Lakeside Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lakeside Dermatology on 11/06/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 policies and procedures and Safety Data, and interview with compliance staff, the laboratory failed to follow safety policies and procedures for chemical and biohazard material for one of one gallon of reagent stored outside of the flammable cabinet. Findings included: On 11/06/2024 at 11:10 am, a beverage cup with a straw and liquid inside the cup was on the lab workbench. Observation of the entrance door to the lab revealed a biohazard, drinking prohibited in this area sign. During the tour, on 11/06/2024 at 11:25 am, a gallon container of 100% Reagent Alcohol was on the floor. The product label revealed the alcohol was flammable and should be stored "locked up." Review of the manufacturer Safety Data Sheet for the 100% Reagent Alcohol revealed, "Highly flammable liquid and vapor" and "Store in an approved Flammable Liquids storage area." Review of the lab Policy and Procedure Manual, approved by the Lab Director in January 2024, under Safety Summary revealed no drinking in the laboratory and ensure no flammable items are stored in the facility except as operations demand. Interview with compliance personnel A on 11/06/2024 at 11:25 am confirmed the beverage should not be present 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 -- in the lab. Interview with compliance personnel A and B on 11/06/2024 at 11:33 am confirmed the 100% Reagent Alcohol was not in the flammable cabinet but should be stored in the flammable cabinet. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with the Consultant, the laboratory director failed to document training for one (B) of two testing personnel. Findings included: A review of CMS Form 209 titled Laboratory Personnel Report signed by the laboratory director on 12/10/18 revealed Testing Person B performed high complexity histology testing. A review of Testing Person B's personnel file revealed no training records. Interview on 12/10/2018 at 11:00 AM with the Consultant, confirmed there were no training records for Testing Person B for histology 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 --