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Order of the Secretary of the Pennsylvania Department of Health Directing Long-Term Care Facilities to Implement Measures for Use and Distribution of Personal Protective Equipment

Frequently Asked Questions

November 16, 2020

The Department of Health and the Department of Human Services are providing this document to address questions from long-term care facilities regarding the Order of the Secretary of the Pennsylvania Department of Health Directing Long-Term Care Facilities to Implement Measures for Use and Distribution of Personal Protective Equipment issued on August 17, 2020. For ease of reference, this document is organized by four main subject areas: Policy and Support Issues, Personal Protective Equipment, Respirators, and Other. A list of acronyms is provided at the end of this document instead of defining them in each question and answer.

Policy and Support Issues

Question:  Why did the Secretary of Health issue this Order?
Answer:
  The Secretary of Health issued this Order because developing, implementing, and adhering to a plan to distribute and use PPE is essential in managing the spread of COVID-19 and protecting the health and safety of staff and residents in LTCFs.

Question: There are no current COVID-19 cases in our facility. Why do we need to have policies and procedures for the procurement and distribution of PPE to staff?
Answer:
  LTCFs throughout the Commonwealth continue to experience new outbreaks of COVID-19. Additionally, facilities need to prepare for a potential surge in the future. Developing capacity to obtain, distribute, and properly use PPE in advance of a surge will help everyone be better prepared.

Question:  Administrators across the state are very busy responding to COVID-19. Can the Commonwealth provide the policies and procedures for us?
Answer:
  While it is understood that administrators are very busy responding to COVID-19, every LTCF is unique and the policies and procedures will vary depending on the specific needs of the individual facility. Therefore, each facility is to develop their own policies and procedures to address the unique needs of their facility.

Question: Is there someone that can help us develop our policies and procedures?
Answer:
Facilities may consult the RRHC assigned to their facility if assistance is needed.

Question: If our facility is operating under contingency or crisis capacity standards of care, do we need to follow this Order?
Answer:
Yes, this Order still applies under contingency or crisis capacity standards of care. It is critical for every facility to develop, implement, and adhere to policies and procedures that provide for the procurement and distribution of PPE in order to be prepared for continuing and future outbreaks.

Personal Protective Equipment

Question: Does the Secretary's Order cover all types of PPE or is it just addressing the use of respirators?  
Answer:
  The Order requires that facilities have policies and procedures for the procurement and distribution of PPE to staff, and this applies to all PPE required to protect staff while on the job, based on their duties. The Order also requires employers to provide approved respirators to staff at the beginning of their shift and when notified by a staff member that theirs has become soiled, damaged, or otherwise ineffective.

Question: Does the Order include eye protection (goggles or face shields, etc.)?  
Answer:
Yes. Eye protection is a critical piece of PPE. The facility's policies and procedures for the procurement and distribution of PPE must include eye protection. Please refer to PA-HAN-524 – Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for 2019 Novel Coronavirus (COVID-19) in a Healthcare Setting for more information about eye protection.

Question:  Is there information on the types of PPE, when to use which type, etc.?
Answer:
Please refer to PA-HAN-524 – Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for 2019 Novel Coronavirus (COVID-19) in a Healthcare Setting for information on proper types and use of PPE. Additional assistance may be obtained by contacting the RRHC assigned to your facility.

Question:  Where can PPE be obtained? There is concern about whether enough PPE will be available in the supply chain to meet our needs.
Answer:
   Facilities should use their existing supply chains to the greatest extent possible since supply chains have largely caught up to demand. If you are unable to obtain appropriate PPE, the RRHC assigned to your facility can provide resources for obtaining PPE. LTCFs are encouraged to review CDC guidance on strategies to optimize the supply of PPE and equipment for information on optimizing their supply when potential shortages are expected to occur.

Question: Who will pay for the additional PPE?
Answer:
  LTCFs are expected to purchase the necessary PPE for their facility. CARES Act funding may be used for this purpose. Please consult the RRHC assigned to your facility if further assistance is needed.

Question: What is the guidance for expired equipment?
Answer:
  The FDA issued an EUA authorizing the use of certain NIOSH-approved respirator models in healthcare settings. This EUA includes respirator units that are past their designated shelf life. To determine if your respirator meets this criteria please visit the FDA website. For surgical masks and gowns, the FDA specifies the following: These products were designed to serve as protective barriers and thus FDA believes they may still offer some protection even when they are used beyond the manufacturer's designated shelf life or expiration date. The user should visibly inspect the product prior to use and if there are concerns (such as degraded materials or visible tears) the product should be discarded. As a conventional capacity strategy, expired products may be used for training and demonstration purposes where barrier protection is not needed. Please consult the RRHC assigned to your facility if further assistance is needed.

