Summary:
Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, procedures for evaluating competency of personnel failed to include assessment of test performance of hematology test systems for 2 of 4 testing personnel in 2019. Findings include: 1) Review on 10/19/2020 of 4 testing personnel competency assessment records from 2019 and 2020 revealed in 2019, Staff A's (testing personnel) competency assessments failed to include assessment of test performance for prothrombin / international normalized ratio (PT /INR) test system. Staff B's (testing personnel) competency assessments in 2019 failed to include assessment of test performance for the complete blood count (CBC) test system. 2) Interview on 10/19/2020 at 11:10 a.m. with the Technical Consultant confirmed the above finding and revealed Staff A performs PT/INR patient testing and Staff B performs CBC patient testing. 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 --