OMH-04-15-00002-P Prevention of Influenza Transmission

1/28/15 N.Y. St. Reg. OMH-04-15-00002-P

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 4

January 28, 2015

RULE MAKING ACTIVITIES

OFFICE OF MENTAL HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. OMH-04-15-00002-P

Prevention of Influenza Transmission

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of Part 509 of Title 14 NYCRR.

Statutory authority:

Mental Hygiene Law, sections 7.07, 7.09 and 31.04

Subject:

Prevention of Influenza Transmission.

Purpose:

Provide clarification and flexible system for documentation.

Text of proposed rule:

1. Section 509.3 of Title 14 NYCRR is amended to read as follows:

§ 509.3 Definitions. For the purposes of this Part:

(a) Facility shall mean:

(1) a psychiatric center established pursuant to Section 7.17 of the Mental Hygiene Law; including all programs or services operated by, or under the auspices of, such psychiatric center;

(2) a hospital operated pursuant to Part 582 of this Title.

(b) Influenza season shall mean the period of time during which influenza is prevalent as determined by the Commissioner of Health.

(c) Influenza vaccine or Vaccine shall mean a vaccine currently licensed for immunization and distribution in the United States by the Food and Drug Administration (FDA) for active immunization for the prevention of influenza disease caused by influenza virus(es) or authorized for such use by the FDA pursuant to an Emergency Use Authorization (EUA) or as an Emergency Investigational New Drug (EIND).

(d) Patient shall mean any person receiving services from a facility, as defined in this section, as well as any person presenting for admission to a facility.

[(d)](e) Personnel shall mean all persons employed or affiliated with a facility, as defined in this Section, whether paid or unpaid, including but not limited to employees, members of the medical, nursing, and other treatment staff, contract staff, students, and volunteers, who engage in activities such that if they were infected with influenza, they could potentially expose patients to the disease.

2. Section 509.4 of Title 14 NYCRR is amended to read as follows:

Section 509.4 Documentation Requirements.

(a) All facilities shall determine and document which persons qualify as "personnel" under this Part.

(b) All facilities shall document the influenza vaccination status of all personnel for the current influenza season in a secure file separate from their personnel history folder. Documentation of vaccination must include [the name and address of the individual who ordered or administered the vaccine and the date of vaccination.]:

(1) a document prepared by the licensed healthcare practitioner who administered the vaccine, indicating that one dose of influenza vaccine was administered, and specifying the vaccine formulation and the date of administration; or

(2) for personnel employed by a healthcare employer other than the facility in which he or she is providing services, an attestation by the employer that the employee(s) named in the attestation has been vaccinated against influenza for the current influenza season, and that the health care employer maintains documentation of vaccination of the employee(s), as described in paragraph (1) of this subdivision; or

(3) for student personnel, an attestation by the professional school that the student(s) named in the attestation has been vaccinated against influenza for the current influenza season, and that the school maintains documentation of the vaccination of the student(s) as described in paragraph (1) of this subdivision.

(c) During the influenza season, all facilities shall ensure that all personnel who have not been vaccinated against influenza for the current influenza season wear a surgical or procedure mask while in areas where patients [may be] are typically present[. Facilities shall supply such masks to personnel, free of charge.], except that:

(1) when personnel provide services outside the facility, mask wear shall not be required by this section, provided that this paragraph shall not be interpreted as eliminating the requirement that personnel wear a mask pursuant to standard and transmission-based precautions not addressed by this section;

(2) personnel required to wear a mask by this subdivision, but who provide speech therapy services, may remove the mask when necessary to deliver care, such as when modeling speech; and

(3) for any person who lip reads, personnel required to wear a mask by this subdivision may remove the mask when necessary for communication.

(d) Upon the request of the Office, a facility must report the number and percentage of personnel that have been vaccinated against influenza for the current influenza season.

(e) All facilities shall develop and implement a policy and procedure to ensure compliance with the provisions of this Part. The policy and procedure shall include, but is not limited to, the identification of those areas where unvaccinated personnel must wear a mask pursuant to subdivision (c) of this Section.

(f) Facilities shall supply surgical or procedure masks required by this section at no cost to personnel.

(g) Nothing in this Part shall be interpreted as prohibiting any facility from adopting policies that are more stringent than the requirements of this Part.

[(f)](h) For those facilities that are required to comply with 10 NYCRR Section 2.59, compliance with such Section shall be deemed compliance with this Part.

Text of proposed rule and any required statements and analyses may be obtained from:

Sue Watson, NYS Office of Mental Health, 44 Holland Avenue, Albany, NY 12229, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

1. Statutory Authority: Section 7.07 of the Mental Hygiene Law charges the Office of Mental Health with the responsibility for seeing that persons with mental illness are provided with care and treatment, and that such care, treatment and rehabilitation is of high quality and effectiveness.

