Title of Regulation: 18VAC85-170. Regulations Governing the Practice of Genetic Counselors (adding 18VAC85-170-10 through 18VAC85-170-190).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.18 of the Code of Virginia.

Public Hearing Information:

October 3, 2016 - 1:05 p.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233-1463

Public Comment Deadline: October 21, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Specific authority requiring the board to regulate genetic counselors is found in § 54.1-2957.19 of the Code of Virginia.

Purpose: Applying established criteria for studying the need to regulate a profession, the Board of Health Professions (BHP) conducted a study in 2011 of the need to regulate genetic counselors. In its report, licensure for genetic counselors was recommended. The board noted the inherent risk of harm and the need to protect the public health and safety. It also recommended genetic counselors be regulated through the advisory committee model under the Board of Medicine. Findings of the BHP study were:

1. Genetic medicine is expanding rapidly. Genetic medicine has traditionally focused on prenatal and postnatal health and genetic diseases. In the past two decades, however, rapid advances in genetic technology have expanded the domain of genetic medicine into several specialties, particularly oncology and pharmacology. Continued expansion of the field could revolutionize the practice of medicine in all specialties. Personalized medicine may be possible, with a focus on prediction and prevention over diagnosis and treatment.

2. Genetic medicine is still in its infancy. Although there are thousands of genetic tests, only a few have clinically useful applications and most are very new. Many physicians do not have significant training in genetics, and clinical guidelines are often underdeveloped, under disseminated, or both. Physicians often lack the knowledge to provide adequate genetic counseling or to refer patients to quality genetic counseling resources. Genetic counselors have only recently expanded from their prenatal and postnatal beginnings in significant numbers and into specialties with clinical useful tests. The total number of genetic professionals remains limited.

3. Genetic tests and commercial genetic testing services have proliferated ahead of clinical knowledge and regulation. The genetic testing industry has expanded rapidly, including the marketing of genetic tests directly to consumers. Genetic testing companies provide some rudimentary analysis and customer service. Although it may not be intended as genetic counseling or medical advice, it may, from time to time, cross the line. Patients may rely on this analysis and service in the absence of sufficient genetic counseling or referrals from licensed practitioners. The U.S. Food and Drug Administration (FDA) is currently examining a new regulatory framework for genetic tests, placing regulations on genetic testing companies for the first time.

4. Regulation of genetic counselors may have little impact on the genetic testing industry. Some of the services provided by genetic testing companies may cross the line into the practice of medicine. If so, these practices are already illegal if not delegated or performed by a licensed practitioner in accordance with statute and regulation. Regulation of genetic counselors in other states does not appear to have reduced access to genetic testing companies or services. Some states have directly regulated genetic tests, particularly direct-to-consumer genetic tests, and the FDA is poised to do so as well.

5. Genetic counselors provide diagnostic services as well as patient counseling. Genetic counselors assist physicians in determining if a genetic test is appropriate and if so, which test is appropriate. They assist physicians in interpreting the results of genetic tests, either for diagnosing genetic conditions or for determining the risk of developing gene-linked conditions. Genetic counselors help patients understand the results of genetic tests and the options available to them. They help patients cope with implications of genetic tests and make referrals if appropriate.

6. Practices inherent to the profession pose a potential risk of harm to patients. Patients rely on the advice of genetic counselors in making significant medical decisions. These include major prophylactic surgeries, decisions to get pregnant or terminate a pregnancy and decisions regarding the frequency and aggressiveness of preventative screenings for fatal diseases. Genetic counselors provide counseling and referrals to help patients cope with the difficult pragmatic, ethical, and social implications related to genetic testing. Since many of these decisions are related to controversial political and moral issues, patients rely on genetic counselors to provide unbiased information and protect patient privacy.

7. Instances of harm from the unregulated practice of genetic counseling are limited or tenuous. Instances of harm related to a lack of quality genetic counseling are numerous in the literature. However, these instances of harm stem from inadequate counseling provided by licensed practitioners, or a failure to refer for genetic counseling, not from the unregulated practice of genetic counseling. Often, physicians and patients alike rely on generic information or customer service provided by testing companies along with test results. These services are often not intended to be medical genetic counseling, but many skirt the line.

