Summary:
Summary Statement of Deficiencies 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 observation of the SciEx Triple Quad 6500+ LC-MS/MS analytic system (Liquid Chromatography- Mass Spectrometers, serial number DZ245082207), review of laboratory records, the lack of records, and interview with Testing Person /Technical Supervisor-2, it was determined the laboratory failed to verify the accuracy of confirmatory drug testing in 2024. Findings included: 1. The laboratory's list of drugs confirmed by LC-MS/MS method included 34 analytes (CMS116- CLIA Application, 5/14/26), as follows:. 6- MAM alpha-hydroxyalprazolam Alprazolam Benzoylecgonine Buprenorphine Carisoprodol Codeine EDDP (Methadone metabolite) Fentanyl Hydrocodone Hydromorphone MDMA (Ecstacy) Meprobamate Methadone Amphetamine Methaphetamine Morphine Oxycodone Oxymorphone PCP Propoxyphene Tapentadol THC-COOH Tramadol EtG (Alcohol metabolite) EtS (Alcohol metabolite) Meperidine Clonazepam Norfentanyl Temazepam (continued) Lorazepam Diazepam Oxazepam Nordiazepam 2. Four laboratory reports of confirmatory drug test results were selected from the timeframe February to December 2024, as follows, for this survey: Date Reported Accession # -------------------------------------------------- 2/04/24 100079 2/05/24 100160 8/08/24 100678 12/10/24 101105 3. The laboratory failed to have records verifying the accuracy of confirmatory testing for drugs in 2024. 4. Technical Supervisor/ Testing Person-2 affirmed (5/14/26 at 3:00 PM) the aforementioned findings; and thus, for 4 out of 4 laboratory reports the laboratory failed to verify the accuracy of confirmatory drug testing in 2024. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of the laboratory list of drugs confirmatory tests, 2025 laboratory records for CAP proficiency testing, the lack of records, and interview with Testing Person/Technical Supervisor-2, it was determined the laboratory failed to establish an ongoing policy and process for monitoring and assessing it's program for at least twice annually verifying the accuracy of confirmatory testing for each Analyte. Findings included: 1. The laboratory listed confirmatory testing for 34 analytes. See D5217. 2. The laboratory chose to participate in the 2025 CAP (College of American Pathologists) proficiency testing program, DMPM, Drug Monitoring for Pain Mangaement, as the means to fulfill the requirement at 493.1236(c)(1). See D5217. 3. Review of the 2025 DMPM Evaluations of intended responses for Events A and B revealed specific drugs were not included, as follows: EDDP PCP Propoxyphene Tapentadol EtG EtS Meperidine Clonazepam Temazepam Lorazepam 4. Review of the 2025 DMPM Evaluations of intended responses for Events A and B revealed specific drugs were included in only one out of two events, as follows: alpha- hydroxyalprazolam Alprazolam Carisoprodol Hydrocodone Hydromorphone MDMA Meprobamate Amphetamine Methamphetamine Morphine (continued) Oxycodone Norfentanyl Diazepam Oxazepam Nordiazepam 5. The laboratory had no other written policy/procedure or records for alternate methods for verifying the accuracy of confirmatory testing. And thus, the laboratory failed to verify the accuracy of confirmatory testing for the aforementioed analytes at least twice annually in 2025. 6. Three laboratory reports from the timeframe April to December 2025, included results of confirmatory drug tests, as follows: Date Reported Accession # ----------------------------------------------------- 4/07/25. 101550 10/27/25 102319 12/15 /25 102790 7. Testing Person/Technical Supervisor-2 affirmed (5/14/26 at 5:00 PM) the aforementioned findings. For 3 out of 3 reports of confirmatory testing, the laboratory lacked a process for monitoring and assessing the effectiveness of the CAP program, and thus, the failure to identify the issues and implement