Because the Board of Regents meets at fixed intervals, the earliest the proposed amendment can be presented for regular (non-emergency) adoption, after expiration of the required 45-day public comment period provided for in State Administrative Procedure Act (SAPA) section 202(1) and (5), would be the June 12-13, 2017 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed amendment, if adopted at the June meeting, would be June 28, 2017, the date a Notice of Adoption would be published in the State Register. However, the provisions of Chapter 502 of the Laws of 2016 became effective on November 28, 2016.

Therefore, emergency action is necessary at the March 2017 Regents meeting for preservation of the public health and general welfare in order to enable the State Education Department to immediately implement Chapter 502 of the Laws of 2016, so that registered professional nurses can perform more effective screening of individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to non-patient specific orders prescribed by a licensed physician or a certified nurse practitioner in order to prevent potential complications due to these infections, which could include, but are not limited to, possible infertility and the spread of these infections to other persons.

It is anticipated that the proposed amendment will be presented for permanent adoption at the June 12-13, 2017 Regents meeting, which is the first scheduled meeting after the expiration of the 45-day public comment period prescribed in the State Administrative Procedure Act for State agency rule makings.

64.7 Administration of immunizations, emergency treatment of anaphylaxis, tuberculosis tests, human immunodeficiency virus (HIV) tests, opioid related overdose treatments, [and] hepatitis C tests and screening for syphilis, gonorrhea and/or chlamydia infections pursuant to non-patient specific orders and protocols.

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(f) . . .

(1) As used in this subdivision, screening means an assessment of an individual to ascertain his or her risk of having a syphilis, gonorrhea and/or chlamydia infection and may include the administration of one or more laboratory or point of care tests approved by the Federal Food and Drug Administration to detect or screen for syphilis, gonorrhea and/or chlamydia infections.

(2) A registered professional nurse may screen persons at increased risk for syphilis, gonorrhea and/or chlamydia pursuant to a written non-patient specific order and protocol prescribed or ordered by a licensed physician or a certified nurse practitioner, provided that the requirements of this subdivision are met.

(3) Order and protocol.

(i) The non-patient specific order shall include, at a minimum, the following:

(a) the name, license number and signature of the licensed physician or certified nurse practitioner who orders or prescribes the non-patient specific order and protocol;

(b) the name of the specific laboratory or point of care test(s) or assessment procedures to be administered;

(c) a protocol for administering the ordered screening for syphilis, gonorrhea and/or chlamydia infections or a specific reference to a separate written protocol for administering the ordered screening for syphilis, gonorrhea and/or chlamydia, which shall meet the requirements of subparagraph (ii) of this paragraph;

(d) the period of time that the order is effective, including the beginning and ending dates;

(e) a description of the group(s) of persons to be screened; and

(f) the name and license number of the registered professional nurse(s) authorized to execute the non-patient specific order and protocol to screen for syphilis, gonorrhea and/or chlamydia infections; or the name of the entity that employs or contracts with registered professional nurses to execute the non-patient specific order and protocol, provided that the registered professional nurses execute the non-patient specific order and protocol only in the course of such employment or pursuant to such contract and provided further that the entity is legally authorized to employ or contract with registered professional nurses to provide nursing services.

(ii) The written protocol, incorporated into the order prescribed in subparagraph (i) of this paragraph, shall, at a minimum, include instructions for screening for syphilis, gonorrhea and/or chlamydia infections and require the registered professional nurse(s) to ensure that:

(a) each potential recipient is assessed, pursuant to criteria in the protocol, for conditions that would qualify or preclude him or her from receiving the ordered screening tests for syphilis, gonorrhea and/or chlamydia infections;

(b) informed consent for administering the ordered screening for syphilis, gonorrhea and/or chlamydia has been obtained from the recipient pursuant to the criteria in the protocol, or when the recipient lacks capacity to consent, from a person authorized pursuant to law to consent to health care for the recipient;

(c) positive test results for syphilis, gonorrhea and/or chlamydia infections are not disclosed to the test recipient or the recipient’s authorized representative by the registered professional nurse without a patient specific order from a licensed physician, licensed physician assistant or certified nurse practitioner; and

(d) the administration of the ordered screening for syphilis, gonorrhea and/or chlamydia is documented in the recipient’s medical record in accordance with criteria in the protocol and that documentation relating to the screening for syphilis, gonorrhea and/or chlamydia is maintained in accordance with section 29.2(a)(3) of this Title.

1. STATUTORY AUTHORITY:

Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.

Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.

Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations in administering the admission to and the practice of the professions.

Paragraph (g) of subdivision (6) of section 6527 of the Education law, as added by Chapter 502 of the Laws of 2016, authorizes registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to a non-patient specific order and protocol prescribed by a licensed physician in accordance with the Regulations of the Commissioner of Education.

