Title of Regulation: 4VAC15-20. Definitions and Miscellaneous: In General (amending 4VAC15-20-130).

Statutory Authority: §§ 29.1-103, 29.1-501, and 29.1-502 of the Code of Virginia.

Effective Date: April 1, 2016.

Agency Contact: Phil Smith, Regulatory Coordinator, Department of Game and Inland Fisheries, 7870 Villa Park Drive, Suite 400, Henrico, VA 23228, telephone (804) 367-8341 or email phil.smith@dgif.virginia.gov.

Summary:

The amendments (i) update the date reference to the federal list of endangered and threatened wildlife species; (ii) update the Virginia List of Endangered and Threatened Species to add the little brown bat and the tri-colored bat as endangered species and remove the state-threatened upland sandpiper and Dismal Swamp southeastern shrew to reflect their status in Virginia more accurately; and (iii) describe certain activities that may be conducted without a permit from the department, provided that the activities are performed in certain manners.

4VAC15-20-130. Endangered and threatened species; adoption of federal list; additional species enumerated.

A. The board hereby adopts the Federal Endangered and Threatened Species List, Endangered Species Act of December 28, 1973 (16 USC §§ 1531-1543), as amended as of May 20, 2014 [ October 2 December 23 ], 2015, and declares all species listed thereon to be endangered or threatened species in the Commonwealth. Pursuant to § 29.1-103.12 subdivision 12 of § 29.1-103 of the Code of Virginia, the director of the department is hereby delegated authority to propose adoption of modifications and amendments to the Federal Endangered and Threatened Species List in accordance with the procedures of §§ 29.1-501 and 29.1-502 of the Code of Virginia.

B. In addition to the provisions of subsection A of this section, the following species are declared endangered or threatened in this Commonwealth, and are afforded the protection provided by Article 6 (§ 29.1-563 et seq.) of Chapter 5 of Title 29.1 of the Code of Virginia:

Title of Regulation: 12VAC5-371. Regulations for the Licensure of Nursing Facilities (amending 12VAC5-371-410; repealing 12VAC5-371-420).

Statutory Authority: §§ 32.1-127 and 32.1-127.001 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: May 6, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, FAX (804) 527-4502, or email erik.bodin@vdh.virginia.gov.

Basis: 12VAC5-371 is promulgated under the authority of §§ 32.1-127 and 32.1-127.001 of the Code of Virginia. Section 32.1-127 requires the board to promulgate regulations including minimum standards for (i) the construction and maintenance of hospitals, nursing homes, and certified nursing facilities to ensure the environmental protection and the life safety of its patients, employees, and the public; (ii) the operation, staffing, and equipping of hospitals, nursing homes, and certified nursing facilities; (iii) qualifications and training of staff of hospitals, nursing homes, and certified nursing facilities, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital or nursing home may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of facilities. Section 32.1-127.001 states, "Notwithstanding any law or regulation to the contrary, the Board of Health shall promulgate regulations pursuant to § 32.1-127 for the licensure of hospitals and nursing homes that shall include minimum standards for the design and construction of hospitals, nursing homes, and certified nursing facilities consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health." The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI) and the latest edition of guidelines for nursing facilities published by the FGI is the 2014 edition of Guidelines for the Design and Construction of Residential Health, Care, and Support Facilities.

Purpose: This regulatory action is in response to a petition for rulemaking. This action will bring the regulations into conformance with the provisions of § 32.1-127.001 of the Code of Virginia, which states that "Notwithstanding any law or regulation to the contrary, the Board of Health shall promulgate regulations for the licensure of hospitals and nursing homes that include minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health." The American Institute of Architects Academy of Architecture for Health has become the FGI and the latest edition of Guidelines published by the Facility Guidelines Institute is the 2014 edition of Guidelines for Residential Health, Care, and Support Facilities. However, the regulations currently state that the Virginia Uniform Statewide Building Code takes precedence over the guidelines and the edition of the guidelines listed within the regulations is outdated. This regulatory provision is contrary to the requirements of § 32.1-127.001.

The Virginia Department of Health (VDH) plans to amend 12VAC5-371-410 pertaining to building and construction codes for nursing facilities. The purpose of the amendment is to specify that nursing facilities' design and construction must be consistent with certain parts of the 2014 edition of the guidelines and remove language stating that the Virginia Uniform Statewide Building Code takes precedence, thus bringing the regulations into compliance with the Code of Virginia and promoting the public health, welfare, and safety.

Substance: VDH intends to amend 12VAC5-371-410 to specify that nursing facilities shall be designed and constructed consistent with Parts 1 and 2 and sections 3.1 and 3.2 of Part 3 of the 2014 edition of the guidelines and remove language that states the Virginia Uniform Statewide Building Code takes precedence over the guidelines, thus bringing the regulations into compliance with the Code of Virginia. Further, the action will repeal the unnecessary12VAC5-371-420.

Issues: The primary advantages of the proposed regulatory action to the public are increased facility and construction safety protections in new nursing facilities. The primary disadvantage to the public associated with the proposed action is the increased cost some facilities may incur to construct their facility in order to comply with the regulations. This increased cost may be passed on to the patient. VDH does not foresee any additional disadvantages to the public. The primary advantage to the agency and the Commonwealth is the promotion of public health and safety. There are no disadvantages associated with the proposed regulations in relation to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to specify that nursing facilities be designed and constructed consistent with the 2014 Guidelines for Residential Health, Care, and Support Facilities of the Facility Guidelines Institute. Additionally, the Board proposes to amend other language for improved clarity.

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

Estimated Economic Impact. Section § 32.1-127.001 of the Code of Virginia states that the Board shall promulgate regulations for the licensure of nursing homes that include minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health. The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI). Consequently the Board proposes to amend this regulation to specify that construction be consistent with the 2014 Guidelines for Residential Health, Care, and Support Facilities of the Facility Guidelines Institute.¹ The current regulation references the 2010 Guidelines.

The Facility Guidelines Institute published a study³ that estimates the change in costs of applying the 2014 Guidelines rather than the 2010 Guidelines for hospitals and outpatient facilities. The study breaks up hospitals and outpatient facilities into five facility types, and lists the estimated percentage cost changes for each. Licensed Virginia architects² have determined that the changes affecting nursing facilities are most comparable to the category for rehab hospitals as they both are similar in nature of design. The study estimates a net change of approximately zero for the rehab hospital facility type. Some of the proposed changes moderately add to cost, while others moderately reduce cost. Consequently, the best available estimate for the net cost impact of requiring that new nursing facilities be designed and constructed consistent with the 2014 Guidelines rather than the 2010 Guidelines would be zero. The Board and the architects and engineers associated with the Facility Guidelines Institute believe that adopting the 2014 edition will increase patient and staff health and safety. Thus, the proposal to specify that renovation or construction of hospitals be consistent with the 2014 Guidelines will likely produce a net benefit.

Businesses and Entities Affected. There are 266 licensed nursing facilities in operation in the Commonwealth. However, the proposal to amend this regulation to specify that the design and construction of nursing facilities be consistent with the 2014 Guidelines would only apply to facilities built after this proposed amendment is put into effect.

