Mckay Dee Anticoagulation Clinic

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on test reports review and confirmation by the technical consultant, the laboratory test report failed to include the location where coagulation testing was performed for 3 of 4 electronic test reports reviewed. Findings include: 1. Test reports review included documentation prothrombin time and International Normalized Ratio test results were performed at McKay Dee Hospital for test 1208694313 on 11/20 /2017; for 1214712619 on 06/29/2018, for 1200448756 on 05/072019. 2. In an interview with the technical consultant on 11/04/2019 at approximately 3:45 P.M. the technical consultant confirmed the electronic test report stated the tests were performed at McKay Dee Hospital instead of McKay Dee Anticoagulation Clinic. 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 accordance with 493.1413 of this subpart. 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 CONDITION is not met as evidenced by: Based on competency evaluations review for moderate complexity testing personnel for one of two years of evaluations reviewed and confirmation by the current technical consultant, it could not be determined testing personnel evaluations were performed by a qualified technical consultant in 2018 for five of seven testing personnel reviewed. Findings include: 1. Competency evaluations review included documentation the facility supervisor performed moderate complexity testing personnel competency evaluations in 2018 for testing personnel B, C, D, E, and G. 2. In an interview conducted on 11/04/2019 at approximately 3:30 P.M. the current technical consultant confirmed the qualifications for the testing person performing competency evaluations were uncertain to qualify as a moderate complexity technical consultant. -- 2 of 2 --

Summary Statement of Deficiencies D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient test records review, quality control records review and interview with staff, the laboratory failed to ensure quality control was performed prior to testing patient samples after a complete change of reagents (new iSTAT lot number of test cartridges) for 1 of 8 lot number changes reviewed for prothrombin time (PT) testing and International Normalized Ratio (INR) calculation results reporting. Findings include: 1. Patient test records review for patient 1200449166 tested on 02/16 /2016 documented PT/INR was reported using i STAT test cartridge lot number 334B15317016 . 2. Quality control (QC) records review failed to include documentation the laboratory performed quality control for lot number 334B15317016 prior to testing patient on 02/16/2016. The QC for lot number 334B15317016 was performed on 02/23/2016. 3. In an interview conducted on 01/26 /2018 at approximately !0 :45 A.M. the staff confirmed QC was performed after patient testing for lot number 334B15317016. 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 --