MODULE 7_BLOOD BANK LAWS PDF

MODULE IN MEDICAL TECHNOLOGY LAWS AND BIOETHICS MLS 214 Department of Medical Laboratory Science...

MODULE IN MEDICAL TECHNOLOGY LAWS AND BIOETHICS MLS 214 Department of Medical Laboratory Science SCHOOL OF NATURAL SCIENCES Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 1  MODULE 7 – BLOOD BANKING LAWS This module focuses on the different blood banking laws that aims to promote voluntary blood donation and to regulate blood banks to provide a sufficient and safe supply of blood products. This module will also tackle on the implementing rules and regulations and administrative orders that prescribes policies and guidelines pertinent to the establishment and operation of blood banks for blood safety and adequacy, quality care and patient safety. MODULE OBJECTIVES: At the end of this module, you are expected to be able to: 1. Discuss the different rules and regulations governing Blood Bank Laws 2. Explain the blood service facility setup ensuring quality assurance and laboratory safety to protect the donor, worker and environment as provided by law. 3. Illustrate a procedural flow chart for the registration and licensure of blood service facilities. 4. Appreciate the role of medical technologists/medical laboratory scientists in a Blood Banking Laboratory ENGAGE BLOOD BANK WORD RELATE Give 5 words that come to your mind whenever you hear the term “Blood Bank”. EXPLORE Blood Banking Laws The contents of this module are from the following laws: R.A. No. 7719  An Act Promoting Voluntary Blood Donation, providing for an Adequate Supply of Safe Blood Regulating Blood Banks and Providing Penalties for Violation Thereof  “National Blood Services Act of 1994”  Approved on May 5, 1994 Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 2  DOH A.O. No. 9 Series of 1995  IRR of R.A. 7719  Approved on April 28, 1995 DOH A.O. No. 2005-0002  Rules and Regulations for the Establishment of the Philippine National Blood Services Amends Pertinent Provisions of A.O. No. 9 s. 1995  Amends Sections 4-8, 12, 14-17, 25, 35, 38-44 of DOH A.O. No. 9 Series of 1995  January 10, 2005 DOH A.O. No. 2008-0008  Rules and Regulations Governing the Regulation of Blood Services Facilities  Revised relevant provisions of DOH A.O. No. 9 Series of 1995 and DOH A.O. No. 17-A Series of 1998  May 2, 2008 DOH A.O. No. 2008-0008A  Amendment to A.O. No. 2008-0008  August 22, 2011 EXPLAIN BLOOD BANK PROVISIONS Declaration of Policy (R.A. No. 7719, Section 2) In order to promote public health, it is hereby declared the policy of the State: 1. to promote and encourage voluntary blood donation by the citizenry and to instill public consciousness of the principle that blood donation is a humanitarian act; 2. to lay down the legal principle that the provision of blood for transfusion is a professional medical service and not a sale of a commodity; 3. to provide for adequate, safe, affordable and equitable distribution of supply of blood and blood products; 4. to inform the public of the need for voluntary blood donation the hazards caused by the commercial sale of blood; 5. to teach the benefits and rationale of voluntary blood donation existing health subjects of the formal education system in all public /private schools, in the elementary, high school and college levels as the non-formal education system; 6. to mobilize all sectors of the community to participate in mechanisms for voluntary and non-profit collection of blood; 7. to mandate the Department of Health to establish and organize a National Blood Transfusion Service Network in order to rationalize and improve the provision of adequate and safe supply of blood; 8. to provide for adequate assistance to institutions promoting non-profit blood services, either through a system of reimbursement for costs from patients who can afford to pay, or donations from governmental and non-governmental entities; Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 3  9. to require all blood collection units and blood banks/centers to operate on a non- profit basis; 10. to establish scientific and professional standards for the operation of blood collection units and blood banks/centers in the Philippines; 11. to regulate and ensure the safety of all activities related to the collection, storage and banking of blood; and 12. to require upgrading of blood banks/centers to include preventive services and education to control spread of blood transfusion transmissible diseases. Scope (DOH A.O. No. 9 Series of 1995, Section 3) These Rules shall apply to all hospitals, entities, establishments or institutions, government owned and operated or private, engaged in blood banking and blood transfusion services in the Philippines, whether full time or part time, local or foreign. Definition of Terms 1. Blood/Blood products – refers to human blood, processed or unprocessed and includes blood components, its products and derivatives a. Blood component – refers to whole blood, red cells, granulocytes, plasma, platelets, cryoprecipitate and cryosupernate. b. Blood derivatives