Summary:
Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Histopathology Slides (HS) and interview with the Office Manager (OM), the laboratory failed to retain HS from 2020. The finding includes: 1. A review of five patient records found on the AL between 1/1/20 to 12/31/20 revealed that five of five patient slides were not available at the time of the survey. 2. Slides were not retained for specimens on the AL in the calendar year 2020. 3. The OM confirmed on 1/25/22 at 12:15 pm the HS were not retained. 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 --