GUIDANCE ON HOSPITALS’ RESPONSES TO COVID-19
UPDATED April 27, 20201
The Department of Health (Department) has received questions and requests for guidance from hospitals, health systems, and their representatives on their responses to Coronavirus Disease-2019 (COVID-19) and whether measures being implemented or contemplated are compliant with the statutory and regulatory requirements under the jurisdiction of the Department.
The Department is issuing the below guidance to update the guidance issued on April 2, 2020. (1)
Emergency Preparedness Plans and Reporting
Hospitals should incorporate any actual or anticipated emergent needs associated with their COVID-19 response into their Emergency Preparedness Plan. Emergent needs include the use of telemedicine, remote locations, onsite family child care for staff, delayed investigation and enforcement under 28 Pa. Code § 103.24, and non-licensed spaces for treatment of patients.
Hospitals must implement their Emergency Preparedness Plans. Prior to or upon implementation, hospitals must report into the Pennsylvania Patient Safety Reporting System (PSRS) that they have or intend to implement their Emergency Preparedness Plan. On the report, under the “describe the event” section, the following information must be included:
1 Red text indicated updates made to the Guidance to Hospitals provided on April 2, 2020.
- A statement that the Emergency Preparedness Plan is being implemented in response to COVID-19. The term “COVID-19” must be included in this section.
- Any locations that may be impacted.
- Services being implemented that have not been previously approved or for which notice was not previously provided to the Department (if applicable).
Hospitals that submitted a report prior to the date of issuance of this guidance indicating their Emergency Preparedness Plan has been implemented must amend their report to include the above information.
If a hospital adds an unlicensed physical location for service after the initial PSRS report is submitted, the hospital must amend the report and add the physical location. Amendments to reports must be submitted within 24 hours of implementation or use of a new location or space.
Hospitals that are offering or intend to offer COVID-19 testing through off-site locations must include that information in their initial PSRS report or amend their report when it is known that the testing will be offered. The Department supports and encourages hospital and health systems efforts to develop their own testing capabilities.
Hospitals do not need approval from the Department to implement any element of their Emergency Preparedness Plan and do not need to provide daily updates. However, if any element of the plan has been discontinued, notice of that discontinuance should be reported.
Mandatory EEI Reporting through Knowledge Center
In accordance with the Order of the Secretary of Health issued on March 24, 2020, all hospitals must complete the Essential Elements of Information (EEI) data collection tool in the Knowledge Center – Health Incident Management System (KC-HIMS) three times per day at 0800, 1600, and 2400 as instructed in the Order.
All fields indicated as mandatory or required must be completed. For this data collection purpose, all hospitals and campuses of hospitals must separately complete the survey even if multiple facilities are under one hospital license.
Hospitals should follow their Emergency Preparedness Plan and the Department encourages hospitals to take any other appropriate measures to protect patient and staff safety. This includes limiting visitor access to vulnerable populations such as hospice, neonatal, SNF units, and other specialty units.
The Department strongly encourages that a hospital’s visitor policy allow for a patient support person at the patient’s bedside for patients in labor and delivery; pediatric patients; and patients for whom the hospital determines a support person is essential to the care of the patient, including patients with intellectual and/or developmental disabilities and patients with cognitive impairments such as dementia.
Hospitals do not need the Department’s approval to implement a new visitor policy in response to COVID-19.
Elective Admissions, Surgeries and Procedures
Hospitals may begin to allow elective admissions and may begin performing elective surgeries and procedures if the hospital makes an affirmative decision that it is able to do so without jeopardizing the safety of patients and staff or the hospital’s ability to respond to the COVID-19 emergency. In determining whether a hospital is able to support elective admissions, surgeries and procedures, the hospital must review the Joint Statement issued by the American College of Surgeons, American Society of Anesthesiologists, Association of perioperative Registered Nurses, and American Hospital Association and consider the operational guidance described therein. Hospitals that provide pediatric treatment and care should additionally review the guidance from the Children’s Hospital Association of the United States when determining whether to proceed with pediatric elective surgeries and procedures.
Hospitals that begin to perform elective surgeries and procedures must update their Emergency Preparedness Plans to reflect that such surgeries and procedures have resumed if suspension of such surgeries and procedures was reflected in their plans. Hospitals must also update their initial PSRS report to indicate that those surgeries and procedures are no longer suspended. Hospitals do not need approval from the Department to begin allowing elective admissions or performing elective surgeries or procedures.
Suspension of Services
Hospitals that have suspended services or intend to suspend services in their response to COVID-19 must report those suspensions of services through PSRS as infrastructure failures.
Alternative Use of Space
Hospitals that have decreased services, including elective surgical services, must assess if their facility can be used to accommodate hospital surge, including providing low acuity patients overnight accommodations and care, offer testing, or other COVID-19 related services. Hospitals must prepare to make any reasonable accommodations or arrangements to allow for an alternative use of space in response to COVID-19, including obtaining food, equipment, and supplies. Please contact your Regional Healthcare Coalitions regarding your facility’s role in the regional medical surge plan.
If a hospital accommodates an alternative use of its space in its response to COVID-19, it must report that alternative use through PSRS and describe how that use is related to a COVID-19 response.
Hospitals do not need approval from the Department to implement an alternative use of space in response to COVID-19.
