Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the survey conducted on July 10, 2024, at approximately 12:30 p.m., review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to attain at least 80% of the acceptable score in routine chemistry for PSA analyte. The findings included: 1. Based on review of PT records for the first event of 2024 (Q1-2024), API reported an unsatisfactory score report as follow: PSA PT Q1-2024 Overall score 50% Specimen Reported Expected IA-01 *3.16 3.19 - 4.07 IA-02 6.00 5.80 - 7.54 2. The TC and TP affirmed on July 10, 2024, at approximately 12:30 p.m. that the laboratory obtained PT scores in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 105,000 routine chemistry test samples including PSA during the time the laboratory had unsatisfactory proficiency testing results. Thus, the reliability and quality of chemistry patient results reported could not be assured. 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 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 -- 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)