Blood Transfusion Safety Authority Act, 2016.
Download FeedBack| Department: | Health Department | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Category: | Acts | ||||||||||||||||||||||||||||||
| Specific Category Name: | Regulate Safe Blood Transfusion | ||||||||||||||||||||||||||||||
| Year | 2016 | ||||||||||||||||||||||||||||||
| Promulgation Date: | 20-10-2016 | ||||||||||||||||||||||||||||||
| Details: | THE
KHYBER PAKHTUNKHWA BLOOD TRANSFUSION SAFETY
AUTHORITY ACT, 2016. (KHYBER
PAKHTUNKHWA ACT NO. XXV OF 2016) CONTENTS PREAMBLE SECTIONS CHAPTER-I Preliminary 1. Short title, application and
commencement. 2. Definitions. 3. Transfusion of safe blood. CHAPTER-II ESTABLISHMENT,
COMPOSITION, POWERS AND FUNCTIONS OF THE
KHYBER PAKHTUNKHWA BLOOD
TRANSFUSION AUTHORITY 4. Establishment of Authority. 5. Constitution of the Authority. 6. Meetings of the Authority. 7. Powers and functions of the Authority. 8. Committees. 9. Chief Executive Officer. 10. Inspectors. 11. Employees of the Authority. 12. Public servant. 13. Delegation. 14. Protection from liability. CHAPTER III FUNCTIONS AND
RESPONSIBILITIES OF THE REGIONAL
BLOOD CENTRE AND BLOOD BANKS 15. Functions and responsibilities of
Regional Blood Centre. 16. Functions and responsibilities of Blood
Banks. 17. Documentation, record keeping and
traceability. 18. Notification of Serious Adverse
Reactions. 19. Data Protection and Confidentiality. 20. Heamovigiliance. CHAPTER IV FUND, BUDGET AND
ACCOUNTS 21. Fund. 22. Annual budget. 23. Annual report and accounts. CHAPTER V MISCELLANEOUS 24. Penalty for contravention. 25. Cognizance of contravention. 26. Removal of difficulties. 27. Overriding effect. 28. Appeal. 29. Power to make rules. 30. Power to make regulations. 31. Repeal and saving. THE
KHYBER PAKHTUNKHWA BLOOD TRANSFUSION SAFETY
AUTHORITY ACT, 2016. (KHYBER
PAKHTUNKHWA ACT NO. XXV OF 2016) [First published
after having received the assent of the Governor of the Khyber Pakhtunkhwa in the Gazette of Khyber Pakhtunkhwa (Extraordinary),dated
the 20th October,2016]. AN ACT to regulate collection, testing, processing, storage,
distribution, issuance and transfusion of human blood and blood components, in
public and private sectors and to establish Khyber Pakhtunkhwa Blood
Transfusion Safety Authority for ensuring health protection and prevention of transfusion
transmissible diseases
WHEREAS it is
expedient to regulate the collection, testing, processing and storage of human
blood and blood components, as well as the rational use of safe blood and its
products including plasma, free from viruses like immunodeficiency (HIV),
Hepatitis B and C or infective agents like Malarial Parasite and Treponema
Palidum (Syphilies), etc., for the purpose of transfusion of safe blood in public and private sectors and to establish
Khyber Pakhtunkhwa Blood Transfusion Safety Authority for and matters
connected therewith or incidental thereto;
It is hereby enacted
as follows:
CHAPTER–I
Preliminary
1. Short
title, application and commencement.---(1) This Act may be called the Khyber Pakhtunkhwa Blood Transfusion Safety
Authority Act, 2016. (2) It shall apply to all Blood Banks and Regional Blood Centres
in public and private sectors of the Province of the Khyber Pakhtunkhwa. (3) It shall come into force at once. 2. Definitions,---In this Act,
unless there is anything repugnant in the subject or context,- (a) “Authority”
means the Khyber Pakhtunkhwa Blood Transfusion Safety Authority established
under section 4 of this Act; (b) “Blood
Bank” includes all organisations carrying out all or any of the purposes of receiving, preserving, storing, analysing,
screening, processing and issuing of blood or blood products, whether
maintained by public or private sector; (c) “blood
component” means a therapeutic constituent of blood (red cells, white cells,
platelets, plasma, cryoprecipitate, cryosupernatant) which can be prepared by
various methods; (d) “blood
product” means any therapeutic product
derived from human blood or plasma (albumin, factor concentrates, prothrombin
complex concentrates, etc.); (e) “Chairman” means the Chairman of the Authority; (f) “Chief
Executive Officer” means the Chief
Executive Officer of the Authority; (g) “Council”
means the Pakistan Medical and Dental Council established under the Pakistan
Medical and Dental Council Ordinance, 1962 (XXXII of 1962); (h) “Designated
Person” means a Person notified under sub-section (2) of section 16 of this
Act; (i) “donor” means a somebody who of his own free will, voluntarily and
non-remunerated, donates blood or a part of his blood (plasma or cellular
components) for use in the course of the medical treatment of patients or for
scientific research; (j)
“Government” means the Government
