Stanley J Miller Mdpa

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the "Quality Assurance Plan for Mohs surgery" procedure and email interview with the lead histotech, the laboratory director did not ensure that the monthly summary report was completed as required. Findings: 1. Section B of the "Quality Assurance Plan for Mohs surgery" procedure states "Monthly, the Laboratory Director will complete a summary report using Attachment 2." 2. The email response received on 09/25/2020 at 7:40 AM stated that "We do not use attachment 2 in the QA." 3. On 09/25/2020 at 7:40 AM, the histotech confirmed that the monthly summary report was not completed per the "Quality Assurance Plan for Mohs surgery" procedure. 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 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 training and competency procedures and interview with the testing person, the laboratory director did not perform competency procedures for all testing persons involved in the analytical process of performing histopathology testing. Findings: 1. The laboratory director did not perform competency procedures in the year 2017. 2. The laboratory director did not perform an assessment for the testing person performing the inking of tissue specimens. 3. The testing person confirmed that competency procedures were not performed for all testing person involved in the analytical process of 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 --