Khyber Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017 (DRAFT)
GOVERNMENT OF KHYBER PAKHTUNKHWA
HEALTH DEPARTMENT
Dated Peshawar the ____________
NOTIFICATION
No-S.O_____________ In
exercise of the powers conferred under section 33 of the Khyber Pakhtunkhwa
Medical Transplantation Regulatory Authority Act, 2014 (Khyber Pakhtunkhwa Act
No. XI of 2014), the Chief Minister Khyber Pakhtunkhwa is pleased to make the
following rules:
1. Short
title and commencement.– (1) These rules may be called the Khyber
Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017.
(2) They shall come into force at once.
2. Definitions.–
(1) In these rules:
a.
“Act” means the Khyber Pakhtunkhwa
Medical Transplantation Regulatory Authority Act, 2014;
b.
“Form” means the form annexed to these
rules;
c.
“non-close blood relative” means a
relative, who is not a close blood relative but does not include an unrelated
donor;
d.
“section” means the section of the Act;
and
e.
“un related donor” means a donor who is
neither close blood relative nor non-close blood relative of the recipient.
(2) All other words and expressions
used and not defined in these rules shall have the meaning assigned to them
under the Act.
3. Authorization for donation during
lifetime.– A living donor, who is not less than eighteen years of
age, may during his lifetime voluntarily donate any organ or tissue of his body
to any other living person and the donation of organ or part or tissue by such
person shall be authorized voluntarily by completing Forms 1, 2 or 3, whichever
is applicable.
4. Authorization for donation after death.–
(1) Any person who is not less than eighteen years of age, may before his
death, in writing duly signed and verified by the concerned Transplant
Evaluation Committee, donate any of his organ or tissue for transplantation and
for this purpose may authorize any recognized institution by voluntarily
completing Form 6 as per terms and conditions contained therein.
(2) A donation under sub-rule (1) may
be revoked at any time during lifetime of the donor as per terms and conditions
contained in Form 6A, under written intimation to the concerned recognized
institution and the concerned Transplant Evaluation Committee.
5. Duties
of the transplant surgeon or physician.– (1) A recognized transplant surgeon
or physician shall, before removing a human organ from the body of a donor
before his death, obtain complete application, documents, details and Forms as
detailed below, from the patient and donor, and only after satisfying himself
about the veracity of the documents and the information so obtained, the
transplant surgeon or physician shall forward the same alongwith annexures, if
any, to all the members of the concerned Transplant Evaluation Committee for
proper evaluation of the case:
(a) donor’s application in Form
10 jointly with the recipient to grant approval for removal and transplantation
of a human organ;
(b) original CNIC of patient and
the donor, issued by the National Database and Registration Authority;
(c) donor’s authorization for
donation in Forms 1, 2 or 3, whichever is relevant;
(d) the recognized transplant
surgeon or physician shall, after ensuring that the donor is in proper state of
health and fit to donate the organ or tissue, sign a certificate as specified
in Form 4; and
(e) in case the recipient is
spouse of the donor, the donor shall give a statement to confirm that they are
so related by signing a certificate in Form 2 and the recognized transplant
surgeon or physician shall also sign and forward a certificate in this regard
as specified in Form 5.
(2) In case of removal of any human
organ or tissue from the body of a person after his death, the recognized
transplant surgeon or physician before forwarding the case to the Transplant
Evaluation Committee shall satisfy himself:
(a) that the donor had, in the presence
of two or more witnesses (at least one of whom is a close blood relative of
such person), unequivocally authorized the concerned recognized institution and
the Transplant Evaluation Committee as specified in Form 6 before his death,
the removal of the human organ of his body, after his death, for therapeutic
purposes;
(b) that written certification
has been obtained from the Transplant Evaluation Committee that death has
occurred;
(c) that the donor has not at any
time during his lifetime revoked the authorization in the manner as per Form
6A, under written intimation to the concerned medical institution or hospital
and the Transplant Evaluation Committee; and
(d) that the person lawfully in
possession of the dead body has signed a certificate as specified in Form 7.
(3) A recognized transplant surgeon or physician shall, before removing a human organ from the body of a person in the event of his brain-stem death, satisfy himself:
(a) that a certificate as
specified in Form 8 has been issued by the Transplant Evaluation Committee; and
(b) that in the case of
brain-stem death of a person, less than eighteen years of age, a certificate
specified in Form 8 has been issued by the Transplant Evaluation Committee and
an authorization as specified in Form 9 has been signed by either of the
parents or other close blood relative of such person.
6. Functioning
of Transplant Evaluation Committees.– (1) Every Transplant Evaluation
Committee shall, for the performance of its functions, hold meetings as may be
necessary but not less than twice a month, at the respective recognized
institution on the date and time as shall mutually be decided by the members of
the hospital Transplant Evaluation Committee.
(2) The quorum for the Transplant
Evaluation Committee shall be five members, however, the quorum shall not be
complete without participation of at least one of the two local notables and
the transplant surgeon.
(3) The Transplant Evaluation Committee
shall perform its functions as provided in the Act in accordance with these
rules.
(4) Brain death of a person shall be
determined in writing by the following members of the Transplant Evaluation
committee:
(a) a neurosurgeon or neurophysician;
and
(b) an intensivist.
(5) At the time of the meeting, the Transplant
Evaluation Committee shall take proper cognizance of all relevant details and
documents and in case it is considered necessary, the Transplant Evaluation
Committee may require any additional information or conduct inquiry, in order
to confirm the veracity or correctness of any information, declaration or
document.
(6) No approval for removal or
transplantation of any human organ or tissue from a living donor shall be given
unless the effects, complications and hazards connected with the removal or
transplantation to the donor and its outcome in the recipient, are explained to
them by the transplant surgeon.
7. Donation
from close blood relatives.– (1) Where the proposed transplant is
between the close blood relatives, the concerned Transplant Evaluation
Committee shall evaluate:
(a) results of tests for Human
Leukocyte Antigen (HLA), alleles A, B and DR performed by serology or DNA-PCR
methods and, if necessary, further testing by contemporary technology that is
micro satellite gene analysis to confirm relationship;
(b) documentary evidence of
relationship including computerized national identity card, birth certificates
and marriage certificate; and
(c) documentary
evidence of identity and residence of the proposed donor including computerized
national identity card, passport, driving license or bank account.
(2) If in the opinion
of the Transplant Evaluation Committee, the relationship is not conclusively
established after evaluating the above evidence, the Transplant Evaluation
Committee may in its discretion direct further medical tests as applicable in
that case under the prevalent medical best practices.
(3) Where the tests
referred to above do not establish a genetic relationship between the donor and
the recipient, the same tests are to be performed on preferably both parents or
at least one parent, if parents are not available, same tests are to be
performed on such relatives of donor and recipient as are available and are
willing to be tested failing which, genetic relationship between the donor and
the recipient shall be deemed to have not been established.
(4) The papers for
approval of transplantation shall be collected and processed by the recognized
transplant surgeon or physician and the approval shall be granted or refused by
the Transplant Evaluation Committee for the reasons to be recorded in writing.
8. Donation
from non-close blood relatives.– (1) Where the proposed transplant is
between the individuals who are non-close blood relatives as per subsection (2)
of section 3 of the Act, the Transplant Evaluation Committee shall:
(i) obtain an affidavit duly
notified by the Notary Public and witnessed by at least two independent
witnesses, along with a credible document of the National Database and
Registration Authority or Director General of Immigration and Passports or
concerned Union Council from the patient, containing the complete particulars
and whereabouts of his all close blood relatives, so that it could be
established without any doubt that no close blood relative, of the recipient is
available to donate any tissue or organ to the patient;
(ii) satisfy itself that a close
blood relative donor exists but he is not medically fit for donation and the
patient has produced all necessary details and credible documents in this
regard;
(iii) satisfy itself
that the donation is voluntary, genuinely motivated and there is no commercial
transaction between the recipient and the donor and no payment of money or
moneys worth has been made or promised to be made to the donor or any other person
and in this connection, the Transplant Evaluation Committee shall take into
consideration:
(a) an explanation
regarding any link between them and the circumstances which led to the offer
being made;
(b) documentary evidence of the
link including proof that they have lived together;
(c) reasons why the donor intends
to donate his body organ or tissue;
(d) any gross disparity between the
status of the two, which must be evaluated in the backdrop of the objective of
preventing commercial dealing;
(e) the financial status of the donor
and the recipient may be probed by asking them to give appropriate evidence of
their profession and income for the previous three financial years;
(f) there is no middleman or tout
involved;
(g) the donor is not a drug addict and
is capable of understanding about his intention to donate an organ, procedure
of
transplantation and the effects thereof
on the donor and the recipient;
(h) the next of kin of the proposed
donor is interviewed regarding awareness about his intention to donate an
organ, the authenticity of the link between the donor and the recipient and the
reasons for donation; and
(i) any strong views of disagreement or
objection of such kin may also be recorded and taken note of.
