Title of Regulation: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (amending 18VAC85-20-22, 18VAC85-20-120, 18VAC85-20-121, 18VAC85-20-131, 18VAC85-20-140, 18VAC85-20-220, 18VAC85-20-235, 18VAC85-20-290, 18VAC85-20-400).

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

Public Hearing Information:

February 17, 2011 - 8:30 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA

Public Comment Deadline: April 15, 2011.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4621, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Specific regulatory authority for the Board of Medicine is found in Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia.

Purpose: On September 19, 2008, the Legislative Committee of the Board of Medicine reviewed 18VAC85-20 to determine whether regulations are necessary to interpret the law or to protect the public health, safety, or welfare of the public. The committee determined that continuation of 18VAC85-20 is essential in order to set criteria for licensure and renewal of licensure for doctors of medicine, osteopathic medicine, podiatry, and chiropractic as required by law. Additionally, regulations governing office-based anesthesia; mixing, diluting, and reconstituting of drugs; and other standards of practice are both responsive to statutory provisions and necessary to protect the public health and safety.

Amendments will update or clarify the regulations for ease of compliance. An amendment to the requirements for mixing, diluting, or reconstituting drugs by doctors or persons under their supervision is necessary to comply with standards for sterile compounding to ensure that drugs mixed in fat emulsions that are highly susceptible to microbial growth are free from contaminates and safe for administration.

Substance: The Legislative Committee of the Board of Medicine served as the workgroup to conduct the periodic review. The following recommendations were adopted by the board:

18VAC85-20-22. Fees: The board did not recommend an increase in any fees charged to applicants or regulants but restated the reinstatement fee to clarify that the total fee includes the application and late fees.

18VAC85-20-120. Prerequisites to licensure: The requirement for applicants discharged from the military to submit discharge papers is eliminated.

18VAC85-20-220. Temporary licenses to interns and residents: Subsection C limits the renewal of an intern or resident license to five annual renewals. Since the license can only be renewed upon recommendation of the chief or director of graduate medical education of the program, the limitation is unnecessary.

18VAC85-20-235. Continued competency requirements for renewal of an active license: The board changed the word "indicate" to "attest to" completion of at least 60 hours of continuing learning activities within the past two years. The board has also eliminated the requirement for completion of the Continued Competency Activity and Assessment Form.

18VAC85-20-400. Requirements for immediate use sterile mixing, diluting, or reconstituting: The board considered inclusion of revised USP Chapter 797 standards but chose to leave the definition of immediate use at administration within 10 hours with an exception for fat emulsion drugs.

Issues: The only issue that generated discussion and had a potential impact on medical practice was the proposed change in immediate use for compounding sterile drug products. Since the draft proposal of a four-hour limitation on immediate use was not adopted by the board, the issue was resolved satisfactorily. A one-hour limitation on fat emulsion drugs will provide greater protection for vulnerable patients from infections resulting from intravenous administration. There are no disadvantages to the public, who continue to be reasonably protected by the rules for mixing, diluting, or reconstituting sterile drug products.

There are no quantitative advantages or disadvantages to the Commonwealth or the agency. Clarification of some requirements may result in fewer requests for interpretation or resubmission of required information.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As a result of the periodic review process, the Board Medicine (Board) proposes to amend its Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry and Chiropractic to make several clarifying and substantive changes. Specifically, the Board proposes to:

• Clarify that the cost for reinstatement of licensure includes both the reinstatement application fee and a late fee by combining the fees,

• Remove a restriction that only allows interns and residents to renew licensure five times,

• Remove the requirement that individuals who are renewing their licenses also fill out a form that lists their continuing education activities, and

• Create an exception to the 10 hour definition of immediate use so that drugs that include a fat emulsion must be used within one hour of being mixed, diluted or reconstituted.

Result of Analysis. The benefits likely exceed the costs for most proposed changes. There is insufficient information to ascertain whether benefits will outweigh costs for one proposed change. Benefits and costs for all changes are discussed below.

Estimated Economic Impact. Current regulations list reinstatement application fees and late fees separately even though individuals who are reinstating a license would have to pay both fees. The Board proposes to amend the fee structure in these regulations so that these fees are added together in one place. No entity will incur any new costs on account of this proposed change. To the extent that the old fee structure may have led to confusion for individuals seeking to reinstate their licenses, this proposed change will bring the benefit of clarity.

