Clinical Pathology is responsible for quantitative and qualitative analysis and interpretation of patient specimens, including tissue, blood, urine, and other body fluids. Approximately 10 million clinical laboratory test results per year are performed in these laboratories.
The department consists of the following sections:
Clinical Biochemistry
Clinical Biochemistry provides a broad array of routine and specialized clinical laboratory testing services on blood, urine, and other body fluids. The laboratories maintain a comprehensive selection of routine, high-volume automated clinical biochemistry tests as well as a diverse menu of serological tests, endocrine/hormone analysis, tumor markers, and others. Additional specialized testing includes:
- Therapeutic drug monitoring
- Toxicological testing
- Trace metals analysis
- Kidney stone analysis
- Serum protein analyses
- Other specialized chemical analysis
Regionally, Clinical Biochemistry operates a satellite facility on Cleveland Clinic’s campus that provides rapid blood gas and acute care testing for operating rooms and intensive care units. Clinical Biochemistry is also responsible for oversight of the entire point of care testing program throughout Cleveland Clinic.
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Hematopathology
Hematopathology is involved in the analysis of the cellular elements of blood, bone marrow, body fluids, and lymphoid tissues with a focus on neoplastic and non-neoplastic hematologic disorders. In addition to high-volume automated hematology laboratory tests (e.g. CBCs), the section’s laboratories perform a wide variety of specialized studies such as hemoglobin variant analysis and red cell membrane disorders.
The facilities and expertise of the Section allow for a comprehensive approach to the interpretation and diagnosis of blood, bone marrow, and lymph node specimens. Morphologic findings are integrated with the results of special procedures such as immunohistochemistry, flow cytometry, molecular studies, and cytogenetic analysis to arrive at a final interpretation.
Molecular hematopathology analyses routinely performed include polymerase chain reaction amplification for immune receptor gene rearrangements and fluorescent in situ hybridization for genetic translocations.
Flow Cytometry
The Flow Cytometry Laboratory provides a full range of services for the assessment and leukemias and lymphomas, immunodeficiency states, transplantation immunosuppression status, DNA ploidy, and paroxysmal nocturnal hemoglobinuria.
Two levels of service are available for special types of samples such as malignant lymphoma and DNA ploidy analysis:
- Full consultation (includes flow cytometry and morphologic interpretation).
- “Special Procedures Only” (numerical values are provided for client interpretation in conjunction with other available information).
Please see the Test Directory for guidelines on specimen preparation and handling. For specific test information, please contact Client Services.
Bone Marrow Consultation
Cleveland Clinic Laboratories offers a full range of expert consultative services for bone marrow evaluation and interpretation. Full morphologic interpretation of bone marrow specimens by a staff hematopathologist is available. Services include: evaluation of prepared peripheral blood smears, bone marrow aspirate smears, touch imprints, core biopsies and clot sections (if available). In some cases, additional studies may be performed on this material such as cytochemistry, immunohistochemistry or molecular studies at the discretion of the pathologist. Please see the Test Directory for more information.
Flow cytometric immunophenotyping services are available on bone marrow samples for the evaluation of suspected hematologic malignancy. This includes a morphologic review of submitted stained or unstained aspirate smears along with four-color flow cytometric analysis and interpretation by a staff hematopathologist. This review includes an initial morphologic evaluation to determine the appropriateness of the panel requested. For more information, please refer to flow cytometry in the test directory.
Lymphoma Consultation
Cleveland Clinic Laboratories offers comprehensive, expert consultative services for the evaluation of lymphoproliferative disorders. A full range of ancillary techniques (flow cytometric immunophenotyping, immunohistochemistry, and molecular diagnostics) is available. Several levels of service are offered:
- Flow Cytometric Immunophenotyping with Histopathologic Evaluation
Clients may send fresh tissue in tissue culture medium for flow cytometric immunophenotyping. When routinely processed tissue is available, histologic slides and paraffin blocks are forwarded for evaluation and diagnosis. Refer to flow cytometry and surgical pathology in the Test Directory for more information.