(2) In the course of determining
eligibility of the donor to donate, the donor should be personally interviewed
by the Transplant Evaluation Committee and minutes of the interview should be
recorded.
(3) In case where the donor is a
female, greater precautions should be taken, her identity and independent
consent should be confirmed by a person other than the recipient.
(4) Any document with regard to the
proof of the residence or domicile and particulars of parentage should be
relatable to the photo identify of the donor in order to ensure that the
documents pertain to the same person, who is the proposed donor and in the
event of any inadequate or doubtful information to this effect, the Transplant
Evaluation Committee may in its discretion seek such other information or
evidence as may be expedient and desirable in the peculiar facts of the case.
(5) The Transplant Evaluation Committee
should state in writing its reasons for rejecting or approving the application
of the proposed donor or patient and all approvals should be subject to the
following conditions:
(a) the approved proposed donor
shall be subject to all such medical tests as required at the relevant stages
to determine his biological capacity and compatibility to donate the organ in
question;
(b) psychiatrist clearance shall
be mandatory to certify his mental condition, awareness, absence of any over or
latent psychiatric disease and ability to give free consent; and
(c) all prescribed forms have
been filled up by all relevant persons involved in the process of
transplantation.
(6) The Transplant Evaluation Committee
shall take the decision quickly, where no further documents, inquiry or tests
are required and use its discretion judiciously and pragmatically, in all such
cases.
(7) The Transplant Evaluation Committee
shall take final decision about donor’s selection within twenty four hours of
holding the meeting for grant of permission or refusal for transplant.
(8) Every recognized hospital or
institution shall maintain a website and the decision of the Transplant
Evaluation Committee shall appear on the website of the hospital or institution
within twenty four hours of taking the decision.
(9) The website of the hospital or
institution shall be updated regularly in respect of the total number of the
transplantations done in that recognized institution along with the essential
details of each transplantation.
9. Transplantation
of unclaimed brain dead persons.– (1) The cases of unclaimed brain
dead hospitalized patients shall be presented to any of the notified Transplant
Evaluation Committees for transplantation after an intense search for their
relatives within twenty four hours including search through National Database
and Registration Authority, local police and any other method as may be deemed
appropriate.
(2) The concerned Transplant Evaluation
Committee may approve any case, referred to in sub-rule (1), for
transplantation of any organ or tissue, after:
(a) determining the brain death
of the person;
(b) determining the identity of
the person, if possible, through computerized national identity card, passport,
driving license or any other method that the Transplant Evaluation Committee
deems fit;
(c) evaluating the efforts for
search of the relatives of the person including search through National
Database and Registration Authority, local police and any other method that the
Transplant Evaluation Committee deems fit; and
(d) determining propriety of
removal of a human organ using brain death protocol, formulated by the Transplant
Evaluation Committee.
10. Preservation of organs and tissues.–
The organ or tissue removed shall be preserved by the recognized institution
according to current and accepted scientific methods in order to ensure
viability for the purpose of transplantation.
11. Functioning
of Transplant Monitoring Committee.– (1) The Transplant Monitoring
Committee shall monitor, supervise and scrutinize transplantation of human
organs and tissues.
(2) The Government may, by notification, dissolve any Transplant
Evaluation Committee after an enquiry conducted on the basis of a complaint
received in writing or upon receipt of complaint of negligence, misconduct or
not complying with any provision of the Act or these rules and, in such an
eventuality, the Government shall reconstitute Transplant Evaluation Committee
within fifteen days of the dissolution of the earlier Committee.
(3) The Transplant Monitoring Committee may organize events
to recognize and acknowledge the act of supreme altruism of living donors and
the family of deceased donors.
(4) The Transplant Monitoring Committee shall create Khyber
Pakhtunkhwa Organ Sharing Network and Organ Procurement Organization consisting
of a doctor, a psychologist or sociologist and a nurse.
(5) The Khyber Pakhtunkhwa Organ Sharing Network shall
obtain information and maintain record of brain death patients whose families
have consented for donation and shall liaise with Organ Procurement
Organization.
(6) The Organ Procurement Organization shall generate the
request of brain death patients and refer the request to the Khyber Pakhtunkhwa
Organ Sharing Network which may allocate organs according to the current
international practices for allocation.
(7) The Transplant Monitoring Committee shall request the
Government to institute an endowment fund which shall be used by the Authority
for the transplantation of indigent patients including post transplant care and
medicines. This endowment fund shall also be used to provide health protection
to a donor in pursuance of Section 26 sub-section (1) provided that the
Authority shall approve such cases on case to case basis for which separate
Regulations may be framed by the Authority. Such Regulations shall also include
a proper health protection mechanism for post-transplant care of a recipient to
be contributed to by Zakat, Baitul Maal, Non Government Organizations and
Philanthropists.
(8) An aggrieved person may give an application under his
own hand to the Transplant Monitoring Committee alongwith a copy of
Computerized National Identify Card and his contact number detailing therein
alleged offence under the Act;
provided that the Transplant Monitoring Committee may
investigate the complaint within 15 days of its lodging and, if found substantiated
as offence under the Act or rules made thereunder, make complaint in writing to
the court
provided further that if the complaint is found
unsubstantiated, informed the aggrieved person through written communication
including of the reasons.
12. Registration and functions of recognized
institution.– (1) An application for registration as recognized
institution or hospital shall be made to the Transplant Monitoring Committee as
specified in Form 11.
(2) The application shall be
accompanied by a fee of rupees one hundred thousand payable to the Transplant
Monitoring Committee by means of a bank draft or postal order provided that the
Authority may increase the fee.
(3) The Transplant Monitoring Committee
shall, after holding an inquiry and after satisfying itself that the applicant
has complied with all the requirements, grant a certificate of interim
registration as specified in Form 12 after physical inspection the hospital or
institution.
(4) The Transplant Monitoring Committee
shall grant a certificate of registration in Form 13 and it shall be valid for
a period of three years from the date of its issuance and it shall be
renewable.
(5) Every hospital or institution shall
maintain complete record of all transplants undertaken including details of the
donors.
(6) All such hospitals or institutions
shall report to the Transplant Monitoring Committee on the follow up of the
donor and the recipient as required under clause (c) of
subsection (2) of section 8.
(7) The hospital or institution shall
maintain the record of follow-up in a manner as laid down in Form 14 and Form
15.
(8) Transplant Registry Form (Form 16)
is to be submitted to Human Organ Transplant Authority on day of operation by
electronic mail or fax, followed by a hard copy by post.
13. Renewal
of registration.– (1) An application for the renewal
of a certificate of registration of hospital or institution shall be made to
the Transplant Monitoring Committee within a period of three months prior to the
date of expiry of the original certificate of registration and shall be
accompanied by a fee of rupees one hundred thousand payable to the Transplant
Monitoring Committee by means of a bank draft or pay order.
(2) A renewal certificate of
registration shall be issued as specified in Form 17 and shall be valid for a
period of three years.
(3) If, after an inquiry including
inspection of the hospital and scrutiny of its past performance and after
giving an opportunity to the applicant, the Transplant Monitoring Committee is
satisfied that the applicant, since grant of certificate of registration or
renewal of registration under these rules has not complied with the
requirements of the Act or the rules made thereunder and conditions subject to
which the certificate of registration has been granted, shall for reasons to be
recorded in writing, refuse to grant renewal of the certificate of
registration.
