Utah Cancer Specialists - Bountiful

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on competency evaluations review, lack of documentation, patient test records review, and interview with the technical consultant, the technical consultant failed to evaluate one of three testing personnel annually (2018) for one of two tests performed, prothrombin time/International Normalized Ratio (INR) tests. Findings include: 1. Competency evaluations review for 2018 and 2019 test years failed to include documentation test person C was evaluated for prothrombin time/ INR tests in 2018. 2. Patient test records review included documentation test person C performed 2 of 2 of the Prothrombin time/INR tests reviewed in 2018( on 04/12/2019 for patient 83346 and on 10/03/2018 for patient 41106). The laboratory performed approximately 5 prothrombin time/INR tests per month. 3. In an interview on 01/15/2019 at approximately 3:30 P.M. with the technical consultant confirmed the laboratory failed to document test person C was evaluated for Prothrombin time/INR testing in 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 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Coulter DXH 800 instrument maintenance records review, lack of documentation, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions to perform monthly maintenance for 4 of 24 months reviewed. The laboratory performed approximately 1000 complete blood counts per month. Findings include: 1. The laboratory used the manufacturer's instructions and preventive maintenance log sheet to record weekly and monthly maintenance for the Coulter DXH 800 complete blood count instrument. 2. The laboratory failed to document they performed monthly maintenance for the months of July, and October of 2016 and February and June of 2017. Monthly maintenance includes cleaning pneumatic supply module and all system filters. 3. In an interview on 03/01/2018 at approximately 12:15 P.M. the technical consultant confirmed the staff failed to record maintenance was performed with the frequency recommended by the manufacturer. 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; 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 proficiency testing record review,