Schedule III

[See rule 3(1)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 accessories necessary for carrying out clinical examination by an obstertician/gyn aeco- logist. (2) Equipment, accessories, materials and 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 cordocentcsis. (d) A suitable foetoscope with 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 chorionic villi biopsy, amniocentesis, cordocentesis and others as indicated at B above). (2) A Radiologist or Registered Medical Practitioner for carrying out ultrasonography. The required ex- perience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques ""These constitute the minimum requirement of equipment for conducting the relevant procedure FORM A [See rules 4(1) and 8(1)] (TO BE SUBMITTED IN DUPLICATE) WITH SUPPORTING DOCUMENTS AS ENCLOSURES. ALSO IN DUPLICATE FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSE LLING CENTRE/GENETIC LABORATORY/GENETIC CLINIC* 1. 2. 3. 4. 5. Name of the applicant (specify Sh./Smt./Kum./Dr.) Address of the applicant Capacity in which applying (specify owner/partner/managing director/other-to be stated) Type of facility to be registered (specify Genetic Counselling Centre/Genetic Labo- ratory/Genetic Clinic/any combination of these) Full name and address/addresses of Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic with Tele- phone/TelegraphicTelx/Fax E-mail numbers. 2* THE GAZETTE OF INDIA: EXTRAORDINARY [PART IJ-r^pc 3(i)1 7. 8. 9. 10. 11. 12. 13. 14. 15. Type of ownership and organisation (specify individual ownersbip/partnership/company/co-operative/any other) In case of type of organisation other than individual ownership, furnish copy of articles of association and names and addresses of other persons responsible for management, as enclosure. Type of Institution (Govt. Hospital/Municipal Hospital/ Public Hospital/Private Hospital/Private Nursing Home/ Private Clinic/Private Laboratory/any other to be stated. Specific prenatal diagnostic procedures/tests for which approval is sought (for example amniocentesis, chorionie villi aspiration/chromosomal/biochemical/molecular studies etc). Leave blank if registration sought for Genetic Councellin; Centre only (a) Space available for the Counselling Centre/Clinic/ Laboratory give total work area excluding lobbies. waiting rooms, stairs etc. and enclose plan) Equipment available with the make and model of each equipment. List to be attached on a separate sheet). (a) Facilities available in the Counselling Centre. (b) Whether facilities are available in the Laboratory/ Clinic for the following tests; (i) Ultrasound (ii) Amniocentesis (iii) Chorionie villi aspiration (iv) Foetoscopy (v) Foetal biopsy (vi) Cordocenteds (c) Whether facilities are available in the Laboratory Clinic for the following : (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies Names, qualifications, experience and registration num- ber of employees. May be furnished as an enclosure. (Refer Schedules I, II or III) State whether the Genetic Co&nselling Centre,Genetic Laboratory/Genetic Clinic* qualifies for registration in terms of minimum requirements laid down in Schedule I, II and III and if not, reasons theiefoi. For renewal applications only : (aj Registration No. )b) Date of issue and date of expiry oi' existing certi- ficate of registration. List of Enclosures : Please attach a list of enclosures giving the supporting documents enclosed to this application. ( -) Namt and signature of applicant Date : Place : DECLARATION I, Sh./Smt./Kumi /Dr son/ daughter/wife cf aged years resident of hereby declare that 1 hav; read and understood the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act. 1994(57 of 1994) and the Pre-natal Diagnostic Techniques (Regulation nnd Prevention of Misuse), Rules, 1995 (ii) 1 also undertake to explain the said Act and Rules to all employees of the Genetic Counselling Centre/ Genetic Laboratory/GeneMc Clinic in rcspec f of Which registration is sought and to ousure that Act and rul.s aco fully complied with ( _—) Name and signature oi applicant Date : Place : *Strike out whichever is not applicable or not necessary. All enclosures are to be authenticated by signatui ol the applicant. ACKNOWLEDGEMENT [See rules 4(2) and 8(1)] The application in Form A in duplicate for grnnt*/'rene\val* nf registration of Gcnet'c Counselling Qntrt*/ Genetic Laboratory's/Genetic Cl ; nic* by (Nams and address of applicant) has been received by the Appropratc. Authority on (date). •"The list of enclosures attached to the application in Form A has been verified with the enclosures submtted and found to be correct. OR "On verification it is found that following documents mentioned in the list of enclosures are not actually enclosed. This acknowledgement docs not confer any rghts on the applci,nt for grant or renewal of registration. ( __ ) Signature and Designation of Appropriate Authority, or authorized person in the office of the Appropriate Authority. Date : SEAL •"Strike out whichever is not applicable or noi necessary. 