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.

Real Estate Development Costs. Depending on the specific attributes of the project, the proposed adoption of the 2014 Guidelines may increase or decrease total real estate development costs. In any case, the change is not likely to be large.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Depending on the specific attributes of the project, the proposed adoption of the 2014 Guidelines may increase or decrease the cost of nursing facility construction. In net, the proposed amendments are unlikely to significantly increase costs for small businesses.

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

Adverse Impacts:

Businesses: The proposed amendments are unlikely to significantly adversely affect businesses.

Localities: The proposed amendments are unlikely to significantly adversely affect localities.

Other Entities: The proposed amendments are unlikely to significantly adversely affect other entities.

____________________________________________

¹The 2014 Guidelines for Residential Health, Care, and Support Facilities is the current edition.

²Gormley T, Garland J, Jones W. "Estimated Cost of Applying the 2014 vs. the 2010 FGI Guidelines for Design and Construction Requirements to Hospitals and Outpatient Facilities."

³The Department of Planning and Budget contacted licensed architects for their expert opinion.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis conducted by the Department of Planning and Budget.

Summary:

The proposed amendments conform the regulation to § 32.1-127.001 of the Code of Virginia, which requires the State Board of Health to adopt minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health. The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI). The latest edition of guidelines published by the FGI for nursing facilities is the 2014 edition of Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.

Part V
Physical Environment

12VAC5-371-410. Architectural drawings and specifications.

A. All construction of new buildings and additions, renovations or, alterations, or repairs of existing buildings for occupancy as a nursing facility shall conform to state and local codes, zoning and building ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, nursing facilities shall be designed and constructed according to Part consistent with Parts 1 and 2 and sections 4.1—1 through 4.2—8 3.1 and 3.2 of Part 4 3 of the 2010 2014 Guidelines for Design and Construction of Residential Health, Care, and Support Facilities of the Facilities Facility Guidelines Institute (formerly of the American Institute of Architects). However, the requirements of the Uniform Statewide Building Code and local zoning and building ordinances shall take precedence pursuant to § 32.1-127.001 of the Code of Virginia.

B. Architectural drawings and specifications for all new construction or for additions, alterations or renovations to any existing building, shall be dated, stamped with licensure professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to building code requirements the Virginia Uniform Statewide Building Code and be consistent with Parts 1 and 2 and sections 3.1 and 3.2 of Part 3 of the 2014 Guidelines for Design and Construction of Residential Health, Care, and Support Facilities of the Facility Guidelines Institute. The certification shall be forwarded to the OLC.

C. Additional approval may include a Certificate of Public Need.

D. Upon completion of the construction, the nursing facility shall maintain a complete set of legible "as built" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

12VAC5-371-420. Building inspection and classification. (Repealed.)

All buildings shall be inspected and approved as required by the appropriate building regulatory entity. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-371)

Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, 2014 Edition, Facilities Guideline Facility Guidelines Institute (formerly of the American Institute of Architects Academy of Architecture), 2010 Edition, http://www.fgiguidelines.org

Guidelines for Preventing Health Care-Associated Pneumonia, 2003, MMWR 53 (RR03), Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention

Prevention and Control of Influenza, MMWR 53 (RR06), Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention

Title of Regulation: 12VAC5-391. Regulations for the Licensure of Hospice (amending 12VAC5-391-460).

Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Effective Date: April 7, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, or erik.bodin@vdh.virginia.gov.

Summary:

Pursuant to Chapter 668 of the 2015 Acts of Assembly, the amendment requires any hospice licensed by the Department of Health or exempt from licensure pursuant to § 32.1-162.2 of the Code of Virginia with a hospice patient residing at home at the time of death to notify every pharmacy that has dispensed partial quantities of a Schedule II controlled substance for a patient with a medical diagnosis documenting a terminal illness, as authorized by federal law, within 48 hours of the patient's death.

12VAC5-391-460. Pharmacy services.

A. Whether medications and biologicals are obtained from community or institutional pharmacies, the hospice facility is responsible for assuring availability for medications and biologicals, including 24-hour emergency services, for its patients and for ensuring that pharmaceutical services are provided according to accepted professional principles and appropriate federal and state laws.

B. The facility shall comply with the Virginia Board of Pharmacy regulations related to pharmacy services in long-term care facilities, (i.e., Part XII (18VAC110-20-530 18VAC110-20-520 et seq.) of the Virginia Board of Pharmacy Regulations Governing the Practice of Pharmacy).

C. Each hospice facility shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, medication errors, self-administration, disposal and accounting of drugs and other pharmacy products.

D. Each facility shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility.

The consultant pharmacist shall make regularly scheduled visits, at least quarterly, to the facility for a sufficient number of hours to carry out the function of the agreement.

E. Each prescription container shall be individually labeled by the pharmacist for each patient or provided in an individualized unit dose system.

F. No drug or medication shall be administered to any patient without a valid verbal order or a written, dated and signed order from a physician, dentist or, podiatrist, nurse practitioner, or physician assistant, licensed in Virginia.

G. Verbal orders for drugs or medications shall only be given to a licensed nurse, pharmacist or physician.

H. Each patient's medication regimen shall be reviewed by a pharmacist licensed in Virginia. Any irregularities identified by the pharmacist shall be reported to the physician and the director of nursing, and their response documented.

I. Medication orders shall be reviewed at least every 60 days by the attending physician, nurse practitioner, or physician's assistant.

J. Prescription and nonprescription drugs and medications may be brought into the facility by a patient's family, friend, or other person provided:

1. The individual delivering the drugs and medications assures timely delivery, in accordance with the facility's written policies, so that the patient's prescribed treatment plan is not disrupted;

2. Each drug or medication is in an individual container; and

3. Delivery is not allowed directly to an individual patient.

In addition, prescription medications shall be:

4. Obtained from a pharmacy licensed by the state or federal authority; and

5. Securely sealed and labeled by a licensed pharmacist according to 18VAC110-20-330 and 18VAC110-20-340.

K. Any hospice licensed by the Department of Health or exempt from licensure pursuant to § 32.1-162.2 of the Code of Virginia with a hospice patient residing at home at the time of death shall notify every pharmacy that has dispensed partial quantities of a Schedule II controlled substance for a patient with a medical diagnosis documenting a terminal illness, as authorized by federal law, within 48 hours of the patient's death.

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-210).

Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 6, 2016.

Effective Date: April 22, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, or erik.bodin@vdh.virginia.gov.

Basis: The regulation is promulgated under the authority of §§ 32.1-12 and 32.1-127 of the Code of Virginia. Section 32.1-12 grants the board the legal authority "to make, adopt, promulgate, and enforce such regulations necessary to carry out the provisions of Title 32.1 of the Code." Section 32.1-127 directs the board to promulgate regulations with minimum standards for the construction and maintenance of hospitals; the operation, staffing, and equipping of hospitals; qualifications and training of staff of hospitals; conditions under which a hospital may provide medical and nursing services to patients in their places of residence; and policies related to infection prevention, disaster preparedness, and facility security.