14. Essential
conditions for grant of certificate of registration.–
No hospital or institution shall be granted a certificate of registration
unless it fulfills the following requirements of manpower, equipment,
specialized services and facilities as laid down below:
(i) General Manpower Requirement
Specialized Services and Facilities:
(a) twenty four hours
availability of medical and surgical, (senior and junior) staff;
(b) twenty four hours
availability of nursing staff, (general and specialty trained);
(c) twenty four hours
availability of intensive Care Units with adequate equipments, staff and supports
system, including specialists in anesthesiology, intensive care;
(d) twenty four hours
availability of laboratory with multiple discipline testing facilities
including but not limited to Microbiology, Bio- Chemistry, Pathology and
Hematology and Radiology departments with trained staff;
(e) twenty four hours
availability of operation theatre facilities for planned and emergency
procedures with adequate staff, support system and equipment;
(f) twenty four hours
availability of communication system, with power backup, including but not
limited to multiple line telephones, public telephone systems, fax, computers
and paper photo-imaging machine;
(g) experts (other than the
experts required for the relevant transplantation) of relevant and associated
specialties including but not limited to and depending upon the requirements,
the experts in internal medicine, diabetology, gastroenterology, nephrology,
neurology, paediatrics, gynaecology, immunology and cardiology should be
available to the transplantation centre;
(ii) Equipment:
equipment as per current and expected
scientific requirement specify to organ or organs being transplanted and the
transplant centre should have the availability of the accessories, spare-parts,
back-up and maintenance service support system in relation to all relevant
equipment;
(iii) Experts and their
qualifications:
(a) kidney
transplantation (Surgeon): FCPS, Urology or equivalent qualification with three
years post FCPS or M.S. training in a recognized centre in Pakistan or abroad
and having attended to adequate number of renal transplantation as an active
member of team;
(b)
kidney transplantation (Nephrologist):
FCPS or equivalent qualification with three years post FCPS training in a recognized
centre in Pakistan or abroad and having attended to adequate number of renal
transplantation as an active member of team;
(c)
Transplantation of liver and other
abdominal organs: FCPS General Surgery or equivalent qualification with at
least three years post FCPS training in an established centre with reasonable
experience of performing liver transplantation as an active member of team;
(d)
Cardiac, pulmonary, cardio-pulmonary
transplantation: FCPS, Cardio-thoracic and vascular surgery or equivalent
qualification in Pakistan or abroad with at least three years’ experience as an
active member of the team performing an adequate number of open heart
operations per year and well-versed with coronary by- pass surgery and
Heart-Valve surgery; and
(e) Cornea
transplantation: FCPS, ophthalmology or equivalent qualification with at least
one year post FCPS training in a recognized hospital carrying out corneal
transplant operations.
15. Procedure of meetings of the Authority.
- (1) The Chairperson may call
meetings of the Authority for conduct of its business, at such time and places,
as he deems fit.
(2)
The Chairperson shall, on the request of not less than three Members, proceed
to call a meeting of the Commission within three days of the receipt of the
requisition.
(3)
The requisition, stating the objects of the meeting, shall be signed by the
Members and shall be deposited at the head office of the Authority.
(4)
The Chairperson may call a meeting of the Authority forthwith or within such
reasonable period depending upon the urgency of the proposed business.
(5)
At least three clear days notice shall be given to all the Members for a
meeting of the Authority and such notice shall set forth the purpose or
purposes for calling the meeting:
Provided
that the Chairperson may in his discretion, call a meeting at such shorter
notice or with such arrangements as he may deem fit.
(6)
The Chairperson shall preside at a meeting of the Authority but if at any
meeting, he is not present and has not designated a Member for the purpose, the
Members present shall choose a Member to preside at the meeting of the
Authority.
(7)
In the case of difference of opinion among the Members, the opinion of the
majority of the Members present at the meeting shall prevail and orders of the
Authority shall be expressed in terms of the views of the majority. Any Member
dissenting from the majority view may record his reasons separately. If the
Members are evenly divided in their opinion, the Chairperson or, as the case
may be, the Member chosen to preside at the meeting, shall have a second or
casting vote.
(8)
A fair and accurate summary of the minutes of all proceedings of the meetings
of the Authority, alongwith the names of those participating in such meetings
shall be entered in properly maintained books.
(9)
The Chairperson may invite any officer of the Authority and such other person
as deemed expedient to attend meetings of the Authority to assist it in the
proceedings but such officer or other person shall not participate in the
decision making of the Authority
(10)
The books containing the minutes of the meetings shall have a “subject index‟
of all the proceedings.
(11)
The draft minutes of the meetings of the Authority shall be circulated for
confirmation, to all the Members within three days of the conclusion of the
proceedings.
(12)
The minutes of the meetings as finalized after taking into account the
observations of the Members, if any, shall be placed before the next meeting of
the Authority for confirmation.
(13)
The proceedings of each meeting of the Authority shall be signed and dated by
the Chairperson, or in his absence, by the Member presiding over the meeting,
as soon as may be, after the confirmation of the minutes and the proceedings so
signed shall be conclusive evidence of the proceedings recorded therein.
(14)
The decisions taken in a Authority meeting shall be circulated to Members of
the Authority and the others concerned for necessary action.
(15)
The Chairperson may authorize, with justification, an emergent matter to be
disposed of through a resolution by circulation:
Provided
that the resolution by circulation shall be signed by all the Members and, in
case of absence from Pakistan of any of the Members, by at least three Members.
16. Removal
of non-official member before completion of tenure: – (1) If a non-official member fails to attend three consecutive
meetings, without obtaining leave of absence from the Chairperson of the
Authority, such member shall be deemed to have resigned from the Authority.
(2) Government may, for reasons to be
recorded in writing, remove a non-official Member during his tenure if ;
(a) he has any interest
which is or may be in conflict with the interest of the Authority;
(b) he
has been convicted of any offence involving moral turpitude or has been held to
be liable in a proceeding under the Act.
(c) he is or has become
physically or mentally incapable of performing his functions
17. Financial and Accounting rules:---(1) The accounts of the authority shall
be maintained in such form and in such manner as Government may determine in
consultation with the Auditor General.
(2) The
Administrator shall be the Principal Accounting Officer of the Authority. He
shall be the Drawing and Disbursing Officer for the personal ledger accounts or
Special Drawing Account at the Treasury.
(3) The
Administrator shall be assisted by the Director Finance to be appointed by
Health Department in consultation with the Finance Department to head the
Finance and Accounts branch. The Director Finance shall be a BS-18 or 19
officer of Government with ten years experience in the relevant field.
(4) The
Authority in its dealing with financial matters shall follow the instructions
made by Government from time to time.
(5) With
the approval of the Authority, the Director Finance shall make arrangements for
the financial management of the institution. The pre-audit of all claims shall
be conducted. Monthly reconciliation of expenditure and receipts between the
accounts/finance branch and Audit Office and the Treasury or Banks.
(6) Any
difference arising on financial issues between the Administrator and the
Director Finance shall be placed before the Authority and subsequently to the
Finance Department, for final decision, through the Health Department.
18. .Fund
Management.---(1)
All moneys received by the Authority, by grant in aid by Government, donations,
users charges, rents, fees or on any other source
shall constitute its fund. Grant-in-aid shall be kept in the Profit and Loss
Account and the amounts may be transferred to the bank to be operated in the
name of the Authority.
(2) All
disbursements shall be made out of the fund, under the order of the
Administrator. All cheques for payment must bear joint signatures, that is the
signature of the Administrator and the signature of the Director Finance.
(3) Funds
not require for immediate use, may be invested in Government securities like
treasury bills with the approval of the
Authority in accordance with the policy of Government.
(4) There shall be endowment fund to which shall be
credited an appropriate percentage of such receipts as may be determined by the
Authority.
19. Budget.---(1) The Director Finance shall, prepare
and submit the Annual Budget within the limits of the available funds to the
Authority through the Administrator for its
approval before the commencement of each financial year.
(2) The
Director Finance shall, prepare the revised budget estimate in the month of
December or with the approval of the Authority and furnish to the Finance
Department, after the receipt of revised estimate, the Finance Department will
hold the meetings with the authority through Administrator on proper time.
Similarly, the budget estimates are to be prepared, finalized and approved
from the Authority in the month of February and shall be forwarded to the
Finance Department in the month of March.
(3) No
contingent liability shall be created by the Authority, for which funds have
not been earmarked in the budget.
