must clearly document efforts to obtain the completed DMAS-122 DMAS-225 from the case manager.

12VAC30-120-754. Supported employment services.

A. Service description.

1. Supported employment services shall include training in specific skills related to paid employment and provision of ongoing or intermittent assistance or specialized training to enable an individual to maintain paid employment. Each supporting documentation must confirm whether supported employment services are available to the individual in vocational rehabilitation agencies through the Rehabilitation Act of 1973 or in special education services through 20 USC § 1401 of the Individuals with Disabilities Education Act (IDEA). Providers of these DRS DARS and IDEA services cannot be reimbursed by Medicaid with the IFDDS Waiver funds. Waiver service providers are reimbursed only for the amount and type of habilitation services included in the individual's approved plan of care based on the intensity and duration of the service delivered. Reimbursement shall be limited to actual interventions by the provider of supported employment, not for the amount of time the recipient is in the supported employment environment.

2. Supported employment may be provided in one of two models. Individual supported employment is defined as intermittent support, usually provided one on one by a job coach for an individual in a supported employment position. Group supported employment is defined as continuous support provided by staff for eight or fewer individuals with disabilities in an enclave, work crew, or bench work/entrepreneurial model. The individual's assessment and plan of care must clearly reflect the individual's need for training and supports.

B. Criteria for receipt of services.

1. Only job development tasks that specifically include the individual are allowable job search activities under the IFDDS Waiver supported employment and only after determining this service is not available from DRS DARS or IDEA.

2. In order to qualify for these services, the individual shall have a demonstrated need for training, specialized supervision, or assistance in paid employment and for whom competitive employment at or above the minimum wage is unlikely without this support and who, because of the disability, needs ongoing support, including supervision, training and transportation to perform in a work setting.

3. A functional assessment must be conducted to evaluate each individual in his work environment and related community settings.

4. The supporting documentation must document the amount of supported employment required by the individual. Service providers are reimbursed only for the amount and type of supported employment included in the plan of care based on the intensity and duration of the service delivered.

C. Service units and service limitations.

1. Supported employment for individual job placement is provided in one-hour units. This service is limited to 40 hours per week.

2. Group models of supported employment (enclaves, work crews, bench work, and entrepreneurial model of supported employment) will be billed according to the DMAS fee schedule.

3. Supported employment services are limited to 780 units per plan of care year. If used in combination with prevocational and day support services, the combined total units for these services cannot exceed 780 units, or its equivalent under the DMAS fee schedule, per plan of care year.

4. For the individual job placement model, reimbursement will be limited to actual documented interventions or collateral contacts by the provider, not the amount of time the individual is in the supported employment situation.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, supported employment providers must meet the following requirements:

1. Supported employment services shall be provided by agencies that are programs certified by the Commission on Accreditation of Rehabilitation Facilities (CARF) Rehabilitation Accreditation Commission to provide supported employment services or are DRS DARS vendors of supported employment services.

2. Individual ineligibility for supported employment services through DRS DARS or IDEA must be documented in the individual's record, as applicable. If the individual is ineligible to receive services through IDEA, documentation is required only for lack of DRS DARS funding. Acceptable documentation would include a copy of a letter from DRS DARS or the local school system or a record of a telephone call (name, date, person contacted) documented in the case manager's case notes, Consumer Profile/Social assessment or on the supported employment supporting documentation. Unless the individual's circumstances change, the original verification may be forwarded into the current record or repeated on the supporting documentation or revised Social Assessment on an annual basis.

3. Supporting documentation and ongoing documentation consistent with licensing regulations, if a DMHMRSAS DBHDS licensed program.

4. For non-DMHMRSAS non-DBHDS programs certified as supported employment programs, there must be supporting documentation that contains, at a minimum, the following elements:

a. The individual's strengths, desired outcomes, required/desired supports, and training needs;

b. The individual's goals and, for a training goal, a sequence of measurable objectives to meet the above identified outcomes;

c. Services to be rendered and the frequency of services to accomplish the above goals and objectives;

d. All entities that will provide the services specified in the statement of services;

e. A timetable for the accomplishment of the individual's goals and objectives;

f. The estimated duration of the individual's needs for services; and

g. Entities responsible for the overall coordination and integration of the services specified in the plan of care.

5. Documentation must confirm the individual's attendance, the amount of time the individual spent in services, and must provide specific information regarding the individual's response to various settings and supports as agreed to in the supporting documentation objectives. Assessment results should be available in at least a daily note or weekly summary.

6. The provider must review the supporting documentation with the individual, and this written review submitted to the case manager, at least semi-annually, with goals, objectives, and activities modified as appropriate. For the annual review and in cases where the plan of care is modified, the plan of care must be reviewed with the individual or his family/caregiver, as appropriate.

7. In instances where supported employment staff are required to ride with the individual to and from supported employment activities, the supported employment staff time may be billed for as supported employment provided that the billing for this time does not exceed 25% of the total time spent in supported employment for that day. Documentation must be maintained to verify that billing supported employment staff coverage during transportation does not exceed 25% of the total time spent in supported employment for that day.

8. There must be a copy of the completed DMAS-122 DMAS-225 form in the record. Providers must clearly document efforts to obtain the DMAS-122 DMAS-225 form from the case manager.

12VAC30-120-756. Therapeutic consultation.

A. Service description. Therapeutic consultation provides expertise, training, and technical assistance in any of the following specialty areas to assist family members, caregivers, and service providers in supporting the individual. The specialty areas include the following: psychology, social work, occupational therapy, physical therapy, therapeutic recreation, rehabilitation, psychiatry, psychiatric clinical nursing, behavioral consultation, and speech/language therapy. These services may be provided, based on the individual's plan of care, for those individuals for whom specialized consultation is clinically necessary to enable their utilization of waiver services and who have additional challenges restricting their ability to function in the community. Therapeutic consultation services may be provided in the individual's home, in other appropriate community settings, and in conjunction with another waiver service. These services are intended to facilitate implementation of the individual's desired outcomes as identified in the individual's plan of care. Therapeutic consultation service providers are reimbursed according to the amount and type of service authorized in the plan of care based on an hourly fee for service.

B. Criteria. In order to qualify for these services, the individual shall have a demonstrated need for consultation in any of these services. Documented need must indicate that the plan of care cannot be implemented effectively and efficiently without such consultation from this service.

1. The individual's plan of care must clearly reflect the individual's needs, as documented in the social assessment, for specialized consultation provided to family/caregivers and providers in order to implement the plan of care effectively.

2. Therapeutic consultation services may not include direct therapy provided to individuals receiving waiver services, or monitoring activities, and may not duplicate the activities of other services that are available to the individual through the State Plan of Medical Assistance.

C. Service units and service limitations. The unit of service shall equal one hour. The services must be explicitly detailed in the supporting documentation. Travel time, written preparation, and telephone communication are in-kind expenses within this service and are not billable as separate items. Therapeutic consultation may not be billed solely for purposes of monitoring. Therapeutic consultations shall be available to individuals who are receiving at least one other waiver service and case management services.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, professionals rendering therapeutic consultation services, including behavior consultation services, shall meet all applicable state licensure or certification requirements. Persons providing rehabilitation consultation shall be rehabilitation engineers or certified rehabilitation specialists. Behavioral consultation may be performed by professionals based on the professional's knowledge, skills, and abilities as defined by DMAS.

1. Supporting documentation for therapeutic consultation. The following information is required in the supporting documentation:

a. Identifying information: individual's name and Medicaid number; provider name and provider number; responsible person and telephone number; effective dates for supporting documentation; and semi-annual review dates, if applicable;

b. Targeted objectives, time frames, and expected outcomes;

c. Specific consultation activities; and

d. A written support plan detailing the interventions or support strategies.

2. Monthly and contact notes shall include:

a. Summary of consultative activities for the month;

b. Dates, locations, and times of service delivery;

c. Supporting documentation objectives addressed;

d. Specific details of the activities conducted;

e. Services delivered as planned or modified; and

f. Effectiveness of the strategies and individuals' and caregivers' satisfaction with service.

3. Semi-annual reviews are required by the service provider if consultation extends three months or longer, are to be forwarded to the case manager, and must include:

a. Activities related to the therapeutic consultation supporting documentation;

b. Individual status and satisfaction with services; and

c. Consultation outcomes and effectiveness of support plan.