Purpose: The Centers for Medicare and Medicaid Services (CMS) revised 42 CFR 482.22(b) in 2014 to add § 482.22(b)(4), which permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals, in accordance with state law. The Regulations for the Licensure of Hospitals in Virginia is currently written in a manner that can be interpreted to be more restrictive than the federal regulations. This was not the intent and therefore this regulatory action will amend the regulations to remove restrictions that may be interpreted to be more stringent than federal law. This regulatory action will protect the health and welfare of Virginians by ensuring that patients within a hospital setting benefit from the improved efficiency and quality and patient safety made possible through a unified, integrated medical staff.

Rationale for Using Fast-Track Process: These amendments simply ensure that the Commonwealth's regulations are not more restrictive than federal regulations. These amendments have also been prepared with input from stakeholders. Therefore, the department does not expect that this regulatory action will be controversial.

Substance: The amendment to 12VAC5-410-210 clarifies the requirement that each hospital have an organized medical staff by adding language that allows hospitals that are part of a hospital system to have a unified and integrated medical staff and adding a citation for the CFR subsections that specify the requirements of unified and integrated medical staffs.

Issues: The primary advantage to the agency, the Commonwealth, and the public of the proposed regulatory action will be less burdensome regulations. The proposed regulatory action will also lead to improved efficiency and quality and patient safety created through unified and integrated medical staffs. There are no known disadvantages to the agency, the Commonwealth, or the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to add a clarifying sentence to this regulation in order to reflect changes to federal regulations.

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

Estimated Economic Impact. This regulation specifies that "Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients." The federal Centers for Medicare and Medicaid Services revised 42 CFR § 482.22 (b) in 2014 to add § 482.22 (b)(4) which permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals. In order to clarify that the federal rule applies in the Commonwealth, the Board proposes to add the following sentence to the regulation: "Nothing in this provision shall prevent hospitals which are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR § 482.22 (b) (4)." The proposed addition of clarifying language will not affect any requirements, but will provide a small benefit in that it will reduce potential confusion and associated time wasted in determining how hospitals may be organized.

Businesses and Entities Affected. The proposed amendment pertains potentially affects the 106 licensed hospitals and critical access hospitals within the Commonwealth.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment will not significantly affect employment.

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

Real Estate Development Costs. The proposed amendment does not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendment is unlikely to significantly affect small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendment will not adversely affect small businesses.

Adverse Impacts:

Businesses: The proposed amendment will not adversely affect businesses.

Localities: The proposed amendment will not adversely affect localities.

Other Entities: The proposed amendment will not adversely affect other entities.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the result of the economic impact analysis prepared by the Virginia Department of Planning and Budget.

Summary:

The amendment clarifies that 42 CFR 482.22(b)(4) applies in the Commonwealth of Virginia. 42 CFR 482.22(b)(4) permits a hospital that is part of a hospital system consisting of multiple, separately certificated hospitals to participate in a unified, integrated medical staff that the hospital system utilizes for two or more of its member hospitals.

12VAC5-410-210. Medical staff.

A. Each hospital shall have an organized medical staff responsible to the governing body of the hospital for its own organized governance and all medical care provided to patients. Nothing in this subsection shall prevent hospitals that are a part of a hospital system from having a unified and integrated medical staff as permitted by 42 CFR 482.22(b)(4).

B. The medical staff shall be responsible to the hospital governing board and maintain appropriate standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review, and other appropriate mechanisms.

C. The medical staff, subject to approval by the governing body, shall develop bylaws incorporating details of the medical staff organization and governance, giving effect to its general powers, duties, and responsibilities including:

1. Methods of selection, election, or appointment of all officers and other executive committee members and officers;

2. Provisions for the selection and appointment of officers of departments or services specifying required qualifications;

3. The type, purpose, composition, and organization of standing committees;

4. Frequency and requirements for attendance at staff and departmental meetings;

5. An appeal mechanism for denial, revocation, or limitation of staff appointments, reappointments, and privileges;

6. Delineation of clinical privileges in accordance with the requirements of § 32.1-134.2 of the Code of Virginia;

7. Requirements regarding medical records;

8. A mechanism for utilization and medical care review; and

9. Such other provisions as shall be required by hospital or governmental rules and regulations.

D. A copy of approved medical staff bylaws and regulations and revisions thereto shall be made available to the OLC on request.

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-442, 12VAC5-410-445, 12VAC5-410-650, 12VAC5-410-760, 12VAC5-410-1350).

Statutory Authority: §§ 32.1-127 and 32.1-127.001 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: May 6, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Richmond, VA 23233, telephone (804) 367-2109, FAX (804) 527-4502, or email erik.bodin@vdh.virginia.gov.

Basis: Section 32.1-127 of the Code of Virginia requires the board to promulgate regulations including minimum standards for (i) the construction and maintenance of hospitals, nursing homes, and certified nursing facilities to ensure the environmental protection and the life safety of its patients, employees, and the public; (ii) the operation, staffing, and equipping of hospitals, nursing homes, and certified nursing facilities; (iii) qualifications and training of staff of hospitals, nursing homes, and certified nursing facilities, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital or nursing home may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of facilities. Section 32.1-127.001 of the Code of Virginia states, "Notwithstanding any law or regulation to the contrary, the Board of Health shall promulgate regulations pursuant to § 32.1-127 for the licensure of hospitals and nursing homes that shall include minimum standards for the design and construction of hospitals, nursing homes, and certified nursing facilities consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health." The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI) and the latest edition of guidelines published by the FGI is the 2014 edition of Guidelines for Design and Construction of Hospitals and Outpatient Facilities.

Purpose: This regulatory action is in response to a petition for rulemaking. This action will bring the regulations into conformance with the provisions of § 32.1-127.001 of the Code of Virginia, which states that "Notwithstanding any law or regulation to the contrary, the Board of Health shall promulgate regulations for the licensure of hospitals and nursing homes that include minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health." The American Institute of Architects Academy of Architecture for Health has become the FGI and the latest edition of guidelines published by the FGI is the 2014 edition of Guidelines for Design and Construction of Hospitals and Outpatient Facilities (guidelines). However, the regulations currently state that the Virginia Uniform Statewide Building Code takes precedence over the guidelines and the editions of the guidelines listed within the regulations are outdated. This regulatory provision is contrary to the requirements of § 32.1-127.001.

The Virginia Department of Health (VDH) plans to amend various regulatory sections pertaining to building and physical plant information and building and construction codes for hospital facilities. The purpose of the proposed amendments is to specify that the facilities shall be designed, constructed, and renovated consistent with the 2014 edition of the guidelines and remove language stating that the Virginia Uniform Statewide Building Code takes precedence, thus bringing the regulations into compliance with the Code of Virginia and promoting the public health, safety, and welfare.

Substance:

12VAC5-410-442 - Obstetric service design and equipment criteria. Update the edition of the guidelines listed within the regulation and the coinciding sections related to obstetric services.

