NEW ART GUIDELINES

Government came out with ART Law 2022 to ensure uniformity of quality care across the country. The law ensures that all registered centers follow some basic guidelines and this will be beneficial for the public as well as the healthcare professionals catering to the Reproductive Health.

The major highlights of the New ART law is mentioned in the article:

Assisted Reproductive Technology (ART):

Has revolutionized the way couples struggling with infertility can still conceive and have children. Level 2 ART refers to technologies such as intrauterine insemination (IUI) and in vitro fertilization (IVF), which are advanced techniques to address fertility issues. Some examples of level 2 ART include:

·???????Intrauterine insemination (IUI) with ovarian stimulation

·???????In vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI)

·???????Pre-implantation genetic testing (PGT)

·???????Egg or embryo donation

·???????Surrogacy

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Assisted Reproduction Technology (ART) banks

Also known as fertility banks, are facilities that collect and store reproductive materials such as sperm, eggs, and embryos for future use in ART procedures. These banks may also provide other services related to ART, such as donor selection, fertility preservation, and genetic testing

·???????Sperm banks

·???????Egg banks

·???????Embryo banks

·???????Surrogacy agencies

·???????Every ART Clinic / Bank shall maintain a record of the names and addresses of the couple/woman who underwent ART procedure/tests, the names of their spouse/father and the date on which they first reported for counseling, procedure /test.

·???????All case related records, consent forms , laboratory results, microscopic pictures, sonographic plates or slides, recommendations and letters shall be preserved by the ART Clinic/ Bank, for a period of ten years from the date of completion of ART procedures.

·???????Every ART clinic/ bank should send a complete report in respect to all ART related procedures/techniques/tests conducted by them in respect to each month by 5th day of the following month to the National Registry.

Consent forms to be maintained by the ART Clinics.

·Consent Form to be signed by the Couple /woman as specified in Form 13

·Consent for Intrauterine Insemination with Husband’s Semen / Sperm as specified in Form 13

· Consent for Intrauterine Insemination with Donor Semen as specified in Form 14.

·?Consent for Freezing of Embryos as specified in Form 15.

·?Consent for freezing gametes as specified in Form 16.

·?Assent for Freezing of Gametes Sperm/Oocytes & Parental consent as specified in Form 17.

·?Consent for withdrawal as specified in Form 18.

·?Consent for oocyte retrieval as specified in Form 21

·?Any other duties as directed by the central government/ National Board & State Board

Consent forms to be maintained by the ART Banks.

·??Record of use of Donor Gametes as specified in Form 19, 19 A, 19 B

·??Results of screening of Semen Donors / Oocyte Donor as specified in Form 20.

·??Consent Form for the Donor of Sperm as specified in Form 22

·??Consent Form for the Donor of Oocytes as specified in Form 23.

Staff Requirement:

Director:

A be a senior person who has considerable experience in all ART Rules aspects of ART. He should be able to co-ordinate the activities of the rest of the

(02)Gynecologist:

·??50 oocyte retrieval under supervision pf a trained ART specialist

·??Minimal 3 years’ experience in reproductive medicine

·??3 years of training in a registered ART Center with superspecialist DM/fellowship in?reproductive medicine

ROLE:

·???????Interviewing of the infertile couple initially

·???????History taking

·???????Physical examination of the female

·???????Recommending appropriate tests to be carried out, interpreting them and treating medical disorders.

·???????Carrying out gynaecological endoscopy and ultrasonographic intervention for diagnosis and therapy of fertility

(01)Andrologist

·???????a urologist or a surgeon who has a post-graduate degree (MS General Surgery with training in Andrology that often takes on the task of treating male infertility along with some experience in the field of andrology or MCH/DNB Genitourinary surgery/Urology)

·???????training in diagnosis of various types of male infertility covering psychogenic impotence, anatomical anomalies of the penis which disable normal intercourse, endocrine factors that cause poor semen characteristics and / or impotence, infections, and causes of erectile dysfunction

·???????knowledge of the occupational hazards, infections and fever that cause reversible or irreversible forms of infertility, and knowledge of ultrasonographic and Vaso graphic studies of the male reproductive tract. He / she must also be wellversed in treating impotence and ejaculatory dysfunction

·???????an individual may act as an andrologist for more than one clinic but each clinic where the andrologist works must own responsibility for the andrologist and ensure that the andrologist is able to take care of the entire work load of the clinic without compromising on the quality of service

(01)Senior Embryologist:

·???????Medical Graduate MBBS OR post graduate in life sciences/ clinical embryology/Biotechnology/Veterinary Sciences/Reproductive biology

·???????minimal of 1 year on site clinical embryology certified training

·???????in addition to this have 2 years’ experience of working in the Embryology lab of a registered ART level 2 clinic

ROLE:

·???????To ensure that all the necessary equipment’s are present in the laboratory and are functional. He will be custodian of the laboratory and the functioning of the lab.

·???????To perform all the procedures pertaining to processing, handling and culturing of gametes and embryos in the laboratory and hand over the embryo to the gynecologist.

·???????To maintain records of all the procedures carried out in the laboratory.

(01)Junior Embryologist:

·???????Graduate in Life sciences/ biotechnology/ reproductive biology/ veterinary science

·???????03 years experiences in the relevant field

·???????Postgraduate in Life sciences/ biotechnology/ reproductive biology/ veterinary science.