Section 7.09 of the Mental Hygiene Law gives the Commissioner of the Office of Mental Health the power and responsibility to adopt regulations that are necessary and proper to implement matters under his or her jurisdiction.

Section 31.04 of the Mental Hygiene Law grants the Commissioner of Mental Health the power and responsibility to adopt regulations to effectuate the provisions and purposes of Article 31 of such law, including procedures for the issuance and amendment of operating certificates, and for setting standards of quality and adequacy of facilities.

2. Legislative Objectives: Articles 7 and 31 of the Mental Hygiene Law reflect the Commissioner’s authority to establish regulations regarding mental health programs and charges OMH with the responsibility for ensuring that persons with mental illness receive high quality care and treatment.

3. Needs and Benefits: Part 509 of Title 14 NYCRR requires all OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and Article 31 “free standing” psychiatric hospitals to ensure that all personnel who have not been vaccinated against influenza wear a mask during the influenza season. These regulations are consistent with New York State Department of Health (DOH) regulations at 10 NYCRR Section 2.59, which require all unvaccinated personnel in certain health settings to wear surgical or procedure masks during the time when the Commissioner of Health determines that influenza is prevalent. The DOH regulations apply to general hospitals, nursing homes, diagnostic and treatment centers, certified home health agencies, long term home health care programs, acquired immune deficiency syndrome (AIDS) home care programs, licensed home care service agencies, limited licensed home care service agencies and hospices (licensed by DOH under Public Health Law, Articles 28, 36 and 40). DOH recently enacted clarifying amendments to its regulations, which codified its interpretation of 10 NYCRR Section 2.59, as published by DOH in a document entitled “Frequently Asked Questions (FAQ) Regarding Title 10 Section 2.59 “Regulations for Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel.” OMH’s proposed amendments to 14 NYCRR Part 509 mirror the DOH amendments. Specifically, the amendments clarify that the masking requirement applies in those areas where patients are “typically” present. The proposed amendments also define “influenza vaccine” to mean a vaccine approved as an influenza vaccine by the Food and Drug Administration (FDA) or pursuant to an Emergency Use Authorization (EUA) or as an Emergency Investigational New Drug (EIND). The amendments also clarify that the regulation is not intended to require mask wearing while a patient is receiving services outside the regulated facility. The final clarification amendment provides that the regulation should not be interpreted as requiring mask wear by unvaccinated personnel who provide speech therapy services, during the time that such personnel are providing care. Similarly, for any person who reads lips, unvaccinated personnel may remove the mask when necessary to communicate.

The proposed amendments to 14 NYCRR Part 509 also replicate a substantive change made by DOH to 10 NYCRR Section 2.59, i.e., they revise the documentation requirement for facilities. The intent of this change is to create a more flexible system for documenting a vaccination status, thereby easing the paperwork burden on regulated facilities. Specifically, required documentation would include only the date of vaccination and information specifying the vaccine formulation administered. Further, where the personnel of a facility includes contract staff and students, the facility may accept an attestation from the employer or school, stating that the specified persons have been vaccinated and that the employer or school maintains the required documentation.

4. Costs: (a) Costs to Local Government: These regulatory amendments will not result in any additional costs to local government.

(b) Costs to State and Regulated Parties: These regulatory amendments will not result in any additional costs to the State or regulated parties.

5. Local Government Mandates: These regulatory amendments will not result in any additional imposition of duties or responsibilities upon county, city, town, village, school or fire districts, except to the extent that the local governmental unit is a provider of services.

6. Paperwork: These amendments will not result in any increase in paperwork requirements of facilities covered by the regulations. In fact, the amendments to the documentation requirements are intended to reduce paperwork burdens.

7. Duplication: These regulatory amendments do not duplicate existing State or federal requirements. In instances where an inpatient program is required to comply with the Department of Health regulations found in 10 NYCRR Section 2.59, compliance with that section shall be deemed compliance with this Part.

8. Alternatives: As the amendments are intended to conform OMH regulations with similar DOH regulations, no alternatives were considered.

9. Federal Standards: The regulatory amendments do not exceed any minimum standards of the federal government for the same or similar subject areas.

