Erica Smithberger Md Pl Dba

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Erica Smithberger MD PL d/b/a Clayton Dermatology Group on 06/06/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 MOHS technician, the laboratory director failed to document training for one (Testing Personnel #B) out of three testing personnel ( #A, #B, and #C). Findings included: A review of CMS Form 209, Laboratory Personnel Report, signed by the laboratory director on 06/01/22 revealed Testing Person #B performed high complexity histopathology testing. A review of Testing Person #B's personnel file revealed training records had not been documented. On 06/06/22 at 11:00 AM, the MOHS technician stated Testing Personnel #B was hired August 2021 and confirmed there were no training records for Testing Person #B for histopathology 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 --

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 record review and interview with the Laboratory Manager, the laboratory failed to follow their procedures for chemical waste disposal for an undetermined amount of time. Findings Included: During an interview on 02/23/18 at 10:20 a.m., the Laboratory Manager revealed that all chemical waste was disposed of by being poured down the sink drain. Review of policies and procedures (last reviewed by Laboratory Director on 08/23/17) revealed that "Hazardous liquid waste will be placed in the 2.5 gallon hazardous waste container stored next to the cryostat machine." The 2.5 gallon hazardous waste container was observed beside the cryostat machine empty on 02/23/18 at 11:00 a.m. Observation of the Safe Clear, Hemotoxylin, Eosin, 95% Reagent Alcohol, and 100% Reagent Alcohol bottles all state "Dispose of contents/container to an approved waste disposal plant." D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on observation, record review and interview with the Laboratory Manager, the laboratory failed to store chemicals per manufacturers instructions since 12/26/17. Findings Included: Tour of the laboratory on 02/23/18 at 9:15 a.m., revealed that the temperature in the laboratory was warm. Review of the thermometer revealed that the temperature in the room was 86 degrees Fahrenheit. During an interview on 02/23/18 at 9:15 a.m., the Laboratory Manager revealed that the laboratory moved to that location on 12/26/17 and that the laboratory had a stand alone air conditioning unit that was only ran when testing occurred. She also confirmed that the chemicals were stored in the laboratory even when testing was not being performed and the air conditioning unit was turned off. Review of the Scott's tap waster substitute (Lot #1714522 exp 05/31/18) states that it needs to be stored at a maximum temperature of 86 degrees Fahrenheit. The emergency eyewash stated that it needs to be stored at a maximum temperature of 77 degrees Fahrenheit. -- 2 of 2 --