Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Through a review of the data log from the Medonic hematology analyzer, a review of patient result printouts from the Medonic hematology analyzer, a review of medical records for two patients tested on 11/18/2018, and interviews with laboratory staff, it was determined the laboratory performed testing on two laboratory employees without a request for patient testing from an authorized person. Survey findings included: A. The data log from the Medonic hematology analyzer included two patients (#12261985 and #07121992) tested on 11/18/2018. B. A review of the instrument result printouts for the complete blood counts performed on #12261985 and #07121992 revealed the reports included handwritten notes stating on #12261985 "lab employee" and on #07121992 "urgent team employee reception". C. At 11:12 on 3/14 /2019 the surveyor requested documentation of the provider orders for the complete blood counts on patients #12261985 and #07121992. At that time the laboratory director (as listed on the form CMS-209) stated that there were no orders for the testing performed on the two employees (two of two complete blood counts performed on 11/18/2018). 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 --