Hematopathology Associates, LLC.

Transcription

1 Hematopathology Associates, LLC. Tests for Diagnosis of Specific Diseasees Acute Leukemia Panel This panel is designed to identify the presence of leukemic blasts. A specific panel of leucocyte markers is used to detect lineage-specific antigens. Lymphoproliferative Panel The Lymphoproliferative panel is designed to differentiate between Lymphadenopathy, Lymphoma, and Chronic Lymphoid Leukemia. Clonal Excess Panel This test is used in monitoring patients with know B -cell malignancies. It detects low numbers of lymphoma/leukemia B -cells. Acquired Cellular Immune Disorder Evaluation (e.g., AIDS, transplants, opportunistic viral infections) This profile quantitates total B -cells, T-cells, T-cells subsets (CD4/CD8), NK s cells, and activat ed T-cells T-cell Helper/Suppressor Evaluation (HIV Monitoring) T-cell Helper/Suppressor (CD4/CD8) counts are useful in monitoring the immune status of known HIV positive patients. This panel reports the absolute count of CD4 and the CD4/CD8 ratio. Hematopathologist: Ricardo E. Duque M.D. Cooley G. Pantazis M.D. Flow Cytometry Technical staff. Jose A.Iturraspe BS. MT

2 Hematopathology, LLC. Flow Cytometry Laboratory for the diagnosis of Lymphoproliferative and Acute Leukemia diseases. We operate 24/7 seven days a week. Verbal reports will generally be given within 24 hours from the time of sample receipt. A hardcopy of all final reports are mailed within 3 business days. The Diagnostic Immunology and Flow Cytometry Laboratory offers state-of-the-art local and outreach laboratory services for clinicians and investigators involved in the diagnosis, monitoring and evaluation of hematological diseases. Specialized testing includes diagnostic screening for immune deficiency disease, leukemia/lymphoma and immunophenotyping lymphocyte subsets, cytogenetics and molecular FISH. All cytogenetic and molecular FISH studies performed by board certified cytogeneticists.. LABORATO RY HIGHLIGHTS During fiscal year 2006, the laboratory accomplished the following: Completed the development and/or validation of each of the following flow cytometry procedures: Improved the routine lymphocyte subset analysis methodology from a 3 color assay to 4 color,. Developed CD34 stem cell quantitation. Developed the dendritic cell receptor repertoire assessment assay. Developed leukemia immunophenotyping with improvement to 4 color panels. Developed and validated im m unophenot ype databas e f or patient archiving. Developed online patient-data retrival system for immediate access to patient test values using an ultra secure-server. This allows for faster testing reduced required technical time. Clinically oriented research resulted in several meeting abstracts, case reports and two publications in peer-reviewed journals. For any additional information please feel free to contact me at Or visit our web site Looking forward in helping you in any way. Thank you José A. Iturraspe, CEO

3 COMPANY OVERVIEW One of the most difficult and long-term challenges a reference laboratory faces is to win the confidence of its physicians and practitioners. Companies that devote considerable energies to building new interactions and relationships with clinicians, clinician- scientists, and scientists throughout the US can outperform many national and local labs in regards to turn around time, dedication and confidence. Hemacon Laboratoies LLC, Inc. was founded in 2005 with the aim to provide local, efficient, economical, high quality, state-of-the-art flow cytometric, cytogenetic, and molecular diagnostic services to physicians and their patients. Hemacon was founded by physicians, is run by physicians, and serves physicians. Hemacon is a privately owned and operated laboratory. MISSION: To aid clinical professionals by providing high quality cell identification, cytogenetic and molecular testing for diagnostic, prognostic and predictive patient treatments. Our major thrust is to be part of the clinician s team by developing a personal relationship and interaction with our faculty which will aid them in providing optimal care for their patients. We can do this by timely communication of abnormal results as soon as they are identified coupled with expert analysis, interpretation and in some cases advice and counseling.

