Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Exclusive Dermatology PLLC on June 9, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the procedure manual, observation of patient specimen slides and interview, the laboratory failed to ensure positive identification of patient specimen slides for one (#3) of five (#1 - #5) patient slides reviewed. Findings: 1. Review of the procedure titled Mohs Slide Preparation (signed and dated by the Laboratory Director on (1/12/26) noted, "Slides are labeled as following: First, the date is across the very top of the white portion of the slide, then the patient's last name and first name Initial, Site, Mohs accession number and Stage." 2. Observation of the patient's slides on 6/09 /26 at 11:30 AM revealed, the slides for Patient #3 listed the first name of the patient and did not have the last name. 3. On 6/09/26 at 11:35 PM, the Risk Management and Compliance Supervisor acknowledged the last name was not on the slides for Patient #3. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, 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 2 -- system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on interview, and record review, the laboratory failed to document maintenance and function checks for one day (4/06/26) on the maintenance logs reviewed from 7/09 /24 to 6/09/26. Findings included: 1. Review of the Mohs Daily Quality Control Worksheet revealed, it was used to document the Hematoxylin and Eosin (H&E) stain control slide, microscope verification and maintenance, cryostat maintenance, cryostat temperature, room temperature, room humidity, technician's initials, and doctor's initials. The worksheet was was not filled out for 4/06/26. 2. Review of the Hematoxylin and Eosin Staining Maintenance Log revealed, it was used to document the changing, rotation, filtering, and adding of the reagent. The log was not filled out for 4/06/26. 3. Review of the Mohs accession log revealed, there were 6 Mohs surgical procedures on 4/06/26. 4. On 6/09/26 at 11:03 AM, the Risk Management and Compliance Supervisor acknowledged the maintenance was not recorded. 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 review of the procedure manual, record review, and interview, the laboratory failed to document the acceptability of the Hematoxylin and Eosin (H&E) control slide for one day (4/06/26) from 7/09/24 to 6/09/26. Findings: 1. Review of the procedure titled, H&E Staining (signed and dated by the Laboratory Director on 1 /12/26) noted, for quality control, "Each slide is examined by a doctor and the quality of the cutting and the staining are documented daily." 2. Review of the Mohs Daily Quality Control Worksheet revealed, it was used to document the acceptability of H&E stain control slide. The worksheet was was not filled out for 4/06/26. 3. Review of the Mohs accession log revealed, there were 6 Mohs surgical procedures on 4/06 /26. 4. On 6/09/26 at 11:03 AM, the Risk Management and Compliance Supervisor acknowledged the daily log was not filled out for 4/06/26. -- 2 of 2 --