Phlebotomy Blood Drawing Expert Witness

I am well versed in the standard of care for phlebotomy performed in various settings, including hospitals, doctor’s offices, patient service centers, and clinical laboratories (outlined in CLSI GP41, the most widely recognized and adopted criteria for acceptable practices in phlebotomy). As a medical expert, I have evaluated and provided my opinion on eighteen phlebotomy-related injury cases involving nerve damage, arterial puncture, and syncope. I have over twenty-five years of experience, including managing the phlebotomy departments at Memorial Sloan Kettering Cancer Center and St. Vincent’s Comprehensive Cancer Center in New York, NY. In these positions, I was responsible for training, supervising, counseling, and assessing the work of approximately 80 phlebotomists. I have written/developed numerous phlebotomy-related policies and procedures, training and educational materials, quality monitors, and competency assessment tools. As a faculty member, I taught theoretical concepts and practical skills in phlebotomy to undergraduate students in medical laboratory science programs. Altogether, I have drawn blood from over 30,000 individuals.

EDUCATION

PhD in Health Sciences, Clinical Laboratory Science with Specialization in Hematology
Rutgers University School of Health Professions, Newark, NJ. 2022
Dissertation: The use of digital morphology for residual disease screening in patients with chronic lymphocytic leukemia.

MS in Health Sciences, Clinical Laboratory Science
Rutgers University School of Health Professions, Newark, NJ. 2009

BS in Medical Technology
Louisiana State University, New Orleans, LA. 1984

WORK EXPERIENCE

Medical and Scientific Affairs Adviser, Cellavision, Lund, Sweden, May 2018 – current

• Advise on a range of topics in clinical and laboratory medicine
• Develop digital morphology technology for the hematology laboratory
• Bone marrow aspirate analysis
• Advanced platelet application
• Advanced red blood cell morphology application
• Reactive vs abnormal lymphocytes
• White blood cell attributes
• Body fluid analysis

• Create hematology case studies
• Provide staff with continuing education
• Lecture at scientific conferences

Global Manager Scientific Affairs, Abbott Hematology, Santa Clara, CA. April 2016 – November 2017
Helped develop next-generation hematology analyzer

• Automated differential algorithms and instrument flags
• Constructed case studies
• Wrote protocols for instrument comparison studies; wrote white papers to summarize results
• Worked with customers to resolve issues with on-market analyzers
• Provided biweekly lectures to staff

Manager: Clinical Hematology Laboratories & Out-Patient Phlebotomy, Memorial Sloan-Kettering Cancer Center, New York, NY. 2010 – April 2016

• Oversaw staff of 65 clinical laboratory scientists and phlebotomists; and administrative/technical functions of:
• Core lab
• Stat lab
• Pediatric lab
• Out-patient lab
• Bone marrow lab
• Breast center lab
• Lymphoma/myeloma center lab

• Developed and implemented capital and operational budgets; reviewed monthly operational variance reports, addressed discrepancies
• Recruited, interviewed, selected technologist and phlebotomist candidates; mentored staff; assessed competency; conducted annual performance appraisals
• Ensured compliance with New York State and Joint Commission standards, participated in periodic internal and external surveys
• Appraised new technology/methods, assessed results of validation data, created policies and procedures as per CLSI guidelines
• Oversaw quality assurance team; created and assessed quality monitors; reported up to the general laboratory and hospital quality improvement committees
• Evaluated calibration, linearity, correlation, peer comparison and quality control data; interpreted various statistical findings and advised staff on how to remediate unacceptable results
• Oversaw internal and external proficiency testing programs, appraised results and provided guidance for corrective action
• Participated in the evaluation and selection of a new laboratory information system, developed policies and procedures, created workflows, trained staff
• Performed and assessed validation studies on the Sysmex XN platform, including Cellavision digital imaging technology, wrote policies and procedures, trained staff, which led to successful implementation
• Designed and developed a new lymphoma center laboratory
• Provided continuing education lectures for the Department of Laboratory Medicine
• Course leader and instructor in the benign and malignant hematology morphology course in the hematology/oncology fellowship program at New York-Presbyterian Hospital/Weill Cornell Medical Center
• Taught various topics in hematology to fellows in the hematology/oncology fellowship program at Memorial Sloan Kettering Cancer Center
• Oversaw clinical laboratory science education program for students in clinical rotation from Rutgers University and Methodist Hospital
• Provided sessions on peripheral blood and bone marrow aspirate review at the microscope for hematopathology fellows and residents at Memorial Sloan Kettering Cancer Center
• Provided continuing education lectures for the Department of Laboratory Medicine at Hospital for Special Surgery, NYC
• Created a comprehensive competency assessment program for phlebotomists, clinical laboratory scientists, and supervisors consistent with New York State (NYS) Department of Health and Joint Commission standards
• Conducted extensive review of the literature and formulated hematology reference intervals for pediatric patients
• Conducted clinical research studies: (1) accuracy of automated platelet counting methods in patients with thrombocytopenia, (2) accuracy of automated hematocrit determination in product of apheresis stem cell collections, (2) peripheral blood CD34 counts on the Abbott Sapphire hematology analyzer
• Taught all didactic hematology coursework to Marist College MLS students at the Memorial Sloan Kettering Clinical Laboratory Science Scholars Program (see teaching experience)