or plasma fraction – partially purified plasma protein made under pharmaceutical manufacturing conditions, including coagulation factors, immunoglobulin and albumin. c. Blood product – a therapeutic substance derived from whole blood or plasma 2. Blood transfusion – a set of activities and functions related to blood transfusion such as, but not limited to:  motivation and recruitment of donors  blood collection  testing and screening of donor blood  compatibility testing  preparation of blood components  storage, distribution, and administration of blood and components  investigation of blood transfusion reactions  inventory control and quality assurance 3. Blood Service Facility (BSF) – a unit, agency or institution providing blood products. The types of BSF are a. Blood Stations b. Blood Collection Unit (BCU) c. Apheresis Facility d. Hospital Blood Bank e. Blood Center Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 4  Philippine National Blood Services (DOH A.O. No. 2005-0002) Structural Organization and Management of the Philippine National Blood Services A. Blood Services Network – an informal organization composed of the designated blood centers and hospital blood banks, blood stations, and end-user hospitals established to provide for the blood needs of a specific geographical area shall consist of: a. National Council for Blood services and its various committees b. Philippine National Blood Services (National, Subnational & Regional Blood Centers) c. Authorized Blood Collection Units and Apheresis Facilities d. Hospital Blood Banks and Blood Stations, both government and private e. End-User Hospitals and Non-Hospital Health Facilities, both government and private f. National Reference Laboratories for Immunology and Immunohematology B. National Council for Blood Services (NCBS) - governing body of the Philippine National Blood Services (PNBS) - chaired by the Secretary of Health Composition: composed of, but not limited, to Heads or Representatives of the following Offices and Associations subject to qualifications: a. Philippine National Red Cross (PNRC) b. Philippine Blood Coordinating Council (PBCC) Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 5  c. Philippine Society of Pathologists (PSP) d. Philippine Society of Hematology & Blood Transfusion (PSHBT) e. Director (or Chief Executive Officer) of the Philippine Blood Center NCBS Committees: a. Executive Committee b. Technical Committee c. Committee on Public Education and Advocacy d. Committee on Professional Education e. Committee on Curriculum Development f. Committee on Finance g. Committee on Information Technology h. Other Committees to be created as necessary NCBS Secretariat: staff from either the a. Philippine Blood Center or b. DOH National Center for Health Facility Development (NCHFD) NCBS Meetings: a. at least quarterly or b. as necessary depending upon the discretion of the chairperson *Non-DOH members shall be entitled to per diems for meetings attended NCBS Functions: a. Approval of policies governing the operation of the Philippine National Blood Services and the utilization of blood products by hospitals and other health services; b. approval of the Standards, Standard Operating Procedures and Guidelines for the i. Recruitment of Donors, ii. Collection, iii. Transport, iv. Testing & Processing of Blood, v. Issuance and Administration of Blood Components, and vi. Monitoring of Blood Transfusion Practices; c. approval of Directional/Strategic Plan of the National Voluntary Blood Services Program (NVBSP) from time to time; d. approval of allocation of funds and monitoring of fund utilization; e. develop the capabilities of the Philippine National Blood Services and Blood Services Network as the need arises; f. creation of other standing and special committees as appropriate; g. approval of certificate of importation privileges. C. The Philippine National Blood Services (PNBS) shall operate under the supervision of National Council for Blood services (NCBS). Under the PNBS are the following Blood Centers: 1. Philippine Blood Center in Metro Manila – shall be designated by the NCBS Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 6  Functions: a. Recruitment, retention and care of voluntary blood donors b. collection of blood (whole blood or component) from qualified voluntary blood donors c. testing of units of blood for infectious disease markers (Anti-HIV ½, Anti-HCV, HBsAg, Syphilis reagin, Malaria parasites), Blood transfusion transmissible diseases – diseases which may be transmitted through blood transfusion, including but not limited to acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, malaria and syphilis. d. processing of whole blood into blood components e. pheresis of blood components f. storage, issuance, transport and distribution of whole blood & blood components to end-user hospitals and non-hospital health facilities g. quality assurance of Sub-National Blood Centers and selected Regional Blood Centers h. conduct training and research i. performance of special confirmatory and