4. If consultation services extend less than three months, the provider must forward monthly contact notes or a summary of them to the case manager for the semi-annual review.

5. A written support plan, detailing the interventions and strategies for providers, family, or caregivers to use to better support the individual in the service.

6. A final disposition summary must be forwarded to the case manager within 30 calendar days following the end of this service and must include:

a. Strategies utilized;

b. Objectives met;

c. Unresolved issues; and

d. Consultant recommendations.

12VAC30-120-758. Environmental modifications.

A. Service description. Environmental modifications shall be defined as those physical adaptations to the individual's primary home or primary vehicle used by the individual, documented in the individual's plan of care, that are necessary to ensure the health, welfare, and safety of the individual, or that enable the individual to function with greater independence in the primary home and, without which, the individual would require institutionalization. Such adaptations may include the installation of ramps and grab-bars, widening of doorways, modification of bathroom facilities, or installation of specialized electrical and plumbing systems that are necessary to accommodate the medical equipment and supplies that are necessary for the welfare of the individual. Excluded are those adaptations or improvements to the home that are of general utility and are not of direct medical or remedial benefit to the individual, such as carpeting, roof repairs, central air conditioning, etc. Adaptations that add to the total square footage of the home shall be excluded from this benefit, except when necessary to complete an adaptation, as determined by DMAS or its designated agent. All services shall be provided in the individual's primary home in accordance with applicable state or local building codes. All modifications must be prior authorized by the prior service authorization agent. Modifications may be made to a vehicle if it is the primary vehicle being used by the individual. This service does not include the purchase of vehicles.

B. Criteria. In order to qualify for these services, the individual must have a demonstrated need for equipment or modifications of a remedial or medical benefit offered in an individual's primary home, primary vehicle used by the individual, community activity setting, or day program to specifically improve the individual's personal functioning. This service shall encompass those items not otherwise covered in the State Plan for Medical Assistance or through another program. Environmental modifications shall be covered in the least expensive, most cost-effective manner. For enrollees in the Acquired Immunodeficiency Syndrome (AIDS) waiver (12VAC30-120-140 through 12VAC30-120-201) or the Elderly or Disabled with Consumer Direction (EDCD) waiver (12VAC30-120-900 through 12VAC30-120-980), environmental modification services shall be available only to those AIDS and EDCD enrollees who are also enrolled in the Money Follows the Person demonstration.

C. Service units and service limitations. Environmental modifications shall be available to individuals who are receiving case management services. To receive environmental modifications in the EDCD waiver, the individual must be receiving at least one other waiver service. To receive environmental modifications in the IFDDS waiver, the individual must be receiving case management services and at least one other waiver service. A maximum limit of $5,000 may be reimbursed per plan of care or calendar year, as appropriate to the waiver in which the individual is enrolled. Costs for environmental modifications shall not be carried over from year to year. All environmental modifications must be prior authorized by the prior service authorization agent prior to billing. Modifications shall not be used to bring a substandard dwelling up to minimum habitation standards. Also excluded are modifications that are reasonable accommodation requirements of the Americans with Disabilities Act, the Virginians with Disabilities Act, and the Rehabilitation Act.

Case managers or transition coordinators must, upon completion of each modification, meet face-to-face with the individual and his family/caregiver, as appropriate, to ensure that the modification is completed satisfactorily and is able to be used by the individual.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-160, 12VAC30-120-730, 12VAC30-120-740, and 12VAC30-120-930, as appropriate, environmental modifications must be provided in accordance with all applicable state or local building codes by contractors who have a provider agreement with DMAS. Providers may not be spouses or parents of the individual. Modifications must be completed within the plan of care or the calendar year in which the modification was authorized, as appropriate to the waiver in which the individual is enrolled.

12VAC30-120-760. Skilled nursing services.

A. Service description. Skilled nursing services shall be provided for individuals with serious medical conditions and complex health care needs who require specific skilled nursing services that cannot be provided by non-nursing personnel. Skilled nursing may be provided in the home or other community setting. It may include consultation and training for other providers.

B. Criteria. In order to qualify for these services, the individual must have demonstrated complex health care needs that require specific skilled nursing services ordered by a physician and that cannot be otherwise accessed under the Title XIX State Plan for Medical Assistance. The individual's plan of care must stipulate that this service is necessary in order to prevent institutionalization and is not available under the State Plan for Medical Assistance.

C. Service units and service limitations. Skilled nursing services to be rendered by either registered or licensed practical nurses are provided in 15-minute units. Services must be explicitly detailed in the CSP and must be specifically ordered by a physician.

D. Provider requirements. Skilled nursing services shall be provided by a DMAS-enrolled home care organization provider or a home health provider, or licensed registered nurse or a licensed practical nurse under the supervision of a licensed registered nurse who is contracted or employed by a DMHMRSAS DBHDS licensed day support, respite, or residential provider. In addition to meeting the general conditions and requirements for home and community-based waiver participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, in order to be enrolled as a skilled nursing provider, the provider must:

1. If a home health agency, be certified by the VDH for Medicaid participation and have a current DMAS provider participation agreement for private duty nursing;

2. Demonstrate a prior successful health care delivery business or practice;

3. Operate from a business office; and

4. If community services boards or behavioral health authority employ or subcontract with and directly supervise a registered nurse (RN) or a licensed practical nurse (LPN) with a current and valid license issued by the Virginia State Board of Nursing, the RN or LPN must have at least two years of related clinical nursing experience that may include work in an acute care hospital, public health clinic, home health agency, or nursing home.

12VAC30-120-762. Assistive technology.

A. Service description. Assistive technology (AT) is available to recipients who are receiving at least one other waiver service and may be provided in a residential or nonresidential setting. AT is the specialized medical equipment and supplies, including those devices, controls, or appliances, specified in the plan of care, but not available under the State Plan for Medical Assistance, that enable individuals to increase their abilities to perform activities of daily living, or to perceive, control, or communicate with the environment in which they live. This service also includes items necessary for life support, ancillary supplies, and equipment necessary to the proper functioning of such items.

B. Criteria. In order to qualify for these services, the individual must have a demonstrated need for equipment or modification for remedial or direct medical benefit primarily in an individual's primary home, primary vehicle used by the individual, community activity setting, or day program to specifically serve to improve the individual's personal functioning. This shall encompass those items not otherwise covered under the State Plan for Medical Assistance. Assistive technology shall be covered in the least expensive, most cost-effective manner. For enrollees in the Acquired Immunodeficiency Syndrome (AIDS) waiver (12VAC30-120-140 through 12VAC30-120-201) or the Elderly or Disabled with Consumer Direction (EDCD) waiver (12VAC30-120-900 through 12VAC30-120-980), assistive technology services shall be available only to those AIDS and EDCD enrollees who are also enrolled in the Money Follows the Person demonstration.

C. Service units and service limitations. AT is available to individuals receiving at least one other waiver service and may be provided in the individual's home or community setting. A maximum limit of $5,000 may be reimbursed per plan of care year or the calendar year, as appropriate to the waiver in which the individual is enrolled or calendar year, as appropriate to the waiver being received. Costs for assistive technology cannot be carried over from year to year and must be preauthorized each plan of care year. AT will not be approved for purposes of convenience of the caregiver/provider or restraint of the individual. An independent, professional consultation must be obtained from qualified professionals who are knowledgeable of that item for each AT request prior to approval by the prior authorization agent, and may include training on such AT by the qualified professional. All AT must be prior authorized by the prior service authorization agent prior to billing. Also excluded are modifications that are reasonable accommodation requirements of the Americans with Disabilities Act, the Virginians with Disabilities Act, and the Rehabilitation Act.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-160, 12VAC30-120-730, 12VAC30-120-740, and 12VAC30-120-930, AT shall be provided by providers having a current provider participation agreement with DMAS as durable medical equipment and supply providers. Independent, professional consultants include speech/language therapists, physical therapists, occupational therapists, physicians, behavioral therapists, certified rehabilitation specialists, or rehabilitation engineers. Providers that supply AT for an individual may not perform assessment/consultation, write specifications, or inspect the AT for that individual. Providers of services may not be spouses or parents of the individual. AT must be delivered within the plan of care year, or within a year from the start date of the authorization, as appropriate to the waiver, in which the individual is enrolled.

12VAC30-120-764. Crisis stabilization services.

