Summary:
Summary Statement of Deficiencies D0000 The Complete Dermatology laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on July 6, 2026 and (re)certification is recommended. 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 a review of the laboratory's policies, the laboratory's records from 2025, and staff interview, the laboratory failed to have documentation of performing one of two Biannual Slide Reviews for Mohs slide evaluation in 2025. Findings include: 1. A review of the laboratory's policy titled 'Total Quality Management Program' revealed the following: "Mohs Lab Biannual Slide Review Purpose: This is performed for the evaluation of the Mohs Surgeon and the slides produced by the Histotechnician. Frequency: Biannually; each calendar year. January and July are the designated months. Exceptions can be made if circumstances require it." 2. A review of the laboratory's records revealed the laboratory performed one Biannual Slide Review in June 2025. The laboratory failed to have documentation of a second Biannual Slide Review in 2025. 3. In an interview on 7/6/26 at 10:55 a.m. in the break room, after review of the records, the office manager confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, surveyor observation, the laboratory's patient test records, and staff interview, the laboratory failed to ensure three of three tissue marking dyes, used on patient's tissue specimens for Mohs testing in 2026, were not used beyond their expiration dates. Findings include: 1. A review of the laboratory's policy titled 'Mohs Map and Color Coding' revealed the following: "Purpose: to ensure accuracy for the specimen testing procedure by providing standard orientation points and a reference map of those points. - Color Codes: a. Red - Superior 12 o'clock on both pieces b. Green - at 3 o'clock c. Blue - at 6 o'clock" 2. Surveyor observation on 7/6/26 at 10:45 a.m. in the laboratory revealed the following tissue marking dyes were being used and were beyond their expiration date: - StatLab Red Tissue Marking Dye Lot number: 198947 expiration date: 5/31/26 - StatLab Green Tissue Marking Dye Lot number: 196884 expiration date: 4/30/26 - StatLab Blue Tissue Marking Dye Lot number: 199385 expiration date: 5/31/26 3. A review of laboratory's patient test records revealed the laboratory estimated 450 blocks were tested annually. 4. In an interview on 7/6/26 at 10:55 a.m. in the break room, after review of the records, the office manager confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient Mohs Flow Sheets, the Case Log Sheets for Mohs Surgeries, and staff interview, the laboratory failed to include the correct procedure dates on the Mohs Flow Sheets for three of ten reports reviewed from October 2025 to March 2026. Findings include: 1. A review of the Patient Mohs Flow Sheets revealed the Mohs procedure was performed on the following 3 patients and the dates documented on each form: - Case number: MS25-187 Date: 10/21/25 - Case number: MS26-21 Date: 1/27/26 - Case number: MS26-53 Date: 3/30/26 2. A review of the Case Log Sheets for Mohs Surgeries revealed the following procedure dates for the 3 patients listed above: - Case number: MS25-187 Date: 10/14/25 - Case number: MS26-21 Date: 2/3/26 - Case number: MS26-53 Date: 3/31/26 3. In an interview on 7 /6/26 at 10:55 a.m. in the break room, after review of the records, the office manager confirmed the correct dates for the Mohs procedures were the dates listed on the Case Log Sheets for Mohs Surgeries. -- 2 of 2 --