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 Laboratory Director (LD) via telephone, the laboratory failed to retain HS from 1/1/19 to the date of survey. The finding includes: 1. A review of five patient records found on the AL between 4/25/19 and 6/20/19 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 with a prefix of "GAST" and "GASG" in the calendar year 2019. 3. The last slide found in the slide box was GA2019-000191 but the last slide number received on the AL for the "GA" prefix was 000298. 4. The LD via telephone confirmed on 9/24/19 at 1:50 pm the HS were not retained. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview 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 -- with the Laboratory Director (LD) via telephone, the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar year 2018. The LD via telephone confirmed on 9/24/19 at 1:40 pm that the laboratory did not verify the accuracy of Histopathology testing twice annually in 2018. 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 the microscope and interview with the Laboratory Director (LD) via telephone, the laboratory failed to follow the procedure to "Maintain Equipment" in the calendar years 2017, 2018 and up to the date of the survey. The finding includes: 1. The PM stated to clean and check microscope each day of use and to perform preventive maintenance annually but there was no evidence of daily maintenance performed since 2016 and annual maintenance was not done in 2018. 2. The LD confirmed via telephone on 9/24/19 at 1:30 pm that the laboratory did not follow the PM. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Laboratory Director (LD) via telephone, the laboratory failed to document the reaction of the Hematoxylin and Eosin stain and Special stains used for Histopathology tests from 4/25/19 to the date of the survey. The LD via telephone confirmed on 9/24/19 at 1:25 pm that the laboratory did not document reaction of stains. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL) included with Histopathology slides and interview with the Laboratory Director (LD) via telephone, the laboratory failed to maintain an accurate information system for Histopathology slides in April 2019. The finding includes: 1 The AL was not found from 4/18/19 to 4/29/19 but patient results and slides were available for review. 2. The LD confirmed on 9/24/19 at 1:45 pm that the laboratory did not maintain an accurate record system. -- 3 of 3 --