20. Complaint Management System:1)---The
authority shall have a complaint Management system under the Transplant Inquiry
Committee for receiving, managing and resolving complaints submitted to it or
the Transplant Inquiry Committee, or taken up by it on its own, as per the provisions of the Act including
sub-sector(2)of section 15.
2) The
Transplant Inquiry Committee may, on its own or through a committee of no less
than three of its member, hold an inquiry into the complaint and finalize
recommendations. In case the complaint is genuine, this Transplant Inquiry
Committee may refer it to the court, however in case of otherwise it may inform
the complainant after recording the reasons in writing on the complaints
received, provided in such a case the aggrieved party may, within thirty days
from the date of communication of the order of the Transplant Inquiry
committee, prefer an appeal in writing to the Authority whose decision shall be
final.
21. Registration of a Complaint. (1) An aggrieved person shall make a
Complaint to the Transplant Inquiry Committee in line with the Complaint
Management System as established under Rule-20
(2) If the Complaint of the Aggrieved
person is not addressed by the Transplant Inquiry Committee within thirty (30)
days from the date of submission of the complaint, the Aggrieved person may
make a Complaint to the Authority as provided in the Act,.
(3) Every Complaint should be
accompanied by an affidavit, bearing signature or the thumb impression, as the
case may be, and it should be duly notarized or attested by an authorized
member of the staff of the Transplant Inquiry Committee. The Affidavit should
clearly indicate that the information provided in the Complaint are true to the
best knowledge of the Complainant; no suit, appeal or any proceedings are
pending in any court of competent jurisdiction regarding the complaint; no allegation
in the Complaint is made without reasonable and justifiable ground (s) and
without any malicious intent to defame, harass, embarrass and/or pressurize the
party complained against.
(4) Every Complaint shall also be
accompanied by a copy of the computerized National Identity Card, address of
the aggrieved person, Medical records (if any), correspondence with the
recognized institution (if any) and other documents in support of the
Complaint.
(5) In case the Complaint is proved to
be false, the Complainant shall be liable to pay fine, which may extend to two
hundred thousand (Rs. 200,000/-).
(6) The
Transplant Inquiry Committee shall not entertain the complaint if
(a) It is
not accompanied by the requisite affidavit as elaborated in the Rules.
(b) The complaint
is anonymous or pseudonymous;
(c) The
Complaint is time barred under sub-rule 2 of the Rule 45;
(d) The
subject matter is sub-judice before a court of competent jurisdiction on the
date of receipt of the complaint;
(e) The
subject matter of the Complaint does not fall within the purview of the Act.
22. Receipt
and Registration of the Complaint. (1)
The Transplant Inquiry Committee after receiving the Complaint shall review it
to decide on its maintainability in accordance with the Act and these Rules. If
the Complaint is maintainable, the Transplant Inquiry Committee shall issue
acknowledge receipt to the Complainant and notices to the party (ies)
complained against.
23. Scope
of Complaints. (1) The Transplant
Inquiry Committee may accept a Complaint regarding medical negligence,
maladministration, malpractice or failure in provision of the services in
accordance with the Act and these Rules.
(2) A “recognized Institution or
Transplant Surgeon or Physician” may be declared guilty of medical negligence
on one of the following two findings:-
(a) The recognized Institution where a
Transplant Surgeon or Physician renders services does not have the requisite
human resource and equipment which it professes to have possessed; or
(b) The Transplant Surgeon or Physician
or any of his associates do not possess the skills that they claim to possess,
or they fail to exercise reasonable competence while rendering transplant
Services.
(3) The recognized and known complications of a
medical or surgical treatment are not considered as medical negligence.
(4) A complaint may be rejected in limine if
the same is incompetent and/or is not maintainable under the Act and these
Rules, or does not require any other investigation for any other reason in view
of the Transplant Inquiry Committee.
(5) If the complaint has been rejected by the
Transplant Inquiry Committee under sub-rule 4 of the Rule 22, the Complainant, may within thirty (30) days from
the date of the receipt of the decision of the Transplant Inquiry Committee,
may file a Representation before Authority challenging the same.
(6) The decision of Authority on the
Representation shall be final.
24. Severity
of Complaint. (1) The
severity of an act of medical negligence, maladministration, malpractice, or any
other act or omission that resulted in compromised Transplant service will be
categorized as;
(a) Severe – which has resulted in or
contributed to the death of the patient
(b) Moderate – which has resulted in or
contributed to the permanent loss of function of a part of body
(c) Mild – which has resulted in or
contributed to the temporary loss of function of a part of body, or it has
delayed the process of recovery from a medical condition
(2) The Transplant Inquiry Committee after
ascertaining the severity of a Complaint as per provision in the sub-rule 1 of
the Rule 23 of these Rules, may recommend the
concerned recognized institution for penalty to the Authority as below:
(a) For cases of severe and moderate
nature – A fine which may extend up to one million Rupees (Rs. 1,000,000/-)
and/or Closure of recognized institution or both with reference to the
professional bodies for taking action under their rules and laws.
In
cases where criminal negligence has been proved, the matter may also be referred by
the Authority through the Transplant Monitory Committee for criminal
proceedings under the PPC and CrPC to the court.
(b) For cases of moderate nature – A
fine which may extend up to five hundred thousand Rupees (Rs. 500,000/-) and/or
Closure of the recognized institution.
(c) For cases of mild nature – A fine
which may extend up to five hundred thousand Rupees (Rs. 500,000/-).
25. Confidentiality of the Information. It shall be the duty of all involved
in any proceedings pending before the Authority or any of its committee under
the Act to keep all the information brought before them including but not
limited to the details of the proceedings, confidential.
26. Regulations:- In all matters not expressly
provided for in the Act or Rules the Authority may make regulations not
inconsistent with the Act or Rules.
SECRETARY TO GOVERNMENT OF KHYBER
PAKHTUNKHWA
HEALTH DEPARTMENT
Khyber
Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017
FORM 1
(To be completed by the prospective close blood donor) [Refer rule]
(To be completed by the prospective close blood donor) [Refer rule]
My
full name is
..................................................................................................................
and this is my photograph
..................................................................................................................
and this is my photograph
Photograph of the Donor
(Attested by Notary Public)
My
permanent Home address is ........................................................................................................................................................................................................................................................................................................................................................
Tel........................................................................
My
present Home address is:
........................................................................................................................................................................................................................................................................................................................................................Tel..........................................................................
Date
of birth........................................................................................................................
(Day/month/year)
·
National Identity Card number and Date
of issue & place.........................................
and / or
·
Form B of National Data Registration
Authority (NADRA) of that family unit.
and / or
·
Passport number and country of issue…….................................................................
where available (photocopy attached)
and/ or
·
Driving License number, Date of issue,
licensing authority.....................................
where available (photocopy attached)
And/ or
·
Other proof of identity and
address............................................................
I hereby authorize removal for the
therapeutic purposes/ consent to donate my.............................................
(state which organ) to my relative .................................... (specify son/ daughter/ father/ mother/
brother/ sister), whose name is
............................................................................................
and who was born on .........................................................................
(day/ month/ year) and whose particulars are as follows:
Photograph of the Recipient
(Attested by Notary Public)
·
National Identity Card number and Date
of issue & place.............................
(Photocopy attached)
(Photocopy attached)
and / or
·
Form B of National Data Registration
Authority (NADRA) of that family unit.
and / or
·
Passport number and country of issue.......................................................................
where available (Photocopy attached)
and/ or
·
Driving License number, Date of issue,
licensing authority......................................
Where available (photocopy attached)
and/ or
·
Other proof of identity and
address.............................................................................
I
solemnly affirm and declare that:
Sections 2, 3 and 11 of The Khyber
Pakhtunkhwa Transplantation of Human Organs and Tissues Ordinance 2017
have been explained to me and I confirm that:
1.
I understand the nature of criminal offences
referred to in the Sections.
2.
No payment of money or money’s worth as
referred to in the Sections of the
Act has been made to me
or will be made to me or any other person.
3.
I am giving the consent and
authorization to remove my........................... (Organ). of my own free will without any undue pressure,
inducement, influence or
allurement.
4.