A. Service description. Crisis stabilization services involve direct interventions that provide temporary, intensive services and supports that avert emergency, psychiatric hospitalization or institutional placement of individuals who are experiencing serious psychiatric or behavioral problems that jeopardize their current community living situation. Crisis stabilization services shall include, as appropriate, neuropsychological, psychiatric, psychological and other functional assessments and stabilization techniques, medication management and monitoring, behavior assessment and support, and intensive care coordination with other agencies and providers. This service is designed to stabilize the individual and strengthen the current living situation so that the individual remains in the community during and beyond the crisis period.

These services shall be provided to:

1. Assist planning and delivery of services and supports to enable the individual to remain in the community;

2. Train family members, other care givers, and service providers in supports to maintain the individual in the community; and

3. Provide temporary crisis supervision to ensure the safety of the individual and others;.

B. Criteria.

1. In order to receive crisis stabilization services, the individual must meet at least one of the following criteria:

a. The individual is experiencing marked reduction in psychiatric, adaptive, or behavioral functioning;

b. The individual is experiencing extreme increase in emotional distress;

c. The individual needs continuous intervention to maintain stability; or

d. The individual is causing harm to self or others.

2. The individual must be at risk of at least one of the following:

a. Psychiatric hospitalization;

b. Emergency ICF/MR ICF/IID placement;

c. Disruption of community status (living arrangement, day placement, or school); or

d. Causing harm to self or others.

C. Service units and service limitations. Crisis stabilization services must be authorized following a documented face-to-face assessment conducted by a qualified developmental disabilities professional (QDDP).

1. The unit for each component of the service is one hour. Each service may be authorized in 15-day increments, but no more than 60 calendar days in a plan of care year may be used. The actual service units per episode shall be based on the documented clinical needs of the individuals being served. Extension of services beyond the 15-day limit per authorization must be authorized following a documented face-to-face reassessment conducted by a qualified professional as described in subsection D of this section.

2. Crisis stabilization services may be provided directly in the following settings (the following examples are not exclusive):

a. The home of an individual who lives with family or other primary caregiver or caregivers;

b. The home of an individual who lives independently or semi-independently to augment any current services and support;

c. A day program or setting to augment current services and supports; or

d. A respite care setting to augment current services and supports.

3. Crisis supervision may be provided as a component of this service only if clinical or behavioral interventions allowed under this service are also provided during the authorized period. Crisis supervision must be provided one-on-one and face-to-face with the individual. Crisis supervision, if provided as a part of this service, shall be billed separately in hourly service units.

4. Crisis stabilization services shall not be used for continuous long-term care. Room and board and general supervision are not components of this service.

5. If appropriate, the assessment and any reassessments shall be conducted jointly with a licensed mental health professional or other appropriate professional or professionals.

D. Provider requirements. In addition to the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, the following crisis stabilization provider requirements apply:

1. Crisis stabilization services shall be provided by entities licensed by DMHMRSAS DBHDS as a provider of outpatient, residential, supportive in-home services, or day support services. The provider must employ or utilize qualified licensed mental health professionals or other qualified personnel competent to provide crisis stabilization and related activities for individuals with related conditions who require crisis stabilization services. Supervision of direct service staff must be provided by a QDDP. Crisis supervision providers must be licensed by DMHMRSAS DBHDS as providers of residential services, supportive in-home services, or day support services.

2. Crisis stabilization supporting documentation must be developed (or revised, in the case of a request for an extension) and submitted to the case manager for authorization within 72 hours of the face-to-face assessment or reassessment.

3. Documentation indicating the dates and times of crisis stabilization services, the amount and type of service provided, and specific information about the individual's response to the services and supports as agreed to in the supporting documentation must be recorded in the individual's record.

4. Documentation of provider qualifications must be maintained for review by DMAS staff. This service shall be designed to stabilize the individual and strengthen the current semi-independent living situation, or situation with family or other primary care givers, so the individual can be maintained during and beyond the crisis period.

12VAC30-120-766. Personal care and respite care services.

A. Service description. Services may be provided either through an agency-directed or consumer-directed model.

1. Personal care services means services offered to individuals in their homes and communities to enable an individual to maintain the health status and functional skills necessary to live in the community or participate in community activities. Personal care services substitute for the absence, loss, diminution, or impairment of a physical, behavioral, or cognitive function. This service shall provide care to individuals with activities of daily living (eating, drinking, personal hygiene, toileting, transferring and bowel/bladder control), instrumental activities of daily living (IADL), access to the community, monitoring of self-medication or other medical needs, and the monitoring of health status or physical condition. In order to receive personal care services, the individual must require assistance with their ADLs. When specified in the plan of care, personal care services may include assistance with IADL. Assistance with IADL must be essential to the health and welfare of the individual, rather than the individual's family/caregiver. An additional component to personal care is work or school-related personal care. This allows the personal care provider to provide assistance and supports for individuals in the workplace and for those individuals attending postsecondary educational institutions. Workplace or school supports through the IFDDS Waiver are not provided if they are services that should be provided by the Department of Rehabilitative Services DARS, under IDEA, or if they are an employer's responsibility under the Americans with Disabilities Act, the Virginians with Disabilities Act, or § 504 of the Rehabilitation Act. Work-related personal care services cannot duplicate services provided under supported employment.

2. Respite care means services provided for unpaid caregivers of eligible individuals who are unable to care for themselves that are provided on an episodic or routine basis because of the absence of or need for relief of those unpaid persons who routinely provide the care.

B. Criteria.

1. In order to qualify for personal care services, the individual must demonstrate a need in activities of daily living, reminders to take medication, or other medical needs, or monitoring health status or physical condition.

2. In order to qualify for respite care, individuals must have an unpaid primary caregiver who requires temporary relief to avoid institutionalization of the individual.

3. Individuals choosing the consumer-directed option must receive support from a CD services facilitator and meet requirements for consumer direction as described in 12VAC30-120-770.

C. Service units and service limitations.

1. The unit of service is one hour.

2. Effective July 1, 2011, respite care services are limited to a maximum of 480 hours per year. Individuals who are receiving services through both the agency-directed and consumer-directed models cannot exceed 480 hours per year combined.

3. Individuals may have personal care, respite care, and in-home residential support services in their plan of care but cannot receive in-home residential supports and personal care or respite care services at the same time.

4. Each individual receiving personal care services must have a back-up plan in case the personal care aide or consumer-directed (CD) employee does not show up for work as expected or terminates employment without prior notice.

5. Individuals must need assistance with ADLs in order to receive IADL care through personal care services.

6. Individuals shall be permitted to share personal care service hours with one other individual (receiving waiver services) who lives in the same home.

7. This service does not include skilled nursing services with the exception of skilled nursing tasks that may be delegated in accordance with 18VAC90-20-420 through 18VAC90-20-460.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, personal and respite care providers must meet the following provider requirements:

1. Services shall be provided by:

a. For the agency-directed model, a DMAS enrolled personal care/respite care provider or by a DMHMRSAS-licensed DBHDS-licensed residential supportive in-home provider. All personal care aides must pass an objective standardized test of knowledge, skills, and abilities approved by DMHMRSAS DBHDS and administered according to DMHMRSAS' DBHDS' defined procedures.

Providers must demonstrate a prior successful health care delivery business and operate from a business office.

b. For the consumer-directed model, a service facilitation provider meeting the requirements found in 12VAC30-120-770.

2. For DMHMRSAS-licensed DBHDS-licensed providers, a residential supervisor shall provide ongoing supervision for all personal care aides. For DMAS-enrolled personal care/respite care providers, the provider must employ or subcontract with and directly supervise an RN who will provide ongoing supervision of all aides. The supervising RN must be currently licensed to practice in the Commonwealth and have at least two years of related clinical nursing experience that may include work in an acute care hospital, public health clinic, home health agency, ICF/MR ICF/IID, or nursing facility.

3. The RN supervisor or case manager/services facilitator must make a home visit to conduct an initial assessment prior to the start of care for all individuals requesting services. The RN supervisor or case manager/service facilitator must also perform any subsequent reassessments or changes to the supporting documentation. Under the consumer-directed model, the initial comprehensive visit is done only once upon the individual's entry into the service. If an individual served under the waiver changes CD services facilitation agencies, the new CD services facilitation provider must bill for a reassessment in lieu of a comprehensive visit.

