Summary:
Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Marshall Health Teays Valley on April 15, 2025, by the West Virginia Office of Laboratory Services. The facility was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory written policies and procedures, laboratory competency assessment records, lack of documentation, interview with the technical consultant (TC), and an exit interview with the laboratory director (LD) and administration, the laboratory failed to document the quarterly competency assessment of 3 of 3 testing personnel (TP) for the performance of a white blood cell count with manual differential in 2024. Findings: 1. Review of hematology policies revealed "Slide Review and Manual Differential" stating "Competency- once a quarter the techs will be given the same slide to perform a manual differential on. These results will be compared to each other as well as the instrument findings." 2. Review of 2024 laboratory testing personnel (TP) competency assessment records revealed no documentation for the quarterly assessment for 3 of 3 TP. 3. During an interview with the TC, 4/15/25 at 11:00 AM, the TC stated that quarterly competency assessment for the manual differential could not be located. 4. An exit interview with the LD, TC, and members of the administration, 4/15/25 at 3:00 PM, confirmed the lack of competency assessment for the performance of a white blood cell count with manual differential for 3 of 3 TP. 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 -- D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures, quality assessment (QA) records, interview with the technical consultant (TC), and exit interview with the laboratory director (LD) and administration, the laboratory failed to document the biannual verification of transmitted test results to the electronic health record (EHR) in 2024 and 2025 (January 2024 thru date of survey). Findings: 1. Review of post analytic QA policies revealed "Testing Protocol for QA" stating "Computer functions to be verified periodically. Among the ones to be checked are: Transmitted test results to the EHR biannually." 2. Review of 2024 and 2025 (January 2024 thru date of survey) QA records revealed no documentation for the biannual verification of test results transmitted to the EHR (CERNER). 3. During an interview, 4/15/25 at approximately 1:15 PM, the TC stated that no documentation for the verification of electronically transmitted results could be located. 4. An exit interview with the LD, TC, and members of the administration, 4/15/25 at 3:00 PM, confirmed the lack of biannual verification of electronically transmitted results into CERNER. -- 2 of 2 --