8. The potential for harm from the unregulated practice of genetic counseling could expand rapidly. Although the FDA is currently developing a regulatory framework for genetic tests, the extent and efficacy of these regulations are as yet unknown. Genetic tests continue to proliferate in variety, scope, and availability. Genetic testing companies and regulated and unregulated providers may increasingly fill the gap between physician knowledge, an inadequate supply of genetic professionals, and the need for counseling services.

Subsequently, Chapters 10 and 266 of the 2014 Acts of Assembly establish licensure for genetic counselors under the Board of Medicine. The Advisory Board on Genetic Counseling reviewed the statutory mandate for the Board of Medicine to establish the qualifications for licensure and renewal and the standards of practice for the profession. Regulations necessary to ensure minimal competency for practice, continued competency for renewal of licensure, and standards of conduct for safe practice were recommended and adopted by the board.

Substance: Regulations for licensure of genetic counselors have not been specifically developed or adopted, but the structure and content of 18VAC85-170 follows the pattern of regulations for other allied health professions, including definitions; requirement for current name and address of record; applicability of public participation guidelines; fees for initial licensure, renewal of license, and administration of the profession; qualifications or credentials required for licensure, including a "grandfathering provision," which is applicable until July 1, 2016, and specified in § 54.1-2957.18 of the Code of Virginia; requirements for temporary licensure, also specified by statute; requirements and schedule for renewal of licensure, including continuing education and current certification; requirements for reactivation of an inactive license or reinstatement of a lapsed license; supervisory responsibility of a genetic counselor for a person practicing under a temporary license; scope of practice of genetic counselors consistent with job description of the American Board of Genetic Counseling; standards of practice consistent with the National Society of Genetic Counselors; requirements for confidentiality and patient records; standards for practitioner-patient communication, including the exercise of the conscience clause; practitioner responsibilities; and prohibition of sexual contact.

Issues: The primary advantage to the public is greater protection for patients or consumers of genetic counseling who will have an avenue for filing a complaint if they believe the counselor has violated a law or regulation or acted unprofessionally. There are no disadvantages for the public. There are no advantages or disadvantages to the agency or the Commonwealth. This proposal represents a compromise between the statutory requirement for a conscience clause and those who opposed to its inclusion.

The Deputy Director of the Department of Health Professions has performed a competitive impact analysis for this regulation. The board is authorized under §§ 54.1-2400 and 54.1-2957.19 of the Code of Virginia to establish the qualifications for licensure that are necessary to ensure the competence and integrity of licensees to engage in the practice of genetic counseling.

As mandated by Chapters 10 and 266 of the 2014 Acts of Assembly, the board has established licensure for genetic counselors. Qualifications for licensure are specified in the Code of Virginia; regulatory requirements are identical and do not exceed the statutory provisions. Other provisions, including fees charged to applicants and licensees, the biennial renewal schedule, and responsibilities of licensees, are identical to all other allied health professions regulated under the board. Continuing education requirements of 50 hours per biennium are consistent with the recertification requirement for maintenance of professional certification. Standards of professional conduct, including requirements for confidentiality, recordkeeping, communication with patients, and prohibition on sexual contact, are also identical to other professional regulations under the Board of Medicine. The provision for exercise of the conscience clause is unique to genetic counseling but is mandated by § 54.1-2957.21 of the Code of Virginia.

Therefore, the requirement for licensure of all practicing genetic counselors in the Commonwealth and the specific requirements associated with that licensure are a foreseeable result of the statutes requiring the board to license and regulate genetic counselors in the Commonwealth. Any restraint on competition that results from these regulations is in accord with the General Assembly's policy as articulated in § 54.1-100 of the Code of Virginia and is necessary for the preservation of the health, safety, and welfare of the public and will further the public's need for assurances of professional ability and competence.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As mandated by Chapter 10 of the 2014 Acts of the Assembly, the Board of Medicine (Board) proposes to promulgate rules for new licensure of genetic counselors.

Result of Analysis. There is insufficient information to ascertain whether the benefits of this proposed regulation will outweigh its costs.