Current regulations allow individuals who are completing an internship or residency to be licensed and to renew their licenses up to five times with the recommendation of the director of their intern or residency program. The Board proposes to eliminate the restriction on the number of times that an intern or resident may renew his or her license because the recommendation of a director is considered sufficient to ensure that interns and residents are working toward being fully licensed in as timely a manner as possible. No entity is likely to incur costs on account of this proposed change. Interns and residents are likely to benefit from the added flexibility to manage their internships and residencies that removing the restriction on license renewal will give them.

Current regulations require individuals who are renewing their licenses to both attest that they have completed required continuing education (by checking a box on their renewal form) and to fill out a form listing the continuing education completed. In the distant past, the Continued Competency Activity and Assessment form was used to help licensees plan out their future continuing education. This form no longer serves this purpose and is duplicative of the attestation on the renewal form. The Board now proposes to eliminate the requirement that licensees complete this form. Because the Board will retain the ability to audit licensees' continuing education by requiring them to produce certificates of successful completion, no entity is likely to be worse off on account of the elimination of this form. Licensees will save the time and expense it would have taken them to complete the form and deliver it to Board staff.

Current regulations require that sterile drugs that are mixed, diluted or reconstituted for use in doctors' offices be administered within 10 hours of the completion time of preparation. This allows doctors' offices that administer, for example, chemotherapy drugs to mix larger batches that will treat multiple patients. The Board now proposes one exception to the 10 hour rule. Under these proposed regulations, drugs that include a fat emulsion will have to be used within one hour of being mixed, diluted or reconstituted. Board staff report that this change is proposed because drugs that include a fat emulsion are more prone to microbial contamination that may cause infections in patients to whom they are administered. Doctors who administer drugs that include fat emulsions will incur increased costs on account of this proposed change because they will potentially have to prepare these drugs several times a day rather than preparing one, larger, batch. These addition costs will likely, however, be small because the percentage of drugs covered by the 10 hour rule that include a fat emulsion is small. Because Board staff reports that there have been no specific complaints that would indicate that patients have actually suffered harm from immediate use drugs that include a fat emulsion, there is insufficient information to decide whether benefits will outweigh costs.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that the Board currently licenses 27,191 doctors of medicine and 1,145 doctors of osteopathic medicine. These individuals plus future licensees will be affected by these proposed regulations.

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

Projected Impact on Employment. This regulatory action will likely have no impact on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory action will likely have no effect on the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. Small business medical practices in the Commonwealth may incur some additional costs on account of the new requirement for using immediate use drugs that include a fat emulsion within one hour of them being mixed, diluted or reconstituted. These costs are likely to be very small because the vast majority of drugs that are mixed, diluted or reconstituted for immediate use in doctors' offices do not contain a fat emulsion.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There are likely no alternate methods that the Board could have employed in writing the requirement for immediate use drugs that would have both accomplished the Board's goal of decreasing the chance of patient harm and further minimized any adverse impact on small businesses.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

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 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, 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 adverse effect on small businesses, Section 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 Board of Medicine concurs with the analysis of the Department of Planning and Budget for 18VAC85-20, Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic, relating to a periodic review of regulations.

Summary:

The proposed amendments (i) clarify that the cost for reinstatement of licensure includes both the reinstatement application fee and a late fee by combining the fees; (ii) eliminate the requirement for applicants discharged from the military to submit discharge papers; (iii) remove a restriction that only allows interns and residents to renew licensure five times; (iv) remove the requirement that individuals who are renewing their licenses also fill out a form that lists their continuing education activities; and (v) create an exception to the 10-hour definition of immediate use so that drugs that include a fat emulsion must be used within one hour of being mixed, diluted, or reconstituted.

18VAC85-20-22. Required fees.

A. Unless otherwise provided, fees established by the board shall not be refundable.

B. All examination fees shall be determined by and made payable as designated by the board.

C. The application fee for licensure in medicine, osteopathic medicine, and podiatry shall be $302, and the fee for licensure in chiropractic shall be $277.

D. The fee for a temporary authorization to practice medicine pursuant to § 54.1-2927 B (i) and (ii) of the Code of Virginia shall be $25.

E. The application fee for a limited professorial or fellow license issued pursuant to 18VAC85-20-210 shall be $55. The annual renewal fee shall be $35. An additional fee for late renewal of licensure shall be $15.