4. The RN supervisor or case manager/services facilitator must make supervisory visits as often as needed to ensure both quality and appropriateness of services.

a. For personal care the minimum frequency of these visits is every 30 to 90 calendar days depending on individual needs. For respite care offered on a routine basis, the minimum frequency of these visits is every 30 to 90 calendar days under the agency-directed model and every six months or upon the use of 240 respite care hours (whichever comes first) under the consumer-directed model.

b. Under the agency-directed model, when respite care services are not received on a routine basis, but are episodic in nature, the RN is not required to conduct a supervisory visit every 30 to 90 calendar days. Instead, the RN supervisor must conduct the initial home visit with the respite care aide immediately preceding the start of care and make a second home visit within the respite care period.

c. When respite care services are routine in nature and offered in conjunction with personal care, the 30-day to 90-day supervisory visit conducted for personal care may serve as the RN supervisor or case manager/service facilitator visit for respite care. However, the RN supervisor or case manager/services facilitator must document supervision of respite care separately. For this purpose, the same record can be used with a separate section for respite care documentation.

5. Under the agency-directed model, the supervisor shall identify any gaps in the aide's ability to provide services as identified in the individual's plan of care and provide training as indicated based on continuing evaluations of the aide's performance and the individual's needs.

6. The supervising RN or case manager/services facilitator must maintain current documentation. This may be done as a summary and must note:

a. Whether personal and respite care services continue to be appropriate;

b. Whether the supporting documentation is adequate to meet the individual's needs or if changes are indicated in the supporting documentation;

c. Any special tasks performed by the aide/CD employee and the aide's/CD employee's qualifications to perform these tasks;

d. Individual's satisfaction with the service;

e. Any hospitalization or change in the individual's medical condition or functioning status;

f. Other services received and their amount; and

g. The presence or absence of the aide in the home during the RN's visit.

7. Qualification of aides/CD employees. Each aide/CD employee must:

a. Be 18 years of age or older and possess a valid social security number;

b. For the agency-directed model, be able to read and write English to the degree necessary to perform the tasks required. For the consumer-directed model, possess basic math, reading and writing skills;

c. Have the required skills to perform services as specified in the individual's plan of care;

d. Not be the parents of individuals who are minors, or the individual's spouse. Payment will not be made for services furnished by other family members living under the same roof as the individual receiving services unless there is objective written documentation as to why there are no other providers available to provide the care. Family members who are approved to be reimbursed for providing this service must meet the qualifications. In addition, under the consumer-directed model, family/caregivers acting as the employer on behalf of the individual may not also be the CD employee;

e. Additional aide requirements under the agency-directed model:

(1) Complete an appropriate aide training curriculum consistent with DMAS standards. Prior to assigning an aide to an individual, the provider must ensure that the aide has satisfactorily completed a training program consistent with DMAS standards. DMAS requirements may be met in any of the following ways:

(a) Registration as a certified nurse aide (DMAS-enrolled personal care/respite care providers);

(b) Graduation from an approved educational curriculum that offers certificates qualifying the student as a nursing assistant, geriatric assistant or home health aide (DMAS-enrolled personal care/respite care providers);

(c) Completion of provider-offered training that is consistent with the basic course outline approved by DMAS (DMAS-enrolled personal care/respite care providers);

(d) Completion and passing of the DMHMRSAS DBHDS standardized test (DMHMRSAS (DBHDS-licensed providers);

(2) Have a satisfactory work record as evidenced by two references from prior job experiences, including no evidence of possible abuse, neglect, or exploitation of aged or incapacitated adults or children; and

(3) Be evaluated in his job performance by the supervisor.

f. Additional CD employee requirements under the consumer-directed model:

(1) Submit to a criminal records check and, if the individual is a minor, the child protective services registry. The employee will not be compensated for services provided to the individual if the records check verifies the employee has been convicted of crimes described in § 37.2-314 of the Code of Virginia or if the employee has a complaint confirmed by the DSS child protective services registry;

(2) Be willing to attend training at the request of the individual or his family/caregiver, as appropriate;

(3) Understand and agree to comply with the DMAS consumer-directed services requirements; and

(4) Receive an annual TB screening.

8. Provider inability to render services and substitution of aides (agency-directed model). When an aide is absent, the provider may either obtain another aide, obtain a substitute aide from another provider if the lapse in coverage is to be less than two weeks in duration, or transfer the individual's services to another provider.

9. Retention, hiring, and substitution of employees (consumer-directed model). Upon the individual's request, the CD services facilitator shall provide the individual or his family/caregiver, as appropriate, with a list of consumer-directed employees on the consumer-directed employee registry that may provide temporary assistance until the employee returns or the individual or his family/caregiver, as appropriate, is able to select and hire a new employee. If an individual or his family/caregiver, as appropriate, is consistently unable to hire and retain an employee to provide consumer-directed services, the services facilitator must contact the case manager and DMAS DBHDS to transfer the individual, at the choice of the individual or his family/caregiver, as appropriate, to a provider that provides Medicaid-funded agency-directed personal care or respite care services. The CD services facilitator will make arrangements with the case manager to have the individual transferred.

10. Required documentation in individuals' records. The provider must maintain all records of each individual receiving services. Under the agency-directed model, these records must be separated from those of other nonwaiver services, such as home health services. At a minimum these records must contain:

a. The most recently updated plan of care and supporting documentation, all provider documentation, and all DMAS-122 DMAS-225 forms;

b. Initial assessment by the RN supervisory nurse or case manager/services facilitator completed prior to or on the date services are initiated, subsequent reassessments, and changes to the supporting documentation by the RN supervisory nurse or case manager/services facilitator;

c. Nurses' or case manager/services facilitator summarizing notes recorded and dated during any contacts with the aide or CD employee and during supervisory visits to the individual's home;

d. All correspondence to the individual, to DBHDS, and to DMAS;

e. Contacts made with family, physicians, DBHDS, DMAS, formal and informal service providers, and all professionals concerning the individual;

f. Under the agency-directed model, all aide records. The aide record must contain:

(1) The specific services delivered to the individual by the aide and the individual's responses;

(2) The aide's arrival and departure times;

(3) The aide's weekly comments or observations about the individual to include observations of the individual's physical and emotional condition, daily activities, and responses to services rendered; and

(4) The aide's and individual's weekly signatures to verify that services during that week have been rendered.;

(5) Signatures, times, and dates; these signatures, times, and dates shall not be placed on the aide record prior to the last date of the week that the services are delivered.; and

(6) Copies of all aide records; these records shall be subject to review by state and federal Medicaid representatives.

g. Additional documentation requirements under the consumer-directed model:

(1) All management training provided to the individuals or their family caregivers, as appropriate, including responsibility for the accuracy of the timesheets.

(2) All documents signed by the individual or his family/caregivers, as appropriate, that acknowledge the responsibilities of the services.

12VAC30-120-770. Consumer-directed model of service delivery.

A. Criteria.

1. The IFDDS Waiver has three services, companion, personal care, and respite services, that may be provided through a consumer-directed model.

2. Individuals who are eligible for consumer-directed services must have the capability to hire, train, and fire their consumer-directed employees and supervise the employee's work performance. If an individual is unable to direct his own care or is under younger than 18 years of age, a family/caregiver may serve as the employer on behalf of the individual.

3. Responsibilities as employer. The individual, or if the individual is unable, then a family caregiver family/caregiver, is the employer in this service and is responsible for hiring, training, supervising, and firing employees. Specific duties include checking references of employees, determining that employees meet basic qualifications, training employees, supervising the employees' performance, and submitting timesheets to the fiscal agent on a consistent and timely basis. The individual or his family/caregiver, as appropriate, must have an emergency back-up plan in case the employee does not show up for work.

4. DMAS shall contract for the services of a fiscal agent for consumer-directed personal care, companion, and respite care services. The fiscal agent will be paid by DMAS to perform certain tasks as an agent for the individual/employer who is receiving consumer-directed services. The fiscal agent will handle responsibilities for the individual for employment taxes. The fiscal agent will seek and obtain all necessary authorizations and approvals of the Internal Revenue Services in order to fulfill all of these duties.