Estimated Economic Impact. Currently, genetic counselors are not licensed. In 2014, the General Assembly passed legislation¹ that: 1) directed the Board to adopt regulations governing the practice of genetic counselors that meets specific criteria,² 2) made it unlawful for individuals to practice, or hold themselves out as practicing, genetic counseling³ without a valid Board license, 3) specified that applicants for licensure in genetic counseling have a master's degree from a genetic counseling education program that is accredited by the accreditation Council of Genetic Counseling, and 4) specified that applicants hold a current, valid certificate issued by the American Board of Genetic Counseling or American Board of Medical Genetics to practice counseling. The General Assembly made provision in this legislation for the Board to waive the educational requirements above for individuals who 1) apply for licensure before July 1, 2016,⁴ 2) have at least 20 years of documented work experience practicing genetic counseling, 3) submit two letters of recommendation (one from a genetic counselor and one from a physician), 4) have completed at least 25 hours of continuing education and 5) comply with the Board's regulations relating to the National Society of Genetic Counselors Code of Ethics. The General Assembly also made provision for the Board to grant temporary licenses to applicants for licensure who have been granted Active Candidate status by the American Board of Genetic Counseling and who are practicing under the supervision of a licensed genetic counselor or physician.

Finally, the General Assembly included a conscience clause (Code of Virginia § 54.1-2057.20) in the legislation that states:

"Nothing in this chapter shall be construed to require any genetic counselor to participate in counseling that conflicts with their deeply-held moral or religious beliefs, nor shall licensing of any genetic counselor be contingent upon participation in such counseling. Refusal to participate in counseling that conflicts with the counselor's deeply-held moral or religious beliefs shall not form the basis for any claim of damages or for any disciplinary or recriminatory action against the genetic counselor, provided the genetic counselor informs the patient that he will not participate in such counseling and offers to direct the patient to the online directory of licensed genetic counselors maintained by the Board."

The Board now proposes to promulgate this regulation for licensure of genetic counselors that mirrors legislative requirements for initial licensure and grandfathering. The Board proposes to set fees for initial licensure ($130), temporary licensure ($50), biennial renewal of active licenses ($135) and inactive licenses ($70), late renewal ($50 added to the renewal fee), license reinstatement ($180), license reinstatement after revocation pursuant to § 54.1-2408.2 ($2,000) and verification letters ($10). The Board additionally proposes to charge the same fees for duplicate licenses ($5), duplicate wall certificates ($15) and returned checks ($35) as they do for all Board licensure programs.

This proposed regulation will also require licensees to complete 50 hours of continuing education (CE) every two years (30 hours of Category 1 training⁵ and 20 hours of Category 2 training⁶ or professional activity). The Chair of the Genetic Counseling Advisory Board reports that costs for CE can vary widely; some CE would likely be free and some opportunities can cost as much as several hundred dollars (plus travel costs and cost of time spent) for national conferences. Genetic counselors will incur costs for pursuing and maintaining licensure that include paying licensure fees, paying for CE (when there is a cost attached) and costs for time spent on these activities (including travel time).

The Board also proposes to set requirements for the exercise of the legislation's conscience clause⁷ that include: 1) requirements for informing patients in a timely fashion if the genetic counselor has a religious or deeply held moral belief that precludes the provision of services (including informing the patient, prior to taking them on as a patient, if there are any limitations on the services that the genetic counselor will be willing to provide), 2) a requirement to direct the patient to an online directory, and 3) a requirement to offer to refer the patient to another licensed health care professional. The last requirement appears to have been added in response to public comment from individuals concerned that there was not currently an online list for patients to access, and that patient care could be delayed and suffer on account of this.

Businesses and Entities Affected. These proposed regulatory changes will affect all genetic counselors in the Commonwealth. The Genetic Counseling Advisory Board estimates that there are 35 to 40 genetic counselors in the Commonwealth.

Localities Particularly Affected. No locality will be disproportionately affected by these proposed regulatory changes.

Projected Impact on Employment. Absent a legislative change to change the end date for grandfathering, the one genetic counselor who has practiced in the Commonwealth (presumably for many years) without a master's degree will either have to stop practicing or incur likely large costs to gain the required education.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

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. Genetic counselors who are in private practice will incur the costs listed above for licensure and CE.

