Huntington Hospitalist Group

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Huntington Hospitalist Group on November 13, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of written policies and procedures for toxicology, maintenance logs for the ABSciex 4500 analyzer, lack of documentation, and interview with the laboratory director (LD) and testing personnel (TP1), the laboratory failed to document the monitoring of daily injections and the dates of column replacement for the ABSciex 4500 analyzer, per established protocol, from January 2025 thru date of survey. Findings: 1. Review of the"Mass Spectrometry Toxicology Procedure with B- Glucuronidase Extraction" policy identified an established maintenance protocol for the ABSciex 4500 analyzer stating "analytic columns need to be replaced approximately each 1000-2000 injections...using a preventative maintenance approach that depends on the number of daily injections." 2. Review of the ABSciex 4500 analyzer monthly maintenance logs (January 2025 thru date of survey) revealed specific areas for recording the running total number of daily injections since last column change and the date of column replacement. The number of daily injections and column replacement dates were not documented on 11 of 11 monthly maintenance logs reviewed. No other documentation indicating that the number of daily injections and dates of column replacement had been monitored could be 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 -- located. 3. During an interview 11/13/2025 at 11:15 AM, the LD and TP1 verified that monitoring of the number of daily injections and dates of column replacement had not been documented on the monthly maintenance logs for the ABSciex 4500 analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Huntington Hospitalist Group on December 20, 2023, 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. 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 record review, lack of documentation, and interview the laboratory failed to verify the accuracy of 11 of the 29 analytes tested on the AB SCIEX toxicology analyzer in 2023. Findings: 1. Review of proficiency testing (PT) records for 2023 identified 11 analytes that are not included in Subpart I and not enrolled in commercial PT. 2. No documentation for the verification of accuracy for the 11 analytes on the Sciex analyzer could be located for 2023. 3. An exit interview with the laboratory director on 12/20/23 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 --