Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of the laboratory procedure manual, laboratory accession log, and examination of the tissue slides, the laboratory failed to properly label a patient MOH's slide properly. Findings include: a. The laboratory's procedure manual state that the MOH's slide(s) be labeled with the following information: "Slides are labeled with number, full patient name, date and stage#, block # and slide #". b. On February 7, 2019, one (MR# 11676238) of four patients randomly selected patients had MOH's procedure performed. The patient was assigned '25'. On the next page of the accession log, another patient (MR# 11520704) was also assigned accession number '25'. The mislabeling was limited to the accession number only, patient name, date, stage#, block#, and slide# were correct on the accession log and slides. c. Representatives of the laboratory confirmed (September 20, 2019, 11:45 A.M.) that the above single accession number was used incorrectly for two different patients. 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 --