Southside Community Health Services

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 record review, interview with laboratory personnel, and email communication, the laboratory failed to report SARS-CoV-2 negative test results for 106 of 168 days reviewed from October 2020 through November 2021. In addition, the laboratory failed to retain documentation of SARS-CoV-2 result reporting for 168 of 168 days reviewed from October 2020 through November 2021. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing using the Quidel Sofia SARS Antigen FIA test as confirmed by the Laboratory Director during the entrance interview at 1:20 p.m. on 11/02/21. 2. In the interview at 1:20 p.m. on 11/02/21, Testing Personnel 1 (TP1) indicated negative SARS-CoV-2 results had not been reported to the appropriate health authorities from test implementation in June 2020 through 05/20/21. 3. Quidel Sofia2 SARS Antigen FIA (COVID) Test patient testing logs were reviewed on date of survey. A test record spreadsheet, provided by the LD via email on 11/09/21, was also reviewed. The documents included testing dates and the number of positive and/or negative results obtained each day of testing from 10/01 /20 - 11/02/21. Days of non-reporting are indicated below. 2020 Days not reported October 21 November 17 December 12 2021 Days not reported January 12 February 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 -- 10 March 15 April 14 May 7 4. 233 negative SARS-CoV-2 test results were not reported as required from 10/01/20 through 05/20/21 as indicated on the test record spreadsheet. 5. The laboratory performed 256 SARS-CoV-2 tests between 10/01/21 and 05/20/21 as indicated on the test record spreadsheet. 6. Documentation of SARS- CoV-2 result reporting was not found during review of laboratory records. The laboratory was unable to provide this documentation upon request. 7. The laboratory performed 373 SARS-CoV-2 tests on 168 days from 10/01/21 through 11/02/21 as indicated on the test record spreadsheet. 8. In an interview at 3:35 p.m. on 11/02/21, TP1 confirmed the above findings. TP1 indicated all positive results had been reported to the appropriate health authorities but negative results were not reported until after 05/20/21. TP1 also indicated the reported results were sent to the health authorities via fax but the fax confirmation pages had not been retained. -- 2 of 2 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory director failed to ensure initial training and competency assessment was performed prior to testing patient specimens for one testing personnel. Findings are as follows: 1. The laboratory performed Vaginal Wet Preparation microscopic examinations as confirmed by The Laboratory Director (LD) during a tour of the laboratory on 11/02 /21 at 1:10 p.m. 2. An Abco microscope were observed as present and available for use during the tour of the laboratory. 3. Testing Personnel 1 indicated Testing Personnel 3 (TP3) was employed by the laboratory prior to the previous survey on 11 /08/19. TP3 was not included on the Laboratory Personnel Report (CLIA) Form CMS- 209 in 2019. 4. The Wet Prep/KOH patient testing logs indicated TP3 had performed testing of patient specimens in 2020 and 2021. See below. 2020 Month Number of tests October 3 2021 Month Number of tests May 1 June 1 5. The Technical Competency procedure located in the Laboratory Policies and Procedures manual indicated all personnel were evaluated for competency prior to working in the laboratory. 6. The Competency Assessment form for TP3 found during survey indicated the initial competency assessment was performed on 10/15/21. 7. In an interview at 2:05 p.m. on 11/02/21, the LD confirmed the above finding. . 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 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure competency was assessed at least semi-annually during the first year of patient specimen testing for one of one testing personnel in 2021. Findings are as follows: 1. The laboratory performed Vaginal Wet Preparation microscopic examinations as confirmed by The Laboratory Director (LD) during a tour of the laboratory on 11/02/21 at 1:10 p.m. 2. An Abco microscope were observed as present and available for use during the tour of the laboratory. 3. Testing Personnel 1 (TP1) received initial competency assessment in December 2020 as indicated in personnel records. 4. The Technical Competency procedure located in the Laboratory Policies and Procedures manual indicated all personnel were evaluated for competency every six months during the first year of testing. 5. A semi-annual competency assessment for TP1 was not found during review of laboratory records. The laboratory was unable to provide the missing assessment upon request. 6. In an interview at 1:45 p.m. on 11/02/21, the LD confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Southside Community Health Service laboratory was found to be in substantial compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493, effective April 24, 2003) upon completion of the recertification survey performed on November 8, 2019. No deficiencies were cited. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --