Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the procedure and eyewash station log and interview with the technical consultant (TC), the laboratory failed to perform weekly preventative maintenance on the eyewash station. Findings: 1. The procedure titled "Eyewash Preventative Maintenance (P.M.)" gave instructions on flushing out the eyewash station and stated to "Document checks and/or concerns with action taken on the Office or Outpatient Log" and that the "Eyewash MUST be checked every 7 days +/- 1 day." 2. The laboratory documented the eyewash checks on the "Eye Wash Station Log." 3. The last entry on the log was dated 08/05/2020. 4. During the survey on 11/14 /2022 at 2:30 PM, the TC confirmed that the weekly flushing of the eyewash station was not documented as performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to verify the accuracy of buprenorphine and tricyclic antidepressants (TCA) at least twice annually in 2019. Findings: 1. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory was enrolled in the College of American Pathologists (CAP) urine drug screen (UDS) PT program which shipped three challenges per year (A-C). 2. The 2019 PT records only contained documentation from the UDS-C PT event. The TC confirmed at 10:15 AM that the laboratory only participated in the UDS-C PT event in 2019. 3. The UDS-C PT event did not include an evaluation of results for buprenorphine and TCA. 4. The laboratory performed split sample testing with another laboratory which included results for buprenorphine and TCA 5. During the survey on 11/14/2022 at 2:30 PM, the TC confirmed that the accuracy of buprenorphine and TCA was not verified at least twice in 2019. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's operator's manual and the monthly preventive maintenance forms and interview with the technical consultant (TC), the laboratory failed to perform all weekly maintenance tasks as defined by the manufacturer for the Indiko Plus toxicology analyzer. Findings: 1. The manufacturer's manual for the Indiko Plus analyzer stated that weekly maintenance included cleaning and checking the probes and mixer paddle and cleaning the wash wells. 2. The monthly "Indiko Plus Analyzer Maintenance Log" template used by the laboratory had these two items crossed off. 3. The laboratory did not perform these two maintenance tasks from 01 /2021-10/2022. 4. The completed maintenance log from 03/2022 was missing. 5. During the survey on 11/14/2022 at 2:30 PM, the TC confirmed that the testing personnel were not performing two of the weekly preventive maintenance tasks for the Indiko Plus toxicology analyzer. D5785