Respirator Study: Assessment of Elastomeric Respirators in Healthcare Delivery Settings

Solicitation 2018-N-67799 is hereby attached to this posting. Please see attached Request for Proposal (RFP), Statement of Work (SOW) and other solicitation attachments.

In accordance with Section L of the attached RFP, questions concerning this effort shall be submitted to the Contract Specialist via email no later than 11:00 AM EST on May 7, 2018. All questions and answers will be added to this posting.

Proposals submitted in response to this RFP shall be submitted electronically to the Contract Specialist no later than 11:00 AM EST on May 29, 2018.

The Centers for Disease Control and Prevention (CDC) and Office of Acquisition Services (OAS) on behalf of the National Institute for Occupational Safety and Health (NIOSH) and the National Personal Protective Technologies Laboratory (NPPTL) intends to issue a solicitation for an initiative is to determine the feasibility and capability of U.S. healthcare delivery organizations to routinely use reusable respirators and/or rapidly convert to their use during a public health emergency.

It is intended that multiple contracts will be awarded as a result of the upcoming solicitation.

Background Information:
The demand for the respiratory protective devices (RPD) worn by U.S. healthcare personnel (HCP) during a large respiratory infectious disease outbreak, such as an influenza pandemic, is expected to far exceed domestic supplies. Approximately 3.6 billion disposable and 1.6 million reusable respirators may be needed. A rapid increase in RPD usage was apparent during the 2009 H1N1 influenza pandemic and the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS). During these events, HCP reported that N95 filtering facepiece respirators were not readily available in some locations due to exhaustion of available supplies, inability of suppliers and manufacturers to meet the surge in demand, and shortages of fit testing equipment.

The U.S. Department of Health and Human Services recommends that healthcare facilities stockpile a six to eight-week supply of disposable N95s, however achieving this recommendation has been a challenge for many due to financial limitations. In 2012, the Association of State and Territorial Health Officials estimated that U.S. acute care hospitals have 60 million N95 respirators on hand, two orders of magnitude smaller than the estimated demand during a severe influenza pandemic. This underscores the importance of including RPD in the Strategic National Stockpile maintained by the Centers for Disease Control and Prevention (CDC).

Wider utilization of reusable elastomeric respirators, which can be cleaned and repeatedly worn, are being considered as one way to mitigate shortages of disposable N95 respirators during public health emergencies. The Veterans Health Administration recently stockpiled elastomeric respirators for use during a surge in demand for N95 respirators. The National Academy of Medicine, Centers for Disease Control and Prevention, and Food and Drug Administration have recently held stakeholder meetings to assess, in part, the potential future role of elastomeric respirators in healthcare delivery. In 2013, Worksafe British Columbia issued a report about the use of elastomeric respirators during a surge in demand. In 2009, the University of Maryland Medical System began fitting HCP with elastomeric respirators to wear during patient care. Another study by the Veterans Health Administration determined that stockpiling elastomeric respirators, in addition to other types of respiratory protection, may result in considerable cost savings.

However, reusable elastomeric respirators are infrequently used in U.S. healthcare delivery, so most HCP have little or no experience with them. CDC and the National Institute for Occupational Safety and Health (NIOSH) need to better understand whether and in what settings elastomeric respirators could be used in the context of patient care, especially during public health emergencies when there is an increase in demand for N95s and other RPD.

The purpose of this initiative is to determine the feasibility and capability of U.S. healthcare delivery organizations to routinely use reusable respirators and/or rapidly convert to their use during a public health emergency. A competitive contract funding mechanism will identify and select up to three U.S. healthcare delivery organizations as partners for a series of demonstration projects and clinical studies.

The Statement of Work includes a Base Contract and two Options (two optional tasks). Offerors may submit a proposal for (1) the Base Contract, (2) the Base Contract and Option A, (3) the Base Contract and Option B, or (4) the Base Contract, Option A, and Option B.

The government intends to post the solicitation around the end of April.