Carolina Pain And Weight Loss

Summary Statement of Deficiencies 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 upon review of 2022 and 2023 CAP-PT (proficiency testing) records and review of the laboratory's policies and procedures, TP (Testing Personnel) who participated in PT events failed to sign Attestation Forms for 3 of 4 CAP-PT events. Findings: Review of the 2022 and 2023 CAP-PT records revealed that TP who performed the peak review of LC/MS (liquid chromatography/mass spectrometry) data for the following events did not sign Attestation Forms for these DMPM (Drug Monitoring and Pain Management) events: 1. 2023 DMPM Event A 2. 2022 DMPM Event B 3. 2022 DMPM Event A Review of the laboratory's "System Level Procedure: Proficiency Testing" policy revealed the following in "5. Procedures: 5.3.10 - Document each round of Proficiency Testing. These records will include..... Attestation Form-signed by the Laboratory Director and the participating testing personnel." D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a 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 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based upon review of 2022 and 2023 calibration verification records and interview with the LD (Laboratory Director) on 11/16/23, the laboratory failed to perform calibration verification activities that included a maximum value near the upper limit of the laboratory's reportable range for 1 of 1 analyte quantified on its Thermo Fisher Indiko chemistry instrument. Findings: Review of the October 2023 calibration verification records for urine alcohol performed on the Thermo Fisher Indiko instrument revealed the following data: Three concentrations of linearity material were used to assess the reportable range of urine alcohol. These three samples demonstrated the following concentrations: 18.7 ng/mL, 73.5 ng/mL, 141.7 ng/mL Review of the May 2022 calibration verification records for urine alcohol performed on the Thermo Fisher Indiko instrument revealed the following data: Three concentrations of linearity material were used to assess the reportable range of urine alcohol. These three samples demonstrated the following concentrations: 24.7 ng/mL, 98.6 ng/mL, 192.3 ng/mL In interview at approximately 1:25 p.m., the LD stated that the laboratory quantitatively reports urine alcohol values within a range of 50-300 ng /mL. The LD reviewed the findings and stated that numerous vials are contained within the kit used to perform calibration verification activities for urine alcohol and that Testing Personnel was not using the correct vials with the appropriate concentrations. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 PT(proficiency testing) records, and absence of documentation 4/19/22, the laboratory director and testing personnel failed to attest that the alternate performance PT was tested in the same manner as patient specimens for 8 of 8 events in 2020 and 2021. Findings: The laboratory's "Proficiency Testing" procedure states, "5.4 Alternate Performance Assessment. 5.4.1...For those analytes/tests where commercially available CAP or non-CAP proficiency testing material are not options, perform alternative performance assessment twice per calendar year... 5.4.10 Document each round of alternative performance assessment testing. These records will include: Copy of the attestation form signed by the Laboratory Director and the participating testing personnel...." Review of 2020, 2021, and 2022 PT records revealed the laboratory director and testing personnel had not signed attestation statements for the following alternate performance PT events: 1. 2020 ETOH- ALT PT- I and II events; 2. 2020 ALT PT-I and II events; 3. 2021 ETOH- ALT PT- I and II events; 4. 2021 ALT PT-I and II events. 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 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 -- system in which performance specifications are not provided by the manufacturer 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 review of laboratory procedure, review of performance verification records and interview with laboratory director (LD) 4/19/22, the laboratory failed to include operator variance in the precision verification of the Bio-Lis analyzer, failed to perform a performance verification of the laboratory information system (LIS) for the Bio-Lis analyzer and failed to verify specimen stability for the testing performed on the Bio-Lis analyzer. 1. The laboratory failed to include operator variance in the precision verification of the Bio-Lis analyzer. Findings: Review of performance verification records revealed the raw data documenting variance included day-to-day, run-to-run, and within run variance for precision verification. The records failed to include operator variance. Interview with LD at approximately 11:00 a.m. confirmed the records failed to include operator variance. She stated the precision verification of the Bio-Lis analyzer was performed by one service representative. 2. The laboratory failed to perform a performance verification of the LIS for the Bio-Lis analyzer. Findings: Review of performance verification records revealed no documentation of a performance verification of the LIS for the Bio-Lis analyzer. Interview with LD at approximately 11:00 a.m. confirmed the records did not include a performance verification of the LIS for the Bio-Lis analyzer. She stated she knew it was performed but she could not locate the records needed to document it. 3. The laboratory failed to verify specimen stability for the testing performed on the Bio-Lis analyzer. Findings: Review of performance verification records revealed no documentation of a specimen stability verification for the testing performed on the Bio-Lis analyzer. Interview with LD at approximately 11:00 a.m. confirmed the laboratory failed to perform a verification of specimen stability. She stated she was unaware they would need to verify specimen stability and she thought they could use the specimen stabilities stated in the manufacturer's package inserts. -- 2 of 2 --