Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed at Children's Medical Center-CLIA # 19D0460199 on November 30, 2020. Children's Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories perfoming moderate complexity testing; Testing Personnel 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 review of the laboratory's COVID reports and interview with personnel, the laboratory failed to report seventy two (72) negative COVID results to the state as required. Findings: 1. In interview on November 30, 2020 at 9:02 am, Testing Personnel 1 stated the laboratory began testing COVID samples on the Abbott ID Now on October 19, 2020 and ended November 19, 2020 because they ran out of kits. 2. In further interview on November 30, 2020 at 9:03 am, Testing Personnel 1 stated positive results were reported to the state. Testing Personnel 1 stated she was unaware that negative results needed to be reported. 3. Review of the laboratory's COVID 19 patient log revealed the laboratory did not report the following patients to the state as required: Total of seventy two (72) patients: Patient 4188 Patient 5476 Patient 3429 Patient 2254 Patient 2660 Patient 2687 Patient 18 Patient 1277 D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, policies and procedures, and interview with personnel, the laboratory failed to perform an assessment for two (2) of six (6) proficiency testing (PT) events. Findings: 1. Review of the laboratory's "Policy Procedure Manual" revealed "When the results of the PT come in they are signed by the general supervisor. If