Title of Regulation: 18VAC105-20. Regulations Governing the Practice of Optometry (amending 18VAC105-20-40, 18VAC105-20-45).

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

Public Hearing Information:

July 22, 2009 - 9 a.m. - Department of Health Professions, 9960 Mayland Drive, 2nd Floor, Richmond, VA

Public Comments: Public comments may be submitted until 5 p.m. on August 7, 2009.

Agency Contact: Elizabeth A. Carter, Ph.D., Executive Director, Board of Optometry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4426, FAX (804) 527-4466, or email elizabeth.carter@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Optometry the authority to promulgate regulations to administer the regulatory system.

Section 54.1-3215 of the Code of Virginia establishes grounds for disciplinary actions by the Board of Optometry against its licensees. Regulations on standards of conduct expand and clarify the statutory provisions.

Purpose: In its proposed regulatory action, the board clarifies and amends certain provisions of the section on unprofessional conduct to address issues and licensee conduct that have been problematic. The board added language relating to retention and destruction of patient records, disclosure of disciplinary actions in other states or malpractice judgments or settlements, prescribing and treating self or family members, practicing with an expired license or registration, sexual misconduct and other areas of practitioner conduct. Provisions are set out in regulation to ensure that the board has the necessary authority to protect the public health and safety from unprofessional conduct or substandard care.

Substance: The board reviewed unprofessional conduct regulations of other boards within the Virginia Department of Health Professions and the optometry regulations of other states. The following changes were made in the standards of conduct:

1. Adding language relating to treating self and family;

2. Adding language on record retention and a requirement to post or inform patients of patient record retention and destruction policies;

3. Adding a prohibition against failure to disclose disciplinary action in another state and malpractice cases;

4. Renaming of the section on Unprofessional Conduct to Standards of Conduct;

5. Including violation of Drug Control Act in the standards of conduct;

6. Requiring provisions for access to the practice for 24-hour patient care coverage;

7. Referencing § 54.1-2405 (transfer of patient records, closure or sale of practice).

8. Including language regarding the practice on an expired or unregistered professional designation.

9. Including provisions for boundary violation or sexual misconduct as grounds for disciplinary action.

10. Including compliance with general provisions of law and law relating to controlled substances and patient confidentiality.

11. Revising and updating requirements for content of a patient record for consistency with current practice and federal rules.

Issues: The advantage to the public may be that optometrists will become more aware of their professional responsibilities and compliance with state and federal law relating to provision of prescriptions, maintenance of records, protection of patient confidentiality and continuity of care.

Amended regulations will require that patients are informed about how long an optometrist will keep records, so a request for a patient record can be made and responded to in a timely manner. There are no disadvantages to the public.

There are no disadvantages to the agency or the Commonwealth. Clarification of the board’s intent and policies relating to professional conduct and standards of practice will enhance public protection.

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

Summary of the Proposed Amendments to Regulation. The Board of Optometry (Board) proposes several amendments to the regulations concerning standards of conduct. Most of the proposed changes are clarifications. Additionally the Board proposes to: 1) add language describing what types of relationships with clients constitutes grounds for disciplinary action and 2) explicitly require that optometrists ensure their "access to the practice location during hours in which the practice is closed in order to be able to properly evaluate and treat a patient in an emergency."

Result of Analysis. The benefits likely exceed the costs for one or more proposed changes.

Estimated Economic Impact. The current regulations do not address unprofessional relationships between optometrist and patient. The Board proposes to add the following to a list of standards of conduct for which practitioners may be subject to discipline for violating:

Not enter into a relationship with a patient that constitutes a professional boundary violation in which the practitioner uses his professional position to take advantage of the vulnerability of a patient or his family, to include but not limited to actions that result in personal gain at the expense of the patient, a nontherapeutic personal involvement or sexual conduct with a patient. The determination of when a person is a patient 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. The consent to, initiation of, or participation in sexual behavior or involvement with a practitioner by a patient does not change the nature of the conduct nor negate the prohibition.

It does seem prudent to include not taking advantage of patients to the list of standards of conduct for the profession. The Board having the ability to deny, suspend or revoke the license to practice of optometrists who harm their patients would seem to be one of the primary arguments in favor of requiring licensure for the profession. Thus, this proposed new language should provide benefit for the public.

