Sedona Medical Center Laboratory

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

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for 2021 and 2022 and an interview with the facility personnel, the lab failed to enroll in an HHS approved PT program for regulated testing performed in the specialty of Chemistry, that is included in subpart I. Findings include: 1. No documentation was presented for review during the survey conducted on August 24, 2023 to indicate the laboratory was enrolled in a CMS-approved PT program for the regulated analytes pH, PCO2 and PO2, for Arterial Blood Gas (ABG) testing during the 3rd event of 2021 and the 1st, 2nd and 3rd events of 2022. 2. The facility personnel interviewed on 8/24/23 at 2:30 PM confirmed the laboratory was not enrolled in a CMS-approved PT program during the 3rd event of 2021 and all 3 events of 2022 for the regulated analytes listed above. 3. The annual reported test volume in the specialty of Chemistry is 87,478. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in 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 -- accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The Condition of Technical Consultant was found to be not met based on the failure of the laboratory to have a Technical Consultant who provides technical oversight as evidenced by: D6041 - failure to ensure that the laboratory was enrolled and participated in an HHS approved Proficiency Testing program commensurate with the services offered. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records from the 3rd testing event of 2021 and the 1st, 2nd and 3rd events of 2022, and interview with the facility personnel, it was determined that the technical consultant failed to ensure that the laboratory was enrolled and participated in an HHS approved PT program for pH, PCO2 and PO2, for Arterial Blood Gas (ABG) testing. See D2000 for findings. -- 2 of 2 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, the laboratory failed to have a system in place to ensure the accuracy of test results that are manually entered into the laboratory's information system (LIS). Findings include: 1. The laboratory performs patient testing in the specialties of Microbiology, Diagnostic Immunology, Chemistry, and Hematology, with an approximate annual test volume of 29,500. It is the practice of the laboratory to manually enter test results into the LIS for the following tests: Gram Stains, Blood Gas testing performed on the I-stat analyzer, Serum hCG, drug screens performed on the Medtox analyzer and urine microscopics. 2. No documentation was presented for review during the survey to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are manually entered into the LIS. 3. The facility personnel confirmed that the laboratory did not have a system in place to verify the accuracy of the patient test results that are manually entered by the testing personnel into the LIS. 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 --