HLT-07-13-00020-A Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel

7/31/13 N.Y. St. Reg. HLT-07-13-00020-A

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 31

July 31, 2013

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

NOTICE OF ADOPTION

 

I.D No. HLT-07-13-00020-A

Filing No. 754

Filing Date. Jul. 11, 2013

Effective Date. Jul. 31, 2013

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 sections 2.59, 405.3, 415.19, 751.6, 763.13, 766.11 and 793.5 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:

Require hosp, DT and Cs, nursing home, home care and hospice personnel to wear a surgical or procedure mask if not vaccinated for Influenza.

Text or summary was published

in the February 13, 2013 issue of the Register, I.D. No. HLT-07-13-00020-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 14 public comments; eleven were opposed to the regulation, two supportive, and one recommended mandatory influenza vaccination for healthcare personnel (HCP) but did not address the issue of masks. Eleven comments were from professional organizations: CareGivers, District Council 37 American Federation of State, County & Municipal Employees (AFSCME), Empire State Association of Assisted Living (ESAAL), American Council on Science and Health (ACSH), New York State Nurses Association (NYSNA), Home Care Association of New York State (HCA), New York State Association of County Health Officials (NYSACHO), Civil Service Employees Union (CSEA), LeadingAge, Genesee Region Home Care Association (Genesee Region HCA), New York Committee for Occupational Safety and Health (NYCOSH). One comment was from the New York City Department of Health and Mental Hygiene (NYCDOHMH). Two comments were from private individuals. The comments were categorized into six groups.

There is a lack of supportive evidence on mask use to prevent influenza transmission; use alternate means to prevent transmission.

(CareGivers, NYSNA, CSEA, LeadingAge, Genesee Region HCA, NYCOSH, District Council 37 AFSCME, Private Individual)

Commenters suggested that the proposed regulations are contrary to Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) recommendations on mask use and the hierarchy of controls. One stated that evidence is lacking that mask use will reduce influenza transmission and noted that CDC states that no studies definitively show that masks prevent influenza transmission. Another commenter stated that CDC recommends that patients with symptoms wear masks, but HCP wear N95 respirators.

Commenters suggested alternative approaches to prevent transmission: mandatory education; focus on community vaccination to develop herd immunity; requiring hospitals to provide free, voluntary influenza vaccinations; visitation restrictions; cohorting patients exhibiting influenza-like illness with immunized staff; adequate sick leave for HCP; promoting hand hygiene and cough etiquette; strict housekeeping measures; and engineering, workplace practices, and administrative controls.

One commenter suggested that influenza vaccine has low efficacy and so all persons, regardless of vaccination status, should be required to wear masks if any are. A commenter noted that shedding may occur before symptoms and that “selective” use of masks might not limit transmission. One commenter questioned the importance of spread by asymptomatic workers, and one noted that HCP mask wear will not control transmission by visitors. Finally, a commenter suggested the possibility of masks becoming a vector of infection.

Response

Although a study directly addressing the efficacy of masks to prevent transmission by HCP has not been done, the Department has analyzed related evidence and drawn reasonable inferences to formulate its policy: In the absence of vaccination, requiring HCP and others in close proximity to patients to wear masks is the best way to prevent influenza transmission, in addition to routine measures already in place such as hand hygiene.

CDC recommends use of masks by potentially infectious persons to help contain respiratory secretions. That principle would apply to unvaccinated HCP who are infected with influenza and potentially contagious but not yet symptomatic, as well as those HCP who are working while being infected with a mild case which is not recognized as influenza. The Infectious Diseases Society of America also recommends that unvaccinated HCP wear masks.

The Department agrees that “selective” mask wear—that is, only requiring mask wear by those HCP who are diagnosed with influenza—would not prevent transmission. Therefore, all unvaccinated HCP are required to wear masks.

Many of the alternative approaches suggested to prevent influenza transmission are already in use. Messaging to HCP around influenza prevention is common. Despite education, HCP influenza immunization rates remain unacceptably low.

Influenza transmission from HCP to patients does occur and, although vaccine efficacy may be low in some years and populations, vaccine generally provides some protection against HCP transmitting influenza. Similarly, mask wear provides some protection against HCP transmitting influenza. The goal is to reduce the risk of transmission via either method.

Infected visitors might spread influenza, and facilities and agencies have developed visitation policies. HCP, who typically move from patient to patient and therefore have more opportunity to infect multiple patients, are the focus of this regulation.

The rule is burdensome for healthcare facilities and personnel

(CareGivers, NYSNA, HCA, LeadingAge, Genesee Region HCA, ESAAL)

Several commenters stated that the cost of implementing mask wear is higher than estimated by the Department and noted the need for frequent mask changes. Commenters stated that requiring masks constituted an unfunded mandate and suggested reimbursement to cover costs. A commenter expressed concern that challenges from unions might present additional burdens, and another stated that required documentation is excessive, particularly name, address, and date of vaccination when given by an outside provider. One commenter suggested that the Department expand the pediatric vaccination reporting system rather than create a new system.

Response

Although there was general agreement on cost per mask, commenters calculated higher overall costs than estimated by the Department. However, in most settings the cost should be less than one dollar per shift per unvaccinated worker, which is a very small proportion of the budget of covered facilities and agencies. Costs can be decreased by encouraging vaccination of all eligible, willing personnel. From a health system perspective, fewer cases of influenza among HCP and fewer instances of transmission to patients may decrease costs.

