All Womens Health Center Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at All Women's Health Center Inc on 5/06/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to 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 for a minimum of two years for five of six proficiency events from 2023 to 2025. Findings included; 1. Proficiency records failed to include testing records, signed attestation records, and submissions to proficiency program for 2023 second event and third event, and 2024 first event, second event, and third event. 3. Testing Person A confirmed at 10:53 a.m. on 5/6/25, the laboratory had not maintained proficiency records of testing records, signed attestation records, and submissions to proficiency program for 2023 second event and third event, and 2024 first event, second event, and third event. 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 -- D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at All Women's Health Center, Inc. on 03/06/2023 to 03/07/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 with the Administrator (Testing Personnel #B) the laboratory failed to perform competency assessment for two out of two years 2021 - 2022) for one (Testing Personnel #B) out of two Testing Personnel (#B and #C). Findings Included: Review of the CMS 209, Laboratory Personnel Report signed by the Laboratory Director on 3/7/2023 revealed the Laboratory Director was also the Technical Consultant and there were 2 Testing Personnel (#B and #C). Record review of the laboratory's policy and procedure titled "General Standards and Guidelines" revealed the Technical Consultant was responsible for evaluating the competency of all testing personnel and assuring that the staff maintained their competency to perform test procedures and report test results promptly, accurately and proficiently. The competency evaluation was to be completed at least annually for individuals testing for greater than one year. Review of Personnel files revealed no competency assessments for Testing Person #B. On 03/06/2023 at 10: 25 AM, the Administrator (Testing Personnel #B) confirmed that no competency assessments had been performed on her, and she had been testing at the laboratory for over one year. 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 CLIA recertification survey was conducted at All Women's Health Center, Inc. on 10/20/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with the Administrator (Testing Personnel #B), the Laboratory Director failed to ensure that the laboratory documented the training of individuals that performed specialty testing of immunohematology (rH testing non- transfusion) on patient specimens. Findings included: 1. Record review of training and competency records revealed that Testing Personnel #B, who had a start date of 05/28 /20, did not have rH testing training records. 2. Interview on 10/20/20 at 11:10 AM with the Administrator (Testing Personnel #B) confirmed her start date of 05/28/20 and reported being trained on rH testing, however, the laboratory had not documented the training. 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 --