Dermatology Associates, Pc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) 209 form (FORM CMS-209), the laboratory's policy, personnel records, and staff interview, revealed that the laboratory failed to follow the established policy for competency assessment for one of six testing personnel (TP) who performed gross examination of surgical pathology specimens in 2024. The findings included: 1. A review of the submitted FORM CMS-209 form listed six testing personnel for high complexity testing who performed gross examination of surgical pathology specimens. 2. A review of the laboratory's "General Laboratory Quality Systems" policy revealed, "At least annually, the laboratory director and/or technical consultant will review the performance of each employee working in the laboratory to assure employee competency." 3. A review of laboratory personnel records revealed no documented annual competency assessment in 2024 for testing personnel five (TP5) as listed on the FORM CMS-209. 4. An interview on 07.15.2026 at 10:45 a.m. with the office manager confirmed the above survey findings. 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 D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: ___________________________________ Based on review of personnel records for two grossing technicians, lack of training documentation for new hire (technician #2) and lack of annual competency for technician #1 and interview with the Laboratory Director, determined the laboratory failed to document training and competencies for 2 of 2 grossing technicians since hire dates. The findings include: 1. Review of personnel records for two of two grossing technicians. 2. Lack of training documentation for new grossing technician (technician #2), hire date in October of 2017. 3. Lack of annual competency documentation for grossing technician #1 since hire date in 2012. 4. Interview at approximately 4:00 p.m. April 16, 2018 with the Laboratory Director confirmed there was no training or annual competency documentation for two of two grossing technicians since their hire dates. ____________________________________ 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 --