12VAC5-410-445 - Newborn service design and equipment criteria. Update the edition of the guidelines listed within the regulation and the coinciding sections related to nursery services.

12VAC5-410-650 - General building and physical plant information. Update the edition of the guidelines listed within the regulation and remove language that states the Virginia Uniform Statewide Building Code takes precedence. Add language stating that the facility's architect shall certify that the facility conforms with the Virginia Statewide Building Code and the FGI Guidelines.

12VAC5-410-760 - Long-term care nursing units. Update the edition of the guidelines within the regulation and the coinciding section related to skilled nursing care units. Add language stating that the facility's architect shall certify that the facility conforms with the Virginia Statewide Building Code and the FGI Guidelines.

12VAC5-410-1350 - Codes; fire safety; zoning; construction standards. Update the edition of the guidelines within the regulation and remove language that states the Virginia Uniform Statewide Building Code takes precedence. Add language stating that the facility's architect shall certify that the facility conforms with the Virginia Statewide Building Code and the FGI Guidelines.

Issues: The primary advantages of the proposed regulatory action to the public are increased facility and construction safety protections in new or renovated hospitals. The primary disadvantage to the public associated with the proposed action is the increased cost some facilities may incur to renovate or construct their facilities in order to comply with the regulations. This increased cost may be passed on to the patient. VDH does not foresee any additional disadvantages to the public. The primary advantage to the agency and the Commonwealth is the promotion of public health and safety. There are no disadvantages associated with the proposed regulations in relation to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to specify that renovation or construction of hospitals be consistent with the 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities of the Facility Guidelines Institute. Additionally, the Board proposes to amend other language for improved clarity.

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

Estimated Economic Impact. Section § 32.1-127.001 of the Code of Virginia states that the Board shall promulgate regulations for the licensure of hospitals that include minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health. The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI). Consequently the Board proposes to amend this regulation to specify that renovations or construction be consistent with the 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities of the Facility Guidelines Institute.¹ The current regulation references the 2010 and 2006 guidelines. Adopting the requirements in the 2014 Guidelines would produce both cost increases and reductions.

Potential Cost Increases. The change in requirements associated with adopting the 2014 edition would produce approximately the following cost increases.²

Potential Cost Reductions. Several of the changes in requirements in the 2014 Guidelines could yield reductions in the percentage of cost increase and could provide significant benefits. The following describe potential cost savings by section of the 2014 Guidelines.³

1.2-2 Functional Program. This section was revised to clarify the requirements for a functional program and to help owners and designers define the actual needs for a project to minimize additional costs for construction of scope beyond programmed requirements or needs and to minimize the need for scope changes later in a project.

1.2-3 Safety Risk Assessment. Combining a number of risk assessments under one umbrella, this new tool clarifies what risks should be assessed at the outset of a project and should help owners and designers define the scope of a project to avoid overbuilding and to improve operational and clinical results.

1.2-5.4 Bariatric–Specific Design Considerations. The percentage of the population that is obese varies considerably in different regions in the United States, making it impossible to determine minimum requirements for facilities and equipment to accommodate provision of care for this portion of the population that would be appropriate everywhere. Therefore, specific requirements were removed so that health care organizations can determine the percentage of their patient population that needs these accommodations. Allowing the decision on how much of a facility must be able to accommodate persons of size to be customized to a locality should allow cost savings in some areas.

2.1-5.1 Central Services. Requirements in this section were clarified so sterile processing services can be provided in a manner that meets local capabilities rather than having minimum requirements that may go beyond what is needed in small hospitals. This would save costs by allowing a customized approach for each location.

Conclusion. The estimated cost increases associated with adopting the 2014 Guidelines are fairly small, and may be offset by cost savings of other changes in the 2014 edition depending on the specifics of individual hospital construction and renovation projects. The Board and the architects and engineers associated with the Facility Guidelines Institute believe that adopting the 2014 edition will increase patient and staff health and safety. Thus, the proposal to specify that renovation or construction of hospitals be consistent with the 2014 Guidelines will likely produce a net benefit.

Businesses and Entities Affected. The proposed amendments potentially affect the 106 licensed hospitals within the Commonwealth.

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

Projected Impact on Employment. The proposed amendments will not likely significantly affect total 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.

Real Estate Development Costs. Depending on the specific attributes of the hospital construction or renovation project, the proposed adoption of the 2014 Guidelines may increase or decrease total real estate development costs. In any case, the change is not likely to be large.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Depending on the specifics of individual hospital construction and renovation projects, the proposed adoption of the 2014 Guidelines may increase or decrease the cost of hospital construction and renovation. In net, the proposed amendments are unlikely to significantly increase costs for small businesses.

Alternative Method that Minimizes Adverse Impact. Depending on the specifics of individual hospital construction and renovation projects, the proposed adoption of the 2014 Guidelines may increase or decrease the cost of hospital construction and renovation. For those projects that would have increased costs due to requirements in the 2014 edition, there is no clear alternative method that meets the intended policy goals at a lower cost.

Adverse Impacts:

Businesses: Depending on the specifics of individual hospital construction and renovation projects, the proposed adoption of the 2014 Guidelines may increase or decrease the cost of hospital construction and renovation. For those businesses that face increased costs, the increase will likely be relatively moderate.

Localities: The proposed amendments are unlikely to significantly adversely affect localities.

Other Entities: The proposed amendments are unlikely to significantly adversely affect other entities.

_________________________________________________

¹ The 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities is the current edition.

² The following table is reproduced from Gormley T, Garland J, Jones W. “Estimated Cost of Applying the 2014 vs. the 2010 FGI Guidelines for Design and Construction Requirements to Hospitals and Outpatient Facilities.” Facility Guidelines Institute and the American Society for Healthcare Engineering (2015).

³ The information for potential cost reductions also comes from Gormley, Garland, and Jones (2015).

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis conducted by the Department of Planning and Budget.

Summary:

The proposed amendments conform the regulation to § 32.1-127.001 of the Code of Virginia, which requires the State Board of Health to adopt minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects Academy of Architecture for Health. The American Institute of Architects Academy of Architecture for Health has become the Facility Guidelines Institute (FGI). The latest edition of guidelines published by the FGI is the 2014 edition of Guidelines for Design and Construction of Hospitals and Outpatient Facilities.

12VAC5-410-442. Obstetric service design and equipment criteria.

A. Renovation or construction of a hospital's obstetric unit shall be consistent with (i) section 2.1-4 2.2-2.11 of Part 2 of the 2006 2014 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the American Facility Guidelines Institute of Architects pursuant to § 32.1-127.001 of the Code of Virginia and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63).

B. Delivery rooms, LDR/LDRP; labor, delivery, and recovery (LDR) rooms; labor, delivery, recovery, and postpartum (LDRP) rooms,; and nurseries shall be equipped to provide emergency resuscitation for mothers and infants.

C. Equipment and supplies shall be assigned for exclusive use in the obstetric and newborn units.

D. The same equipment and supplies required for the labor room and delivery room shall be available for use in the LDR/LDRP rooms during periods of labor, delivery, and recovery.

