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 record review and interview the laboratory failed to monitor the eyewash per their policy since received their eyewash on 10/19/2021 (See D3011). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the laboratory failed to follow manufacturer's instructions (MI) for Complete Blood Count (CBC) controls from 11 /15/2021 to 11/30/2021. Findings Included: During a tour of the laboratory on 11/24 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 -- /21 at 3:45 PM Low, Normal, and High CBC controls (Lot 1306) were observed with an open date of 11/10/2021. MI for the 3 levels of controls state "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8 C after being re-capped." Interview on 11/30/2021 at 1:31 PM the Office Manager confirmed that the controls with the open date of 11/10/2021 were still in use (20 days later). -- 2 of 2 --