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 proficiency testing (PT) records and interview with the laboratory director (LD) and testing personnel, the laboratory failed to ensure that the attestation worksheet was printed and signed by the appropriate laboratory personnel and the final results were reviewed by the appropriate staff. Findings: 1. The College of American Pathology (CAP) chemistry (C) PT records for 2022 (three events) were reviewed. The attestation worksheet for two of three events had not been signed and dated by the appropriate laboratory personnel. 2. The CAP urine toxicology (UT) PT records from 2022 and the first event of 2023 (four events) were reviewed. The "Attestation/Use of Other Form" for UT-A 2023 included the typed initials, "DD", for the LD/designee and three sets of typed initials, "SH", "DD", and "DM" for the testing personal (TP). The "Internal Chain of Custody" form had one set of initials which was "SH." The "Urine Toxicology Survey" attestation form has the signature of the LD /designee and the signature of one TP which was "TF". 3. The lead TP for screening urine toxicology specimens stated that "TF" had prepared the specimens for testing but had not tested and verified the test results. 4. The American Association of 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 -- Bioanalysts (AAB) Urine Drug Screening PT records for 2022 were reviewed (three events). Two of three events, AAB events Q-1 and Q-2, failed to show that the designee had documented a review of the reports with a signature and date. 5. During the survey on 07/14/2023 at 3:30 PM, the LD confirmed that the attestation worksheets had did not have the signatures of the appropriate laboratory personnel, that one signature was of a person who prepared the specimen but not actually verified the test results, and the final results for AAB events Q-1 and Q-2 had not been documented as being reviewed and acceptable. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the maintenance charts for the Quantis (toxicology analyzer) and interview with the laboratory director (LD), the laboratory failed to provide the manufacturers acceptable reference ranges for the N2 Pressure, Check Vacuum Pressure level, and Pump Initial Pressure Daily Run on the "Quantis Maintenance Sheet" on the worksheet. Findings: 1. The "Quantis Maintenance Sheet" for the months of February, November, and December 2022 and March and May 2023 were reviewed. 2. The "Quantis Maintenance Sheet" worksheet failed to provide and acceptable reference range for N2 Pressure, Check Vacuum Pressure level, and Pump Initial Pressure Daily Run. Values were recorded each day of testing but with no reference ranges there was no way to ensure that the values recorded were within acceptable limits. 3. During the exit survey on 07/14/2023 at 3:30 PM, the LD confirmed that the "Quantis Maintenance Sheet" and the procedure manual did not include limits of acceptability for N2 Pressure, Check Vacuum Pressure level, and Pump Initial Pressure Daily Run. D5781