HLT-30-14-00016-A Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel

11/19/14 N.Y. St. Reg. HLT-30-14-00016-A

NEW YORK STATE REGISTER

VOLUME XXXVI, ISSUE 46

November 19, 2014

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

NOTICE OF ADOPTION

 

I.D No. HLT-30-14-00016-A

Filing No. 929

Filing Date. Nov. 04, 2014

Effective Date. Nov. 19, 2014

Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel

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

Action taken:

Amendment of section 2.59 of Title 10 NYCRR.

Statutory authority:

Public Health Law, sections 225, 2800, 2803, 3612 and 4010

Subject:

Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel.

Purpose:

To clarify regulatory amendments and implement more flexible reporting provisions.

Text or summary was published

in the July 30, 2014 issue of the Register, I.D. No. HLT-30-14-00016-P.

Final rule as compared with last published rule:

No changes.

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

Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Assessment of Public Comment

The Department received 8 public comments. Four were from home care agencies and associated organizations: VIP Health Care Services, PHI New York, Home Care Association of New York State, and New York State Association of Health Care Providers. One was from District Council 37, American Federation of State, County & Municipal Employees, AFL-CIO, and one was from the New York State Association of County Health Officials. One was from a local health department employee, and one was from an administrative assistant at an academic medical center. In general, all commenters support the amendments, although some expressed concerns about provisions in the original regulation that remain unchanged or suggested additional changes. Given the small number of comments received, each is summarized below with a response.

One commenter stated that although “the rule is just one more regulation to adhere to”, it has merits and positive impact. The commenter supports the change in documentation that no longer requires the name and address of the person ordering or administering the vaccine. The commenter questions why the vaccine formulation is included among the new documentation requirements and questions whether an attestation stating that the individual received the vaccine and the date of vaccine would suffice. Additionally, the commenter requests clarification on the mechanism for employers to attest to the immunization status of their employees, and questions whether the employer should be required to pay for masks for employees who refuse vaccine.

Response: Vaccine formulation is a standard part of immunization documentation. Inclusion of the formulation (e.g., brand name, generic name, or other generally accepted designation such as “LAIV” or “IIV”) will bring the documentation requirements for this regulation in line with documentation requirements for other vaccines. Asking healthcare providers only to give an attestation for this regulation would not relieve them of the need to appropriately document receipt of the vaccine, including formulation.

Regarding the attestation of the immunization status of their employees, this amendment relieves the burden placed on regulated entities, especially those that involve contract staff.

Finally, the requirement that covered entities pay for masks for personnel who refuse vaccine is not new. 10 NYCRR 2.59 currently requires healthcare and residential facilities and agencies to supply such masks to personnel, free of charge. It is standard procedure for healthcare facilities to provide appropriate personal protective equipment.

One commenter writes “in support of the proposed amendments to the regulations pertaining to the prevention of influenza transmission by healthcare and residential facility and agency personnel.” The commenter further states that “the proposed changes will ease the regulatory burden on the agencies while still serving the intended purpose of the regulation”.

Response: The Department agrees that these amendments will lessen the burden on covered entities while maintaining the important functions of the regulation.

One commenter “supports the July 30th proposed changes” while noting concerns over provisions in the original regulation that have not been revised and suggesting additional changes. Regarding documentation of vaccination, the commenter states that the new language eases documentation burden but urges “continued effort” in this regard. Specifically, the commenter suggested changes to reduce “duplicative and excessive reporting”. This commenter described challenges ensuring compliance with the regulation in the home care setting and “urge[d] the Department to be cognizant of the realistic challenges faced by home care agencies when judging agency efforts to ensure compliance with this mandate.” The commenter questioned the suitability of mask wear in the home care setting, but focused on provisions in the original regulation rather than the proposed amendments. The commenter noted the provision that covered facilities and agencies must supply masks to unvaccinated personnel free of charge to the personnel and suggested that agencies be compensated for the costs of doing so.

Response: The Department agrees that these proposed amendments will ease administrative burden and continues to monitor implementation.

Regarding the commenter’s suggestion about eliminating duplicative reporting (where one healthcare worker is reported more than once if working for more than one covered agency or facility), reporting is intended to focus on the vaccination statistics for the facility or agency, rather than individual healthcare workers. Because the focus of reporting is on vaccination coverage at facilities or agencies, it is appropriate to include healthcare workers who work at more than one facility or agency in each report.

The Department recognizes the challenges of ensuring compliance with mask wear in the home care setting and suggests that methods similar to those used to monitor compliance with other infection control practices (e.g., hand hygiene) should be used.

As noted above, the requirement that covered entities pay for masks for personnel who refuse vaccine is not new, and it is standard procedure for healthcare facilities to provide all appropriate personal protective equipment.

One commenter expressed opposition to the regulation, while supporting the proposed amendments as improvements. Specifically, the commenter stated that the proposals allowing for removal of masks when outside the home in the community, during speech therapy, or when communicating with persons who lip read are “critical clarifications”. The commenter also described the previous reporting requirements in the original regulation as “daunting” and “burdensome” and supports the change to allow for attestations from contract employers regarding vaccination status. The commenter also supports the change to remove the documentation requirement of name and address of the person who ordered or administered the vaccine, noting that it “posed particular challenges” to providers. Despite overall support for the proposed amendments, the commenter expressed continued concern about the appropriateness of the regulation in the home care setting and stated that home care consumers should decide whether masks are worn. Finally, the commenter opposed including healthcare workers as part of the report from each facility or agency where they work.