E. Sterilizing equipment shall be available in the obstetric unit or in a central sterilizing department. Flash sterilizing equipment or sterile supplies and instruments shall be provided in the obstetric unit.

F. Daily monitoring is required of the stock of necessary equipment in the labor, delivery, and recovery LDR rooms (LDR) and labor, delivery, recovery and postpartum (LDRP) LDRP rooms and nursery.

G. The hospital shall provide the following equipment in the labor, delivery and recovery rooms and, except where noted, in the LDR/LDRP rooms:

1. Labor rooms.

a. A labor or birthing bed with adjustable side rails.

b. Adjustable lighting adequate for the examination of patients.

c. An emergency signal and intercommunication system.

d. A sphygmomanometer, stethoscope and fetoscope or doppler.

e. Fetal monitoring equipment with internal and external attachments.

f. Mechanical infusion equipment.

g. Wall-mounted oxygen and suction outlets.

h. Storage equipment.

i. Sterile equipment for emergency delivery to include at least one clamp and suction bulb.

j. Neonatal resuscitation cart.

2. Delivery rooms.

a. A delivery room table that allows variation in positions for delivery. This equipment is not required for the LDR/LDRP rooms.

b. Adequate lighting for vaginal deliveries or cesarean deliveries.

c. Sterile instruments, equipment, and supplies to include sterile uterine packs for vaginal deliveries or cesarean deliveries, episiotomies or laceration repairs, postpartum sterilizations and cesarean hysterectomies.

d. Continuous in-wall oxygen source and suction outlets for both mother and infant.

e. Equipment for inhalation and regional anesthesia. This equipment is not required for LDR/LDRP rooms.

f. A heated, temperature-controlled infant examination and resuscitation unit.

g. An emergency call system.

h. Plastic pharyngeal airways, adult and newborn sizes.

i. Laryngoscope and endotracheal tubes, adult and newborn sizes.

j. A self-inflating bag with manometer and adult and newborn masks that can deliver 100% oxygen.

k. Separate cardiopulmonary crash carts for mothers and infants.

l. Sphygmomanometer.

m. Cardiac monitor. This equipment is not required for the LDR/LDRP rooms.

n. Gavage tubes.

o. Umbilical vessel catheterization trays. This equipment is not required for LDR/LDRP rooms.

p. Equipment that provides a source of continuous suction for aspiration of the pharynx and stomach.

q. Stethoscope.

r. Fetoscope.

s. Intravenous solutions and equipment.

t. Wall clock with a second hand.

u. Heated bassinets equipped with oxygen and transport incubator.

v. Neonatal resuscitation cart.

3. Recovery rooms.

a. Beds with side rails.

b. Adequate lighting.

c. Bedside stands, overbed tables, or fixed shelving.

d. An emergency call signal.

e. Equipment necessary for a complete physical examination.

f. Accessible oxygen and suction equipment.

12VAC5-410-445. Newborn service design and equipment criteria.

A. Construction and or renovation of a hospital's nursery shall be consistent with sections 2.2—2.12.1 through 2.2—2.12.6.6  (i) section 2.2-2.12 of Part 2 of the 2010 2014 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the Facilities Facility Guidelines Institute (formerly of the American Institute of Architects) pursuant to § 32.1-127.001 of the Code of Virginia and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63). Hospitals with higher-level nurseries shall comply with sections 2.2—2.10.1 through 2.2—10.9.3 section 2.2-2.10 of Part 2 of the 2010 guideline 2014 edition of the guidelines as applicable.

B. The hospital shall provide the following equipment in the general level nursery and all higher level nurseries, unless additional equipment requirements are imposed for the higher level nurseries:

1. Resuscitation equipment as specified for the delivery room in 12VAC5-410-442 G 2 shall be available in the nursery at all times;

2. Equipment for the delivery of 100% oxygen concentration, properly heated, blended, and humidified, with the ability to measure oxygen delivery in fractional inspired concentration (FI02). The oxygen analyzer shall be calibrated every eight hours and serviced according to the manufacturer's recommendations by a member of the hospital's respiratory therapy department or other responsible personnel trained to perform the task;

3. Saturation monitor (pulse oximeter or equivalent);

4. Equipment for monitoring blood glucose;

5. Infant scales;

6. Intravenous therapy equipment;

7. Equipment and supplies for the insertion of umbilical arterial and venous catheters;

8. Open bassinets, self-contained incubators, open radiant heat infant care system or any combination thereof appropriate to the service level;

9. Equipment for stabilization of a sick infant prior to transfer that includes a radiant heat source capable of maintaining an infant's body temperature at 99°F;

10. Equipment for insertion of a thoracotomy tube; and

11. Equipment for proper administration and maintenance of phototherapy.

C. The additional equipment required for the intermediate level newborn service and for any higher service level is:

1. Pediatric infusion pumps accurate to plus or minus 1 milliliter (ml) per hour;

2. On-site supply of PgE1;

3. Equipment for 24-hour cardiorespiratory monitoring for neonatal use available for every incubator or radiant warmer;

4. Saturation monitor (pulse oximeter or equivalent) available for every infant given supplemental oxygen;

5. Portable x-ray machine; and

6. If a mechanical ventilator is selected to provide assisted ventilation prior to transport, it shall be approved for the use of neonates.

D. The additional equipment required for the specialty level newborn service and a higher newborn service is as follows:

1. Equipment for 24-hour cardiorespiratory monitoring with central blood pressure capability for each neonate with an arterial line;

2. Equipment necessary for ongoing assisted ventilation approved for neonatal use with on-line online capabilities for monitoring airway pressure and ventilation performance;

3. Equipment and supplies necessary for insertion and maintenance of chest tube for drainage;

4. On-site supply of surfactant;

5. Computed axial tomography equipment (CAT) or magnetic resonance imaging equipment (MRI);

6. Equipment necessary for initiation and maintenance of continuous positive airway pressure (CPAP) with ability to constantly measure delineated pressures and including alarm for abnormal pressure (i.e., vent with PAP mode); and

7. Cardioversion unit with appropriate neonatal paddles and ability to deliver appropriate small watt discharges.

E. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in its medical protocol and that are required for the specialty level newborn service.

F. The additional equipment requirements for the subspecialty level newborn service are:

1. Equipment for emergency gastrointestinal, genitourinary, central nervous system, and sonographic studies available 24 hours a day;

2. Pediatric cardiac catheterization equipment;

3. Portable echocardiography equipment; and

4. Computed axial tomography equipment (CAT) and magnetic resonance imaging equipment (MRI).

G. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in the medical protocol and are required for the subspecialty level newborn service.

Part III
Standards and Design Criteria for New Buildings and Additions, Alterations and Conversion of Existing Buildings

12VAC5-410-650. General building and physical plant information.

A. All construction of new buildings and additions, renovations, alterations or repairs of existing buildings for occupancy as a hospital shall conform to state and local codes, zoning and building ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed according to consistent with Part 1 and sections 2.1—1 through 2.2—8 of Part 2 of the 2010 2014 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the Facilities Facility Guidelines Institute (formerly of the American Institute of Architects). However, the requirements of the Uniform Statewide Building Code and local zoning and building ordinances shall take precedence pursuant to § 32.1-127.001 of the Code of Virginia.

