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 deficiency was cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. 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 Papanicolaou stain to ensure predictable staining characteristics for their quality control used in diagnostic interpretations of nongynecological cytology specimens for 2 out of 5 days of testing reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled "Microscopic Examination of Anatomic Pathology Specimens." revised 03/15/2025, 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 for surgical cases. The results of this review are recorded on the CPA Daily Log of Outpatient Surgical Pathology and Cytology Slide Quality. A rating of 'Good Quality' indicates the following: 2. Cytology Papanicolaou stained slides: a. Slide Quality: Processing Acceptable (sufficient cellularity for diagnosis) Papanicolaou stain: i. Nuclei (Chromatin) blue ii. Keratin orange iii. Cytoplasm shades of blue-green iv. Squamous cells, RBCs, nucleoli, and cilia shades of pink iii. Cover slipped appropriately." B. Random review of patient test reports against the Surgical and Cytology Stain Quality Log revealed two out of five days of testing without QC for the Papanicolaou stain as listed by date reported and accession numbers: Date Reported Accession Number 1. 06 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 -- /28/2024 ATNG24-000065 2. 02/19/2024 AT24-001311 C. Review of the CMS Form 116 showed an estimated annual test volume of 169 in nongynecological cytology. D. Interview with the Client Services Manager on March 26, 2025 at 1315 hours in the conference room confirmed there was no documentation of the QC on those days of testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, case lists, pre-survey paperwork, accuracy assessments and interview, the laboratory failed to verify the accuracy of its interpretation of its hematopathology cases for two of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Pathologists' Competency Assessments, effective 05/29/2018, stated, "2. Where applicable, pathologists participate in quality assurance activities as required by institutional policies (i.e., hospital practices, outpatient laboratory, others) to assure competency. These may include but are not limited to: - Random prospective case review - Retrospective case review - Frozen section -permanent correlation - Intradepartmental consultation correlation - Extradepartmental consultation correlation Refer to institutional specific quality specific assurance policies for further details." B. Review of the case lists and patient test reports showed the lab was reporting out bone marrow hematopathology reports, not represented on the CMS form 116. The form was updated by the Laboratory Director and Clinical Support Manager. C. Review of the CMS form 116 showed an annual test volume of 7 cases in the specialty of hematopathology. D. Review of the Intradepartmental Consultation peer reviews showed one case for 2021 and 2022. E. Interview with the Laboratory Director on January 26, 2023, at 1540 hours acknowledged he was not sure if they did any random reviews for hematopathology, and they had been reporting 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 -- hematopathology cases as long as they've had the CLIA certificate. Email with the Clinical Support Manager on January 27, 2023, at 1217 hours confirmed there was only one peer review each year in hematopathology. -- 2 of 2 --