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  "title": "PUNJAB BLOOD TRANSFUSION SAFETY ACT 2016",
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  "source_url": "https://punjabcode.punjab.gov.pk/en/show_article/BzICNVRhBzY-",
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  "text": "THE PUNJAB BLOOD TRANSFUSION SAFETY ACT 2016 \r\n(XLVI of 2016) \r\nCONTENTS \r\n1. Short title, extent and commencement \r\n2. Definitions \r\n3. Authority \r\n4. Functions of the Authority \r\n5.  Secretary \r\n6. Technical Committee \r\n7. Licensing Board \r\n8. Appellate Committee \r\n9. Inspectors \r\n10. Functions of blood centers \r\n11. Functions of hospital blood banks \r\n12. Documentation, record keeping and traceability \r\n13. Information to the Authority \r\n14. Data protection, etc. \r\n15. District blood transfusion committees \r\n16. Registration and licensing \r\n17. Obligation \r\n18. Offence \r\n19. Penalty \r\n20. Cognizance \r\n21. Offences by companies \r\n22. Publication of offender's name \r\n23. Secretariat and employees \r\n24. Fund of the Authority \r\n25. Accounts and Audit \r\n26. Delegation \r\n27. Miscellaneous \r\n28. Immunity \r\n29. Power to make rules \r\n30. Power to make regulations \r\n31. Repeal \r\n \r\n \r\nTEXT \r\n1\r\nTHE PUNJAB BLOOD TRANSFUSION SAFETY ACT 2016 \r\n(XLVI of 2016) \r\n[29th October 2016] \r\nAn \r\nAct \r\nto regulate collection, testing, processing, storage, distribution, issuance, transfusion \r\nof human blood, blood components, ensuring health protection and prevention of \r\ntransfusion transmissible diseases. \r\nIt is necessary  to regulate the collection, testing, processing and storage of \r\nhuman blood and blood components, as well as the rational use of safe blood and its \r\nproducts whenever intended for transfusion; and, to deal with ancillary matters. \r\nBe it enacted by Provincial Assembly of the Punjab as follows:– \r\n1. Short title, extent and commencement .– (1) This Act may be cited as the \r\nPunjab Blood Transfusion Safety Act 2016. \r\n (2) It extends to whole of the Punjab. \r\n (3) It shall come into force at once. \r\n2. Definitions.– In this Act: \r\n(a) “Act” means the Punjab Blood Transfusion Safety Act 2016; \r\n(b) “Authority” means Punjab Blood Transfusion Authority  constituted \r\nunder the Act; \r\n(c) “autologous donation” means that donor and recipient are the same;  \r\n(d) “blood” means whole blood collected from a donor; \r\n(e) “blood center” means any structure or a body which manufactures \r\nblood and blood components; and , performs collection, testing, \r\nprocessing, storage, and distribution of blood and blood components to \r\nthe hospital blood banks;  \r\n(f) “blood component” means a therapeutic constituent of blood including \r\nred cells, white cells, pla telets, plasma, cryoprecipitate and  \r\ncryosupernatant prepared by various methods; \r\n(g) “blood establishment” means any facility carrying out one or more of \r\nthe processes in the blood transfusion chain; \r\n(h) “blood product” means any therapeutic product derived from human \r\nblood or plasma such as albumin, factor concentrates, prothrombin \r\ncomplex concentrates; \r\n                                                           \r\n1This Act was passed by the Provincial Assembly of the Punjab on 19 October 2016; assented to by the Governor of the Punjab \r\non 28 October 2016; and, was published in the Punjab Gazette (Extraordinary), dated: 29 October 2016, pp. 2449-2459. \r\n(i) “deferral” means temporary or permanent suspen sion of the eligibility \r\nof an individual to donate blood or blood components; \r\n(j) “distribution” means an act of delivery of blood  or blood components to \r\nother blood centres, hospital blood banks and manufacturers of blood \r\nand plasma derived products  but shall  not include the issuance of \r\nblood or blood components for transfusion; \r\n(k) “donor” means a person who, by his free will and without compensation \r\nor payment , do nates blood or a part of his  blood such as plasma or \r\ncellular components  for use in the medical trea tment or for scientific \r\nresearch; \r\n(l) “Government” means Government of the Punjab; \r\n(m) “haemovigilance” means a continuous process of data collection and \r\nanalysis of transfusion -related adverse events and reactions, \r\nconducted to investigate their causes and outcom es, to prevent their \r\noccurrence or recurrence throughout the blood transfusion chain, and \r\nto increase the safety, efficacy and efficiency of blood transfusion , but \r\nhaemovigilance shall be  dependent on the traceability of blood and \r\nblood products from donor s to recipients and vice versa (bi-directional \r\ntracking); \r\n(n) “hospital