B. All buildings shall be inspected and approved as required by the appropriate building regulatory entity. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose. Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and Part 2 of the 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities of the Facility Guidelines Institute. The certification shall be forwarded to the OLC.

12VAC5-410-760. Long-term care nursing units.

Construction and renovation of long-term care nursing units, including intermediate and skilled nursing care nursing units, shall conform to be designed and constructed consistent with section 2.1—3.9 2.2-2.15 of Part 2 of the 2006 2014 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the American Facility Guidelines Institute of Architects pursuant to § 32.1-127.001 of the Code of Virginia.

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with section 2.2-2.15 of Part 2 of the 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities of the Facility Guidelines Institute. The certification shall be forwarded to the OLC.

Part V
Design Standards for New Outpatient Surgical Hospitals and Additions and Alterations to Existing Outpatient Surgical Hospitals

Article 1
General Considerations

12VAC5-410-1350. Codes; fire safety; zoning; construction Local and state codes and standards.

A. All construction of new buildings and additions alterations or repairs to existing buildings for occupancy as a "free-standing" outpatient hospital shall conform to state and local codes, zoning and building ordinances, and the Statewide Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed according to consistent with Part 1 and sections 3.1-1 through 3.1-8 3.1 and 3.7 of Part 3 of the 2010 2014 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the Facilities Facility Guidelines Institute (formerly of the American Institute of Architects). However, the requirements of the Uniform Statewide Building Code and local zoning and building ordinances shall take precedence pursuant to § 32.1-127.001 of the Code of Virginia.

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and sections 3.1 and 3.7 of Part 3 of the 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities of the Facility Guidelines Institute. The certification shall be forwarded to the OLC.

B. All buildings shall be inspected and approved as required by the appropriate building regulatory entity. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose.

C. B. The use of an incinerator shall require permitting from the nearest regional office of the Department of Environmental Quality.

D. C. Water shall be obtained from an approved water supply system. Outpatient surgery centers shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

E. D. Each outpatient surgery center shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

F E. All radiological machines shall be registered with the Office of Radiological Health of the Virginia Department of Health. Installation, calibration and testing of machines and storage facilities shall comply with 12VAC5-480 12VAC5-481, Virginia Radiation Protection Regulations.

G. F. Pharmacy services shall comply with Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20, Regulations Governing the Practice of Pharmacy.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-410)

Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities, 2014 Edition, Facilities Facility Guidelines Institute (formerly of the American Institute of Architects), Washington, D.C., 2010 Edition, http://www.fgiguidelines.org

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (adding 12VAC5-410-1175).

Statutory Authority: § 32.1-127 of the Code of Virginia.

Effective Date: April 8, 2016.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, or erik.bodin@vdh.virginia.gov.

Summary:

Pursuant to Chapter 18 of the 2015 Acts of Assembly, which created § 32.1-137.03 of the Code of Virginia, this action requires hospitals to (i) provide each patient admitted as an inpatient the opportunity to designate an individual who will care for or assist the patient in his residence following discharge from the hospital and to whom the hospital shall provide information regarding the patient's discharge plan and follow-up care, (ii) make that designation part of the patient's medical record, (iii) include certain specific information regarding the designated person as part of that record, and (iv) allow the patient to change the designation any time prior to release from the hospital.

12VAC5-410-1175. Discharge planning.

A. Every hospital shall provide each patient admitted as an inpatient or his legal guardian the opportunity to designate an individual who will care for or assist the patient in his residence following discharge from the hospital and to whom the hospital shall provide information regarding the patient's discharge plan and any follow-up care, treatment, and services that the patient may require.

B. Every hospital upon admission shall record in the patient's medical record:

1. The name of the individual designated by the patient;

2. The relationship between the patient and the person; and

3. The person's telephone number and address.

C. If the patient fails or refuses to designate an individual to receive information regarding his discharge plan and any follow-up care, treatment, and services, the hospital shall record the patient's failure or refusal in the patient's medical record.

D. A patient may change the designated individual at any time prior to the patient's release, and the hospital shall record the changes, including the information referenced in subsection B of this section, in the patient's medical record within 24 hours of such a change.

E. Prior to discharging a patient who has designated an individual pursuant to subsection A or D of this section, the hospital shall (i) notify the designated individual of the patient's discharge, (ii) provide the designated individual with a copy of the patient's discharge plan and instructions and information regarding any follow-up care, treatment, or services that the designated individual will provide, and (iii) consult with the designated individual regarding the designated individual's ability to provide the care, treatment, or services. Such discharge plan shall include:

1. The name and contact information of the designated individual;

2. A description of follow-up care, treatment, and services that the patient requires; and

3 Information, including contact information, about any health care, long-term care, or other community-based services and supports necessary for the implementation of the patient's discharge plan.

A copy of the discharge plan and any instructions or information provided to the designated individual shall be included in the patient's medical record.

F. The hospital shall provide each individual designated pursuant to subsection A or D of this section the opportunity for a demonstration of specific follow-up care tasks that the designated individual will provide to the patient in accordance with the patient's discharge plan prior to the patient's discharge, including opportunity for the designated individual to ask questions regarding the performance of follow-up care tasks. Such opportunity shall be provided in a culturally competent manner and in the designated individual's native language.

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-685, 18VAC110-20-700, 18VAC110-20-725, 18VAC110-20-726, 18VAC110-20-727).

Statutory Authority: §§ 54.1-2400 of the Code of Virginia.

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: April 6, 2016.

Effective Date: April 21, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia. Section 54.1-2400 provides the Board of Pharmacy the authority to promulgate regulations. Section 54.1-3420.2 of the Code of Virginia provides: "E. Prescription drug orders dispensed to a patient and delivered to a program of all-inclusive care for the elderly (PACE) site licensed by the Department of Social Services pursuant to § 63.2-1701 and overseen by the Department of Medical Assistance Services in accordance with § 32.1-330.3 upon the signed written request of the patient or the patient's legally authorized representative may be stored, retained, and repackaged at the site on behalf of the patient for subsequent delivery or administration. The repackaging of a dispensed prescription drug order retained by the PACE site for the purpose of assisting a client with self-administration pursuant to this subsection shall only be performed by a pharmacist, pharmacy technician, nurse, or other person who has successfully completed a Board-approved training program for repackaging of prescription drug orders as authorized by this subsection. The Board shall promulgate regulations relating to training, packaging, labeling, and recordkeeping for such repackaging." The authority to promulgate regulations to establish criteria for repackaging by PACE sites is mandatory.

Purpose: The purpose of the planned regulatory action is to comply with a legislative mandate to promulgate regulations for PACE sites to receive, store, retain, and repackage prescription drug orders dispensed to a patient for the purpose of assisting a client with self-administration of the drug.

