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Department of Laboratory Medicine

The Department of 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 the laboratories. More specific information about activities of the individual sections is available by opening the categories below.

The Department of Clinical Pathology has been at the forefront of introducing new testing methods for clinical and research uses at Cleveland Clinic. In addition to providing an ever-expanding menu of tests available for clinical use, the Department of Clinical Pathology provides the facilities and expertise to support translational research projects. Productive collaborative multidisciplinary research working groups are functioning with clinical departments and the Lerner Research Institute at Cleveland Clinic. The success of research and development efforts in the department is also evidenced by success in attracting extramural funding for such efforts. Individual research efforts in pathology at Cleveland Clinic are profiled in the semiannual publication, Pathology Research: Clinical and Translational.

Educational activities are a key component of the departmental mission. The residency training program in Clinical Pathology provides exposure to a wide array of methodologies and interpretive issues that span the discipline, augmented by didactic sessions. Members of the department are active on Cleveland Clinic Lerner College of Medicine committees. The department supports postgraduate fellowships in Transfusion Medicine, Hematopathology, Clinical Microbiology and Clinical Biochemistry.

Clinical Biochemistry
Clinical Biochemistry

The Section of Clinical Biochemistry provides a broad array of routine and specialized clinical laboratory testing services on blood, urine, and other body fluids for patients throughout Cleveland Clinic. 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 analyses.

The Section operates a satellite facility on the CCF campus that provides rapid blood, gas and acute care testing for operating rooms and intensive care units. The Section is also responsible for oversight of the entire point of care testing program throughout Cleveland Clinic.

The Section employs state of the art instrumentation that includes pre-analytical laboratory automation, automated specimen storage and retrieval, automated chemistry workstations, HPLC,GC/MS, LC/MS, and atomic absorption spectrometry. The Section is working on a state-of-the-art technology (TLX2-MS/MS) for high specialty testing.

In addition to serving as clinical and technical consultants in their areas of expertise, the faculty of the Section contribute to research achievements of allied clinical departments in areas of primary interest, among them endocrinology testing, nephrology, and cardiovascular medicine. Section faculty has been an instrumental participant in the ongoing discovery in cardiovascular and chronic kidney diseases at  Cleveland Clinic.

Hematopathology
Hematopathology

The Section of 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.

The Flow Cytometry laboratory provides a full range of services for the assessment of leukemias and lymphomas, immunodeficiency states, transplantation immunosuppression status, DNA ploidy, and paroxysmal nocturnal hemoglobinuria. Molecular hematopathology analyses routinely performed include polymerase chain reaction amplification for immune receptor gene rearrangements and fluorescent in situ hybridization for genetic translocations.

The Section of Hematopathology participates in interdisciplinary patient management conferences in Hematology/Oncology and supports educational efforts in this and other departments at Cleveland Clinic. Staff members also hold appointments in Cleveland Clinic Lerner College of Medicine. The section offers two 1-year ACGME-approved fellowships in Hematopathology.

Members of the section carry out various research projects in hematopathology, with primary areas of interest that include extranodal lymphomas, lymphoid leukemias, and bone marrow transplantation. In addition to individual projects, section faculty collaborate extensively with investigators elsewhere in the institution as well in multicenter trials.

Transfusion Medicine
Transfusion Medicine

The Transfusion Medicine Core Laboratory (TMCL) of the Department of Clinical Pathology pursues one overriding objective: to provide adequate amounts of safe blood in a timely manner for our hospital patients.

We supply the complete menu of blood component options 24 hours a day, 7 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 TMCL works closely with the Division of Nursing and the Medical Staff to support the transfusion service according to the needs of our patients and the preferences of their attending staff.

The transfusion service at Cleveland Clinic is one of the largest in the world, dispensing over 143,000 units of blood and blood components. We type 65,000 samples per year and screen those samples for red cell antibodies. There are more than 90,000 crossmatches performed. Major vascular surgery, high-risk obstetrics, trauma, and transplantation are supported without restriction every hour of every day, 365 days a year.

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 1000 procedures each year, harvesting and transfusing the equivalent of about 2,500 units of Autologous Red Blood Cells. Under the direction of Dr. Jonathan Waters, this service is actively researching better methods to manage preoperative anemia and complex intraoperative hemostasis problems.

The Human Progenitor Cell Laboratory manages the isolation, preparation, and storage of peripheral blood and bone marrow stem cells for the Transplant Program. More than 700 collections are processed each year under the expert direction of Dr. Karl Theil.

In partnership with the American Red Cross Blood Services, Northern Ohio Region and University Hospitals of Cleveland, the Section offers a fellowship in blood banking and transfusion medicine.

