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515 MAIN STREET

OLEAN, NY 14760

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on medical record review, document review, and interview, the facility did not ensure that a negative COVID-19 (SARS-CoV-2 RNA) test was resulted prior to the start of elective surgery in accordance with facility policy for 4 out of 8 patients (Patient #12, 13, 18 and 19).

Findings include:

Review of medical records revealed the following:
-Patient #12 underwent surgery for a left rotator cuff tear on 07/22/20. COVID-19 testing was obtained on 07/17/20 with the result pending at the time of surgery.
-Patient #13 underwent surgery for carpal tunnel release on 07/22/20. COVID-19 testing was obtained on 07/17/20 with the result pending at the time of surgery.
-Patient #18 underwent surgery for a left knee repair on 07/22/20. COVID-19 testing was obtained on 07/17/20 with the result pending at the time of surgery.
-Patient #19 underwent surgery for a right rotator cuff tear on 07/22/20. COVID-19 testing was obtained on 7/17/20 with the result pending at the time of surgery.

Review of facility policy titled "COVID-19 Surgical Patient Process", last revised 06/16/20 revealed all CMS and/or State guidelines will be followed when preparing a patient for surgery. All COVID "diagnostic" (nasal swab) laboratory testing must be performed within five days of surgical procedure. Patient must have a negative COVID-19 result by the day of surgery, or the procedure will be delayed, postponed or cancelled.

Review of New York State Department of Health guidance dated 06/14/20 for Resumption of Non-Essential Elective Surgeries and Non-urgent procedures in Hospitals, Ambulatory Surgery Centers, Office based Surgery Practices and Diagnostic and Treatment Centers revealed the April 29th directive included a requirement that hospitals test all patients receiving elective surgeries and procedures for COVID-19 and patients must test negative using a molecular assay for detection of SARS CoV-2 RNA prior to such surgery or procedure. Test results must be received and reviewed before conducting the surgery or procedure.

Interview on 07/22/20 at 02:00PM with Staff (D), MD Senior VP revealed the facility currently does not have the capability for rapid COVID-19 testing and relies upon the local heath department and labs for SARS-CoV-2 RNA testing prior to elective surgeries. They have experienced recent challenges getting the test results back in 5 days. Staff (D) stated that for elective surgery cases where results for COVID-19 were not received the day of surgery, a COVID-19 antibody test was obtained and resulted and a decision was made to proceed with the surgery despite not having the SARS CoV-2 RNA results.

Interview on 07/22/20 at 02:15PM with Staff (A), Systems Director of Quality and Staff (LL), RN QI, Clinical Coordinator verified these findings.