Summary:
Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview, the lab director did not ensure that the written procedure to conduct proficiency (testing accuracy) checks for both technical supervisors [pathologist(s)], conducting histopathology testing, included reviews for both Technical Supervisor 1 and Technical Supervisor 2. Findings: 1. The laboratory's written procedure stated that 10 random cases are reviewed every six months by a second pathologist; 2. The Technical supervisor 1 stated (during interview on the day of survey) that all 20 cases selected for review in 2018 were tested by Technical Supervisor 1; and 3. The proficiency check records showed that all 20 cases reviewed in 2018 were performed for testing performed by Technical Supervisor 1, and there were no case reviews for testing performed by technical Supervisor 2. 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 --