blood bank” means a hospital unit which receives and stores \r\nscreened blood and blood components received from a blood centre, \r\nperforms compatibility testing and issues blood and blood components \r\nfor clinical use; \r\n(o) “inspection” means an official, formal and objective inspection based \r\non the adopted standards to assess and measure the non -compliance \r\nof the Act, rules and regulations; \r\n(p) “Inspector” means a blood safety inspector  appointed under section 9 \r\nof the Act;  \r\n(q) “issuance” means the provision of blood or blood components by a \r\nhospital blood bank, or specialized blood transfusion service  for \r\ntransfusion to a recipient; \r\n(r) “non-compliance” means deviation from the standards prescribed by or \r\nunder the Act or the Authority, as the case may be, and shall include: \r\n(i) critical non-compliance that directly affects the safety of a \r\nrecipient or donor; or \r\n(ii) serious non-compliance that on its own does not directly affect \r\nthe safety of a recipient or donor; or \r\n(iii) significant non-compliance for which there is insufficient \r\ninformation to classify it as critical or serious non-compliance; \r\n(s) “offence” includes a critical and significant offence as prescribed under \r\nsection 18 of the Act; \r\n(t) “prescribed” means prescribed by the rules or regulations made under \r\nthe Act; \r\n(u) “processing” means any step in the preparation of a blood component  \r\ncarried out between the collection of blood and its storage; \r\n(v) “recipient” means a person who receives transfusion  of blood or blood \r\ncomponents; \r\n(w) “responsible person” means a person accountable for ensuring that \r\nevery unit of blood or blood components has been collected , tested, \r\nprocessed, stored, distributed and issued in compli ance with the \r\nprovisions of the Act, rules or regulations made thereunder; \r\n(x) “safe blood” means the blood which is safe for both the donor and the \r\nrecipient; \r\n(y) “screened blood” means human blood or blood products which, based \r\non established testing methods, ha s been tested negative for HIV, \r\nHepatitis B and Hepatitis C viruses or other viruses or infective agents, \r\nlike malarial parasites and treponema pallidum (syphilis) or such other \r\nviruses or infective agents as the Authority may specify; \r\n(z) “Secretary” means the Secretary of the Authority; \r\n(aa) “serious adverse event” means an untoward oc currence associated \r\nwith the collection, testing, processing, storage and distribution of blood \r\nand blood components that might lead to death or life -threatening, \r\ndisabling or incapacitating conditions for the patients or which results in \r\nor prolongs hospitalization or morbidity; \r\n(bb) “serious adverse reaction” means an undesirable response or effect in \r\na donor or in a patient associated with the collection or administration \r\nof blood or blood components which is fatal, life -threatening, disabling, \r\nincapacitating, or which results in or prolongs  hospitalization or \r\nmorbidity; \r\n(cc) “traceability” means the capacity of a blood transfusion system to trace  \r\nblood and blood components from the donor to its final destination  and \r\nvice versa (bi-directional tracking); and \r\n(dd) “unhygienic” means anything or atmosphere harmful to dono r, blood, \r\nreagents or equipment.  \r\n3. Authority.– (1) The Government may, by notification , establish the A uthority \r\nto be known as Punjab Blood Transfusion Authority.  \r\n(2) The Authority shall be a body corpo rate, having perpetual succession \r\nand a common seal with power to acquire, hold and dispose of property and shall by \r\nthe said name sue and be sued.  \r\n(3) The Authority shall consist of the following: \r\n(a) three members, including at least one female member , of Provincial \r\nAssembly of the Punjab; \r\n(b) Additional Secretary (Technical) to the Government, Specialized \r\nHealthcare and Medical Education Department; \r\n(c) Director General Health, Punjab; \r\n(d) Director, Institute of Blood Transfusion Services, Punjab; \r\n(e) Four professors, including at least one female  Professor of Medicine, \r\nSurgery and Hematology or Transfusion Medicine; \r\n(f) Commandant, Combined Military Hospital, Lahore; \r\n(g) Director General of Punjab Employees Social Security Institution; and \r\n(h) a representative of the blood donor organization s, to be nominated by \r\nthe Authority. \r\n (4) A member , other than an ex-officio member, shall hold office for a \r\nperiod of three years from the date of assuming  office but the Government may \r\nextend the term of a member for such period as it may deem necessary . \r\n (5) The Government shall nominate the Minister for Health or Advisor to \r\nChief Minister for Health as the Chairperson of the Authority and determine the terms \r\nand conditions of such appointment. \r\n (6) In case of a casual vacancy in the Authority, the Government shall \r\nnominate a new member for the remaining term of the outgoing member. \r\n4. Functions of the Authority.