Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of standard operating procedures (SOPs), competency assessment records, as well as interview with the Office Manager (OM), the laboratory failed to perform and document personnel training and competency assessments. FINDINGS: 1. There was no documentation of training and competency assessment for testing personnel (TP), JS. 2. The current, approved SOPs did not include instructions for performing clinical consultant (CC), technical supervisor (TS), and general supervisor (GS) competency assessments. 3. The OM confirmed the findings on January 16, 2025, at approximately 4:30 P.M. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory systems quality assessment (QA) procedures, QA records, as well as interview with the OM, the laboratory failed to perform and document QA. FINDINGS: 1. There was no documentation of QA records for years 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 -- 2022, 2023, and 2024. 2. This is contrary to instructions indicated in the current, approved Quality Systems Assessment Plan. 3. The OM confirmed the findings on January 16, 2025, at approximately 4:30 P.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)