Clinical Pathology Associates

Summary Statement of Deficiencies D0000 An announced routine recertification survey of the laboratory was conducted from 07 /29/2025 to 07/30/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties /subspecialties for which it was surveyed. Standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of the laboratory's proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attest to the routine integration of PT samples into the patient workload for one of three American Proficiency Institute (API) PT events and one of two College of American Pathologists (CAP) PT events in 2024. Findings include: 1. Review of the laboratory's policy titled "PROFICIENCY TESTING AND ACCURACY VERIFICATION -QA" stated: " ...i. The individual testing the samples must sign the attestation statement section of the results sheet to attest to the routine integration of the samples into the patient workload using routine methods ... ...j. The Medical Director must also sign the attestation form ..." 2. Review of the laboratory's PT records in 2024 determined the laboratory failed to ensure PT attestation pages were signed for one of three API PT events and one of two CAP PT events in 2024: a. PT Provider: API Event: 2024 Microbiology - 1st event Person performing test: no signature b. PT Provider: CAP Event: MGEN-B 2024 Mycoplasma genitalium, Molecular Survey Director (or Designee): no signature 3. The general supervisor-2 (as listed on the CMS-209) form confirmed the findings in an interview on 07/29/2025 at 1110 hours in the office. Key: CMS: Centers for Medicare and Medicaid Services 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 -- D5303 TEST REQUEST CFR(s): 493.1241(b) (b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of the laboratory's patient order forms and confirmed in interview, the laboratory failed to ensure patient test requisitions included information necessary for proper interpretation of results for Papanicolaou (PAP) smear testing for 12 of 13 patients randomly reviewed from August 2023 to July 2025. Findings include: 1. Review of the laboratory's policy titled "GENERAL LABORATORY POLICY - REQUISITION", approved by the laboratory director on 01/08/2024 stated: "PROCEDURE: A. GYN Cytology Specimen Demographic Information: ...2. Clinical Information a. Last menstrual period b. Hormonal status (e.g., pregnant, post-menopausal) c. Exogenous hormone therapy (birth control pills, estrogen cream) d. Use if IUD e. History of previous abnormal report, treatment or biopsy f. Patient's risk factors for cervical cancer g. Any other patient history" 2. Review of the laboratory's patient order forms determined the laboratory failed to ensure patient test requisitions included information necessary for proper interpretation of results for PAP smear testing for 12 of 13 patients randomly reviewed from August 2023 to July 2025. a. Patient ID: 470430 Patient date of birth: 07/01/1972 Requisition Number: 3725437CE23308 Date: 08/03/2023 3:33pm b. Patient ID: 628777 Patient date of birth: 11/29/1975 Requisition Number: 5974363CE21794 Date: 10/10/2023 2:48pm c. Patient ID: 284223 Patient date of birth: 03/15/1961 Requisition Number: 3715013CE23308 Date: 11/01/2023 1:48pm d. Patient ID: 506132 Patient date of birth: 11/13/1988 Requisition Number: 3988927CE23308 Date: 02/20/2024 8:59am e. Patient ID: 464319 Patient date of birth: 06/04/1983 Requisition Number: 4041813CE23308 Date: 05/13/2024 1:47pm f. Patient ID: 547922 Patient date of birth: 08/01/2000 Requisition Number: 4089356CE23308 Date: 07/30/2024 3:10pm g. Patient ID: 235295 Patient date of birth: 03/26/2002 Requisition Number: 6784899CE21794 Date: 09/09/2024 4:16pm h. Patient ID: 11937119 Patient date of birth: 08/13/1989 Requisition Number: 6916769CE21794 Date: 10/30/2024 4:26pm i. Patient ID: 649705 Patient date of birth: 08/27/1992 Requisition Number: 7038554CE21794 Date: 01/02/2025 8:41am j. Patient ID: 707419 Patient date of birth: 11/15/1990 Requisition Number: 7306014CE21794 Date: 04/07/2025 3:59pm k. Patient ID: 478020 Patient date of birth: 09/10/1976 Requisition Number: 7371892CE21794 Date: 05/02/2025 10:27am l. Patient ID: 11918579 Patient date of birth: 03/24/1998 Requisition Number: 7482745CE21794 Date: 07/02/2025 1:07pm 3. The general supervisor-2 (as listed on the CMS-209 form) confirmed the findings in an interview on 07/29/2025 at 1325 hours in the office. Key: CMS: Centers for Medicare and Medicaid Services -- 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, laboratory statistical records and interview with the Technical Operations Manager/Pathology Assistant, the laboratory failed to establish and follow written policies and procedures for an annual statistical evaluation of one of six required gynecologic laboratory statistics. The laboratory failed to document one of six required gynecologic laboratory statistics for 2022 and 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation of one of six required annual gynecologic laboratory statistics. Statistic includes: - The number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasms. 2. The Survey Team requested and the laboratory failed to provide records of one of six required annual gynecologic statistics for 2022 and 2023. Statistic includes: - The number of gynecologic cases where any rescreen of a normal or 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 -- negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma, or other malignant neoplasms. 3. During an interview on April 16, 2024 at 4:00 PM, these findings were confirmed by the Technical Operations Manager/Pathology Assistant. D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, workload limit records and interview with the Technical Operations Manager/Pathology Assistant, the laboratory failed to establish and follow written policies and procedures to ensure that workload limits for the Technical Supervisors and the Cytotechnologist would be prorated when examining slides in less than an eight-hour work day. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to prorate workload limits for the Technical Supervisors and the Cytotechnologist when examining slides in less than an eight-hour day, or with duties other than examining cytology specimen slides. 2. The Survey Team requested and the laboratory failed to provide documentation of prorated workload limits for three of three Technical Supervisors and one of one Cytotechnologists when examining slides in less than eight hours. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 Cytotechnologist includes: - The Cytotechnologist 3. During an interview on April 16, 2024 at 09:40 AM, these findings were confirmed by the Technical Operations Manager/Pathology Assistant. