Wilmington Health

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of personnel records, review of IFU (instructions for use), and interviews with testing personnel (TP #1) and laboratory director (LD) 4/29/21, the laboratory failed to follow manufacturer's instructions for the SARS-CoV-2 testing performed to ensure 11 of 11 TP (testing personnel) had received appropriate training for the performance of SARS-CoV-2 testing and to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. The laboratory began testing for SARS-CoV-2 using the Quidel Sophia2 Flu and SARS test system 1/29/21 and the Cepheid GeneXpert Xpress SARS-CoV-2 test system on 2 /2/21. 1. The laboratory failed to ensure 11 of 11 TP received appropriate training for the performance of SARS-CoV-2 testing. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings...All operators using your product must be appropriately trained in performing and interpreting the results of your product... and use your product in accordance with the authorized labeling." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of personnel records for TP #1, TP #2, TP #3, TP #4, TP #5, TP #6, TP #7, TP #8, TP #9, TP #10 and TP #11 revealed no documentation of training for the SARS-CoV- 2 testing performed. Interview with TP #1 at approximately 10:45 a.m. confirmed the personnel records did not contain documentation of training. She stated that she had verbally Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- trained everyone and then observed them run quality control (QC), but she did not have documentation of the training. 2. The laboratory failed to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings... Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...Authorized laboratories using your product must include with test result reports all authorized Fact Sheets." Interview with LD at approximately 10:00 a.m. confirmed the laboratory does not provide the authorized Fact Sheets to patients and providers with the SARS- CoV-2 test result reports. He stated the facility was unaware that Fact Sheets should have been provided to patients and providers. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of SARS-CoV-2 test records, review of SARS-CoV-2 reporting documentation and interview with laboratory director (LD) 4/29/21, the laboratory failed to report SARS-CoV-2 negative test results for 3 of 3 days reviewed in February and March of 2021. Findings: 1. Review of SARS-CoV-2 test records and reporting documentation for 2/16/21, 2/17/21 and 3/1/21 revealed the laboratory tested approximately 58 patients. 2. Review of SARS-CoV-2 test records and reporting documentation for 2/16/21, 2/17/21 and 3/1/21 revealed approximately 53 negative test results were not reported. 3. Interview with LD at approximately 11:00 a. m. confirmed the laboratory failed to report the negative SARS-CoV-2 test results. He stated he has been made aware of the problem cited at previous surveys occurring earlier in the week. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, and 2021 API (American Proficiency Institute) proficiency testing records and interview with TP #1 on 4/29/21, the laboratory failed to evaluate all ungraded proficiency testing results. Findings: Review of API proficiency testing results revealed the laboratory failed to evaluate the following -- 2 of 7 -- ungraded results: 1. 2019 1st Hematology/Coagulation event - no evaluation of ungraded urine sediment sample US-02 and vaginal wet prep sample VKP-01; 2. 2020 3rd Hematology/Coagulation event - no evaluation of ungraded urine sediment sample US-06. During interview at approximately 10:45 a.m., TP #1 confirmed there was no documentation that the ungraded results were evaluated to determine whether

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of personnel records, review of IFU (instructions for use), and interviews with testing personnel (TP #1) and laboratory director (LD) 4/29/21, the laboratory failed to follow manufacturer's instructions for the SARS-CoV-2 testing performed to ensure 11 of 11 TP (testing personnel) had received appropriate training for the performance of SARS-CoV-2 testing and to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. The laboratory began testing for SARS-CoV-2 using the Quidel Sophia2 Flu and SARS test system 1/29/21 and the Cepheid GeneXpert Xpress SARS-CoV-2 test system on 2 /2/21. 1. The laboratory failed to ensure 11 of 11 TP received appropriate training for the performance of SARS-CoV-2 testing. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings...All operators using your product must be appropriately trained in performing and interpreting the results of your product... and use your product in accordance with the authorized labeling." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of personnel records for TP #1, TP #2, TP #3, TP #4, TP #5, TP #6, TP #7, TP #8, TP #9, TP #10 and TP #11 revealed no documentation of training for the SARS-CoV- 2 testing performed. Interview with TP #1 at approximately 10:45 a.m. confirmed the personnel records did not contain documentation of training. She stated that she had verbally Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- trained everyone and then observed them run quality control (QC), but she did not have documentation of the training. 2. The laboratory failed to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings... Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...Authorized laboratories using your product must include with test result reports all authorized Fact Sheets." Interview with LD at approximately 10:00 a.m. confirmed the laboratory does not provide the authorized Fact Sheets to patients and providers with the SARS- CoV-2 test result reports. He stated the facility was unaware that Fact Sheets should have been provided to patients and providers. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of SARS-CoV-2 test records, review of SARS-CoV-2 reporting documentation and interview with laboratory director (LD) 4/29/21, the laboratory failed to report SARS-CoV-2 negative test results for 3 of 3 days reviewed in February and March of 2021. Findings: 1. Review of SARS-CoV-2 test records and reporting documentation for 2/16/21, 2/17/21 and 3/1/21 revealed the laboratory tested approximately 58 patients. 2. Review of SARS-CoV-2 test records and reporting documentation for 2/16/21, 2/17/21 and 3/1/21 revealed approximately 53 negative test results were not reported. 3. Interview with LD at approximately 11:00 a. m. confirmed the laboratory failed to report the negative SARS-CoV-2 test results. He stated he has been made aware of the problem cited at previous surveys occurring earlier in the week. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, and 2021 API (American Proficiency Institute) proficiency testing records and interview with TP #1 on 4/29/21, the laboratory failed to evaluate all ungraded proficiency testing results. Findings: Review of API proficiency testing results revealed the laboratory failed to evaluate the following -- 2 of 7 -- ungraded results: 1. 2019 1st Hematology/Coagulation event - no evaluation of ungraded urine sediment sample US-02 and vaginal wet prep sample VKP-01; 2. 2020 3rd Hematology/Coagulation event - no evaluation of ungraded urine sediment sample US-06. During interview at approximately 10:45 a.m., TP #1 confirmed there was no documentation that the ungraded results were evaluated to determine whether