Skin Care Specialists, Pllc

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and (re)certification is recommended. Standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the Microscope Maintenance Records, patient test records, and staff interview, the laboratory failed to have documentation of performing the daily microscope maintenance procedures for five of eight days from September 2024 to April 2025. Findings include: 1. A review of the laboratory's policy titled 'Quality Control Program' revealed the following: "Equipment Quality Control- Microscope 1. Microscope stage and ocular eyepieces are to be cleaned daily. Stage is to be cleaned with alcohol or similar cleaner and ocular eyepieces are to be cleaned with lens paper. - Every action is documented on the maintenance record form." 2. A review of the Microscope Maintenance Records from September 2024 to April 2025 revealed the laboratory failed to have documentation of performing the daily microscope maintenance procedures for the following 5 days: 9 /25/24 11/27/24 12/17/24 2/26/25 3/26/25 3. A review of patient test records revealed the following patients were tested on days when the daily microscope maintenance procedures were not documented: Date tested: 9/25/24 Patient Case Numbers: TF24- M064 through TF24-M073 Date tested: 11/27/24 Patient Case Numbers: TF24-M081 through TF24-M088 Date tested: 12/17/24 Patient Case Numbers: TF24-M089 through TF24-M098 Date tested: 2/26/25 Patient Case Numbers: TF25-M001 through Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- TF25-M010 Date tested: 3/26/25 Patient Case Numbers: TF25-M011 through TF25- M020 4. In an interview on 6/2/25 at 10:15 a.m. in the laboratory, after review of the records, the regional manager confirmed the above findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on a review of laboratory's policies, the laboratory's H&E and QC Slide Logs, patient test records, and staff interview, the laboratory failed to document the intended reactivity of the H&E (hematoxylin and eosin) stain for MOHS histopathology slides each day of use for two of four days in February and March 2025. Findings include: 1. A review of the laboratory's policy titled 'MOHS Laboratory Procedure Manual Histopathology- MOHS Surgery' revealed the following: "A daily control slide for H&E stain is documented representing stain quality for each date of use." 2. A review of the laboratory's H&E and QC Slide Logs from February and March 2025 revealed the laboratory failed to have documentation of the intended reactivity for the H&E stain on the following 2 days: 2/26/25 3/26/25 3. A review of patient test records revealed the following patients were tested on days when the intended reactivity of the H&E slide was not documented: Date tested: 2/26/25 Patient Case Numbers: TF25- M001 through TF25-M010 Date tested: 3/26/25 Patient Case Numbers: TF25-M011 through TF25-M020 4. In an interview on 6/2/25 at 10:20 a.m. in the laboratory, after review of the records, the regional manager confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found in compliance with applicable CLIA conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and test records, and staff interview, it was revealed the laboratory failed to have documentation of monitoring the temperature of the Advantik Cryostat for 11 of 11 months from October 2020 to September 2021. Findings include: 1. A review of the laboratory's policies revealed the Advantik Cryostat "should be maintained at -21C to -35C for best mohs sectioning." 2. The histotech was asked to provide documentation that the laboratory monitored the temperature of the cryostat for the 11 months, from October 2020 to September 2021. No documentation was provided. 3. A review of the laboratory's testing records revealed the laboratory began testing on October 28, 2020 with an estimated annual test volume of 120. 4. An interview with the histotech at 9:50 a.m. in the laboratory, after review of the records, confirmed the above 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 --