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 review of the laboratory policy titled "Quality Assessment Plan", the laboratory's quality assessment records, and interview with the technical consultant, the laboratory failed to follow the policy for patient test management in 2017, 2018, and 2019. The findings include: 1. Review of the laboratory policy titled "Quality Assessment Plan" revealed that the following under the section titled "Patient Test Management": We will evaluate our criteria for: a. Patient preparation, specimen collection, labeling, preservation, and transportation; b. The laboratory test requisition requirements; c. The criteria used for specimen rejection; d. The test report for completeness, usefulness and accuracy of the report information necessary for the interpretation or utilization of report; and e. The timely reporting of test results based on testing priorities such as STAT or routine. 2. Review of the laboratory's quality assessment records revealed no patient test management records were present. 3. Interview with the technical consultant on February 21, 2019 at 9:30 am confirmed the laboratory did not follow the quality assessment policy for patient test management in 2017, 2018, and 2019. 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, 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 -- 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)