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 record review and interview with the Laboratory Director (LD), the laboratory failed to retain histopathology slides for 2 (Patients 1 and 2) of 10 patient histopathology slides reviewed. Findings include: 1. The surveyor requested patient histopathology slides for 10 patients on 9/16/20 at 2:33 pm and the following patient slides were not made available during the survey: a. Patient 1 tested on 10/3/18 b. Patient 2 tested on 12/27/18 2. A review of the laboratory's established "Quality Assessment/Assurance Program as it applies to the diagnostic QA program at Eastern Pathology" procedure revealed a section stating, "All slides and reports and requisition forms filed/stored permanently at Eastern Pathology Beckley location are available for review by laboratory accrediting agencies." 3. An interview on 9/16/20 at 4:11 pm with the LD confirmed histopathology slides for the patients listed above were not made available. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to retain requests for patient testing for 2 (Patients 1 and 2) of 9 patient test requests reviewed. Findings include: 1. The surveyor requested patient test requests for 9 patients receiving testing at the laboratory and the following were not made available during the survey: a. Patient 1 tested on 10/3/18 b. Patient 2 tested on 12/27 /18 2. A review of the laboratory's established "Quality Control and Quality Assurance" procedure revealed a section stating, "All information pertaining to specimen collection, preservation and rejection are covered in the procedure manual. All patient test information will be maintained in the appropriate logs in documented in the patient's chart." 3. A review of the laboratory's established "Quality Assessment /Assurance Program as it applies to the diagnostic QA program at Eastern Pathology" procedure revealed a section stating, "All slides and reports and requisition forms filed /stored permanently at Eastern Pathology Beckley location are available for review by laboratory accrediting agencies." 4. An interview on 9/16/20 at 4:11 pm with the LD confirmed the laboratory did not make the patient test requests available. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)