– (1) The Authority shall: \r\n(a) be responsible for the general administration, supervision, \r\nsuperintendence and management of the affairs of the Authority; \r\n(b) approve polices and schemes; \r\n(c) regulate all matters relating to blood transfusion throughout the Punjab; \r\n(d) ensure that the standards and specifications shall, at least, cover: \r\n(i) the registration and licensing of blood establishments;  \r\n(ii) standards for processes performed by blood establishments; \r\n(iii) specifications and quality control requirements  of blood and \r\nblood components;  \r\n(iv) storage and transportation of blood and blood components;  \r\n(v) traceability and haemovigilance;  \r\n(vi) motivation of blood donors; \r\n(vii) autologous donation and transfusion; \r\n(viii) imparting relevant information to donors  and obtaining from \r\nthem appropriate information such as identification, health \r\nhistory and signature of the donor;  \r\n(ix) determining the requirements con cerning the suitability of \r\ndonors of blood and blood components; \r\n(x) screening of donated blood including deferral criteria and \r\npossible exemption thereto; and \r\n(xi) procedures for notifying serious adverse reactions and events, \r\nnotification format and  guidelines on  optimal clinical use of \r\nblood; \r\n(e) ensure that any serious adverse events related to the collection, \r\ntesting, processing, storage and distribution, issuance or administration \r\nof blood and blood components, which may have an influence on the \r\nquality and safety of blood and blood components or on donor and staff \r\nsafety, as well as any serious adverse reactions observed in donors \r\nthat may be attributed to the donation or in patients that may be \r\nattributed to the transfusion are notified to the Authority;  \r\n(f) take al l necessary measures to ensure that blood and blood \r\ncomponents collected, tested, processed, stored, released, distributed \r\nor issued are traced from donor to recipient and vice versa;  \r\n(g) take all necessary measures to ensure that the system used for the \r\nlabeling of blood and blood components complies with the identification \r\nsystem; \r\n(h) manage and report data for planning, implementation and evaluation of \r\nservices; \r\n(i) take all necessary measures to ensure that access is provided to \r\ndocuments (operational procedures, guidelines, training, reference \r\nmanuals and reporting forms) to the officials entrusted with inspections \r\nand control measures; \r\n(j) hold regular meetings with the bodies designated by the Government, \r\ndelegations of experts and other relevant parties to exchange  \r\ninformation on the experience acquired with regard to the \r\nimplementation of the Act; \r\n(k) register blood establishments, categorize them indicating which \r\nprocesses the blood establishments are entitled to perform , issue \r\nlicenses, and, subject to the fulfillmen t of prescribed conditions , renew \r\nlicenses; \r\n(l) regulate matters relating to the meetings of the Authority; and  \r\n(m) perform such other functions as may be prescribed. \r\n (2) The Authority may: \r\n(a) suspend or revoke the license of a person if any condition of the \r\nlicense or any provisions of the Act, rules or regulations has been \r\ninfringed; \r\n(b) prescribe minimum standards and specifications for registration and \r\nlicensing; \r\n(c) collaborate with other institutions, professional bodies and experts;  \r\n(d) take all necessar y measures to ensure that each blood establishment \r\nestablishes and maintains a quality management system as prescribed \r\nby the Authority; \r\n(e) set up minimum req uirements for record keeping of  blood \r\nestablishments and keep records of the data received from t he blood \r\nestablishments with regard to registration and licensing, inspections, \r\nresponsible person and notification of serious adverse reactions and \r\nevents; and \r\n(f) organize inspections and appropriate control measures in blood \r\nestablishments, to make cert ain that the requirements of th e Act, and \r\nany rules, regulations, and standards hereunder, are complied with. \r\n5.  Secretary.