Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation of nine complete blood count (CBC) specimens in the laboratory on 2/15/22 at 1:30 p.m., review of four patient CBC results from the Abbott Cell-Dyn Emerald hematology analyzer, dated 2/15/22, and confirmation by Testing Personnel #1 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to establish and follow written policies and procedures that ensure positive identification of patients' specimens from the time of collection, or receipt, of the specimen through completion of testing and reporting of results. Findings include: Observation of nine CBC specimens in the laboratory on 2/15/22 at 1:30 p.m. revealed all nine specimens were labeled with patient name only. Review of four patient CBC results from the Abbott Cell-Dyn Emerald hematology analyzer, dated 2/15/22, revealed all four CBC analyzer printouts included patient name only for identification. The patient CBC specimens and CBC results were not labeled with a unique identification number in order to ensure positive identification of patients' specimens and patients' results from the time of collection through completion of testing and reporting of results. Testing Personnel #1 confirmed patient CBC results are entered into patient electronic medical records manually from the hematology analyzer printouts. 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 --