Una Sibirceva Md Pc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), CAP Drug Monitoring for Pain Management (DMPM) records, CAP DMPM test menu, as well as interview with the Technical Consultant (TC), the laboratory failed to successfully participate in a toxicology specialty PT program for three analytes. FINDINGS: 1. There was no documentation of Phencyclidine, Ritalinic Acid, and Tricyclic Antidepressants (TCAs) PT performance or twice year verification for 2023 and 2024. 2. This is contrary to instructions indicted in the current, approved SOPs. 3. It was noted that quality control and assessment was performed for the respective analytes. 4. Approximately 333 patients were tested for the respective analytes in 2023 and 2024. 5. The TC confirmed the findings on April 23, 2025, at 12:00 P.M. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of SOPs, lack of PT documentation, as well as interview with the TC, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D5217. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) records 2021 and 2022, the pain management test list and confirmed in an interview with the technical/general supervisor/testing personnel, the laboratory failed to evaluate and verify the accuracy of 53 out of 53 toxicology analytes in the years 2021 and 2022. FINDINGS: 1. The laboratory performed API PT Urine Drug Screening (UDS) testing for the two adulterants: pH & specific gravity, and five analytes: Oxycodone, Opiates, Methadone, Cocaine, and Acetylmorphine(6-AM), performed on the Carolina Bolis 24i 480 analyzer for the calendar year 2021 and discontinued screening testing on the analyzer 1/2022. 2. The laboratory failed to verify 53 out of 53 confirmatory testing performed on the Aligent AB Sciex mass spectrometry (LC/MS/MS) for the calendar years 2021 and 2022. 3. Approximately 1500 patients specimens were tested during calendar years 2021 and 2022. 4. The technical/general supervisor/testing personnel, confirmed on January 25, 2023, at approximately 2:00 P.M., that the laboratory failed to verify the accuracy of 53 out of 53 toxicology analytes in the calendar years 2021 and 2022. a. The laboratory is enrolled in 2023 College of American Pathologists (CAP) Drug Monitoring Pain Management (DMPM) for twice year verification for 53 analytes. 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 --