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 from October 2018 to the date of survey. The finding includes: 1. Review of five patient records revealed that one out of the five patient slides were not available at the time of the survey. 2. The OM confirmed on 4/16/19 at 10:00 am the HS were not retained. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of microscope and interview with the Office Manager (OM), the laboratory failed to follow Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Microscope Maintenance Procedure (MMP) in the calendar year 2018. The finding includes: 1. The maintenance sticker on the microscope stated that maintenance was from October 2012. 2. The PM stated to perform preventive maintenance of microscope annually but there was no evidence of maintenance performed. 3. The OM confirmed on 4/16/19 at 10:30 am that the laboratory did not follow MMP. -- 2 of 2 --