Response: While understanding the commenter’s concerns about the home care setting, the Department continues to believe that home care consumers deserve the same protection from influenza as patients in other healthcare settings. A provision to relax the mask wear requirement in homes could easily be misused, especially with vulnerable patients and/or providers who prefer not to wear masks.

The Department has put considerable thought and effort into the reporting procedures. The Department believes that the current system appropriately focuses on the proportion of vaccinated personnel providing services to a facility or agency. Specifically, attempting to identify personnel who work for multiple facilities or agencies would be burdensome to facilities, agencies, and the Department. Some healthcare workers are employed by one agency but contracted to other agencies or facilities and, furthermore, some healthcare workers are directly employed by multiple agencies or facilities.

One commenter expresses opposition to the regulation itself and suggests “a more comprehensive approach to infection control.” The commenter suggests additional amendments requiring employers to provide different types of masks for personnel who have difficulty wearing one style. The commenter objects to the language allowing employers to adopt more stringent policies than are contained within the regulation. The commenter states that the amendments that provide additional guidance on where masks must be worn and provide exemptions for care outside of homes or facilities, speech therapists, and personnel communicating with individuals who lip read are “generally beneficial”, while noting that the proposed language might be open to interpretation. The commenter notes use of different terminology (“influenza vaccine” vs. “vaccine”) and suggests that this could create misinterpretation. The commenter notes that the process for requesting consent for vaccination records and de-identifying employee health information before it is sent is not described, and notes that some facilities use stickers on badges to denote vaccination status. The commenter states that there is continued confusion about which personnel are covered, and the question of who might expose patients is left open to interpretation. Finally, the commenter states that the start and end of the “flu season” is confusing and suggests amendments to directly notify workers.

Response: Regarding the concern about employers providing different types of masks, employers are expected to provide appropriate personal protective equipment (PPE).

Although not explicitly stated in the original regulation, facilities and agencies have always been allowed to implement more stringent policies than those embodied in this regulation. Therefore, this is not a substantive change. The regulation was merely clarified in this regard.

The Department does not expect use of the terms “influenza vaccine” and “vaccine” to cause confusion in the context of this regulation.

Regarding the commenter’s concerns about consent for transmission of vaccination records, nothing in this regulation or the amendments changes current consent procedures. It would not be appropriate to attempt to duplicate consent requirements by including them within this regulation. Regarding de-identification of employee health information, in cases where facilities or agencies are providing an attestation of which employees are vaccinated, de-identification would not be appropriate because the receiving facility or agency needs to know who is vaccinated and who is not. Again, the usual procedures for obtaining consent for release of records would apply. Similarly, procedures for identifying vaccinated and unvaccinated employees must conform to applicable privacy laws and regulations.

Regarding the commenter’s concerns about parts of the regulation and amendments being open to interpretation, in the context of different settings and facility layouts, the Department believes that the language in the regulation and amendments—referring to areas where patients or residents are “typically” present—provides the appropriate level of guidance.

The Department believes that notification to healthcare facilities and agencies, which can then notify their employees, is the best way to communicate the mask requirement. Additionally, the beginning and end of mask wear are reported on the Department’s web site.

One commenter recommends that the Department amend regulations affecting the Early Intervention (EI) program such that EI providers are subject to mask wear requirements if unvaccinated for influenza. The commenter states a belief that regulations obligate the Department to implement mask wear requirements for EI providers.

Response: EI providers are not “personnel” within the meaning of the regulation. The Department believes that the regulation is appropriately limited to healthcare personnel.

One commenter stated that the addition of vaccine formulation among the documentation requirements “makes things much more complicated”.

Response: As noted in the response to a previous comment, the formulation of vaccine is a standard part of immunization documentation, similar to what is required for measles and rubella vaccine documentation requirements.

One commenter suggested that a distinction be made between mental health facilities and other medical facilities. The commenter states that some patients leave the patient areas on a pass and might travel through various administrative or non-patient areas of the hospital. The commenter also asks if there are boundaries within which facilities must stay if they adopt more stringent policies than required by the regulation and notes several examples of additional institutional requirements.

Response: Mental health facilities that do not otherwise meet the definition of “healthcare or residential facility or agency” are not covered by this regulation. The Department believes that the regulation appropriately protects patients and residents from transmission of influenza from healthcare workers. The facility is expected to use reasonable judgment in determining whether a given area is one in which patients or resident are typically present, such that unvaccinated personnel must wear masks during the influenza season.

Regarding the statement that facilities may adopt more stringent policies, as noted in a previous response, this is not a change from the original regulation but rather a clarification. Questions regarding the boundaries of a facility’s or agency’s authority to issue employee policies, which may be more stringent that this regulation, are beyond the scope of this document and should be directed to legal counsel for the facility or agency.