Getting To Know IVF Unit Start Up Guidelines




The IVF Unit will provide facilities for In vitro fertilisation (IVF) procedures. IVF is one of several Assisted Reproductive Techniques (ART) used to help infertile couples to conceive a child. The procedure involves removal of eggs (mature Oocyte or Ovum) from the woman's ovary. Ova are then fertilised with sperm in a laboratory procedure (in vitro). If fertilisation occurs, a fertilized ovum, after undergoing several cell divisions, is transferred to the mother for normal development in the uterus, or frozen for later implantation.

The IVF centre must have adequate functionalities to minimize any damaging effects upon reproductive cells and ensure good laboratory practice. Also, laboratory design should ensure optimal workflow over minimal distances while handling reproductive cells during all treatment phases. The IVF Unit will provide facilities for In vitro fertilization (IVF) procedures. IVF is one of several Assisted Reproductive Techniques (ART) used to help infertile couples to conceive a child. Once the architecture and ergonomics of your clinic are sorted. What is the ideal environment to create a wellness centre and IVF clinic focused on the whole person?

The IVF laboratory may use Intracytoplasmic Sperm Injection (ICSI) in the process of IVF.
Services provided by the IVF Unit include:

Patient consultation and interview on an outpatient basis
 Pre-treatment assessment
 Blood collection
 Semen collection
 Artificial insemination
 Ovarian stimulation therapy
 Ultrasound examination
 Oocyte (egg) collection
 Embryo culture
 In vitro / ICSI fertilisation
 Cryopreservation
 Embryo transfer
 Recovery

Functional Areas

The IVF Unit may consist of a number of Functional Areas or zones:

 Entry/ Consult Area

- Entry/ Reception and waiting areas
- Administration/ Records
- Interview Room/s
- Consult/ Examination/ Treatment Room/s
- Ultrasound room/s
- Collection Room/s with Ensuite shower and Toilet
- Public Toilets

Patient Procedural Area

 - Operating Room/s for oocyte (egg) collection and re-implantation
 - Recovery areas
- Change areas and toilets for staff and patients 

Laboratory Area

 - Laboratories (Embryology, IVF, ICSI, Andrology, Genetics)
 - Cryopreservation facilities
- Gas Bottle Store

 Staff and Support Area

 - Clean-Up and Disposal room
 - Store rooms and Sterile store
 - Offices, meeting rooms, staff room
- Sterilising area:

 if the IVF unit is a stand-alone building, dedicated sterilising facilities will be required

Reproduction clinic expands while keeping eye on design - CCRM Fertility

Here are some design tips from experts in the field of clinic design:

Create Texture:

 Use natural materials such as wood, stone and natural textiles to create texture and contrast in your clinic. Locally made textiles, utilised as wall hangings or furniture accessories such as cushions, can then embody the uniqueness of the location. You can create a subliminal impression of balance i.e. holism by combining elements that complement each other. Use reclaimed wood and other recyclables on horizontal surfaces. Textured glass and ceramic tiles and metals such as copper and bronze for railings and fixtures.

Bring the outdoors indoors:

an impression of nature, her beauty, wildness and fecundity, can be created by conveying a sense of the outdoors. The outdoors can be brought indoors by using mini-waterfalls, bamboo (both living and inert) and stone. Natural elements such as water features and meditative garden enclaves intrigue, but also calm, visitors as they experience the environment along with their treatments.

Dramatic doors and crossing over points:

pay great attention to doors and entrances. These signify a crossing over point to a place where people can leave their previous lives behind.

1.      Different levels and procedures of ART Treatment Centers


According to ICMR (Indian Council for Medical Research) an ART center can be categorized and the responsibilities as mentioned below:

            Primary (Level 1A) infertility care units


These would be clinics where preliminary investigations are carried out and type and cause of infertility diagnosed. Primary infertility care unit or clinic could be a doctor’s consulting room, such as a gynaecologist’s or a physician’s consulting room, or even a general hospital. Depending on the severity of infertility, the couple could be treated at the Level 1A clinic or referred to a specialist (Level 1B, Level 2 or Level 3) clinic.

Procedures/Facilities

a.       Completion of the basic investigations mentioned above.
b.      Ability to carry out AIH
c.       Ability to carry out IUI using processed semen of husband or donor obtained from an accredited laboratory or semen bank which must maintain a record
d.      Referral of the couple to Level 1B, Level 2 or Level 3 infertility care unit as appropriate
e.      Consulting Room for Patient and Doctor

            Primary (Level 1B) infertility care units engaging in IUI


Infertility clinics falling into this category shall need accreditation. The IUI in such clinics must be done under the supervision of a gynaecologist with a post-graduate degree.

