Guidance on Hospitals' Responses To COVID-19
UPDATED November 3, 2022
The Department of Health (Department) continues to receive 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 most recently updated on July 1, 2022.
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:
- 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 prior report indicating their Emergency Preparedness Plan has been implemented must ensure their report includes the above information. If it does not, it must be amended accordingly.
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.
A PSRS report may only be amended for a 90-day period. If a hospital receives notices through PSRS that it has reached its 90-day amendment limit, the hospital must enter a new report and indicate the report is a continuation of the prior emergency preparedness plan reporting and include the report number of the original PSRS report submitted under this section. The hospital must then continue to report as prescribed through this guidance.
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 CORVENA (previously known as Knowledge Center) and PA-NEDSS
In accordance with the Secretary of Health's Order Requiring Hospitals to Make Daily Reports of Specified Data Regarding Supplies and Equipment, dated March 24, 2020, as amended on July 10, 2020, January 27, 2021, and August 13, 2021, all hospitals must complete the Essential Elements of Information (EEI) data collection tool in CORVENA (formerly Knowledge Center) one time per day at 1000 as instructed in the Amended Orders.
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.
Additionally, all hospitals must submit a COVID-19 report to PA-NEDSS (listed as PA-NEDSS condition "coronavirus, novel 2019") indicating that a patient was hospitalized, when the hospitalization is attributed to COVID-19. Hospitalizations attributed to COVID-19 include hospitalizations where COVID-19 is documented as the patient's admitting or primary diagnosis or COVID-19 has contributed to the admitting or primary diagnosis. Hospitalizations where COVID-19 was an incidental finding on an admission screening do not need to be reported.
The reporting requirement is intended to improve the completeness of COVID-19 hospitalization data reported to the Department through PA-NEDSS. As indicated in the Amended Order, hospitalization status shall be entered by the hospital on the PA-NEDSS Clinician Short Form if the hospitalization was attributed to COVID-19. This requires manual entry into PA-NEDSS only once, at the time of admission.
While some laboratory information systems can send hospitalization data as part of the "Ask on Order Entry" ELR report, for purposes of compliance with the Amended Order, laboratory reporting of hospitalizations is not an acceptable substitute for clinician reporting. Laboratory reporting is often incomplete or incorrectly formatted, the patient's test may precede a subsequent hospitalization, or the positive test result may be an incidental finding on admission screening; and, therefore is not appropriate for reporting hospitalizations attributed to COVID-19. Laboratory staff should not alter their current ELR message content as a result of this reporting requirement.
Failure to report daily through CORVENA or update reports in PA-NEDSS in accordance with the amended Order may result in the imposition of sanctions as authorized under the Health Care Facilities Act, including the imposition of a provisional license and/or a civil monetary penalty.
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.
While hospitals are entitled to discretion in the implementation of visitor policies, the terms of those policies must adhere to Federal and State law. Specifically, a hospital, through its visitor policy, cannot deny access to an attendant, caregiver or family member of a patient who has an intellectual, developmental or cognitive disability, communication barrier, or behavioral concerns.
The Department also strongly encourages that hospitals, through their visitor policies, allow for the following:
- the presence of a patient support person at the patient's bedside for patients in labor and delivery and pediatric patients;
- the presence of a patient's doula, in addition to the patient's support person, for labor and delivery patients; and
- visitors for patients receiving end-of-life care.
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 allow elective admissions and may perform 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. Acute Care Hospitals in a Region subject to a Reduction Notice or Extension Notice must reduce the performance of elective procedures in accordance with the Secretary's Order.
Hospitals that have resumed performing 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 in their response to COVID-19 must resume those services as soon as practical and must update their initial or updated PSRS report to indicate that those services are no longer suspended. Alternatively, if the hospital will cease to offer the services permanently, the hospital must submit a notice in accordance with 28 Pa. Code § 51.3 (c).
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, offering testing, or providing 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.
In accordance with Section 802-A(a.3) of Act 2022-30, hospitals must discontinue use of alternative space upon expiration of the U.S. Department of Health and Human Services (US DHHS) waivers of 42 CFR §482.41 and 42 CFR §485.623, unless discontinuation is required earlier by the Department.
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. This section does not authorize the use of a patient's home as a new space for patient care. For guidance on the provision of acute care services in a patient's home, please refer to the section titled "Acute Care at Home" below.
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. However, the ambulatory surgical facility must suspend its services while the hospital is using the site as an alternative care site. A hospital and an ambulatory surgical facility that has allowed the hospital to use its facility as an alternative care site may not occupy and use the ambulatory surgical facility simultaneously and a hospital may not occupy or use space in an ambulatory surgical facility on an intermittent, scheduled basis (i.e. a hospital may not operate the ambulatory surgical facility as an alternative care site on Tuesdays and Thursdays while the ambulatory surgical facility operates on Mondays, Wednesdays, and Fridays). 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. If the space would require the use of an inpatient hospice unit, in addition to the PSRS reporting requirements, the hospital administrator must contact the Division of Home Health 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.
In accordance with Section 802-A(a.3) of Act 2022-30, hospitals must discontinue use of any new, altered, or renovated space upon expiration of the US DHHS waivers of 42 CFR §482.41 and 42 CFR §485.623, unless discontinuation is required earlier by the Department.
Acute Care at Home
Hospitals that have been approved by the Centers for Medicare & Medicaid Services (CMS) to participate in the Acute Hospital Care at Home (AHCH) program may provide acute care inpatient services to patients in their home in accordance with the AHCH requirements and this section. Specifically, a participating hospital must meet the following requirements:
Daily Patient Visits
- Once daily for Medical Doctor (MD)/Advanced Practice Provider (APP). This visit can be remote after the initial in-person History and Physical Exam performed by the admitting MD/APP consistent with hospital policies.
