Mclaren Northern Michigan Medcenter-Petoskey South

Summary Statement of Deficiencies D1002 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 record review and interview with the laboratory liaison (LL), the laboratory failed to report SARS-Co-V-2 test results as required for 6 (October - December 2020 and January - April 2020) of 6 months of patient testing. Findings include: 1. A record review revealed the laboratory was using 2 different methods of Covid testing as follows: a. BD Veritor Plus Analyzer - started testing on 10/22/2020 b. Cepheid GeneXpert - started testing on 11/23/2021 2. When queried on 4/21/2021 at 10:54 am, the LL informed the surveyor that the laboratory failed to report all patient testing to the health department. 3. An interview on 4/21/2021 at 10:54 am, the LL confirmed the laboratory failed to report all patient testing to the health department, they were reporting only the positive test results. D5781

Summary Statement of Deficiencies D1002 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 record review and interview with the laboratory liaison (LL), the laboratory failed to report SARS-Co-V-2 test results as required for 6 (October - December 2020 and January - April 2020) of 6 months of patient testing. Findings include: 1. A record review revealed the laboratory was using 2 different methods of Covid testing as follows: a. BD Veritor Plus Analyzer - started testing on 10/22/2020 b. Cepheid GeneXpert - started testing on 11/23/2021 2. When queried on 4/21/2021 at 10:54 am, the LL informed the surveyor that the laboratory failed to report all patient testing to the health department. 3. An interview on 4/21/2021 at 10:54 am, the LL confirmed the laboratory failed to report all patient testing to the health department, they were reporting only the positive test results. D5781

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to authorize the release of their American Proficiency Institute (API) proficiency testing reports to the Health and Human Services (HHS) regulatory agency for two (2017 and 2018) of two years reviewed. Findings include: 1. On January 15, 2019 at 12:15 PM, record review of the CMS database and the API proficiency testing reports revealed there was no documentation to show the facility authorized the release of their reports to the HHS regulatory agency for 2017 and 2018. 2. On January 15, 2019 at 12:15 PM when requested, testing personnel #3 as listed on the CMS-209 called API to investigate and was informed that API did not have the facilities CLIA number on file to report results to HHS. 3. During the interview on January 15, 2019 at 12:15 PM, testing personnel #3 confirmed proficiency testing program was not given the authority to release results to HHS. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory 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 -- director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require