Arizona Center For Pain Relief

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of the laboratory's CMS 116 application, the FDA website, the laboratory's policies and records, patient sample lists, and confirmed in an interview, the laboratory failed to failed to monitor and evaluate the overall quality of the preanalytic system as evidenced by: 1. The laboratory failed to have documentation of patient sample stability validations following the laboratory's policy for tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument. Refer to D5311-A. 2. The laboratory failed to have documentation of transporatation studies following the laboratory's policy for tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument. Refer to D5311-B. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL 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 -- CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on the review of the laboratory's CMS 116 application, the FDA website, the laboratory's policies and records, patient sample lists from 2/27/2023 to 5/18/2023, and confirmed in an interview, the laboratory failed to have documentation of patient sample stability validations following the laboratory's policy for 59 of 59 tests performed on one of one laboratory developed test instrument: AbiSciex 4000 QTRAP LC-MS/MS instrument. 6-MAM 7-Aminoclonazepam Alpha- Hydroxyalprazolam Alprazolam Amitriptyline Amphetamine Benzoylecgonine Buprenorphine Carboxyzolpidem Carisoprodol Clonazepam Codeine Cyclobenzaprine Desalkylflurazepam Desmethyldoxepin Diazepam Doxepin EDDP Fentanyl Flunitrazepam Gabapentin Hydrocodone Hydromorphone Imipramine Ketamine Lorazepam MDMA Meperidine Meprobamate Methamphetamine Methylphenidate Mitragynine Morphine Naloxone Naltrexone Norbuprenorphine Nordiazepan=m Norfentanyl Norhydrococodone Norketamine Normeperidine Noroxycodone Norpropoxyphene Nortriptyline O-Desmethyl-Tramadol Oxazepam Oxycodone Oxymorphone PCP Phentermine Pregabalin Propoxyphene Ritalinic Acid Tapentadol Temazepam THC-COOH Tramadol Trazodone Zaleplon The findings were: 1. Review of the laboratory's CMS 116 application, signed by the laboratory director on 5/17/2023, revealed the laboratory performed toxicology on AbiSciex 4000 QTRAP LC-MS/MS instrument (SN:AR23790902). 2. Review of the FDA website for categorization of tests revealed the tests performed on AbiSciex 4000 QTRAP LC-MS/MS was not available for categorization of complexity, therefore the tests were classified as high complexity, laboratory developed tests. 3. Review of the laboratory's policy, signed by the laboratory director on 4/1/2023, titled Storage of Laboratory Specimens: Toxicology revealed "All urine samples for LC-MS/MS testing will be kept in original container, refrigerated at a temperature of 2-8 degrees and kept for a period of 7-14 days, depending on laboratory stability validation study." 4. Review of the laboratory's policy, signed by the laboratory director on 4/1/2023, titled Urine Collections, Storage and Transportation for Toxicology Testing under Storage revealed "Laboratory stability requirements: "3 days at room temperature 7 days at refrigerator temperature" 5. Review of the laboratory's records revealed no documentation of patient sample stability validations for 59 of 59 tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument according to the laboratory's policies. 6. Review of the patient sample list revealed 556 samples were performed on AbiSciex 4000 QTRAP LC-MS/MS instrument starting on 2/27/2023. Refer to the attachment "Patient Sample list for ACPR". 7. An interview with the technical consultant on 5/18/2023 at 10:22 am in the laboratory confirmed the above findings. B. Based on the review of the laboratory's CMS 116 application, the FDA website, the laboratory's policy and records, patient sample lists from 2/27/2023 to 5/18/2023, and confirmed in an interview, the laboratory failed to have documentation of transporatation study following the laboratory's policy for 59 of 59 tests (Refer to D5311-A) performed on one of one laboratory developed test instrument: AbiSciex 4000 QTRAP LC-MS/MS instrument. The findings were: 1. Review of the -- 2 of 5 -- laboratory's CMS 116 application, signed by the laboratory director on 5/17/2023, revealed the laboratory performed toxicology on AbiSciex 4000 QTRAP LC-MS/MS instrument (SN:AR23790902). 2. Review of the FDA website for categorization of tests revealed the tests performed on AbiSciex 4000 QTRAP LC-MS/MS was not available for categorization of complexity, therefore the tests were classified as high complexity, laboratory developed tests. 