Privilege Dx Medical Laboratories, Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 29, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and 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 American Proficiency Institute (API) records (2024-3 and 2025-1), the laboratory failed to successfully participate in a proficiency testing 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 -- 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 Antinuclear Antibodies (ANA) analyte resulting in unsuccessful performances. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute report, the laboratory failed to achieve satisfactory performance for two consecutive events (2024-3 and 2025-1) for the analyte Antinuclear Antibodies (ANA) analyte in General Immunology specialty. The finding include: 1. ANA 40% - 2024 third testing event; ANA 60% - 2025 first testing event; A review of the 2024 & 2025 scores from American Proficiency Institute 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 0155D report and the American Proficiency Institute records for 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 the CASPER 0155D report and the American Proficiency Institute records for 2024-3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2084. -- 2 of 2 --

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 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with the technical supervisor (TS) and technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Urinalysis for the urine Glucose analyte. The findings include: 1. The surveyor reviewed the PT records wherein AAB-MLE reported an unsatisfactory score of 0% for the Glucose analyte in Urinalysis. 2. The TS and TC affirmed by interviews on December 9, 2025, at approximately 9:40 a.m. that the laboratory obtained the unsatisfactory PT scores for urine Glucose analyte as mentioned in statement #1. 3. The accuracy and reliability of patient test reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 4,805 patient test samples annually for Urinalysis including the Glucose analyte during the time the laboratory received an unsatisfactory proficiency testing scores. D2098 ENDOCRINOLOGY CFR(s): 493.843(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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, PT documentation, and interviews with the laboratory's technical supervisor (TS) and technical consultant (TC); the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the serum pregnancy (hCG) analyte for the third event of 2022 (Q3-2022). The findings include: 1. The surveyor reviewed the CASPER report and AAB-MLE PT documentation and found that the laboratory obtained an unsatisfactory score of 0% for serum hCG for the Q3-2022 event. 2. The TS and TC affirmed by interviews on December 9, 2025, at approximately 9:40 a.m. that the laboratory obtained the unsatisfactory PT scores for serum hCG for Q3-2022 event as mentioned in statement #1. 3. According to the laboratory's testing declaration, the laboratory performed and reported approximately 41 patient test samples for serum hCG analytes annually including the time the laboratory received unsatisfactory proficiency testing scores. Thus, the accuracy and reliability of patient test reported cannot be determined. 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 the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, and interviews with the technical supervisor (TS) and technical consultant (TC) on December 9, 2025, at 9:40 a.m., it was determined that the laboratory failed to attain a score of at least 80% of acceptable responses for White Blood Cell (WBC) count which is an unsatisfactory analyte performance for the testing event. The findings include: 1. The surveyor's review of the PT documentation indicated that the laboratory participated in the AAB-MLE PT program for the first event of 2025 (Q1-2025) and obtained a score of 60% for WBC count. Therefore, the accuracy of the patient test results for WBC count reported by the laboratory during the failed proficiency testing period cannot be assured and might have caused potential patient harm. 2. The TS and TC on December 9, 2025, at 9:40 a.m., affirmed that the laboratory received less than 80% score at the Q1-2025 PT event for the WBC count in Hematology specialty. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/05/2025 stated that the laboratory performed approximately 15,227 tests in WBC count annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy and procedure, proficiency testing (PT) -- 2 of 3 -- records and interviews with the technical supervisor (TS) and technical consultant (TC) on December 9, 2025; it was determined that the laboratory failed to perform and document a

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 Surveyor review of proficiency testing (PT) records from American Association of Bioanalysts (AAB) and interview with the laboratory Technical Supervisor, the laboratory failed to attain at least 80% score for Lymphocyte and Neutrophil in the 3rd event of 2019, and is determined unsatisfactory analyte performance. The findings include: a. The PT records of the 3rd event of 2019 shows that the laboratory obtained "40%" score for the analyte Neutrophil and "60%" score for the analyte Lymphocyte. b. PT sample results review and an interview with the laboratory Technical Supervisor on 02/12/2020 at 2:50 pm, confirmed that the laboratory received the following scores: Sample ID Reported Result Expected Result (Neutrophil %) 2 52.3 56.0 - 61.0 3 52.8 37.8 - 51.4 5 52.8 55.9 - 61.1 Sample ID Reported Result Expected Result (Lymphocyte %) 2 33.0 11.1 - 20.9 5 33.1 11.0 - 20.7 c. The laboratory's testing declaration form signed by the laboratory director on 2 /10/2020 shows that the laboratory runs 11,374 WBC differentials tests, annually. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on Surveyor review of proficiency testing records, and interview with the 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 Technical Supervisor and testing personnel, it was determined that the laboratory Director failed to ensure the maintenance of acceptable levels of analytical performance for each test system. See D2121. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, random patient sampling test results and interview with the technical consultant, it was determined that the laboratory did not follow written policies and procedures for the critical read back which was established by the laboratory. The findings included: a, According to the laboratory's policy and procedure for "Critical Value Reporting." Procedure "ii Read Back: The individual accepting the critical test result must record and then read back the critical test results, in its entirely, to the reporter at the time the result is given." b. For two (2) out of two (2) random critical test results reviewed on 9/15/2017 and 10/23 /2017 the laboratory analyzed and reported a critical high and a critical low test results respectively, but did not document the read back portion of the reporting. c. The technical consultant affirmed (1/3/2018, 12N), that the laboratory did not document the read back information; therefore, not following what is established by the laboratory's policy and procedure. 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 --