SCHEDULE III
[See rule 3(1)]
REQUIREMENTS FOR REGISTRATION OF A GENETIC CLINIC
| A. | Place |
| A room with an area of twenty (20) square metres with appropriate aseptic arrangements. | |
| B. | EQUIPMENT |
| (1) Equipment and accessoris necessary for carrying out clinical examination by an obstertician / gynaecologist. | |
| (2) Equipment, accessories, necessary for other facilities required for operations envisaged in the Act. | |
| * (a) An ultra-sonography machine. | |
| * (b) Appropriate cathethers and equipment for carrying out chorionic villi aspirations per vagina or per abdomen. | |
| * (c) Appropriate sterile needles for amniocentesis or cordocentesis. | |
| * (d) A suitable foetoscope with a appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling shall be optional. | |
| (3) Equipment for dry and wet sterilization. | |
| (4) Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need. | |
| C. | EMPLOYEES |
| (1) A gynaecologist with adequate experience in pre-natal diagnostic procedures (should have performed at least 20 procedures under supervision of a gynaecologist experienced in the procedure which is going to be carried out, for example chrionic villi biopsy, amniocentesis, cordocentesis and others as indicated at B above). | |
| (2) A Rediologist or Registered Medical Practitioner for carrying out ultrasonography. The required experience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques. |
ACKNOWLEDGEMENT
[See rules 4(2) and 8(1)]
The application in Form A in duplicate for grant*/renewal* of registration of Genetic Counselling
Centre*/Genetic Laboratory*/Genetic Clinic* by .....................................................................................
.......................................................................................................(Name and address of applicant) has
been received by the Appropriate Authority..............................................................................................
........................................................................................................................................................................
.......................................................................................on............................................................(date).
*The list of enclosures attached to the application Form A has been verified with the enclosures submitted and found to be correct.
OR
*On verification it is found that following documents mentioned in the list of enclosures are not actually enclosed.
...............................................
*strike out whichever is not applicable or not necessary.
This acknowledgement does not confer any rights on the applicant for grant or renewal of registration.
(............................................)
Signature and Designation of Appropriate Authority, or
authorized person in the office of the Appropriate Authority.
Date : SEAL
................................................................................................................................................................................
ORIGINAL*
DUPLICATE FOR DISPLAY
FORM
[See rules 6(2), 6(5) and 8(2)]
CERTIFICATE OF REGISTRATION
(To be issued in duplicate)
1. In exercise of the powers conferred under section 19(1) of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994), the Appropriate Authority .............................................................................................hereby grants registration to the Genetic Counselling Centre*/Genetic Laboratory*/Genetic Clinic* named below for purposes of carrying out Genetic Counselling Pre-natal Diagnostic Procedures*/Pre-natal Diagnostic Tests as defined in the aforesaid Act for a period of five years ending on......................................................................
2. This registration is granted subject to the aforesaid Act and Rules thereunder and any contravention there of shall result in suspension or cancellation of this Certificate of Registration before the expity of the said period of five years.
A. Name and address of the Genetic Counselling Centre*/Genetic Laboratory*/Genetic Clinic*.
B. Name of Applicant for registration.
C. Pre-natal diagnostic procedures approved for (genetic clinic).
(i) Ultrasound
(ii) Amniocentesis
(iii) Chorionic villi biopsy
(iv) Foetoscopy
(v) Foetal skin or organ biopsy
(vi) Cordocentesis
(vii) Any other (specify)
D. Pre-natal diagnostic tests* approved (for Genetic Laboratory)
(i) Chromosomal studies
(ii) Biochemical studies
(iii) Molecular studies
3. Registration No. allotted
4. For renewed Certificate of Registration only
Period of validity of earlier Certificate Form........................................To...............................or
Registration. Signature, name and designation of the
Appropriate Authority..............
Date :
SEAL
----------------------------
* Strike out whichever is not applicable or necessary.
DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE PLACE OF BUSINESS.