of the Khyber Pakhtunkhwa; (k) “prescribed”
means prescribed by the rules or regulations; (l) “Province”
means the Province of the Khyber Pakhtunkhwa; (m) “recipient”
means someone who receives transfusion of blood or blood components; (n) “Regional
Blood Centre” means any structure or body which manufactures blood and blood
components and performs processes related to the promotion of blood donations,
collection, testing, proceeding, storage, transport, distribution of blood and blood components, whether maintained by
public or private sector at such regional level as may be determined by the
Authority; (o) “regulations”
mean regulations made under this Act; (p) “rules” mean rules made under this Act; (q) “safe
blood” means human blood or blood products which is healthy and free from human
immunodeficiency HIV, Hepatitis-B and C viruses, and ineffective agents like
Malarial Parasite and Treponema Palidum and other infective agents, as the
Authority may specify; (r) “serious
adverse reaction” means an undesirable response or effect in a donor or
in a patient associated with the collection or administration of blood or blood
components which is fatal, life-threatening, disabling, incapacitating, or
which results in, or prolongs, hospitalization or morbidity; and (s) “traceability”
means the capacity of a blood transfusion system to trace blood and blood components
from the donor to its final destination and vice versa (bi-directional
tracking). 3. Transfusion
of safe blood.---It shall be the responsibility of every physician,
surgeon and other relevant staff to- (a)
ensure
that blood and blood components being transfused are certified as safe blood by
a registered or licensed Blood Bank or Regional Blood Centre; (b)
ensure rational clinical use of blood and blood
components through their hospital transfusion committees, in accordance with
guidelines adopted and endorsed by the Authority; and (c)
ensure that all processes
performed at hospital level in relation to transfusion therapy are documented
in accordance with the procedures as may be prescribed by the Authority. CHAPTER
- II ESTABLISHMENT, COMPOSITION, POWERS AND
FUNCTIONS OF THE KHYBER PAKHTUNKHWA BLOOD TRANSFUSION AUTHORITY 4. Establishment of
Authority.---(1) As soon as after the commencement of this Act,
Government shall by notification in the official Gazette, establish an
Authority to be known as the Khyber
Pakhtunkhwa Blood Transfusion Authority. (2) The
Authority shall be a body
corporate, having perpetual succession and a common seal, with powers to
acquire and dispose of property both movable and immovable and shall be the
said name sue and be sued. (3) The head office of the Authority shall
be in Peshawar and shall have such other regional offices at such places in the
Province as Government may deem appropriate. 5. Constitution of the
Authority.---(1) The
Authority shall consist of:
(2) The members appointed under clauses (h)
and (j) may resign their membership by tendering resignation to the Government. (3) The members appointed under clauses (h)
and (j) may be removed by Government
from the membership of the Authority on grounds of an efficiency and
misconduct: Provided
that before removal the member concerned shall be given an opportunity of being
heard. (4) In case of vacancy due to death,
resignation or removal the Government shall fill up the vacancy by nomination
of another person as member. 6. Meetings of the Authority.---(1) The Authority shall hold at least
four meetings annually. (2) The meetings of the Authority shall be
presided over by the Chairman and in case he is absent by a member agreed upon
by other members of the Authority. (3) The decision of the meeting shall be
taken by majority of the members present and in case of tie the Chairman shall
have a casting vote. (4) Quorum of the meetings shall be one
third of the membership of the Authority. (5) The Authority shall follow in respect of
meetings such procedure as may be prescribed. 7. Powers and functions of the Authority.---The Authority shall exercise and perform
the following powers and functions: (a)
adopt policy to regulate all aspects of blood transfusion in the Province
and ensure that processes related to collection, testing of
human blood and blood components, and to their preparation, storage,
distribution, issuance and administration are undertaken only by Blood Banks or
Regional Blood Centre; (b)
prescribe
minimum standards and specifications for registration and licensing of the
Blood Banks or Regional Blood Centre; (c)
register and issue licences to
Blood Banks or Regional Blood Centre in private sector on payment of
such fee and in manner as may be prescribed; (d)
renew licences issued to Blood