– (1) The Government shall appoint the Secretary of the Authority \r\non such term and conditions as it may determine or as may be prescribed. \r\n(2) The Secretary shall be the Chief Executive Officer of the Authority and \r\nshall exercise such powers as may be prescribed or as are delegated to him by the \r\nAuthority. \r\n(3) A person shall not be appointed as Secretary if he is a director, officer or \r\nemployee of any healthcare service provider or ha s an interest or share in any blood \r\nestablishment. \r\n6. Technical Committee .– (1) The Authority shall, for a specified period, \r\nconstitute the Technical Committee, consisting of the following: \r\n(a) Additional Secretary  (Technical) to the Government, Specialized \r\nHealthcare and Medical Education Department; \r\n(b) Director, Institute of Blood Transfusion Services, Punjab; \r\n(c) Two Professors of Haematology; \r\n(d) a representative of the blood donor organizations, to be nominated by \r\nthe Authority; and \r\n(e) a legal expert. \r\n(2) The Authority shall nominate the convener of the Technical Committee  \r\nfrom amongst its members. \r\n(3) The Technical Committee shall provide advice on any matter referred \r\nto it by the Authority including mat ters related to blood transfusion standards and \r\nquality assurance. \r\n7. Licensing Board .– (1) There shall be a Licensing Board consist ing of the \r\nfollowing: \r\n(a) Secretary; \r\n(b) one haematologist; and \r\n(c) one other technical expert nominated by the Authority fo r a specified \r\nperiod. \r\n(2) The Secretary shall be the convener of the Licensing Board. \r\n(3) The Licensing Board shall: \r\n(a) review all inspection reports and decide on the issuance of licenses to \r\nblood establishments, blood centers, hospital blood banks, and \r\nspecialized blood transfusion services; and \r\n(b) categorize non-compliances observed as critical or significant. \r\n (4) The Licensing Board, in case of non -compliance or violation of the Act, \r\nrules or regulations, may, in the manner prescribed by the Authority: \r\n(a) refer a case to the Inspector concerned or the local police for \r\nprosecution in the blood safety court; \r\n(b) direct sealing of the premises of the blood establishment; \r\n(c) impose fine up to one hundred thousand rupees; \r\n(d) order to take into custody the blood, blood components, equipment and \r\nany other materials being used in violation of the Act, rules or \r\nregulations; \r\n(e) enter or seal the blood establishment in the case of any gross violation \r\nof the Act, rules or regulations; \r\n(f) mark, seal or otherwi se secure any equipment or material in the case \r\nof any violation of the Act, rules or regulations; \r\n(g) place a blood establishment on probation; \r\n(h) suspend or cancel the license of the blood establishment; and \r\n(i) debar the re -licensing of the blood estab lishment for the specified \r\nperiod. \r\n8. Appellate Committee. – (1) The Government shall, for a specified period, \r\nconstitute an Appellate Committee  consisting of four members , including a \r\nHaematologist or blood transfusion expert and a legal expert.  \r\n (2) The Government shall nominate one of the members as convener  of \r\nthe committee.  \r\n (3) A person aggrieved by any decision or order of the Authority or the \r\nLicensing Board may prefer an appeal to the Committee within fifteen da ys from the \r\ncommunication of such decision or order. \r\n (4) The Committee may, after due investigation and affording opportunity \r\nof hearing to all concerned, pass an appropriate order within thirty days. \r\n9. Inspectors.– (1) The Government shall appoint blood safety Inspectors in \r\neach district. \r\n(2) An Inspector shall carry out inspection of  blood establishment s and \r\nperform other functions assigned to him by the Authority. \r\n(3) An Inspector shall implement the decisions of the Licensing Board, with \r\nthe assistance of the local police, if required. \r\n(4) An Inspector shall inspect and report an unregistered  establishment to \r\nthe Authority. \r\n10. Functions of blood c enters.– (1) A blood centre shall implement the \r\nrequirements of the Act, the rules and regulations made thereunder. \r\n(2) A blood centre shall: \r\n(a) perform processes related to the promotion of blood donation s, \r\ncollection, testing, processing, storage, transport, distribution of human \r\nblood and blood components according to the license issued; \r\n(b) not accept blood from paid donors and shall ensure to get blood and \r\nblood components for transfusion through voluntary and non -\r\nremunerated blood donations; \r\n(c) follow the procedures and criteria prescribed by the Authority for donor \r\nselection of blood; \r\n(d) follow the criteria of permanent and temporary blood donor deferr al \r\nprescribed by the Authority; \r\n(e) communicate the reasons for deferral to