Laboratory Manager, St. Vincent’s Comprehensive Cancer Center, New York, NY. 2003-2010
Managed administrative and technical functions of the clinical laboratory: hematology, chemistry, immunochemistry, coagulation, urinalysis, point of care, phlebotomy

• Ensured regulatory compliance as per NYS & College of American Pathologists (CAP) standards.
• Hired, trained, and maintained competency of 6 clinical laboratory scientists, 1 cytotechnologist, 3 phlebotomists
• Developed/monitored comprehensive quality assurance & quality improvement program
• Validated and implemented several new instruments/methods (see below)
• Represented laboratory on various groups: clinical practice committee, performance improvement team, hospital laboratory managers, cancer center managers
• Created/maintained hundreds of policies and procedures for the clinical lab and phlebotomy
• Managed laboratory information system: test dictionary, billing system, user/class maintenance, test requisition and reporting processes, and more
• Prepared and administered capital and operational budget

• Member of the hospital CAP inspection team
• Expanded laboratory services to meet the needs of large multiple myeloma program
  • Validated and implemented new tests:
    • Protein electrophoresis/immunofixation
      • Interpreted and reported complex myeloma patterns daily
    • Free kappa/lambda light chains
      • First lab in the U.S. to develop testing on the SPA Plus system (See poster presentation)
    • Urine protein
      • Researched the best method to measure myeloma proteins
        • One of the first labs in the U.S to implement the pyrogallol red method as a user-defined assay on Ortho Vitros Fusion 5,1 (See poster presentation)
    • C-Reactive protein
      • Developed creative use of Ortho Vitros high sensitivity CRP by extending linear range to measure CRP in myeloma patients
    • Quantitative serum immunoglobulins
    • Beta-2 microglobulin
    • Achieved <24 turnaround time for results on the above tests
• One of the first labs in the U.S. to utilize the Helena PlateletWorks arachidonic acid method for monitoring patients on low-dose aspirin therapy
• Carried out preliminary studies which showed the importance of performing immunoplatelet counts (CD61) in patients with circulating microcytes/schistocytes and large/giant platelets. Created protocol for determining when and how to perform CD61; set up a mechanism for obtaining physician order and subsequent billing

Hematology Manager, Beth Israel Medical Center, New York, NY. 2002-2003
Managed administrative and technical functions of a high-volume automated laboratory; served 5 hospitals and hundreds of outreach clients

• 5 supervisors and 25 technologists
• Upgraded physician office laboratory to hospital lab status as per NYS standards
• Wrote SOPs in hematology, chemistry, specimen collection/processing
• Developed test requisitioning and reporting system

Project Manager, SynerMed Communications, Califon, NJ. 2000-2002
Developed continuing medical education programs for physicians, focused on neurology, psychiatry, and gastroenterology

• Collaborated with prominent physician/scientist thought leaders and created:
• Journal articles and supplements
• Newsletters, monographs
• CD ROMS
• Scientific posters
• Slide lecture kits
• Taught in-service classes on interpretation of study data

