Affiliated Dermatologists &

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 Histopathology reagents and interview with the Testing Personnel (TP), the laboratory failed to discard expired Histopathology reagents from 6/30/23 to the date of survey. The finding include: 1. One Yellow Tissue Marking Dye Lot 123412 expired on 6/30/23. 2. No patients were tested with the expired reagent. 3. The TP #2 listed on the CMS-209 form confirmed on 7/26/23 at 10:30 am that the laboratory did not discard the expired reagent. 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 the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to use the applicable elements to assess Mohs testing on four of four TP in the calendar year 2017. The TP #1 listed on the CMS form 209 confirmed on 7/17/18 at 1:35 pm the applicable elements were not used to assess CA. 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 --