the donor through a qualified \r\nhealth professional  registered with the Pakistan Medical and Dental \r\nCouncil, and shall provide counseling, if so required; \r\n(f) while performing testing of donated blood, ensure that each donation of \r\nblood and blood components is tested for ABO and Rh blood groups \r\nand screened for HBV, HCV, HIV, Malaria, Syphilis and any other \r\ncommunicable disease or such other disease as may be prescribed; \r\n(g) not receive or supply  blood unless it is registered and licensed under \r\nthe Act; \r\n(h) have qualified personnel  having relevant qualification from a  \r\nrecognized institution  for the collection, testing, processing, storage, \r\ntransport and distribution of human blood and blood components; \r\n(i) have a dedicated department, staff and set of equipment for the \r\nperformance of each type of processes under the license; \r\n(j) comply with minimum requirements for the performance regarding \r\nlocation, process flow, personnel, equipment, reagents and \r\ndocumentation adopted and endorsed by the Authority; \r\n(k) submit an annual report to the Authority in such form as may be \r\nprescribed or determined by the Authority; \r\n(I) notify to the Authority the name of the responsible person and job \r\ndescription of other staff working in the blood centre; and \r\n(m) distribute blood and blood components to a hospital, based on hospital \r\nblood bank request , and in accordance with provisions of a written \r\ncontract. \r\n (3) The responsible person in a blood centre shall be a qualified individual, \r\npreferably having post -graduate qualification in blood transfusion, haematology or \r\nclinical pathology recognized by the Pakistan Medical and Dental Council. \r\n (4) Where the responsible person in a blood centre is permanently or \r\ntemporarily replaced, the blood centre shall immediately communicate the name and \r\nother details of the new responsible person to the Authority. \r\n11. Functions of hospital blood banks .– (1) Every hospital blood bank  shall \r\nobserve and implement the requirements of the Act, rules and regulations. \r\n (2) A hospital blood bank shall: \r\n(a) receive, store and perform compatibility tests before issuance of blood \r\nand blood components; \r\n(b) have qualified personnel directly involved in compatibility testing, \r\nstorage, transport and issuance of hum an blood and blood \r\ncomponents; \r\n(c) designate a responsible person in the hospital blood bank; \r\n(d) have a dedicated location, staff and set of reagents and equipment for \r\nthe performance of each type of licensed processes; and \r\n(e) ensure that blood and blood components issued by them are \r\ntransfused in a licensed medical institution by a clinician registered with \r\nPakistan Medical and Dental Council. \r\n (3) The physician shall ensure that blood and blood components being \r\ntransfused are certified as safe blood by a licensed blood establishment. \r\n(4) The hospital administration shall ensure rational clinical use of blood \r\nand blood components through the hospital transfusion committee in accordance \r\nwith guidelines adopted and endorsed by the Authority. \r\n (5) All processes performe d at hospital level in relation to transfusion \r\ntherapy shall be documented in accordance with the prescribed procedures. \r\n12. Documentation, record keeping and traceability .– A blood establishment \r\nshall: \r\n(a) maintain documentation on procedures, guidelines, tra ining, reference \r\nmanuals and reporting forms; \r\n(b) maintain records of the information obtained from donors, including \r\ntheir identification, health history, temporary and permanent deferral \r\nand signature; total number of donors and donations; whole blood \r\ndonations not used; number of every blood component produced and \r\ndistributed, as well as screening results of the donated blood; \r\n(c) keep the record safe for a minimum of fifteen years; and \r\n(d) implement a system for the identification of every single blood \r\ndonation, every single blood unit and components thereof, allowing full \r\ntraceability to the donor as well as to the transfusion and its recipient. \r\n13. Information to the Authority .– A blood establishment shall immediately \r\ninform the Authority , in the prescribed manner , of any serious adverse event or \r\nserious adverse reaction. \r\n14. Data protection, etc.