Intermountain Holladay Clinic

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency/competency records, Standard Operating Procedure (SOP), the CMS-209, and interviews with staff, the laboratory failed to perform competency assessment for 2 of 12 Testing Personnel (TP). The laboratory performs approximately 11,000 tests annually. Findings include: 1. During a review of the biannual proficiency/competency testing records and the CMS-209 report revealed that the Provider Performed Microscopy (PPM) providers, failed to have completed 4 of 4 competency assessments for 2020 through August 2022 that addresses the six minimal regulatory requirements for the assessment of competency. 2. In an interview on 08/11/2022 at approximately 14:45, Technical Consultant 2 (TC2) confirmed that the laboratory does not assess the competency of PPM providers using the six minimal regulatory requirements. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on direct observation of laboratory equipment and interview with Technical Consultant 2 (TC2), the laboratory failed to recalibrate 1 of 1 timer once the calibration had expired. The laboratory performs approximately 11,000 tests annually. Findings include: 1. During a tour of the laboratory on 08/11/2022 at approximately 14:00, it was obseved that a timer being used that indicated on the manufacturers sticker that the calibration had expired. 2. In an interview on 08/11/2022, TC2 confirmed that they do not calibrate timers when the calibration expires. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation and interview with the laboratory technical consultant, the laboratory failed to retain complete blood count (CBC) proficiency testing instrument print outs for at least two years for 1 of 6 proficiency testing events reviewed. Findings include: 1. Proficiency testing records review failed to include CBC instrument printouts from the third American Proficiency Institute (API) event of 2018. 2. In an interview with the technical consultant on 09/04/2019 at approximately 12:50 P.M. staff stated the testing personnel performing proficiency testing for the 3rd event of 2018 discarded the instrument printout prior to leaving the employ of the laboratory and that the printouts could not be retrieved from the pocH-i 100 instrument. 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 --