Skin Care Specialists, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on January 12, 2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, twice annual test accuracy verification records and staff interview, the laboratory failed to document twice annual test accuracy verification for one of two required events in 2025. Findings included: 1. Review of laboratory's policy/procedure "Quality Control" (last reviewed 02/15/2025) revealed: "Skin Cancer Specialists conducts a semi-annual proficiency test to ensure quality and accurate interpretation of slides from Mohs surgery cases. Random selections of Mohs surgical cases are chosen every six-months." 2. Review of twice annual test accuracy verification records from 2025 revealed test accuracy verification was documented on 09/15/2025. There was no other documentation of test accuracy verification in 2025. 3. In an interview on 01/12/2025 at 0915 hours in the laboratory, the facility's Practice Manager (as indicated on submitted Entrance /Exit Conference document) confirmed the findings. 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 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 -- 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 review of laboratory's policies/procedures, microscope maintenance records, patient test logs and staff interview, the laboratory failed to follow its own policy and document microscope maintenance for three of three days microscope maintenance was required in January and February 2025. Findings included: 1. Review of laboratory's policy/procedure "Quality Control Program" (last reviewed 02/04/2025) revealed: "EQUIPMENT QUALITY CONTROL - MICROSCOPE 1. Microscope stage and ocular eyepieces are to be cleaned daily." And, "4. Every action is documented on the maintenance record form." 2. Review of laboratory's microscope maintenance records from January and February 2025 revealed there was no documentation of microscope maintenance documented on the following three days microscope was in use: 01/31/3035 02/14/2025 02/21/2025 3. Review of laboratory's patient test logs revealed the following patient Mohs case numbers were tested on the days microscope maintenance was not documented: Patient cases tested on 01/31 /3035: TF25-K017 TF25-K018 TF25-K019 TF25-K020 TF25-K021 TF25-K022 TF25-K023 TF25-K024 Patient cases tested on 02/14/2025: TF25-K025 TF25-K026 TF25-K027 TF25-K028 TF25-K029 TF25-K030 TF25-K031 TF25-K032 TF25-K033 Patient cases tested on 02/21/2025: TF25-K034 TF25-K035 TF25-K036 TF25-K037 TF25-K038 TF25-K039 TF25-K040 TF25-K041 TF25-K042 4. In an interview on 01 /12/2025 at 1010 hours in the laboratory, the facility's Practice Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the 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 review of laboratory's policies/procedures, H&E (hematoxylin and eosin) stain control records, patient test logs and staff interview, the laboratory failed to document stain acceptability for three of three days stain quality control record was required in November 2024 and February 2025. Findings included: 1. Review of policy/procedure "Quality Control" (last reviewed 02/15/2025) revealed: "Quality control is performed for the adequacy of staining. A daily control slide for H&E stain is documented representing stain quality for each day of use." 2. Review of daily H&E stain acceptability logs from November 2024 and February 2025 revealed the following three days of patient testing stain acceptability was not documented: 11/22 /2024 02/14/2025 02/21/2025 3. Review of laboratory's patient test logs revealed the following patient Mohs case numbers were tested on the days H&E stain acceptability was not documented: Patient cases tested on 11/22/2024: TF24-K261 TF24-K262 TF24-K263 TF24-K264 TF24-K265 TF24-K266 TF24-K267 TF24-K268 TF24-K269 Patient cases tested on 02/14/2025: TF25-K025 TF25-K026 TF25-K027 TF25-K028 TF25-K029 TF25-K030 TF25-K031 TF25-K032 TF25-K033 Patient cases tested on 02/21/2025: TF25-K034 TF25-K035 TF25-K036 TF25-K037 