Alternative Method that Minimizes Adverse Impact. There are no alternatives that would both lower costs and meet the legislative mandate for licensure.

Adverse Impacts:

Businesses. Genetic counselors who are in private practice will incur the costs listed above for licensure and CE.

Localities. Localities in the Commonwealth are unlikely to see any adverse impacts on account of these proposed regulatory changes.

Other Entities. No other entities are likely to be adversely affected by these proposed changes.

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¹Chapter 10 of the 2014 Acts of Assembly (http://leg1.state.va.us/cgi-bin/legp504.exe?141+ful+CHAP0010) and the identical Chapter 266.

²§ 54.1-2957.18 (A) requires that Board regulations on this matter: 1) set forth requirements for licensure to practice genetic counseling, 2) provide for appropriate application and renewal fees, 3) include requirements for licensure renewal and continuing education, 4) be consistent with the American Board of Genetic Counseling's current job description for the profession and the standards of practice of the National Society of Genetic Counselors and 5) allow for independent practice.

³The General Assembly provides exemptions to this provision for physicians practicing within their scopes of practice (so long as he does not use the title "genetic counselor"), students who are performing genetic counseling under supervision as a part of a course of studies and employees of rare disease organizations who are certified by the American Board of Genetic Counseling or the American Board of Medical Genetics who provide genetic counselling for fewer than 10 days per year.

⁴Board staff reports that no individuals will be able to apply to be grandfathered in to licensure before the required deadline because there are currently no regulations in effect under which to apply. Legislation would have to be introduced to change this date in order for any individual to qualify to have the legislatively required master's degree waived. Board staff reports that only one genetic counselor in the state does not already have a master's degree.

⁵Activities approved by the American Board of Genetic Counselors, the American Board of Medical Genetics or the National Society of Genetic Counselors.

⁶Category 2 training can include consultation with another genetic counselor, independent research or reading, authorship, clinical supervision, volunteer leadership in the profession, preparation for a presentation or other such experiences that promote continued learning.

⁷Board staff reports that the information they have on genetic counselors in the state indicates that this is unlikely to be an issue as no genetic counselor in current practice would exercise this conscience clause.

Agency's Response to Economic Impact Analysis: The Board of Medicine concurs with the analysis of the Department of Planning and Budget for Regulations Governing the Practice of Genetic Counselors with the exception of the adverse impact notification to the Joint Commission on Administrative Rules, House Committee on Appropriations, and the Senate Committee on Finance.

The "adverse impact" of this regulation is no different from and no greater than any of the 80 professions regulated by boards at the Department of Health Professions; all of which require initial and ongoing evidence of competency and fees for the operation of the board and department.

Summary:

As mandated by Chapters 10 and 266 of the 2014 Acts of Assembly, the Board of Medicine is promulgating Regulations Governing the Practice of Genetic Counselors (18VAC85-70) to establish licensure for genetic counselors. Qualifications for licensure are specified in the Code of Virginia, so regulations set identical requirements. Other provisions, including fees charged to applicants and licensees, the biennial renewal schedule, and responsibilities of licensees, are identical to other allied health professions regulated under the board. Continuing education requirements of 50 hours per biennium are consistent with the recertification requirement for maintenance of professional certification. Standards of professional conduct, including requirements for confidentiality, recordkeeping, communication with patients, and prohibition on sexual contact, are also identical to other professional regulations under the Board of Medicine. The provision for exercise of the conscience clause is unique to genetic counseling and is mandated by § 54.1-2957.21 of the Code of Virginia.

CHAPTER 170
REGULATIONS GOVERNING THE PRACTICE OF GENETIC COUNSELORS

Part I
General Provisions

18VAC85-170-10. Definitions.

A. The following words and terms when used in this chapter shall have the meanings ascribed to them in § 54.1-2900 of the Code of Virginia:

"Board"

"Genetic counselor"

"Practice of genetic counseling"

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

"ABGC" means the American Board of Genetic Counseling.

"ABMG" means the American Board of Medical Genetics.