reference immunohematologic examinations such as: i. resolution of incompatible red cell crossmatches, ii. identification of red cell alloantibodies and autoantibodies, iii. phenotyping of patients and donors, iv. provision of antigen-negative red cell units j. manufacture and provision of Typing Sera and Panel of reagent red cells k. preparation of special plasma derivatives l. ensure that safe supply of blood and blood products to all hospitals and other health facilities are adequate in terms of distribution and delivery m. other functions as may be assigned by the NCBS 2. Subnational and Regional Blood Centers for Luzon, Visayas and Mindanao Functions: a. Recruitment, retention and care of voluntary blood donors b. collection of blood from qualified voluntary blood donors c. testing of units of blood for infectious disease markers (Anti-HIV ½, Anti-HCV, HBsAg, Syphilis reagin, Malaria parasites) for Subnational Blood Centers and selected Regional Blood Centers d. processing of whole blood into blood components e. pheresis of blood components f. storage, issuance, transport and distribution of whole blood & blood components g. quality assurance and supervision by Sub-National Blood Centers of Regional Blood Centers according to specific geographic areas h. conduct training and research i. performance of special confirmatory and reference immunohematologic examinations such as: (Subnational Blood Centers and selected Regional Blood Centers) i. resolution of incompatible red cell crossmatches, ii. identification of red cell alloantibodies and autoantibodies, Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 7  iii. phenotyping of patients and donors, iv. provision of antigen-negative red cell units j. ensure that safe supply of blood and blood products to all hospitals and other health facilities are adequate in terms of distribution and delivery k. develop other capabilities as the arises, in the respective regions based on the evaluation of the NCBS 3. Authorized Blood Collection Units and Apheresis Facilities - under the supervision of the National, a Subnational or Regional Blood Center Authority to operate – a formal permit issued by the DOH-CHD to an individual, partnership, corporation or association which has complied with all the technical requirements as prescribed by law and in the Manual of Standards for Blood Collection Units/ Blood Stations in the Philippines. Blood Collection Unit (BCU) – a blood service facility duly authorized by the DOH CHD pursuant to DOH A.O. 101-A s. 2003 with the following service capabilities: a. Recruitment, retention and care of voluntary blood donors b. screening and selection of qualified voluntary blood donors c. conduct of health education and counselling services d. collection of whole blood or components from qualified voluntary blood donors e. transport of units of blood to the Blood Center for testing and processing and distribution to hospitals and other health facilities Apheresis Facility – a blood service facility where blood collection procedure is done in which whole blood is removed, a selected component separated and the remainder returned to the donor. 4. Hospitals - shall be one of the following depending on the size and complexity of services provided: i. Hospital Blood Bank – a blood service facility in a hospital duly licensed by the DOH BHFS with the following service capabilities:  storage of whole blood & blood components obtained from a blood center or another hospital;  compatibility testing of red cell units;  direct Coombs test;  red cell antibody screening;  investigation of transfusion reactions;  assist the Hospital Blood Transfusion Committee (ConA) in the conduct of post-transfusion surveillance (hemovigilance) ii. Hospital Blood Station – a blood service facility duly authorized by the DOH CHD pursuant to DOH A.O. 101-A s. 2003 with the following service capabilities:  provision of whole blood and packed red cells; Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 8   storage, issuance of whole blood and packed red cells;  compatibility testing of red cell units, if hospital-based. iii. End-User Hospital (EU) – a hospital with a licensed clinical laboratory capable of red cell typing and cross-matching and which does not have any blood service facility but which only receives blood and blood components for transfusion as needed. - shall establish and maintain a proper audit and inventory system of blood and blood products to ensure adequate, safe supply of blood including emergencies to patients 5. End-User Non-Hospital Health Facility - licensed/accredited non-hospital health facility without a licensed clinical laboratory but which provide transfusion of blood or blood components - includes i. renal dialysis centers ii. ambulatory surgical clinics iii. birthing centers - shall establish and maintain a proper audit and inventory system of blood and blood products to ensure adequate, safe supply of blood including emergencies to patients 6. National Reference Laboratories (NRL) for Immunology and Immunohematology