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 review of the Laboratory Procedure Manual and observation of ten complete blood count (CBC) pediatric specimens in the laboratory on 9-18-19 at 9:45 a.m., the laboratory failed to establish a written policy for specimen labeling of CBC specimens, to include a unique patient identifier. Findings include: Review of the Laboratory Procedure Manual revealed no written policy for labeling CBC specimens to be run on the Horiba Medical ABX Micros 60 hematology analyzer. Observation of ten complete blood count (CBC) pediatric specimens in the laboratory on 9-18-19 at 9: 45 a.m. revealed a written label lying under each pediatric CBC specimen with no label attached to each specimen. The written label lying under one of the ten specimens included a name only. There was no unique patient identifier, in order to distinguish between patients with the same first and last name. 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 --