3. Review of the laboratory's policy, signed by the laboratory director on 4/1/2023, titled Urine Collections, Storage and Transportation for Toxicology Testing under Transportation revealed the following, "- If samples are stored at room temperature at the office then they must be sent to lab no more that every 3 days to keep with stability protocol of the lab. -If samples are stored at refrigerator temperature at the office then they must be sent to lab no more that every 5 days to keep with stability protocol of the lab. -Samples must be transported with 2 frozen ice packs to keep temperature correct during transport..." 4. An interview with the testing personnel#2 (TP#2) on 5/18/2023 at 10:18am in the laboratory that the TP#2 stated the patient samples were shipped by FedEx from Arizona Center for Pain Relief Clinic. The front desk did not take temperatures of patient samples in the FedEx box when received. The front desk put the complete FedEx box in the refrigerator waiting for the TP#2 to open and receive. In addition, FedEx boxes did not have ice packs in them. 5. Review of the laboratory's records revealed no documentation of patient sample transportation studies for tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument according to the laboratory's policy. 6. Review of the patient sample list revealed 556 samples were performed on AbiSciex 4000 QTRAP LC-MS/MS instrument starting on 2/27/2023. Refer to the attachment "Patient Sample list for ACPR". 7. Another interview with the technical consultant on 5/18/2023 at 10:22 am in the laboratory confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of the laboratory's CMS 116 application, the FDA website, the laboratory's policy and records, patient sample lists, and confirmed in an interview, the laboratory failed to document complete establishment studies in analytic system as evidenced by: 1. The laboratory failed to have documentation of establishment and verification of performance specifications for tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument. Refer to D5423. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer -- 3 of 5 -- must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 116 application, the FDA website, the laboratory's policy and records, patient sample lists from 2/27/2023 to 5/18/2023, and confirmed in an interview, the laboratory failed to have documentation of establishment and verification of performance specifications for 59 of 59 tests performed on one of one laboratory developed test instrument: AbiSciex 4000 QTRAP LC-MS/MS instrument. 6-MAM 7-Aminoclonazepam Alpha- Hydroxyalprazolam Alprazolam Amitriptyline Amphetamine Benzoylecgonine Buprenorphine Carboxyzolpidem Carisoprodol Clonazepam Codeine Cyclobenzaprine Desalkylflurazepam Desmethyldoxepin Diazepam Doxepin EDDP Fentanyl Flunitrazepam Gabapentin Hydrocodone Hydromorphone Imipramine Ketamine Lorazepam MDMA Meperidine Meprobamate Methamphetamine Methylphenidate Mitragynine Morphine Naloxone Naltrexone Norbuprenorphine Nordiazepan=m Norfentanyl Norhydrococodone Norketamine Normeperidine Noroxycodone Norpropoxyphene Nortriptyline O-Desmethyl-Tramadol Oxazepam Oxycodone Oxymorphone PCP Phentermine Pregabalin Propoxyphene Ritalinic Acid Tapentadol Temazepam THC-COOH Tramadol Trazodone Zaleplon The findings were: 1. Review of the laboratory's CMS 116 application, signed by the laboratory director on 5/17/2023, revealed the laboratory performed toxicology on AbiSciex 4000 QTRAP LC-MS/MS instrument (SN:AR23790902). 2. Review of the FDA website for categorization of tests revealed the tests performed on AbiSciex 4000 QTRAP LC-MS/MS was not available for categorization of complexity, therefore the tests were classified as high complexity, laboratory developed tests. 3. Review of the laboratory's policy, signed by the laboratory director on 4/1/2023, titled Validation Study revealed "Linearity, Accuracy and Precision...Carry Over Results...Inter-day Accuracy and Precision...Intra-day Accuracy and Precision...Limits of Detection and Quantitation...Matrix Effects and Ion Suppression...Selectivity-Interferences..." 4. Review of the laboratory's records revealed no documentation of establishment and verification of performance specifications for 59 od 59 tests performed on AbiSciex 4000 QTRAP LC-MS/MS instrument. 5. Review of the patient sample list revealed 556 samples were performed on AbiSciex 4000 QTRAP LC-MS/MS instrument starting on 2/27/2023. Refer to the attachment "Patient Sample list for ACPR". 6. An interview with the technical consultant on 5/18/2023 at 4:10 pm in the laboratory confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: -- 4 of 5 -- Based on the review of laboratory's records, the laboratory's policy, and confirmed in an interview, the Laboratory Director failed to ensure laboratory provided quality services in pre-analytic and analytic aspects of testing. Refer to D5311-A, B, and D5423. -- 5 of 5 --