consistent with the provisions of Department Order 301-I s. 1999 a. NRL for Immunology for the confirmatory testing of blood donors and blood units – Research Institute for Tropical Medicine (RITM) b. NRL for Immunohematology – National Kidney and Transfusion Institute (NKTI) The NCBS has the authority to transfer or change the designation of health facilities as the NRL for Immunology and Immunohematology for the confirmatory testing of blood donors and blood units as need arises. D. Funding Provisions 1. NCBS shall be supported by funds from: a. Main source: i. Budgetary allocation from the National Government ii. National Government Financing Agencies  Philippines Charity Sweepstakes Office (PCSO)  Philippine Amusement and Gaming Corporation (PAGCOR) iii. Reimbursement from Philippine Health Insurance Corporation (PhilHealth) directly or through the Hospitals iv. Blood Services Fees from Government and Private Hospitals for units of blood provided and for services rendered. b. Collaborating support: i. National Donor Agencies and Foundations ii. International Development and Donor Organizations iii. Contributions from Local Government Units Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 9  Functions of the NCBS a. work out a plan for the continued funding and material support from the National Government and National Government Financing Agencies like PCSO and PAGCOR; and b. work out plan for funding from National Donor Agencies/Foundations and International Development and Donor Organizations 2. NVBSP and PNBS a. A trust fund shall be established out of the blood service fees, donations and revenues generated by the blood services facilities. b. DOH shall allocate an annual budget for personnel, capital outlay, infrastructure, maintenance, operating and other expenses 3. Blood Centers (National, Subnational and Regional) a. reimbursed actual cost of blood products and services as provided by a MOA signed with hospitals/hospital facilities b. PhilHealth reimbursement for blood transfusion expenses to hospitals/patients based on the following criteria: i. Blood unit is collected from a voluntary blood donor only; ii. blood unit is tested at the Philippine Blood Center, Subnational Blood Center and selected Regional Blood Centers only; iii. blood unit is transfused in accordance with the indications for rational blood use. E. General Guidelines 1. Voluntary blood donations, Mobile and health facility-based, shall be aggressively promoted. Blood shall be collected from qualified healthy voluntary blood donors only. 2. The PNBS shall ensure the availability of quality health care to its clients through the establishment of appropriate capabilities and competencies in their respective units. 3. All blood units issued by the Philippine Blood Centers, Sub-national Blood Centers and Regional Blood Centers under the Philippine National Blood Services Network, need not to be retested for Transfusion-Transmitted infections (TTIs) by the hospitals (government or private) and other health facilities. It is the responsibility of the issuing blood centers to ensure that all units of blood issued have been tested and found to be negative for TTIs. However, in the event that retesting of blood is deemed warranted by the attending physician, said tests shall be performed using the reagents as recommended by the NVBSP Technical Committee and charged corresponding laboratory fees. 4. Hospitals and other Health Facilities shall only use blood and blood products for transfusion to patients from licensed and authorized blood centers. F. Operationalization and Management of PNBS 1. Personnel/staffing Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 10  a. The organizational structure of the PBC (Metro Manila), Subnational and Regional Blood Centers (for Luzon, Visayas and Mindanao) shall be created and approved by the NCBS. b. NVBSP personnel may be reassigned to the National and Subnational Blood Centers, and if necessary, to selected Regional Blood Centers. c. New personnel shall be hired as needed. 2. Procurement/Equipment a. NVBSP-procured equipment and vehicles shall be centralized in the National, Sub-national and Regional Blood Centers i. Blood banking equipment - essential laboratory machines, instruments and their accessories used in the different steps in the blood banking process, such as those used  to centrifuge blood or separate blood into its various components;  preserve blood or blood products in cold storage or freezer; and  perform blood tests such as haemoglobin tests and screening tests for blood transmissible diseases.  