1 GI/96-4 26 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II-SEC. 3(1)) ORIGINAL* DUPLICATE FOR DISPLAY FORM B [See rules 6(2), 6(5) and 8(2) ] CERTIFICATE OF REGISTRATION l,To bs issued in duplicate) 1. In o^rcise of the powers conferred under section 19(1) cf the PrcnEtal Dicgnciit c Techniques (Regulation and Prevention of Misusg Act, 1994 (57 of 1994), the Appr3priate AuLrority he ehy grants vcgistiation to the Gonotic Counsell- ing Cente*/Genotic Li'.bo •Ptory'VGcnetic Cl nic* namud below fc r pui poses of carrying out Genetic Counsc 11 ng*/ Pr-natalE>i:'g::ositic Pr ccdun:s*/Pr<natal Diagnostic Tests* as denned in the aforesaid Act fora period of five years ending on 2. This registration is granted subject to the aforesaid Act and Rules thereunder, and any contravention thereof shall result in suspension or cancellation of this Certificate of Registration before the expiry of the said period of five years. A. Name and address of the Genetic Counselling Centre*/Genetic Laborarory*/Genetic Clinic* B. Name of Applicant for registration C. Prenatal diagnositic 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. Prenatal 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 CertincateFrom , .To of Registration. Signature .namefand 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 C [See rules 6(3), 6(5) and 8(3)] REJECTION OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION In exercise of the powers conferred undci section 19(2) of the Prenatal Diagnostic Techniques (R<xu!et-'cn [r .d Prevention of Misuse) Act, 1994 the Appropriate Authority he tby rejects the application for grant*/rcnewal* of registration of the Genetic Counselling Cerjtre*/Ge:netc Ltbcittav/Guctc Clinic* named below for the reasons stated. Name and address of the Genet c Coousell ng Centre*/Genetic Laboratory*/Gcnetic Cl'nic* Name of Applcant who has applied foi registration Reasons for rejection of application for registration Signature, name and designation of Appropriate Authority Date : SEAL *Strike out whichever is not applicable or necessary. FORM D [See rule 9(2)] NAME ADDRESS AND REGISTRATION. NO OF GENETIC COUNSELLING CENTRE RECORD TO BE MAINTAINED BY THE GENETIC COUNSELLING CENTRE 1. 2, 3. 4. 5. 6. 7. 8, Patient's name Age Husband's/Father's name Full address with Tel. No. if any Referred by (Full name and address of Doctor(s) with registration No.(s) (Referral note to be preserved carefully with case papers) Last menstrual poricd/ weeks of pregnancy H ; story of genetic/medical disease : n the family (specify) Basis of diagnosis: (a) Clinical (b) Bio-Chemical (c) Cyto-genetic (d) Other (e.g. radiological) Indication for prenatal diagnosis* A. Previous child/children with: (i) Chromosomal disorders (ii) Metabolic disorders (iii) Congenital anomaly 28 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 9- 10. 11. 12. 13. 14. (iv) Mental rota idat on (v) Hacmoglcbinopathy (vi) Sex linked disorders (vii) Any other (specify) B. Advanced maternal age (—35 yeEib) C. Mother/father/sibling has genetic disease (specify) D. Others (specify) Procedure advised* (0 Ultrasound CO Amniocentesis (iii) Chorionic VilH biopsy (iv) Fouioscopy (v) Fectal skin or organ biopsy (vi) Cordocentesis (vii) Any other (specify) Laboratory tests to be carried out (i) Chromosomal studies (ii) Biochemical studies (iii) Molecular studies Result of prenatal diagnosis: Normal/Abnormal If abnormal give details. Was MTP advised? Name and address of Genetic Clinic* to which patient referred. Dates of commencement and comp!ct : on of genetic counselling. Name, Signature and Registration No. of the Medical Geneticist/Gynaecologist/ Paediatrician. Date •Strike out whichever is not applicable or not necessary. Form E [See rule 9 (3)] NAME, ADDRESS AND REGISTRATION NO. OF GENETIC LABORATORY RECORD TO BE MAINTAINED BY THE GENETIC LABORATORY 1. 2. 3. 4. 5. 6. Patient's name , Age Husband's/Father's name Full address with Tel. No., if any Referred by/sample sent by (full name and address of Genetic Clinic (Referral note to be preserved care- fully with case paper). Type of samplo : Maternal blood/Chorionic villus sample/amniotlc fluid/Foetal blood or other foetal tissue (Specify) 7. 8. 9. 