F. The application fee for a limited license to interns and residents pursuant to 18VAC85-20-220 shall be $55. The annual renewal fee shall be $35. An additional fee for late renewal of licensure shall be $15.

G. The fee for a duplicate wall certificate shall be $15; the fee for a duplicate license shall be $5.

H. The fee for biennial renewal shall be $337 for licensure in medicine, osteopathic medicine, and podiatry and $312 for licensure in chiropractic, due in each even-numbered year in the licensee's birth month. An additional fee for processing a late renewal application within one renewal cycle shall be $115 for licensure in medicine, osteopathic medicine, and podiatry and $105 for licensure in chiropractic.

I. The fee for requesting reinstatement of licensure or certification pursuant to § 54.1-2408.2 of the Code of Virginia or for requesting reinstatement after any petition to reinstate the certificate or license of any person has been denied shall be $2,000.

J. The fee for reinstatement of a license issued by the Board of Medicine pursuant to § 54.1-2904 of the Code of Virginia that has expired for a period of two years or more shall be $382 $497 for licensure in medicine, osteopathic medicine, and podiatry ($382 for reinstatement application in addition to the late fee of $115) and $367 $472 for licensure in chiropractic ($367 for reinstatement application in addition to the late fee of $105). The fee shall be submitted with an application for licensure reinstatement.

K. The fee for a letter of verification of licensure to another jurisdiction shall be $10, and the fee for certification of grades to another jurisdiction by the board shall be $25. Fees shall be due and payable upon submitting a request for verification or certification to the board.

L. The fee for biennial renewal of an inactive license shall be $168, due in the licensee's birth month. An additional fee for late renewal of licensure shall be $55 for each renewal cycle.

M. The fee for an application or for the biennial renewal of a restricted volunteer license shall be $75, due in the licensee's birth month. An additional fee for late renewal of licensure shall be $25 for each renewal cycle.

N. The fee for a returned check shall be $35.

Part III
Licensure: General and Educational Requirements

18VAC85-20-120. Prerequisites to licensure.

A. Every applicant for licensure shall:

1. Meet the educational requirements specified in 18VAC85-20-121 or 18VAC85-20-122 and the examination requirements as specified for each profession in 18VAC85-20-140;

2. File the complete application and appropriate fee as specified in 18VAC85-20-22 with the executive director of the board; and

3. File the required credentials with the executive director by a date established by the board and as specified below:

a. Graduates of an approved institution shall file:

(1) Documentary evidence that he received a degree from the institution; and

(2) A complete chronological record of all professional activities since graduation from professional school, giving location, dates, and types of services performed.

b. Graduates of an institution not approved by an accrediting agency recognized by the board shall file:

(1) Documentary evidence of education as required by 18VAC85-20-122;

(2) A translation made and endorsed by a consul or by a professional translating service of all such documents not in the English language; and

(3) A complete chronological record of all professional activities since graduation from professional school, giving location, dates, and types of services performed.

B. Every applicant discharged from the United States military service within the last five years shall in addition file with his application a notarized copy of his discharge papers.

18VAC85-20-121. Educational requirements: Graduates of approved institutions.

A. Such an applicant shall be a graduate of an institution that meets the criteria appropriate to the profession in which he seeks to be licensed, which are as follows:

1. For licensure in medicine. The institution shall be approved or accredited by the Liaison Committee on Medical Education or other official accrediting body recognized by the American Medical Association, or by the Committee for the Accreditation of Canadian Medical Schools or its appropriate subsidiary agencies or any other organization approved by the board.

2. For licensure in osteopathic medicine. The institution shall be approved or accredited by the Bureau of Professional Education of the American Osteopathic Association or any other organization approved by the board.

3. For licensure in podiatry. The institution shall be approved and recommended by the Council on Podiatry Podiatric Medical Education of the American Podiatry Podiatric Medical Association or any other organization approved by the board.

B. Such an applicant for licensure in medicine, osteopathic medicine, or podiatry shall provide evidence of having completed one year of satisfactory postgraduate training as an intern or resident in a hospital or health care facility offering approved internship and residency training programs when such a program is approved by an accrediting agency recognized by the board for internship and residency training.

C. For licensure in chiropractic.

1. If the applicant matriculated in a chiropractic college on or after July 1, 1975, he shall be a graduate of a chiropractic college accredited by the Commission on Accreditation of the Council of Chiropractic Education or any other organization approved by the board.