Subdivision (1) of section 6902 of the Education Law defines the practice of the profession of nursing for registered professional nurses.

Paragraph (g) of subdivision (4) of section 6909 of the Education Law, as added by Chapter 502 of the Laws of 2016, authorizes registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to a non-patient specific order and protocol prescribed by a certified nurse practitioner in accordance with the Regulations of the Commissioner of Education.

2. LEGISLATIVE OBJECTIVES:

The proposed rule carries out the intent of the aforementioned statutes that the Department shall supervise the regulation of the practice of the professions for the benefit of the public. The proposed rule will conform the Regulations of the Commissioner to Chapter 502 of the Laws of 2016. Paragraph (g) of subdivision (6) of section 6527 of the Education Law and paragraph (g) of subdivision (4) of section 6909 of the Education law, as added by Chapter 502 of the Laws of 2016, were enacted to protect the public health of New York State by facilitating much needed screening of individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. According to the United States Centers for Disease Control (CDC), sexually transmitted infections (STIs) such as syphilis, gonorrhea and/or chlamydia are a major public health problem throughout the United States. Because syphilis, gonorrhea and/or chlamydia infections are frequently asymptomatic, persons are often unaware that they are infected and require medical treatment. Earlier treatment prevents complications from these infections, including, but not limited to, infertility and prevents further spread of these infections. The CDC recommends screening individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections to identify and treat infected persons before they develop complications and to identify test and treat their sex partners to prevent transmission and reinfections.

3. NEEDS AND BENEFITS:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 502 of the Laws of 2016. The purpose of the proposed rule is to establish uniform requirements for registered professional nurses to meet when executing non-patient specific orders to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. Specifically, the proposed rule establishes the requirements for the type of information that must be included in the non-patient specific orders and protocols for a registered professional nurse to follow when screening individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. The proposed rule is needed to implement paragraph (g) of subdivision (6) of section 6527 of the Education Law and paragraph (g) of subdivision (4) of section 6909 of the Education Law, as added by Chapter 502 of the Laws of 2016.

4. COSTS:

(a) Costs to State government: There are no additional costs to state government.

(b) Costs to local government: There are no additional costs to local government.

(c) Cost to private regulated parties. There are no mandatory costs to private regulated parties.

(d) Cost to the regulatory agency: There are no additional costs to the Department.

5. LOCAL GOVERNMENT MANDATES:

The proposed rule does not impose any program service, duty, responsibility, or other mandate on local governments.

6. PAPERWORK:

The proposed rule does not impose any paperwork mandates because it does not require any licensed physician or certified nurse practitioner to prescribe any non-patient specific orders and protocols and does not require registered professional nurses to execute any non-patient specific orders and protocols. The proposed rule does not impose any reporting, record keeping or other requirements on licensed physicians and certified nurse practitioners unless they choose to prescribe non-patient specific orders and protocols to permit registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. If the licensed physicians and/or certified nurse practitioners choose to prescribe such non-patient specific orders and protocols, the proposed rule requires them to, inter alia, issue these orders and protocols in writing. In addition, registered professional nurses must document the screening services provided to each patient in the patient's medical records.

7. DUPLICATION:

There are no other state or federal requirements on the subject matter of the proposed rule. Therefore, the amendment does not duplicate other existing state or federal requirements, and is necessary to implement Chapter 502 of the Laws of 2016.

8. ALTERNATIVES:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 502 of the Laws of 2016. There are no significant alternatives to the proposed rule and none were considered.

9. FEDERAL STANDARDS:

Since, there are no applicable federal standards for authorizing registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to a non-patient specific order prescribed by a licensed physician or a certified nurse practitioner, the proposed rule does not exceed any minimum federal standards for the same or similar subject areas.

10. COMPLIANCE SCHEDULE:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 502 of the Laws of 2016. Consistent with the statute, licensed physicians or certified nurse practitioners may, but are not required to, prescribe non-patient specific orders and protocols. Likewise, the rule authorizes, but does not require, registered professional nurses to execute non-patient specific orders and protocols. It is anticipated that the regulated parties, licensed physicians and certified nurse practitioners, who choose to issue these non-patient specific orders and the registered nurses, who choose to execute such orders, will be able to comply with the proposed amendments by the effective.

The purpose of the proposed rule is to conform the Commissioner’s Regulations to Chapter 502 of the Laws of 2016, which authorizes registered professional nurses to execute non-patient specific orders prescribed by a licensed physician or certified nurse practitioner to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. The proposed rule establishes requirements for the non-patient specific orders and the types of information that must be set forth in the written protocols for the registered professional nurse to follow when screening individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. The proposed rule neither requires licensed physicians or certified nurse practitioners to issue non-patient specific orders to authorize registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections nor does it require registered professional nurses to perform such screening pursuant to such orders.