5. Individuals choosing consumer-directed services must receive support from a CD services facilitator. Services facilitators assist the individual or his family/caregiver, as appropriate, as they become employers for consumer-directed services. This function includes providing the individual or his family/caregiver, as appropriate, with management training, review and explanation of the Employee Management Manual, and routine visits to monitor the employment process. The CD services facilitator assists the individual/employer with employer issues as they arise. The services facilitator meeting the stated qualifications may also complete the assessments, reassessments, and related supporting documentation necessary for consumer-directed services if the individual or his family/caregiver, as appropriate, chooses for the CD services facilitator to perform these tasks rather than the case manager. Services facilitation services are provided on an as-needed basis as determined by the individual, family/caregiver, and CD services facilitator. This must be documented in the supporting documentation for consumer-directed services and the services facilitation provider bills accordingly. If an individual enrolled in consumer-directed services has a lapse in consumer-directed services for more than 60 consecutive calendar days, the case manager must shall notify DMAS DBHDS so that consumer-directed services may be discontinued and the option given to change to agency-directed services.

B. Provider qualifications. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, services facilitators providers must meet the following qualifications:

1. To be enrolled as a Medicaid CD services facilitation provider and maintain provider status, the CD services facilitation provider must operate from a business office and have sufficient qualified staff who will function as CD services facilitators to perform the service facilitation and support activities as required. It is preferred that the employee of the CD services facilitation provider possess a minimum of an undergraduate degree in a human services field or be a registered nurse currently licensed to practice in the Commonwealth. In addition, it is preferable that the CD services facilitator has two years of satisfactory experience in the human services field working with individuals with related conditions.

2. The CD services facilitator must possess a combination of work experience and relevant education which that indicates possession of the following knowledge, skills, and abilities. Such knowledge, skills, and abilities must be documented on the application form, found in supporting documentation, or be observed during the job interview. Observations during the interview must be documented. The knowledge, skills, and abilities include:

a. Knowledge of:

(1) Various long-term care program requirements, including nursing home, ICF/MR ICF/IID, and assisted living facility placement criteria, Medicaid waiver services, and other federal, state, and local resources that provide personal care services;

(2) DMAS consumer-directed services requirements, and the administrative duties for which the individual will be responsible;

(3) Interviewing techniques;

(4) The individual's right to make decisions about, direct the provisions of, and control his consumer-directed services, including hiring, training, managing, approving time sheets, and firing an employee;

(5) The principles of human behavior and interpersonal relationships; and

(6) General principles of record documentation.

(7) For CD services facilitators who also conduct assessments and reassessments, the following is also required. Knowledge of:

(a) Types of functional limitations and health problems that are common to different disability types and the aging process as well as strategies to reduce limitations and health problems;

(b) Physical assistance typically required by people with developmental disabilities, such as transferring, bathing techniques, bowel and bladder care, and the approximate time those activities normally take;

(c) Equipment and environmental modifications commonly used and required by people with developmental disabilities that reduces the need for human help and improves safety; and

(d) Conducting assessments (including environmental, psychosocial, health, and functional factors) and their uses in care planning.

b. Skills in:

(1) Negotiating with individuals or their family/caregivers, as appropriate, and service providers;

(2) Observing, recording, and reporting behaviors;

(3) Identifying, developing, or providing services to persons with developmental disabilities; and

(4) Identifying services within the established services system to meet the individual's needs.

c. Abilities to:

(1) Report findings of the assessment or onsite visit, either in writing or an alternative format for persons who have visual impairments;

(2) Demonstrate a positive regard for individuals and their families;

(3) Be persistent and remain objective;

(4) Work independently, performing position duties under general supervision;

(5) Communicate effectively, orally and in writing;

(6) Develop a rapport and communicate with different types of persons from diverse cultural backgrounds; and

(7) Interview.

3. If the CD services facilitator is not an RN, the CD services facilitator must inform the primary health care provider that services are being provided and request skilled nursing or other consultation as needed.

4. Initiation of services and service monitoring.

a. If the services facilitator has responsibility for individual assessments and reassessments, these must be conducted as specified in 12VAC30-120-766 and 12VAC30-120-776.

b. Management training.

(1) The CD services facilitation provider must make an initial visit with the individual or his family/caregiver, as appropriate, to provide management training. The initial management training is done only once upon the individual's entry into the service. If an individual served under the waiver changes CD services facilitation providers, the new CD services facilitator must bill for a regular management training in lieu of initial management training.

(2) After the initial visit, two routine visits must occur within 60 days of the initiation of care or the initial visit to monitor the employment process.

(3) For personal care services, the CD services facilitation provider will continue to monitor on an as needed basis, not to exceed a maximum of one routine visit every 30 calendar days but no less than the minimum of one routine visit every 90 calendar days per individual. After the initial visit, the CD services facilitator will periodically review the utilization of companion services at a minimum of every six months and for respite services, either every six months or upon the use of 300 respite care hours, whichever comes first.

5. The CD services facilitator must be available to the individual or his family/caregiver, as appropriate, by telephone during normal business hours, have voice mail capability, and return phone calls within 24 hours or have an approved back-up CD services facilitator.

6. The CD services fiscal contractor for DMAS must submit a criminal record check within 15 calendar days of employment pertaining to the consumer-directed employees on behalf of the individual or family/caregiver and report findings of the criminal record check to the individual or his family/caregiver, as appropriate.

7. The CD services facilitator shall verify bi-weekly timesheets signed by the individual or his family caregiver, as appropriate, and the employee to ensure that the number of plan of care approved hours are not exceeded. If discrepancies are identified, the CD services facilitator must contact the individual to resolve discrepancies and must notify the fiscal agent. If an individual is consistently being identified as having discrepancies in his timesheets, the CD services facilitator must contact the case manager to resolve the situation.

8. Consumer-directed employee registry. The CD services facilitator must maintain a consumer-directed employee registry, updated on an ongoing basis.

9. Required documentation in individuals' records. CD services facilitators responsible for individual assessment and reassessment must maintain records as described in 12VAC30-120-766 and 12VAC30-120-776. For CD services facilitators conducting management training, the following documentation is required in the individual's record:

a. All copies of the plan of care, all supporting documentation related to consumer-directed services, and all DMAS-122 DMAS-225 forms.

b. CD services facilitator's notes recorded and dated at the time of service delivery.

c. All correspondence to the individual, to others concerning the individual, and to DMAS and DBHDS.

d. All training provided to the consumer-directed employees on behalf of the individual or his family/caregiver, as appropriate.

e. All management training provided to the individuals or his family/caregivers, as appropriate, including the responsibility for the accuracy of the timesheets.

f. All documents signed by the individual or his family/caregiver, as appropriate, that acknowledge the responsibilities of the services.

12VAC30-120-772. Family/caregiver training.

A. Service description. Family or caregiver training is a service that provides training and counseling services to families or caregivers of individuals receiving waiver services. For purposes of this service, "family" is defined as the unpaid people who live with or provide care to an individual served on the waiver, and may include a parent, spouse, children, relatives, foster family, or in-laws. "Family" does not include people who are employed to care for the individual. All family/caregiver training must be included in the individual's written plan of care.

B. Criteria. The need for the training and the content of the training in order to assist family or caregivers with maintaining the individual at home must be documented in the individual's plan of care. The training must be necessary in order to improve the family or caregiver's ability to give care and support.

C. Service units and service limitations. Services will be billed hourly and must be prior authorized. Family, as defined in this section, may receive up to 80 hours of family/caregiver training per individual's plan of care year.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based waiver services participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, family/caregiver training providers must meet the following requirements:

1. Family/caregiver training must be provided on an individual basis, in small groups or through seminars and conferences provided by DMAS-enrolled family and caregiver training providers.

2. Family/caregiver training must be provided by providers with expertise in, experience in, or demonstrated knowledge of the training topic identified in the plan of care, and who work for an agency or organization that have has a provider participation agreement with DMAS to provide these services. Providers must also have the appropriate licensure or certification as required for the specific professional field associated with the training area. Providers include the following: qualified staff of provider agencies; psychologists; licensed clinical social workers; and licensed professional counselors. Qualified staff of provider agencies must be licensed and include occupational therapists, physical therapists, speech/language pathologists, physicians, psychologists, licensed clinical social workers, licensed professional counselors, registered nurses, and special education teachers. Provision of services is monitored by the individual or his family/caregiver, as appropriate, and/or or the case manager.

12VAC30-120-774. Personal emergency response system (PERS).