Chapter 505 of the 2015 Acts of Assembly addresses a problem for the PACE program in handling the unique prescription needs of its patient population. The legislation does two things. It authorizes the PACE sites to retain prescription medications for elderly patients, who may need assistance or monitoring of self-administration or who may not be capable of self-administering. And, it authorizes PACE personnel, who hold appropriate licensure or who have passed a training course approved by the Board of Pharmacy, to repackage a portion of a patient's medication to assist that patient with self-administration and compliance with dosage instructions.

Because of the urgent need for the change in law and for regulations to implement those changes, the Board of Pharmacy is promulgating amendments by a fast-track rulemaking process. Regulations addressing storage, repackaging, recordkeeping, and training of persons who handle drugs will ensure that client or patient needs are being met while protecting the security and integrity of the drugs and the health and safety of the client and general population.

Rationale for Using Fast-Track Process: This action will not be controversial as repackaging authorization is needed as soon as possible. Cindy Williams with Riverside Health Systems, which has a number of PACE facilities, gave public comment at the meeting on September 29, 2015, urging the board to adopt the draft regulations recommended by the Regulation Committee. The board adopted the recommendation without change.

Substance: Regulations promulgated pursuant to the legislative mandate set forth requirements for PACE sites to possess, repackage, and deliver or administer drugs and for a program to train nonpharmacists in repackaging. Amendments add PACE to requirements for other facilities (CSBs and BHAs) that have similar authority. The amendments add "PACE site" to existing requirements for labeling, storage, recordkeeping, destruction, and other requirements for repackaging in those facilities that do not have a pharmacy, persons authorized to repackage, and information to clients about repackaged drugs. There are also curricula and instructional criteria for approval of repackaging training programs and for expiration and renewal of program approval.

Issues: The advantage to the public is assurance that a facility has followed appropriate procedures in the storing, retaining, and repackaging of dispensed prescription drug orders for the purpose of assisting elderly clients with self-administration. Without proper training, there are concerns about drug safety and security and about improper dispensed of prescriptions that enable a person to remain in a community-based program. There are no disadvantages. The advantage to the Commonwealth is facilitation of a community program that assists elderly clients with health-related needs. Since there was no statutory authority for emergency regulations, the board is promulgating a fast-track action to authorize repackaging as soon as possible.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 505 of the 2015 Acts of the Assembly, the Board of Pharmacy (Board) proposes to amend its pharmacy regulation to allow programs of all-inclusive care for the elderly (PACE sites) that are licensed by the Department of Social Services and overseen by the Department of Medical Assistance Services to be able to possess, repackage, deliver and administer prescription medications to their patients as community service boards (CSBs) and behavioral health authorities (BHAs) do now.

Result of Analysis. Benefits likely outweigh costs for implementing these proposed changes.

Estimated Economic Impact. Currently, the Board allows CSBs and BHAs that have obtained controlled substances registration to have staff trained in repackaging of prescription drug orders to repackage prescription drugs for these entities' clients. Pursuant to Chapter 505 of the 2015 Acts of the Assembly, the Board now proposes to add PACE sites to the list of entities that may repackage prescriptions for their clients. Pace sites will have to meet the same criteria as CSBs and BHAs do and will have to pay the fees set for approval (and renewal and late renewal) of repackaging training programs ($50, $30 and $10, respectively) and meet criteria for training programs as well as rules that trained individuals must follow in repackaging drugs. The rules for repackaging include information that must be on packaging labels, information that must be dispensed to clients with the drugs, rules for storage and destruction of drugs, and recordkeeping requirements.

PACE sites will incur the same explicit costs as CSBs and BHAs incur now; these costs comprise the $50 fee for approval of a repackaging training program to train their staff (as well as biennial fees of $30 for renewal of these programs). PACE sites will also incur implicit costs for staff time spent in training. PACE sites will likely only seek repackaging authority if they believe that the costs they would incur are outweighed by the benefits that they and their clients will accrue. The benefits of these proposed regulations have the potential to be quite large, especially for elderly clients who lack the capacity to independently follow a prescribed drug regimen.

Businesses and Entities Affected. The Department of Health Professions reports that there are eight PACE provider organizations that serve 12 licensed PACE sites in the Commonwealth. All of these entities and their clients will be affected by these regulations.

Localities Particularly Affected. No locality will be particularly affected by this regulatory change.

Projected Impact on Employment. This regulatory change is unlikely to impact employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory change is unlikely to affect the use or value of private property in Virginia.

Real Estate Development Costs. This proposed change will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Alternative Method that Minimizes Adverse Impact. No small business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Adverse Impacts:

Businesses: No business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Localities: Localities in the Commonwealth are unlikely to see any adverse impacts on account of this proposed regulatory change.

Other Entities: No entities in the Commonwealth are likely to suffer any adverse impacts on account of this proposed regulatory change.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

Chapter 505 of the 2015 Acts of the Assembly requires the Board of Pharmacy to promulgate regulations "relating to the training, packaging, labeling, and recordkeeping" for repackaging of prescription drug orders dispensed to a patient and delivered to a program of all-inclusive care for the elderly (PACE) site licensed by the Department of Social Services and overseen by the Department of Medical Assistance Services. The amendments add PACE sites to the repackaging requirements previously adopted for a similar purpose for community services board facilities and behavioral health authority facilities.

Part XVI
Controlled Substances Registration for Other Persons or Entities

18VAC110-20-685. Definitions for controlled substances registration.

For purposes of this part, the following definitions shall apply:

"BHA" means a behavioral health authority facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the board.

"CSB" means a community services board facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the board.

"PACE" means a program of all-inclusive care for the elderly overseen by the Department of Medical Assistance Services in accordance with § 32.1-330.3 of the Code of Virginia.

18VAC110-20-700. Requirements for supervision for controlled substances registrants.

A. A practitioner licensed in Virginia shall provide supervision for all aspects of practice related to the maintenance and use of controlled substances as follows:

1. In a hospital or nursing home without an in-house pharmacy, a pharmacist shall supervise.

2. In an emergency medical services agency, the operational medical director shall supervise.

3. For any other type of applicant or registrant, a pharmacist or a prescriber whose scope of practice is consistent with the practice of the applicant or registrant and who is approved by the board may provide the required supervision.

B. The supervising practitioner shall approve the list of drugs which may be ordered by the holder of the controlled substances registration; possession of controlled substances by the entity shall be limited to such approved drugs. The list of drugs approved by the supervising practitioner shall be maintained at the address listed on the controlled substances registration.

C. Access to the controlled substances shall be limited to (i) the supervising practitioner or to those persons who are authorized by the supervising practitioner and who are authorized by law to administer drugs in Virginia,; (ii) such other persons who have successfully completed a training program for repackaging of prescription drug orders in a CSB or, BHA, or PACE site as authorized in § 54.1-3420.2 of the Code of Virginia,; or (iii) other such persons as designated by the supervising practitioner or the responsible party to have access in an emergency situation. If approved by the supervising practitioner, pharmacy technicians may have access for the purpose of delivering controlled substances to the registrant, stocking controlled substances in automated dispensing devices, conducting inventories, audits and other recordkeeping requirements, overseeing delivery of dispensed prescriptions at an alternate delivery site, and repackaging of prescription drug orders retained by a CSB or, BHA, or PACE site as authorized in § 54.1-3420.2 of the Code of Virginia. Access to stock drugs in a crisis stabilization unit shall be limited to prescribers, nurses, or pharmacists.

