Coppe Laboratories

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the general supervisor, the laboratory did not evaluate the accuracy for fifteen of fifteen ungraded PT results in event two of Tick Transmitted Diseases (TTD) in 2022. Findings include: 1. Review of College of American Pathologists (CAP) PT records showed CAP entered notes for the ungraded analytes stating "Educational Challenge" for fifteen results for TTD-B 2022. Further review showed the laboratory did not evaluate the accuracy of the fifteen results to include three Borrelia burgdorferi IgM results, three Borrelia burgdorferi IgG results, three Babesia microti IgG results, three Anaplasma phagocytophilum IgM results and three Anaplasma phagocytophilum IgG results. 2. Review of CAP PT evaluation for the event showed one of three Babesia microti IgG results obtained by the laboratory did not concur with the expected results provided in the evaluation. 3. Interview with the general supervisor on March 23, 2023 at 11:55 AM confirmed the laboratory did not evaluate the accuracy for fifteen of fifteen ungraded educational challenge PT results for the Tick Transmitted Disease testing for event two in 2022. D5781

Summary Statement of Deficiencies 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 surveyor review of testing records, observation of test orders, and interview with testing personnel and the technical supervisor, the laboratory failed to report approximately 2200 positive or negative SARS CoV-2 test results for samples received from a Clinical Research Organization (CRO) without a subject's name or address since the laboratory began testing for the CRO in May 2020. Findings include: 1. Review of worksheets for SARS CoV-2 testing showed the laboratory performed tests using the CDC (Centers for Disease Control and Prevention) and Euroimmun EUA (Emergency Use Authorization) test systems. 2. Observation of test orders on May 6, 2021 at 9:00 AM for SARS CoV-2 testing from a CRO showed the orders included the subject's initials, an identification number, and date of birth. An additional specimen identification number was also on the order added by the testing laboratory. The order did not include the subject's name or address. 3. Interview with testing personnel (staff A) on May 6, 2021 at 1:00 PM revealed the laboratory did not report positive or negative SARS CoV-2 test results to public health for samples received from a Clinical Research Organization (CRO) without a subject's name or address. 4. Interview with the technical supervisor (staff B) on May 6, 2021 at 2:00 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- PM confirmed the laboratory did not report results to public health from samples received from a CRO without a subject's name or address. Further interview confirmed the contract between the laboratory and the CRO did not address the responsibility for reporting results from these samples to the state health department. 5. Email communication with staff B on May 7, 2021 at 12:01 PM confirmed the CRO laboratory did not report SARS CoV-2 test results from samples tested at this laboratory to state public health entities. 6. Email on May 25, 2021 at 1:59 PM confirmed the laboratory tested approximately 2200 samples without a subject's name or address from a CRO. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of proficiency testing (PT) reports and interview with the technical supervisor, the laboratory director did not verify the accuracy of Anaplasma phagocytophilum immunoglobulin testing for two of two ungraded results in 2018. Findings include: 1. Review of College of American Pathologist (CAP) PT reports for the first event of 2018 showed the laboratory reported "positive" for specimen TTD-03 for the Anaplasma phagocytophilum immunoglobulin M (IgM) test. The PT provider did not grade the result; sixty percent of reporting laboratories reported "negative". The laboratory's records did not include a review of the ungraded result to verify the accuracy of the test system. 2. Review of CAP PT reports for the second event of 2018 showed the laboratory reported "positive" for specimen TTD-05 for the Anaplasma phagocytophilum immunoglobulin G (IgG) test. The PT provider did not grade the result; seventy-seven percent of reporting laboratories reported "negative". The laboratory's records did not include a review of the ungraded result. 3. Interview with the technical supervisor, staff A, on March 6, 2019 at 10:45 AM confirmed the laboratory director did not evaluate the accuracy of Anaplasma phagocytophilum immunoglobulin results for the two ungraded samples in 2018. Item 2: Based on surveyor review of proficiency testing (PT) reports and interview with the technical supervisor, the laboratory director did not verify the accuracy of the class designation reported for peanut allergy for three ungraded results in 2018. Findings include: 1. Review of College of American Pathologists (CAP) PT reports for the first Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- event of 2018 showed the laboratory reported "Class Four" for specimen SE-03 for peanut allergy. Seventy-eight percent of laboratories reported "Class Two". The laboratory director noted, "Will monitor" on the report. 2. Review of CAP PT reports for the second event of 2018 showed the laboratory reported "Class Four" for specimen SE-07 for peanut allergy. Eighty-eight percent of laboratories reported "Class Two". The laboratory director noted, "Will monitor" on the report. 3. Review of CAP PT reports for the third event of 2018 showed the laboratory reported "Class Four" for specimen SE-12 for peanut allergy. Eighty-seven percent of laboratories reported "Class Two". The laboratory director noted, "Will monitor" on the report. 4. Interview with the technical supervisor, staff A, on March 6, 2019 at 11:15 AM confirmed the laboratory director did not verify the accuracy of the class designation reported for peanut allergy for three immunology PT events in 2018. -- 2 of 2 --