4 Cancer Cytogenetics Laboratory The Cancer Genetics Laboratory offers classical cytogenetic, and molecular cytogenetics testing for the diagnosis of diseases and hematological disorders. The Cytogenetic Laboratory performs the preparation of chromosomes from patient material and the study of chromosome morphology. Chromosome abnormalities are detected in many leukemias and pre-leukemias. In addition to the morphologic evaluation of chromosomes, the lab also performs the molecular cytogenetic technique of fluorescence in situ hybridization (FISH). FISH analysis allows for the identification of specific chromosome abnormalities, which are beyond the resolution of a standard morphologic evaluation. The two tests are complementary and often both evaluations must be performed to completely assess the chromosome architecture. Harold Chen, MD FACMG Laboratory Director, Genetics Laboratories; Head, Clinical Genetics; Professor of Pediatrics, Chief, Birth Defects Center, School of Medicine in Shreveport, LA K. L. Satya-Prakash, Ph.D Cytogenetics Laboratory; Supervisor Larry Vroegendewey Chief Cytogenetics Technician, LABORATORY HIGHLIGHTS During fiscal year 2006, Hemacon recruited many key personnel. As the service expands, the following areas with the following people will be the focus: Harold Chen, MD, shares his almost 40 years of clinical genetics practice by providing in depth consultation on genetic cases. He is the author of a comprehensive pictorial atlas of 203 genetic disorders, malformations, and malformation syndromes. The Atlas of Genetic Diagnosis and Counseling is considered by most cytogenetists to be the gold standard in clinical cytogenetic malformations. genetic diseases and malformation syndromes. K.L. Satya-Prakash, Ph.D has over 20 years experience in Hematology oncology cytogenetics in the area of leukemias.and lymphomas. Having served as assistant geneticist at MD Anderson hospital, and director of Cytogenetics at the Medical College of Georgia. Dr Prakash has developed novel techniques of bone marrow and solid tumor culture thus further assuring the most optimal testing condtions. HEMACON LABORATORIES 106 SW 10 TH Street, Suite C Gainesville, Florida

5 Morphologic Hematology Laboratory The Special Hematology Laboratory provides expert morphological evaluation and classification of bone marrow, blood and lymph node tissues using routine H&E, Giemsa, Wright s and special stains. Our faculty consists of hematopathologists boarded by the American Board of Pathology. Our doctors are available 7 days a week for assessment of tissue samples and test data. Ricardo E. Duque. MD Hematopathologist Cooley G. Pantazis, MD Hematopathologist, LABORATORY HIGHLIGHTS During fiscal year 2006, the laboratory accomplished the following: Obtained full certification for molecular FISH studies by CAP. Implemented both whole cell and chromosome FISH for more specific diagnoses of hematological diseases. Completed and passed CAP surveys pertaining to molecular FISH. Developed a four day turn around time for molecular FISH testing. HEMACON LABORATORIES 106 SW 10 TH Street, Suite C Gainesville, Florida

6 Quality Assurance and Performance Improvement Each Laboratory s quality management program includes the quality control, quality assurance, quality improvement and regulatory/accreditation activities. They participate in CAP check sample programs and serve as inspectors for the CAP.. Each laboratory director is responsible for planning and execution of quality management in his or her laboratory section.: By running quarterly CAP check samples, daily controls and other proficiency tests. By holding quarterly quality improvement meetings with all faculty and staff. By attending national and international meetings. By being involved in cytometry and cytogenetic networks. The Laboratory provides expert advice, suggests follow-up actions and assures accountability for activities.. Quality management reports directly to the director, and summaries of its activities are documented monthly. Cooley Pantazis, MD Director, Quality Assurance and Performance Improvement FISCAL YEAR 2006 HIGHLIGHTS Accreditation. The department underwent its biannual College of American Pathologists (CAP) inspection for accreditation in April 2006 CAP inspectors noted only two deficiencies; both were corrected the same day. Standarization of laboratories. Each laboratory is now synchronized and fully functional. By laboratorylaboratory communication the best possible analysis per sample is optimized. Patient satisfaction. The flow cytometry laboratory. under Hematopathology Associates, has enjoyed a high level of patient satisfaction by continued 5 year support from 6 major hospitals and clinics. The goal now is to bring that same level of satisfaction to the newly acquired cytogenetic and molecular laboratory organized under Hemacon Laboratories. Quality improvement. Quality activities brought about many incremental improvements in 2005.

