Clark Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of Tissue Marking Dyes and Reagents, surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM) the laboratory used and failed to discard expired Tissue Marking Dye used for Histopathology testing from 6/30/24 to 12/11/24. The findings include: 1. One Green Tissue Marking Dye Lot# 154057 was observed to be expired on 7/31/24. 2. One Black Tissue Marking Dye Lot# 153190 was observed to be expired on 6/30/24. 3. Approximately 85 tests were performed and reported with the expired dyes. 4. The OM confirmed on 12/11/24 at 1:35 pm that the laboratory used and failed to discard expired dyes for Histopathology testing. 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents and interview with the Office Manager (OM), the laboratory failed to ensure protection from chemical and physical hazards from 9/13/21 to the date of survey. The findings include: 1. All flammable and inhalation risk reagents were not kept in a flammable cabinet. 2. Five containers of 100% alcohol reagent, one container of Histoclear reagent and two containers of Xylene reagent were observed under the sink in the laboratory. 3. The OM confirmed on 8/23/23 at 2:00 pm that the laboratory did not ensure protection from chemical and physical hazards. 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), the lack of a Reagent Tracking Log and interview with the Office Manager (OM), the laboratory failed to provide documented evidence for the procedure "Statement of Policy" Letter C from 9 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 -- /13/21 to the date of survey. The findings include: 1. The procedure states "Reagents and other supplies must be inspected at time of delivery." 2. There was no documented evidence the above mentioned procedure was followed. 3. The OM confirmed on 8/23/23 at 1:45 pm that the laboratory failed to have documented evidence that reagents were inspected at time of delivery. -- 2 of 2 --

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 the Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform the CA for Testing Personnel (TP) in 2020.The finding includes: 1. One out of two TP did not have a CA performed in the calendar year 2020. 2. The OM confirmed on 9/13/21 at 12:30 pm that the CA was not performed. 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) and interview with the Office Manager (OM), the laboratory failed to have a procedure for slide retention of Moh's slides from 1/26/17 to the date of the survey. The OM confirmed on 2/13/19 at 10:00 am that the laboratory did not have a procedure for slide retention of Moh's slides. 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 --