The proposed rule will not impose any new reporting, recordkeeping, or other compliance requirements or costs, or have any adverse economic impact on small businesses or local governments. Because it is evident from the nature of the proposed rule that it will not adversely affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required, and one has not been prepared.

1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:

The proposed rule applies to all New York State registered professional nurses who screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to non-patient specific orders issued by licensed physicians or certified nurse practitioners, including those who are located in the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the approximately 290,000 registered professional nurses who are registered to practice in New York State, approximately 31,000 reported that their permanent address of record is in a rural county of New York State.

The proposed rule applies to all New York State certified nurse practitioners who issue non-patient specific orders and protocols to authorize registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections, including nurse practitioners who are located in the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the approximately 22,000 certified nurse practitioners who are registered to practice in New York State, approximately 2,800 reported that their permanent address of record is in a rural county of New York State.

Additionally, the proposed rule applies to all New York State licensed physicians who issue non-patient specific orders and protocols to authorize registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections, including physicians who are located in the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the approximately 94,000 licensed physicians who are registered to practice in New York State, approximately 2,600 reported that their permanent address of record is in a rural county of New York State.

2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:

The proposed rule adds subdivision (g) to section 64.7 of the Regulations of the Commissioner of Education, which implements Chapter 502 of the Laws of 2016. This law became effective on November 28, 2016. It authorizes registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea or chlamydia infections pursuant to a non-patient specific order and protocol prescribed by a licensed physician or certified nurse practitioner.

The proposed rule authorizes, but does not require, any certified nurse practitioner or licensed physician to prescribe non-patient specific orders and protocols. In addition, the rule authorizes, but does not require, registered professional nurses to execute non-patient specific orders to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. The proposed rule does not impose any reporting, record keeping, other compliance requirements, or professional services requirements on health care providers in rural areas unless a licensed physician or certified nurse practitioner issues a non-patient specific order and protocol for registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. In such cases, the proposed rule requires the licensed physician or certified nurse practitioner to issue the non-patient specific orders and protocols in writing. In addition, registered professional nurses must document in the patient’s medical records that they performed the ordered screening services.

3. COSTS:

The proposed rule will not impose any additional costs on any licensed physician, certified nurse practitioner, registered professional nurse or other party. Neither paragraph (g) of subdivision (4) of section 6909 nor paragraph (g) of subdivision (6) of section 6527 of the Education Law impose any obligations on licensed physicians or certified nurse practitioners to issue non-patient specific orders and protocols to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections.

4. MINIMIZING ADVERSE IMPACT:

The proposed rule is necessary to conform the Commissioner’s Regulations with Education Law sections 6527 and 6909 as amended by Chapter 502 of the Laws of 2016 relating to the execution by registered professional nurses of non-patient specific orders to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. These statutory provisions do not make exceptions for individuals who live or work in rural areas. Thus, the Department has determined that the proposed rule's requirements shall apply to all physicians, certified nurse practitioners and registered professional nurses in New York State. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.

5. RURAL AREA PARTICIPATION:

Comments on the proposed rule were solicited from statewide organizations representing all parties having an interest in the practice of licensed physicians, certified nurse practitioners, and registered professional nurses. These organizations included the New York State Department of Health, the State Board for Nursing and professional associations representing the nursing and medical professions. These groups have members who live or work in rural areas.

6. INITIAL REVIEW OF RULE (SAPA § 207):

Pursuant to State Administrative Procedure Act section 207(1)(b), the Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed rule is necessary to implement the statutory provisions of Chapter 502 of the Laws of 2016 and, therefore, the substantive provisions of the proposed rule cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 16 of the Notice of Emergency Adoption and Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.

The proposed rule conforms the Commissioner’s Regulations to Chapter 502 of the Laws of 2016, which authorizes registered professional nurses to execute non-patient specific orders to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections. The proposed rule establishes criteria for registered professional nurses to follow when screening individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections pursuant to non-patient specific orders and protocols prescribed by a licensed physician or certified nurse practitioner.

The proposed rule implements specific statutory provisions. The proposed rule neither requires licensed physicians or certified nurse practitioners to issue non-patient specific orders to authorize registered professional nurses to screen individuals at increased risk of syphilis, gonorrhea and/or chlamydia infections nor does it require registered professional nurses to perform such screening pursuant to such orders. The proposed rule will not have a substantial adverse impact on jobs and employment opportunities. Because it is evident from the nature of the proposed rule, which implements specific statutory provisions, that it will not affect job and employment opportunities or only have a positive impact, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one was not prepared.