7 Hematopathology Associates, LLC. FLOW Specimen Collection, Peripheral Blood 3-5 ml collected in EDTA. Heparin is acceptable, EDTA is preferred. Ship with a refrigerated gel pack within 24 hours of collection. Include a freshly made smear and, if possibl e, WBC and differential count. Bone Marrow Collect 3-5 ml of marrow and place in an EDTA vacutainer tube. Heparin is acceptable, EDTA is preferred. Ship with a refrigerated gel pack within 24 hours of collection Include a freshly made smear and, if p ossible, WBC and differential count. Bone Marrow or Tissue Core Biopsy Collect FRESH (unfixed) biopsy and place in culture media or saline. Ship sample in an insulated container on wet ice or refrigerated gel packs within 24 hours of collection. Fluids Needle aspirates should be collected in culture medium or saline. Ship sample in an insulated container on wet ice or refrigerated gel packs within 24 hours of collection. Include a freshly made smear. Tissues Submit an unfixed representative fr agment (0.3 cm 3 or larger) in a15 ml conical centrifuge tube, cover the tissue fragment with RPMI. Verify that the cap is securely tightened and cover with parafilm. Ship sample in an insulated container on wet ice or refrigerated gel packs within 24 hours of collection. 3. Include frozen section, if available. 4. Whenever possible, please submit a representative portion of the biopsy, fixed in formalin. Cytogenetics/FISH Specimen Collection, Peripheral Blood 3-5 ml collected in sodium Heparin is acceptable. DO NOT use lithium heparin it is toxic to cells. Ship with a refrigerated gel pack within 24 hours of collection. Include a freshly made smear and, if possible, WBC and differential count. Bone Marrow Collect 3-5 ml of marrow and place in sodium Heparin. DO NOT use lithium heparin it is toxic to cells. Ship with a refrigerated gel pack within 24 hours of collection 3. Include a freshly made smear and, if possible, WBC and differential count. Handling and Transport Specimen Transport Place the biohazard bag inside a suitable shipping box. Multiple samples may be placed in the same box. FED EX Account # Call FedEx at GOFEDEX ( ) or DHL at to schedule a pick up. 3. All specimens must be placed in a biohazard bag, include all paperwork in the outer sleeve of the biohazard bag. Verify that all caps and lids are securely tightened. 4. Enclose a refrigerated gel pack in the shipping box with the specimen(s). Place a paper towel or something similar between the gel pack and the specimens so the gel pack does not come into direct contact with the specimens. 5. The box should then be placed in a FedEx or DHL specimen transport envelope. If Saturday is needed place a SATURDAY DELIVERY sticker on the envelope and check the Sat Delivery box on the air bill.

8 Hematopathology Associates, LLC. CLIENT BILLING The client fee schedule may be discounted based upon the client s total test volume including genetic testing performed at Hematopathology Associates LLC. Clients will be billed on a monthly basis by a n itemized invoice, terms are payable upon receipt. If you have any questions, please notify the client billing department at Any adjustments will be shown on the following month s statement. INSURANCE AND THIRD PARTY ADMINISTRATION Hematopathology Associates LLC. can bill the patient s insurance company or third party administrator directly. Please ensure the patient s insurance information and all applicable diagnostic codes in the ICD -9 format are provided. PATIENT BILLING Hematopathology Associates LLC. can bill the patient directly. Please complete the test requisition form including the responsible party s name, address and telephone number.