Mon Health Wedgewood Primary Care

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Mon Health Wedgewood Primary Care & Psychiatry on July 27, 2021, 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. 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 record review and interview the laboratory failed to assess the annual competency of 2 of 8 testing personnel (TP) in 2020 and the six month competency of 1 of 8 TP in 2020. Findings: 1. Review of TP personnel files revealed no annual competency for TP2 and TP3 for 2020. 2. Review of TP personnel files revealed no six month competency for TP4 for December 2020. TP4 hired date 6/29/2020. 3. An interview with the laboratory supervisor, on 7/27/21 at approximately 9:30 AM, confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) documents, patient test results, and interview the laboratory failed to ensure that quality control materials for the ACT2Diff Hematology analyzer were not being used after expiration date. Findings: 1. Review of QC daily printouts from the ACT2Diff hematology analyzer (October 2020 thru February 2021) identified QC lot 068100, 078100, 088100 Lot Expiration 10/27/2020 programmed into the analyzer as QC for 10/28/2020 and 10/30/2020. 2. Review of patient test results revealed 3 patients had CBCs reported 10/28/2020 and no patient CBCs ran 10/30/2020. 3. An interview with the laboratory manager, 7/27/21 at approximately 10:30 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory failed to submit PT results to API for the 2019 Immunology 2nd testing event within the timeframe specified. Findings: 1. A review of PT records for 2019 identified an unsatisfactory performance with a result of 0% for the API 2019 Immunology 2nd testing event. 2. An interview with TC1, on 9/25/19 at approximately 12:30 PM, confirmed that the laboratory failed to return the PT results to API before the deadline for the 2019 Immunology 2nd testing event. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory Proficiency Testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory received unsatisfactory analyte performance scores from American Proficiency Institute (API) for PT results submitted for the API 2018 Hematology 2nd testing event and the API 2019 Hematology 1st testing event Findings: A. 1. A review of 2018 API PT records 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 -- identified an unsatisfactory performance of 0% for Vaginal Wet Preparation in the 2018 Hematology 2nd testing event. For sample VA-02 the laboratory reported "clue cells seen", when the correct answer was "no yeast, Trich, or clue cells". This resulted in an unsatisfactory score of 0%. 2. An interview with TC1, on 9/25/19 at approximately 12:30 PM, confirmed the findings. 3. The laboratory took remedial action and documented the remedial action taken. B. 1. A review of 2019 API PT records identified unsatisfactory analyte performance scores of 60% for Erythrocyte Count and 33% for White Blood Cell Differential in the automated hematology of the API 2019 Hematology 1st testing event. 2. An interview with TC1, on 9/25/19 at approximately 12:30 PM, confirmed the findings. 3. The laboratory took remedial action and documented the remedial action taken. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory received an unsuccessful overall testing event score of 67% for the automated Hematology in the API 2019 Hematology/Coagulation 2019 1st event. Findings: 1. A review of PT records for 2019 identified unsuccessful analyte scores of 60% for Erythrocyte Count and 33% for White Blood Cell Differential in the API 2019 Hematology/Coagulation 1st testing event. The other analytes in the automated Hematology (HCT, HGB, WBC count, and Platelet count) had successful scores. 2. An interview with TC1, on 9/25/19 at approximately 12:15 PM, confirmed the findings. 3. The laboratory took remedial action and documented the remedial action taken. -- 2 of 2 --