Clark Dermatology

Summary Statement of Deficiencies D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (f), or (g). This STANDARD is not met as evidenced by: Based on surveyor review of the Histopathology Slides (HS) Accession Log (AL) and interview with the Office Manager (OM) The laboratory failed to retain all HS from 7 /14/25 to 9/23/25. The finding includes: 1. The AL stated there were to Stage One HS for patient 25-128 2. The laboraotry retained one out of two Stage One HS for patient 25-128 recorded in the AL. 3. The OM confirmed on 9/23/25 at 10:30 am that all HS were not retained. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform CA for all Testing Personnel (TP) in the calendar year 2020. The finding includes: 1. Two out of two TP did not have a CA performed in the calendar year 2020. 2. The TC confirmed on 11/10 /21 at 10:00 am that the CA was not performed. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Records (PR) and interview with the Office Manager (OM), the Laboratory Director failed to ensure that the education records were available for all Testing Personnel (TP) on the date of the survey. The finding includes: 1. Education records were not available for one out of two TP. 2. The OM confirmed on 11/10/21 at 10:00 am that education records were not available. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of the Staining Station (SS) and interview with the Office Manager (OM), the laboratory failed to follow Mohs Staining Procedure from 5/24/19 to the date of the survey. The findings include: 1. The SS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated step four was for three changes of tap water but SS had two. 2. The OM confirmed on 10/3/19 at 12:30 pm that PM procedure did not match with SS. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of the Personnel Files and interview with the Office Manager (OM), the Laboratory Director (LD) failed to specify in writing the list of job responsibilities for the LD and Mohs Surgeon (MS) from 5/24/19 to the date of survey. The OM confirmed on 10/3/219 at 12:40 pm that LD and MS job duties and responsibilities were not documented. -- 2 of 2 --