East Valley Internal Medicine Pc

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on lack of function check documentation for the three centrifuges maintained by the laboratory, review of policies and procedures, and interview with the testing personnel (TP-1), the laboratory failed to perform function checks on the three centrifuges which are used as peripheral equipment involved in patient testing. Findings include: 1. The laboratory maintains three centrifuges (two Drucker Diagnostics Model 642E and one UNICO Powerspin Hx Centrifuge). 2. The laboratory's established policy titled, "General Maintenance Program" states," Centrifuges: RPM and timer check biannually (If speed or time dependent specimens are obtained)." 3. The laboratory failed to provide evidence that function checks were performed on the three centrifuges listed above biannually during 2021, 2022, and 2023 as required per laboratory policy. 4. The TP-1 interviewed on 11/29/23 at 3:15 PM confirmed that the required function checks for the three centrifuges listed above were not performed during 2021, 2022, and 2023. 5. The laboratory's annual test volume in the specialty of Chemistry is 45,000. 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 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 laboratory policies and procedures, review of the laboatory's critical test report log and interview with the testing personnel, the laboratory failed to follow established policies and procedures for documenting critical test values. Findings include: 1. The laboratory performs testing under the specialties of Chemistry and Hematology, with an approximate annual test volume of 62,000. 2. The laboratory's policy reviewed during the survey conducted on June 2, 2021 titled "Critical Values" states, "Document the call in the 'Critical Values Test To Be Reviewed' Log noting the patient's name, ID number, test, value, date and your initials. Also document the last name of the physician or nurse to whom the results were given, and the date and time this was done. The Laboratory Supervisor or designee will review the log to assure compliance and to analyze for possible instrumentation problems. This log should be checked at least weekly for review." 3. The Critical Value Log reviewed during the survey failed to include documentation of the last name of the physician or nurse to whom the results were given, and the date and time this was done, as required by laboratory policy. 4. The Critical Value Log reviewed during the survey failed to indicate the log was reviewed by the Laboratory Supervisor or designee at least weekly during 2019 through the date of the survey conducted on June 2, 2021. 5. Review of the "Critical Values Test To Be Reviewed" log during the survey listed approximately 8 patients with critical test results since January 2019 to the date of the survey. 6. The testing personnel confirmed that 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 failed to document the last name of the physician or nurse to whom the results were given, and the date and time this was done, and acknowledged that the log was not reviewed at least weekly per laboratory policy. -- 2 of 2 --