Pain Relief Solutions, Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/12/2024 found the PAIN RELIEF SOLUTIONS, LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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: 1-Based on record review and interview, the laboratory failed to test three out of three samples reviewed within the acceptable timeframe for urine drug testing. Findings included: -Review of the form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FOR CERTIFICATION, signed by the Laboratory Director (LD) on 07/19/2024 revealed that the laboratory performed the following tests in urine: in the Horiba Pentra C-400 analyzer they performed screening for the following drugs Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolites, Opiates, pH and Creatinine. For the confirmation test, the laboratory used the Liquid Chromatography Tandem Mass Spectrometry (LC/MS) for the following drugs: Alpha-Hydroxyalprazolam, Lorazepam, Nordiazepam, Temazepam, Benzoylecgonine (Cocaine metabolite), Fentanyl, Methadone, Norbuprenorphine, Tapentadol, Tramadol, 6-MAM (6- Monoacetylmorphine), Hydromorphone, Morphine, Oxycodone, Amphetamine, Carisoprodol, Gabapentin, Methamphetamine and Pregabalin. The laboratory has an estimated testing volume of 35,00 tests performed annually. -Review of procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- signed by the LD on 05/28/2024 revealed that the policy "Specimen Rejection" stated that: "Specimen rejection is used to ensure quality laboratory testing and the integrity of the samples. Specimen rejection protocol establishes criteria for rejection and occurs during specimen accessioning and processing. Our laboratory reserves the right to reject any sample that may be inadequate due to any one of the following reasons: 1. Specimen received containing insufficient volume. 2. Specimen that is not labeled with the full name of the patient. 3. Specimen has not completed requisition form. 4. Specimen for which the identifying information on the container does not match the requisition form. 5. If more that two validation parameters are not met, the ordering physician will be alerted. 6. Specimens that do not adhere to our laboratory stability standards Urine stability: i. Frozen: 30 days ii. Refrigerated: 10 days iii. Ambient temperature: 7 days" -Review of three patients reports revealed the following: Patient #1 (collected on 07/24/2024), screening test performed on 08/06/2024 (the 10 days timeframe was due on 08/03/2024) and the confirmation test on 08/07/2024. The two tests were done outside of the acceptable storage stability. Patient #2 and #3 (collected on 07/31/2024), screening test performed on 08/10/2024 and confirmation on 08/11 /2024 (outside of the 10 days) During an interview on 08/12/2024 at 01:30 PM, the laboratory testing person confirmed that the patients listed above were tested outside of the acceptability stability criteria for refrigerated samples. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of records and interview, the laboratory failed to perform the verification of the analyzer Horiba Pentra C-400 after the analyzer was moved to the new location before patient testing on 07/17/2023. Findings included: -Review of the form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FOR CERTIFICATION, signed by the Laboratory Director (LD) on 07/19/2024 revealed that the laboratory performed the screening in urine in the Pentra C-400 analyzer for the following drugs: Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolites, Opiates and the measurement of pH and Creatinine. -Review of procedure signed by the LD on 05/28/2024 revealed that the policy; "Validation of Test Methods" stated the following: "Before introducing a new instrument or test method into the laboratory, evaluation studies must be performed prior to initiating patient testing in order to: " Examine its performance under laboratory conditions " Develop lab-specific performance claims " Compare the new method with a similar method presently in use in another laboratory " Determine acceptable precision and accuracy and reportable range for each analyte to be tested. This requirement applies when: " An instrument is RELOCATED*. *If the relocated instrument produces comparable results on previously tested patient samples and the control results are in range, the laboratory may determine that performance specifications are not affected. In this case, a full performance verification study would not be required." -the laboratory had no records that performed the comparison -- 2 of 3 -- study for the Pentra C-400 analyzer after the relocation and before patient testing on 07/17/2023. -The laboratory tested 4423 samples from 07/17/2023 to 08/12/2024. During an interview on 08/12/2024 at 01:35 PM, with the testing person, he confirmed that the laboratory failed to perform the Horiba Pentra C-400 verification before patient testing. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at PAIN RELIEF SOLUTIONS, LLC on 10 /26/2022 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have attestation signed by the Laboratory Director (LD) or its designee for 1 out of 1 event reviewed for the specialty of Chemistry in 2022. Findings include: Review of Proficiency American Institute (API) proficiency testing (PT) records revealed that for second event of 2022 the LD failed to sign the attestation for the Chemistry specialty. During an interview on 10/26/2022 at 05:45 PM, the Office Manager confirmed that the laboratory failed to have a signed attestation by the LD for the event of reference. 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 record review and interview the laboratory failed to document the weekly, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- monthly and bimonthly maintenance on the Horiba PentraC400 Analyzer as per manufacturer instructions and procedure manual since June 2022. Findings include: - Review of the policy for the operation of the Horiba PentraC400 signed by the Laboratory Director on 06/20/2022, revealed the requirement for the following maintenance actions. Daily: ISE module activation and ISE module etching. Weekly: Needle deproteinization and ISE module cleaning. Monthly: Wash tower cleaning, Syringe plunger tips replacement, Qualitest and Cooling Unit Filter cleaning. Bimonthly (every two months): Filter replacement and Glycol level checking. Review of the "PC400 Instrument Maintenance Log" since June 2022, revealed that the laboratory failed to document the following maintenance actions: Weekly: fourth week of June, third and fourth week of July, third and fourth week of August, second, third and fourth week of September and third and fourth week of October. Monthly: No documentation in July and October. Bimonthly: No documentation during this period. During an interview on 10/26/2022 at 04:00 PM, the TP # A confirmed that the laboratory failed to document all weekly, monthly and bimonthly maintenance actions for the period of reference. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of records and interview, the laboratory failed to validate their laboratory information management system (LIMS) before use to ensure it was properly exporting the testing results since 06/20/2022. Findings include: -Review of LIMS records revealed that the laboratory used LABTRACK LIMS software. The laboratory had no records of the LABTRACK LIMS validation. Review of the procedure manual revealed was signed by the Laboratory Director on 06/20/2022. During an interview over the phone with Laboratory Director on 10/26/2022 at 5:50 pm, he explained that the laboratory performed a validation of the LABTRACK LIMS before patients testing and they were going to contact the providers of the system, no documentation of the validation of the LIMS was provided till 10/28/2022. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to sign and date the test performance verification for the confirmation test panel for -- 2 of 3 -- analysis of pain management drugs and metabolites in human urine using liquid chromatography with tandem mass spectrometry (LC-MS/MS) before patient testing on 06/20/2022. Findings include: -Review of the performance verification study for the confirmation panel for drugs and metabolites in human urine using LC-MS/MS revealed that it was not signed and dated by the LD before patient testing on 06/20 /2022. During an interview on 10/26/2022 at 05/55 PM the LD confirmed that he failed to sign and date the complete validation of the confirmation panel in human urine for pain management drugs and its metabolites before patients testing on 06/20 /2022. -- 3 of 3 --