Samir Anabi Md / Anabi Medical Corp

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 review of the American Proficiency Institute (API) proficiency testing (PT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) randomly selected patient test records, and interviews with the laboratory staff (LS); the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for direct bilirubin, magnesium, and LDL cholesterol analytes for the third event in 2024 (Q3-2024). The findings include: 1. Review of PT records for Q3-2024, API reported an unsatisfactory score report as follows: Direct Bilirubin 60% Magnesium 20% and LDL Cholesterol (calculated) 0%. 2. LS confirmed by interview on May 14, 2025, at approximately 2: 30 p.m. that the laboratory obtained the PT scores mentioned in statements #1. 3. According to the laboratory's testing declaration submitted on the day of the survey May 15, 2025, the laboratory performed approximately 55,000 Routine Chemistry tests including direct bilirubin, magnesium, and LDL cholesterol analytes during the time the laboratory received unsatisfactory proficiency testing results D2099 ENDOCRINOLOGY CFR(s): 493.843(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 review of the America Proficiency Institute (API) proficiency testing (PT) records and the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) randomly selected patient results, and interview with the laboratory staff (LS); the laboratory failed to attain a score of at least 80 percent of acceptable responses for Endocrinology folate analyte. The finding included: 1. Based on review of PT records from API for the first event of 2025 (Q1-2025) the laboratory obtained a 0% for the folate analyte which constitutes an unacceptable performance. 2. Based on the laboratory testing declaration submitted at the time of the survey on May 14, 2025, and signed by the laboratory director on May 10, 2025, the laboratory analyzed and reported approximately 4,500 Endocrinology tests including folate analyte during the time the laboratory had unsatisfactory proficiency testing results. 3. The LS affirmed on 05/14/2024 at approximately 2:20 p.m. that the laboratory received the above unsatisfactory proficiency testing score from API. D2122 HEMATOLOGY CFR(s): 493.851(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: Based on the surveyor's review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, five (5) random patients sampling, and interview with the laboratory staff (LS); the laboratory failed to attain a score of at least 80 percent of acceptable responses for the hematocrit analyte in Hematology on the first event of 2025 (Q1-2025) which was unsatisfactory performance for the testing event. The findings included: 1. The API proficiency program gave an overall unsatisfactory score of 0% for the hematocrit analyte for Q1- 2025. 2. The LS confirmed on May 14, 2025, at approximately 2:30 p.m. that the laboratory received the above proficiency score of 0% for the hematocrit analyte for the event Q1-2025. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/10/2025 stated that the laboratory performed 15,000 tests in hematology annually. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 deficiencies given, the laboratory director is herein cited for deficient practice in ensuring that systems for the preanalytic, analytic, and postanalytic phases of the laboratory were monitored and followed. Findings include: 1. The laboratory received an unsatisfactory performance score for Routine Chemistry. See D2087 2. The laboratory received an unsatisfactory performance score for Endocrinology. See -- 2 of 3 -- D 2099 3. The laboratory received an unsatisfactory performance score for Hematology. See D2122 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, 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 Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute program records (2023-3, 2024-2 and 2024-3), the laboratory failed to successfully participate in a proficiency 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 -- testing program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory's failure to successfully participate in the subspecialty of Hematology, for the analyte Cell ID, resulting in subsequent unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 out of three consecutive events (2023-3, 2024-2 and 2024-3 events) for the analyte Cell ID: The findings include: Cell ID - 40% 2023 third testing event, Cell ID - 40% 2024 second testing event, Cell ID - 47% 2024 third testing event. 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 American Proficiency Institute records for 2023-3, 2024-2 and 2024-3 proficiency 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) 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 the CASPER 0155D report and American Proficiency Institute records for 2023-3, 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(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 review of the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory attained a score of 40% for FT4 which was less than 80% of acceptable responses for API Endocrinology 1st 2023 PT event which was unsatisfactory analyte performance for the testing event. b. The laboratory performed FT4 in approximately 66 patient sample monthly c. The laboratory personnel affirmed (6/30/2023 @ 12:35 PM) that the laboratory failed to attain a score of at least 80 percent of acceptable responses for FT4 in API endocrinology 1st 2023 PT event was unsatisfactory analyte performance for the testing event. 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 API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory personnel, it was 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 -- determined that the laboratory failed to verify the accuracy of the tests it performed that were not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed PSA, Testosterone (TST), and 25-OH Vitamin D (25-OH) and enrolled its evaluation of proficiency testing performance with API PT program to verify the accuracy of the testing procedures. b. The laboratory failed to perform, at least twice annually, evaluation of proficiency testing performance to verify the accuracy for the test procedures mentioned above (a). c. The laboratory attained scores of less than 80% for the following analytes: Event Analyte Result (%) 3rd 2022 PSA 50 3rd 2022 TST 0 3rd 2022 25-OH 0 1st 2023 25-OH 50 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 review of the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required. The findings included: a. The laboratory performed FT4, which is included in the subpart I of 42 CFR part 493 and the laboratory enrolled its PT program with API (American Proficiency Institute) to ensure the accuracy of FT4 testing procedure. b. The laboratory attained a score of 40% which was less than 80 percent of acceptable responses for FT4 in API endocrinology Q1 2023 PT event was unsatisfactory analyte performance for the testing event (see D-2098) c. The laboratory performed PSA, Testosterone, 25-OH Vitamin D which are not listed in subpart I of 42 CFR part 493 and failed to attain at least 80 percent of acceptable responses in PT events was unsatisfactory analyte performance (see D-5217) -- 2 of 2 --