2. If the applicant matriculated in a chiropractic college prior to July 1, 1975, he shall be a graduate of a chiropractic college accredited by the American Chiropractic Association or the International Chiropractic Association or any other organization approved by the board.

18VAC85-20-131. Requirements to practice acupuncture.

A. To be qualified to practice acupuncture, licensed doctors of medicine, osteopathic medicine, podiatry, and chiropractic shall first have obtained at least 200 hours of instruction in general and basic aspects of the practice of acupuncture, specific uses and techniques of acupuncture, and indications and contraindications for acupuncture administration. After December 5, 2001, at At least 50 hours of the 200 hours of instruction shall be clinical experience supervised by a person legally authorized to practice acupuncture in any jurisdiction of the United States. Persons who held a license as a physician acupuncturist prior to July 1, 2000, shall not be required to obtain the 50 hours of clinical experience.

B. The use of acupuncture as a treatment modality shall be appropriate to the doctor's scope of practice as defined in § 54.1-2900 of the Code of Virginia.

Part IV
Licensure: Examination Requirements

18VAC85-20-140. Examinations, general.

A. The Executive Director of the Board of Medicine or his designee shall review each application for licensure and in no case shall an applicant be licensed unless there is evidence that the applicant has passed an examination equivalent to the Virginia Board of Medicine examination required at the time he was examined and meets all requirements of Part III (18VAC85-20-120 et seq.) of this chapter. If the executive director or his designee is not fully satisfied that the applicant meets all applicable requirements of Part III of this chapter and this part, he shall refer the application to the Credentials Committee for a determination on licensure.

B. A Doctor of Medicine or Osteopathic Medicine who has passed the examination of the National Board of Medical Examiners or of the National Board of Osteopathic Medical Examiners, FLEX Federation Licensing Examination, or the United States Medical Licensing Examination, or the examination of the Licensing Medical Council of Canada or other such examinations as prescribed in § 54.1-2913.1 of the Code of Virginia may be accepted for licensure.

C. A Doctor of Podiatry who has passed the National Board of Podiatric Medical Examiners examination and has passed a clinical competence examination equivalent to the Virginia Board of Medicine examination acceptable to the board may be accepted for licensure.

D. A Doctor of Chiropractic who has met the requirements of one of the following may be accepted for licensure:

1. An applicant who graduated after January 31, 1996, shall document successful completion of Parts I, II, III, and IV of the National Board of Chiropractic Examiners examination (NBCE).

2. An applicant who graduated from January 31, 1991, to January 31, 1996, shall document successful completion of Parts I, II, and III of the National Board of Chiropractic Examiners examination (NBCE).

3. An applicant who graduated from July 1, 1965, to January 31, 1991, shall document successful completion of Parts I, II, and III of the NBCE, or Parts I and II of the NBCE and the Special Purpose Examination for Chiropractic (SPEC), and document evidence of licensure in another state for at least two years immediately preceding his application.

4. An applicant who graduated prior to July 1, 1965, shall document successful completion of the SPEC, and document evidence of licensure in another state for at least two years immediately preceding his application.

E. The following provisions shall apply for applicants taking Step 3 of the United States Medical Licensing Examination or the Podiatric Medical Licensing Examination:

1. Applicants for licensure in medicine and osteopathic medicine may be eligible to sit for Step 3 of the United States Medical Licensing Examination (USMLE) upon evidence of having passed Steps 1 and 2 of the United States Medical Licensing Examination (USMLE).

2. Applicants who sat for the United States Medical Licensing Examination (USMLE) shall provide evidence of passing Steps 1, 2, and 3 within a 10-year period unless the applicant is board certified in a specialty approved by the American Board of Medical Specialties or the Bureau of Osteopathic Specialists of the American Osteopathic Association.

3. Applicants shall have completed the required training or be engaged in their final year of required postgraduate training.

4. Applicants for licensure in podiatry shall provide evidence of having passed the National Board of Podiatric Medical Examiners Examination to be eligible to sit for the Podiatric Medical Licensing Examination (PMLEXIS) in Virginia.

18VAC85-20-220. Temporary licenses to interns and residents.