Laboratory Manager, St. Vincent’s Comprehensive Cancer Center, New York, NY. 1997-2002

• Designed, developed, and managed three new clinical oncology laboratories in New York City as per NYS & CAP standards
• Subsections: phlebotomy, hematology, chemistry, immunochemistry, coagulation, urinalysis
• Developed appropriate tests/methodologies to best fit the needs of each center, negotiated with vendors, set up reagent/instrument service contracts
• Recruited, hired, trained staff
• Set up laboratory information system including test dictionary, interim/cumulative reports, requisitions, interfaces, printers
• Set up reference lab contracts, a system for sending out testing and reporting procedures

Senior Laboratory Technologist, New York University Medical Center, New York, NY. 1991-1997
Performed automated and manual procedures in the hematology/coagulation laboratory

• Presented in-service talks on HIV/AIDS

Medical Technologist, Woman’s Hospital, Baton Rouge, LA. 1984-1991
Collected blood samples on inpatients and outpatients

• Performed various automated and manual procedures in the clinical laboratory: Hematology, Coagulation, Urinalysis, Clinical Chemistry, Immunology, Blood Bank, Microbiology

TEACHING EXPERIENCE

Assistant Adjunct Professor, Advanced Hematology & Hemostasis, Rutgers University School of Health Professions, Newark, NJ. 2009 – Present

• Teach hematology and hemostasis modules to graduate students

Adjunct Instructor, Clinical and Laboratory Hematology, Marist College, New York, NY. 2015 – 2016

• Taught benign/malignant class hematology classes at the Memorial Sloan Kettering Clinical Laboratory Science Scholars Program

Adjunct Lecturer, Hunter College, School of Health Sciences, Medical Laboratory Sciences Program, New York, N.Y. 2009 – 2013
Taught undergraduate hematology laboratory course

• Taught phlebotomy theory and practice

Instructor of Medicine, New York Medical College, Department of Medicine, Valhalla, NY. 2008 – 2010
Taught diagnostic hematology classes to fellows and residents at St. Vincent’s Fellowship Program in Hematology/Oncology

Clinical Instructor, St. Vincent’s School of Medical Technology, NY, NY. 2002 – 2010
Taught recurring 9-month comprehensive hematology and coagulation series to senior students in the Medical Laboratory Technology program

Instructor, New York Blood Center, Consortium Training Program, New York, NY. 1993 – 1998
Developed and taught comprehensive didactic hematology/hemostasis course to students preparing to work in clinical laboratories in New York City

Lecturer, Beth Israel Hospital, New York, NY. 1995

Taught cross-training course in hematology for technologists working in clinical chemistry

Guest Lecturer, New York Blood Center, New York, NY. 1997
Presented mini-lecture series on anemia and malignant/non-malignant WBC disorders

CERTIFICATIONS AND LICENSES

• Clinical Laboratory Technologist license from New York State Department of Education
• Medical Technologist, American Society for Clinical Pathology, MT(ASCP)

HONORS/AWARDS

Academic Excellence Award – 2009 (GPA 4.0), MS in Health Sciences, University of Medicine and Dentistry of New Jersey, School of Health Related Professions, Newark, NJ

Graduate Student Poster Award, Research Category – 2009, University of Medicine and Dentistry of New Jersey, School of Health Related Professions, Newark, NJ

ASCP Regional Member Award for the Northeast Region, 2009; Presented at the ASCP Leadership Exchange, Philadelphia, PA.

Featured (cover story) in News-Line for Laboratory Professionals: “Improving Tests, Improving Lives,” June/July, 2008

Featured in Learn & Lead: “Advance Your Career at SHRP” University of Medicine and Dentistry periodical, 2011

RELATED ACTIVITIES:

Serve as expert witness in cases involving phlebotomy induced nerve damage, 2010-current

PROFESSIONAL AFFILIATIONS

• American Society for Clinical Pathology
• American Association for Clinical Chemistry
• International Society for Laboratory Hematology
• American Society of Hematology
• American Society for Clinical Laboratory Science

PUBLICATIONS & EDITORIAL ACTIVITIES: Available upon request.