(01)Counsellor:

·???????a degree (preferably a post-graduate) in Social Sciences, Social work, Psychology, Life Sciences / Medicine

ROLE:

·???????and a good knowledge on various causes of infertility and its social and gender implications,

·???????the possibilities offered by the various treatment modalities, should be considered as qualified to occupy this position.

·???????The counsellor must invariably educate the couple of the advantages of adoption as against resorting to ART.

·???????A person can act as a counsellor for more than one ART Clinic/Bank but he is able to take care of the entire counselling load of the clinic without compromising on the quality of the counselling service.

·???????In ART Clinic/Banks carrying out pre-implantation genetic diagnosis or mitochondrial donation should ensure that patients have access to counsellors with appropriate knowledge and expertise in these specialisms, including a good understanding of the risks and implications for patients who have treatment involving mitochondrial donation techniques and any children that may be born following such treatment.

(01) Anesthetist:

·???????MD/ DA in anesthesia .

ROLE:

·????????In a surrogacy clinic is to provide pain relief to the patients during oocyte retrieval and embryo transfer procedures.

Equipment and Facilities Level 2 ART Clinic:

·???????Facility for control of temperature & humidity (Air handling unit)

·???????Filtered air with an appropriate number of air exchanges per hour

·? Wall and floors are composed of materials that can be easily washed and Disinfected

·???????A laminar flow bench with a thermostatically controlled heating plate

·???????An IVF grade Stereo Microscope preferably with CCD camera and recording software

·???????A routine high powered Trinocular light microscope (IVF grade and preferably with CCD camera and recording software)

·???????A high-resolution inverted microscope with phase contrast or Hoffman Optics (with standard IVF grade objective), preferably with facilities for video recording

·???????A micromanipulator

·???????A CO2 incubator, preferably with a back up

·???????A laboratory centrifuge

·???????Equipment for freezing embryos

·???????Liquid nitrogen cans for Screened Negative samples

·???????Infected samples

·???????A pharmaceutical refrigerator

·???????Heating plates

·???????Test tube heater

·???????Heating blocks

·???????Alloy blocks/ Plates

·???????Biometrics (to restrict the entry)

·???????Anaesthesia station and basic resusication equipment

·???????VOC – Photoionisation detector

Physical Requirements and Facilities for an ART 2 Clinics and Banks

A well-designed ART clinic / ART banks should have a non-sterile and a strictly sterile area. The place can be combined but on a condition the sterile areas can’t be combined with non-sterile area and vice-versa

General Requirements:

1. Reception Area

2. Waiting Room

3. Consulting Room

4. Storage Room

5. Records Room

6. Examination Room with Privacy

7. Fire Safety Arrangement

Laboratory Services

1. General purpose clinical laboratory (inhouse/ referral)

2. Blood Collection Area

Requirement for Clean Area

1. IUI Room

2. Semen Collection Room

Sterile Area

1. Semen Processing Laboratory

2. Operation Theatre : Should have laparotomy set with suture material

3. Embryo Transfer Laboratory: and OT should be conneted directlr to Embryology lab complex

4. Autoclaving Room

5. IVF/Culture Laboratory: The embryology laboratory must have facilities to control temperature and humidity and must have filtered air with an appropriate number of air exchanges per hour. Walls and floors must be composed of materials that can be easily washed and disinfected,carpeting must be strictly avoided.

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The embryology laboratory must have the following:

i)????????????????A laminar flow bench with a thermostatically controlled heating plate

ii)???????????????A stereo microscopeA routine high-powered binocular light microscope

iii)??????????????A high-resolution inverted microscope with phase contrast or Hoffman optics, preferably with facilities for video recording

iv)??????????????A micromanipulator (if ICSI is done)

v)???????????????A CO2 incubator, preferably with a back up

vi)??????????????A hot air oven vii) A laboratory centrifuge

vii)?????????????Equipment for freezing embryos

viii)???????????Liquid nitrogen storage tanks

ix)??????????????A refrigerator

x)???????????????Appropriate steps need to be taken for the correct identification by using appropriate labelling system preferably with barcodes.

xi)??????????????All material from the operation room, culture dishes and Falcon tubes for sperm collection (including lids), must have the name of the patient. In the incubator, identified oocytes and sperm should be kept together on the same tray and double-checked.

xii)????????????The embryology laboratory must have daily logbook in which all the day’s activities are recorded, including the performance of the equipment.

6.Store Room

7. Record Room

8. The cabinets in the Records should have proper fire safety arrangements

9. Proper measures should be taken to make the clinic Vermin proof

10. The Quality and maintenance of the Laboratory shouldn’t be compromised

11. The Consumables in the laboratory should be if great quality

12.There needs to power back up in the form of UPS or Generator

In conclusion, setting up a Level 2 assisted reproductive technology (ART) center is a complex process that requires specialized knowledge, equipment, and personnel.

It involves offering more sophisticated ART procedures to patients who have not had success with Level 1 ART or who have specific fertility issues.

While Level 2 ART procedures can significantly increase the chances of a successful pregnancy, it is important to consider the ethical, legal, and financial implications of offering these services.

It is also essential to ensure adherence to strict regulatory guidelines and to prioritize patient safety.

Establishing a Level 2 ART center requires careful planning and consideration, and working with healthcare providers and experts in the field of ART can help to ensure the best possible outcomes for patients.

If you are planning to set your Level 2 ART center reach out to us at www.hosconnnconsulting.com

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