Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on the review of the laboratory's records API Proficiency Testing (PT) the laboratory failed to include CEA as part of PT module for year 2020 through survey date. It was confirmed on an interview with the laboratory technical consultant on 10/6 /2022 about 2pm. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview with the technical consultant, the laboratory failed to establish written policies and procedures for specimen storage. FINDINGS: 1. The laboratory failed to provide written policies and procedures for specimen storage. 2. The laboratory failed to provide temperature log of patient specimen storage refrigerator. 3. The technical 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 -- consultant confirmed on 10/6/2022 at approximately 2pm, the laboratory failed to establish written policies and procedure of blood specimens storage. 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 review of New Control Lot Validation Method procedure and lack of new control lot validation records for Beckman AU680, Beckman DXH800, Tosoh G8 and Beckman DXI600, the laboratory failed to follow the procedure to validate by running new lot control 20 times over 5 days. The technical consultant confirmed in an interview on 10/6/2022 about 12:00pm, the laboratory failed to follow the written procedure. 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)