Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), lack of manufacturer's instructions, as well as interview with Testing Personnel (TP), the laboratory failed to retain and follow waived test manufacturer's instructions. FINDINGS: 1. There was no documentation of waived test manufacturer instructions for the hCG urine pregnancy test cassettes; Jant Pharmacal Corporation; lot: 2304070; expiration: March 31, 2025. 2. The current SOPs did not include instructions for performing respective waived testing. 3. The TP confirmed the findings on July 30, 2025, at approximately 2: 30 P.M. 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 SOPs, personnel competency assessment records, as well as interview with the TP, the laboratory failed to perform and document competency assessments. FINDINGS: 1. There was no documentation of competency assessment performance for the Clinical Consultant (CC), Technical Supervisor (TS), and General Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Supervisor (GS). 2. The current SOPs did not include instructions for performing CC, TS, and GS competency assessments. 3. It was noted that Histotechnician TP competency assessment was performed and documented. 4. The TP confirmed the findings July 30, 2025, at approximately 11:30 A.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)