HCLD Laboratory Director

Laboratory Management and Direction:

Our team is available to provide off-site Laboratory Management and Direction. The level of oversight and direction can be tailored to the specific needs of the clinic and can include but are not limited to the following services:

Assistance with CLIA, FDA, DOH, CAP, SART and CDC registration/licensure and reporting.
Assistance navigating New York State-Tissue Bank (NYSTB) and NYS-CLEP licensure application and maintenance of quality standards.
Assistance with Laboratory Developed Test (LDT) validation and licensure (New York State).
Writing and review of scientific protocols necessary for CAP and JCAHO certification.
Establishment and Monitoring of Quality Management Programs.
Preparation for and Participation in Accreditation Inspections
Establishment, Monitoring and Review of Key Performance Indicators (KPIs).
Establishment and Review of Laboratory Quality Control Systems.
Generation of Cryo Inventory Database and Auditing Processes.
Establishment of Personnel Training Systems and Competency Evaluation.
On-Site Supervision during IVF Cycles.
IVF Cycle Review and Sign Off.
Phone/email Consultation.
Hands on Assistance with Advanced Techniques such as Embryo Biopsy, Embryo Vitrification and Oocyte Vitrification for Fertility Preservation.