I have been given a full explanation of the nature of the
medical procedure
involved and the risks involved for me in the removal of my
..................................................................... (organ).
That explanation was given by ........................................... (name
of recognized transplant surgeon or physician).
5. I
understand the nature of that medical procedure and of the risks to me as explained by
that practitioner.
6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes place.
7. I state that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed by me.
6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes place.
7. I state that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed by me.
....................................
........................ …………………………………
Signature
of the prospective donor Date
Note:
To be sworn before Notary Public, who while attesting shall ensure that the
person/ persons swearing the affidavit(s) sign(s) on the Notary Registrar, as
well.
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017 FORM 2
(To be completed by the prospective spousal donor)
[Refer rule 3]
(To be completed by the prospective spousal donor)
[Refer rule 3]
My
full name is ……………..................................................................................................................
and this is my photograph
Photograph of the Donor
(Attested by Notary Public)
My
permanent Home address is:
........................................................................................
..................... .......................................................................................................................
Tel............................................................................
My
present Home address is: .............................................................................................
..........................Tel..................................Date of birth .................................................
.........(day/month/year)
I authorize to removal for therapeutic purposes/ consent to donate my
I authorize to removal for therapeutic purposes/ consent to donate my
................................................................
(state which organ) to my husband/wife ………………………………….whose full name is …..……............................
................................ and who was born on ........................................................ (day/
month/ year) and whose particulars are as follows:
(Photograph
of the Recipient)
(Attested by Notary Public)
·
National
Identity Card number and Date of issue & place.................................
and / or
·
Passport
number and country of issue................................................................
where
available (photocopy attached)
and/ or
·
Driving License number, Date of issue,
licensing authority ……..............................
· where available (photocopy attached)
and/
or
· Other proof of identity and address…………......................................
I submit the following evidence of being married to the recipient:-
· Certified copy of a marriage certificate.
or
· an affidavit of a ‘close blood
relative’ confirming the status of marriage to be sworn before Class-I
Magistrate / Notary Public.
· Family photographs/ marriage
photographs.
· Letter from Nazim/ Councilor certifying
factum and status of marriage.
· Other credible evidence including the
Form B of National Data Registering Authority (NADRA) of that family unit.
I
solemnly affirm and declare that:
Sections 2, 3 and 11 of The Khyber Pakhtunkhwa Transplantation of
Human Organs and Tissues Ordinance 2017
have been explained to me and I confirm that:
1.
I understand
the nature of criminal offences referred to in the Sections.
2.
No
payment of money or money’s worth as referred to in the Sections of the Ordinance
has been made to me or will be made to me or any other person.
3.
I am
giving the consent and authorization to remove my...................................
(organ) of my own free will without any undue pressure, inducement, influence
or allurement.
4.
I have
been given a full explanation of the nature of the medical procedure
involved and the risks involved for me
in the removal of my ....................................(organ). That
explanation was given by ...........................................(name of
recognized transplant surgeon or physician).
5.
I
understand the nature of that medical procedure and of the risks to me as
explained by that practitioner.
6.
I
understand that I may withdraw my consent to the removal of that organ
at any time before the operation takes place.
7.
I state
that particulars filled by me in the form are true and correct to my knowledge
and nothing material has been concealed by me.
.................................... ..............................................
Signature of the prospective donor Date
Note: To
be sworn before Notary Public, who while attesting shall ensure that the
person/ persons swearing the affidavit(s) sign(s) on the Notary Registrar, as
well.
Khyber
Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017 FORM 3
(To be completed by the prospective non close blood donor)
[Refer rule 3]
(To be completed by the prospective non close blood donor)
[Refer rule 3]
My full name is ........................................................................................................
and this is my photograph
Photograph
of the Donor
(Attested by Notary Public)
My permanent Home address is: ..........................................................................................................................................................................................................................................………………..
Tel:……………………………................................................................................
My present Home address: is................................................................................... Tel.......................................................................
My present Home address: is................................................................................... Tel.......................................................................
Date of birth................................................................................(day/
month/ year)
·
National Identity Card number and Date
of issue & place....................................
· (photocopy attached)
and / or
·
Passport number and country of
issue...........................................................
where available
(photocopy attached)
and/ or
·
Driving License number, Date of issue,
licensing authority .................................
where available (photocopy attached)
and/ or
·
Other proof of identity and
address............................................................
·
Details of last three years income and
vocation of donor .............................................................................................................................................
...................................................
·
A description of the relationship /
interaction with the recipient in the past.................................................................................................................
I hereby authorize to remove for
therapeutic purposes/ consent to donate my
............................................. (state which organ) to a person
whose full name is ................................................ and who was
born on ................................. (day/ month/ year) and whose
particulars are
Photograph
of the Donor
(Attested
by Notary Public)
· National Identity Card number and Date of issue &
place....................................
(photocopy attached)
and / or
· Passport number and country of
issue...........................................................
where available (photocopy attached)
and/ or
·
Driving License number, Date of issue,
licensing authority .................................
where available
(photocopy attached)
and/ or
· Other proof of identity and
address.............................................................................
I solemnly affirm and declare that:
Sections 2, 3 and 11 of The Khyber Pakhtunkhwa Transplantation of
Human Organs and Tissues Ordinance 2017
have been explained to me and I confirm that:
1.
I understand
the nature of criminal offences referred to in the Sections.
2.
No
payment of money or money’s worth as referred to in the Sections ofthe
Ordinance has been made to me or will be made to me or any other person.
3.
I am
giving the consent and authorization to remove my..................... (organ) of my own free will without any undue
pressure, inducement, influence or
allurement.
4.
I have
been given a full explanation of the nature of the medical procedure involved
and the risks involved for me in the removal of my ................................(organ),
that explanation was given by ........................................... (name
of recognized transplant surgeon or physician).
5.
I
understand the nature of that medical procedure and of the risks to me as
explained by that practitioner.
6.
I
understand that I may withdraw my consent to the removal of that organ at any time before the operation takes
place.
7.
I state
that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed
by me.
........................................................ ………………………………………
Signature of the prospective donor Date
Note: To
be sworn before Notary Public, who while attesting shall ensure that the
person/ persons swearing the affidavit(s) sign(s) on the Notary Registrar, as
well.
Khyber Pakhtunkhwa Medical Transplantation Regulatory
Authority Rules, 2017
FORM.4
(To be completed by the recognized transparent surgeon or physician)
[Refer.rule.5(1)(d)]
I Dr. ................................................................................. Processing qualification of………………............................... registered as medical practitioner at serial no ......................................................................by the......................................................... Medical Council, certify that I have examined Mr./ Mrs. Ms. ……………… …… .. . . .......................... S/o, D/o, W/o........................................... .......aged ........... ...... ...... ..................who has given informed consent about donation of the organ, namely...... ..........................................to Mr./ Mrs./ Ms. ........................ ............... ............. ....... ... ...... who is a ‘close blood relative’ of the donor/ non close blood relative of the donor, who had been approved by the Transplant Evaluation Committee and that the said donor is in proper state of health and is medically fit to be subjected to the procedure of organ removal.
(To be completed by the recognized transparent surgeon or physician)
[Refer.rule.5(1)(d)]
I Dr. ................................................................................. Processing qualification of………………............................... registered as medical practitioner at serial no ......................................................................by the......................................................... Medical Council, certify that I have examined Mr./ Mrs. Ms. ……………… …… .. . . .......................... S/o, D/o, W/o........................................... .......aged ........... ...... ...... ..................who has given informed consent about donation of the organ, namely...... ..........................................to Mr./ Mrs./ Ms. ........................ ............... ............. ....... ... ...... who is a ‘close blood relative’ of the donor/ non close blood relative of the donor, who had been approved by the Transplant Evaluation Committee and that the said donor is in proper state of health and is medically fit to be subjected to the procedure of organ removal.
Place...................................... ……………………………..
Date................................................................
Signature
of Doctor Seal
 |
Photograph of the Donor
Photograph of the Recipient
(Attested by doctor) (Attested by doctor)
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017 . FORM 5
(To be completed by the recognized transplant surgeon or physician)
[Refer rule 5(1)(e)]
I, Dr. .................................................... Processing qualification of …… …...... .. .................... ............................. registered as medical practitioner at serial no. .............................................................................. by the................................ Medical Council, certify that- (i).Mr.................................................S/o Mr....................aged........................Resident of ……………..........................and Mrs.............................d/o, W/o Mr..................................................... aged .........................Resident of ............ ....................................................... are related to each other as spouse according to the statement given by them and their statement has been confirmed by means of following evidences by Transplant Evaluation Committee before effecting the organ removal from the body of the said Mr./ Mrs./ Ms. .........................................