"Active practice" means a minimum of 160 hours of professional practice as a genetic counselor within the 24-month period immediately preceding application for reinstatement or reactivation of licensure. The active practice of genetic counseling may include supervisory, administrative, educational, or consultative activities or responsibilities for the delivery of such services.

"Conscience clause" means the provision of § 54.1-2957.21 of the Code of Virginia.

"NSGC" means the National Society of Genetic Counselors.

18VAC85-170-20. Public participation.

A separate board regulation, Public Participation Guidelines (18VAC85-11), provides for involvement of the public in the development of all regulations of the Virginia Board of Medicine.

18VAC85-170-30. Current name and address.

Each licensee shall furnish the board his current name and address of record. All notices required by law or by this chapter to be given by the board to any such licensee shall be validly given when mailed to the latest address of record provided or served to the licensee. Any change of name or change in the address of record or public address, if different from the address of record, shall be furnished to the board within 30 days of such change.

18VAC85-170-40. Fees.

The following fees are required:

1. The application fee for licensure, payable at the time the application is filed, shall be $130.

2. The application fee for a temporary license, payable at the time the application is filed, shall be $50.

2. The biennial fee for renewal of active licensure shall be $135 and for renewal of inactive licensure shall be $70, payable in each odd-numbered year in the license holder's birth month.

3. The additional fee for late renewal of licensure within one renewal cycle shall be $50.

4. The fee for reinstatement of a license that has lapsed for a period of two years or more shall be $180 and shall be submitted with an application for licensure reinstatement.

5. The fee for reinstatement of a license pursuant to § 54.1-2408.2 of the Code of Virginia shall be $2,000.

6. The fee for a duplicate license shall be $5, and the fee for a duplicate wall certificate shall be $15.

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

8. The fee for a letter of good standing or letter of verification to another jurisdiction shall be $10.

Part II
Requirements for Licensure as a Genetic Counselor

18VAC85-170-50. Application requirements.

An applicant for licensure shall submit the following on forms provided by the board:

1. A completed application and a fee as prescribed in 18VAC85-170-40.

2. Verification of a professional credential in genetic counseling as required in 18VAC85-170-60.

3. Verification of practice as required on the application form.

4. If licensed or certified in any other jurisdiction, documentation of any disciplinary action taken or pending in that jurisdiction.

18VAC85-170-60. Licensure requirements.

A. An applicant for a license to practice as a genetic counselor shall provide documentation of (i) a master's degree from a genetic counseling training program that is accredited by the Accreditation Council of Genetic Counseling and (ii) a current, valid certificate issued by the ABGC or ABMG to practice genetic counseling.

B. Pursuant to § 54.1-2957.19 D of the Code of Virginia, applicants for licensure who do not meet the requirements of subsection A of this section may be issued a license provided they (i) apply for licensure before July 1, 2016; (ii) comply with the board's regulations relating to the NSGC Code of Ethics; (iii) have at least 20 years of documented work experience practicing genetic counseling; (iv) submit two letters of recommendation, one from a genetic counselor and another from a physician; and (v) have completed, within the last five years, 25 hours of continuing education approved by the NSGC or the ABGC. For the purpose of this subsection, the board deems the provisions of Part IV (18VAC85-170-110 et seq.) of this chapter to be consistent with the NSGC Code of Ethics.

C. An applicant for a temporary license shall provide documentation of having been granted the active candidate status by the ABGC. Such license shall expire 12 months from issuance or upon expiration of active candidate status, whichever comes first.

Part III
Renewal and Reinstatement

18VAC85-170-70. Renewal of license.

A. Every licensed genetic counselor who intends to maintain an active license shall biennially renew his license each odd-numbered year during his birth month and shall:

1. Submit the prescribed renewal fee; and

2. Attest to having met the continuing education requirements of 18VAC85-170-100.

B. The license of a genetic counselor that has not been renewed by the first day of the month following the month in which renewal is required is lapsed. Practice with a lapsed license may be grounds for disciplinary action. A license that is lapsed for two years or less may be renewed by payment of the renewal fee, a late fee as prescribed in 18VAC85-170-40, and attestation of compliance with continuing education requirements.

18VAC85-170-80. Inactive license.

