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's policy and procedure manual, direct observation of patient specimens and interview with the laboratory director (LD) on 4/09/26 at 2: 18 PM, the laboratory failed to establish and follow written policies and procedures to ensure positive identification of patient specimens that were tested on the Frend Nano EnTek analyzer from 12/17/24 through 4/09/26. Findings include: 1. The laboratory began Testosterone and Prostate-Specific Antigen (PSA) testing on 12/17/24 on the Frend Nano EnTek analyzer in the subspecialties of routine chemistry and endocrinology with a reported annual test volume of 500. 2. Direct observation of patients' blood specimens on 4/09/26 revealed the testing personnel labeled the specimens with the only the first name and the initial of the last name. No other patient identifiers were documented on the specimen labels. 3. The laboratory failed to establish a written policy and procedure to ensure positive patient identification of blood specimens tested for Testosterone and PSA on the Frend Nano EnTek analyzer from 12/17/24 through 4/09/26. 4. LD interviewed on 4/09/26 at 2:18 PM confirmed the laboratory failed to provide evidence of an established policy and procedure to ensure positive identification of patient specimens tested on the Frend Nano EnTek analyzer as indicated above. D5301 TEST REQUEST CFR(s): 493.1241(a) 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 -- (a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of test requisition documentation and interview with the laboratory director (LD) on 4/09/26 at 2:20 PM, the laboratory failed to have a written or electronic request for Testosterone and Prostate-specific Antigen (PSA) testing performed on the Frend Nano EnTek analyzer for 1 out of 4 patient records reviewed. Findings include: 1. No written or electronic request for Testosterone and PSA testing was presented for review for 1 out of 4 patient records reviewed during the survey (record #2). 2. LD interviewed on 4/09/26 at 2:20 PM confirmed the laboratory failed to have an electronic or written test requisition for Testosterone and PSA testing as indicated above. 3. The laboratory began Testosterone and Prostate-Specific Antigen (PSA) testing on 12/17/24 on the Frend Nano EnTek analyzer in the subspecialties of routine chemistry and endocrinology with a reported annual test volume of 500. 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)