Bank or Regional Blood Centre in private sector annually on
payment of such fee as may be prescribed, subject to the condition that the
instructions issued by it for safe blood transfusion were being followed by
such Blood Bank or Regional Blood Centre, as the case may be; (e)
register the Blood Bank or
Regional Blood Centre in public sector; (f)
cancel licenses issued to the
Blood Bank or Regional Blood Centre in private section in the
prescribed manner; (g)
prescribed registration and
licence fees debitable to the relevant head of account; (h)
fix service charges of the blood
and blood products; (i)
ensure that the Blood Banks or
Regional Blood Centre, as the case may be, are managed and run by qualified
professionals having qualifications in blood transfusion, preferably
Haematology and alternately clinical pathology recognized by the Council; (j)
ensure that bio-safety measures
specified in the regulations framed under this Act and instructions issued by
the World Health Organization (WHO) are strictly adhered to by the Blood Banks; (k)
take all necessary measures to ensure that each Blood
Bank or Regional Blood Centre establishes and maintains a quality management
system as defined by the Authority; (l) ensure that any serious adverse reaction related to the
collection, testing, processing, storage and distribution, issuance or
administration of blood and blood components, observed in donors or patients,
which may have a influence on the quality and safety of blood and blood
components or on donor or patient and staff safety, are notified to the
Authority; (m) take all necessary measures to ensure that
blood and blood components collected,
tested, processed, stored, released, distributed or issued can be traced from
donor to recipient and vice versa; (n) take all necessary measures to ensure that the system used
for the labeling of blood and blood components complies with the identification
system; (o) manage and report data for planning,
implementation and evaluation of services; (p) take all necessary measures to ensure
that access is provided to documents (operational procedures, guidelines,
training, reference manuals and reporting forms) for officials entrusted with
inspections and control measures; (q) hold regular meetings with the authorities designated by
Government, delegations of experts and other relevant parties to exchange
information on the experience acquired with regard to the transfusion of safe
blood, blood product and procedures related thereto; (r) set up minimum requirements for record
keeping for blood banks and keep records of the data received from the blood
banks establishments with regard to registration and licensing, inspections,
responsible person and notification of serious adverse reactions; (s) organize inspections and appropriate control measures in
blood banks on regular basis; (t) prescribe procedure for appointment, terms and conditions of
service, disciplinary and other service matter for the employees of the
Authority; (u) approval of financial plans and annual budget; and (v) perform any other function assigned to it by Government from
time to time. 8. Committees.---The
Authority shall establish the following committees and may establish other
committees for assistance to the Executive Officer in relation to the
performance of functions of the Authority and determine the membership,
remuneration of members and terms of reference of each committee: (a)
Technical Committee; (b)
Licensing Committee; (c)
Hospital Blood Transfusion
Committees; (d)
District Blood Transfusion
Committee; and (e)
Grievances Redressal Committee. 9. Chief Executive
Officer.---(1)
The Authority shall appoint a person as a Chief Executive Officer on such terms
and conditions and such qualification as may be prescribed. (2) The
Chief Executive Officer shall, subject to the supervision and control of the
Authority, manage the affairs of the Authority and may exercise such powers as
are delegated to him by the Authority. (3) In
particular, the Chief Executive Officer may,- (a)
manage the administration, operations and functions of
the Authority; (b)
act as the principal accounting officer responsible
and accountable for the management of the Authority funds and assets in an
efficient and effective manner; and (c)
to provide leadership or directions to all staff of
the Authority. (4) The
Chief
Executive Officer shall be Secretary to the Authority with no right of vote and
shall prepare and circulate agenda and minutes of the Authority meetings. (5) The
Chief Executive Officer shall not be an employee of any health care service
provider both public and private sectors nor have interest or share in any
Blood Bank. 10. Inspectors.---(1) The
