Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted from 08/29/2023 through 09/01/2023. Additional documentation was requested for review on 09/07/2023, concluding the survey. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the laboratory' procedure, record review and interview with the Technical Supervisor of Virology, the laboratory failed to follow their own written policy in performing daily pipette cleaning tasks as part of work area preparation for 19 of 31 days in August 2023. Findings Include: a. A review of the laboratory's procedure titled, "Molecular Policies & Procedures Virology & Rabies Laboratory, Public Health Laboratory - SCDHEC" revealed on page 3 of 6 the following: "A. Work Area Preparation 1. Clean work surfaces where reagents will be prepared. Wipe down work surfaces with 2.5 to 3.5% (0.35M to 0.5M) sodium hypochlorite solution. Allow the sodium hypochlorite solution to contact surfaces for at least 1 1 minute and then follow with a deionized (D1) water rinse. Do not allow the sodium hypochlorite solution to dry. Cover the bench surface on which the reagents and samples will be prepared with clean, plastic-backed absorbent laboratory bench covers. 2. Clean a separate work surface where samples will be prepared. Use the procedure described above (Step A.1). 3. Clean any pipettors. Use the procedure described above (Step A. 1)." b. A review of the Biosafety Maintenance Log for the biosafety cabinet in Room 219 did not include instructions and documentation of A.3, pipette cleaning for the following dates where the work area was utilized: August 1-3, August 7-9, August 14- 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 -- 18, August 21-25, August 28-31 c. An interview with the Technical Supervisor of Virology on 08/31/2023 at 11:19 AM in Room 219 confirmed these findings. Word Key: SCDHEC - South Carolina Department of Health & Environmental Control 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)