Hemostasis & Thrombosis
Hemostasis & Thrombosis

The Section of Hemostasis and Thrombosis provides testing for the diagnosis and characterization of coagulation system disorders that lead to bleeding or thrombosis. In addition to high-volume, automated coagulation tests, the Section’s laboratories maintain a comprehensive test menu for specialized testing of common and esoteric coagulation disorders, encompassing coagulation protein abnormalities, fibrinolytic disorders and platelet function defects.

The Section is an integral part of the clinical care of medical and surgical patients throughout the Cleveland Clinic Foundation. The Section’s faculty offer 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. State of the art molecular testing is employed for the Factor V Leiden, Prothrombin G20210A and methylene tetrahydrofolate reductase C677T mutations. The laboratories also provide full panels of platelet aggregation testing and platelet flow cytometry that are employed in appropriate settings to characterize platelet-related disorders. These approaches provide diagnostic interpretive reports and recommendations to ordering physicians.

The Section faculty has received numerous intramural and extramural grant awards for investigations into the study of antithrombotic drugs, the molecular genetics of cardiovascular diseases, and mechanisms of thrombotic and bleeding disorders. Major active projects include the Gene Bank study, a repository of 10,000 DNA, serum and plasma samples on patients with cardiovascular disease, which has been used for the GASH study, aimed to identify new genetic haplotypes associated with stable vs. unstable coronary artery disease. Another research effort is the clinical, biological and genetic study of aspirin and clopidogrel resistance.

The Section participates provide training in coagulation for the Hematopathology Fellowship and Transfusion Medicine Fellowship offered by the Department of Clinical Pathology. In addition, faculty in the Section offer a daily hemostasis teaching rounds for Clinical Pathology residents, Hematology Fellows and Vascular Medicine Fellows.

Clinical Microbiology

Cleveland Clinic's Microbiology Department offers comprehensive testing for patients with infectious diseases. Our high quality, state-of-the-art diagnostic services, combined with readily available consultation with MD pathologists and PhD 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 have been 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 The Cleveland Clinic Foundation, are becoming the standard of care in laboratories nationwide.

Infectious disease may be acute or chronic and may be caused by a variety of microorganisms, including a number of medically important bacteria, viruses, fungi, and parasites. Our staff of experienced clinical microbiologists are trained in the most effective, advanced diagnostic methods for the detection and testing of microbial pathogens. We offer expert assistance in test selection and test result interpretation, as well as additional testing, when necessary.

Molecular Pathology

The Molecular Pathology facilities provide a resource for the entire Tomsich Pathology Laboratories. Molecular Microbiology, Molecular Genetic Pathology, Molecular Oncologic Pathology and Molecular/Dermatopathology laboratories are located within this department.

Clinical activities in the Department of Molecular Pathology include the molecular diagnosis of inherited genetic abnormalities, hematologic and solid tumor malignancies, clinical pharmacogenomics, monitoring of engraftment in patients who have undergone bone marrow transplants, and the diagnosis and monitoring of a variety of viral, fungal, and bacterial infectious agents including therapy-related genotyping.

More than 75,000 diagnostic molecular assays are performed annually. The laboratories play a major role in national molecular pathology quality assurance programs in collaboration with the College of American Pathologists.

The Molecular Pathology laboratories also function as core facilities for translational molecular research programs and the extraction and storage of DNA and RNA for multiple investigators throughout Cleveland Clinic. For example, DNA is being extracted and stored from ~10,000 samples for Molecular Cardiology Research Programs. Multiple active clinical research programs span a variety of molecular pathology disciplines.

The Molecular Pathology laboratories employ clinical medical technologists, research technologists, molecular pathology research fellows, and Project Staff Faculty. The major techniques in use are gel-based and real time polymerase chain reaction (PCR), hybrid capture, reverse blot hybridization, chemiluminescent Southern Blot analysis, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), gold enhanced autometallographic in situ hybridization (GOLDFISH), peptide nucleic acid (PNA) FISH, and array-based comparative genomic hybridization (A-CGH).

Our laboratories utilize state-of-the-art technology, including real time PCR LightCycler®, a SmartCycler®, a Rotor-Gene™, an EasyQ®, and automated nucleic acid extractors, ABI/CE 310 and 3100 Genetic Sequencing Analyzers, a Pyrosequencer®, Benchmark® and Discovery™ automated ISH stainers, interphase FISH scanning and imaging systems, laser capture microdissection and tissue microarray workstations, Arial bright field image analysis, and gene expression and BAC array-based comparative genomic hybridization workstations.