A licensed genetic counselor who holds a current, unrestricted license in Virginia shall, upon a request at the time of renewal and submission of the required fee, be issued an inactive license. The holder of an inactive license shall not be entitled to perform any act requiring a license to practice genetic counseling in Virginia.

18VAC85-170-90. Reactivation or reinstatement.

A. To reactivate an inactive license or to reinstate a license that has been lapsed for more than two years, a genetic counselor shall submit evidence of competency to return to active practice to include one of the following:

1. Information on continued active practice in another jurisdiction during the period in which the license has been inactive or lapsed;

2. Attestation of meeting requirements for continuing education as specified in 18VAC85-170-100 for each biennium in which the license has been inactive or lapsed, not to exceed four years; or

3. Current certification by ABGC or ABMG.

B. To reactivate an inactive license, a genetic counselor shall pay a fee equal to the difference between the current renewal fee for inactive licensure and the renewal fee for active licensure.

C. To reinstate a license that has been lapsed for more than two years a genetic counselor shall file an application for reinstatement and pay the fee for reinstatement of his licensure as prescribed in 18VAC85-170-40. The board may specify additional requirements for reinstatement of a license so lapsed to include education, experience, or reexamination.

D. A genetic counselor whose licensure has been revoked by the board and who wishes to be reinstated shall make a new application to the board, fulfill additional requirements as specified in the order from the board, and make payment of the fee for reinstatement of his licensure as prescribed in 18VAC85-170-40 pursuant to § 54.1-2408.2 of the Code of Virginia.

E. The board reserves the right to deny a request for reactivation or reinstatement to any licensee who has been determined to have committed an act in violation of § 54.1-2915 of the Code of Virginia or any provisions of this chapter.

18VAC85-170-100. Continuing education requirements.

A. In order to renew an active license biennially, a licensee shall complete the Continued Competency Activity and Assessment Form that is provided by the board indicating completion of at least 50 contact hours of continuing learning activities as follows:

1. A minimum of 30 of the 50 hours shall be in Category 1 activities approved by the ABGC, the ABMG, or the NSGC and may include in-service training, self-study courses, continuing education courses, or professional workshops.

2. No more than 20 of the 50 hours may be Category 2 activities or professional activity credits, which may include consultation with another counselor or a physician, independent reading or research, authorship, clinical supervision, volunteer leadership in the profession, preparation for a presentation, or other such experiences that promote continued learning.

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

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

D. The board shall periodically conduct a random audit of its active licensees to determine compliance. The licensees selected for the audit shall provide 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.

Part IV
Scope of Practice

18VAC85-170-110. General responsibility.

A genetic counselor shall engage in the practice of genetic counseling, as defined in § 54.1-2900 of the Code of Virginia. The practice of genetic counseling may include supervisory, administrative, educational, or consultative activities or responsibilities for the delivery of such services.

18VAC85-170-120. Supervisory responsibilities.

A. A genetic counselor shall be responsible for supervision of unlicensed personnel who work under his direction and ultimately responsible and accountable for patient care and outcomes under his clinical supervision.

B. Delegation to unlicensed personnel shall:

1. Not include delegation of the discretionary aspects of the initial assessment, evaluation, or development of recommendations for a patient, or any task requiring a clinical decision or the knowledge, skills, and judgment of a licensed genetic counselor;

2. Only be made if, in the judgment of the genetic counselor, the task or procedures do not require the exercise of professional judgment and can be properly and safely performed by appropriately trained unlicensed personnel, and the delegation does not jeopardize the health or safety of the patient; and

3. Be communicated on a patient-specific basis with clear, specific instructions for performance of activities, potential complications, and expected results.

18VAC85-170-125. Responsibilities of a temporary licensee.

A. A person holding a temporary license as a genetic counselor shall practice under the clinical supervision of a genetic counselor or a physician licensed in the Commonwealth.

B. Clinical supervision shall require that:

1. The supervisor and temporary licensee routinely meet to review and evaluate patient care and treatment; and

2. The supervisor reviews notes on patient care entered by the temporary licensee prior to reporting study results and making recommendations to a patient. Such review shall be documented by some method in a patient record.

Part V

Standards of Professional Conduct

18VAC85-170-130. Confidentiality.