– (1) Every blood establishment shall have a procedure \r\nin place to accurately, efficiently and verifiably prevent distribution or issuance of any \r\nunhealthy blood or blood components. \r\n (2) The blood establishment performing blood collection shall take all \r\nnecessary measures to ensure that all data , including genetic information , collected \r\nunder the Act to which third parties have access have been rendered anonymous so \r\nthat the donor is no longer identifiable. \r\n(3) For the purpose, every blood establishment performing blood collection \r\nshall ensure that: \r\n(a) data security measures are in place and safeguards are provided \r\nagainst unauthorized data additions, deletions or modifications to donor \r\nfiles or deferral records and transfer of information; \r\n(b) procedures are in place to resolve data discrepancies; and \r\n(c) no unauthorized disclosure of such information occurs, whilst \r\nguaranteeing the traceability of donation. \r\n15. District blood transfu sion committees .– (1) The Government may \r\nconstitute District Blood Transfusion Committees, consisting of  philanthropists, \r\nsocial workers and such other persons as the Government may deem appropriate. \r\n (2) A Committee shall perform such functions as are assigned to it by the \r\nAuthority or as may be prescribed. \r\n16. Registration and licensing .– (1) A blood establishment shall not receive or \r\nsupply blood unless it is registered with the Authority and holds a valid license issued \r\nby the Authority in such manner and on payment of such fee as may be prescribed. \r\n(2) The Authority may issue a provisional license to a blood establishment \r\nin a case where the non -compliance is not critical, subject to the condition that the \r\nblood establishment shall rectify the non -compliance documented by the Authority \r\nwithin the specified time. \r\n17. Obligation.– A person shall: \r\n(a) not operate a blood establishment unless it is registered with Authority \r\nand holds a valid license under the Act; \r\n(b) fully observe the provisions of the Act or rules or regulations; and \r\n(c) ensure that the standards prescribed or specified by the Authority are \r\nfully implemented. \r\n18. Offence.– The offence under the Act shall be of two kinds: \r\n(a) “critical offence ” which means an offence involving a serious adverse \r\nevent or serious adverse reaction; \r\n(b) “significant offence” means an offence falling under any of the following \r\ncategories: \r\n(i) unhygienic premises;  \r\n(ii) inadequate number of staff or engagement of  non-qualified staff \r\nand untrained staff; \r\n(iii) the use of any equipment , incl uding the storage equipment \r\nwhich is not functioning according to prescribed protocols or \r\nstanding operating procedures;  \r\n(iv) non-observance of standard operating procedures; \r\n(v) any equipment present in blood unit not functioning acco rding to \r\nprescribed temperature; \r\n(vi) improper display of standard operating procedures in working \r\nareas of the blood unit; \r\n(vii) use of substandard or  expired consumable, reagent, chemical, \r\ndisposal, kit, solution or water in use of blood unit or \r\nmanufactured by a non-registered manufacturer; \r\n(viii) improper maintenance of records regarding an inventory \r\nrelatable to blood, blood products, consumables, disposables, \r\nchemicals in use or stock, issued or used, expired, discarded, \r\nsupplied, re-deposited; \r\n(ix) lack of alternate source for electric supply causing  interrupted \r\nfunctioning of cold chain or processing in blood unit; \r\n(x) improper labeling of blood, blood products, blood samples with \r\ncareless, incomplete, non -legible, erasable, tampered, \r\noverwritten written or a label without bar-coding; \r\n(xi) improper transportation of blood and blood products or reagent; \r\nand \r\n(xii) lack of separate areas for donor reception, history taking and \r\nexamination, donor bleeding, cross -matching and screening of \r\nblood in a Blood Bank.  \r\n19. Penalty.– (1) Subject to subsection (2) w hoever, either by himself or through \r\nanother person, commits an offence under section 18 or willfully contravenes any of \r\nthe provisions of the Act, rules, regulations or standards prescribed thereunder shall \r\nbe punishable with imprisonment of either description for a term which may extend to \r\nseven years and with fine which may extend to one million rupees. \r\n (2) Whoever, either by himself or through another person, willfully \r\ncontravenes the provisions of  clause (b) of s ubsection (2) of s ection 11 shall be \r\nliable to fine w hich may extend to fifty thousand rupees but which shall not be less \r\nthan ten thousand rupees. \r\n (3) An offence under the Act shall be non-bailable. \r\n20. Cognizance.– A court shall not take cognizance of an offence under the Act \r\nexcept on a complaint in writing by an officer authorized by the Authority. \r\n21. Offences by companies .