Clinical Pathology Associates Namc

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 policy and procedure, quality control (QC) records, test reports, presurvey paperwork, and interview, the laboratory failed to document the intended reactivity to ensure predictable staining characteristics for the Papanicolaou (PAP) stain used in cytology interpretations of non-GYN cases stained predictably for two of four cases 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 Histopathology H&E stained slides a H&E stain: i. Nuclei and basophilic structures stain blue ii. Cytoplasm acidophilic structures stain pink b. Gross quality is acceptable i. Specimen was submitted with correct measurements ii. Specimen number of pieces is acceptable iiii. No cross contamination of specimens c. Slide quality is acceptable i. Slide demonstrates tissue as expected ii. No cutting artifact that impacts rendering of a diagnosis as defined by the pathologist. iii. Cover Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- slipped appropriately 2. Cytology Papanicolaou stained slides: a. Slide Quality: i. Processing Acceptable (sufficient cellularity for diagnosis) ii. Papanicolaou stain: 1. nuclei (Chromatin) blue 2. Keratin orange 3 Cytoplasm shades of blue-green 4. Squamous cells, RBCs, nucleoli, and cilia shades of pink iii. Cover slipped appropriately 3. Special Stains/immunohistochemistry stains are assessed only when performed. a. When a special stain is performed, there will be a working control that is performed with that stain. b. The pathologist will assess the patient and control stain for quality and results. i. Stain performance is based on the results criteria outlined in the attached documents from CPA. These are maintained on location for reference for testing personnel. c. The assessment of this stain is documented in the pathology report. Language similar to the following will be used: "XX stain is performed in the presence of a(n) appropriately functioning/positive control." This statement should be interpreted as the assessment that the stain functioned as expected and is adequate for diagnosis." B. Random review of patient test reports against the Surgical and Cytology Stain Quality Log revealed two out of four days of testing without QC for the PAP stain as listed by date reported and accession numbers: Date Reported Accession Number 1. 12/22/2023 PAP23-012245 2. 01/30/2024 AT24-000790 C. Review of the CMS Form 116 showed an estimated annual test volume of 6349 in histopathology. D. Interview with the Client Services Manager on November 17, 2024 at 1505 hours in the office confirmed there was no documentation of the QC on those days of testing after a review of the records. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, quality control (QC) records, test reports, presurvey paperwork, and interview, the laboratory failed to document the intended reactivity to ensure predictable staining characteristics for the Immunohistochemical (IHC) stains and Special stains for the diagnostic interpretation of histopathology specimens for three of three reports reviewed. Finding 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 Histopathology H&E stained slides a H&E stain: i. Nuclei and basophilic structures stain blue ii. Cytoplasm acidophilic structures stain pink b. Gross quality is acceptable i. Specimen was submitted with correct measurements ii. Specimen number of pieces is acceptable iiii. No cross contamination of specimens c. Slide quality is acceptable i. Slide demonstrates tissue as expected ii. No cutting artifact that impacts rendering of a diagnosis as defined by the pathologist. iii. Cover slipped appropriately 2. Cytology Papanicolaou stained slides: a. Slide Quality: i. Processing Acceptable (sufficient cellularity for diagnosis) ii. Papanicolaou stain: 1. nuclei (Chromatin) blue 2. Keratin orange 3 Cytoplasm -- 2 of 3 -- shades of blue-green 4. Squamous cells, RBCs, nucleoli, and cilia shades of pink iii. Cover slipped appropriately 3. Special Stains/immunohistochemistry stains are assessed only when performed. a. When a special stain is performed, there will be a working control that is performed with that stain. b. The pathologist will assess the patient and control stain for quality and results. i. Stain performance is based on the results criteria outlined in the attached documents from CPA. These are maintained on location for reference for testing personnel. c. The assessment of this stain is documented in the pathology report. Language similar to the following will be used: "XX stain is performed in the presence of a(n) appropriately functioning/positive control." This statement should be interpreted as the assessment that the stain functioned as expected and is adequate for diagnosis." The policy did not address the documentation of controls for IHC and Special stains. The laboratory's practice was to document controls for the IHC and Special stains only in the test report. B. Review of the Surgical and Cytology Stain Quality Log did not have a column to record the QC for Immunohistochemical (IHC) or Special stains. C. Random review of 18 test reports from 07/13/2022 - 08/27/2024 showed 3 with IHC/special stains. Three of three test reports/cases did not include QC for the intended reactivity to ensure predictable staining characteristics for the following IHC and Special stains: Surgical Path # Date Reported IHC/Special Stain 1. D0090916-2201 12/15/2022 PAS 2. DP23- 007842 08/23/2023 Sox-10, PRAME 3. DP24-006516 06/18/2024 PAS D. Review of the CMS form 116 showed approximately 6349 histopathology specimens were reported annually. E. Interview with the Client Services Manager on October 17, 2024 at 1430 hours confirmed the performance of the QC for the IHC and Special stains was not recorded on a QC log. -- 3 of 3 --

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, pre- survey paperwork, and interview, the laboratory failed to ensure the competency was accessed for one of six Technical Supervisors performing histopathology and cytology microscopic interpretations. Findings follow. A. Review of the Technical Supervisor /General Supervisor policy and procedure, effective May 30, 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 Assessment, dated 06/17/2022, stated, 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 -- "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 # 5 on the CMS form 209, was not listed. C. Review of the pre-survey paperwork, Laboratory Personnel, showed Technical Supervisor #5 was hired on 8/16/2021. D. Interview with the Clinical Support Manager on July 27, 2022 at 0940 hours in the office acknowledged Technical Supervisor #5 was not on the list. 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,

Summary Statement of 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 review of the laboratory's policies and procedures, competency records, pre- survey paperwork, and interview, the laboratory failed to ensure the competency of 1 of 6 Technical Supervisors. Findings follow. A. Review of the Technical Supervisor /General Supervisor policy and procedure, effective May 30, 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 Assessment, dated 06/25/2018, 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 # 7 on the CMS form 209, was not listed. C. Review of the pre-survey paperwork, 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 -- Laboratory Personnel, showed Technical Supervisor #7 was hired on October 5, 2020. D. Interview with the Clinical Pathology Technical Supervisor on June 2, 2021 at 1240 in the office acknowledged Technical Supervisor #7 was not on the list and that the form needs to be updated. She added Technical Supervisor #7 had started in October of 2020 and was in the process of compiling data for the [Laboratory Director] to review. -- 2 of 2 --