A practitioner shall not willfully or negligently breach the confidentiality between a practitioner and a patient. A breach of confidentiality that is required or permitted by applicable law or beyond the control of the practitioner shall not be considered negligent or willful.

18VAC85-170-140. Patient records.

A. Practitioners shall comply with the provisions of § 32.1-127.1:03 of the Code of Virginia related to the confidentiality and disclosure of patient records.

B. Practitioners shall provide patient records to another practitioner or to the patient or his personal representative in a timely manner in accordance with provisions of § 32.1-127.1:03 of the Code of Virginia.

C. Practitioners shall properly manage and keep timely, accurate, legible, and complete patient records.

D. Practitioners who are employed by a health care institution or other entity in which the individual practitioner does not own or maintain his own records shall maintain patient records in accordance with the policies and procedures of the employing entity.

E. Practitioners who are self-employed or employed by an entity in which the individual practitioner owns and is responsible for patient records shall:

1. Maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:

a. Records of a minor child shall be maintained until the child reaches the age of 18 years or becomes emancipated, with a minimum time for record retention of six years from the last patient encounter regardless of the age of the child;

b. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or his personal representative; or

c. Records that are required by contractual obligation or federal law may need to be maintained for a longer period of time.

2. Post information or in some manner inform all patients concerning the timeframe for record retention and destruction. Patient records shall only be destroyed in a manner that protects patient confidentiality, such as by incineration or shredding.

3. When closing, selling, or relocating his practice, meet the requirements of § 54.1-2405 of the Code of Virginia for giving notice that copies of records can be sent to any like-regulated provider of the patient's choice or provided to the patient.

18VAC85-170-150. Practitioner-patient communication; conscience clause; termination of relationship.

A. Communication with patients.

1. Except as provided in § 32.1-127.1:03 F of the Code of Virginia, a practitioner shall accurately present information to a patient or his legally authorized representative in understandable terms and encourage participation in decisions regarding the patient's care.

2. A practitioner shall not deliberately withhold pertinent findings or information or make a false or misleading statement regarding the practitioner's skill or the efficacy or value of a medication, treatment, or procedure provided or directed by the practitioner in the treatment of any disease or condition.

3. When a genetic procedure is recommended, informed consent shall be obtained from the patient in accordance with the policies of the health care entity. Practitioners shall inform patients of the risks, benefits, and alternatives of the recommended procedure that a reasonably prudent practitioner practicing genetic counseling in Virginia would tell a patient.

a. In the instance of a minor or a patient who is incapable of making an informed decision on his own behalf or is incapable of communicating such a decision due to a physical or mental disorder, the legally authorized person available to give consent shall be informed and the consent documented.

b. An exception to the requirement for consent prior to performance of a genetic procedure may be made in an emergency situation when a delay in obtaining consent would likely result in imminent harm to the patient.

c. For the purposes of this provision, "genetic procedure" means any diagnostic or therapeutic procedure performed on a patient that is not part of routine, general care and for which the usual practice within the health care entity is to document specific informed consent from the patient or surrogate decisionmaker prior to proceeding.

4. Practitioners shall adhere to requirements of § 32.1-162.18 of the Code of Virginia for obtaining informed consent from patients prior to involving them as subjects in human research with the exception of retrospective chart reviews.

B. Exercise of the conscience clause.

1. Notwithstanding provisions of subsection A of this section, a practitioner may exercise the conscience clause pursuant to requirements of § 54.1-2957.21 of the Code of Virginia. If a genetic counselor has deeply held moral or religious beliefs that may prevent him from participating in genetic counseling, he shall immediately inform a prospective patient with specificity about any associated limitations on counseling resulting therefrom, prior to the initiation of the patient-practitioner relationship and shall:

a. Offer to refer the patient to another licensed health care practitioner with a relevant scope of practice and direct the patient to the online directory of licensed genetic counselors maintained by the board;

b. Immediately notify any referring practitioner, if known, of this refusal to participate in genetic counseling for the patient; and

c. Alert the patient and the referring practitioner if the referral is time sensitive.