Respirators

Question:  Does the Order require the use of respirators for exposed and potentially exposed residents (i.e., Yellow zone described in HAN 530 – Long-term Care Facility Guidance for Testing and Cohorting: Response to an Outbreak and Residents with Exposure to COVID-19)?
Answer:   Yes, the Order requires respirator use for "COVID-19 positive and suspected cases."  This includes those who meet the definition of a probable or confirmed case, and meet criteria for requiring transmission-based precautions for COVID-19 as given in PA-HAN-517 – Discontinuation of Transmission-Based Precautions for Patients with COVID-19 and PA-HAN-524 – Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for 2019 Novel Coronavirus (COVID-19) in a Healthcare Setting.  It also includes those persons requiring transmission-based precautions for COVID-19 due to known or potential exposure. When using the zones as described in PA-HAN-530, the Order applies to all residents in Red and Yellow zones including those under observation following inpatient hospital admission.

Question:  Which respirators require fit testing and where can we obtain the fit test?
Answer:
 Fit testing is required for all filtering facepiece respirators. LTCFs are encouraged to contact the RRHC assigned to their facility for assistance with fit testing.

Question:  Must staff who will be wearing respirators be fit tested on the particular brand, style and size of respirator they will be using?
Answer:  Staff must be fit tested with the same make, model, style, and size of respirator that will be used. A medical evaluation is also required to document that the user can wear the respirator without negatively impacting breathing. A seal check must also be done each time the respirator is donned, in order to assure proper fit.

Question: We don't currently have any staff who are fit tested for respirators that we have in stock. Should non-fit-tested staff be wearing respirators?
Answer: Fit testing is required for all filtering facepiece respirators. LTCFs are encouraged to contact the RRHC assigned to their facility for assistance with fit testing.

Question:  We have a few staff members who cannot wear a respirator due to health reasons but are able to wear a surgical mask. Are there exceptions to the Order for these staff persons?
Answer:  There are two acceptable options for these staff persons. First, they could be considered for assignments where they are not caring for residents in need of transmission-based precautions for COVID-19. A second option is to offer them the use of a PAPR, which is generally well-tolerated and does not need to be fit-tested. However, PAPRs require that the user be trained in proper donning, operation, and doffing procedures. If the facility does not have access to PAPRs and cannot re-assign staff to non-COVID resident care, they are encouraged to contact the RRHC assigned to their facility for assistance.

Question: We heard that our staff can use non-NIOSH approved respirators if they are authorized for use by the FDA through an EUA. Is this true?
Answer:  The respirators distributed by each facility must be NIOSH-approved particulate filtering facepiece respirators, or if those are not available, respirators authorized by the FDA, including through an EUA. For information on those authorized by the EUA, go to the EUA for Personal Protective Equipment website. Scroll down the page to locate two lists with authorized respirators to search for the respirator model of interest:

  • Appendix A; Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Exhibit 1, Authorized Imported, Non-NIOSH Disposable FFR

If your respirator is not located in Appendix A or Exhibit 1, it may have been removed. On the same page, there is a list of Respirator Models Removed from Appendix A (Respirator Models No Longer Authorized). Search for the respirator model in the search box. If found, this respirator model is no longer authorized for use due to failure to provide adequate particulate filter efficiency during testing. Please consult the RRHC assigned to your facility if further assistance is needed.

Question: When implementing extended use, is there a recommended way to protect respirators from surface contamination in order to prolong their use?
Answer:
During extended use of respirators, PADOH and the CDC recommends wearing a reusable face shield over a respirator to help protect these devices from potential surface contamination.  Do not wear a surgical or cloth mask over a respirator. NIOSH has not approved nor recommends wearing a surgical or cloth mask over an N95 is because it is inconsistent with the conditions of approval and voids their certification. Furthermore, double-masking may cause the worker to more frequently touch the face to make adjustments, putting them at risk for self-contamination.