Use of New Space and Alterations or Renovations of Existing Space
If a hospital needs to use new space or alter or renovate existing space in their response to COVID-19, the hospital must update its Emergency Preparedness Plan to include a description of the new use, alteration or renovation. The hospital must then amend its PSRS report implementing its Emergency Preparedness Plan to include a brief description of the new use or alteration or renovation. The description must include a statement that the new use, alteration or renovation is related to the facility’s response to COVID 19. The term “COVID-19” must be used. If the space is being use for patient care, the description must include the type of patients to be cared for in that space.
A hospital may also use space in another health care facility licensed by the Department with the agreement of the other licensed facility. If the space is located in a licensed or registered ambulatory surgical facility and the hospital has submitted an amended PSRS report as described in this section, the hospital does not need the Department’s approval to use the space. If the space is located in a licensed nursing care facility, in addition to the PSRS reporting requirements, the hospital administrator jointly with an administrator of the nursing care facility must contact the Department’s Division of Nursing Care Facilities and provide written notice of the intended use.
Any time new space is used, or a space is altered or renovated, that information must be included in the hospital’s emergency preparedness plan and an amended PSRS report must be submitted and it must include the information described above.
Prior to use, the facility must determine the new space or altered, or renovated space is safe for its intended use and the hospital must plan to staff and equip the space to provide safe care.
Hospitals must maintain documentation of new spaces being used, or spaces being altered or renovated, with dates of initiation and cessation of use, to be part of their internal emergency response documentation.
Department approval is not needed for a hospital to use new space or alter or renovate space in their response to COVID-19, if the above reporting requirement is satisfied.
Hospitals must discontinue use of any new, altered or renovated space upon the expiration of the Governor’s Proclamation of Disaster Emergency issued on March 6, 2020.
Hospital Laboratory Testing
The Department is revising its previous guidance to clarify hospitals must obtain approval from the Department’s Bureau of Laboratories (BOL) to conduct testing for COVID-19. If a hospital’s laboratory has not already obtained approval from BOL for COVID-19 testing, the laboratory must contact BOL as soon as possible via e-mail at RA-DHPACLIA@pa.gov with the laboratory’s name, Pennsylvania clinical laboratory permit number, and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number. Laboratories that wish to conduct testing and require approval in order to do so must also submit a Change of Status Form to the BOL via email, fax or mail.
Hospitals and health systems approved to perform testing are asked not to restrict testing to only specimens received from their own health system-based providers.
Laboratories that adopt a COVID-19 test that has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) must follow the manufacturer’s instructions/package insert. Laboratories that are certified under CLIA to perform moderate or high complexity testing must verify the performance of the tests, as required by CLIA.
Laboratories that develop their own tests for COVID-19 must be CLIA-certified to perform high complexity testing and must apply for an EUA by following the process described in the FDA document Policy for Diagnostic Tests for Coronavirus Disease-2019. The BOL can provide the FDA-required confirmatory testing to laboratories that are seeking an EUA. Confirmatory testing may be performed at other laboratories that are already testing with an existing EUA.
Per Pennsylvania reportable disease regulations regarding Public Health Emergencies, laboratories must report all COVID-19 test results, both positive and negative, to the Department’s electronic surveillance system, PA-NEDSS.
PSRS Reporting for COVID-19 Positive Patients
Hospitals are not required to report the presence of a patient who has tested positive for COVID-19 through PSRS as an infrastructure failure. However, if there is an occurrence involving or relating to a COVID-19 positive patient that would meet the MCARE definition of incident, serious event, or infrastructure failure, those occurrences must still be reported. This does not replace the NEDSS reporting requirement described in the previous section for all patients who undergo COVID-19 testing.
MCARE – Patient Safety and Infection Control Committee Meetings
While the disaster proclamation remains in effect, hospitals may handle their Patient Safety Committee meetings electronically. This can be accomplished by having the patient safety officer provide updates to the committee and get feedback on critical patient safety issues that may be occurring at the hospital outside of the COVID-19 response. Hospitals may conduct virtual meetings with the committee members, allowing for two-way communication for all participants.
While the disaster proclamation remains in effect, Infection Control Committee requirements can be met by maintaining daily documentation of the infection control efforts that are taking place at the hospital. Maintaining this documentation will satisfy the infection control committee requirements imposed through MCARE and the Department’s regulations.
Hospital staff and administrators should use screening protocols as outlined in their Emergency Preparedness and Infection Control Plan. In accordance with current CDC guidance, health care personnel with even mild symptoms of COVID-19 should consult with occupational health before reporting to work. If symptoms develop while working, health care personnel must cease patient care activities, don a facemask (if not already wearing), and leave the work site immediately after notifying their supervisor or occupational health services.
This guidance is intended to assist with hospital response to COVID-19. With the Governor’s authorization as conferred in the disaster proclamation issued on March 6, 2020, all statutory and regulatory provisions that would impose an impediment to implementing this guidance are suspended. Those suspensions will remain in place while the proclamation of disaster emergency remains in effect.
Any new services or projects of a hospital unrelated to COVID-19 should be undertaken in accordance with the Department’s statutory and regulatory standards.
This updated guidance will be in effect immediately and through the duration of the Governor’s COVID-19 Disaster Declaration. The Department may update or supplement this guidance as needed.