- At least once daily in-person or remote Registered Nurse (RN) visit who develops a nursing plan consistent with hospital policies.
- At least two in-person daily visits by either an RN or Mobile Integrated Health paramedics, depending on the established nursing plan.
Minimum Services (in addition to medical and nursing)
- Respiratory care including oxygen delivery
- Diagnostics (labs, radiology)
- Monitoring with at least 2 sets of patient vitals daily
- Food services including meal availability as needed by the patient
- Durable Medical Equipment
- Physical, Occupation, and Speech Therapy
- Social Work and care coordination
- Immediate, on-demand remote audio connection with an AHCH team member who can immediately connect either an RN or MD to the patient.
- In-home appropriate emergency personnel team to the patient's home within 30 minutes. This can be provided by 911 or emergency paramedics.
Prior to offering Acute Care at Home services, a hospital must submit to the Department documentation evidencing submission of a waiver request to CMS and documentation of CMS's approval. The documentation must be submitted to the Division of Acute and Ambulatory Care (DAAC) via e-mail at RA-DAAC@pa.gov and the hospital's DAAC Field Office Health Facility Quality Examiner (HFQE) must be copied on the e-mail communication. Once the approval documentation is submitted to the Department, the hospital may begin to offer the services to patients. Department approval is not required and a PSRS report does not need to be entered or amended prior to operationalizing the program. However, hospitals must continue to report through PSRS, as required by MCARE, any incidents, serious events, or infrastructure failures relating to acute care services provided in the home. When participating in the program, the patient's home is considered an extension of the hospital. The hospital must determine whether inpatient acute care can be safely provided in each patient-participant's home and is responsible for adequate staffing, equipment, and services as needed by the patient and described in this section. Documentation of a patient's inpatient care at their home must be consistent with existing hospital policies and procedures for inpatient admissions.
Patient participation in any Acute Care at Home program must be voluntary and may only be offered to patients who meet the patient selection criteria and screening protocols approved by CMS. In addition to the above criteria, the Department recommends an infection prevention and control (IPC) consultation is conducted by an infection preventionist or designated RN that would be well-positioned to educate on IPC measures, as resources allow. This best practice approach can be on-site or remote, and is intended to ensure that the patient-participant and their household contacts, as well as visiting clinical staff, can implement and maintain IPC practices consistent with guidance in PA-HAN-524, or its successor.
A hospital's use of a patient's home to provide hospital services that is not consistent with this section is prohibited.
In accordance with Section 802-A(a.3) of Act 2022-30, hospitals must discontinue acute care at home programs upon expiration of the US DHHS waivers of 42 CFR §482.23(b) and (b)(1), unless discontinuation is required earlier by the Department.
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, 28 Pa. Code §§ 27.1-27.51, laboratories must report all COVID-19 test results, both positive and negative, to PA-NEDSS.
Mandatory Patient Testing for COVID-19 Prior to Discharge to a Receiving Facility
Hospitals treating inpatients who will be discharged to a nursing care facility, personal care home, assisted living residence, or intermediate care facility must test the patient for COVID-19 prior to discharging the patient. Patients who are not currently exhibiting symptoms of COVID-19 and who tested positive for COVID-19 within the last 90 days do not need to be tested prior to discharge. Patients who are not currently exhibiting symptoms of COVID-19 and who are fully vaccinated, as defined by the CDC, also do not need to be tested prior to discharge.
For patients requiring a test under this section, the test must be administered within the 72-hour period prior to discharge, and the result must be obtained prior to discharge. If a test is administered upon admission to the facility, and the resident is discharged within the 72-hour period, a second test is not required.
Hospitals that do not have their own laboratory that has been approved to perform COVID-19 testing must utilize a commercial laboratory. If a patient tested positive for COVID-19 prior to admission to the hospital, the hospital does not need to test the patient again under this section.
Prior to discharge, the hospital must communicate the result of the test to the receiving facility. Patients with a positive COVID-19 test result should only be discharged to a facility with the ability to adhere to infection prevention and control recommendations of the Department and the CDC for the care of COVID-19 patients. Receiving facilities that meet this criteria may not refuse to accept or readmit a patient or resident with a positive COVID-19 test result but may refuse to accept a patient-resident if a COVID-19 test has not been administered.
PSRS Reporting for COVID-19 Outbreaks
Hospitals are required to report outbreaks of COVID-19, as defined by Pennsylvania Health Alert Network (PA-HAN) 540 - 12/09/20 – ADV – Hospital Outbreak Identification and Reporting for COVID-19, or its successor, into PSRS as a new infrastructure failure. Hospitals must adhere to the guidance in the HAN regarding how to report an outbreak. This outbreak reporting requirement does not replace the NEDSS reporting requirement described in the previous section for all patients who undergo COVID-19 testing or the reporting of COVID-19 cases, capacity data, or other reporting requirements that are part of state and federal COVID-19 surveillance (i.e. CORVENA, the COVID TeleTracking system, or the National Health Safety Network (NHSN)).
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.
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 and as extended on June 3, 2020, August 31, 2020, and on November 24, 2020, all statutory and regulatory provisions that would impose an impediment to implementing this guidance are suspended. Pursuant to Section 802-A(a.3) of Act 2022-30, suspensions of regulations related to Federal exemptions granted under the Federal Public Health Emergency (PHE) may continue through the Federal PHE unless sooner terminated by the Department. Suspension of the Department's regulations that have not been extended by Section 802-A(a.3) have been terminated, effective November 1, 2022.
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 October 31, 2022. The Department may update or supplement this guidance as needed.
Red text indicated substantive updates made to the Guidance on Hospitals' Responses to COVID-19 provided on July 1, 2022.