D. The supervising practitioner shall establish procedures for and provide training as necessary to ensure compliance with all requirements of law and regulation, including, but not limited to, storage, security, and recordkeeping.

E. Within 14 days of a change in the responsible party or supervising practitioner assigned to the registration, either the responsible party or outgoing responsible party shall inform the board and a new application shall be submitted indicating the name and license number, if applicable, of the new responsible party or supervising practitioner.

18VAC110-20-725. Repackaging by a CSB or, BHA, or PACE site.

A. Definition. For purposes of this section, "repackaging" shall mean removing a drug from a container already dispensed and labeled by a pharmacy or medical practitioner authorized to dispense, for a particular client of a CSB or, BHA, or PACE site, and placing it in a container designed for a person to be able to repackage his own dispensed prescription medications to assist with self-administration and compliance with dosage instructions. Such repackaging shall not include the preparation of a patient-specific label that includes drug name, strength, or directions for use or any other process restricted to a pharmacist or pharmacy technician under the direct supervision of a pharmacist.

B. Persons authorized to repackage. Repackaging shall be performed by a pharmacist, pharmacy technician, nurse, or such other person who has successfully completed a board-approved training program for repackaging of prescription drug orders as authorized in § 54.1-3420.2 of the Code of Virginia. A CSB or, BHA, or PACE site using such other person shall maintain documentation of completion of an approved training program for at least one year from date of termination of employment or cessation of repackaging activities.

C. Requirements for repackaging.

1. The repackaging of a dispensed prescription drug order pursuant to § 54.1-3420.2 of the Code of Virginia shall only be done at a CSB or, BHA, or PACE site.

2. The repackaging of dispensed prescription drugs shall be restricted to solid oral dosage forms and a maximum of a 14-day supply of drugs.

3. The drug container used for repackaging pursuant to this section shall bear a label containing the client's first and last name, and name and 24-hour contact information for the CSB or, BHA, or PACE site.

4. A clean, well-closed container that assists the client with self-administration shall be used when multiple doses of a repackaged drug are provided to the client at one time.

5. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.

D. Written information for client. At the time a repackaged drug is initially given to a client, and upon any subsequent change in the medication order, the client shall be provided written information about the name and strength of the drug and the directions for use. Such written information shall have been prepared by a pharmacy or by a nurse at the CSB or, BHA, or PACE site.

E. Retention, storage, and destruction of repackaged drugs.

1. Any portion of a client's prescription drug order not placed into a container intended to assist with self-administration may be either given to the client or retained by the CSB or, BHA, or PACE site for subsequent repackaging. If retained by the CSB or, BHA, or PACE site, the remaining portion shall be stored within the board-approved drug storage location in the original labeled container, and shall only be used for the client for whom the drug was originally dispensed.

2. Any portion of a prescription drug order remaining at the CSB or, BHA, or PACE site that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client. Remaining portions of discontinued prescription drug orders retained by the CSB or, BHA, or PACE site shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client.

F. Recordkeeping.

1. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following:

a. Date of repackaging;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Pharmacy name;

e. Drug name and strength;

f. Quantity of drug repackaged; and

g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container.

2. A record of destruction shall be made and maintained for one year for any prescription drug orders destroyed by the CSB or, BHA, or PACE site and shall include the following:

a. Date of destruction;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Drug name and strength;

e. Quantity of drug destroyed; and

f. Initials of the person performing the destruction.

18VAC110-20-726. Criteria for approval of repackaging training programs.

A. Application. Any person wishing to apply for approval of a repackaging training program shall submit the application fee prescribed in 18VAC110-20-20 and an application on a form approved by the board and shall meet the criteria established in this section. The application shall name a program director who is responsible for compliance with this section.

B. Curriculum. The curriculum for a repackaging training program shall include instruction in current laws and regulations applicable to a CSB or, BHA, or PACE site for the purpose of assisting a client with self-administration pursuant to § 54.1-3420.2 of the Code of Virginia and in the following repackaging tasks:

1. Selection of an appropriate container;

2. Proper preparation of a container in accordance with instructions for administration;

3. Selection of the drug;

4. Counting of the drug;

5. Repackaging of the drug within the selected container;

6. Maintenance of records;

7. Proper storage of drugs;

8. Translation of medical abbreviations;

9. Review of administration records and prescriber's orders for the purpose of identifying any changes in dosage administration;

10. Reporting and recording the client's failure to take medication;

11. Identification, separation, and removal of expired or discontinued drugs; and

12. Prevention and reporting of repackaging errors.

C. Instructors and program director. Instructors for the program shall be either (i) a pharmacist with a current license in any jurisdiction and who is not currently suspended or revoked in any jurisdiction in the United States or (ii) a pharmacy technician with at least one year of experience performing technician tasks who holds a current registration in Virginia or current PTCB certification and who is not currently suspended or revoked in any jurisdiction in the United States. The program director shall maintain a list of instructors for the program.

D. Program requirements.

1. The length of the program shall be sufficient to prepare a program participant to competently perform repackaging consistent with § 54.1-3420.2 of the Code of Virginia and 18VAC110-20-725.

2. The program shall include a post-training assessment to demonstrate the knowledge and skills necessary for repackaging with safety and accuracy.

3. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by a CSB, BHA, PACE site, or the board.

4. The program shall maintain records of training completion by persons authorized to repackage in accordance with § 54.1-3420.2 of the Code of Virginia. Records shall be retained for two years from date of completion of training or termination of the program.

5. The program shall report within 14 days any substantive change in the program to include a change in program name, program director, name of institution or business if applicable, address, program content, length of program, or location of records.

E. Expiration and renewal of program approval. A repackaging training program approval expires after two years, after which the program may apply for renewal. For continued approval, the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the board at the time of renewal notification. Renewal of a program's approval is at the discretion of the board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this section.

18VAC110-20-727. Pharmacists repackaging for clients of a CSB or, BHA or PACE.

A. As an alternative to repackaging as defined in 18VAC110-20-725, a pharmacist at a CSB or, BHA, or PACE site may repackage a client's prescription drugs that have been dispensed by another pharmacy into compliance packaging under the following conditions:

1. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.

2. The compliance packaging shall comply with the requirements of 18VAC110-20-340 B.

3. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following:

a. Date of repackaging;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Pharmacy name;

e. Drug name and strength;

f. Quantity of drug repackaged; and

g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container.

4. Any portion of a prescription drug order remaining at the CSB or, BHA, or PACE site that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client. Remaining portions of discontinued prescription drug orders retained by the CSB or, BHA, or PACE site shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client.

B. A primary provider pharmacy may also provide this service in compliance with the provisions of 18VAC110-20-535.