Summary:
Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) 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 laboratory CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, competency records, and interview with testing personnel (TP) #3; the laboratory director (LD) failed to ensure two of two testing personnel (TP) were competent to conduct histopathology grossing. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed two TP (TP #2 and TP #3) qualified to perform histopathology grossing on the date of the survey, 07/30/2025. 2. Review of the laboratory policy titled "Responsibilities of laboratory director /consultant" outlined the director's responsibilities as, "10. Ensure that policies and procedures are established for monitoring individuals who conduct the test to assure that they are competent and maintain their competency to process specimens, perform test procedures and deliver test results promptly and proficiently. Also, whenever necessary identify the need for remedial training or continuing education to improve skills." 3. Review of "Dermatology Competency Evaluation" forms found no competency assessments were documented for two of two TP (TP #2 and TP #3) for histopathology grossing. 4. An interview with TP #3 at 10:20 am on 07/30/2025 confirmed that the laboratory director had failed to ensure that testing personnel were competent for histopathology grossing prior to 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 --