Outreach Recovery Laboratory

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the competency procedure and interview with the technical supervisor (TS), the laboratory failed to ensure that a competency assessment was performed for the TS who is also the general supervisor (GS) in their regulatory roles as TS and GS. Findings: 1. Procedure OR-028 titled "Competency Assessment" stated "Documented competency assessment shall be required for individuals fulfilling the following staff responsibilities as outlined in Subpart M of the CLIA regulations: Clinical consultant (CC), Technical consultant (TC), Technical supervisor (TS), General supervisor (GS), Testing personnel (TP)" and "CCs, TCs, TSs and GSs who perform testing on patient specimens are required to have the six (6) required procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities." 2. During the exit interview on 03 /20/2024 at 4:15 PM, the TS confirmed that a competency assessment was not performed by the laboratory director for the TS/GS in their regulatory responsibilities as the TS and GS. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) records and interview with the technical supervisor (TS), the laboratory failed to ensure that two levels of QC were run each day patient specimens were tested for the urine drug screening assay. Findings: 1. The QC Levey-Jennings charts were reviewed from 01/2023-02/2024 for a total of 14 months. 2. A single level of QC for buprenorphine was run for 6 of 14 months reviewed and for 19 of 20 days tested in 07/2023; 20 of 21 days tested in 01/2023 and 11/2023; 21 of 22 days tested in 03/2023, 05/2023, and 01/2024; and 22 of 23 days tested in 06/2023 and 08/2023. 3. A single level of QC for phencyclidine was run for 9 of 19 days tested in 04/2023. 4. A single level of QC for cannabinoids was run for 21 of 21 days in 01/2023. 5. During the exit interview on 03/20/2024 at 4:20 PM, the TS confirmed that two levels of QC were not run each day patient specimens were tested for the urine drug screening assay. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the procedure and instrument comparison study results and interview with the technical supervisor (TS), the laboratory failed to define the acceptability criteria when detected values were above the upper limit of quantification (ULOQ) for the urine drug confirmation testing performed using liquid chromatography tandem mass spectrometry (LC/MS/MS) analyzers. Findings: 1. The procedure titled "Comparison Study between Two instruments (LC-1/LC2)" was reviewed. 2. The procedure stated that either proficiency testing (PT) samples or samples spiked with drug standards would be run on both LC/MS/MS analyzers designated "LC-1" and "LC-2" and the results compared. 3. The procedure stated that each analyte should be within plus or minus 10% of PT samples and plus or minus 15% of spiked samples to be considered acceptable. 4. The laboratory routinely performed instrument comparison studies using the PT results from the urine drug screening (UDC) programs. 5. The comparison using the PT event UDC-B 2022 showed that specimen UDC-07 tested positive for morphine with a value of 8574 for LC-1 and value of 6720.3 for LC-2, greater than 10%. 6. The comparison using the PT event UDC-A 2022 showed that specimen UDC-04 tested positive for the drug phenobarbital with a value of 6462.8 for LC-1 and 5510.3 for LC-2, greater than 10%. 7. The TS stated that when the values were above the ULOQ, it was acceptable for the results to be greater than 10%. This was not stated in the procedure or on the results summary from each comparison study. 8. During the survey on 08/19/2022 at 4:15 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- PM, the TS confirmed that the instrument comparison study procedure and results summary did not define acceptability criteria for results that were above the ULOQ. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of final test reports and interview with the technical supervisor (TS), the laboratory's final test reports failed to provide correct interpretation of urine drug screening and confirmation test results. Findings: 1. The laboratory's final report included a section stating the patients' prescribed medications titled "Medications", a section listing all drugs detected as positive titled "Positive Summary", a section titled "Inconsistent: Prescribed - Not Detected" for drugs that were prescribed and not detected, a section titled "Inconsistent: Not Prescribed - Detected" for drugs that were not prescribed and detected, and sections for the results of individual drugs tested on the screening and confirmation assays. 2. All final test reports reviewed listed drugs that were prescribed and were detected in the patient urine specimens under the "Inconsistent: Not Prescribed - Detected" section. 3. For example, the final test report for accession number 104090 listed prescribed medications as "buprenorphine- naloxone." 4. The "Positive Summary" listed "Benzodiazepines", "Buprenorphine", and "THC" (tetrahydrocannabinol) as positive from the screening assay and "7- Aminoclonazepam", "Buprenorphine", "Norbuprenorphine", and "THC" as positive from the confirmation assay. 5. The drug "Naloxone" was listed under the section titled "Inconsistent: Prescribed - Not Detected" as the patient was prescribed a form of naloxone and tested negative for the drug in the confirmation assay. 6. The drugs "Benzodiazepines", "7-Aminoclonazepam" (a metabolite of the benzodiazepine clonazepam), and "THC" were listed in the section titled "Inconsistent: Not Prescribed - Detected" as the patient tested positive but was not prescribed any of these drugs. 7. The drugs "Buprenorphine" and "Norbuprenorphine" (a metabolite of buprenorphine) were, however, also listed in the section titled "Inconsistent: Not Prescribed - Detected" when these drugs were consistent with the patient's prescribed medication. 8. The TS stated that there was an error in the reporting software that enabled detected drugs that were consistent with prescribed medications to be reported as "Inconsistent: Not Prescribed - Detected" and the error had not been fixed. 9. During the survey on 08/19/2022 at 4:15 PM, the TS confirmed that the laboratory's final reports for urine drug screening and confirmation testing incorrectly interpreted drugs that were detected and consistent with prescribed medications as "Inconsistent: Not Prescribed - Detected." -- 2 of 2 --