Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of three (3) of thirteen (13) patients' histopathology slides (Mohs) surgical procedures from 05/09/2016 to 02/07/2018, patients medical records, and an interview with a laboratory director and a laboratory staff, it was determined that the laboratory failed to ensure that a histopathology medical records (MR) result were accurately entered onto the patients' medical record. The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. The findings included: a. The laboratory's policies and procedure manual listed both Hematoxylin and Eosin (H & E) and Toluidine Blue (TBlue) as staining methods. Review on 02/08/2018 (survey date) of the laboratory's test records, slide identifiers and electronic medical report (EMR) for the patient's Mohs slides ID# 21856280 (0/17/2018), ID# 02/05/2018 (02/05/2018) and ID# 1008735 (02/07/2018), it was determined of the patient's electronic medical records (EMR) reviewed that the slide staining method transcribed in patients' EMR were not the same stain method used on the patients' slides. The patients Mohs slides listed above were stained with TBlue, but were denoted in the patients' EMR under "SURGICAL PROCEDURE" as 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 -- H & E staining. c. On 02/08/2018 (survey date) the laboratory director affirmed that the patient's EMR denotations for Mohs slide staining under "SURGICAL PROCEDURE" were incorrect. d. From 11/01/2017 to 02/07/2018 approximately 227 Mohs surgical procedures were perform in which the slide staining transcribed in the patients' EMR could not be assured. -- 2 of 2 --