TF25-K038 TF25-K039 -- 2 of 3 -- TF25-K040 TF25-K041 TF25-K042 4. In an interview on 01/12/2025 at 1010 hours in the laboratory, the facility's Practice Manager (as indicated on submitted Entrance /Exit Conference document) confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, Quality Assessment (QA) monthly reports and staff interview, the laboratory's QA failed to identify and correct issues with H&E stain acceptability and microscope maintenance for one of one laboratory's test platforms, histologic examination of Mohs surgery tissues. Findings included: 1. Review of laboratory's policy/procedure "Quality Assessment Manual" (last reviewed 02/04/2025) revealed: "The QA program assures the accurate, reliable and prompt reporting of test results and provides methods to evaluate the effectiveness of its policies and procedures, to identify and correct problems, and to assure the adequacy and competency of the staff." And, "The Laboratory Director reviews all quality control charts and logs on at least a monthly basis. ... The Laboratory Director will review the

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 recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's accuracy assessment records from 2022, and staff interview, the laboratory failed to have documentation of performing one of two twice annual accuracy assessments for Mohs slide interpretations in 2022. Findings include: 1. A review of the laboratory's policy titled 'Mohs Laboratory Procedure Manual Histopathology- Mohs Surgery' revealed the following: "Skin Cancer Specialists conducts a semi-annual proficiency test to ensure quality and accurate interpretation of slides from Mohs surgery cases. Random selections of Mohs surgical cases are chosen every six-months." 2. A review of the laboratory's accuracy assessment records revealed the laboratory performed one accuracy assessment in May 2022. The laboratory failed to have documentation of verifying the accuracy of the Mohs slide interpretations a second time in 2022. 3. In an interview on 6/3/24 at 9:25 a.m. in the laboratory, after review of the records, the Operations Coordinator confirmed the above findings. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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, the Humidity and Temperature Log for 2023, patient test records, and staff interview, the laboratory failed to have documentation of monitoring the temperature and humidity in the laboratory for eight of twenty nine days from January to December 2023. Findings include: 1. A review of the laboratory's policy titled 'Quality Assessment Manual' revealed the following: "The environment in the working area of the laboratory will be controlled by commonly used heating, air-conditioning and ventilation equipment used throughout the entire medical office, which will maintain a working temperature of 50-80 degrees Fahrenheit, and humidity of less than 60%." 2. A review of the Humidity and Temperature Log for 2023 (January to December) revealed the following: "Humidity and temperature are logged to ensure proper function and storage of all mohs lab equipment." 3. Further review of the Humidity and Temperature Log for 2023 revealed the laboratory failed to have documentation of monitoring the temperature and humidity in the laboratory for the following 8 days patient specimens were tested: 6/2/23 6/16/23 7/14/23 7/28/23 8/12/23 9/15/23 10/13/23 10/27/23 4. A review of patient test records revealed the following patients were tested on days when the laboratory's temperature and humidity were not documented: Date tested: 6/2/23 Patient Case Numbers: TF23-K071, TF23-K072, TF23-K073, TF23-K074, TF23- K075, TF23-K076, TF23-K077 Date tested: 6/16/23 Patient Case Numbers: TF23- K078, TF23-K079, TF23-K080, TF23-K081 Date tested: 7/14/23 Patient Case Numbers: TF23-K091, TF23-K092, TF23-K093, TF23-K094, TF23-K095, TF23- K096, TF23-K097 Date tested: 7/28/23 Patient Case Numbers: TF23-K105, TF23- K106, TF23-K107, TF23-K108, TF23-K109, TF23-K110, TF23-K111, TF23-K112 