– (1) Where an offence under this Act has been \r\ncommitted by a Company, every person, who at the time of the commission of the \r\noffence, was in charge of the Company , shall be liable to punishment for the offence \r\nand the Company shall also be liable to the punishment of fine specified for the \r\noffence. \r\n (2) Notwithstanding anything contained in sub -section (1), where it is \r\nproved that the offence is attributable to any neglect on the part  of any director, \r\nmanager, secretary or other officer of the Company, such director, manager, \r\nsecretary or other officer shall also be liable to punishment for the offence.  \r\nExplanation.– In this section, “Company” means a body corporate and includes a \r\nfirm or any other association of persons.  \r\n22. Publication of offender's name .– The Authority shall publish the name of \r\nany person convicted of an offence under th e Act in such manner as may be \r\nprescribed. \r\n23. Secretariat and employees.– (1) The head-office of the Authority shall be at \r\nLahore and it may have such other offices in the Punjab as the Authority, with the \r\napproval of the Government, may determine. \r\n(2) The Authority may employ, in the prescribed manner, such officers and \r\nstaff as may be necessary for the performance of functions under the Act. \r\n24. Fund of the Authority .– (1) Th e Government shall establish a F und of the \r\nAuthority to be known as the Punjab Blood Transfusion Authority  Fund which shall \r\nvest in the Authority. \r\n (2)  The Authority shall maintain the Fund in the prescribed manner. \r\n (3)  The Fund shall consist of: \r\n(a) grants received from the Government through budgetary allocations; \r\n(b) income received from registration fees and license fee and all other \r\nsums received by the Authority; \r\n(c) money received from the Federal Government or any international \r\norganization by way of grant, loan, advance or others; \r\n(d) money received from the disposal of movable and immovable property \r\nof the Authority; and \r\n(e) any other money received by the Authority. \r\n25. Accounts and Audit .– (1) The Authority shall maintain complete and \r\naccurate books of accounts of its actual expenses and receipts  in the manner \r\nprescribed. \r\n(2) The Board shall approve the annual budget of the Authority in the \r\nprescribed manner. \r\n(3) The accounts of the Authority shall be audited annually by the Auditor \r\nGeneral of Pakistan. \r\n26. Delegation.– The Authority may delegate any of its functions to the Secretary \r\nor any other officer of the Authority except the following functions: \r\n(a) making of regulations; \r\n(b) approval of budget of the Authority in addition to the budget allocated \r\nby the Government; and \r\n(c) making of policies. \r\n27. Miscellaneous.– (1) The Act shall apply to the collection and testing of blood \r\nand blood components, and to their processing, storage, d istribution, issuance and \r\nuse but it shall not apply to blood stem cells. \r\n(2) The Authority may allow import into or export from the Punjab of blood \r\nand blood components provided tha t the requirements of quality and safety under \r\nthe Act shall be observed. \r\n(3) The following principles shall also be followed with regard to the blood \r\ntransfusion process: \r\n(a) blood donation shall be a voluntary, anonymous and non -remunerated \r\nact; \r\n(b) transfusion is a not-for-profit health sector activity; \r\n(c) implementation of a common set of stan dards across blood \r\nestablishments shall ensure an equivalent level of quality and safety of \r\nblood and blood components in the Punjab, regardless of the source; \r\nand \r\n(d) self-sufficiency in blood and blood components and its rational and \r\noptimal use in complianc e with modern good clinical practices shall be \r\nthe priority of the Government. \r\n(4)  A person shall not perform blood transfusion therapy unless it is \r\nprescribed and performed under a physician's responsibility and surveillance and \r\nmay only be performed in licensed medical institution. \r\n28. Immunity.– No suit or other legal proceedings shall be instituted against the \r\nmembers, officer or officials of the Authority for any actions taken in good faith under \r\nthe Act. \r\n29. Power to make rules .– The Government may, by notification in the official \r\nGazette, make rules to carry out the purposes of the Act. \r\n30. Power to make regulations .– Subject to the Act and the rules, t he Authority \r\nmay, by notification in the official Gazette, frame regulations to give effect to the \r\nprovisions of the Act. \r\n31. Repeal.– The Punjab Transfusion of Safe Blood Ordinance, 1999 ( XXXVI of \r\n1999) is hereby repealed.",
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