Anne Arundel Dermatology Berlin

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the histotechnologist, the laboratory did not ensure that the in-use histology stain reagents were labeled with the date that they were opened. Findings: 1. During a tour of the laboratory at 11:15 AM, it was observed that the opened and in-use histology stain reagents in the laboratory flammable cabinet were not labeled with the date that they were opened and put in to use. 2. During an interview on 07/20/2022 at 12:15 PM, the histotechnologist confirmed that the histology stain reagents in-use were not labeled with the date that they were opened. 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 observation in the Histology laboratory and interview with the laboratory manager, the laboratory did not have an eyewash in the Histology laboratory where staining and slide preparation is being performed. Findings: 1. The laboratory is required to implement safety policies and procedures to ensure safety in the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. 2. The area where laboratory was staining and preparing slides was toured during the survey. Observation of the staining area showed that there was no eyewash attached to the sink to aid in flushing out the eyes of the histotech if they were to have been splashed with any stains or chemicals. The eyewash equipment was in the box next to the sink. 3. During the survey on 03/10/2020 at 12:00 PM the laboratory manager confirmed that the eyewash equipment was not attached to the sink faucet in the area where the staining and slide preparation is being performed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)