- Histopathologic Evaluation, Paraffin-Embedded Tissues
Specimens (slides and tissue blocks) may be sent for diagnostic consultation. Ancillary studies will be performed (immunohistochemistry, molecular diagnostics) if required. Refer to surgical pathology section in the Test Directory for more information.
- Flow cytometry only
Specimens may be sent fresh in tissue culture medium for flow cytometric immunophenotyping with interpretation by a staff hematopathologist.
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Immunopathology
Immunopathology comprises testing that focuses on the function of the immune system, both normal and pathological. Immune function can be assessed by measurement of immunoglobulin levels and subtyping analysis. Specialized testing is also available to evaluate cellular immune function. Testing for systemic autoimmunity (such as anti-nuclear antibody screening, and multiplex ENA analysis), and organ specific autoimmunity (such as celiac disease, Myasthenia Gravis, thyroid autoimmune diseases and diabetes antibody assays) is performed using various immunologic techniques such as direct immunoflourescence.
The immunopathology test menu also includes more than 100 allergens, as well as infectious disease serologies such as rubella, hepatitis, fungal and syphilis. Serum and urine protein electrophoresis is also performed in this area.
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Microbiology
Microbiology offers comprehensive testing for patients with infectious diseases. Our high quality, state-of-the-art diagnostic services including Microbiology Molecular Testing, combined with readily available consultation with pathologists and laboratory scientists have made us a national referral center for microbiology testing.
Our staff is committed to improving and advancing the diagnosis of infectious diseases. They are responsible for the development and evaluation of several innovative molecular tests for the rapid identification and characterization of infectious agents. The results of their studies have been published in leading medical journals, and these new tests, already in use at Cleveland Clinic, are becoming the standard of care in laboratories nationwide.
Test Request Form
Submit a completed Test Request Form for each culture requested. Information regarding the patient, the specific source of the specimen, collection time and date, clinical history, symptoms and diagnosis, antimicrobial therapy (or use of any other chemotherapeutic agents) and any suspected organism(s) is essential for the optimal and appropriate processing of the specimen. If an organism is sent for identification, the suspected organism or type must also be indicated. Clearly indicate the source and type of culture requested as well as the date and time the specimen was collected.
Results Reporting
Preliminary and final results for Microbiology are included on the patient report. Preliminary results will be called to the client on any positive, significant culture (e.g., blood, CSF, sterile body fluid and Salmonella or Shigella isolates) or stain. Other results will be called to the client if the client writes “Call Results” on the test request form and indicates a phone number to which results should be called. Results or interpretations of results may be obtained by contacting Client Services.
Specimen Handling
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Thrombosis and Hemostasis
Cleveland Clinic Laboratories offers comprehensive testing for the evaluation of patients with inherited and acquired bleeding disorders, platelet dysfunction, thromboembolic complications, hypercoagulable states and anticoagulant monitoring.
The Section’s faculty offers a diagnostic interpretive service whereby they evaluate specialized testing of hemostatic and thrombotic abnormalities using algorithmic approaches to determine proper testing based on initial results, medication history, prior laboratory testing and clinical findings.
In addition to our traditional reference laboratory services, we offer complete core laboratory services for large, multicenter hemostasis research studies and clinical trials. Our experience in this area includes site coordination, protocol development, sample kit design and preparation, assay performance, database entry and data analysis.
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Transfusion Medicine
The Transfusion Medicine Core Laboratory (TMCL) pursues one overriding objective: to provide adequate amounts of safe blood in a timely manner for hospital patients.
We supply the complete menu of blood component options 24 hours-a-day, seven days a week. Integrated into the activities of the transfusion service are the donor program, the human progenitor cell processing and storage laboratory, viral marker testing for organ transplantation, and the intraoperative autotransfusion program.
The section’s Perioperative Autotransfusion Service was the first in the country to be accredited by the American Association of Blood Banks (AABB). This service performs nearly 1,000 procedures each year, harvesting and transfusing the equivalent of about 2,500 units of Autologous Red Blood Cells. This service is actively researching better methods to manage preoperative anemia and complex intraoperative hemostasis problems.