(To be completed by the recognized transplant surgeon or physician)
[Refer rule 5(1)(e)]
I, Dr. .................................................... Processing qualification of …… …...... .. .................... ............................. registered as medical practitioner at serial no. .............................................................................. by the................................ Medical Council, certify that- (i).Mr.................................................S/o Mr....................aged........................Resident of ……………..........................and Mrs.............................d/o, W/o Mr..................................................... aged .........................Resident of ............ ....................................................... are related to each other as spouse according to the statement given by them and their statement has been confirmed by means of following evidences by Transplant Evaluation Committee before effecting the organ removal from the body of the said Mr./ Mrs./ Ms. .........................................
Place.....................................................................
…………………………………..
Date.....................................
Signature
of Doctor Seal
Khyber Pakhtunkhwa Medical Transplantation Regulatory
Authority Rules, 2017
FORM 6A
(To be completed by person in his / her lifetime revoking his/ her authorization to donate his / her organs / tissues after death)
(To be completed by person in his / her lifetime revoking his/ her authorization to donate his / her organs / tissues after death)
[Refer rule 4(2)]
I .............................................................................. S/o, d/o, w/o Mr.......................... .... ..........aged ..............................Resident of.............................................................. ................in the presence of persons mentioned below hereby unequivocally revoke my authorization dated ........................................................................... and after my death my organ/organs, namely ...................................................... shall not be removed from my body for therapeutic purposes.
I .............................................................................. S/o, d/o, w/o Mr.......................... .... ..........aged ..............................Resident of.............................................................. ................in the presence of persons mentioned below hereby unequivocally revoke my authorization dated ........................................................................... and after my death my organ/organs, namely ...................................................... shall not be removed from my body for therapeutic purposes.
Date.....................................
……………………………
Signature
of Donor
Signature..................................................
Witnesses
(1). Mr./ Mrs./ Ms. .......................................................... S/o, D/o, W/o, Mr.....................................................aged..............................resident of…..................... ............................................................................................................................................................................Tel....................................
(1). Mr./ Mrs./ Ms. .......................................................... S/o, D/o, W/o, Mr.....................................................aged..............................resident of…..................... ............................................................................................................................................................................Tel....................................
Signature:
...............................................................
(2). Mr./ Mrs./ Ms.
.......................................................... S/o, D/o, W/o,
Mr.....................................................aged………………………………..............................resident
of .............................................................................................................
.................................................................................Tel....................................is
a close blood relative to the donor as
.........................................................................................
Date
.............................................
Khyber Pakhtunkhwa Medical Transplantation Regulatory
Authority Rules, 2017
FORM.7
(To be filed by a person having lawful possession of the dead body)
(To be filed by a person having lawful possession of the dead body)
[Referrule5(2)(d)]
I ............................................................ S/o, d/o, w/o Mr, ..............................aged ......... ............. resident of .................................................................................. .................................................. having lawful possession of the dead body of Mr./ Mrs./ Ms.......................................................s/o/d/o/w/o Mr…….............................................. ..................aged of............................ resident of ...................................................... ........................................................ having known that the deceased has singed Form 6 for therapeutic purposes after his/ her death and also having reasons to believe that no close blood relative of the said deceased person has objection to any of his/ her organ being used for therapeutic purposes, authorize removal of the body organs, namely...........................................................
I ............................................................ S/o, d/o, w/o Mr, ..............................aged ......... ............. resident of .................................................................................. .................................................. having lawful possession of the dead body of Mr./ Mrs./ Ms.......................................................s/o/d/o/w/o Mr…….............................................. ..................aged of............................ resident of ...................................................... ........................................................ having known that the deceased has singed Form 6 for therapeutic purposes after his/ her death and also having reasons to believe that no close blood relative of the said deceased person has objection to any of his/ her organ being used for therapeutic purposes, authorize removal of the body organs, namely...........................................................
.........................................................
Signature
Date:.....................................
Place..................................................
Person in lawful possession of the dead body Address;
Place..................................................
Person in lawful possession of the dead body Address;
.......................................................................................................................................
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM 8
(To be filled by the Board of Medical Experts)
[Refer rule 5(3)(a)]
(To be filled by the Board of Medical Experts)
[Refer rule 5(3)(a)]
We, the following members of the Board
of Medical Experts after careful personal examination,
hereby certify that Mr./Mrs./Ms............................... .......................aged........................ S/o, d/o, w/o...................................................................resident of............................... ...........................................................................................................................................is dead on account of permanent an irreversible cessation of all functions of the brain-stem. The tests carried out by us and the findings therein are recorded in the brain-stem death certificate annexed hereto.
hereby certify that Mr./Mrs./Ms............................... .......................aged........................ S/o, d/o, w/o...................................................................resident of............................... ...........................................................................................................................................is dead on account of permanent an irreversible cessation of all functions of the brain-stem. The tests carried out by us and the findings therein are recorded in the brain-stem death certificate annexed hereto.
Date.....................................
Signature.............................................
1. Medical Director or Medical Superintendent
of the Hospital
2. A neurosurgeon/neurophysician; and
3. An intensivist.
3. An intensivist.
BRAIN-STEM
DEATH CERTIFICATE
(A). Patient Details:
1. Name of the patient: Mr. Mrs./Ms..................................................................................................S/o, d/o, w/o………………………………………………………….......
Sex: Male……………………Female…………………………..Age.................... years
1. Name of the patient: Mr. Mrs./Ms..................................................................................................S/o, d/o, w/o………………………………………………………….......
Sex: Male……………………Female…………………………..Age.................... years
2.Address.................................................................................................................
Tel#...........................................................................................................................
Tel#...........................................................................................................................
3. Hospital
Number........................................................................................
4. Name
and address of next of kin of person responsible for the patient (if none
exist, this must be specified).
.......................................................... ...............
resident of.................................................................................................
5. Has the patient or next kin agreed
to any transplant?
.................................................................
6. Is this a police case? yes No
(B) Pre-conditions:
1. Diagnosis: Did the patient suffer from any illness or accident that led to irreversible brain damage? Specify details
1. Diagnosis: Did the patient suffer from any illness or accident that led to irreversible brain damage? Specify details
....................................................................................................................................................................................................................................................................
Date and time of accident/ onset of illness............................................................
Date and onset of no-responsible coma?.............................................................
2. Finding of Board of Medical Experts:
(1) The
following reversible causes of coma have been excluded:
Intoxication (Alcohol)
Depressant Drugs
Relaxants (Neuromuscular Blocking agents)
Relaxants (Neuromuscular Blocking agents)
Others
|
First Medical
Examination
1st
2nd
|
Second Medical Examination
1st
2nd
|
Primary hypothermia
Hypovolemic shock
Metabolic or endocrine Disorders
Tests for absent of Brain stem
functions
2. Coma
3. Cessation of spontaneous breathing
4. Pupillary size
5. Pupillary light reflexes
6. Dolt’s Head eyes movement
7. Corneal reflexes (Both Sizes)
8. Motor response in any cranial nerve distribution, any responses to simulation of face, limb or trunk
9. Gag reflex
10. Cough (Tracheal)
11. Eye movements on caloric testing bilaterally
12. Apnea tests as specified
13. Were any respiratory movements seen?
............................................................................................................................................
3. Cessation of spontaneous breathing
4. Pupillary size
5. Pupillary light reflexes
6. Dolt’s Head eyes movement
7. Corneal reflexes (Both Sizes)
8. Motor response in any cranial nerve distribution, any responses to simulation of face, limb or trunk
9. Gag reflex
10. Cough (Tracheal)
11. Eye movements on caloric testing bilaterally
12. Apnea tests as specified
13. Were any respiratory movements seen?
............................................................................................................................................
Date and time of first testing................................................................................
Date and time of second testing.............................................................................
This to
certify that the patient has been carefully examined twice after an interval of
about six hours and on the basis of findings recorded above.
