Skin Care Specialty Physicians Llc

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. This STANDARD is not met as evidenced by: Based on record review and interview the histology laboratory (MOHS surgery) did not have a written quality control procedure to perform and document that the reactivity of the immunohistochemistry stains reacted as expected prior to reporting patient results. 1. The laboratory performs MART-1, SOX-10, CK-5 and CK-7 stains on patient tissue during MOHS surgery. 2. The written procedure for each immunohistochemistry stain did not have written procedures describing how the laboratory ensures that each stain is working by checking reactivity with a tissue testing positive for each stain and how this quality control check is documented in the testing records. 3. As an example, the histotechnician stated, during interview on November 24, 2025 at 11:00 am, that the surgeon would sometimes include a piece of patient skin tissue as a positive check for the Mart-1 stain, but the surgeon did not always do this. 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 D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) procedure, PT documentation, and interview with the histology technician (HT) and laboratory director (LD), the laboratory failed to ensure that PT was performed at least twice annually for each person listed on the "Laboratory Personnel Report (CLIA)" form. Findings: 1. The external PT procedure states that the technician will randomly select two slides every six months to be sent out to the Institute of Dermatopathology for evaluation. The external review of the slides documents the proficiency of the testing person evaluating the Moh's slides. 2. The PT documentation shows that only one of the two testing personnel listed on the "Laboratory Personnel Report (CLIA)" form were having slides sent out for review every six months. 3. During an interview on 09/27 /2023 at 12:20 PM, the HT and LD confirmed that external PT was not being completed on both of the testing personnel listed on the "Laboratory Personnel Report (CLIA)" form. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory did not document the manufacturer's name, lot number and expiration date of test kits and stains for Mart-1, SOX-10 and CK-5 stains to ensure they are not used past expiration. Findings: 1. The laboratory did not document the manufacturer name, lot number and expiration dates for immunohistochemical stains used for patient testing; 2. This was confirmed with the histotechnologixt on the afternoon of the day of 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)