These equipments also include those used in specific supportive processes such as sterilization and sanitary disposal of blood and blood products. ii. Blood bags – sterile, sturdy plastic bags containing anti-coagulants which are especially designed for blood collection and transfusion. Blood bags can either be single or multiple types and have integral sterile needle and collection tubing. iii. Reagents – substances employed to detect or measure another substance or convert one substance to another by means of the reaction that it causes. In blood banking, the reagents used are those necessary to  measure haemoglobin;  screen for blood transmissible diseases such as HIV, hepatitis, malaria, syphilis, among other;  identify blood groupings; and  perform cross-matching and other immunohematologic examinations. b. A Bids and Awards Committee (BAC) of the PBC shall be created whose composition and functions shall follow the existing Procurement Law, c. The PBC, in consultation with the Department of Finance and Bureau of Customs, shall prepare the detailed list of equipment, blood bags and reagents and complete specifications as necessary, which may be allowed to be imported tax- and duty-free under the provisions of RA 7719. The list together with the application for exemption from customs, duties and taxes shall be filed with the Revenue Office, Department of Finance, Manila by authorized participants who can avail of this privilege. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 11  Promotion of Voluntary Blood Donation (DOH A.O. No. 9 Series of 1995, Chapter III) Voluntary blood donor – an individual who donates blood on one’s own volition or initiative and not induced, directly or indirectly, in any manner whatsoever, by any monetary compensation. Walking blood donor – an individual who has been screened by history and physical examination, found to be fit to donate blood, and included in the list of qualified voluntary donors who is ready to donate blood when needed in his or her community. A. National Advocacy and Promotion Sub-committee Composition: shall be composed of, but not limited to representatives of the: a. Department of Health b. Philippine National Red Cross (PNRC) c. Philippine Blood Coordinating Council (PBCC) d. Philippine Information Agency e. other similar organizations whose activities are related to advocacy and promotion of voluntary blood donation Functions: a. Preparation of a five-year advocacy and promotion plan based on the NVBSP five-year directional/strategic plan which shall be submitted to the Secretary of Health for approval; b. Formulation of designs for non-monetary or non-profit oriented incentives for voluntary blood donors such as, but not limited to, Blood Assurance Plans; c. Planning, coordination, monitoring and evaluation of the national advocacy and promotion activities B. Regional Advocacy and Promotion Sub-committee - created in each region of the country with similar corresponding composition as that of the National Advocacy and Promotion Sub-committee but may be expanded to include other organizations - encourage the creation of similar committees at the provincial and city levels - chaired by the representative of the Department of Health a. Formulation of the regional advocacy and promotion operational plan which shall be submitted to the Regional Health Director for approval and endorsement to the National Voluntary Blood Services Program Committee; b. Implementation, monitoring and evaluation of the regional advocacy and promotion activities C. National Voluntary Blood Services Program Sub-committee on Curriculum Development - chaired by the Secretary of Education Composition: composed of members including, but not limited to, the representatives from the: Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 12  a. Department of Health b. Philippine Society of Hematology and Blood Transfusion c. Philippine Society of Pathologists d. Philippine Association of Medical Technologists e. Philippine Association of Schools of-Medical Technology and Public Health f. Philippine Nursing Association g. Association of Philippine Medical Colleges h. Philippine Medical Association i. Philippine National Red Cross Function: Promotion of Voluntary Blood Donation in Schools and Communities a. Development, printing and distribution of instructional materials and methods focused on voluntary blood donation for integration into the health subjects of all schools, public or private, and at all levels of education, formal or non-formal; b. orientation and/or training of teachers on the utilization of such materials and methods; c. monitoring of the use and effectiveness of such materials and methods in terms of process and product, and continuing revision of such as necessary; d. preparation and submission to the National Voluntary Blood Services Unit of the annual budgetary requirements for the promotion of voluntary blood services in the schools; e. provide training programs and technical assistance to enable communities, schools, industrial and business sectors, barangays, military groups and local government units to implement their own voluntary blood donation programs. D. Professional Education and Rational Use of Blood and Blood Products 1. Role of the PRC a. Encourage all medical and other health professional associations and societies especially those accredited by the PRC to conduct trainings on rational use of blood and blood products including the benefits of voluntary blood donation for their respective members as part of the continuing professional education. b. Provide equivalent continuing professional education units for all training courses on rational use of blood and blood products. 