Adventhealth Imaging Center Roeland Park

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the review of the procedure "Siemens epoc IQCP", quality control (QC) documentation from 2/1/22 to 6/26/23, and interview with the laboratory director (LD), the laboratory failed to follow written procedures for the frequency of QC testing for creatinine. Findings: 1. Review of the Siemens epoc IQCP procedure, page 3, under Quality Control Plan revealed the following QC interval. External (Liquid) QC, Item 1." Gas ISE Metabolites Levels 1 & 3 run on new lot/shipments of test cards."; Item 2. "Test QC levels 1 & 3 Gas ISE Metabolites at least every 31 days." 2. Review of the QC control data from 2/1/22 to 6/26/23 revealed 5 occurrences where QC levels 1 & 3 were not performed at least every 31 days. a. QC Level 1 &3 performed on 4/27/22. Next QC Level 1 & 3 performed 5/31/22. Interval of 34 days. b. QC Level 1 & 3 performed on 6/30/22. Next QC Level 1 & 3 performed 8/18/22. Interval of 49 days. c. QC Level 1 & 3 performed on 8/29/22. Next QC Level 1 & 3 performed 10/3/22. Interval of 36 days. d. QC Level 3 only performed on 9/14/22. e. QC Level 1 & 3 performed on 10/27/22. Next QC Level 1 & 3 performed 12/14/22. Interval of 48 days. 3. Documentation of review by both TC #1 and TC #2 are present with "QC acceptable" in Last Review note column. 4. No documentation of unacceptable QC interval,

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