Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the review of laboratory's Standard Operating Procedure 3.3 Specimen Handling step f, the procedure failed to include second identifier unique to the patient. Confirmed finding on an interview with testing person on 5/12/2023 about 12:30pm. 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 the laboratory's standard procedure manual, lack of a written Quality Assessment (QA) procedure and an interview with the laboratory testing person, the laboratory failed to establish a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems. FINDINGS 1. The laboratory's standard operating procedure manual did not contain a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems. 2. The testing person confirmed on 5/12/2023 at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- approximately 12:45 PM, that the laboratory did not have a written procedure to monitor, evaluate all phases of laboratory testing. 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)