Repromedix - Helping Doctors Help Couples
For Clinicians
laboratory operations

Repromedix's recently expanded lab facilities are staffed with highly skilled technicians who routinely perform esoteric and complex clinical tests. Our Research and Development team keeps us in the forefront of reproductive laboratory testing by maintaining a working relationship with many of the leading clinicians and researchers worldwide. And our Client Services function is staffed by experienced people dedicated to your satisfaction.

operations staff

Donna Drinkwater: Laboratory Manager
BS University of Massachusetts-Amherst
Focus: Supervision of laboratory technicians, quality assurance, quality control, regulatory compliance.

Laboratory Technicians
Close to 90% have BS degrees in Life Sciences or Chemistry; others are ASCP certified. Upon joining Operations, our technicians undergo a well-documented and carefully planned training program led by a senior technician. Training on new test services is similarly carefully planned and documented. Such thorough one-on-one training helps ensure minimal errors, the highest quality consistent results, and reliable throughput.

R&D staff

R&D is responsible for maintaining state-of-the-art knowledge of clinical and academic research in all aspects of reproductive medicine and high-risk pregnancy. R&D conducts technical testing and validation of all new tests offered by Repromedix as well as clinical studies to validate test methodologies and results and to establish or confirm normal ranges and cut-off values.

Benjamin Rivnay: VP of R&D; Laboratory Director
PhD Weizmann Institute of Science, Israel
Research experience: Senior Scientist and Associate Professor Weizmann Institute; Fogarty Fellow National Institute of Health; Senior Scientist Neurex Corporation and Procept, Inc.; over 50 published papers and abstracts.
Focus: All reproductive scientific disciplines; clinical studies; lab operations management; quality assurance.

Jie Zhao: Research Investigator
PhD University of Montreal; MD Shanghai Second Medical University
Research experience: Harvard Medical School and Howard Hughes Institute at Brandeis University. Twenty years of research experience in cellular/molecular biology, genetics, endocrinology and physiology.
Focus: Andrology, Genetics

David Brown: Research Investigator (R&D)
PhD in Biomedical Science, University of Texas, Health Science Center
Research experience: 20+ years of research in cell cycle biology and sperm biology at Yale, University of Texas Medical Branch. Holds appointment as a special member of the graduate faculty at the University of Texas Graduate School of Biomedical Sciences at Galveston.
Focus: Advanced sperm diagnostics and clinical studies

quality control

Repromedix operates four levels of Quality Control:

Pre-testing (sample receipt)
This process begins when our laboratory technicians receive the patient's samples from our clients. The quality of the specimen is carefully inspected to ensure sample integrity and proper preparation and shipment. Physician and patient demographics are also examined for proper documentation.

Test Level
QC results for each test run are monitored by a supervisor who enters each run's QC results directly on that test's data reduction reporting file, where they are then compared to pre-established QC specifications. Among the QC control elements are expiration dates of reagents, the value of control specimens relative to recommended/established ranges, slopes and linearity of calibration curves, max OD in a calibration curve, levels of background, similarity of replicates (where relevant), and others. Lab management evaluates any failed QC elements. Test runs may be approved with deviation noted, failed and entire test repeated, or specific specimens may be failed individually.

Post-testing (reporting review)
Once the run QC is approved, all data is entered into the Lab Reporting System. The accuracy, completeness, and final contents of each report are manually reviewed before the report is signed and transmitted to the client.

Compliance Quality Assurance
The QC and Operation Managers oversee and document:

  • Proficiency testing for all technicians
  • Updating test protocols
  • Equipment maintenance
  • Timeliness of reporting
  • regulatory oversight

    Repromedix is licensed by CLIA (The Commonwealth of Massachusetts) and the State of New York.

    As part of the compliance, Repromedix participates in the following proficiency testing programs:

  • CAP (College of American Pathology)
  • AAB (American Association of Bioanalysts)
  • NY State PT program
  • Copies of all current certifications are available upon request

    client service

    Repromedix has a full time, dedicated Client Services department that serves as the primary point of contact for all inquiries or requests related to any aspect of laboratory operations including: QC, reporting, billing, shipping, and technical questions. All calls from clients or patients are logged and either handled by the department or directed to the appropriate person/function in the company for attention/action.

    We also provide clients with immediate access to technical and clinical support, often directly from the people who themselves either developed a test or incorporated the test into Repromedix. We can provide access through our network of research-oriented physicians nationwide to an MD who can discuss and share his or her experience and clinical knowledge on any specific test.

     

    operations staff

    R&D staff

    quality control

    regulatory oversight

    client services