Advanced Dermatology, Pc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the lack of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar years 2021 and 2020. The OM confirmed on 11/3/22 at 11:00 am that BA was not performed. 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: a) Based on surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) and interview with the Office Manager (OM), the laboratory failed to have a complete procedure for BA at the time of survey. The finding includes: 1. The OM stated that "BA was not performed in 2020 and 2021 due to the fact that the reference laboratory where they sent BA cases was closed due to Covid" 2. The OM confirmed they had no alterative procedure for the above mentioned situation. 3. The OM confirmed on 11/3/22 at 11:40 am the laboratory did not have a complete procedure for BA. b) Based on surveyor review of the Procedure Manual (PM), observation of 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 -- Staining Station (SS) and interview with the Office Manager (OM), the laboratory failed to follow the PM for Hematoxyilin-Eosin (HE) staining form 10/10/19 the date of the survey. The findings include: 1. The SS in the laboratory did not correspond with the staining procedure in the PM. 2. The observation of the staining solutions and reagents in the SS had 2 changes of Clearing agent. 2. The PM stated to have three changes of clearing agent. 3. The OM confirmed on 11/3/22 at 11:30 am that the laboratory did not follow the PM. -- 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 Manage (OM), the laboratory failed to perform a CA on two out of two TP in the calendar years 2018 and 2019. The OM confirmed on 10/10/19 at 10:00 am that CA was not performed on TP in 2018 and 2019. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Mohs testing twice annually in the Calendar year 2018. The OM confirmed on 10/10/19 at 10:45 am that the laboratory did not verify the accuracy of Mohs 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 --