Date tested: 8/12/23 Patient Case Numbers: TF23-K120, TF23-K121, TF23-K122, TF23-K123, TF23-K124, TF23-K125 Date tested: 9/15/23 Patient Case Numbers: TF23-K140, TF23-K141, TF23-K142, TF23-K143, TF23-K144, TF23-K145, TF23- K146 Date tested: 10/13/23 Patient Case Numbers: TF23-K153, TF23-K154, TF23- K155, TF23-K156, TF23-K157, TF23-K158, TF23-K159 Date tested: 10/27/23 Patient Case Numbers: TF23-K167, TF23-K168, TF23-K169, TF23-K170, TF23- K171, TF23-K172, TF23-K173 5. In an interview on 6/3/24 at 9:40 a.m. in the laboratory, after review of the records, the Operations Coordinator confirmed the above findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the Microscope Maintenance Logs, patient test records, and staff interview, the laboratory failed to have documentation of performing microscope maintenance procedures for eight of fifteen days from June to October 2023. Findings include: 1. A review of the laboratory's policy titled 'Quality Assessment Manual' revealed the following: "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." 2. A review of the Microscope Maintenance Logs from June to October 2023 revealed the laboratory failed to have documentation of performing microscope maintenance procedures for the following 8 days: 6/2/23 6/16/23 7/14/23 7/28/23 8/12/23 9/15/23 10/13/23 10/27/23 3. A review of patient test records revealed the following patients were tested on days when the microscope maintenance procedures were not documented: Date tested: 6/2/23 Patient Case Numbers: TF23-K071, TF23-K072, TF23-K073, TF23-K074, TF23-K075, TF23-K076, TF23-K077 Date tested: 6/16/23 Patient Case Numbers: TF23-K078, TF23-K079, TF23-K080, TF23-K081 Date tested: 7/14/23 Patient Case Numbers: TF23-K091, TF23-K092, TF23-K093, TF23-K094, TF23-K095, TF23-K096, TF23- K097 Date tested: 7/28/23 Patient Case Numbers: TF23-K105, TF23-K106, TF23- K107, TF23-K108, TF23-K109, TF23-K110, TF23-K111, TF23-K112 Date tested: 8 /12/23 Patient Case Numbers: TF23-K120, TF23-K121, TF23-K122, TF23-K123, TF23-K124, TF23-K125 Date tested: 9/15/23 Patient Case Numbers: TF23-K140, TF23-K141, TF23-K142, TF23-K143, TF23-K144, TF23-K145, TF23-K146 Date tested: 10/13/23 Patient Case Numbers: TF23-K153, TF23-K154, TF23-K155, TF23- K156, TF23-K157, TF23-K158, TF23-K159 Date tested: 10/27/23 Patient Case Numbers: TF23-K167, TF23-K168, TF23-K169, TF23-K170, TF23-K171, TF23- K172, TF23-K173 4. In an interview on 6/3/24 at 9:50 a.m. in the laboratory, after review of the records, the Operations Coordinator confirmed the above findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory's policies, the laboratory's H&E and QC Stain Logs, patient test records, and staff interview, the laboratory failed to document the intended reactivity of Hematoxylin & Eosin (H&E) stain for MOHS histopathology slides each day of use for eight of fifteen days from June to October 2023. Findings include: 1. A review of the laboratory's policy titled 'Mohs Laboratory Procedure Manual Histopathology- Mohs Surgery' revealed the following: "Quality control is performed for the adequacy of staining. A daily control slide for H&E stain is documented representing stain quality for each day of use." 2. A review of the laboratory's H&E and QC Stain Logs from June to October 2023 revealed no documentation of the intended reactivity for the H&E stain on the following 8 days: 6/2/23 6/16/23 7/14/23 7/28/23 8/12/23 9/15/23 10/13/23 10/27/23 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: 6/2/23 Patient Case Numbers: TF23- K071, TF23-K072, TF23-K073, TF23-K074, TF23-K075, TF23-K076, TF23-K077 -- 3 of 4 -- Date tested: 6/16/23 Patient Case Numbers: TF23-K078, TF23-K079, TF23-K080, TF23-K081 Date tested: 7/14/23 Patient Case Numbers: TF23-K091, TF23-K092, TF23-K093, TF23-K094, TF23-K095, TF23-K096, TF23-K097 Date tested: 7/28/23 Patient Case Numbers: TF23-K105, TF23-K106, TF23-K107, TF23-K108, TF23- K109, TF23-K110, TF23-K111, TF23-K112 Date tested: 8/12/23 Patient Case Numbers: TF23-K120, TF23-K121, TF23-K122, TF23-K123, TF23-K124, TF23- K125 Date tested: 9/15/23 Patient Case Numbers: TF23-K140, TF23-K141, TF23- K142, TF23-K143, TF23-K144, TF23-K145, TF23-K146 Date tested: 10/13/23 Patient Case Numbers: TF23-K153, TF23-K154, TF23-K155, TF23-K156, TF23- K157, TF23-K158, TF23-K159 Date tested: 10/27/23 Patient Case Numbers: TF23- K167, TF23-K168, TF23-K169, TF23-K170, TF23-K171, TF23-K172, TF23-K173 4. In an interview on 6/3/24 at 9:40 a.m. in the laboratory, after review of the records, the Operations Coordinator confirmed the above findings. Key: QC = Quality Control *NOTE- this was a repeat deficiency from the survey performed on 5/16/22 -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. 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, the laboratory's Humidity and Temperature Logs from 2022, surveyor observation, a random review of patient test records, and staff interview, it was revealed that the laboratory failed to have a mechanism in place to monitor the humidity of the laboratory for six of six days from February to May 2022. Findings include: 1. A review of the laboratory's policy titled 'Quality Control Program' revealed the following: "The environment in the working area of the laboratory will be controlled by commonly used heating, air-conditioning and ventilation equipment used throughout the entire medical office, which will maintain at a working temperature of 50 -80 degrees Fahrenheit, and humidity of less than 60%." 2. A review of the laboratory's Humidity and Temperature Logs from 2022 revealed the laboratory documented the humidity at 30% for the following 6 days from February to May 2022: 2/11/22 3/11/22 3/25/22 4/9/22 *Documented on the wrong date, patient's specimens were processed on 4/8/22 4/22/22 5/6/22 3. 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 -- Surveyor observation of the laboratory on 5/16/22 at 9:30 revealed the laboratory used the thermostat to document the room temperature of the laboratory. Further observation of the laboratory revealed there was no humidity monitor and the thermostat did not measure the humidity of the room. 4. A random review of the laboratory's patient test records revealed the following 12 patient's specimens were processed when the laboratory's humidity was not being monitored: Patient: TF22- K001 Date: 2/11/22 Patient: TF22-K006 Date: 2/11/22 Patient: TF22-K012 Date: 3/11 /22 Patient: TF22-K015 Date: 3/11/22 Patient: TF22-K018 Date: 3/25/22 Patient: TF22-K021 Date: 3/25/22 Patient: TF22-K028 Date: 4/8/22 Patient: TF22-K031 Date: 4/8/22 Patient: TF22-K036 Date: 4/22/22 Patient: TF22-K039 Date: 4/22/22 Patient: TF22-K041 Date: 5/6/22 Patient: TF22-K044 Date: 5/6/22 5. An interview with the MOHS histotech on 5/16/22 at 9:30 a.m. in the laboratory, after review of the records, confirmed the above findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory's policies, the laboratory's H&E and QC Stain Logs from 2022, a review of patient test records, and staff interview, it was revealed that the laboratory failed to document the intended reactivity of Hematoxylin & Eosin (H&E) stain for MOHS histopathology slides each day of use for one of six days reviewed from February to May 2022. Findings include: 1. A review of the laboratory's policy titled 'Quality Assessment Manual' revealed the following: "Quality control is performed for the adequacy of staining. A daily control slide for H&E stain is documented representing stain quality for each day of use." 2. A review of the laboratory's H&E and QC Stain Logs from February to May 2022 revealed no documentation of the intended reactivity for the H&E stain on April 8, 2022. 3. A review of patient test records revealed the following 8 patients were tested on April 8, 2022 when the intended reactivity of the H&E slide was not documented: Patient Case Numbers: 025, 026, 027, 028, 029, 030, 031, 032 4. An interview with the MOHS histotech on 5/16/22 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. Key: QC = Quality Control -- 2 of 2 --