Parties covered by this regulation already must maintain a health record for employees with information such as rubella status and tuberculosis testing results. It should not be a large additional burden to add influenza immunization status and to report rates. Reporting will be accomplished through the Department’s Healthcare Emergency Response Data System (HERDS), which many healthcare facilities use to report influenza morbidity during the influenza season.

Regarding immunization of personnel by outside providers and required documentation, the data elements of date, provider name, and address are typically provided on immunization cards given as proof of vaccination and are needed to ensure that vaccination was obtained.

The rule imperils worker safety

(NYSNA, CSEA, LeadingAge)

Commenters speculated that mask wear might create a communication barrier, especially for patients with hearing impairment or mental health issues, and it was suggested that this is a violation of the New York State Public Employer Workplace Violence Prevention regulation. Commenters suggested that masks might be a physiologic burden for persons with lung disease, claustrophobia, etc. Finally, a commenter suggested that the regulation would require facilities to conduct additional OSHA hazard analyses.

Response

The masks called for under this regulation are light-weight surgical or procedure masks that do not form a seal and are worn in hospitals every day for hours at a time, such as in operating rooms. The regulation does not call for N95 respirators, which could potentially form a physiologic barrier. Under certain conditions, personnel covered by this regulation already have to wear masks as a matter of course in healthcare settings.

When communication barriers, violence, or other negative reactions are a concern, the Department expects facilities and agencies to use the same procedures as are used now when masks are required for other reasons. The regulation's requirement to wear masks does not violate the New York State Public Employer Violence Prevention Regulations. Currently, HCP may be required to wear a mask for a variety of reasons not related to these regulations.

OSHA regulations require that all employers evaluate their workplaces for hazards and take appropriate measures. This regulation does not require any additional hazard analysis beyond what is already required under OSHA regulations, nor does it violate OSHA laws or regulations.

The rule adversely impacts workers’ rights

(NYSNA, LeadingAge, NYCOSH, Private Individual)

Commenters suggested that the regulation is coercive and punitive rather than preventative, that it could stigmatize workers, and that it is a human rights violation. There was concern that the regulation indirectly tries to achieve mandatory vaccination. Commenters suggested that it is a privacy issue for workers because the mask might indicate that a person was not vaccinated, and that it therefore might be a Health Insurance Portability and Accountability Act (HIPAA) violation.

Response

This regulation is designed to give HCP a choice in how they protect patients from influenza – either immunization or mask wear, and while neither is perfect, both are expected to provide some level of protection for patients. A state regulation requiring that unvaccinated personnel wear masks does not violate HIPAA.

Miscellaneous concerns

(Private Individual, NYSNA, CareGivers, Genesee Region HCA, LeadingAge, ESAAL, HCA)

Home Care agencies expressed concern that the regulation cannot be enforced in the community and home care setting. One commenter stated that the regulation does not accommodate those who cannot get the vaccine. Another commenter stated that the Department’s surveillance does not show that HCP transmit influenza in hospitals. There was concern that the regulation would not prevent an epidemic because no similar measures are proposed in non-healthcare settings. One commenter suggested that mask wear might create a false sense of security and make it appear acceptable to work if ill. A commenter suggested that the regulation is overly broad in that it requires mask wear by anyone in patient areas regardless of role. A commenter suggested that masks detract from a home-like environment in long-term care settings. A commenter expressed concern that the mandate might result in staffing shortages from terminations or voluntary resignations or might discourage people from working or volunteering. Finally, a commenter suggested exceptions for cases in which persons might be frightened by masks.

Response

Agencies will need to develop policies and a means of assessing compliance, just as they currently do for other regulations that affect home care. Mask wear is the alternative method of protecting patients from influenza for HCP who are unvaccinated, regardless of the reason. Each year the Department receives numerous reports of influenza outbreaks in healthcare facilities, and it is known that HCP can transmit influenza to patients. The regulation is focused on preventing healthcare-associated transmission. Healthcare facilities and agencies should continue to stress the importance of not working when ill and enforce relevant policies. The regulation applies to any personnel who are around patients because proximity determines likelihood of transmission more than the person’s role. There are circumstances outside of this regulation where mask use is required in long term care settings, and any detraction from the home-like environment can be minimized by ensuring that all eligible, willing personnel are vaccinated. The Department does not expect staffing shortages as a result of this regulation; on the contrary, fewer ill HCP should improve the staffing situation during influenza season. If any persons are frightened by masks, facilities and agencies should have plans to address those fears as they would when masks are required for other reasons.

Supportive and other comments

NYCDOHMH supports the intent of the proposal and expresses concern about the definition of the influenza season, stating that local health departments (LHDs) should be able to make the determination themselves.

NYSACHO states that the past influenza season highlights the need to promote vaccinations and put other measures in place, notes that lower than optimal HCP vaccination rates are concerning, and states that the regulation is “an important step in ensuring that patient care comes first.” Further, masks can potentially decrease transmission and there is a “need for strong policies to minimize the risk that unvaccinated healthcare workers pose to patients and co-workers”. Finally, they state that the “proposed regulation balances workers’ rights and patient safety while providing for appropriate flexibility”.

ACSH suggest a policy mandating influenza immunization for all HCP.

Response

The definition of the influenza season for the purpose of this regulation is based on State surveillance data and determined by the Commissioner. The Commissioner may consider data and input from LHDs and other knowledgeable entities. The Department agrees that this regulation will improve patient safety, while providing an alternative way to protect patients for HCP who cannot be vaccinated or who refuse to be vaccinated.

Conclusion

After careful review and consideration of all comments the Department determined that the regulation will be published for final adoption with no changes.