The Board proposes to require that optometrists ensure their "access to the practice location during hours in which the practice is closed in order to be able to properly evaluate and treat a patient in an emergency." According to the Department of Health Professions, this proposed language is intended to address problems that have arisen when an optometrist practice is located in conjunction with a mall, big box store or other entity; the optometrist needs to ensure access to his records and practice location in case of a patient emergency after hours.

Having this language in the regulation may help optometrists to convince owners or managers of relevant malls, etc., that they do truly need access to their office through a key or other means in off hours. On the other hand, this requirement may effectively reduce potential office location possibilities, which in turn could raise costs for some optometrists who would have preferred to locate in such facilities. Given that there likely are some relatively infrequent instances where having access to records off hours can make a significant difference in health outcomes for a small number of patients, the cumulative benefit for these improved health outcomes likely exceed the cost of some instances where location choices are slightly reduced.

Businesses and Entities Affected. There are 1436 licensed optometrists¹ and 470 offices of optometrists² in Virginia who would be affected by these amendments. All 470 offices of optometrists qualify as small businesses.

Localities Particularly Affected. The proposals do not disproportionately affect specific localities.

Projected Impact on Employment. The proposed amendments are not anticipated to have any significant impact on employment.

Effects on the Use and Value of Private Property. The proposal to require that optometrists ensure their "access to the practice location during hours in which the practice is closed in order to be able to properly evaluate and treat a patient in an emergency" may in a small number of incidences effectively reduce potential office location possibilities, which in turn could raise costs for some optometrists who would have preferred to locate in such facilities.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect costs for most small businesses. The proposal to require that optometrists ensure their "access to the practice location during hours in which the practice is closed in order to be able to properly evaluate and treat a patient in an emergency" may in a small number of incidences effectively reduce potential office location possibilities, which in turn could raise costs for some optometrists who would have preferred to locate in such facilities.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both achieve intended policy goals and reduce adverse impact.

Real Estate Development Costs. The proposed amendments do not create additional costs related to the development of real estate for commercial or residential purposes.

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, § 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.

________________________

¹Source: Department of Health Professions

²Source: Virginia Employment Commission

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Optometry concurs with the analysis of the Department of Planning and Budget on proposed regulations for 18VAC105-20, Regulations Governing the Practice of Optometry, relating to standards of professional conduct.

Summary:

The proposed amendments to the board's standards of conduct and standards of practice provide authority to address unprofessional actions or substandard patient care by optometrists. The amendments specify policy on patient records, continuity of care, prescribing for self or family, boundary violations, and compliance with law and regulations. The standard for content of a record during an eye examination is updated and clarified, and the specific requirements of federal rule for contact lens and eyeglass prescriptions are referenced.

18VAC105-20-40. Unprofessional Standards of conduct.

It shall be deemed unprofessional conduct for any licensed optometrist in the Commonwealth to violate any statute or regulation governing the practice of optometry or to fail to The board has the authority to deny, suspend, revoke or otherwise discipline a licensee for a violation of the following standards of conduct. A licensed optometrist shall:

1. Use in connection with the optometrist's name wherever it appears relating to the practice of optometry one of the following: the word "optometrist," the abbreviation "O.D.," or the words "doctor of optometry."

2. Maintain records on each patient for not less than five years from the date of the most recent service rendered Disclose to the board any disciplinary action taken by a regulatory body in another jurisdiction.

3. Post in an area of the optometric office which is conspicuous to the public, a chart or directory listing the names of all optometrists practicing at that particular location.

4. Maintain patient records, perform procedures or make recommendations during any eye examination, contact lens examination or treatment as necessary to protect the health and welfare of the patient and consistent with requirements of 18VAC105-20-45.

5. Notify patients in the event the practice is to be terminated or relocated, giving a reasonable time period within which the patient or an authorized representative can request in writing that the records or copies be sent to any other like-regulated provider of the patient's choice or destroyed in compliance with requirements of § 54.1-2405 of the Code of Virginia on the transfer of patient records in conjunction with closure, sale, or relocation of practice.

6. Ensure his access to the practice location during hours in which the practice is closed in order to be able to properly evaluate and treat a patient in an emergency.

7. Provide for continuity of care in the event of an absence from the practice or, in the event the optometrist chooses to terminate the practitioner-patient relationship or make his services unavailable, document notice to the patient that allows for a reasonable time to obtain the services of another practitioner.

8. Comply with the provisions of § 32.1-127.1:03 of the Code of Virginia related to the confidentiality and disclosure of patient records and related to the provision of patient records to another practitioner or to the patient or his personal representative.

