Wv Drug Testing Laboratories

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at WV Drug Testing Laboratories on June 26, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain the signed review and approval for the establishment of the performance specifications for 3 of 3 analytes validated on the Thermo Transcend II LX-2 TSQ Quantis LC-MS analyzer in January 2024. Findings: 1. Review of the January 2024 toxicology validation records revealed no documentation for the review and approval of the performance specifications established in January 2024 for Carfentanil, Acetylfentanyl, and Xylazine testing on the Thermo Transcend II LX-2 TSQ Quantis. 2. Review of patient toxicology test results from the Thermo Transcend II LX-2 TSQ Quantis (May 2024) identified Carfentanil, Acetylfentanyl, and Xylazine quantitative results released. 3. An interview with the general supervisor and technical supervisor, 6/26/24 at 3:00 PM, confirmed the lack of documentation retention for the review and approval of the established performance specifications for the 3 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 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at WV Drug Testing Laboratories Inc. on June 7, 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interviews, the laboratory failed to ensure the external quality control (QC) met the requirements for acceptability, before releasing patient results, on 2 of 12 patient testing days in March 2022 for the TSQ Quantis LC/MS analyzer. Findings: 1. Review of QC records (February thru April 2022) for the TSQ Quantis LC/MS analyzer identified 2 days patient results were released in March when Level 1 QC did not meet the defined criteria for acceptability (3/17 and 3/29). 2. An interview with the general supervisor, 6/7/22 at approximately 12:00 PM, substantiated that 2 days in March had no acceptable Level 1 QC. 3. An exit interview with the laboratory director and general supervisor, 6/7/22 at approximately 1:00 PM, confirmed the findings. 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 D0000 An announced, on site recertification survey was conducted at WV Drug Testing Laboratories on March 12, 2020 by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratories Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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 laboratory College of American Pathologist (CAP) proficiency testing (PT) records, the test menu for the Au 400 chemistry/toxicology analyzer, quality assurance (QA) records, and an interview with testing personnel (TP1) and the laboratory director (LD), the laboratory failed to verify the accuracy of Tramadol and 6AM testing, which are not included in Subpart I, twice a year. Findings: 1. A review of CAP PT records from 2018 and 2019 identified no enrollment for the analytes Tramadol and 6AM in the CAP PT program. 2. A review of the test menu for the Au 400 chemistry/toxicology analyzer identified testing for the analytes Tramadol and 6AM. 3. A review of QA records for the moderate complexity testing identified no documentation of verifying the accuracy of Tramadol and 6AM testing twice a year. 4. During an interview with TP1, on 3/12/2020 at approximately 9:30 AM, TP1 stated that there was no documentation for verifying the accuracy of Tramadol and 6AM testing twice a year. TP1 stated that the laboratory was not enrolled in commercial PT for the analytes Tramadol and 6AM. 5. During an interview with the LD, on 3/12 /2020 at approximately 2:00 PM, the LD stated that the laboratory had not performed 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 -- commercial PT or alternate accuracy verification for Tramadol and 6AM. The LD stated that a written policy and procedure would be established and adhered to for verifying the accuracy of Tramadol and 6AM twice a year. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of written laboratory policies and procedures (P&P), monthly maintenance logs, and an interview with testing personnel (TP1) and the laboratory director (LD), the laboratory failed to define, monitor, and document criteria for conditions of (1) water quality for accurate and reliable test system operation and test result reporting for the Au 400 chemistry/toxicology analyzer. Findings: 1. The laboratory written P&P were reviewed. No written P&P defining suitable water quality for the operation of the Au 400 chemistry/toxicology analyzer was found. 2. Monthly instrument maintenance logs were reviewed. No documentation of monitoring for water quality was found. 3. During an interview with TP1, on 3/12 /2020 at approximately 10:00 AM, TP1 stated the only documentation of monitoring the water quality of the Evoqua water system for the Au 400 chemistry/toxicology analyzer were Evoqua service invoices. TP1 stated Evoqua came to the facility twice a year for preventative maintenance or service on the water system. 4. During the exit interview with the LD, on 3/12/2020 at approximately 2:00 PM, the LD stated there was no written P&P to define, monitor, and document the water quality for the Au 400 but one will be established and implemented. -- 2 of 2 --