Intermountain Alta View 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 laboratory records, Standard Operating Procedure (SOP) review, and an interview with the Technical Consultant (TC), the laboratory failed to follow its written policies and procedures for performing competency assessment for 1 out of 23 Testing Personnel (TP) listed on the CLIA CMS-209 Laboratory Personnel Report. Findings: 1. Laboratory Quality Assurance SOP (#MG002) stated "Providers performing Provider-Performed Microscopy Procedures (PPMP) testing will complete biannual proficiency and competency testing ..." 2. Review of the biannual proficiency /competency testing records and CMS-209 report revealed that TP#11, failed to have completed one of the two require proficiency/competency test for 2021. 3. Interview conducted on April 12, 2022 at 2:00 PM with the TC confirmed the laboratory was missing the TP#11 proficiency/competency test record for 2021. 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on verification documentation review, lack of documentation and interview with the technical consultant, the laboratory failed to verify the reportable range for complete blood count tests performed on the XS 1000i instrument transferred to the laboratory from Sandy Clinic. The laboratory performed approximately 10 complete blood counts per day. Findings include: 1. Verification documentation failed to include an approved reportable range verification study to ensure the instrument could accurately report values at the manufacturer's or laboratory's lower and upper levels for white blood cell counts, red blood cell counts, hemoglobin, hematocrit, mean corpuscular volume, and platelets. 2. In an interview conducted on 03/27/2019 the technical consultant confirmed a reportable range study was not performed for the instrument transferred to the Alta View Clinic on 2/10/2018. 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 --