Question: The Order specifies the respirator must be replaced as soon as practical if the facility is notified by a staff member that it has become soiled, damaged, or otherwise ineffective. How will staff know when a new respirator is ineffective?
Answer:
Staff should discard their respirator under the following circumstances:

  • The respirator becomes contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients.
  • If the respirator becomes visibly soiled, damaged in any other way, or is difficult to breathe through.
    • Refer to manufacturers' and CDC guidance on extended use and reuse of respirators:
      • Per CDC, "To reduce the chances of decreased protection caused by a loss of respirator functionality, respiratory protection program managers should consult with the respirator manufacturer regarding the maximum number of donnings or uses they recommend for the N95 respirator model(s) used in that facility. If no manufacturer guidance is available, preliminary data suggests limiting the number of reuses to no more than five uses per device to ensure an adequate safety margin. Management should consider additional training and/or reminders for users to reinforce the need for proper respirator donning techniques including inspection of the device for physical damage (e.g., Are the straps stretched out so much that they no longer provide enough tension for the respirator to seal to the face?, Is the nosepiece or other fit enhancements broken?, etc.). Healthcare facilities should provide staff clearly written procedures to:
        • Follow the manufacturer's user instructions, including conducting a user seal check.
        • Follow the employer's maximum number of donnings (or up to five if the manufacturer does not provide a recommendation) and recommended inspection procedures.
        • Refer to manufacturers' and CDC guidance on extended use and reuse of respirators:
          • Per CDC, "To reduce the chances of decreased protection caused by a loss of respirator functionality, respiratory protection program managers should consult with the respirator manufacturer regarding the maximum number of donnings or uses they recommend for the N95 respirator model(s) used in that facility. If no manufacturer guidance is available, preliminary data suggests limiting the number of reuses to no more than five uses per device to ensure an adequate safety margin. Management should consider additional training and/or reminders for users to reinforce the need for proper respirator donning techniques including inspection of the device for physical damage (e.g., Are the straps stretched out so much that they no longer provide enough tension for the respirator to seal to the face?, Is the nosepiece or other fit enhancements broken?, etc.). Healthcare facilities should provide staff clearly written procedures to:
            • Follow the manufacturer's user instructions, including conducting a user seal check.
            • Follow the employer's maximum number of donnings (or up to five if the manufacturer does not provide a recommendation) and recommended inspection procedures.
            • Discard any respirator that is obviously damaged or becomes hard to breathe through.
            • Pack or store respirators between uses so that they do not become damaged or deformed."
          • Per CDC, "A key consideration for safe extended use is that the respirator must maintain its fit and function. Workers in other industries routinely use N95 respirators for several hours uninterrupted. Experience in these settings indicates that respirators can function within their design specifications for 8 hours of continuous or intermittent use. Some research studies have recruited healthcare workers as test subjects and many of those subjects have successfully worn an N95 respirator at work for several hours before they needed to remove them. Thus, the maximum length of continuous use in non-dusty healthcare workplaces is typically dictated by hygienic concerns (e.g., the respirator was discarded because it became contaminated) or practical considerations (e.g., need to use the restroom, meal breaks, etc.), rather than a pre-determined number of hours." Some facilities have successfully issued staff multiple masks per day to provide the opportunity to doff the used mask, go to break, and re-don another mask when returning from break. Issuing staff 5 sets of 4 masks may allow for an intra- and between day rotation that would prevent a single mask from being reused more often than every 5 days. Although this requires a large initial supply of respirators, 20 masks issued to a single healthcare worker would be expected to last 25 work days.

Further assistance may be obtained by contacting the RRHC assigned to your facility.

Other

Question:  What is the penalty if I do not follow the Secretary's Order?  Will I receive a deficiency or fine?
Answer:  If it appears that a facility willfully refuses to comply or is negligent in complying with the Secretary's Order, DOH has the option to fine the facility under the Disease Prevention and Control Law and DHS has the option to take enforcement action under the applicable regulation for the facility type. Facilities are strongly urged to request help when necessary and take every step necessary to comply with the Secretary's Order.

Question: Who do I contact if I have additional questions?
Answer: If you are a facility licensed by DOH, contact RA-dhSNFquestion@pa.gov. If you are a facility licensed by OLTL, contact RA-pwarlheadquarters@pa.gov. If you are a facility licensed by the ODP, contact RA-PWODPEMRGNCYRSPRQ@pa.gov.

DEFINITION OF ACRONYMS
Acronym Definition
CARES ActCoronavirus Aid, Relief, and Economic Security Act
COVID-19The illness caused by the novel coronavirus SARS-coV-2
CDC Centers for Disease Control and Prevention
DHSDepartment of Human Services
DOHDepartment of Health
EUAEmergency Use Authorization
FDAFood and Drug Administration
FFRFiltering Facepiece Respirator
LTCFLong-Term Care Facility
NIOSHNational Institute for Occupational Safety and Health
ODPOffice of Developmental Programs
OLTLOffice of Long-Term Living
PA-HAN Pennsylvania Health Alert Network
PAPRPowered Air Purifying Respirator
PEMAPennsylvania Emergency Management Agency
PPEPersonal protective equipment
RRHC Regional Response Health Collaboration