Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Winke Orthopedic Pain Management Center on July 15, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6076 -42 CFR. 493.1441 Laboratory Director. 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 a review of policies and procedures, available proficiency testing (PT) records, test logs, and an interview, the laboratory failed to perform twice annual accuracy verification for fifty-five (55) of seventy-three (73) urine toxicology (non regulated) tests reported on the Sciex mass spectrometer (MS) analyzer per their policy for the twenty-four (24) months reviewed (July 2019 to up to date of the inspection on July 15, 2021). Findings include: 1. Review of the laboratory's Quality Assurance policies revealed a PT policy (titled: Split Sample Testing) that stated, "The lab will externally verify the accuracy of all non regulated non waived tests not enrolled in PT using a minimum of five specimens twice per year". 2. Review of the laboratory's College of American Pathologists (CAP) UT Urine Toxicology PT documentation for calendar year 2019 to the date of survey on 7/15/21, a total of four (4) events, revealed participation for eighteen analytes included on the laboratory's screening panel. The PT events did not include all analytes assayed by the laboratory included on their confirmation panel. 3. Review of the patient test logs revealed the confirmation panel included the following additional 55 analytes: 6-Acetlymorphine, 7-Aminoclonazepam, Hydroxyalprazolam, Amphetamine, Alprozolam, Amitiptyline, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Benzoylecgonine, Buproprion, Butalbital, Carisoprodol, Clonazepam, Codeine, Clycobenzaprine, Desipramine, Diazepam, Doxepin, Dulozetine, Ethyl-Sulfate, Meprobamate, Mitragynine, EDDP, Fentanyl, Fluoxetine, Gabpentin, Hydrocodone, Hydromorphone, Ketamine, Lorazapam, MDMA, Methamphetamine, Meperidine, Morphine, Nortriptyline, Naloxine, Naltrexone, Norbuprenorphine, Nordiazepam, Norfentanyl, N-desmethyl-Tapentadol, Norhydrocodone, Normeperidine, Noroxycodone, Oxymorphone, Oxaepam, PCP, Pregabalin, Phenobarbitol, Ritalinic Acid, Secobaritol, Sertraline, Tapentadol, Temazepam, Tramadol, Venlafaxine, and Zolpidem. The inspector requested documentation of twice annual PT or accuracy verification for the additional drug confirmation panel test analytes outlined above in calendar years 2019, 2020, and up to the date of the survey. The Technical Supervisor (TS) provided one split panel accuracy verification report for all analytes (performed on 3/17/20, reviewed by the LD 6/25/21). No additional accuracy verification was available for review. 4. An exit interview with the TS on 7/15/21 at approximately 2 PM confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of policy/procedure manual, CLIA Centers for Medicare and Medicaid Services Survey (CMS 116) form, instrument maintenance logs, manufacturer's operations manual, a tour, interviews, and lack of documentation , the laboratory failed to: 1. ensure their procedure for mass spectrometer (MS) urine toxicology screening/confirmation panels included an assessment for interfering substances, criteria for the evaluation of potential carryover, or quality control procedures outlining cut off values for positive and negative results for each of seventy-three (73) drug analytes analyzed/reported on the Sciex MS instrument; 2. document retired policies and procedures noted on the date of the survey July 15, 2021; 3. document performance of required MS analyzer maintenance protocols for seventeen (17) of eighteen (18) months reviewed (January 2020 to July 15, 2021); 4. document function checks of revolutions per minute (RPM) verification for the VWR centrifuge twice annually per their policy in calendar years 2019 and 2020. See D5403, D5409, D5429, D5435. 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 -- 2 of 7 -- 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)