10. on. Specify indication for prenatal diagnosis (A) Previous Child/children with: (i) Chromosomal disorders (ii) Metabolic disorders (iii) Malformation(s) (iv) Mental retardation (v) Hereditary hacmolytic anaemia (vi) Sex linked disorder (vii) Any other,, (specify) (B) Advanced maternal age (—35 years) (C) Mother/father/sibling has genetic disease (specify) (D) Other/speicfy) Laboratory tests carried out (give details) (i) Cromosonial studies (ii) Biochemical studies (iii) Molecular studies Result of pre-natal diagnosis: Normal/Abnormal if abnormal, give details Date(s) on which tests carried out The results of the prc-nata [diagnostic tests were conveved 1c? Name, signature and Registration number of the Medical Geneticist Date Form F [Sec role 9 (4)] NAME, ADDRESS AND REGISTRATION NO. Of GENETIC CLINIC RECORD TO BE MAINTAINED BY THE GENETIC CLINIC ], 2. 3. 4. 5. 6. 7. Patient's name Ago Husband's/Father's name Full Address with Tel. No., if any Referred by (full name and address ofdoctor(s)/Genetic Counselling Centre (Referral note to be preserved cavefolly with case papers). Last menstroal period/ weeks of pregnancy. History of genetic/medical disease in tho family (specify). Basis of diagnosis: (a) Clinical (b) Bio-C-homital (e) Cyto-gonetic (d) Olliet (e.g. radioingical-specify) 30 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] 8. 9. 12. 14. 15. 16. 17. Indication for prenatal 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 genet c disease (specify) (D) Other (specify) Procedures carried out (with name and registration No. of Gynoecologist/Radiologist/Registcrcd Medical Practitioner) who performed it. (i) Ultrasound (ii) Aminiocentesis (iii) Chorionic Villi aspiration (iv) Foetal biopsy (v) Cordocentesis (vi) Any other (specify) Any complication of procedure—please specify . Laboratory tests recommended* (i) Chromosmal studies (ii) Biochemical studios (iii) Molecular studies Result of pre-natal diagnostic procedure and specify Normal/AbnormBl abnormality detected, if any- . Was MTP advised/cenducted Date(s) on which procedures carried out. Date on which MTP carried out. Date on which consent obtained. The result of prt-natal diagnostic procedure were convoyed to on Dato Place Name, signature and Regstration number of the Gynaocologjst/Radiologist/Regi8tered Medical Prac- titioner • Strike out whichever is not appliable or not necessary. FORM G [See rule 10)] FORM OF CONSENT l t wife/daughter of age years residing at hereby state that I hav« boon explained fully the probable side effects and after effeots 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 prescribed in the Pre-natal Dia- gnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994). Date Signature Place 1 have explained the contents of the above consent to the patient and her companion (Name Address relationship ) in a lagnague sho/they understand. Date Name, signature and Registration number of Gynae- cologist Name, address and Registration number of Gene- tic 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. 2. 3. 4. 5. 6. 7. 8* 9. SI. No. File number of Appropriate Authority. Date of rectipt of application for grant of registration. Name, Address, Phone/Fax etc, of Applicant. Name and address (cs) of Genetic Counselling Centre*/ Genetic Laboratoy*/ Genetic Clinic* Date on which case considered by Advisory Committee and recommendation of Advisory Committee, in summary. Outcome of application (state granted/rejected/and date of issue of orders). Registration number allotted and date of expiry of re- gistration. Renewals (date of renewal and renewed upto) . File number in which renewals dealt. . Additional information, if any. Name, designation and signature of appropriate Authority 32 THE GAZETTE Q* INDIA: EXTRAORDINARY [PARI II—SKC. 3(i)J Guidance for Appropriate Auihority (a) Form H is a permamont reocrd to be maintained as a register, in the custody of the Appropriate Authority. (b) *means strike out woLher.ts 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 iho Genetic Couselling Centre/Genetic Laboraiory/Oenetic Clinic will not change. A fresh registration Number will bo allotted in the event of change of ownership or management. (c) No registration number shall be allotted twice. (f) Each Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic may be allotted a folio consisting of two facing pages of the Register for reoording 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 proceedings, etc. (h) Every folio (i.e. 2 pages) of the Register shall be authenticated by signature of the Appropriate Authority; with data, and every subsequent entry shall also be similarly authenticated. Printed by the Manager, Govt, of India Preii, Rinfl Road, Maya Pur!, New DelhI-110064 and Published by the Controller »f Publication!, Delhi-110054, 1996