A. Service description. PERS is a service that monitors individual safety in the home and provides access to emergency assistance for medical or environmental emergencies through the provision of a two-way voice communication system that dials a 24-hour response or monitoring center upon activation and via the individual's home telephone line. PERS may also include medication monitoring devices.

B. Criteria. PERS may be authorized when there is no one else is in the home who is competent or continuously available to call for help in an emergency.

C. Service units and service limitations.

1. A unit of service shall include administrative costs, time, labor, and supplies associated with the installation, maintenance, monitoring, and adjustments of the PERS. A unit of service is one-month rental price set by DMAS. The one-time installation of the unit includes installation, account activation, individual and caregiver instruction, and removal of PERS equipment.

2. PERS services must be capable of being activated by a remote wireless device and be connected to the individual's telephone line. The PERS console unit must provide hands-free voice-to-voice communication with the response center. The activating device must be waterproof, automatically transmit to the response center an activator low battery alert signal prior to the battery losing power, and be able to be worn by the individual.

3. PERS cannot be used as a substitute for providing adequate supervision of the individual.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, providers must also meet the following requirements:

1. A PERS provider is a certified home health or personal care agency, a durable medical equipment provider, a hospital, or a PERS manufacturer that has the ability to provide PERS equipment, direct services (i.e., installation, equipment maintenance, and service calls), and PERS monitoring.

2. The PERS provider must provide an emergency response center staff with fully trained operators that who are capable of receiving signals for help from an individual's PERS equipment 24 hours a day, 365, or 366 as appropriate, days per year; of determining whether an emergency exists; and of notifying an emergency response organization or an emergency responder that the PERS individual needs emergency help.

3. A PERS provider must comply with all applicable Virginia statutes, all applicable regulations of DMAS, and all other governmental agencies having jurisdiction over the services to be performed.

4. The PERS provider has the primary responsibility to furnish, install, maintain, test, and service the PERS equipment, as required to keep it fully operational. The provider shall replace or repair the PERS device within 24 hours of the individual's notification of a malfunction of the console unit, activating devices, or medication-monitoring unit while the original equipment is being repaired.

5. The PERS provider must properly install all PERS equipment into the functioning telephone line of an individual receiving PERS and must furnish all supplies necessary to ensure that the system is installed and working properly.

6. The PERS installation includes local seize line circuitry, which guarantees that the unit will have priority over the telephone connected to the console unit should the phone be off the hook or in use when the unit is activated.

7. A PERS provider must maintain all installed PERS equipment in proper working order.

8. A PERS provider must maintain a data record for each individual receiving PERS at no additional cost to DMAS. The record must document all of the following:

a. Delivery date and installation date of the PERS;

b. The signature of the individual or his family/caregiver, as appropriate, verifying receipt of PERS device;

c. Verification by a test that the PERS device is operational, monthly or more frequently as needed;

d. Updated and current individual responder and contact information, as provided by the individual or the individual's care provider, or case manager; and

e. A case log documenting the individual's utilization of the system and contacts and communications with the individual or his family/caregiver, as appropriate, case manager, or responder.

9. The PERS provider must have back-up monitoring capacity in case the primary system cannot handle incoming emergency signals.

10. Standards for PERS equipment. All PERS equipment must be approved by the Federal Communications Commission and meet the Underwriters' Laboratories, Inc. (UL) safety standard Number 1635 for Digital Alarm Communicator System Units and Number 1637, which is the UL safety standard for home health care signaling equipment. The UL listing mark on the equipment will be accepted as evidence of the equipment's compliance with such standard. The PERS device must be automatically reset by the response center after each activation ensuring that subsequent signals can be transmitted without requiring manual reset by the individual.

11. A PERS provider must furnish education, data, and ongoing assistance to DMAS DBHDS and case managers to familiarize staff with the service, allow for ongoing evaluation and refinement of the program, and must instruct the individual, his family/caregiver, as appropriate, and responders in the use of the PERS service.

12. The emergency response activator must be activated either by breath, by touch, or by some other means, and must be usable by persons who are visually have visual or hearing impaired impairments or physically disabled physical disabilities. The emergency response communicator must be capable of operating without external power during a power failure at the individual's home for a minimum period of 24 hours and automatically transmit a low battery alert signal to the response center if the back-up battery is low. The emergency response console unit must also be able to self-disconnect and redial the back-up monitoring site without the individual resetting the system in the event it cannot get its signal accepted at the response center.

13. Monitoring agencies must be capable of continuously monitoring and responding to emergencies under all conditions, including power failures and mechanical malfunctions. It is the PERS provider's responsibility to ensure that the monitoring agency and the agency's equipment meets the following requirements. The monitoring agency must be capable of simultaneously responding to multiple signals for help from multiple individuals' PERS equipment. The monitoring agency's equipment must include the following:

a. A primary receiver and a back-up receiver, which must be independent and interchangeable;

b. A back-up information retrieval system;

c. A clock printer, which must print out the time and date of the emergency signal, the PERS individual's identification code, and the emergency code that indicates whether the signal is active, passive, or a responder test;

d. A back-up power supply;

e. A separate telephone service;

f. A toll free number to be used by the PERS equipment in order to contact the primary or back-up response center; and

g. A telephone line monitor, which must give visual and audible signals when the incoming telephone line is disconnected for more than 10 seconds.

14. The monitoring agency must maintain detailed technical and operations manuals that describe PERS elements, including the installation, functioning, and testing of PERS equipment; emergency response protocols; and recordkeeping and reporting procedures.

15. The PERS provider shall document and furnish within 30 calendar days of the action taken a written report to the case manager for each emergency signal that results in action being taken on behalf of the individual. This excludes test signals or activations made in error.

16. The PERS provider is prohibited from performing any type of direct marketing activities.

12VAC30-120-776. Companion services.

A. Service description. Companion services is a covered service when its purpose is to supervise or monitor those individuals who require the physical presence of an aide to ensure their safety during times when no other supportive people are available. This service may be provided either through an agency-directed or a consumer-directed model.

B. Criteria.

1. The inclusion of companion services in the plan of care is appropriate only when the individual cannot be left alone at any time due to mental or severe physical incapacitation. This includes individuals who cannot use a phone to call for help due to a physical or neurological disability. Individuals may receive companion services due to their inability to call for help if PERS is not appropriate for them.

2. Individuals having a current, uncontrolled medical condition making them unable to call for help during a rapid deterioration may be approved for companion services if there is documentation that the individual has had recurring attacks during the two-month period prior to the authorization of companion services. Companion services shall not be covered if required only because the individual does not have a telephone in the home or because the individual does not speak English.

3. There must be a clear and present danger to the individual as a result of being left unsupervised. Companion services cannot be authorized for individuals whose only need for companion services is for assistance exiting the home in the event of an emergency.

4. Individuals choosing the consumer-directed option must receive support from a CD services facilitator and meet requirements for consumer direction as described in 12VAC30-120-770.

C. Service units and service limitations.

1. The amount of companion service time included in the plan of care must be no more than is necessary to prevent the physical deterioration or injury to the individual. In no event may the amount of time relegated solely to companion service on the plan of care exceed eight hours per day.

2. A companion cannot provide supervision to individuals on ventilators, requiring continuous tube feedings, or requiring suctioning of their airways.

3. Companion services will be authorized for family members to sleep either during the day or during the night when the individual cannot be left alone at any time due to the individual's severe agitation and/or or physically wandering behavior. Companion services must be necessary to ensure the individual's safety if the individual cannot be left unsupervised due to health and safety concerns.

4. Companion services may be authorized when no one else is in the home is competent to call for help in an emergency.

D. Provider requirements. In addition to meeting the general conditions and requirements for home and community-based care participating providers as specified in 12VAC30-120-730 and 12VAC30-120-740, companion service providers must meet the following requirements:

1. Companion services providers shall include:

a. For the agency-directed model: companion providers include DMHMRSAS-licensed DBHDS-licensed residential services providers; DMHMRSAS-licensed DBHDS-licensed supportive, in-home residential service providers; DMHMRSAS-licensed DBHDS-licensed day support service providers; DMHMRSAS-licensed DBHDS-licensed respite service providers; and DMAS-enrolled personal care/respite care providers.

b. For the consumer-directed model: a services facilitator must meet the requirements found in 12VAC30-120-770.