10. Compliance Schedule: These regulatory amendments will be effective immediately upon adoption.

Regulatory Flexibility Analysis

14 NYCRR Part 509 requires all OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and Article 31 “free standing” psychiatric hospitals to ensure that all personnel who have not been vaccinated against influenza wear a mask during the influenza season. These regulations are consistent with similar New York State Department of Health (DOH) regulations at 10 NYCRR Section 2.59. DOH recently enacted clarifying amendments to its regulations, and OMH’s proposed amendments to 14 NYCRR Part 509 mirror the DOH amendments. Specifically, the amendments:

- clarify that the masking requirement applies in those areas where patients are “typically” present;

- define “influenza vaccine” to mean a vaccine approved as an influenza vaccine by the Food and Drug Administration (FDA) or pursuant to an Emergency Use Authorization (EUA) or as an Emergency Investigational New Drug (EIND);

- clarify that the regulation is not intended to require mask wearing while a patient is receiving services outside the regulated facility;

- clarify that the regulation should not be interpreted as requiring mask wear by unvaccinated personnel who provide speech therapy services, during the time that such personnel are providing care, and for any person who reads lips, unvaccinated personnel may remove the mask when necessary to communicate; and

- revise the documentation requirement to create a more flexible system for documenting a vaccination status, thereby easing the paperwork burden on regulated facilities.

As stated above, the provisions of 14 NYCRR Part 509 apply to OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and “free standing” psychiatric hospitals licensed under Article 31 of the Mental Hygiene Law. All of these hospitals employ more than 100 people; therefore, none of them qualify as a small business. As there will be no adverse economic impact on small business or local governments, a Regulatory Flexibility Analysis for Small Business and Local Governments has not been submitted with this notice.

Rural Area Flexibility Analysis

1. Description of the types and estimation of the number of rural areas in which the rule will apply: In New York State, 43 counties have a population of less than 200,000: Allegany, Cattaraugus, Cayuga, Chautauqua, Chemung, Chenango, Clinton, Columbia, Cortland, Delaware, Essex, Franklin, Fulton, Genesee, Greene, Hamilton, Herkimer, Jefferson, Lewis, Livingston, Madison, Montgomery, Ontario, Orleans, Oswego, Otsego, Putnam, Rensselaer, St. Lawrence, Schenectady, Schoharie, Schuyler, Seneca, Steuben, Sullivan, Tioga, Tompkins, Ulster, Warren, Washington, Wayne, Wyoming and Yates. Additionally, 10 counties with certain townships have a population density of 150 persons or less per square mile: Albany, Broome, Dutchess, Erie, Monroe, Niagara, Oneida, Onondaga, Orange, and Saratoga.

14 NYCRR Part 509 requires all OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and Article 31 “free standing” psychiatric hospitals to ensure that all personnel who have not been vaccinated against influenza wear a mask during the influenza season. These regulations are consistent with similar New York State Department of Health (DOH) regulations at 10 NYCRR Section 2.59. DOH recently enacted clarifying amendments to its regulations, and OMH’s proposed amendments to 14 NYCRR Part 509 mirror the DOH amendments. Specifically, the amendments:

- clarify that the masking requirement applies in those areas where patients are “typically” present;

- define “influenza vaccine” to mean a vaccine approved as an influenza vaccine by the Food and Drug Administration (FDA) or pursuant to an Emergency Use Authorization (EUA) or as an Emergency Investigational New Drug (EIND);

- clarify that the regulation is not intended to require mask wearing while a patient is receiving services outside the regulated facility;

- clarify that the regulation should not be interpreted as requiring mask wear by unvaccinated personnel who provide speech therapy services, during the time that such personnel are providing care, and for any person who reads lips, unvaccinated personnel may remove the mask when necessary to communicate; and

- revise the documentation requirement to create a more flexible system for documenting a vaccination status, thereby easing the paperwork burden on regulated facilities.

2. Reporting, recordkeeping and other compliance requirements and professional services: All facilities covered by the regulation will have to document the vaccination status of each personnel member as defined in this regulation for influenza virus; however, the amendments to Part 509 revise the documentation requirements to create a more flexible system for documenting a vaccination status, thereby easing the paperwork burden on regulated facilities. No additional professional services are required as a result of this regulation.

3. Compliance costs: These amendments do not create any new costs for small businesses or local governments. To the extent that regulated parties are located in rural areas, the revised documentation requirements are expected to ease the regulatory burden on these entities.

4. Economic and technological feasibility: This proposal is economically and technically feasible, as it does not impose any additional burdens.

5. Minimizing adverse impact: This proposal does not create any adverse effect on regulated parties that would require a minimization analysis.

6. Participation of public and private interests in rural areas: In accordance with statutory requirements, the rule will be presented to the Behavioral Health Services Advisory Council for review and recommendation at an upcoming meeting.

Job Impact Statement

A Job Impact Statement for these amendments is not being submitted with this rule making. The amendments to 14 NYCRR Part 509 provide clarification and allow for a more flexible documentation system with respect to mask wearing requirements during influenza season in all OMH-operated psychiatric centers (including all programs and services operated by, and under the auspices of, such psychiatric centers) and Article 31 “free standing” psychiatric hospitals. It is apparent from the nature and purpose of the rule that it will not have an impact on jobs and employment opportunities.