Authority may appoint the Inspectors on such terms and conditions and with such
qualifications as may be prescribed for the purposes of this Act within such
local limits as it may assign to them respectively: Provided that no person who has any
financial interest in any Blood Bank or blood center as the case maybe, shall
be so appointed. (2) The
Inspector shall- (a)
inspect the Blood Bank or Regional Blood Centre, as the case may be, at the time of
issuance and renewal of license or on receipt of a complaint by aggrieved
person or any person; (b)
seal the premises of the Blood
Bank or Regional Blood Centre, as the case may be, which is
not registered under this Act or repeatedly violates the provisions of this Act
or rules and regulations made thereunder; (c)
confiscation of the equipment
used and any other materials which is dangerous or detrimental to any person
therein or otherwise unsuitable for the purpose for which it is used or carried
out; (d)
seizure and prevention of the
release of blood or blood components which are considered unsafe; and (e)
take samples of blood, blood
components, blood product or any other chemical or substance used for the
preservation of blood for ascertaining the safety thereof. 11. Employees of the Authority.---To carry out
the purposes of this Act, the Authority may, from time to time appoint
employees on such terms and conditions as may be prescribed. 12. Public servant.---The
employees of the Authority shall be deemed to be public servants within the
meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860). 13. Delegation.---The
Authority may, by general or special order, delegate its power or function to
the Chairperson or a member or any other employee of the Authority under this
Act, subject to such conditions or restrictions as it may determine. 14. Protection from liability.---No suit or other legal proceedings
shall lie against the Authority and various Committees constituted under this
Act, Chief
Executive Officer and employees of the Authority for anything done in good
faith in the execution or purported execution of this Act and rules or
regulations made thereunder. CHAPTER III FUNCTIONS AND
RESPONSIBILITIES OF THE REGIONAL BLOOD CENTRE AND BLOOD
BANKS 15. Functions
and responsibilities of Regional Blood Centre.---Every Regional
Blood Center shall- (a) perform processes related to the
promotion of blood donations, collection, testing, processing, storage,
transport, distribution of human blood and blood components, according to the
license issued; (b)
take all possible measures to
encourage voluntary and non-remunerated blood donations and not accept blood from
paid donors; (c)
make certain that procedures and
criteria prescribed by the Authority for donor selection and collection of
blood are met; (d)
follow the criteria of permanent
and temporary blood donor deferral prescribed by the Authority and to
communicate the reasons therefore through a qualified health professional; (e)
be supported by such staff as may
be determined by Government in case maintained, by public sector or as may be
determined by the Authority in case maintained by private sector. (f)
ensure that each donation of
blood and blood components is tested for ABO and Rh blood groups and screened
for HBV, HCV, HIV, Malaria, Syphilis and any other communicable disease as may
be determined by the Authority; (g)
have a set of equipment for the
performance of each type of processes relating to blood transfusion; (h)
submit an annual report to the
Authority in the format prescribed by the Authority; and (i)
not receive or supply blood
unless it is registered with the Authority and is in possession of a valid
licence issued to it by the Authority. 16. Functions and responsibilities of Blood
Banks.---(1)
Every Blood Bank shall- (a)
receive and store blood and blood
components and perform compatibility tests before issuance of blood and blood
components; (b)
have qualified personnel having
experience in compatibility testing, storage, transport and issuance of human
blood and blood components; (c)
have a dedicated location, staff
and set of reagents and equipment for the performance of each type of processes
relating to blood transfusion; (d)
ensure
that blood and blood components issued by them are transfused in a licensed
medical institution by a doctor registered with the Pakistan Medical and Dental
Council; (e)
maintain a separate department,
equipment and staff for the purpose of receiving blood donations and for
selection, handling, care and safety of the donors; (f)
cause the donated blood and blood
products to be screened to ensure that the blood is a safe blood and record a
certificate to this effect on each blood bag meant for transfusion; (g)
possess equipment required for
hemoglobin estimation, blood grouping, cross matching, antibodies detection and
screening of infectious agents including human immunodefinency, Hepatitis B and
C viruses, Malaria, Syphilis and any other communicable disease as may be
determined by the Authority; (h)
equip itself with proper
reservation and storage of blood, blood products and ensure un-interrupted
power supply for refrigeration; (i)
observe standard operation
procedure approved by the Authority and more particularly specified in the
regulations; and (j)
submit periodical reports to the
Authority in respect of blood donations received by it with break-up of blood
groups, detection of antibodies and screening of infectious agents; and (k)
not receive or supply blood
unless it is registered with the Authority and is in possession of a valid
licence issued to it by the Authority. (2) All
Blood Banks or Regional Blood Centres as the case may be, shall notify to the
Authority the name of the Designated Person. (3) The
Designated Person shall be a qualified individual, preferably having
post-graduate qualifications in blood transfusion, haematology, or clinical
pathology recognized by the Pakistan Medical and Dental Council. (4) Where
the Designated Person is permanently or temporarily replaced, the Blood Bank or
Regional Blood Centre, as the case may be, shall provide immediately the name
of the new Designated Person and his date of assuming charge as such to the
Authority. (5) The
Designated Person shall ensure distribution of blood and blood components to
hospitals, based on hospital Blood bank requests, in accordance with provisions
set up by a written contract. 17. Documentation, record keeping and
traceability.---(1)
All Blood Banks or Blood Centres as the case may be, shall maintain
documentation on procedures, guidelines, training, reference manuals and
reporting forms. (2) Blood
Banks or Regional Blood Centres as the case may be, shall maintain records of
the information obtained from donors, including their identification, health
history, temporary and permanent deferral and signature total number of donors
and donations whole blood donations not used and number of every blood
component produced and distributed, as well as screening results of donated
blood. (3) The
records shall be kept for a minimum of 15 years. (4) Blood
Banks or Regional Blood Centres, as the case may be, shall implement a system
for the identification of every single
blood donation, every single blood unit and components
thereof, allowing full traceability to the donor as well as to the transfusion
and its recipient. (5) The
data needed for full traceability in accordance with this section shall be kept
for at least 30 years. 18. Notification
of Serious Adverse Reactions.---(1)
Serious adverse reactions shall be notified in accordance with the procedure
and notification prescribed by the Authority. (2) Blood
Banks shall have a procedure in place to accurately, efficiently and verifiably
withdraw from distribution or issuance of any blood or blood components
associated with the notification referred to above. 19. Data
Protection and Confidentiality.---(1) All Blood Banks or Regional Blood Centres performing blood
collection shall take all necessary measures to ensure that all data, including
genetic information, collated within the scope of this Act, to which third
parties have access, have been rendered anonymous so that the donor is no
longer identifiable. (2) For the purpose mentioned in sub-section
(1), every Blood Bank or Regional Blood Centre performing blood collection
shall ensure that- (a)
data security measures are in place and safeguards are
provided against unauthorized data additions, deletions or modifications to
donor files or deferral records and transfer of information; (b)
procedures are in place to resolve data discrepancies;
and (c)
no unauthorized disclosure of such information occurs,
whilst guaranteeing the traceability of donations. 20. Heamovigilance.---The Authority shall continuously
perform heamovigilance in order to insure safe transfusion of blood, prevent
serious adverse reactions and to maintain documentation regarding blood
procedures. Explanation.---Haemovigilance means a
continuous process of data collection and analysis of transfusion-related
adverse events and reactions, conducted in order to investigate their causes
and outcomes, to prevent their occurrence or recurrence throughout the blood
transfusion chain, and to increase the safety, efficacy and efficiency of blood
transfusion; CHAPTER
IV FUND,
BUDGET AND ACCOUNTS 21. Fund.---(1) There shall be a fund to
be known as Khyber Pakhtunkhwa Blood Transfusion Authority Fund. (2) The
Fund shall consist of- (a)
such sums as Government may grant
