Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at A Capital Women's Health Clinic on 08/25/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F. R. 493-1250 Condition: Analytic Systems. 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 the review of proficiency testing (PT) records, lack of documentation, and interview, the laboratory failed to maintain documentation of the attestation statement, event scores and review of final scores for one of five events reviewed at the date of survey on 08/25/22. Findings include: 1. Review of the available American Proficiency Institute (API) PT records revealed lack of documentation of the attestation statement, the ABO/RHO D (RHO) Type final results, and documentation of the review of the results for the 2022 API Immunology/Immunohematology 1st event. During an interview with the medical office staff on 08/25/22 at approximately Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 10:30 AM the inspector requested the PT records. The records were not available for review. 2. An exit interview with the medical office staff on 08/25/22 at approximately 11:30 AM confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of policy and procedures (P&P), quality assurance (QA) records, quality control (QC) records, temperature records, lack of documentation and interview, the lab failed to: 1) perform Rh blood typing QC each day from 05/25/22 up to 08/23/22 (Refer to D5403); 2) monitor and document the refrigerator and room temperatures from 05/25/22 up to 08/23/22 (Refer to D5411); and 3) ensure the QA monitors and checklists were performed on a quarterly basis from 06/01/21 up to the date of survey on 08/25/22 (Refer to D5791). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)