Health Alert
IMPLEMENTATION OF THE RECENTLY ISSUED CDC GUIDANCE ON HEALTHCARE INFECTION CONTROL MEASURES FOR H1N1 PERTAINING TO RESPIRATORY PROTECTION, SPECIFICALLY, THE USE OF N95 RESPIRATORS

On October 14, 2009 CDC released Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel. These guidelines can be found here: http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

The purpose of this Health Alert is to highlight key issues associated with implementation of these guidelines and approaches health facilities in Delaware may want to consider.

Key Provisions of the Guidance:

• Applies uniquely to the special circumstances of the current 2009 H1N1 pandemic
• Recommends the use of a "hierarchy of controls" including: 1) elimination of potential exposures, 2) Engineering Controls, 3) Administrative Controls, and 4) Personal Protective Equipment.
• Places strong emphasis on vaccination as an effective Administrative Control.
• Defines healthcare personnel covered by this guidance as "all persons whose occupational activities involve with patients or contaminated material in a healthcare, home healthcare, or clinical laboratory setting...engaged in a range of occupations... and in the following settings: acute care hospitals, nursing homes, skilled nursing facilities, physician's offices, urgent care centers, outpatient clinics, and home healthcare agencies.  It also includes...school nurses or personnel staffing clinics in correctional facilities."
• Defines close contact as "working within 6 feet of the patient or entering a small enclosed airspace shared with the patient (e.g. average patient room.)"
• CDC continues to recommend the use of respiratory protection that is at least as protective as a fit-tested disposable N95 respirator for healthcare personnel who are in close contact with patients with suspected or confirmed 2009 H1N1 influenza.
• The guidance acknowledges that some facilities are currently experiencing shortages of respiratory protection equipment and that further shortages are anticipated. In the face of shortages, appropriate selection and use of respiratory protection is critical and a key strategy is to use source control, engineering, and administrative measures to reduce the numbers of workers who come in contact with patients who have influenza-like illness to reduce the consumption of respiratory protection equipment.
• Under circumstances where a shortage of respirators exists "despite reasonable efforts to obtain and maintain a sufficient supply for anticipated needs" ...a facility should consider shifting to a prioritized respirator use mode." In this mode, respirator use is prioritized to ensure availability for healthcare personnel at most risk from 2009 H1N1 influenza exposure, such as aerosol generating procedures. Prioritization should be adapted to local conditions, and should consider intensity and duration of exposure, personal health risk factors for complications of infection, and vaccination status. The objective is to reduce exposure while conserving supplies realizing that the flu season will last until May 2010 and a reliable supply for other highly communicable disease concerns such as TB must be maintained.
• In a prioritized respirator use mode, respirators may be carefully reused or their use may be extended, their use may be temporarily discontinued for employees at low risk of exposure or lower risk of complicated infection, and suitable facemasks could be used. It must be emphasized that even under this operating mode, N95 or better respiratory protection must be provided during high risk (e.g. aerosol generating) procedures.

How Regulatory Agencies will Enforce these Guidelines

The following information is preliminary and based on the best available information.

• Occupational Safety and Health Administration (OSHA): OSHA fully intends to enforce this guidance through its Respiratory Protection Standard (including training and fit testing) and through its General Duty Clause. Inspections will be done on a complaint basis and OSHA plans to release its detailed compliance directive in the next couple of weeks. OSHA will require facilities to demonstrate a good faith effort to acquire sufficient supplies of N95s in accordance with the CDC guidance and document such efforts and outcomes. Facilities unable to acquire sufficient quantities, substantiated by adequate documentation of effort, can shift to the prioritized use mode and would not be considered out of compliance as long as they also implemented the specified hierarchy of controls.
• Centers for Medicare and Medicaid Services (CMS) and the Division of Public Health’s (DPH) Office of Health Facilities Licensing and Certification: These agencies, likely in response to complaints, will require facilities to have a policy in place that addresses respiratory protection and procedures that show that the policy is being implemented. These agencies will look at the current facility policy and will expect the facility to maintain compliance with that policy.

Suggested Steps for Healthcare Facilities

Anticipating that most, if not all facilities, will come up short in their ability to purchase the desired amount of commercially available suitable respirators due to the lack of sufficient commercial supply, facilities should determine at what point they will need to move to the prioritized use mode and devise an implementation plan following the recommendations and advice contained in the CDC guidance.

Documentation of (1) a good faith effort to analyze needed N95 respirators through May 2009 and acquire them; and (2) implementation of the hierarchy controls should be sufficient for prioritizing the use of N95s and be in full compliance with OSHA regulations.

Healthcare facilities should consider the following.

1. Review the CDC guidance in detail.
2. Implement CDC guidance
   • Includes implementation of hierarchy of controls
   • Includes N95 for healthcare personnel who are in close contacts with patients suspected or confirmed 2009 H1N1 influenza
   • Requires "good-faith" effort to comply
3. Assess the need and possible shortage of N95s
   • Develop and document a methodology to determine N95s needed to fully implement CDC guidance through May 2010 as well as to protect workers needing N95 for other than H1N1 procedures.  This need not be a complicated methodology
   • Calculate and document the need based on the above methodology and the current stock of N95s
   • Contact supplier and document supplier’s ability or inability to supply N95s to meet the identified need
4. Implement a plan to prioritize of use of N95s
   • Assumes facility shortage as documented above
   • Assumes the facility documented and implemented hierarchy of controls
   • Document and implement a facility-specific policy to prioritize use of N95's

For further questions about this Health Alert contact the Division of Public Health at 1-800-282-8672.

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