Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of pre-survey paperwork, quality control (QC) records, test reports, interview, and query, the laboratory failed to document the intended reactivity to ensure predictable staining characteristics for the Papanicolaou (PAP) stain used in cytology screening and interpretations of GYN and non-GYN cases stained predictably for ten of ten months reviewed. Findings follow. A. Review of the pre- survey paperwork titled Annual Test Volume & Proficiency Testing Programs Worksheet showed cytology screening and interpretations of GYN and non-GYN cases began 04/01/2023. B. Quality control records for cytology were requested at 1540 hours on January 25, 2024 but not provided. C. The following test reports/cases with the PAP stain were reviewed: Accession # Date Reported 1. PAP23-001882 01 /19/2024 2. PAP23-002458 04/13/2023 3. PAP23-006043 07/20/2023 4. PAP23- 006664 08/03/2023 5. PAP23-009469 10/10/2023 D. Interview with the General Supervisor on January 25, 2024 at 1540 hours by phone acknowledged the main lab that prepared the slides and performed the technical component did that and confirmed there was no documentation of the quality control for the PAP screening and interpretations performed at this location. E. Review of the file titled "PAP cases 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 -- for Inspection 2023" showed the total GYN cases reported was 9,174 in 2023. Review of the file titled "2023 cases read at CPA" showed the total non-GYN cases was 13 in 2023. KEY: GYN = gynecological D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,