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory workload records and interview with the Technical Operations Manager/Pathology Assistant, the laboratory failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of hours each individual spent examining slides during each 24-hour period. The laboratory failed to maintain records of the number of hours three of three Technical Supervisors spent examining slides in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies -- 2 of 4 -- and procedures to ensure that the laboratory maintained records of the number of hours each individual spent examining slides per 24-hour period. 2. Three of three Technical Supervisors failed to document the number of hours spent exxamining slides during each 24-hour period in 2023 and January 1, 2024 to the date of the survey in 2024. Refer to D6133 3. During an interview on April 15, 2024 at 03:14 PM these findings were confirmed by the Technical Operations Manager/Pathology Assistant. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: A. Based on microscopic review of 329 random negative gynecologic slides and corresponding final cytology test reports from February 2, 2024 through April 5, 2024 and confirmation by Technical Supervisor #2 on April 17, 2024 the Technical Supervisor failed to verify the accuracy of six gynecologic cytology tests. 1. OG24- 01922 03/21/2024 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR #2 DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion 2. OG24-02027 03/29/2024 Imaged ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR #2 DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion 3. OG24-00716 02/02/2024 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory: Limited Cellularity TECHNICAL SUPERVISOR #2 DIAGNOSIS: Unsatisfactory: Scant Cellularity 4. OG24-01983 03 /25/2024 Imaged ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory: Limited Cellularity TECHNICAL SUPERVISOR #2 DIAGNOSIS: Unsatisfactory: Scant Cellularity 5. OG24-01992 03/25/2024 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory: Limited Cellularity TECHNICAL SUPERVISOR #2 DIAGNOSIS: Unsatisfactory: Scant Cellularity 6. OG24-02073 03/27/2024 ImagedThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory: Limited Cellularity TECHNICAL SUPERVISOR #2 DIAGNOSIS: Unsatisfactory: Scant Cellularity B. Based on microscopic review of 47/57 non-negative gynecologic cases /slides and corresponding final cytology test reports from February 2, 2024 through April 5, 2024 and confirmation by Technical Supervisor #2 on April 17, 2024 the Technical Supervisor failed to verify the accuracy of two gynecologic cytology tests. 3. OG24-01921 03/21/2024 ThinPrep Pap Test LABORATORY DIAGNOSIS: Atypical Squamous Cells cannot rule out High Grade Squamous Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy TECHNICAL SUPERVISOR #2 DIAGNOSIS: Benign Cellular Changes 4. OG24- 01974 03/26/2024 Imaged ThinPrep Pap Test LABORATORY DIAGNOSIS: -- 3 of 4 -- Atypical Squamous Cells cannot rule out High Grade Squamous Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy TECHNICAL SUPERVISOR #2 DIAGNOSIS: Benign Cellular Changes D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) In cytology, the technical supervisor or the individual qualified under 439.1449(k)(2), if responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24- hour period to screening cytology slides. This STANDARD is not met as evidenced by: Based on review of laboratory workload records and interview with the Technical Operations Manager/Pathology Assistant, three of three Technical Supervisors failed to document the number of hours devoted to screening slides during each 24-hour period in 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. Three of three Technical Supervisors failed to document the number of hours devoted to screening slides during each 24-hour period in January through December 2023 and January 2024 to the date of the survey in 2024. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 -Technical Supervisor #2 -Technical Supervisor #3 2. During an interview on April 15, 2024 at 03:14 PM, these findings were confirmed by the Technical Operations Manager /Pathology Assistant. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient records, quality control records, and interview with facility personnel, the laboratory failed to document negative reactivity each time of use for the Cytokeratin (CK 5/6) immunohistochemical stain for two of two patient records reviewed for the month of November 2021. The findings included: 1. Two patient records where the Cytokeratin (CK5/6) immunohistochemical stain was used in patient testing were identified for the month of November 2021: OS2105203 - received 11/16/2021 OS2105345 - received 11/23/2021 2. Based on review of quality control records, positive control reactivity was graded, but negative control reactivity was not documented for the dates of processing OS2105203 and OS2105345. 3. In an interview at 16:11 hours on 12/28/2021, the Laboratory Manager confirmed there was no documentation of negative reactivity on immunohistochemical stains such as the CK5/6 immunohistochemical stain. Instead there was a comment on the patient report that stated the following: "Any immunohistochemical stains or special stains performed had quality controls that were within an acceptable range, unless otherwise noted." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Review of laboratory records for 2018 and 2019 and interview of facility personnel found no documentation available for review to ensure the negative and positive reactivity of Hematoxylin and Eosin staining was acceptable for each day of patient testing between January 1, 2018 through January 31, 2019. The findings included: 1. Review of quality control records for Hematoxylin and Eosin (H and E) staining found no documentation of staining acceptability between January 1, 2018 and January 31, 2019. 2. Interview of testing person 7 conducted on September 5, 2019 at 11:19 AM confirmed the H and E quality control records were not available available for review. She stated that the laboratory changed the format for documenting H and E quality control staining in February 2019, and misplaced previous records. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) PAP proficiency testing records from 2018 and 2019 and interview of facility personnel, the laboratory failed to retain all proficiency testing records for at least 2 years in 1 of 2 reviewed events. The findings included: 1. PAP Proficiency testing (PT) records include all 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 -- information regarding the PT event including the original submission forms, proctor examinations, testing records, signed attestation statements, PT results and scores from the provider and documentation of review and records of any

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --