Clinical Pathology Associates

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. Standard level deficiencies were cited. 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 the laboratory's policies and procedures, test reports, quality control (QC) records, pre-survey paperwork, and interview, the laboratory failed to document the reactivity of the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics for their quality control used in diagnostic interpretations of histopathology specimens for six out of 14 days of testing reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled "Microscopic Examination of Anatomic Pathology Specimens." revised 04/30/2020, under Testing Accuracy and Quality Assurance stated, "The pathologist will review the staining and slide quality each day as well as the quality of the gross. The results of this review are recorded on the CPA Daily Histology and Cytology QA Log. A rating of 'Good Quality' indicates the following respectively: 1. Histology H&E stained slides a. H& E stain: i. Nuclei and basophilic structures stain blue ii. Cytoplasm and acidophilic structures stain pink b. Gross quality is acceptable i. Specimen was submitted with correct measurements ii. Specimen number of pieces is acceptable iii. No cross contamination of specimens c. Slide quality is acceptable i. 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 -- Slide demonstrates tissue as expected ii. No cutting artifact that impacts rendering of a diagnosis as defined by the pathologist iii. Cover slipped appropriately." B. Random review of patient test reports against the Surgical and Cytology Stain Quality Log revealed six out of 14 days of testing without QC for the H&E stain as listed by date reported and accession numbers: Date Reported Accession Number 1. 09/21/2023 AT23-007841 2. 10/16/2023 AT23-008716 3. 12/20/2023 AT23-010948 4. 02/08 /2024 DP24-001284 & DP24-001327 5. 04/25/2024 AT24-003669 6. 04/26/2024 DP24-004641 C. Review of the CMS Form 116 showed an estimated annual test volume of 7836 in histopathology. D. Interview with the Client Services Manager on July 17, 2024 at 1740 hours in the office confirmed there was no documentation of the QC on those days of testing after a review of the records. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, test reports, quality control (QC) records, pre-survey paperwork, and interview, the laboratory director failed to ensure the quality control programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings follow. 1. The laboratory failed to document the reactivity of the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics for their quality control used in diagnostic interpretations of histopathology specimens for six out of 14 days of testing reviewed (see D5473). -- 2 of 2 --

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the laboratory's policies and procedures, competency records, credentialling file, and interview, the laboratory failed to ensure the competency of one of eight Technical Supervisors and one of eight General Supervisors. Findings follow. A. Review of the Technical Supervisor/General Supervisor policy and procedure, effective May 31, 2018, under Competency Assessments of the Technical Supervisor/General Supervisor stated, "1. Each pathologist serving as a technical supervisor and general supervisor will receive a competency assessment for the duties. 2. This assessment will be performed initially and will be performed any time that the assigned duties are changed or new duties are added. 3. The CPA Scheduling and Credentialing office will accumulate competency metrics as outlined in the SOP Professional Competency Policy for Pathologist. On an annual basis (or semiannually for new pathologists), CPA Scheduling and Credentialing will collect pathologist metrics and data from competency activities described above for review on an individual basis by the president of CPA, a board-certified pathologist, or a designated (pathologist) quality officer. A summary of competency activities is maintained by CPA Scheduling and Credentialing to be available to or distributed to Laboratory Director as required by credentialing agencies, inspection authorities, or institutional policies." B. Review of the Technical Supervisor /General Supervisor Competency 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 -- Assessment, dated 08/16/2021, stated, "These individuals are authorized to perform histopathology testing to include microscopic examinations and macroscopic examination of patient specimens without supervision or need for review prior to reporting results." Technical Supervisor & General Supervisor # 4 on the CMS form 209, was not listed. C. Review of the Hire and Term Date Credentialling File showed Technical Supervisor/General Supervisor #4 was hired on 7/30/2018. D. Interview with the Clinical Support Supervisor on May 18, 2022 at 1000 in the office confirmed Technical Supervisor/General Supervisor #4 was not on the list and acknowledged she had been employed for two years. -- 2 of 2 --

Summary Statement of Deficiencies D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (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) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, annual cytology statistics documentation, and interview with facility personnel, the laboratory failed to establish an annual statistical laboratory evaluation of the number of Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison and Gynecologic cases where cytology and histology are discrepant for 2017. The findings included: 1. Based on the laboratory's policy " Gynecologic Case Statistical Data " effective 5/31/2018, the laboratory had established a procedure to evaluate annually the statistics for cytology to detect errors in the performance of cytology examinations and the reporting of results. The policy stated the following: "POLICY PURPOSE: This policy establishes guidelines for the collection and review of GYN statistical data for this location. POLICY STATEMENT: CPA pathologists perform cytology examination on slides processed 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 -- and stained at {Other Lab Name Redacted} retains all statistical data for each testing location. Statistical Data Collection and Review Procedure 1. {Other Lab Name Redacted} Cytology pulls statistical information by location on an annual basis. 2. The data sets include the following information: a. Cases examined b. Specimens processed for the location by type c. Number of cases reported by diagnosis including any unsatisfactory for diagnostic interpretation d. Number of HSIL, adenocarcinoma, or other malignancy cases for which histology results were available for comparison. e. Number of cases where cytology and histology were discrepant f. Major Diagnostic Discrepancies: cases where the rescreen of normal or negative specimen results in a reclassification as low-grade squamous intraepithelial lesion, HSIL, adenocarcinoma, or other malignant lesions." 2. Based on review of the documentation on-site during the inspection, the annual statistics for cytology, provided by the laboratory failed to address number of Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison and Gynecologic cases where cytology and histology are discrepant for 2017. Additional documentation was provided at 13:30 hours on 9/6/2018 via email. The documentation was titled "HIGH GRADE CORRELATION SUMMARY 2017". In an email response at 13:56 hours on 9/6/2018 via email, the Clinical Pathology Support Manager stated "Also...to clarify, this is not by location, it is for the practice as a whole." 3. In a phone interview at 10:08 hours on 9/7/2018, the Clinical Pathology Support Manager confirmed the statistics had been evaluated practice-wide, and not for this specific laboratory. -- 2 of 2 --