Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the toxicology proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to ensure that the PT attestation statements were being signed and dated by the laboratory director and testing person and the split sample results were being reviewed by the laboratory director. Findings: 1. The laboratory records show that the laboratory was enrolled in PT for Urine Drug Testing, Screening, Limited (UDS6), Urine Drug Adulterant/Integrity (DAI), and Ethanol Biomarkers (ETB). Each module has two annual events identified as A & B. A total of eight PT events from 2020 and 2021 were reviewed. 2. The following events from 2020 failed to include the signature and date of the laboratory director and testing person; UDS6-A, UDS6-B, DAI-B, and ETB-B. Events DAI-A, and ETB- A were missing. 3. The following events from 2021 failed to include the signature and date of the laboratory director and testing person; DAI-B, and ETB-B. Events UDS6- A, UDS6-B, DAI-A, and ETB-A were missing. 4. The TP explained that the PT modules were missing because the laboratory had not enrolled with the PT agency in a timely manner in 2020 and 2021. 5. In June of 2021 the laboratory discovered that 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 -- they had not enrolled in an approved PT module for ETB and performed split samples with another facility. The split sample documentation did not include an evaluation and was not reviewed and dated by the laboratory director. 6. During the survey on 09 /21/2021 at 2:00 PM, the TP confirmed that the attestation statement and PT records were not being signed and dated as required; the split sample results were not reviewed by the laboratory director; and the laboratory was not enrolled in all the required modules for 2020 and 2021. 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)