Clark Dermatology

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on survey review of the Procedure Manual (PM), Biannual Assessment Documentation (BAD) and interview with the Office Manager (OM) the laboratory failed to verify the accuracy of Histopathology testing from 11/23/21 to the date of survey. The findings include; 1) The PM states " Cases will be referred to an outside laboratory/physician for complete review of slides and Mohs Map. 2) The laboratory failed to include physician agreement for the biopsy diagnosis of each case submitted for complete review for the Biannual Assessment (BA). 3) The reviewing and referring physicians failed to sign the BAD. 4) There was no documented evidence the Mohs Maps were reviewed for each case submitted. 5) The OM confirmed on 10/17 /23 at 1:30 pm that the laboratory failed to verify the accuracy of Histopathology testing. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). 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 record a discontinuance date for 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 -- procedures not performed in the laboratory from 11/23/21 to the date of survey. The finding includes: 1. The PM had two procedures for slide retention that had different slide retention dates. 2. The OM confirmed on 10/17/23 at 2:15 pm that a discontinuance date was not documented. 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, the Flammable Cabinet, and interview with the Office Manager (OM), the laboratory used and failed to dispose expired Histopathology reagents from 10/4/23 to the date of survey. The findings include: 1. One Eosin Working Solution one gallon container Lot L245-04 expired on 10/4/23. 2. 7 patients were run and reported with the expired reagent. 3. The OM confirmed on 10/17/23 at 2:30 pm that the laboratory used and failed to dispose the expired reagent. -- 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 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. One out of two TP did not have a CA performed in the calendar year 2020. 2. The OM confirmed on 11 /23/21 at 12:15 pm 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 11/23/21 at 12:15 pm 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: +Based on surveyor review of the Procedure Manual, Maintenance Records (MR) and interview with the Office Manager (OM), the laboratory failed to perform and document maintenance as specified by the manufacturer on the Tissue Tek Cryostat and the Microscope used for Histology tests from 7/6/17 to the date of the survey. The OM confirmed on 12/11/18 at 2:15 pm that annual maintenance as specified by the manufacturer was not performed on above instruments. 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 --