2. Role of Professional Societies and Associations a. All medical and other health professional associations and societies whose activities are related to professional education and blood transfusion shall be encouraged to conduct trainings and seminars on the rational use of blood and blood products including the dangers of commercial blood and the benefits of voluntary blood donation for their respective members as part of their continuing professional education activities and residency programs. b. Through Sub-committees created by the National Voluntary Blood Services Program Committee, technical manuals and training modules for health professionals on the "Rational Use of Blood and Blood Products and Blood Transfusion Medicine" shall be developed involving various professional societies and associations. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 13  3. Role of the Department of Health a. Ensure the conduct of training on rational use of blood and blood products, on the practice of blood transfusion medicine, and on the merits of voluntary blood donation for the health personnel. b. Require training hospitals to conduct continuing professional education programs and trainings on the rational use of blood and blood products and the merits of voluntary blood donation as one of the prerequisite for licensure of hospitals. It shall also provide guidelines for the inclusion of the rational blood and blood products use and the merits of voluntary blood donation in the examination for residency training admission and the monitoring of such activities in hospitals. c. Require the establishment of a hospital Blood Transfusion Committee as a prerequisite for licensure of teaching/training hospitals and hospitals with blood banks/centers. Hospital Blood Transfusion Committee Composition i. Physicians from the Department of Pediatrics, Medicine, Surgery, Obstetrics and Gynecology, and Pathology ii. Hematology consultant iii. Representatives from the nursing service iv. Hospital Medical Training Officer and v. Blood Service Quality Assurance Officer Function: i. establishment of hospital policies and guidelines for blood transfusion therapy and monitoring and audit of the use of blood and blood products within the facility according to the Standard Operation Manual on Blood Services of the BRL Voluntary Blood Donation Recruitment (DOH A.O. No. 9 Series of 1995, Section 13) A. Department shall adopt a system of procedures or programs to promote blood donor recruitment arid ensure the increase in the number and retention of voluntary blood donors as follows: 1. coordinate with heads of agencies, institutions, offices, organizations, business establishments and communities, be they government or non-government, and encourage them to actively participate in donor recruitment in order to secure commitments to regular blood donations in their particularly designated blood services facility; 2. lead agency in collaboration with PNRC in the celebration of the Blood Donor's Week which shall be held annually on the second week of July. During the Blood Donor's Week, the Department, in coordination with other agencies, shall adopt a program or system of awards, rites, ceremonies or activities in special recognition of the voluntary blood donors; Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 14  3. coordinate the professionalization of voluntary blood donors, health educators and donor recruiters through organized training activities; 4. encourage and convince local government units to pass ordinances or resolutions that will promote the walking blood donor concept such as, but not limited to, a. mandatory keeping of a list of qualified voluntary blood donors in the government hospitals, rural health units, health centers and barangays, and b. conduct of mass blood typing activities in areas where there are no adequate blood service facilities. Upgrading of Services (DOH A.O. No. 9, Section 21, 22, 23) A. Philippine National Red Cross. The Department shall assist the PNRC in mobilizing resources and in updating their facilities or chapters by facilitating linkages with private or government hospitals with laboratory facilities and trained personnel. B. Preventive Services. All blood service facilities shall provide preventive health services such as education and pre- and post- counselling on blood transfusion transmissible diseases in line with the guidelines and standards of the National Voluntary Blood Services Units. C. Recognition Awards. The Department, in coordination with the PNRC, shall grant seals of excellence in recognition of outstanding service of blood service facilities to be awarded in a formal ceremony of the Blood Donor’s Week. Phase-Out of Commercial Blood Banks (DOH A.O. No. 9 Series of 1995, Chapter IV, Section 33) Commercial blood bank – a blood bank that exists for profit, money or any