A. An intern or resident applying for a temporary license to practice in Virginia shall:

1. Successfully complete the preliminary academic education required for admission to examinations given by the board in his particular field of practice, and submit a letter of confirmation from the registrar of the school or college conferring the professional degree, or official transcripts confirming the professional degree and date the degree was received.

2. Submit a recommendation from the applicant's chief or director of graduate medical education of the approved internship or residency program specifying acceptance. The beginning and ending dates of the internship or residency shall be specified.

3. Submit evidence of a standard Educational Commission for Foreign Medical Graduates (ECFMG) certificate or its equivalent if the candidate graduated from a school not approved by an accrediting agency recognized by the board.

B. The intern or resident license applies only to the practice in the hospital or outpatient clinics where the internship or residency is served. Outpatient clinics in a hospital or other facility must be a recognized part of an internship or residency program.

C. The intern or resident license shall be renewed annually upon the recommendation of the chief or director of graduate medical education of the internship or residency program no more than five times.

A residency program transfer request shall be submitted to the board in lieu of a full application.

D. The extent and scope of the duties and professional services rendered by the intern or resident shall be confined to persons who are bona fide patients within the hospital or who receive treatment and advice in an outpatient department of the hospital or outpatient clinic where the internship or residency is served.

E. The intern and resident shall be responsible and accountable at all times to a fully licensed member of the staff where the internship or residency is served. The intern and resident is prohibited from employment outside of the graduate medical educational program where a full license is required.

F. The intern or resident shall abide by the respective accrediting requirements of the internship or residency as approved by the Liaison Council on Graduate Education of the American Medical Association, American Osteopathic Association, American Podiatric Medical Association, or Council on Chiropractic Education.

18VAC85-20-235. Continued competency requirements for renewal of an active license.

A. In order to renew an active license biennially on or after January 1, 2002, a practitioner shall complete the Continued Competency Activity and Assessment Form ("Form") which is provided by the board and which shall indicate attest to completion of at least 60 hours of continuing learning activities within the two years immediately preceding renewal as follows:

1. A minimum of 30 of the 60 hours shall be in Type 1 activities or courses offered by an accredited sponsor or organization sanctioned by the profession.

a. Type 1 hours in chiropractic shall be clinical hours that are approved by a college or university accredited by the Council on Chiropractic Education or any other organization approved by the board.

b. Type 1 hours in podiatry shall be accredited by the American Podiatric Medical Association, the American Council of Certified Podiatric Physicians and Surgeons or any other organization approved by the board.

2. No more than 30 of the 60 hours may be Type 2 activities or courses, which may or may not be approved by an accredited sponsor or organization but which shall be chosen by the licensee to address such areas as ethics, standards of care, patient safety, new medical technology, and patient communication.

B. A practitioner shall be exempt from the continuing competency requirements for the first biennial renewal following the date of initial licensure in Virginia.

C. The practitioner shall retain in his records the completed Form with all supporting documentation for a period of six years following the renewal of an active license.

D. The board shall periodically conduct a random audit of at least 1.0% to 2.0% of its active licensees to determine compliance. The practitioners selected for the audit shall provide the completed Form and all supporting documentation within 30 days of receiving notification of the audit.

E. Failure to comply with these requirements may subject the licensee to disciplinary action by the board.

F. The board may grant an extension of the deadline for continuing competency requirements for up to one year for good cause shown upon a written request from the licensee prior to the renewal date.

G. The board may grant an exemption for all or part of the requirements for circumstances beyond the control of the licensee, such as temporary disability, mandatory military service, or officially declared disasters.

H. The board may grant an exemption for all or part of the requirements for a licensee who:

1. Is practicing solely in an uncompensated position, provided his practice is under the direction of a physician fully licensed by the board; or

2. Is practicing solely as a medical examiner, provided the licensee obtains six hours of medical examiner training per year provided by the Office of the Chief Medical Examiner.

18VAC85-20-290. Reporting of medical malpractice judgments and settlements.

A. In compliance with requirements of § 54.1-2910.1 of the Code of Virginia, a doctor of medicine, osteopathic medicine, or podiatry licensed by the board shall report all medical malpractice judgments and settlements of $10,000 or more than $10,000 in the most recent 10-year period within 30 days of the initial payment. A doctor shall report a medical malpractice judgment or settlement of less than $10,000 if any other medical malpractice judgment or settlement has been paid by or for the licensee within the preceeding 12 months. Each report of a settlement or judgment shall indicate:

1. The year the judgment or settlement was paid.

2. The specialty in which the doctor was practicing at the time the incident occurred that resulted in the judgment or settlement.