2. Companion qualifications. Companions must meet the following requirements:

a. Be at least 18 years of age;

b. Possess basic math skills and English reading and writing skills, to the degree necessary to perform the tasks required;

c. Be capable of following a plan of care with minimal supervision;

d. Submit to a criminal history record check and if providing services to a minor, submit to a record check under the State's Child Protective Services Registry. The companion will not be compensated for services provided to the individual if the records check verifies the companion has been convicted of crimes described in § 37.2-416 of the Code of Virginia;

e. Possess a valid Social Security social security number; and

f. Have the required skills to perform services as specified in the individual's plan of care.

g. Additional CD employee requirements under the consumer-directed model:

(1) Be willing to attend training at the request of the individual or his family/caregiver, as appropriate;

(2) Understand and agree to comply with the DMAS consumer-directed services requirements; and

(3) Receive an annual TB screening.

3. Companions may not be the individual's spouse. Other family members living under the same roof as the individual being served may not provide companion services unless there is objective, written documentation as to why there are no other providers available to provide the services. Companion services shall not be provided by adult foster care/family care providers or any other paid caregivers.

4. Family members who are reimbursed to provide companion services must meet the companion qualifications.

5. For the agency-directed model, companions are employees of entities that enroll with DMAS to provide companion services. Providers are required to have a companion services supervisor to monitor companion services. The supervisor must be an LPN, or an RN, have a current license or certification to practice in the Commonwealth, and have at least one year of experience working with individuals with related conditions; or must have a bachelor's degree in a human services field and at least one year of experience working with individuals with related conditions.

6. Retention, hiring, and substitution of companions (consumer-directed model). Upon the individual's request, the CD services facilitator shall provide the individual or his family/caregiver, as appropriate, with a list of potential consumer-directed employees on the consumer-directed employee registry that may provide temporary assistance until the companion returns or the individual or his family/caregiver as, appropriate, is able to select and hire a new companion. If an individual or his family/caregiver, as appropriate, is consistently unable to hire and retain a companion to provide consumer-directed services, the CD services facilitator must contact the case manager and DMAS DBHDS to transfer the individual, at the choice of the individual or his family/caregiver, as appropriate, to a provider that provides Medicaid-funded agency-directed companion services. The CD services facilitator will make arrangements with the case manager to have the individual transferred.

7. The provider or case manager/services facilitator must conduct an initial home visit prior to initiating companion services to document the efficacy and appropriateness of services and to establish a plan of care for the individual. Under the agency-directed model, the provider must provide follow-up home visits quarterly or as often as needed to monitor the provision of services. Under the consumer-directed model, the case manager/services facilitator will periodically review the utilization of companion services at a minimum of every six months or more often as needed. The individual must be reassessed for services every six months.

8. Required documentation. The provider or case manager/services facilitator must maintain a record of each individual receiving companion services. At a minimum these records must contain the following:

a. An initial assessment completed prior to or on the date services are initiated and subsequent reassessments and changes to the supporting documentation.

b. The supporting documentation must be reviewed by the provider or case manager/services facilitator quarterly under the agency-directed model, semiannually under the consumer-directed model, annually, and more often, as needed, modified as appropriate, and the written results of these reviews submitted to the case manager. For the annual review and in cases where the supporting documentation is modified, the plan of care must be reviewed with the individual or his family/caregiver, as appropriate.

c. All correspondence to the individual, family/caregiver, case manager, DBHDS, and DMAS.

d. Contacts made with family/caregiver, physicians, formal and informal service providers, and all professionals concerning the individual.

e. The companion services supervisor or case manager/service facilitator must document in the individual's record a summary note following significant contacts with the companion and quarterly or semiannual home visits with the individual. This summary must include the following at a minimum:

(1) Whether companion services continue to be appropriate;

(2) Whether the plan is adequate to meet the individual's needs or changes are indicated in the plan;

(3) The individual's satisfaction with the service; and

(4) The presence or absence of the companion during the visit.

f. A copy of the most recently completed DMAS-122 DMAS-225 form. The provider must clearly document efforts to obtain the completed DMAS-122 DMAS-225 form from the case manager.

g. Additional documentation requirements under the consumer-directed model:

(1) All training provided to the companion on behalf of the individual or his family/caregiver, as appropriate.

(2) All management training provided to the individual or his family/caregiver, as appropriate, including responsibility for the accuracy of the timesheets.

(3) All documents signed by the individual or his family/caregiver, as appropriate, that acknowledge the responsibilities of the services.

h. Under the agency-directed model, all companion records. The companion record must contain the following:

(1) The specific services delivered to the individual by the companion, dated the day of service delivery, and the individual's response;

(2) The companion's arrival and departure times;

(3) The companion's weekly comments or observations about the individual to include observations of the individual's physical and emotional condition, daily activities, and responses to services rendered; and

(4) The weekly signatures of the companion and the individual or his family/caregiver, as appropriate, recorded on the last day of service delivery for any given week to verify that companion services during that week have been rendered.

FORMS (12VAC30-120)

Virginia Uniform Assessment Instrument (UAI) (1994)

Consent to Exchange Information, DMAS-20 (rev. 4/03)

Provider Aide/LPN Record Personal/Respite Care, DMAS-90 (rev. 12/02)

LPN Skilled Respite Record, DMAS-90A (eff. 7/05)

Personal Assistant/Companion Timesheet, DMAS-91 (rev. 8/03)

Questionnaire to Assess an Applicant's Ability to Independently Manage Personal Attendant Services in the CD-PAS Waiver or DD Waiver, DMAS-95 Addendum (eff. 8/00)

Medicaid Funded Long-Term Care Service Authorization Form, DMAS-96 (rev. 10/06)

Screening Team Plan of Care for Medicaid-Funded Long Term Care, DMAS-97 (rev. 12/02)

Provider Agency Plan of Care, DMAS-97A (rev. 9/02)

Consumer Directed Services Plan of Care, DMAS-97B (rev. 1/98)

Community-Based Care Recipient Assessment Report, DMAS-99 (rev. 4/03)

Consumer-Directed Personal Attendant Services Recipient Assessment Report, DMAS-99B (rev. 8/03)

MI/MR Level I Supplement for EDCD Waiver Applicants, DMAS-101A (rev. 10/04)

Assessment of Active Treatment Needs for Individuals with MI, MR, or RC Who Request Services under the Elder or Disabled with Consumer-Direction Waivers, DMAS-101B (rev. 10/04)

Technology Assisted Waiver Provider RN Initial Home Assessment, DMAS-116 (11/10)

Medicaid Long Term Care Communication Form, DMAS-225 (rev. 10/11)

Technology Assisted Waiver/EPSDT Nursing Services Provider Skills Checklist for Individuals Caring for Tracheostomized and/or Ventilator Assisted Children and Adults, DMAS-259

Home Health Certification and Plan of Care, CMS-485 (rev. 2/94)

IFDDS Waiver Level of Care Eligibility Form (eff. 5/07)

Request for Screening for Individual and Family Developmental Disabilities Support Waiver (DD Waiver), DMAS 305 (rev. 3/09)

DD Medicaid Waiver - Level of Functioning Survey Summary Sheet, DMAS-458 (undated)

Technology Assisted Waiver Adult Aide Plan of Care, DMAS 97 T (rev. 6/08)

Technology Assisted Waiver Supervisory Monthly Summary, DMAS 103 (rev. 4/08)

Technology Assisted Waiver Adult Referral, DMAS 108 (rev. 3/10)

Technology Assisted Waiver Pediatric Referral, DMAS 109 (rev. 3/10)

Title of Regulation: 14VAC5-200. Rules Governing Long-Term Care Insurance (amending 14VAC5-200-65).

Statutory Authority: §§ 12.1-13 and 38.2-223 of the Code of Virginia.

Public Hearing Information: A public hearing will be scheduled upon request.

Public Comment Deadline: March 31, 2014.

Agency Contact: Robert Grissom, Chief Insurance Market Examiner, Life and Health Division, Bureau of Insurance, State Corporation Commission, P.O. Box 1157, Richmond, VA 23218, telephone (804) 371-9152, FAX (804) 371-9944, or email bob.grissom@scc.virginia.gov.

