Summary:
Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, Ocala Dermatology and Skin Cancer Center, was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. 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, review of material safety data sheets (MSDS), and interview, the laboratory failed to store flammable liquid in an approved flammable liquids storage area for Eosin Y Stain. The findings include: During observations taken on 9 /14/21 at approximately 11:00 AM a one gallon container of Platinum line Eosin Y stain, 1% w/v in alcohol (Lot#1924210 exp. 9/4/2021) was found stored under the sink in a cabinet. Review of the MSDS sheets for the Eosin Y stain states to "Store in approved Flammable Liquids storage area." During an interview on 9/14/21 at approximately 11:30 AM, laboratory personnel confirmed that the flammable liquid was not stored properly. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation, and staff interview, the facility failed to ensure the two bottles used for storing Hematoxylin and Eosin on the counter top were labeled with the identity of the stain, preparation, and expiration date. The findings include: During the tour of the laboratory on 9/14/21 at 10:30am, a bottle with an orange liquid was placed next to the fume hood which contained the histopathology stain line. The bottle had no label to indicate the identity of the liquid, when it was prepared, or what the expiration date was. The interview with laboratory personnel on 9/14/21 at 11:00am confirmed the liquid was Eosin and the bottle was not labeled as required. A second bottle with a dark purple liquid was sitting next to the fume hood which contained the histopathology stain line. The bottle was labeled "Hematoxylin". The label contained no information about when the stain was prepared or what the expiration date was. The interview with laboratory personnel on 9/14/21 at 11:00am confirmed the liquid was Hematoxylin and the bottle was not labeled as required. D5781