Advanced Dermatology And Skin Surgery, Pa

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 upon review of personnel records and interview with TP (Testing Personnel) #13 on 11/15/23, the Laboratory Director did not ensure that TP #15, 1 of 16 total TP, held the appropriate education required to perform high complexity testing in the laboratory. Findings: Review of two transcripts for TP#15's associate and bachelor degrees by the Regional CMS (Centers for Medicare & Medicaid Services) Office revealed that TP #15 did not have the appropriate education to perform high complexity testing. It was determined that TP #15 did not complete at least six chemistry semester hours. In interview at approximately 9:45 a.m., TP# 13 stated that TP #15 began performing gross examinations 90 days after her hire in July of 2022, approximately 16 months prior to the survey. 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 D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of laboratory's procedure and logs, and interview with the laboratory supervisor 2/19/20, the laboratory failed to check and document negative control reactivity for the Melan-A IHC (immunohistochemical) stain. Findings: The manufacturer's instructions for the Stat Lab Medical Products MART-1/Melan-A, Melanoma Marker states under Storage and Handling, "...Positive and negative controls should be run simultaneously with all patient specimens..." Review of the laboratory's procedures revealed the laboratory began testing the Melan-A IHC stain in April 2018. The Melan-A stain procedure states, "PROCEDURE...2. Add a positive Melan-A control above the patient tissue (Positive control results are recorded on the "Immuno Stain Control Slide Check" form..." Review of the IHC stain log revealed the laboratory only documents positive control reactivity for Melan-A. At approximately 11:20am, the laboratory supervisor confirmed the laboratory only uses a positive control for Melan-A IHC stain. She confirmed that negative control reactivity is not documented. 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 --