Anchorage Neighborhood Health Center

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review patient test reports, the manufacturer's package inserts, and an interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for reporting test methodology for Total Prostate Specific Antigen (PSA) using the Beckman Coulter Access 2 since implementation of the new laboratory information system (LIS) in May 2025. Findings include: 1. A review of results on patient #839842 revealed the report did not include the identity of the Beckman Coulter Access 2 Assay as required in the manufacturer's instructions. 2. A review of the package insert for the Beckman Coulter Access 2 PSA states: 'The results reported by the laboratory to the physician must include the identity of the PSA assay used.' 3. The technical consultant confirmed these findings in an interview at 2:30 PM on 8/14/2025. 4. The laboratory reports performing 1000 PSA tests annually." 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 D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of education, training and competency records and an interview with the laboratory director, the laboratory failed to ensure one of three laboratory testing personnel had the appropriate education prior to performing non-waived patient testing. Findings: 1. A review of testing personal educational records revealed the degree from one of three testing persons was from a foreign institution. 2. A request was made to review the equivalency evaluation of their credentials, and the evaluation could not be provided. 3. The laboratory director confirmed these findings during an interview on 9/5/2023 at 12:30 PM. 4. The laboratory reports performing approximately 180,000 patient tests annually. 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 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 an off-site desk review of the laboratory's 2021 American Proficiency Institute (API) proficiency testing (PT) records and telephone interview with the laboratory director on February 4, 2022 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Hematology White Blood Cell Differential in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. See 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 an off-site desk review of the laboratory's 2021 American Proficiency Institute (API) proficiency testing (PT) records and telephone interview with the laboratory director on February 4, 2022 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for White Blood Cell (WBC) Differential on in two (2) out of three (3) Hematology testing events. Findings include: 1. Desk review of the laboratory's 2021 API PT records revealed White Blood Cell Differential scores of less than eighty percent for the following Hematology events: 2021 API event 2 score of 0% 2021 API event 3 score of 28% 2. A telephone interview with the laboratory director on February 4, 2022 confirmed the laboratory failed to achieve satisfactory performance for the White Blood Cell Differential in the second and third PT events for 2021. -- 2 of 2 --