Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc. on 08/19/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 review of employee competencies and interview with the Laboratory Manager, the Laboratory Director failed to ensure competency evaluations were performed on 2 (#B and #C) out of 5 testing personnel (#A - #E) for 2 of 2 (2018- 2019) years reviewed. Findings Included: Review of the CMS 209 Laboratory Personnel Report signed by the Laboratory Director on 8/19/20 revealed Employee #B and #C were listed as testing personnel, technical consultants and technical supervisors. A review of employee competencies revealed no competencies were performed for Employee #B and #C who performed histopathology interpretation of hematoxylin and eosin slides. Interview on 08/19/20 at 11:20 a.m. with the Laboratory Manager revealed she did not know that competencies needed to be performed for technical consultants, technical supervisors, and testing personnel who interpreted histopathology hematoxylin and eosin slides. 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 --