Mr./ Mrs. Ms......................................................................... is declared brain- stem dead.
Mr./ Mrs. Ms......................................................................... is declared brain- stem dead.
1. Medical Director or Medical Superintendent
of the Hospital
2. A neurosurgeon/neurophysician; and
3. An intensivist.
3. An intensivist.
NB.
The minimum time interval between the
first testing and second testing will be six hours.
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM
6
(To
be completed by person in his / her lifetime and willing to donate his/ her
organ / tissues after death)
[Refer rule 4(1)]
I ........................................ S/o, d/o, w/o Mr, ............................................... aged .................... resident of .......................................................................................... ..... .......................................... ................................................................................in the presence of persons mentioned below hereby unequivocally authorize the removal of my body organs, namely ................................................................................. ................................. from my body after my death for therapeutic purposes.
[Refer rule 4(1)]
I ........................................ S/o, d/o, w/o Mr, ............................................... aged .................... resident of .......................................................................................... ..... .......................................... ................................................................................in the presence of persons mentioned below hereby unequivocally authorize the removal of my body organs, namely ................................................................................. ................................. from my body after my death for therapeutic purposes.
.........................................................
Signature of the donor
Date.....................................
Signature.................................
Witnesses
(1). Mr./ Mrs./ Ms. .......................................................... S/o, D/o, W/o, Mr.....................................................aged..............................resident of................. .........................................................................................................................................................................................Tel....................................
(1). Mr./ Mrs./ Ms. .......................................................... S/o, D/o, W/o, Mr.....................................................aged..............................resident of................. .........................................................................................................................................................................................Tel....................................
Signature)...............................................................
(2). Mr./
Mrs./ Ms. .......................................................... S/o, D/o,
W/o,
Mr.....................................................aged..............................resident
of ……….......... ......................................................................................................................................................................................Tel....................................as
a close blood relative to the donor as……………….....................................................................................
Date .............................................
Date .............................................
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017 FORM 9
(to be filed by either parent of dead child under 18 years)
(to be filed by either parent of dead child under 18 years)
[Refer
rule 5(3) (b)]
I Mr. / Mrs./ Ms.................................................................. Son of, wife of…….... ............................. resident of ………………......................................................... ....................................................... hereby authorize removal of the organ/ organs namely........................................ For therapeutic purposes from the dead body of my son/ daughter, Mr/ Mrs. .......................................... aged .......................................... whose brain stem death has been duly certified in accordance with the law
I Mr. / Mrs./ Ms.................................................................. Son of, wife of…….... ............................. resident of ………………......................................................... ....................................................... hereby authorize removal of the organ/ organs namely........................................ For therapeutic purposes from the dead body of my son/ daughter, Mr/ Mrs. .......................................... aged .......................................... whose brain stem death has been duly certified in accordance with the law
Signature..............................................
Name
.................................................
Place.......
..........................................
Date
..................................................
Khyber
Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017
FORM
10
Application
for Approval for Transplantation (Live Donor)
(To
be completed by the proposed recipient and the proposed donor)
[Rule
5(1) (a)]
Photograph of the Donor Photograph
of the Donor
(Self-attested) (Self-attested)
Whereas
I .............................................................
S/o, w/o ............................................................ .............
aged .................................... residing at .............................................................
have been advised by my doctor
.......................................................................that I
am suffering from.......................... .....................................
and may be benefited by transplantation of.................................into
my body.
And whereas I
...........................................s/o, d/o,
w/o..................................... aged ....................................
residing at........................................................ by the
following reason(s):-
a)
by virtue of being a close blood
relative i.e.
b)
by reason of affection/attachment/other
special reason as explained below:-
...................................................................................................................................................................................................................................................................................................................................................
I would therefore like to donate my
....................................... to Mr./ Mrs/ Ms......................
We.........................................................and.......................................................................
(Donor) (Recipient)
To be self attested across the affixed
photograph hereby apply to Transplant Evaluation Committee for permission for
such transplantation to be carried out.
We solemnly affirm that the above
decision has been taken without any undue pressure, inducement, influence or
allurement and that all possible consequences and options of organ
transplantation have been explained to us.
Instructions for the applicants:-
1.
Form B
must be submitted along with the completed Form 1(A), or Form 1(B) of Form 1(c)
as may be applicable.
2.
The
applicable Form i.e. Form 1(A) or Form 1(B) or Form 1(C) as the case may be,
should be accompanied with all documents mentioned in the applicable form and
all relevant queries set out in the applicable form must be adequately
answered.
3.
Laboratory
report soft issue typing.
4.
The
doctor’s advice recommending transplantation must be enclosed with the
application.
5.
In addition
to above, in case the proposed transplant is between non close blood relative,
appropriate evidence of vocation and income of the donor as well as the
recipient preferably for the last three years must be enclosed with this
application. It is clarified that the evidence of income does not necessarily
mean the proof of income tax returns, keeping in view that the applicant(s) in
a given case may not be filing income tax returns.
6.
The application
shall be accepted for consideration by the Evaluation Committee only if it is
complete in all respects and any omission of the documents or the information
required in the forms mentioned above, shall render the application incomplete.
7.
A brief
description of relationship / interaction in the past in case of non close
blood relative.
We have read and understood the above
instructions.
................................. .......................................
Signature of the prospective donor Signature
of Prospective
Recipient
Date.....................................
Date.....................................
Place…………………......... Place
.......................................
Khyber
Pakhtunkhwa Medical Transplantation Regulatory Authority Rules, 2017
FORM 11
RECOGNITION
OF INSTITUTION/ UNIT FOR TRANSPLANTATION
To
be completed and sent to the Transplant Monitoring Committee, Ministry of
Health, Islamabad. Email. Secretary@health.gov.pk
Name of the Institution: _____________________________________________
Mailing Address ______________________________________ Tel No.______________________
_____________________ Fax no._____________________________________ Email__________________________________
Mailing Address ______________________________________ Tel No.______________________
_____________________ Fax no._____________________________________ Email__________________________________
Name of the Head of the Institution
_________________________________________________________________Designation_________________________________Mailing
address _________ ______________________________________________________________________________________________________Tel
No._____________________ Fax no. ______________________________
Email__________________________________
Name of institution
Public Sector Private
Any
other ____________________________
Units/ departments accredited with CPSP/PMDC/University _________________________________________________________________
Units/ departments accredited with CPSP/PMDC/University _________________________________________________________________
|
Sr. No.
|
Name of Specialty
|
Accreditation Authority
|
Name of Deptt. Heads with
postgraduate qualification
|
|
1.
|
Urology
(Kidney Transplant) |
|
|
|
2.
|
Nephrology
(Kidney Transplant)
|
|
|
|
3.
|
GI
and Hepatology
(Liver & Intestinal transplant) |
|
|
|
4.
|
Pulmonology
(Lung Transplant)
|
|
|
|
5.
|
Cardiology
(Cardiac Transplant) |
|
|
|
6.
|
Hematology
(BMT, Stem Cell Transplant) |
|
|
|
7.
|
Radiology
|
|
|
|
8.
|
Anesthesiology
|
|
|
|
9.
|
Pathology
|
|
|
(Provide list of faculty in all
specialties with qualification and experience in Transplantation as Annexure)
Total
beds in the institution:____________ Male _________ Female___________ Children
_____________
No. of
CPDs ___________ Attendance/ year Male _________ Female _________ Children_________________
Total beds of Transplant Unit:____________ Male _________ Female _________ Children _______________
Total beds of Transplant Unit:____________ Male _________ Female _________ Children _______________
SUPPORT
FACILITIES Blood Bank
Blood Bank proposed? Yes No
If no, please specify about
shortage___________________________
Are cross matching facilities
available? Yes No
Are blood products available in house? Yes No
If no, what arrangements are in place for 24 hours availability________________
(Attach separate sheet if required)
If no, what arrangements are in place for 24 hours availability________________
(Attach separate sheet if required)
Laboratory
Please supply a list of tests, which
are done in the laboratory in the following area. (Attach spate sheet if
required)
Bio-Chemistry _________________________________________________________________Histopathology _________________________________________________________________Microbiology _________________________________________________________________ Immunology _________________________________________________________________Drug Monitoring _________________________________________________________________Radiology
Bio-Chemistry _________________________________________________________________Histopathology _________________________________________________________________Microbiology _________________________________________________________________ Immunology _________________________________________________________________Drug Monitoring _________________________________________________________________Radiology
Please furnish a list of radiological
tests routinely carried out in the institution (Attach separate sheet if
required)
Specified diagnostic facilities:
|
Ultrasound
|
Yes
|
No
|
MRI
|
Yes
|
No
|
|
CT Scan
|
Yes
|
No
|
Radioisotope
|
Yes
|
No
|
|
Doppler
|
Yes
|
No
|
Portable X-ray
|
Yes
|
No
|
Intensive Care Unit
If yes
No. of ICU beds with high and monitoring and ventilation _________________________
Number of Monitors_____________________________________________ Total Ventilators available_______________
Number of Monitors_____________________________________________ Total Ventilators available_______________
AGB machine in ICU Yes No Other
facilities
__________________________________________________________________________________________________________________________________
Dialysis Yes No Availability of dialysis
facility in ICU Yes No
If yes
No. of Dialysis in hospital _____________ Number of sessions/ day
________________
If the following specialties are not
available in house please mention the arrangements for access at all times
(Attach separate sheet if needed).
