Central Valley Pain Management And Wellness Clinic

Summary Statement of Deficiencies D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 5 /18/2022 between 11:30 a.m. and 12:30 p.m, it was determined that there were proficiency testing (PT) scores below 80 % for one Toxicology subgroup. The issue relates to Cycle 1 in 2022. Findings include: 1. On 5/18/22, an inspection was conducted between 11:30 a.m and 1:30 p.m. 2. During a review of the laboratory documentation from CAP (College of American Pathology- the agency providing the proficiency specimens), it was noted at approximately 12:30 p.m. that the laboratory had unacceptable Toxicology results as indicated below: 3. The findings and acceptable ranges were as follows: Cycle Q1 2022 Category: DMPM Specimen DMPM-02 Analyte Actual Result Expected Result (range) Oxycodone 418 132-273 Oxymorphone 529 139-267 Norfentanyl 142 67-140 4. The LP recognized the above 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 1 --

Summary Statement of Deficiencies D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of College of American Pathologists (CAP) proficiency testing reports and interview with the Laboratory Director and Testing Personnel, the laboratory failed to undertake appropriate steps to investigate and correct (if necessary) when reviewing a CAP proficiency testing report. Findings include: a. The laboratory has been enrolled for toxicology testing with CAP (Drug Monitoring for Pain Management). b. CAP reported (original evaluation: 9/13/2019) for DMPM-06 Oxycodone as Unacceptable. c. The laboratory had no documentation that the above unacceptable proficiency testing result was investigated. d. Testing Personnel affirmed (approximately 12/3/2019, 10:30 A.M.) that the laboratory did not investigate the unacceptable proficiency testing result. e. On 8/13/2019, the laboratory tested the above proficiency testing sample along with approximately 50 other patients. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --