COMMERCIAL HEMATOLOGY LABORATORY AND HEMATOPATHOLOGY SERVICE: HIDDEN COMPROMISE OF DIAGNOSTIC PROCESS, PATIENT SAFETY AND FINANCIAL LOSSES

ABSTRACT Objectives: This review highlights some important problematic issues in hematology laboratory and hematopathology diagnostic process, which are well known to professionals in these areas but are largely ignored for a variety of reasons.

Methods: Microscopic evaluation of peripheral blood smears at Quest Diagnostics; Ameripath Nort East (ANE; part of Quest Diagnostics); Umass Memorial Medical Center (UMMC), Tufts Medical Center (TMC), Beth Israel Deaconess Medical Center (BIDMC). Microscopic evaluation of aspirate smears, bone marrow biopsies and clots, cytospins of lymph nodes and body fluids (including CSF, peritoneal and pleural fluids) and Flow Cytometry testing within laboratories listed above.

Conclusions: While operation of clinical hematology laboratories and laboratory components of hematopathology services is extensively regulated, there is insufficient attention to the quality of materials arriving for diagnostic work up. For example, there is no College of American Pathologist Checklist item dealing with issues of how laboratory establishes stability criteria to assure that a process generating stability criteria addresses reasons for blood cells’ alteration and disruption during transportation. Also, there is little attention to how hematopathology services identify and report suboptimal or inadequate materials in relation to a clinical history prompting evaluations (bone marrow biopsy, aspirate, and flow cytometry). The specific issues relevant to the above and some possible steps for remediation are discussed below in more detail.