Select Skin Md Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 27, 2022. Select Skin MD LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document quality control information including the lot number, expiration date and open date for all reagents used in their Hematoxylin & Eosin (H & E) stains from 03/02/2021 to 04/27 /2022. Findings: Review of the procedure titled Staining noted the laboratory used the following reagents in their H&E stain: Reagent Alcohol, Hematoxylin Stain, Bluing Reagent, Eosin Stain, and Xylene Substitute. Review of the Stainer Maintenance log showed only the lot number of the Hematoxylin and Eosin Stain were recorded. On 04 /27/2022 at 3:28 PM, the Lead Mohs Technician acknowledged that not all lot numbers, expiration dates and dates opened were documented. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the facility failed to establish and follow a written quality assessment policy, and the procedure for proficiency testing was incomplete. Findings included: Record review of the laboratory procedure manual showed that their was no quality assessment policy. During an interview on 4/9/18 at 3:07 PM, General Supervisor stated that they did not have a quality assessment policy for the laboratory. Record review of the laboratory procedure on proficiency testing showed that the procedure was incomplete. The procedure failed to include what the laboratory would do if there was a discrepancy in the diagnosis between the Laboratory Director who made the initial diagnosis and the Clinical Consultant who performed the blind review. The procedure also failed to mention what