How to Establish a successful IVF Center

How to Define success!

Maintain performance

Growflow

Expand

IVF Center

IVF

Laboratory

Viable

embryos

Clinical team Ob/Gyn

- Ovulation induction

- Monitoring- Ovum pick-upClinical team

Ob/Gyn

How to Establish!

• KnowHowAvailable or not

• Budget (small vs large)

• Team(one man show vs group)

• District : central vs periphary

• Target : Upper class vs middle class

• Aim : finance / prestigue / adjuvant service

Site selection

Inside a hospital: UNIT- To benefit from the infrastructure of :

• Electric generator• Laundry facilities• Sterilization facilities

Specialised Center• Independent• Focused• Fame : rapid and easy• Much more risk taking• High running costs

Design - Enough space to allow equipment

installation and free movement of personnel

- Enough space to allow for expansion- allow enough time after construction

before installing equipments and use.

So How to make ur decision?

• Usually circumstances drive ur decision

• But none of the previous factors will make it succeeds : they will help u for the setup

• For success: it is all about Personnel

Establishing An IVF Center

1- Training of personnel.

2- Equipment selection.

Training of personnel

I. Training the IVF laboratory practitioners• Minimum of one year (hands on) work

II. Training of the IVF clinical team• Gynecologists working in infertility

• Three months (hands on) work

Strict System

• From the start• Applied to all (no exception)• Be ready for turn over

• Do not forget training of nurses and workers (infertility is a special entity)

Essential Equipments

I- Microscopes

1- ordinary light microscopes

2- sterio microscopes (inside a laminar flow)

II- CO2 incubators (number & type)

Other equipments in the IVF lab

III- centrifuges

IV- refrigerators

V- media preparation

(H2O purification – ph meter – osmometer -

balance)

IVF Laboratory should be backed by:

1. Cryopreservation facilities

2. Micromanipulation equipments

Clean Room•HEPA filters•Positive pressure•Stainless steel furniture,

smooth, non-porous walls

•Constant temperature•Constant UPS

Again this is a setup• What about success? • How to maintain it?

Quality Control& Quality Assurance

What is Quality Control (QC)?

QC involves all measures undertaken to control the quality of:

products equipment

protocols environment

to insure that the IVF Laboratory is functioning correctly

What is Quality Assurance (QA)?QA is a comprehensive program

QCMeasures of :- Equipment- Protocols-

Environment- Products

Results

reportingRecord keeping

Treatment auditing

and incident

reporting

Education of

laboratory staff

Benefits of EmployingQC & QA

- Maintain the optimal laboratory performance- Detect problems before they become

significant.- Evaluating personnel performance and

motivating staff.

Micro droplet – Oil Overlay

VOC’s Filtration Oil Issues

Plastic Ware

MediapHTemperature

QC Program

routine monitoring

1) Equipment

2) Culture media and consumables

3) The environment

4) Protocols

initial validation +

Equipment validation

- Installed by the manufacturer

- Switched on and monitored for a sufficient time to identify problems before use in clinical treatment

Quality Control Measures Range ± accuracy

Method Frequency Test Equipment

± 0.5%-10 to + 50

± 0.5ºC

0.03 EU/mL-10 to +50

±1 ºC

- 10 to + 50 ± 1 ºC

FyriteThermometer

Sperm survival

assay

Limulus amoebocyte

test

Thermometer

Thermometer

3 / weekDaily

as required

Weekly

Daily

Monthly

CO2%TemperatureEnvironment

Endotoxin

Temperature

Temperature

Incubator

Water System

Refrigerator

Heated stages

Company-manufactured media:

- QC testing of all new batches of culture media is important because of transport, and incorrect storage conditions.

Air pollutants

Volatile organic compounds (VOCs) and

chemical airborne contaminants (CACs)

can significantly affect culture

conditions

Prevention of VOCs

- Consideration should be given to the

site and location of the laboratories

- The use of air purification units

- Positive pressure airflow

- Sealants, toxic glues, paint, should be

avoided

Cleaning- Routine cleaning after every procedure

during work.

- Daily cleaning after work (microscopes – all surfaces – laminar flows)

- Weekly cleaning

Incubators - laminar flows

Assessment of Follicular Stimulation

Length of stimulation

A. E2 level

B. No. of mature oocytes

C. Dosage (Type?) of gonadotrophin Oocyte response during ICSI

A. post-retrieval

1. Immediate

2. Fertilisation rate

What is Quality Assurance (QA)?QA is a comprehensive program

QCMeasures of :- Equipment- Protocols-

Environment- Products

Results

reportingRecord keeping

Treatment auditing

and incident

reporting

Education of

laboratory staff

Keeping Records andDocumentation

Accurate documentation and record keeping of all aspects of the scheme is fundamental to the success of an QA program

Paper Work Design

- Detailed information

- Easy information retrieval

- Security of the documents

Monitoring laboratory performance

- Auditing fertilization and embryo cleavage rates and embryo quality

- Auditing pregnancy rate, implantation rate, and birth rate.

Appraisal of Performance

Staff evaluation

Equipments evaluation

How to Estimate Success?

• Money gain• Pregnancy rate• Growth rate

If it is money?

• What is the acceptable percent of profit 20% 40%50% 100%

• How to reduce running costs !!

• Yearly vs monthly order !!

How to Maximize Profit?

• Cafeteria : ? Location

•Auxulliary services: Lab

?? Pharmacy

Good Egg

Bad Egg

Fertilization

•2 Pronuclei (2PN)

•1 day after egg retrieval

Day 3 Embryo

Day 3 Embryo

Day 3 Embryo

Day 3 Embryo

Hatching Blastocyst

Embryo Transfer

Embryo Transfer