Interventional Pain Institute

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and the exit interview with the quality manager (QM), the laboratory failed to retain quality assessment (QA) records for one of ten months reviewed. Findings: 1. Every month the testing person would send a packet of QA documentation to the laboratory director for review. 2. The packet included the liquid chromatography mass spectrometry maintenance log, the Indiko Plus maintenance log, the temperature and humidity log, and the monthly QA review form which documented the review of a different QA monitor each month according to a schedule. 3. The QA records were reviewed from 06/2022 - 03/2023 for a total of 10 months. Records from 07/2022 were not available during the survey. 4. During the exit interview on 05/23/2023 at 2:45 PM, the QM confirmed that the QA records for 07/2022 were not available at the time of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, review of the procedure, and interview with the quality manager (QM), the laboratory failed to document a self- evaluation of toxicology PT scores that were ungraded by the College of American Pathologists (CAP) PT program. Findings: 1. The laboratory was enrolled with CAP for two annual events (A and B) for Urine Drug Adulterant (DAI) and Drug Monitoring for Pain Management (DMPM) PT programs. 2. The CAP PT program used reason codes when a PT sample was not graded. 3. Reason code [22] was "Result is outside the method/instrument reportable range" and used in the following PT events: a. DMPM-A 2022 for sample DMPM-01 b. DMPM-B 2021 for sample DMPM-06 4. Reason code [26] was "Educational challenge" and used in the following PT events: a. DAI-A 2023 for samples DAI-01 through DAI-03 b. DAI-A 2022 for samples DAI-01 through DAI-03 c. DAI-B 2021 for samples DAI-04 through DAI-06 5. Reason code [27] was "Lack of participant or referee consensus" and used in PT event DMPM-B 2022 for sample DMPM-08. 6. Reason code [30] was "Scientific committee decision" and used in PT event DMPM-A 2022 for sample DMPM-04. 7. Reason code [42] was "No credit assigned due to absence of response" and used in PT event DMPM-B 2022 for sample DMPM-05. 8. Reason code [46] was "Quantitation not appropriate" and was used in PT event DMPM-B 2022 for sample DMPM-05. 9. The laboratory's procedure, SLP 10 Proficiency Testing, stated that ungraded PT challenges "will be reviewed and documented using guidance from Appendix I in the CAP Laboratory Accreditation Manual for listing of PT exception codes and actions." Appendix I was not attached to the procedure. 10. There was no indication on any of the PT documentation that the laboratory's results for samples with ungraded PT results were compared with results listed in CAP's participant summary to verify accuracy. 11. During the survey on 04/25/2023 at 5:00 PM, the QM confirmed that self-evaluations of ungraded CAP PT results were not documented. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL 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: Based on review of the procedure manual, "Corrective/Preventive Action Request" (CAPA), quality control product insert (PI), referenced stability study, and batch tracking log, and exit interview with the testing person (TP) and quality manager (QM), the laboratory's procedure manual failed to reflect laboratory practice for urine specimen storage and failed to establish urine specimen stability criteria to ensure accurate and reliable results for toxicology testing using liquid chromatography tandem mass spectrometry (LCMSMS). Findings: 1. The laboratory tested urine specimens for drug analytes using LCMSMS. 2. During the exit interview on 05/23 /2023 around 2:30 PM, the TP explained that an aliquot of the patient specimens was pipetted into a deep well plate and then frozen after patients were tested on the LCMSMS. The TP stated that the original specimen containers were stored in the -- 2 of 10 -- refrigerator for up to 7 days. If a retest was required within 7 days of collection, then the original specimen stored in the fridge was used. If it was after 7 days, then the aliquot from the frozen deep well plate was thawed and used for the retest. If another retest was needed, then the deep well plate would be thawed a second time and the specimen aliquot used again. If multiple retests were required, then the deep well plate would be thawed and frozen multiple times. 3. A CAPA dated 06/17/2022 stated that the "Quality team confirmed samples were stable refrigerated for 7 days and frozen for 30 days. Aliquoting specimens and freezing was an approved storage method." 4. The "Specimen Rejection Criteria" (5.5.2) of the procedure titled "Specimen Collection and Handling" (SLP 13) stated "The specimen collection date should be within 7 days of the date it is to be tested at the laboratory. If the storage period exceeds this criteria, specimens may still be tested and reported at the discretion, approval, and instruction of the Supervisor and/or Laboratory Director." 5. The laboratory did not provide a procedure that stated specimens were stable frozen for 30 days or instructed where to obtain a patient specimen when a retest was required. 6. The laboratory provided an article to be referenced for data on urine specimen stability for drug testing. The article included stability data for 30 of the 42 analytes tested by the laboratory. Each analyte was tested at time point 0 and then 2, 3, and 6 months after collection and at storage temperatures of 4 degrees Celsius (C), -20 C, and -20 C with an additional freeze-thaw cycle. Results showed that buprenorphine, norbuprenorphine, methadone, lorazepam, and meprobamate results were outside acceptance criteria at 2 months when stored at -20 C with an additional freeze-thaw cycle indicating that multiple freeze-thaw cycles impacted results accuracy. 7. The PI for the calibrators and quality control reagents used in each batch of testing stated "Freeze-thaw cycles may impact accuracy of results. It is recommended that laboratories perform in-house freeze-thaw testing to determine the maximum cycle number for their assay." 8. The laboratory procedures did not state how many freeze- thaw cycles urine specimens could be subjected to before the accuracy of results were affected. 9. The laboratory utilized a batch tracking log to document patient testing. All patient accession numbers and when they were screened using the Indiko Plus analyzer and confirmed using LCMSMS were documented on the batch tracking log. Review of the batch tracking log showed many instances where patient specimens were retested multiple times. Some example accession numbers are listed below: a. 1801: The specimen was screened on 02/16/2023 and run with LCMSMS on 02/21 /2023, 02/24/2023, 02/27/2023, 02/28/2023, 03/02/2023, and lastly on 03/06/2023 (18 days after the screen). b. 1926: The specimen was screened on 02/27/2023 and run with LCMSMS on 02/27/2023, 02/28/2023, 03/02/2023, 03/06/2023, 03/09/2023, and lastly on 03/13/2023 (14 days after the screen). c. 2250: The specimen was screened on 03/14/2023 and run with LCMSMS on 03/17/2023, 03/23/2023, and lastly on 04/10 /2023 (27 days after the screen). d. 2674: The specimen was screened on 04/04/2023 and run with LCMSMS on 04/11/2023, 04/14/2023, 04/18/2023, 04/28/2023, and lastly on 05/03/2023 (29 days after the screen). 10. The laboratory did not have stability data demonstrating that results for all reported analytes were accurate and reliable after multiple freeze-thaw cycles. 11. During the exit interview on 05/23/2023 at 2:45 PM, the QM confirmed that the laboratory did not have approved procedures describing the specimen storage and retest protocols currently in use and did not have stability data demonstrating that all reported analytes were stable after multiple urine specimen freeze-thaw cycles. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 3 of 10 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)