Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's established Quality Assessment policies, review of QA records and interview with the facility personnel, the laboratory failed to identify and correct errors found within the accuracy verification process. Findings include: 1. The laboratory performs a microscopic examination on biopsy specimens and issues a diagnosis under the sub-specialty of Histopathology, with an approximate annual test volume of 5,201. 2. It is the practice of the laboratory to randomly select cases for review each month for each physician (5 total) who perform testing. The review is documented on a "Monthly Slide Professional Review (QA)" form, including an area to note if there is a discrepancy and the action taken. 3. Review of the Monthly Slide Professional Review (QA) form from April 2019 indicated a noted discrepancy for case# AG19-568. The action taken indicated that the report was amended. 4. No amended report for case# AG19-568 was presented for review during the survey. The original pathology report was reviewed by the surveyor but no amendment was documented. 5. During the survey the facility personnel contacted the reviewing physician who stated that the QA form was incorrect. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems 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 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's 'Specimen Error/Issues Log' and interview with the facility personnel, the laboratory failed to correct ongoing, repetitive issues identified with specimen collection. Findings include: 1. The laboratory performs testing in the specialty of Pathology with an approximate annual test volume of 5,201. The biopsy specimens are collected and transported to the pathology lab from the adjacent surgery center. 2. Review of the laboratory's "Specimen Error/Issues Log" revealed the laboratory identified the following number of errors associated with the collection and/or transportation of the specimen: 17 errors identified in 2017 from the date of the last survey conducted on July 20, 2017 through December 31, 2017; 19 errors identified in 2018; and 18 errors identified in 2019 through the date of the survey conducted on July 22, 2019. 3. The repetitive errors identified on the log indicated above included specimen missing from the container, pathology requisition discrepancies to the number of specimens actually received by laboratory, patients Date of Birth missing or incorrect on pathology requisition, incorrect or missing site /source, patient name misspelled and/or incorrect on pathology requisition or container, and specimen container mislabeled. 4. The facility personnel confirmed that the majority of the errors were made by one individual responsible for the documentation of pathology requisitions, labeling of specimen containers and transportation of the specimen to the pathology laboratory. 5. No documentation was presented for review to indicate the laboratory corrected the ongoing, repetitive errors and issues stated above. 6. The facility personnel stated that verbal discussions took place with the surgery center personnel regarding the ongoing, repetitive issues but no evidence was presented for review to indicate the laboratory documented