Summary:
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 review of SARS-Co-V-2 test records and SARS-Co-V-2 reporting documentation 2/25/21 - 2/26/21, and interviews with staff 2/26/21, the laboratory failed to report negative SARS-Co-V-2 test results for patients from North Carolina 9 of 9 days reviewed in December 2020 and January and February 2021. Findings: 1. Review of SARS-Co-V-2 test records and reporting documentation for the period 12/1 /20 through 2/25/21 revealed the laboratory tested approximately 9386 patients from North Carolina from 12/1/20 through 2/25/21. 2. Review of SARS-Co-V-2 test records and reporting documentation for 9 random days during the period 12/1/20 through 2/25/21 revealed a total of 1518 patients from North Carolina were tested and 1494 negative results were not reported on the following days: a. On 12/2/20, the laboratory tested 171 patients from North Carolina and failed to report 170 negative test results. b. On 12/16/20, the laboratory tested 118 patients from North Carolina and failed to report 115 negative test results. c. On 12/29/20, the laboratory tested 102 patients from North Carolina and failed to report 98 negative test results. d. On 1/5/21, the laboratory tested 309 patients from North Carolina and failed to report 305 negative test results. e. On 1/8/21, the laboratory tested 168 patients from North Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Carolina and failed to report 166 negative test results. f. On 1/13/21, the laboratory tested 49 patients from North Carolina and failed to report 48 negative test results. g. On 1/26/21, the laboratory tested 231 patients from North Carolina and failed to report 223 negative test results. h. On 2/9/21, the laboratory tested 286 patients from North Carolina and failed to report 285 negative test results. i. On 2/23/21, the laboratory tested 84 patients from North Carolina and failed to report 84 negative test results. 3. During interview 2/26/21 at approximately 10:05 a.m., the corporate compliance consultant stated that with the exception of one county, the laboratory does not report negative SARS-Co-V-2 results for North Carolina patients. During interview 2/26/21 approximately 10:30 -11:00 a.m., the data entry staff confirmed that she reports both positive and negative SARS-Co-V-2 results by email to the health department in one North Carolina county, but only positive results are reported for all other counties. The data entry staff stated that both positive and negative SARS-Co-V-2 results are reported electronically to other states. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)