Cardiology
_________________________________________________________________
Pulmonology
_________________________________________________________________
GI/Hepatology
_________________________________________________________________
Infectious Disease
_________________________________________________________________
Neurology
_________________________________________________________________
Orthopedics
Operation Theatre and Anesthesiology
Please provide List of Equipment for
transplant surgery as annexure.
Record Keeping
Systems of storage and retrieval of
records _________________________________________________________________Do you
produce Annual Report? Yes No
(if yes please furnish the copy of
annual report of last year)
How are the case records maintained? Manual No computerized
How are the case records maintained? Manual No computerized
Library Yes No
Working days of the Library_____________________Daily working hours_______________
(Please provide the list of Textbooks of Transplant Sciences and Journals available in the Institution Department)
Working days of the Library_____________________Daily working hours_______________
(Please provide the list of Textbooks of Transplant Sciences and Journals available in the Institution Department)
Research Facilities
No. of in
hand projects and title of research conducted by the faculty of the department:
(Attach separate sheet if needed)
_____________________________________________________________________
_____________________________________________________________________
|
Additional Essentials Activities/
Facilities
Nursing : |
Adequate number and of sufficient
seniority to cover transplant ward and ICU
|
|
Medical
Social Officer
(Transplant Coordinator):
|
Depending on transplant activity minimum of 3 to help out
pre transplant assessment and donor selection
|
|
Isolation Facility:
|
1 to 2 rooms for isolation of patients when required
|
|
Pharmacy:
|
Dedicated staff to respond to needs of transplant Patients specially immunosuppression,
antibiotics and
other drugs
|
|
Seminar Room;
|
For daily patient related Meetings
(AM and PM) Morbidity Mortality review, Clinical Audits
|
|
Other resources:
|
Computers, Video films, internet access, multimedia Video
conferencing facilities with reference centre in future.
|
Neurology
_____________________________________________________________________
Orthopedics _____________________________________________________________________
Operation Theatre and Anesthesiology
Please provide List of Equipment for
transplant surgery as annexure.
Record Keeping
Systems of storage and retrieval of
records____________________________________________________________________________________________________________________________________
Do you produce Annual Report? Yes No
(if yes please furnish the copy of annual report of last year)
How are the case records maintained? Manual computerized
(if yes please furnish the copy of annual report of last year)
How are the case records maintained? Manual computerized
Library.
Working day of the
Library_______________ Daily working hours________________
(Please provide the list of Textbooks of Transplant Sciences and Journals available in the Institution Department)
(Please provide the list of Textbooks of Transplant Sciences and Journals available in the Institution Department)
Research Facilities
No. of in hand projects and title of
research conducted by the faculty of the department. (Attach separate sheet if
needed)
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
Additional Essentials Activities/
Facilities:
|
Nursing :
|
Adequate number and of sufficient seniority to cover
transplant ward and ICU
|
|
Medical
Social Officer
(Transplant Coordinator):
|
Depending on transplant activity minimum of 3 to help out
pre transplant assessment and donor selection
|
|
Isolation Facility:
|
1 to 2 rooms for isolation of patients when required
|
|
Pharmacy:
|
Dedicated staff to respond to needs of transplant Patients specially immunosuppression,
antibiotics and
other drugs
|
|
Seminar Room;
|
For daily patient related Meetings
(AM and PM) Morbidity Mortality review, Clinical Audits
|
|
Other resources:
|
Computers, Video films, internet access, multimedia Video
conferencing facilities with reference centre in future.
|
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM 12
CERTIFICATE
OF INTERIM REGISTRATION
(As
per government format)
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM
13
CERTIFICATE OF RECOGNITION
(As
per government format)
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM 14
PROFORMA FOR DONOR FOLLOW-UP
S.
No. _________________ Date
___________________
Name
__________________________________________ s/w/d/o_______________ ______ Age
_______________________ Sex _______________________________
Occupation___________________________________
Address________________________________________________________________
Address________________________________________________________________
Phone:
_________________________________________________________________
|
Education
|
Uneducated
|
Primary School
|
Secondary School
|
|
Graduate
|
Post-Graduate
|
Professional
|
Recipient’s Name:________________________
Relationship__________________________________ Tax no._________________ Site of
Nephrectomy:____________________________ Right Left
Date of Nephrectomy:_______________________
|
Habits:
|
Cigarettes
|
Pan
|
Tuberculosis
|
Gutka
|
|
|
Naswar
|
Bids
|
Alcohal
|
|
Rehabilitation: Working Not Working
Reason for not working___________________________________________________
|
Illnesses in intervening period:
|
Liver
disease
|
Tuberculosis
|
UTI
|
|
|
Malaria
|
Hypertension
|
Diabetes
|
|
Surgery
|
|
Others
|
|
|
|
|
Long Term Medications:
|
Name of
Drugs
|
Dose
|
Duration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Family
History:
|
Diabetes
|
Hypertension
|
Renal Failure
|
Angina / MI
|
|
Martial
History
|
Married
|
Unmarried
|
Divorced
|
|
Number of Wives __________________
Total Children ____________________Males _________ Females ________________
Father: alive / expired Mother: alive/ expired Brothers _______Sister ____________
Father: alive / expired Mother: alive/ expired Brothers _______Sister ____________
|
Obstetric History:
FTND
_________________________
LSCS
_________________________
Abortions______________________
|
Menstrual History
Menarche __________________
D/C__________________
|
|
Still Births _______________________
|
Flow_____________________________
|
|
Last Delivery _____________________
|
LMP ____________________________
|
|
|
Time
|
Diet
|
|
Breakfast
|
|
|
|
Mid-Morning
Snack
|
|
|
|
Lunch
|
|
|
|
Afternoon
Snack
|
|
|
|
Dinner
|
|
|
|
Bed-Time
Snack
|
|
|
Cooking: Medium Ghee Oil Atta Exercise:_______________
General
Examination: Weight________________ Height _______________________
BMI__________________
Oedema Lymph
Nodes Throid Pallor
Jaundice Clubbing
Blood
Pressure: Lying_________ Sitting____________ Standing________________
Systemic Examination:
JVP __________Heart Sounds _____________ Murmurs _______________________
Systemic Examination:
JVP __________Heart Sounds _____________ Murmurs _______________________
Respiratory
Systems:
Auscultation
of Lung Fields __________Advent.___________Sounds______________
GI: Oray Cavity: Tenth __________ Gums ___________ Tongue__________________
Abdomen:
GI: Oray Cavity: Tenth __________ Gums ___________ Tongue__________________
Abdomen:
Liver
__________ Spleen_________Kidney__________Scar ____________________
Nervous System:
Cranial
Nerves ________ Reflexes______Coordinator _____Deep Reflexes ________
Psychoanalysis:
Depression____________ Satisfaction
_____________ Fear
____________________
Doctor’s
Name____________________ Signature ____________________________
Khyber Pakhtunkhwa Medical
Transplantation Regulatory Authority Rules, 2017
FORM 17
RENEVAL CERTIFICATE OF REGISTRATION
(As
per government format)
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