Physicians Immunodiagnostic

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the College of American Pathologists (CAP) proficiency testing (PT) records and interviews with the laboratory director (LD), technical consultant (TC), and testing personnel (TP), the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Urea Nitrogen (UN) analyte. The findings include: 1. The surveyor reviewed the PT records reported by CAP for the second event of 2024 (Q2-2024) as an unsatisfactory score for UN analyte of 20%. 2. The LD, TC, and TP affirmed by interviews on April 10, 2026, at approximately 11:30 a.m. that the laboratory obtained the unsatisfactory PT scores for UN as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) signed by the LD and submitted on the day of the survey 04/10/2026, the laboratory performed approximately 29,716 UN patient test samples annually including at the time when the laboratory received the unsatisfactory proficiency for UN analyte testing score. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: 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 -- Based on the surveyor's review of the College of American Pathologists (CAP) proficiency testing (PT) reports and interviews with the laboratory director (LD), technical consultant (TC), and testing personnel (TP), the laboratory failed to attain a score of at least 80 percent in Endocrinology for Triiodothyronine (T3) for the second event of 2025 (Q2-2025). The findings include: 1. The laboratory obtained a score of 60% for the T3 analyte as reported by CAP-PT for the Q2-2025 event. 2. The LD, TC, and TP affirmed on the day of the survey April 10, 2026 , at approximately 11:40 a. m. that the laboratory obtained the unsatisfactory proficiency score as mentioned on statement#1 for the T3 analyte. 3. Based on the laboratory's annual test volume declaration signed by the laboratory director on 04/09/2026, the laboratory analyzed and reported approximately 1,079 T3 patient tests. The reliability and quality of patient tests reported during the period the laboratory received an unacceptable T3 - PT report cannot be assured. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of College of American Pathologists (CAP) proficiency testing (PFT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, nine (9) randomly selected patient test records, and interviews with the laboratory's laboratory director (LD), technical supervisor (TS) and testing personnel (TP); the laboratory failed to attain at least 80 percent of the acceptable response resulting to an unsatisfactory performance for the Prothrombin Time (PT) analyte third event for 2025 (Q3-2025) . The findings include: 1. The laboratory was enrolled in the CAP - PT program and received an unsatisfactory score of 60% for PT for Q3-2025 event. 2. The LD, TC, and TP affirmed by interviews on April 10, 2026, at approximately 12:00 a.m. that the laboratory obtained for the PT analyte PFT unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 2,623 samples annually for PT analytes. Thus, the reliability and quality of PT patient results reported could not be assured at the time when the laboratory obtained unsatisfactory CAP-PT scores. 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 laboratory's proficiency testing (PT) records (peer review), and interview with the Laboratory Director (LD) and technical supervisors (TS) on April 10., 2026, the laboratory failed to verify the accuracy of histopathology testing at least twice annually. The findings included: 1. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for the laboratory testing performed in the laboratory. However, Histopathology did not have a competency -- 2 of 3 -- evaluation or peer review performed for the years 2023, 2024, and 2025. 2. The laboratory performed Histopathology, which is not listed in subpart I of 42 CFR part 493. For the test procedure not listed in subpart I, the laboratory must verify the accuracy of the test procedure twice annually. The laboratory did not have any record for Histopathology accuracy verification for the years 2023, 2024, 2025. 3. The laboratory director confirmed by interview that the laboratory did not verify the accuracy of histopathology at least twice annually for the years 2023, 2024, and 2025. 4. The laboratory's testing declaration form, signed by the laboratory director on April 9, 2026 2026, stated that the laboratory performed approximately 1,104 Histopathology testing annually for which no verification of accuracy was performed for 2023, 2024, and 2025. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of the proficiency testing results documentation, randomly selected patient test records, and interviews with the laboratory personnel on April 10, 2026; the laboratory director is herein cited due to failure to ensure that several aspects of the analytic and postanalytic phases of the laboratory testing were monitored. The findings include See D2087, D2099, D2121, and D5217. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 8/12/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation / College of American Pathologists/EXCEL ) records (2023-2, 2023-3) and (2024-1), the laboratory failed to 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 -- successfully participate in a proficiency testing program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Parasitology, General Immunology analyte C4, and Routine Chemistry analyte BUN resulting in unsuccessful performances. Refer to D2. D2055 PARASITOLOGY CFR(s): 493.829(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation / College of American Pathologists/EXCEL ) reports, the laboratory failed to achieve satisfactory performance for two of three events proficiency events in 2023 and 2024 for Parasitology. The finding include 1. The laboratory received the following scores: 0% on the 2023 Parasitology third event 75% on the 2024 Parasitology first event 2. A review of the 2023 and 2024 proficiency Testing scores from AAB and CAP confirmed the above findings. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation / College of American Pathologists/EXCEL ) reports, the laboratory failed to achieve satisfactory performance for two of three events proficiency events in 2023 and 2024 for C4. The finding include 1. The laboratory received the following scores: 0% on the 2023 C4 third event 60% on the 2024 C4 first event 2. A review of the 2023 and 2024 proficiency Testing scores from AAB and CAP confirmed the above findings. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical -- 2 of 3 -- Laboratory Evaluation / College of American Pathologists/EXCEL ) reports, the laboratory failed to achieve satisfactory performance for two of three events proficiency events in 2023 and 2024 for BUN. The finding include 1. The laboratory received the following scores: 0% on the 2023 BUN third event 75% on the 2024 BUN second event 2. A review of the 2023 and 2024 proficiency Testing scores from AAB and CAP confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 155 report API records for 2023-2, 2023-3 and 2024-1 events, the laboratory director failed to provide overall management and a direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 155 report, AAB & CAPI records for 2023-2 and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2055, D2085, and D2097.. -- 3 of 3 --

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of

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 laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of technical supervisors. The laboratory failed to assess the competency of two of two technical supervisors in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process to assess the competency of technical supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two technical supervisors during 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 3. During an interview on April 26, 2022 at 10:00 AM, Laboratory Director/Technical Supervisor #1 confirmed these findings. 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 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 -- 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 records and interview it was determined that the laboratory failed to follow written policies and procedures for an annual statistical evaluation of two of six required gynecologic laboratory statistics. The laboratory failed to document two of six required gynecologic annual statistics for 2020 and 2021. Findings include: 1. The laboratory failed to follow the procedure LABORATORY'S OVERALL STATISTICS AND EVALUATION REPORTS which states: "Statistical evaluation items: - Gyn cases where any rescreen of a normal or neg specimen results in reclassification of LSIL, HSIL, adenocarcinoma or other malignant neoplasms. - Gyn cases where cytology and histology findings are discrepant." 2. The Survey Team requested and the laboratory failed to provide two of six required gynecologic annual statistics for 2020 and 2021. Statistics include: - The number of gynecologic cases where cytology and histology are discrepant - The number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms. 3. During an interview on April 26, 2022 at 10:00 AM, Laboratory Director/Technical Supervisor #1 confirmed these findings. 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: Based on microscopic review of 387 random negative gynecologic cases/slides and the corresponding final test reports from March 31, 2022 through April 12, 2022 and confirmation by Laboratory Director/Technical Supervisor #1 on April 27, 2022 it was determined that the Technical Supervisor failed to verify the accuracy of one gynecologic cytology test. 1. 22 03561 04/07/2022 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion and Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory. Scant Cellularity, Obscuring Inflammation LABORATORY DIRECTOR/TECHNICAL SUPERVISOR #1 DIAGNOSIS: Unsatisfactory With Clusters of Inflammatory Cells 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. -- 2 of 2 --