OMH-08-14-00014-E Prevention of Influenza Transmission
3/19/14 N.Y. St. Reg. OMH-08-14-00014-E
NEW YORK STATE REGISTER
VOLUME XXXVI, ISSUE 11
March 19, 2014
RULE MAKING ACTIVITIES
OFFICE OF MENTAL HEALTH
EMERGENCY RULE MAKING
I.D No. OMH-08-14-00014-E
Filing No. 162
Filing Date. Feb. 28, 2014
Effective Date. Feb. 28, 2014
Prevention of Influenza Transmission
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Addition of Part 509 to Title 14 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 7.07, 7.09 and 31.04
Finding of necessity for emergency rule:
Preservation of public health, public safety and general welfare.
Specific reasons underlying the finding of necessity:
The immediate adoption of these amendments is necessary for the preservation of the health, safety, and welfare of individuals receiving services in OMH-operated psychiatric centers and freestanding psychiatric hospitals licensed under Article 31 of the Mental Hygiene Law.
Influenza is an unpredictable disease that can cause serious illnesses, death, and healthcare disruption during any given year. Recent influenza seasons in New York State have been worse than those experienced a decade ago. In response to this increased public health threat, New York must take active steps to prevent and control transmission of seasonal influenza. The seriousness of the continuing influenza threat and the failure of the health care system to achieve acceptable vaccination rates through voluntary programs necessitate further action.
Although masks are not as effective as vaccination, evidence indicates that wearing a surgical or procedure mask will lessen transmission of influenza from patients experiencing respiratory symptoms. It is also known that persons incubating influenza may shed the influenza virus before they have noticeable symptoms of influenza. The Centers for Disease Control and Prevention (CDC) recommends that patients who may have an infectious respiratory illness wear a mask when not in isolation and that healthcare personnel wear a mask when in close contact with symptomatic patients. Further, the Infectious Disease Society of America recommends that healthcare personnel who are not vaccinated for influenza wear masks. Recently, the New York State Department of Health adopted regulations at 10 NYCRR Section 2.59 to 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.
It is critical for the Office of Mental Health to join in a statewide effort to reduce the morbidity and mortality of influenza, by combining efforts and pursuing a common path of prevention and intervention. Therefore, OMH is adopting on an emergency basis this rule to require that, during the influenza season, all OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and “free standing” Article 31 psychiatric hospitals 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 present. Facilities shall supply such masks to personnel, free of charge.
For the health and safety of patients in OMH-operated psychiatric hospitals and Article 31 licensed freestanding psychiatric facilities, this rule is being adopted on an emergency basis until such time as it has been formally adopted through the SAPA rule promulgation process.
Subject:
Prevention of Influenza Transmission.
Purpose:
Require unvaccinated personnel to wear surgical masks in certain OMH-licensed or operated psychiatric centers during flu season.
Text of emergency rule:
A new Part 509 is added to Title 14 NCYRR as follows:
PART 509
PREVENTION OF INFLUENZA TRANSMISSION
§ 509.1 Background and Intent.
(a) Influenza is an unpredictable disease that can cause serious illnesses, death, and healthcare disruption during any given year. Recent influenza seasons in New York State have been worse than those experienced a decade ago.
(b) In response to this increased public health threat, New York must take active steps to prevent and control transmission of seasonal influenza. The seriousness of the continuing influenza threat and the failure of the health care system to achieve acceptable vaccination rates through voluntary programs necessitate further action.
(c) Although masks are not as effective as vaccination, evidence indicates that wearing a surgical or procedure mask will lessen transmission of influenza from patients experiencing respiratory symptoms. It is also known that persons incubating influenza may shed the influenza virus before they have noticeable symptoms of influenza. The Centers for Disease Control and Prevention (CDC) recommends that patients who may have an infectious respiratory illness wear a mask when not in isolation and that healthcare personnel wear a mask when in close contact with symptomatic patients. Further, the Infectious Disease Society of America recommends that healthcare personnel who are not vaccinated for influenza wear masks.
(d) Recently, the New York State Department of Health (DOH)adopted regulations at 10 NYCRR Section 2.59 to 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. Specifically, 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).
(e) It is critical for the Office of Mental Health to join in a statewide effort to reduce the morbidity and mortality of influenza, by combining efforts and pursuing a common path of prevention and intervention.
§ 509.2 Legal Base.
(a) 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.
(b) 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.
(c) 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.
§ 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) 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.
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.
(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 present. Facilities shall supply such masks to personnel, free of charge.
(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) 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.
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. OMH-08-14-00014-P, Issue of February 26, 2014. The emergency rule will expire April 28, 2014.
Text of rule and any required statements and analyses may be obtained from:
Sue Watson, NYS Office of Mental Health, 44 Holland Avenue, Albany, NY 12229, (518) 474-1331, email: Sue.Watson@omh.ny.gov
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. The proposed rule creates a new 14 NYCRR Part 509 to establish provisions designed to reduce the transmission of the influenza virus in inpatient psychiatric facilities operated or licensed by OMH. This rule furthers the legislative policy of providing high quality services to individuals with mental illness in a safe and secure environment.
3. Needs and benefits: Influenza is an unpredictable disease that can cause serious illnesses, death, and healthcare disruption during any given year. Recent influenza seasons in New York State were worse than experienced in a decade, and serve as a reminder that influenza could have this devastating effect in any year. In response to this increased public health threat, New York must take active steps to prevent and control transmission of seasonal influenza. The seriousness of the continuing influenza threat and the failure of the health care system to achieve acceptable vaccination rates through voluntary programs necessitate further action.
The new 14 NYCRR Part 509 establishes provisions whereby 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 shall ensure that, during the influenza season, 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 present. Such masks shall be provided free of charge to personnel. Although masks are not as effective as vaccination, evidence indicates that wearing a surgical or procedure mask will lessen transmission of influenza from patients experiencing respiratory symptoms. It is also known that persons incubating influenza may shed the influenza virus before they have noticeable symptoms of influenza. The Centers for Disease Control and Prevention (CDC) recommends that patients who may have an infectious respiratory illness wear a mask when not in isolation and that healthcare personnel wear a mask when in close contact with symptomatic patients. Further, the Infectious Disease Society of America recommends that healthcare personnel who are not vaccinated for influenza wear masks.
Recently, the New York State Department of Health adopted regulations at 10 NYCRR Section 2.59 to 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. Specifically, 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).
It is critical for the Office of Mental Health to join in a statewide effort to reduce the morbidity and mortality of influenza, by combining efforts and pursuing a common path of prevention and intervention. On December 2, 2013, the Office of Mental Health issued an influenza health alert for all OMH-operated psychiatric centers and “free standing” licensed Article 31 psychiatric hospitals.
4. (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: Although it is impossible to quantify the exact cost of providing surgical or procedure masks for those personnel who have not been vaccinated, it is anticipated that this cost will not be significant. The Department of Health estimates that on average, the price of a surgical or procedure mask varies between approximately 10 to 25 cents per mask, subject to the quantity ordered. This is a modest investment to protect the health and safety of patients and personnel, especially when compared to both the direct medical costs and indirect costs of personnel absenteeism, including personnel working less effectively or being unable to work. Therefore, the minimal cost of surgical or procedure masks is expected to be offset by the savings reflected in a reduction of influenza in personnel and the loss of productivity and available staff.
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: This rule will result in a minor increase in the paperwork requirements of all facilities covered by the regulation as they will have to determine and document which persons qualify as personnel under the new Part 509. Facilities must document the influenza vaccination status of all personnel for the current influenza season in a secure file separate from an individual’s personnel history folder. Upon request of OMH, facilities must report the number and percentage of personnel that have been vaccinated against influenza for the current influenza season. Facilities must develop and implement a policy and procedure to ensure compliance with the provisions of this Part.
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: One alternative to requiring a surgical or procedure mask for unvaccinated personnel would be to require all personnel to be vaccinated for influenza. While OMH strongly encourages all personnel be vaccinated, requiring unvaccinated staff to wear a surgical or procedure mask is the most effective and least burdensome way to immediately reduce the potential for transmission of influenza at this time. The only other alternative that was considered was inaction, but because of the seriousness of the influenza threat and the failure of the health care system to achieve acceptable vaccination rates through voluntary programs, that alternative was necessarily rejected.
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
The provisions of the new 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. The proposed rule creating a new 14 NYCRR Part 509 establishes provisions designed to reduce the transmission of the influenza virus by ensuring that, during the influenza season, 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 present. Costs to regulated parties are expected to be minimal and offset by the savings reflected in the reduction of influenza in personnel. 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.
The rule establishes provisions designed to reduce the transmission of the influenza virus in OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and “free standing” Article 31 psychiatric hospitals by ensuring that, during the influenza season, 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 present. Costs to regulated parties are expected to be minimal and offset by the savings reflected in the reduction of influenza in personnel. The geographic location of any given program (urban or rural) will not be a contributing factor to any additional costs to providers.
2. Reporting, recordkeeping and other compliance requirements and professional services: All facilities covered by the regulation will have to determine and document which persons qualify as personnel under the new Part 509. In addition, facilities must document the influenza vaccination status of all personnel for the current influenza season in a secure file separate from their personnel history folder. At the request of OMH, facilities must report the number and percentage of personnel that have been vaccinated against influenza for the current flu season. Facilities must develop and implement a policy and procedure to ensure compliance with the provisions of this Part. No additional professional services are required as a result of this regulation.
3. Compliance costs: There will be modest costs to providers, regardless of their geographic location, as a result of this regulation. The exact costs, while impossible to quantify, are not expected to be significant. The Department of Health has estimated that on average, the price of a surgical or procedure mask varies between approximately 10 to 25 cents per mask, subject to the quantity ordered. These costs are expected to be offset by the savings reflected in the reduction of influenza in personnel and the loss of productivity and available staff.
4. Minimizing adverse impact: The regulations could have required all personnel be vaccinated for influenza; however, OMH believes it to be less burdensome to require the use of surgical or procedure masks for personnel who have not been vaccinated. The requirement to wear a surgical mask does not impose any physical limitations on the individual wearing the mask, as it would if the regulation required the use of a respirator, which would provide a higher level of protection. In addition, the requirement that personnel who have not been vaccinated wear a mask is only in effect during influenza season as determined by the Commissioner of Health.
5. Participation of public and private interests in rural areas: OMH has released a health advisory notifying OMH-operated psychiatric centers and free standing Article 31 psychiatric hospitals that the agency is promulgating a regulation establishing provisions designed to reduce the transmission of the influenza virus. The health advisory was shared with union representatives. In accordance with statutory requirements, the rule was presented to the Behavioral Health Services Advisory Council for review and recommendation at their meeting on December 13, 2013. The Council voted to approve the proposal.
Job Impact Statement
A Job Impact Statement for these amendments is not being submitted with this rule making. The new 14 NYCRR Part 509 is being created to establish provisions designed to reduce the transmission of the influenza virus in OMH-operated psychiatric centers (including all programs and services operated by, or under the auspices of such psychiatric centers) and “free standing” Article 31 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.