Summary:

The proposed amendments enhance the mailing notice provisions to long-term care insurance policyholders or designees. The current rules require that notice only be mailed by first class United States mail. The proposed amendments (i) require that long-term care insurance carriers provide the policyholder or certificateholder, as well as a person designated by the policyholder or certificateholder, notice of lapse or termination of the policy or certificate for nonpayment of premium at least 30 days prior to the effective date of such lapse or termination; (ii) expand the notice mailing provisions to allow mailing by one of several means; and (iii) require that carriers must retain evidence of mailing the required notices because these proof-of-mailing provisions will assist with determining whether a notice was properly sent.

AT RICHMOND, FEBRUARY 11, 2014

COMMONWEALTH OF VIRGINIA, ex rel.

STATE CORPORATION COMMISSION

CASE NO. INS-2014-00019

Ex Parte: In the matter of
Amending the Rules Governing
Long-Term Care Insurance

ORDER TO TAKE NOTICE

Section 12.1-13 of the Code of Virginia ("Code") provides that the State Corporation Commission ("Commission") shall have the power to promulgate rules and regulations in the enforcement and administration of all laws within its jurisdiction, and § 38.2-223 of the Code provides that the Commission may issue any rules and regulations necessary or appropriate for the administration and enforcement of Title 38.2 of the Code.

The rules and regulations issued by the Commission pursuant to § 38.2-223 of the Code are set forth in Title 14 of the Virginia Administrative Code. Copies of these rules and regulations may also be accessed via the Commission's website: http://www.scc.virginia.gov/boi/laws.aspx.

The Bureau of Insurance ("Bureau") has submitted to the Commission a proposal to amend the Rules Governing Long-Term Care Insurance at Chapter 200 of Title 14 of the Virginia Administrative Code, specifically set forth at 14 VAC 5-200-65, Unintentional lapse.

The purpose of the amendments to 14 VAC 5-200-65 is to enhance the mailing of notice provisions to long-term care insurance policyholders and/or designees. The current rules require that notice only be mailed by first class United States mail. The proposed amendment requires that long-term care insurance carriers provide the policyholder or certificateholder, as well as a person designated by the policyholder or certificateholder, notice of lapse or termination of the policy or certificate for nonpayment of premium at least 30 days prior to the effective date of such lapse or termination. It also specifies that notice may be mailed by one of several means and that carriers must retain evidence of mailing the required notices. These proof-of-mailing provisions will assist with determining whether a notice was properly sent.

NOW THE COMMISSION is of the opinion that the proposed amendment submitted by the Bureau to amend 14 VAC 5-200-65 should be considered for adoption.

Accordingly, IT IS ORDERED THAT:

(1) The proposal to amend Chapter 200 of Title 14 of the Virginia Administrative Code, specifically 14 VAC 5-200-65, Unintentional lapse, is attached hereto and made a part hereof.

(2) All interested persons who desire to comment in support of or in opposition to, or request a hearing to consider the amendments to 14 VAC 5-200-65, shall file such comments or hearing request on or before March 31, 2014, with Joel H. Peck, Clerk, State Corporation Commission, c/o Document Control Center, P.O. Box 2118, Richmond, Virginia 23218. Interested persons desiring to submit comments electronically may do so by following the instructions at the Commission's website: http://www.scc.virginia.gov/case. All comments shall refer to Case No. INS-2014-00019.

(3) If no written request for a hearing on the proposal to amend 14 VAC 5-200-65 is received on or before March 31, 2014, the Commission, upon consideration of any comments submitted in support of or in opposition to the proposal, may amend 14 VAC 5-200-65.

(4) AN ATTESTED COPY hereof, together with a copy of the proposal to amend 14 VAC 5-200-65, shall be sent by the Clerk of the Commission to the Bureau in care of Deputy Commissioner Althelia P. Battle, who forthwith shall give further notice of the proposal to amend 14 VAC 5-200-65 by mailing a copy of this Order, together with the proposal, to all companies licensed by the Commission to write long-term care insurance in the Commonwealth of Virginia, as well as all interested persons.

(5) The Commission's Division of Information Resources forthwith shall cause a copy of this Order, together with the proposal to amend 14 VAC 5-200-65, to be forwarded to the Virginia Registrar of Regulations for appropriate publication in the Virginia Register of Regulations.

(6) The Commission's Division of Information Resources shall make available this Order and the attached proposed amendment to 14 VAC 5-200-65 on the Commission's website: http://www.scc.virginia.gov/case.

(7) The Bureau shall file with the Clerk of the Commission an affidavit of compliance with the notice requirements of Ordering Paragraph (4) above.

14VAC5-200-65. Unintentional lapse.

A. Each insurer offering long-term care insurance shall, as a protection against unintentional lapse, comply with the following:

1. Notice before lapse or termination. No individual long-term care policy or certificate shall be issued until the insurer has received from the applicant either a written designation of at least one person, in addition to the applicant, who is to receive notice of lapse or termination of the policy or certificate for nonpayment of premium, or a written waiver dated and signed by the applicant electing not to designate additional persons to receive notice. The applicant has the right to designate at least one person who is to receive the notice of termination, in addition to the insured. Designation shall not constitute acceptance of any liability on the third party for services provided to the insured. The form used for the written designation must provide space clearly designated for listing at least one person. The designation shall include each person's full name and home address. In the case of an applicant who elects not to designate an additional person, the waiver shall state: "Protection against unintended lapse. I understand that I have the right to designate at least one person other than myself to receive notice of lapse or termination of this long-term care insurance policy for nonpayment of premium. I understand that notice will not be given until 30 days after a premium is due and unpaid. I elect NOT to designate a person to receive this notice."

The insurer shall notify the insured in writing of the right to change this written designation, no less often than once every two years.

2. When the policyholder or certificateholder pays premium for a long-term care insurance policy or certificate through a payroll or pension deduction plan, the requirements contained in subdivision 1 of this subsection need not be met until 60 days after the policyholder or certificateholder is no longer on such a payment plan. The application or enrollment form for such policies or certificates shall clearly indicate the payment plan selected by the applicant.

3. Lapse or termination for nonpayment of premium. No individual long-term care policy or certificate shall lapse or be terminated for nonpayment of premium unless the insurer, at least 30 days before the effective date of the lapse or termination, has given notice to the insured and to those persons designated pursuant to subdivision 1 of this subsection, at the address provided by the insured for purposes of receiving notice of lapse or termination. Notice shall be given by first class United States mail, postage prepaid; and notice No notice shall be effective unless it has been mailed in accordance with one of the following:

a. The notice is sent by certified mail, or the insurer obtains a certificate of mailing by the United States Postal Service;

b. The notice is sent by a commercial delivery service, and the insurer shall (i) obtain at the time of mailing a written receipt from the service showing the date of mailing and the number of items mailed and (ii) retain a mailing list showing the name and address of the insured and of those persons designated pursuant to subdivision 1 of this subsection to whom the notices were mailed, together with a signed statement by the insurer that the written receipt from the service corresponds to the mailing list retained by the insurer; or

c. The notice is sent by first-class United States mail, and the insurer shall (i) obtain at the time of mailing a written receipt from the United States Postal Service showing the date of mailing and the number of items mailed and (ii) retain a mailing list showing the name and address of the insured and of those persons designated pursuant to subdivision 1 of this subsection to whom the notices were mailed.

Notification shall also be provided to the agent of record of the insured, if any, within 72 hours after the notice has been mailed to the insured and those persons designated pursuant to subdivision 1 of this subsection.

There is a presumption that notice is delivered five days after the date that certified mail, commercial delivery service mail, or first-class United States mail is sent, the date of a certificate of mailing, or the date that notice was returned as undeliverable. The insurer shall retain evidence of mailing the notice, including the street address of the recipients, as applicable, and the content of the notification, for at least three years following the date of notice. Notice may not be given until 30 days after a premium is due and unpaid. Notice shall be deemed to have been given as of five days after the date of mailing.

B. Reinstatement. In addition to the requirement in subsection A of this section, a long-term care insurance policy or certificate shall include a provision that provides for reinstatement of coverage in the event of lapse if the insurer is provided proof that the policyholder or certificateholder was cognitively impaired or had a loss of functional capacity before the grace period contained in the policy expired. This option shall be available to the insured if requested within five months after termination and shall allow for the collection of past due premium, where appropriate. The standard of proof of cognitive impairment or loss of functional capacity shall not be more stringent than the benefit eligibility criteria on cognitive impairment or the loss of functional capacity contained in the policy and certificate.