by way of seed money; (b)
grant-in-aid in lieu of services
rendered to Health/Blood Bank; (c)
donations from domestic and
international donor agencies and other institutions; (d)
grant of money and sums borrowed
or raised by the Authority for the purpose of meeting any of its obligations or
discharging any of its duties; (e)
fee or other charges imposed
under this Act; and (f)
all other sums, which may in any
manner become payable to or vested in the Authority in respect of any matter
incidental to the exercise of its functions and powers. (3) The
Fund shall be utilized for the purpose of Authority and shall be regulated
under the overall supervision of the Authority in such a manner as may be
prescribed by the Authority. 22. Annual budget.---(1)The
Authority shall prepare and approve annual budget for a financial year in the
prescribed manner. (2) No
expenditure shall be made for which provision has not been made in any approved
budget except if made from any previously approved contingency fund, unless
further approval is sought and obtained from the Authority. 23. Annual report and accounts.---(1) The
Chief Executive Officer shall within ninety days from the end of each financial
year, prepare a report on the activities and performance of the Authority, and
submit a copy of the report to Government, after approval from the Authority. (2) The
Authority shall keep proper accounts and shall as soon as practicable, after
the end of each financial year, prepare a statement of accounts of the
Authority through Chief Executive Officer for the financial year which shall
include a balance sheet and an account of income and expenditure. (3) The
accounts of the Authority shall be audited by the Auditor General of Pakistan. (4) The
Authority shall, within one hundred and twenty days of the end of each
financial year, together with the annual report of the Authority, send a copy
of the statement of accounts of the Authority certified by the auditor and a
copy of auditor’s report to Government. (5) The
Authority may invest money not required for immediate expenditure in Government
Saving Scheme or in fixed deposit with banks approved by Government. CHAPTER
V MISCELLANEOUS 24. Penalty
for contravention.---Whoever contravenes any of the provisions of this
Act shall be punished with imprisonment for a period not less than six months
and which may extend to three years, or with fine which shall not be less than
fifty thousand rupees and may extend to ten hundred thousand rupees, or with
both. 25. Cognizance
of contravention.---No court shall take cognizance of any contravention
under this Act, except on a complaint in writing made by the Authority or on
the report of Inspector provided that this will not debar the person aggrieved
by any such contravention to seek remedy of his grievance through a court of
law. 26. Removal of difficulties.---If any
difficulty arises in giving effect to any provision of this Act, Government may
make such order not inconsistent with the provisions of this Act as may appear
to it to be necessary for the purpose of removing such difficulty. 27. Overriding effect.---Notwithstanding
anything to the contrary contained in any other law, the provisions of this Act
shall have an overriding effect and the provisions of any such law to the extent
of inconsistency to this Act shall cease to have effect. 28. Appeal.---The Blood Bank or Regional
Blood Center as the case may be, whose registration has been cancelled shall
have the right to appeal to High Court within thirty (30) days of such cancellation. 29. Power to make rules.---Government
may, by notification in the official Gazette, make rules for giving effect to
the provisions of this Act. 30. Power to make regulations.---The
Authority may make regulations, not inconsistent with the provisions of this
Act and the rules, for carrying out the purposes of this Act. 31. Repeal and saving.---(1) The
Khyber Pakhtunkhwa Transfusion of Safe Blood Act, 1999 (Khyber Pakhtunkhwa Act
No. IX of 1999) is hereby repealed. (2) On
commencement of this Act,- (a)
all employees of the Khyber
Pakhtunkhwa Safe Blood Transfusion Authority under the repealed Act; and (b)
all assets and liabilities,
including furniture, fixtures, machinery and vehicles etc; shall
stand transferred to the Khyber Pakhtunkhwa Blood Transfusion Authority
established under this Act. (3) Notwithstanding
the aforesaid repeal, anything done, action taken, rules made, and notification
or order issued under the aforesaid Act, shall, so far as it is not
inconsistent with the provisions of this Act, be deemed to have been done;
taken, made or issued, appointed, constituted, given, commenced or taken, under
this Act, and shall have effect accordingly. |