Edward M Kramer Md, Inc

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, preventive maintenance (PM) documentation, ten (10) patient records and interviews with the laboratory assistant (LA) and office manager (OM); it was determined that the laboratory failed to follow an established policy and procedure in place for the preventive maintenance (PM) as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings include: 1.The laboratory failed to provide PM documentation for the years 2023 and 2024 for the microscope and cryostat used at the facility according to manufacturer's requirements, to be performed annually. 2. No

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records and documentation, and an interview with laboratory personnel (LP) on 9/16/2020 between 10 am and 11:30 am, it was determined that there was no histotechnician competency procedure or annual checklist. Findings include: 1. On 9/16/2020, an inspection was conducted between 10 am and 11:30 am. 2. During a review of the laboratory procedure documentation, there was no procedure or checklist to support the annual requirement for histotechnician competency for MOHS procedures. The LP was made aware of this deficiency. 3. According to the CMS 116 report, the laboratory performs 2,554 MOHS tests per year. 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 --