FORM F
[ See rule 9(4)]
NAME, ADDRESS AND REGISTRATION NO. OF GENETIC CLINIC RECORD TO BE
MAINTAINED BY THE GENETIC CLINIC
1. Patient's name
2. Age
3. Husband's/Father's Name
4. Full Address with Tel. No., if any
5. Referred by (full name and address of doctor(s) / Genetic Counselling Centre (Referral note to be preserved carefully with case papers)
6. Last menstrual period/.......weeks of pregnancy
7. History of genetic/medical disease in the family (specify) Basis of diagnosis :
(a) Clinical
(b) Bio-Chemical
(c) Cyto-genetic
(d) Other (e.g. radiological-specify)
8. Indication for pre-natal diagnosis
(A) Previous child/children with :
(i) Chromosomal disorders
(ii) Metabolic disorders
(iii) Congenital anomaly
(iv) Mental ratardation
(v) Haemoglobinopathy
(vi) Sex linked disorder
(vii) Any other (specify)
(B) Advanced maternal age (-35 years)
(C) Mother/father/sibling has genetic disease (specify)
(D) Other (specify)
9. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered medical Practitioner) who performed it.
(i) Ultrasound
(ii) Aminiocentesis
(iii) Chorionic Villi aspiration
(iv) Foetal biopsy
(v) Cordocentesis
(vi) Any other (specify)
10. Any complication of procedure-please specify
11. Laboratory tests recommended*
(i) Chromosmal studies
(ii) Bio-Chemical studies
(iii) Molecular studies
12. Result of pre-natal diagnostic procedure and specify abnormality detected, if any.
13. Was MTP advised/conducted
14. Date(s) on which procedures carried out.
15. Date on which MTP carried out.
16. Date on which consent obtained.
17. The result of pre-natal diagnostic procedure were conveyed to .................................
on................................
Date Name, Signature and Registration number of the
Place Gynaecologist/Radiologist/Registered Medical
Practitioner
FORM G
[See rule 10]
FORM OF CONSENT
1...........................................................................................................................wife/daughter of........................
.....................................................................................................................................................................................
age ............................................................... years residing at ...............................................................................
....................................................................................................................................................................................
hereby state that I have been explained fully the probable side effects and after effects of the pre-natal diagnostic procedures. I wish to undergo the pre-natal diagnostic procedures in my interest to find out the possibility of any abnormality (i.e. deformity or disorder) in the child I am carrying.
I undertake not to terminate the pregnancy if the pre-natal procedure and any pre-natal tests conducted show the absence of deformity or disorders. I understand that the sex of the foetus will not be disclosed to me.
I understand that breach of this undertaking will make me liable to penalty as preseribed in the pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, (57 of 1994).
Date Signature
Place
I have explained the contents of the above consent to the patient and her companion
(Name ............................................................... Address .............................................................
.........................................................................................................................................................
relationship .............................................................................................................) in a language
she/they understand.
Date Name, Signature and / Registration number
of Gynaecologist
Name, Address and Registration number of Genetic Clinic.
FORM H
[See rule 9(5)]
PERMANENT RECORD OF APPLICATION FOR REGISTRATION, GRANT OF REGISTRATION REJECTION OF APPLICATION FOR REGISTRATION AND RENEWALS OF REGISTRATION
1. Sl. No.
2. File number of Appropriate Authority.
3. Date of receipt of application for grant of registration.
4. Name, Address, Phone/Fax etc. of Applicant.
5. Name and address(es) of Genetic Counselling Centre*/Genetic Laboratory*/Genetic Clinic*.
6. Date on which case considered by Advisory Committee and recommendation of Advisory committee, in summary.
7. Outcome of application (state granted/rejected and date of issue of orders).
8. Registration number allotted and date of expiry of registration.
9. Renewals (date of renewal and renewed upto).
10. File number in which renewals dealt.
11. Additional information, if any.
Name, Designation and Signature of appropriate Authority
Guidance for Appropriate Authority
(a) Form H is a permanent record to be maintained as a register, in the custody of the Appropriate Authority.
(b) *Means strike out which ever is not applicable.
(c) Against item 7, record date of issue of order in Form B or Form C.
(d) On renewal, the Registration Number of the Genetic Conselling Centre/Genetic Laboratory/Genetic Clinic will not change. A fresh registration Number will be allotted in the event of change of ownership or management.
(e) No registration number shall be allotted twice.
(f) Each Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic may be allotted a folio consisting of two facing pages of the Register for recording Form H.
(g) The space provided for 'additional information' may be used for recording suspension, cancellations, rejection of application for renewal, change of ownership/management, outcome of any legal proceeding, etc.
(h) Every folio (i.e. 2 pages) of the Register shall be authenticated by signature of the Appropriate Authority with date, and every subsequent entry shall also be similarly authenticated.