3. The total amount of the judgment or settlement in United States dollars.

4. The city, state, and country in which the judgment or settlement occurred.

B. The board shall not release individually identifiable numeric values of reported judgments or settlements but shall use the information provided to determine the relative frequency of judgments or settlements described in terms of the number of doctors in each specialty and the percentage with malpractice judgments or settlements within the most recent 10-year period. The statistical methodology used will include any specialty with more than 10 judgments or settlements. For each specialty with more than 10 judgments or settlements, the top 16% of the judgments or settlements will be displayed as above average payments, the next 68% of the judgments or settlements will be displayed as average payments, and the last 16% of the judgments or settlements will be displayed as below average payments.

C. For purposes of reporting required under this section, medical malpractice judgment and medical malpractice settlement shall have the meanings ascribed in § 54.1-2900 of the Code of Virginia. A medical malpractice judgment or settlement shall include:

1. A lump sum payment or the first payment of multiple payments;

2. A payment made from personal funds;

3. A payment on behalf of a doctor of medicine, osteopathic medicine, or podiatry by a corporation or entity comprised solely of that doctor of medicine, osteopathic medicine, or podiatry; or

4. A payment on behalf of a doctor of medicine, osteopathic medicine, or podiatry named in the claim where that doctor is dismissed as a condition of, or in consideration of the settlement, judgment or release. If a doctor is dismissed independently of the settlement, judgment or release, then the payment is not reportable.

Part IX
Mixing, Diluting, or Reconstituting of Drugs for Administration

18VAC85-20-400. Requirements for immediate-use sterile mixing, diluting, or reconstituting.

A. For the purposes of this chapter, the mixing, diluting, or reconstituting of sterile manufactured drug products when there is no direct contact contamination and administration begins within 10 hours of the completion time of preparation shall be considered immediate-use with the exception of drugs in fat emulsion for which immediate use shall be one hour. If manufacturers' instructions or any other accepted standard specifies or indicates an appropriate time between preparation and administration of less than 10 hours, the mixing, diluting, or reconstituting shall be in accordance with the lesser time. No direct contact contamination means that there is no contamination from touch, gloves, bare skin, or secretions from the mouth or nose. Emergency drugs used in the practice of anesthesiology and administration of allergens may exceed 10 hours after completion of the preparation, provided administration does not exceed the specified expiration date of a multiple use vial and there is compliance with all other requirements of this section.

B. Doctors of medicine or osteopathic medicine who engage in immediate-use mixing, diluting, or reconstituting shall:

1. Utilize the practices and principles of disinfection techniques, aseptic manipulations and solution compatibility in immediate-use mixing, diluting, or reconstituting;

2. Ensure that all personnel under their supervision who are involved in immediate-use mixing, diluting, or reconstituting are appropriately and properly trained in and utilize the practices and principles of disinfection techniques, aseptic manipulations, and solution compatibility;

3. Establish and implement procedures for verification of the accuracy of the product that has been mixed, diluted, or reconstituted to include a second check performed by a doctor of medicine or osteopathic medicine or a pharmacist, or by a physician assistant or a registered nurse who has been specifically trained pursuant to subdivision 2 of this subsection in immediate-use mixing, diluting, or reconstituting. Mixing, diluting, or reconstituting that is performed by a doctor of medicine or osteopathic medicine, a pharmacist, or by a specifically trained physician assistant or registered nurse or mixing, diluting, or reconstituting of vaccines does not require a second check;

4. Provide a designated, sanitary work space and equipment appropriate for aseptic manipulations;

5. Document or ensure that personnel under his supervision documents in the patient record or other readily retrievable record that identifies the patient; the names of drugs mixed, diluted or reconstituted; and the date of administration; and

6. Develop and maintain written policies and procedures to be followed in mixing, diluting, or reconstituting of sterile products and for the training of personnel.

C. Any mixing, diluting, or reconstituting of drug products that are hazardous to personnel shall be performed consistent with requirements of all applicable federal and state laws and regulations for safety and air quality, to include but not be limited to those of the Occupational Safety and Health Administration (OSHA). For the purposes of this chapter, Appendix A of the National Institute for Occupational Safety and Health publication (NIOSH Publication No. 2004-165), Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings is incorporated by reference for the list of hazardous drug products and can be found at www.cdc.gov/niosh/docs/2004-165.

