Advanced Biomedical

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 31, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 College of American Pathologist (CAP) Proficiency Testing (PT) report and staff interview, the Laboratory failed to at least twice annually, verify the accuracy of any test or procedure it performs. The laboratory did not verify the 2021 (SCDD-A) Synthetic Cannabinoid/Designer Drug or 2021 (SCBB-B) Synthetic Cannabinoid/Designer Drug, Findings: 1. Review of the CAP PT results for the 2021 (SCDD-A) Synthetic Cannabinoid/Designer Drug and 2021 (SCBB-B) Synthetic Cannabinoid/Designer Drug, the laboratory received scores that were educational challenges or the test was not in their test menu. The PT results did not verify the accuracy of the Synthetic Cannabinoid/Designer Drugs. 2. Phone Interview with staff # 3 (CMS form 209), the Laboratory Director, and the Owner, on August 31, 2022, in the facility Conference room, at approximately 1pm, confirmed the aforementioned statements. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) reportb and staff interview, the Laboratory failed to at least twice annually verify the accuracy of any test or procedure it performs. The laboratory did not verify the 2021 (SCDD-A) Synthetic Cannabinoid/Designer Drug or 2021 (SCBB-B) Synthetic Cannabinoid/Designer Drug. The Laboratory Director (LD) is responsible for the overall operation and administration of the laboratory. Findings: 1. Review of the CAP PT results for the 2021 (SCDD-A) Synthetic Cannabinoid/Designer Drug and 2021 (SCBB-B) Synthetic Cannabinoid/Designer Drug, the laboratory received scores that were educational challenges or the test was not in their test menu. The results did not verify the accuracy of the Synthetic Cannabinoid/Designer Drugs being performed in the laboratory. 2. Phone Interview with staff # 3 (CMS form 209), the Laboratory Director, and the Owner, on August 31, 2022, in the facility Conference room, at approximately 1pm, confirmed the aforementioned statements. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 28, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd 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 -- and 3rd events of 2017), resulting in the first unsuccessful occurrence for prothrombin time, analyte # 845 . Findings include: Refer to D 2130 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #845 prothrombin time event 2 of 2017 with a score of 40% and event 3 of 2017 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed prothrombin time on events 2 and 3 of 2017 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for prothrombin time, analyte # 845 . Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #845 prothrombin time on event 2 of 2017 with a score of 20% and event 3 of 2017 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed prothrombin time on events 2 and 3 of 2017 resulting in the first unsuccessful performance. -- 2 of 2 --