Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an interview with the Laboratory Director (LD) and the Technical Consultants (TC's) and a review of the physician office laboratory (POL), there was no evidence of testing taking place at the physician office. Findings: 1. The LD and TC's confirmed at approximately 11:30 AM on July 19th that the patient specimens were collected at an Ambulatory Surgery Center (ASC). The Department of Health Division of Legal Affairs has determined that patient specimens collected at an ASC belong to the ASC and not to the individual physician performing the surgery. These specimens can only be processed at a Clinical Laboratory Evaluation Program (CLEP) permitted laboratory. 2. The LD also confirmed that the slides were processed and read at a CLEP New York State permitted laboratory (Micropath, LLC PFI-9181). 3. Based on the fact that no laboratory exists at this location, POLEP will close the laboratory. This deficiency is for internal use only. The POL will be closed after survey is completed and the Cert Kit is uploaded. A termination letter will be sent to the facility. 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 --