Proposal for Offsite Laboratory Director

Background
I am an HCLD-certified PhD with 20 years experience as an IVF Laboratory Director.  After completing my PhD in Reproductive Physiology from Auburn University and a postdoc in Biochemistry at Southwestern Medical School in Dallas, I received my IVF training in the mid-80’s at The University of California San Francisco where I was the Co-Director of the IVF program and also directed research for REI Fellows.  Since then I directed an IVF program in Las Vegas for 3 years, Seattle for 14 years and am currently an Associate Professor and Laboratory Director for the IVF program in the Dept. of Ob/Gyn at the University of Arkansas Medical School.

At the present I serve on the Scientific Advisory Board for Irvine Scientific and am a consultant for them.  I have traveled throughout the US, Canada, Mexico, Europe and the Middle East teaching embryologist how to vitrify human eggs and embryos using their vitrification products.

I am available to consult as an off-site director for IVF programs on a part time basis.  My fee is determined by the services the laboratory needs. 

Level 1 

This level requires the least involvement on my part with the contracted laboratory.  It is designed to apply to programs that have an onsite AAB-certified ELD, Laboratory Supervisor, or medical technologist, and just need HCLD oversight primarily to review paperwork.  This level particularly applies to the andrology and endocrine labs which are performing high complexity testing whose oversight is outside the range of an ELD.  This level provides the following services to the participating program:

  • Write any protocols in NACCLS format necessary for CAP/JCAHO certification. This will include, but not be limited to protocols for ICSI, cryopreservation, vitrification, PGD, laser hatching, oocyte imaging, semen preparation and analysis, and endocrinology procedures.
  • Review protocols for certification.
  • Assist the laboratory in establishing a Quality Management program.
  • Review the performance of the QM program.
  • Be present for CAP or JACHO inspections.
  • Follow up on CAP deficiencies.
  • Verify and perform Interim Self Inspections.

 
The fee for this service is $1200/month with a 1 year contract plus expenses for any time I need to be on-site (such as CAP inspections).

Level 2
This level requires more involvement on my part.  It is designed to apply to programs that have on site supervisors, but are also interested in having more contact with a PhD lab director.  This Level involves some onsite consultation.  All of the services associated with Level I would still apply.  In addition I would provide the following additional services:

  • Available by phone and/or email for consultations on a weekly basis,
  • Spend 2 days every quarter in the laboratory reviewing protocols, troubleshooting existing techniques, or training staff in new techniques.
  • Be present in the laboratory for the week prior to the CAP inspection to do paperwork and prepare the laboratory for inspection.

 
The fee for this service is $2500/month plus airfare, hotel, and meals while on-site with a 1 year contract.

Level 3
This level is for the program that is interested in expanding their arena of contact for proficiency testing, QC and/or research.  It includes all of the services of Level 1 and 2, plus:

  • Weekly review and signing off on andrology/endocrinology reports.
  • On-site approximately 2 days/month.
  • FDA paperwork preparation.
  • Emergency coverage in embryology laboratory.
  • Interlab proficiency testing.
  • Collaboration on prospective or retrospective research studies.
  • Editorial/writing services for research papers.
  • Some routine embryology coverage including ICSI and/or PGD services.

The annual fee for this service is $5000/month plus airfare, hotel, and meals while on-site with a 1 year contract.


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