Procedures/Facilities

a.       Facilities for semen preparation and certification and for intrauterine insemination (IUI), including an appropriate sterile area for IUI
b.      Consulting Room for Patent and Doctor
c.       Andrology: A Sterile room for Semen Preparation

       Secondary (Level 2) infertility care units


These units must have infrastructure for further in-depth investigation and extended treatment of infertility except where oocytes are handled outside the body. Some of the investigations and treatment facilities required for Level 2 care units

Procedures/Facilities


a.       Facilities for semen preparation and certification and for intrauterine insemination (IUI), including an appropriate sterile area for IUI
b.      Provision for semen collection in men with a vibrator or an electro ejaculator in functional erectile and ejaculatory problems
c.       Consulting Room for Patent and Doctor
d.      Andrology: A Sterile room for Semen Preparation
e.      Operation Theatre for conservative surgery either through a laparoscope, hysteroscope or via laparotomy. It should be possible to perform hysteroscopic cannulation of locked tubes, and resection of sub mucous myoma or uterine septum. Combined medical- surgical therapy by a co-ordinate team as in-endometriosis or in some cases of polycystic ovaries
f.        Provision for extended treatment of infertility except for oocyte pick up and IVF, ICSI

       Tertiary (Level 3) infertility care units


Such units will have three functions to perform, viz. diagnostic and therapeutic at the highest level of specialization and with the best of facilities, and research.

Procedures/Facilities

a. Facilities for semen preparation and certification and for intrauterine insemination (IUI), including an appropriate sterile area for IUI
b.   Provision for semen collection in men with a vibrator or an electro ejaculator in functional erectile and ejaculatory problems
c.       Consulting Room for Patent and Doctor
d.      Andrology: A Sterile room for Semen Preparation
e.  Operation Theatre for conservative surgery either through a laparoscope, hysteroscope or via laparotomy. It should be possible to perform hysteroscopic cannulation of locked tubes, and resection of sub mucous myoma or uterine septum. Combined medical-surgical therapy by a co-ordinate team as in- endometriosis or in some cases of polycystic ovaries
f.        A Pre-Culture room for processing the embryos
g.       Culture room for developing the embryos and to carry out the ICSI process

 Space and Equipment Requirements
A complete IVF Tertiary (Level 3) Center requires the following Infrastructure and Equipments:

S.No.
Partition Name
Amenities & Equipments Required
Area Required (in sq.ft)
1.
Waiting Hall/
Entry for IVF
Chairs and Tables
Air Curtain(Recommended)
150 - 200
2.
Dress Change Room with a
bathroom
Dress Shelves, Dress Hangers
100 - 120
3.
Doctors Consulting Room
Chairs and Tables and a bed for screening the patient. A Scan machine would be ideal to
have.
150 - 200
4.
Wash Area
To wash hands for disinfections
Water Pipeline with 3 – 4 Taps (pedaling model is recommended)
50 – 75
5.
Operation Theatre
To carry out aspiration of Ovum; Egg Scan Machine
Operation Beds
Suction Pump, Aspiration Needles, Embryo
Transfer catheters and operation Theatre Accessories
250 – 300
6.
Andrology Lab
Laminar Workstation – Sterile area to do semen preparation
Heating Block – To Keep the sample during the preparation
Centrifuge – Necessary during semen preparation
Microscope – To view the unprocessed or processed semen
Software – For documentation purpose Disposables : IUI Catheters, Cannula, Conical test tube and Micropipette
Media for washing and immunization
80 – 120
7.
Pre-Culture
Room
For pick up of ovum and washing it with media
and process it for further grading purpose
125 – 150


8.
Culture
Integrated Workstation comprising of Laminar Workstation, stereo zoom microscope, stage warmer, Heated table along with heating block with temperature controllers
CO2 Incubators
Inverted Microscope with Micromanipulator for ICSI
Television or Computer to view microscopic details
Pipelines for co2, nitrogen gas connecting to utility room
Concealed wiring for electricity, UPS line and video transmissions, Air Condition
150 – 200
9.
Utility Room
CO2/Nitrogen Cylinders Positive Pressure Module
Shelves
80 – 100


Total
1200 - 1500

Discuss with your IVF Lab Specialist for more information

            B Manpower Requirements


The Following trained man power is required for starting up an IVF center

a.       A Gynaecology doctor for patient screening
b.      A trained staff for counseling the patient about IVF
c.       A trained staff as in-charge of the IVF Department
d.        Staff trained in carrying out andrology procedures
e.      Embryologist for Ovum Pickup, Grading Embryos and to undergo ICSI
f.        One or Two Assistants for Embryologist
g.       A Service Engineer to check all equipments and to avoid break down during the case
h.      One or Two Assistants for ovum pickup process

           

Initiative Measures for Center Development

Factors or Measure for Center Development

a.         Better Hospital Environment
b.         Good Team of professionals
c.         Excellent Hospitality and Care
d.         Marketing Initiatives to receive infertility cases from small and medium sized hospitals
e.         Maintaining the Lab
f.          Convert/Register more positive results
g.         Regular follow-up of patients
h.         Organize IUI workshop and IVF conferences for awareness of the center to other doctors
i.          Continuous advertisement on media adds more value

Credit:Sivakumar Murugesan,Consultant Projects, Medpoint Healthcare

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