Pineview Gynecology

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Pineview Gynecology on October 26, 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. 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 written policies and procedures (P&P), record review, lack of documentation, and interview the laboratory failed to follow the established process to assess employee competency for all 6 required criteria in 2021 for 3 of 4 laboratory testing personnel. Findings: 1. Review of P&P identified an established process for assessing the elements of competency of laboratory testing personnel for the BD Affirm test system. 2. Review of TP competency records for 2021 identified a competency assessment of criteria (6) Problem solving skills for 4 of 4 TP. 3. Review of TP competency records for 2021 revealed no documented competencies of the other 5 required criteria for 3 of 4 TP; 1) Direct observation of routine patient testing 2) Monitoring the recording and reporting of test results 3) Review of test results, worksheets, QC records, PT records, maintenance records 4) Direct observation of instrument maintenance 5) Assessment of test performance with external blind testing or external PT 4. An interview with the laboratory manager, 10/26/22 at approximately 8:00 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, recertification survey was conducted at Pineview Gynecology on November 24, 2020, by the West Virginia Office of Laboratory 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. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of the laboratory testing personnel (TP) files, the West Virginia licensure verification source, and an interview with the technical consultant (TC) and laboratory manager, 1 out of the 4 laboratory TP did not have a current West Virginia laboratory license as required by the West Virginia state rule WV 64 CFR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Findings: 1. A comparative review of the laboratory TP files and the West Virginia licensure verification source identified one TP (TP1) with an expired West Virginia laboratory license. a. TP1 had a license that expired 1/1/2020. b. The 3 other TP had current West Virginia laboratory licenses. 2. During an interview with the TC and the laboratory manager, on 11/24/2020 at approximately 8:30 AM, both stated they had a current TP with an expired West Virginia laboratory license and they will immediately begin the process of reinstating TP1 license. 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 --