material gain earned out of sale of, or exchanged of blood or blood products which profit, money or any material gain are not used solely for the operation and maintenance of the blood bank service. A. Process of Phasing-Out. DOH shall effect the phasing-out of all commercial blood banks over a period of two (2) years, extendible for maximum period of (2) years after the effectivity of R.A. 7719. The decision to extend shall be based on the result of a careful study and review of the blood supply and demand public safety. B. Options for Commercial Blood Banks. The Department shall encourage and assist existing commercial blood banks to convert to solely clinical laboratories in order to ensure job security of their personnel and allow a reasonable return on their investment on training and equipment. C. Phase-out of Commercial Blood Banks. No new license shall be issued for a commercial blood bank. Renewal of license of existing commercial blood banks beginning January 1, 1997 shall be upon compliance with the new requirements. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 15  Rules and Regulations Governing the Regulation of Blood Service Facilities (DOH A.O. No. 2008-0008) A. Objective: to protect and promote the health of the people by ensuring available licensed blood service facilities with adequate staff, equipment and resources to perform all the required functions safely, efficiently and effectively. B. Scope: all government and private blood service facilities engaged in blood banking and transfusion services C. General Guidelines 1. Every BSF shall be an integral part of a blood services network and guided by administrative issuances governing the establishment and operation of blood services networks. a. Each BC shall have responsibility for and authority over the conduct and close supervision of the BCU/BS affiliated with its Blood Services Network. b. The head of the BC or his designated staff shall conduct on site periodic evaluation of each affiliated BB, BCU and BS. 2. All BSF are required to comply with the standards and technical requirements embodied in the inspection tools. It shall be posted at the DOH website www.doh.gov.ph 3. Blood shall be collected from qualified healthy voluntary non-remunerated blood donors only. 4. Testing for TTIs shall be based on the DOH prescribed methodology. The number of infections to be screened as well as the method for their detection shall be determined and reviewed periodically by the NCBS. 5. Testing for TTIs shall be done at the national, sub-national and designated regional BCs including PNRC BCs. Such designation shall be determined by the NCBS pursuant to AO 2005-0002. 6. All units of blood issued by the Philippine BC, sub-national BCs, regional BCs and PNRC under the Philippine National Blood Services Network shall not be retested for TTIs by the end-user hospitals and other health facilities. It is the responsibility of the issuing BCs to ensure that all units of blood issued have been tested and found to be negative to TTIs. 7. Blood and blood products for transfusion shall be obtained from licensed and authorized BSF only. D. Specific Guidelines 1. Classification of BSF a. Ownership ii. Government – operated and maintained partially or wholly by a national, provincial, city or municipal government or other political unit by any department, division, board or agency thereof or by a government owned or controlled operation. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 16  iii. Private (for hospital-based BSF only) – privately owned, established and operated with funds through donation, capital or other means by an individual, corporation, association or organization. b. Institutional Character i. Hospital-based – a BSF located within the premises of a hospital. ii. Non-hospital-based – a government-owned or PNRC-owned BSF located outside the premises of a hospital consistent with the NVBSP strategic plan. c. Service Capability BS BCU BB BC Advocacy and promotion of voluntary blood donation and healthy lifestyle Recruitment, retention and care of voluntary blood donors Screening and selection of voluntary blood donors Conduct of health education and counselling services Collection of blood (mobile or facility-based) from qualified blood donors Transport of blood to BC for testing and processing Testing of units of blood for TTIs Processing and provision of blood components Provision of whole blood and packed red cells Storage, issuance, transport and distribution of whole blood and packed red cells Storage and issuance of whole blood and blood components obtained from a BC Storage, issuance, transport and distribution of units of whole blood and/or blood products to hospitals and other health facilities Compatibility testing of red cell units, if hospital-based Direct Coombs Test Red cell antibody screening Investigation of transfusion reactions Assist the HBTC in the conduct of post-transfusion surveillance (hemovigilance) ***DOH AO 2008-0008A provides the following amendments: Hospital Blood Banks of Level 3 and Level 5 private and government hospitals may continue blood component collection from volunteer blood donors; blood testing using the NVBSP recommended methodologies and component processing. Said hospital blood banks must comply with the requirements for said services in addition to the hospital blood bank licensing requirements already stated in AO 2008- 0008. