Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 10, 2024. Schorr and Feder DPM PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the pathology reports, observation, and interview, the laboratory's Surgical Pathology Report failed to provide the test results of the special stains Periodic Acid - Schiff (PAS) and Grocott Methenamine Silver (GMS) for 5 of 5 (#1 - #5) patient pathology reports reviewed. Findings: Review of the Surgical Pathology Reports for Patients #1 to #5 read, "PAS and GMS stains were ordered due to the clinician's suspicion of onychomycosis." Review of the pathology reports showed results of the PAS stain and GMS stain were not included in the reports. Observation on 07/10/2024 at 10:20 AM, of the slides for Patients #1 to #5 showed each patient had a stained slide for PAS and GMS. On 07/10/2024 at 9:55 AM, the Laboratory Consultant acknowledged the results of the PAS and GMS stains were not on the pathology 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 1 --