9. Treat or prescribe based on a bona fide practitioner-patient relationship consistent with criteria set forth in § 54.1-3303 of the Code of Virginia. A licensee shall not prescribe a controlled substance to himself or a family member other than Schedule VI as defined in § 54.1-3455 of the Code of Virginia. When treating or prescribing for self or family, the practitioner shall maintain a patient record documenting compliance with statutory criteria for a bona fide practitioner-patient relationship.

10. Comply with provisions of statute or regulation, state or federal, relating to the diversion, distribution, dispensing, prescribing or administration of controlled substances as defined in § 54.1-3401 of the Code of Virginia.

11. Not enter into a relationship with a patient that constitutes a professional boundary violation in which the practitioner uses his professional position to take advantage of the vulnerability of a patient or his family to include, but not limited to, actions that result in personal gain at the expense of the patient, a nontherapeutic personal involvement, or sexual conduct with a patient. The determination of when a person is a patient 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. The consent to, initiation of, or participation in sexual behavior or involvement with a practitioner by a patient does not change the nature of the conduct nor negate the prohibition.

12. Cooperate with the board or its representatives in providing information or records as requested or required pursuant to an investigation or the enforcement of a statute or regulation.

13. Not practice with an expired or unregistered professional designation.

14. Not violate or cooperate with others in violating any of the provisions of Chapters 1 (§ 54.1-100 et seq.), 24 (§ 54.1-2400 et seq.) or 32 (§ 54.1-3200 et seq.) of Title 54.1 of the Code of Virginia or regulations of the board.

18VAC105-20-45. Standards of practice.

A. A complete record of all examinations made of a patient shall include a diagnosis and any treatment and shall also include but not be limited to An optometrist shall legibly document in a patient record the following:

1. During a comprehensive routine or medical eye examination:

a. Case An adequate case history, including the patient's chief complaint;

b. Acuity measure The performance of appropriate testing;

c. Internal health evaluation The establishment of an assessment or diagnosis; and

d. External health evaluation; and

e. Recommendations and directions to the patients, including prescriptions d. A recommendation for an appropriate treatment or management plan, including any necessary follow up.

2. During an initial contact lens examination:

a. The requirements of a comprehensive routine or medical eye examination as prescribed in subdivision 1 of this subsection;

b. Assessment of corneal curvature;

c. Assessment of corneal/contact lens relationship Evaluation of contact lens fitting;

d. Acuity through the lens; and

e. Directions for the wear, care, and handling of lenses and an explanation of the implications of contact lenses with regard to eye health and vision.

3. During a follow-up contact lens examination:

a. Assessment Evaluation of corneal/contact contact lens relationship fitting and anterior segment health;

b. Acuity through the lens; and

c. Such further instructions as in subdivision 2 of this subsection, as necessary for the individual patient.

4. In addition, the record of any examination shall include the signature of the attending optometrist and, if indicated, refraction of the patient.

B. The following information shall appear on a prescription for ophthalmic goods:

1. The printed name of the prescribing optometrist;

2. The address and telephone number at which the patient's records are maintained and the optometrist can be reached for consultation;

3. The name of the patient;

4. The signature of the optometrist;

5. The date of the examination and an expiration date, if medically appropriate; and

6. Any special instructions.

C. Sufficient information for complete and accurate filling of an established contact lens prescription shall include but not be limited to the power, the material or manufacturer or both, the base curve or appropriate designation, the diameter when appropriate, and medically appropriate expiration date An optometrist shall provide a patient with a copy of the patient's contact lens prescription in accordance with the Federal Trade Commission Contact Lens Rule (16 CFR Part 315).

D. A licensed optometrist shall provide a written prescription for spectacle lenses upon the request of the patient once all fees have been paid. In addition, he shall provide a written prescription for contact lenses upon the request of the patient once all fees have been paid and the prescription has been established and the follow-up care completed. Follow-up care will be presumed to have been completed if no reappointment is recommended within 60 days after the last visit in accordance with the Federal Trade Commission Eyeglass Rule (16 CFR Part 456).

E. Practitioners shall maintain a patient record for a minimum of five years following the last patient encounter with the following exceptions:

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

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

F. From (one year after the effective date of this regulation), practitioners shall post information or in some manner inform all patients concerning the time frame for record retention and destruction. Patient records shall only be destroyed in a manner that protects patient confidentiality.