The provincial government of Khyber Pakhtunkhwa has passed Blood Transfusion Safety Authority Bill, 2016 to regulate the collecting, 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 in public and private sectors and to establish regulatory authority for it.
Under the law, it shall be the responsibility of every physician, surgeon and other relevant staff to that blood and blood components being transfused are certified as safe blood by a registered or licensed Blood Bank or Regional Blood Centre; ensure rational clinical use of blood and blood components through their hospital transfusion committees and all process performed at hospital level in relation to transfusion therapy are documented.
As soon as after the commencement of this Act, the provincial government would notify the establishment of a nine-member Khyber Pakhtunkhwa Blood Transfusion Authority with Secretary Health as chairman, Director General, Health Services, Chief Executive, Health Care Commission, Medical Directors, Khyber Teaching Hospital (KTH), Lady Reading Hospital (LRH), Hayatabad Medical Complex (HMC), Commandant, Combined Military Hospital (CMH), legal expert nominated by the provincial government for a period of three years, a senior haematologist nominated on rotation basis for a period of three years and a member of civil society, blood donor organization, non-government organization for a period of three years.
The authority shall adopt policy to regulate all aspects of blood transfusion in the province and ensure that provinces related to collection, testing of human blood and blood components and to their preparation, storage, distribution, issuance and administration are undertaken only by blood bank or regional blood centre; prescribed minimum standards and specifications for registration and licensing of the blood bank or regional blood centre; register and issue licenses to blood banks or regional blood centre in private sector on payment of such fee and in manner as may be prescribed.
The authority will also ensure that blood banks or regional blood centre are managed by qualified professionals having qualifications in blood transfusion, preferably Haematology and alternatively clinical pathology recognized by the council; ensure that bio-safety measures specified in the regulations framed under the Act and instructions issued by the World Health Organization are strictly adhered to by the blood banks; fix service charges of the blood and blood products; take necessary measures to ensure that each blood bank or regional blood centre establishes and maintain a quality management system; 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 influence on the quality and safety of blood and blood components or on donor or patient and staff safety; ensure all necessary measures to ensure that the system used for the labelling of blood and blood components complies with the identification system.
The authority would also establish five committees including technical, licensing, hospital blood transfusion, district blood transfusion and grievances redressal committees for the 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.
The authority would also appoint a person as Chief Executive Officer to manage the affairs and may exercise such powers as delegated to him and he would not be an employee of any health care service provider both public and private sectors nor have interest or share in any blood bank.
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 may be assign to them respectively. The inspectors will inspect the blood bank, or regional blood bank centre at the time of issuance and renewal of license or on receipt of a complaint by aggrieved person or any person; seal premises of the blood bank or regional blood centre, which is not registered or repeatedly violates the provisions of the Act or rules and regulations made there under; 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; seizure and prevention of the release of blood or blood components which are considered unsafe; and take samples of blood, blood components, blood products or any other chemical or substance used for the preservation of blood and for ascertaining the safety thereof.
Under the law, a fund known as Khyber Pakhtunkhwa Blood Transfusion Authority Fund comprising of such sums as government may grant by way of seed money; grant-in-aid in lieu of services rendered to health/blood bank; donations from domestic and international donor agencies and other institutions, 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; fee or other charges imposed under the Act and 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. The fund would be utilized for the purpose of authority and would be regulated under the overall supervision of the authority.
The authority would prepare and approve annual budget for a financial year. No expenditure would 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.
The Chief Executive Officer will 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. The accounts of the authority will be audited by the Auditor General of Pakistan (AGP) and 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 certified by the auditor and a copy of auditor's report to provincial government.
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