Women's Health Center Of West Virginia

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Women's Health Center of West Virginia on January 30, 2024, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on record review and interview the laboratory has no qualified clinical consultant under CFR 493.1417. Findings: 1. Review of laboratory personnel files, documented education, and the CMS 209 form identified no qualified clinical consultant. Refer to D6057. 2. An interview with the laboratory director, 1/30/24 at 10: 00 AM, confirmed the findings. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. 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 record review and interview the laboratory has no qualified clinical consultant under sections (a) or (b) of CFR 493.1417. Findings: 1. Review of personnel files, documented education, and the CMS 209 form identified the following laboratory personnel: Laboratory director qualifies under CFR 493.1405(a) (b)4 Technical consultant qualifies under CFR 493.1411(a)(b)3 2. Review of personnel files and documented education identified no qualified personnel for the position of clinical consultant. 3. An interview with the laboratory director, 1/30/24 at 10:00 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Womens Health Center of WV Inc. on November 17, 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. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to (5) document the testing of proficiency testing (PT) samples and retain the signed attestation statements for the American Proficiency Institute (API) proficiency testing program in 2020 and 2021. Findings: 1. Review of API records revealed a lack of documentation for the processing and examination of PT samples in 9 of 9 testing events for 2020 and 7 of 7 testing events for 2021. 2. Review of API records identified no attestation statement signed by testing personnel and the laboratory director for one of two 2021 Hematology/Coagulation testing events. 2. An interview with the laboratory consultant, 11/17/21 at approximately 9:00 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 2 -- D2127 HEMATOLOGY CFR(s): 493.851(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 record review and interview the laboratory failed to submit proficiency testing (PT) results within the timeframe specified by the American Proficiency Institute (API) for one of two Hematology/Coagulation 2021 events. Findings: 1. Review of API PT records identified the following: 1st event 2021 Hematology /Coagulation- 0% failure to participate 2. An interview with the laboratory consultant, 11/17/21 at approximately 9:45 AM, confirmed the findings. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to attain a satisfactory score for Microscopy (Vaginal Wet Preparation ) in two consecutive American Proficiency Institute (API) proficiency testing (PT) events, resulting in an unsuccessful performance for analyte. Findings: 1. Review of API records identified the following scores: 0% 2020 3rd event- Microscopy Vaginal Wet Preparation 0% 2021 1st event- Microscopy Vaginal Wet Preparation 2. An interview with the laboratory consultant, 11/17/21 at approximately 9:30 AM, confirmed the findings. 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, lack of documentation, and interview the laboratory failed to perform and document training and competency for 2 of 3 laboratory testing personnel (TP2 and TP3) as required by established policies and procedures. Findings: 1. Review of testing personnel records identified the following: TP2- 6 month competency for serum HCG testing was not completed TP3- Initial training was completed 10/14/21 for all test methods. Review of testing logs (January 2021 thru date of survey)identified TP3 performing quality control 8/23/21 and 2/15/21. 2. An interview with the laboratory consultant, 11/17/2021 at approximately 11:00 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 an unsatisfactory score of 0% for Vaginal Wet Preparation in 2 of 5 American Proficiency Institute testing events in 2018 and 2019. Findings: 1. A review of 2018 API records 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. A review of 2019 API PT records identified an unsatisfactory performance of 0% for Vaginal Wet Preparation in the 2019 Hematology 1st testing event. For sample VA-01 the laboratory reported "yeast seen", when the correct answer was "clue cells seen". This resulted in an unsatisfactory score of 0%. 3. An interview with TC1, on 10/3/19 at approximately 8:40 AM, confirmed the findings. 4. The laboratory took remedial action for both unsatisfactory performances and documented the action taken. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: 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 -- Based on a review of laboratory policies and procedures and an interview with the Technical Supervisor 1 (TS1), the laboratory failed to have the procedure manuals for the Anti-D testing procedure signed by the current Laboratory Director (LD). Findings: 1. A review of the laboratory policies and procedures identified that manufacturer directions/product inserts are utilized as the procedure for the Anti-D testing performed. 2. The manufacturer directions/product inserts used as the procedure manual for Anti-D testing, Quotient Anti-D Delta Albaclone and Reagent Control for Anti-D Albacheck, were not signed by the current LD. 3. An interview with TS1, on 10/3/19 at approximately 8:32 AM, confirmed that those manufacture direction/product inserts for Quotient Anti-D Delta Albaclone and Reagent Control for Anti-D Albacheck are the current procedures for Anti-D testing and that the current LD had not signed them. -- 2 of 2 --