2. If, during the course of patient care, the genetic counselor encounters a situation in which his deeply held moral or religious beliefs would prevent him from participating in counseling, he shall immediately inform the patient with specificity about any associated limitations on counseling and shall:

a. Document the communication of such information in the patient record;

b. Offer to refer the patient to another licensed health care practitioner with a relevant scope of practice and direct the patient to the online directory of licensed genetic counselors;

c. Immediately notify any referring practitioner, if known, of such refusal and referral of the patient; and

d. Alert the patient and the referring practitioner if the referral is time sensitive.

C. Termination of the practitioner-patient relationship.

1. The practitioner or the patient may terminate the relationship. In either case, the practitioner shall make the patient record available, except in situations where denial of access is allowed by law.

2. A practitioner shall not terminate the relationship or make his services unavailable without documented notice to the patient that allows for a reasonable time to obtain the services of another practitioner.

18VAC85-170-160. Practitioner responsibility.

A. A practitioner shall not:

1. Perform procedures or techniques that are outside the scope of his practice or for which he is not trained and individually competent;

2. Knowingly allow subordinates to jeopardize patient safety or provide patient care outside of the subordinate's scope of practice or area of responsibility. Practitioners shall delegate patient care only to subordinates who are properly trained and supervised;

3. Engage in an egregious pattern of disruptive behavior or interaction in a health care setting that interferes with patient care or could reasonably be expected to adversely impact the quality of care rendered to a patient; or

4. Exploit the practitioner-patient relationship for personal gain.

B. Advocating for patient safety or improvement in patient care within a health care entity shall not constitute disruptive behavior provided the practitioner does not engage in behavior prohibited in subdivision A 3 of this section.

18VAC85-170-170. Solicitation or remuneration in exchange for referral.

A practitioner shall not knowingly and willfully solicit or receive any remuneration, directly or indirectly, in return for referring an individual to a facility as defined in § 37.2-100 of the Code of Virginia or hospital as defined in § 32.1-123 of the Code of Virginia.

"Remuneration" means compensation, received in cash or in kind, but shall not include any payments, business arrangements, or payment practices allowed by 42 USC § 1320a-7b(b), as amended, or any regulations promulgated thereto.

18VAC85-170-180. Sexual contact.

A. For purposes of § 54.1-2915 A 12 and A 19 of the Code of Virginia and this section, sexual contact includes sexual behavior or verbal or physical behavior that:

1. May reasonably be interpreted as intended for the sexual arousal or gratification of the practitioner, the patient, or both; or

2. May reasonably be interpreted as romantic involvement with a patient regardless of whether such involvement occurs in the professional setting or outside of it.

B. Sexual contact with a patient.

1. The determination of when a person is a patient for purposes of § 54.1-2915 A 19 of the Code of Virginia is made on a case-by-case basis with consideration given to the nature, extent, and context of the professional relationship between the practitioner and the person. The fact that a person is not actively receiving treatment or professional services from a practitioner is not determinative of this issue. A person is presumed to remain a patient until the practitioner-patient relationship is terminated.

2. The consent to, initiation of, or participation in sexual behavior or involvement with a practitioner by a patient neither changes the nature of the conduct nor negates the statutory prohibition.

C. Sexual contact between a practitioner and a former patient after termination of the practitioner-patient relationship may still constitute unprofessional conduct if the sexual contact is a result of the exploitation of trust, knowledge, or influence of emotions derived from the professional relationship.

D. Sexual contact between a practitioner and a key third party shall constitute unprofessional conduct if the sexual contact is a result of the exploitation of trust, knowledge, or influence derived from the professional relationship or if the contact has had or is likely to have an adverse effect on patient care. For purposes of this section, key third party of a patient means spouse or partner, parent or child, guardian, or legal representative of the patient.

E. Sexual contact between a supervisor and a trainee shall constitute unprofessional conduct if the sexual contact is a result of the exploitation of trust, knowledge, or influence derived from the professional relationship or if the contact has had or is likely to have an adverse effect on patient care.

18VAC85-170-190. Refusal to provide information.

A practitioner shall not willfully refuse to provide information or records as requested or required by the board or its representative pursuant to an investigation or to the enforcement of a statute or regulation.

FORMS (18VAC85-170)

Continued Competency Activity and Assessment Form (undated)