Greenbrier Day Report Center

Summary Statement of Deficiencies D0000 A routine recertification survey was performed at Greenbrier Day Report Center on July 30, 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. 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 verification of the performance specifications for two of 13 analytes validated on the Thermo Scientific Indiko Plus analyzer in December 2022. Findings: 1. Review of the December 2022 toxicology verification records revealed no documentation for the review and approval of the performance specifications for heroin metabolite (6AM) and Oxycodone testing on the Indiko Plus. 2. Review of patient toxicology test results (July 2024) from the Thermo Scientific Indiko Plus identified 6AM and Oxycodone qualitative results released. 3. An interview with the testing personnel (TP1) and the laboratory director (LD), 7/30/24 at 9:10 AM, confirmed the lack of documentation retention for the review and approval of the performance specifications for the two analytes. 4. An exit interview with the LD and TP1, 7/30/24 at 11:30 AM, 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, routine recertification survey was conducted at Greenbrier Day Report Center on July 12, 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed and found to be In Compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. No deficiencies were cited. 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 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 9:30 AM, 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 9:30 AM, 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 10:30 AM, the LD confirmed the findings. -- 2 of 2 --