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Guidance on Ambulatory Surgical Facilities' Responses to COVID-19

May 23, 20201

The Department of Health (Department) has received questions and requests for guidance from ambulatory surgical facilities (ASFs), 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 27, 2020.

Emergency Preparedness Plan

ASFs should incorporate any actual or anticipated emergent needs or actions associated with their COVID-19 response into their Emergency Preparedness Plan and implement the Plan. Emergent needs include the suspension of services and facility operations and the alternative use of space. Prior to or upon implementation, ASFs must report into the Pennsylvania Patient Safety Reporting System (PSRS) that they have or intend to implement their Emergency Preparedness Plan.

Additional details for required reporting of plan elements is described in later sections of this guidance.

ASFs 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 must be reported.

Elective Surgeries and Procedures

ASFs may begin performing elective surgeries and procedures if the ASF makes an affirmative decision that it is able to do so without jeopardizing the safety of patients and staff or the ASF's ability to respond to the COVID-19 emergency. In determining whether an ASF is able to support elective admissions, surgeries and procedures, the ASF 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 to the extent applicable to ASFs. ASFs that provide pediatric treatment and care should additionally review the guidance from the Children's Hospital Association of the United States, to the extent applicable to ASFs, when determining whether to proceed with pediatric elective surgeries and procedures.

ASFs must comply with the PSRS reporting requirements described in the next section if the ASF intends to resume elective procedures and surgeries pursuant to this guidance. ASFs do not need approval from the Department to begin performing elective surgeries or procedures.

Suspension of Services and Reporting

ASFs that have suspended surgical services or facility operations must report those suspensions through PSRS as infrastructure failures within 24 hours of implementation. This may be done in the Emergency Preparedness Plan PSRS report described earlier in this guidance or as a separate report.

In either case, on the report, under the "describe the event" section, ASFs must include a statement that the surgical services and/or operations are being suspended in response to COVID-19. The term "COVID-19" must be included in this section. The report must also include anticipated closure dates. ASFs must amend their PSRS report within 24 hours of resuming services or facility operations.

ASF Mandatory Survey

Pursuant to the Amended Order of the Secretary of Health, issued on April 1, 2020, all facilities licensed as ASFs, including those that have suspended services, must complete and submit an initial survey to the Department. All fields must be completed for the initial submission. For ASFs that have not suspended services in response to COVID-19, the ASF must complete the fields of the survey indicated to be mandatory at 0800 on every day the ASF is in operation. Further, if any non-mandatory field has changed from the initial submission, the ASF must update that field on the next calendar day's submission. An ASF that has reopened after a period of suspended services must complete the survey on the first day of its reopening and every operational day thereafter, in addition to the other reporting requirements described in this Guidance.

Visitor Policies

ASFs should take any appropriate measures to protect patient and staff safety. This includes limiting visitor access to the ASF. ASFs do not need the Department's approval to implement a new visitor policy in response to COVID-19.

Alternative Use of Space

ASFs 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. ASFs 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. Facilities should coordinate with their Regional Healthcare Coalition to determine their appropriate roles within the region's medical surge plans and processes.

If an ASF implements an alternative use of its space in its response to COVID-19, it must report that alternative use through PSRS and briefly describe how that use is related to a COVID-19 response.

ASFs do not need approval from the Department to implement an alternative use of space in response to COVID-19.

ASF COVID-19 Laboratory Testing

ASFs that intend to provide COVID-19 testing to patients and staff must hold the appropriate CLIA certificate type and a state laboratory permit and be approved for COVID-19 testing. If an ASF does not have a state laboratory permit and CLIA certificate or has not already obtained approval from the Department's Bureau of Laboratories (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 or ASF's name, address, Pennsylvania clinical laboratory permit number (if applicable), and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number (if applicable) and a brief description of the ASFs intended testing plan.

For additional information on CLIA certification requirements for COVID-19 testing, please review PA HAN 505.

Per Pennsylvania's reportable disease regulations, laboratories must report all COVID-19 test results, both positive and negative, to the Department's electronic surveillance system, PA-NEDSS. If the ASF is not currently a PA-NEDSS registered user, please consult the Registration Procedures document and complete the Contact Information form and return to the Department as described in the instructions.

ASFs that do not have their own laboratory and do not want to become authorized to perform their own testing may utilize a commercial laboratory with the appropriate authorizations to conduct COVID-19 testing.

PSRS Reporting

ASFs are not required to report the presence of a patient or staff member who has tested positive for COVID-19 through PSRS as an infrastructure failure. However, if the ASF conducted the COVID-19 testing, the ASF must comply with the PA-NEDSS reporting requirements described in the previous section.

If there is an occurrence involving or relating to a COVID-19 positive patient or staff member that would meet the MCARE definition of incident, serious event, or infrastructure failure, those occurrences must still be reported.

Equipment and Supplies

The Department encourages ASFs who have suspended services and facility operations and are otherwise unable to accommodate hospital surge or other alternative services to donate or provide equipment and supplies to hospitals and other facilities providing assistance in the response to COVID-19. Please contact your Regional Healthcare Coalition or County Emergency Management Agency if assistance in coordinating these efforts is needed.

Other Information

ASF staff and administrators should use screening protocols as outlined in their 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, wear 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 ASF response to COVID-19. Any new services or projects of an ASF unrelated to COVID-19 should be undertaken in accordance with the Department's statutory and regulatory standards.

With the Governor's authorization as conferred in the Proclamation of Disaster Emergency issued on March 6, 2020, all statutory and regulatory provisions that would impose an impediment to implementing the guidance outlined in this letter are suspended.  Those suspensions will remain in place while the proclamation of disaster emergency remains in effect. 

1 Text in red indicates updated language from the Guidance issued on April 27, 2020.