Wv Drug Testing Laboratories Inc

Summary Statement of Deficiencies D0000 A routine recetification survey was conducted at WV Drug Testing Laboratories Inc. Mercer Day Report on June 6, 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 cited are explained below. 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 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)

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at WV Drug Testing Laboratories Inc on August 3, 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. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on policies and procedures (P&P), record review, lack of documentation, and interview the laboratory failed to perform and document calibration procedures (2) at the frequency established by the laboratory two of 11 weeks reviewed for the AU400 analyzer. Findings: 1. Review of P&P identified that a weekly calibration was required for all analytes. 2. Review of quality control (QC) and calibration records for May 2022 thru July 2022 revealed 2 instances the weekly calibration of analytes was not performed and documented: weeks of 6/13 and 5/9/22 3. An interview with testing 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 -- personnel (TP1), on 8/3/22 at approximately 9:45 AM, confirmed that no documentation for the weekly calibrations could be located. 4. An exit interview with the laboratory director, on 8/3/22 at approximately 12:00 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at WV Drug Testing Laboratories- Mercer on September 2, 2020, by the West Virginia Office of Laboratories Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory written policies and procedures (P&P),quality control (QC) records, calibration records, the "Reagent/QC/Calibration Log Book", a tour of the laboratory, and an interview with the laboratory manager and laboratory director (LD), the laboratory failed to document and retain all analytic systems activities regarding the qualitative urine drug screen testing performed on the AU 400 as specified in CFR 493.1252 (d). Findings: 1. A review of the laboratory P&P identified a "Quality Control Policy" that states "Purpose: To ensure proper handling, storage, and use of all quality control materials. To provide precise and accurate results.." by incorporating the following processes: a. "Upon receiving Quality Control material into the laboratory the lot numbers and expiration dates will be documented in the Reagent/QC/Calibration Log Book with the date received." b. "Anytime reagent, quality control, or calibrators need to be replenished for use on the analyzer documentation in the Log Book will occur." 2. A review of the QC and calibration records identified that QC and calibrations were being performed at the appropriate and required times. 3. A review of the "Reagent/QC/Calibration Log Book" identified a lack of documentation of lot numbers and expiration dates for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- reagents, quality control, and calibration material used in the AU 400 analytic system. a. No documentation of lot numbers and expiration dates for the reagents cocaine, propoxyphene, barbiturate, amphetamine, tetracannabinoids, and alcohol could be located in the log book. 1. The log book had the last entry for the reagent benzodiazepine as lot number 73312172 with an expiration date of 2/2020. b. No documentation of lot numbers and expiration dates for the calibrator Multi Drug Cal I could be located in the log book. 1. The log book had the last entry for the calibrator Multi Drug II as lot number 73552649 with an expiration date of 5/2020. 2. The log book had the last entry for the calibrator Multi Drug III as lot number 72394545 with an expiration date of 9/2019. c. No documentation of lot numbers and expiration dates for the QC materials for cocaine, methadone, opiates, oxycodone, propoxyphene, and specific gravity could be located. 4. A tour of the laboratory identified that (1) there were no expired reagents, QC, and calibration materials being utilized by the laboratory for testing on the AU 400 analytic system and (2) there was not an electronic record of lot numbers and expiration dates stored on the AU 400 analyzer. 5. An interview with the laboratory manager was conducted on 9/02/2020 at approximately 10:15 AM. The laboratory manager stated the "Reagent/QC /Calibration Log Book" reviewed by the state surveyor was the current log book being used by the testing personnel. 6. During an interview with the laboratory director (LD), on 9/2/2020 at approximately 11:00, the LD stated that the lack of documentation for the lot numbers and expiration dates for reagents, quality control, and calibration materials was an issue that will addressed immediately. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory College of American Pathologists (CAP) proficiency testing (PT) records and an interview with the laboratory director (LD), the laboratory failed to investigate and document the

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to enroll in proficiency testing for the analyte of Urine Creatinine for 6 of 6 PT events reviewed. Review was from May 2016 to April 2018. The findings: 1. Review of the laboratory's PT records identified no PT results for Urine Creatinine for 2016 Event 2, 2016 Event 3, 2017 Event 1, 2017 Event 2, 2017 Event 3 and 2018 Event 1. 2. On 4/3/18 at approximately 1:15 PM, the LD confirmed the findings. 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 laboratory's proficiency testing records and interview with the 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 -- Laboratory Director (LD), the laboratory failed to perform twice annual verification of accuracy of Urine Specific Gravity performed on the AU480 from May 2016 to April 2018. The findings include: 1. Review of the laboratory's records from May 2016 until April 2018 identified no documentation of twice annual verification of accuracy of Urine Specific Gravity performed on the AU480. 2. On 4/3/18 at approximately 1:15 PM, the LD confirmed the findings. 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 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 on review of the laboratory's calibration/calibration verification records and interview with the Laboratory Director (LD), the laboratory failed to perform and document calibration verification every 6 months for Urine Creatinine and Urine Specific Gravity performed on the Olympus 480. Record review was from May 2016 to April 2018. The findings include: 1. Review of the Olympus 480 calibration /calibration verification records from May 2016 to April 2018 identified no calibration verification from May 2016 to April 2018. 2. On 4/3/18 at approximately 2:00 PM, the LD confirmed the findings. -- 2 of 2 --