Connolly Dermatology

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 Clinical Supervisor (CS), the laboratory failed to ensure protection from chemical and physical hazards at the time of survey. The findings include: 1. Observation of the flammable cabinet and laboratory sink revealed that all flammable and inhalation risk reagents were not kept in the flammable cabinet. 2. One container each of 95% alcohol, Gill 1 Hematoxylin, 1% acidic alcohol and two containers of 100% alcohol were in the laboratory sink. 3. The CS confirmed on 1/28/20 at 10:30 am 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), observation of the Manual Staining Station (MSS) and interview with the Clinical Supervisor (CS), the laboratory failed to follow Mohs Staining Procedure from 1/24/18 to the date of the 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 -- survey. The findings include: 1. The MSS in the laboratory did not correspond with the staining procedure in the PM. a) The PM stated Step # 5 was Scott's Bluing reagent but the MSS had 1% acid alcohol. b) The PM stated Step # 7 was 1% acid alcohol but the MSS had Scott's water. c) The PM stated Step # 9 was 95% alcohol but the MSS had water. 2. Approximately 1500 patients were stained. 3. The CS confirmed on 1/28/20 at 10:00 am that laboratory failed to follow the PM. -- 2 of 2 --

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 Biannual Assessment (BA) procedure, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed follow the BA procedure for the Calendar years 2016 and 2017. The finding includes: 1. The BA procedure stated that the BA will be performed semiannually with two cases sent out for evaluation. 2. BA was performed once in the calendar year 2016 with three cases sent out. 3. The BA was performed once in the calendar year 2017 with six cases sent out. 4. The OM confirmed on 1/24/18 at 12:30 pm that the BA procedure was not followed. 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 --