FORMS (18VAC85-20)

Instructions for Completing an Application to Practice Medicine in Virginia for Graduates of Approved Medical Schools in the US/Canada (rev. 7/08).

Instructions for Completing an Application to Practice Medicine for Graduates of Nonapproved Medical Schools (outside of the US/Canada) (rev. 7/08).

Information for Completing Chiropractic Endorsement Application (rev. 8/07).

Instructions for Completing Podiatry Endorsement Application (rev. 8/07).

Instructions for Completing Osteopathic Medicine Licensure Application (rev. 11/07).

Form A, Claims History Sheet (rev. 8/07).

Form B, Activity Questionnaire (rev. 8/07).

Form C, Clearance from Other State Boards (rev. 8/07).

Form E, Disciplinary Inquiry (rev. 8/07).

Application for a License to Practice Medicine and Surgery (rev. 11/07).

Application for a License to Practice Osteopathic Medicine (rev. 11/07).

Application for a License to Practice Podiatry (rev. 8/07).

Application for a License to Practice Chiropractic (rev. 8/07).

Form H, Federation of Podiatric Medical Boards Report (rev. 8/07).

Requirements and Instructions for an Intern/Resident License (rev. 8/07).

Intern/Resident, Form A, Memorandum from Associate Dean of Graduate Medical Education (rev. 8/07).

Intern/Resident, Form B, Certificate of Professional Education (rev. 8/07).

Application for a Temporary License for Intern/Resident Training Program (rev. 8/07).

Form G, Intern Resident, Request for Status Report of ECFMG Certification (eff. 8/07).

Form H, Report of Clinical Rotations (rev. 12/02).

Transfer Request, Intern /Resident (eff. 8/07).

Instructions for Completing an Application for a Limited License to Foreign Medical Graduates Pursuant to 54.1-2936 (rev. 8/07).

Application for a Limited License to Foreign Medical Graduates Pursuant to 54.1-2936 (rev. 8/07).

Form G, Request for Status Report of Educational Commission for Foreign Medical Graduates Certification (rev. 8/07).

Form L, Certificate of Professional Education (rev. 8/07).

Continued Competency Activity and Assessment Form (rev. 9/07).

Instructions for Reinstatement of Medicine and Surgery Licensure Application (rev. 4/08).

Application for Reinstatement of License to Practice Medicine (rev. 8/07).

Form A, MD Reinstatement, Claims History Sheet (rev. 8/07).

Form B, MD Reinstatement, Activity Questionnaire Form (rev. 8/07).

Form C, MD Reinstatement, State Questionnaire Form (rev. 8/07).

MD Reinstatement, Disciplinary Inquiries to Federation of State Medical Boards (rev. 8/07).

Instructions for Reinstatement of Osteopathic Medicine Licensure Application (rev. 4/08).

Application for Reinstatement of License to Practice Osteopathic Medicine (rev. 8/07).

Form A, Osteopathy Reinstatement, Claims History (rev. 8/07).

Instructions for Reinstatement of a Chiropractic Licensure Application (rev. 4/08).

Application for Reinstatement of License to Practice as a Chiropractor (rev. 8/07).

Instructions for Reinstatement of Podiatry Licensure Application (rev. 4/08).

Application for Reinstatement of License to Practice Podiatry (rev. 8/07).

Reinstatement Application Instructions for Medicine & Surgery or Osteopathy Licensure after Reinstatement Denied or License Revoked (rev. 8/07).

Reinstatement Application Instructions for Medicine & Surgery or Osteopathy Licensure after Mandatory Suspension, Suspension or Surrender (rev. 8/07).

Reinstatement Application Instructions for Podiatry Licensure after Mandatory Suspension, Suspension or Surrender (rev. 8/07).

Application for Reinstatement of License to Practice Medicine/Osteopathy After Petition for Reinstatement Denied or License Revoked (rev. 8/07).

Application for Registration for Volunteer Practice (rev. 8/07).

Sponsor Certification for Volunteer Registration (rev. 8/08).

Guidelines for Completing the Practitioner Profile Questionnaire (rev. 12/02).

Practitioner's Help Section (rev. 11/07).

Practitioner Questionnaire (rev. 8/04).