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 17  2. Standards and Technical Requirements a. The BSF appoints and allocates personnel who are suitably qualified, skilled and trained to assume the responsibilities, authority, accountability and functions of the position. A. MANAGEMENT REQUIREMENTS 1. Management Responsibility. The Blood Service Facility shall be managed effectively and efficiently and in accordance with its vision, mission, and objectives. a. There shall be a continuing program on staff development and training. b. There shall be a policy for hiring, orientation and promotion for all levels of personnel. c. There shall be a policy for discipline, suspension, demotion and termination of personnel at all levels. 2. Manpower. The Blood Service Facility appoints and allocates personnel who are suitably qualified, skilled and/ or trained to assume the responsibilities, authority, accountability and functions of the position. a. The organizational chart shall be clearly structured indicating the names with pictures and designation, reflecting lines of authority, accountability, communication, interrelationship, hierarchy of functions and flow of referrals b. Duties and responsibilities shall be clearly spelled out. c. The BSF is headed by a duly licensed physician  BC and BB o Certified in Clinical Pathology or Blood Banking by the PSP, and with experience of at least 3 years in the category of Blood Service Facility he/ she will head, OR o Certified in blood transfusion by PSHBT, and with experience of at least 3 years in the category of Blood Service Facility he/ she will head, OR o Certified in Anatomic Pathology by PSP or in Hematology by PSHBT with additional training in blood banking for at least 6 months in a training institution accredited by PSP or PSHBT, with experience of at least 3 years in the category of Blood Service Facility he/ she will head.  Hospital based BCU/BS o Certified in Clinical Pathology by the PSP, OR o Physician authorized to head the clinical laboratory of the hospital where the BCU/BS is located  Non-Hospital Based BCU/BS o Physician with at least 3 months formal training in blood banking recognized by the DOH-NVBSP, OR o Physician with at least 1 year experience in a Blood Bank/ Center that performs blood collection activities recognized by the DOH- NVBSP d. There shall be adequate number of qualified medical technologists who shall work on shifts to cover a 24-hour service proportional to the workload as determined by the head of the Blood Service Facility. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 18   At least 9 in BC; at least 4 in BB RMT distributed in shifts  At least 6 months on-the-job experience in blood banking service under an institution recognized by the DOH-NVBSP for RMT in BC & BB e. For BC & BCU only: There shall be sufficient number of qualified phlebotomists either medical technologist or nurse who shall work during remote or in-house blood donation.  At least 3 months on-the-job experience in blood banking service under an institution recognized by the DOH-NVBSP. f. For all BSF except BS: The Blood Service Facility shall designate one (1) qualified and trained Donor Recruitment Officer (DRO). Such training shall be recognized by the DOH-NVBSP and shall include training on pre- and post- donation counselling. g. The Blood Service Facility shall designate and train one (1) of its senior medical technologists as a Quality Assurance Officer. Such training shall be recognized by the DOH-NVBSP. b. Services are provided in an environment that promotes safety, has adequate space, meets the needs of clients, service providers and other stakeholders, and conforms to the current Manual of Standards issued by the DOH. 3. Physical Facilities/ Work Environment. Services are provided in an environment that promotes safety, has adequate space, meets the needs of clients, service providers and other stakeholders, and conforms to the current Manual of Standards issued by the DOH. a. The Blood Service Facility has adequate space for the conduct of its activities. b. The Blood Service Facility shall be adequately ventilated, well-lighted, clean, safe and functional based on the services it provides. c. There shall be a program of proper maintenance and monitoring of physical plant and facilities. d. There shall be a policy on laboratory biosafety and biosecurity and the proper disposal of waste and hazardous/ infectious substances that shall conform to the standards set by the DOH. c. All equipment and instruments necessary for the safe and effective provision of services are available and are properly maintained. 4. Equipment. All equipment and instruments necessary for the safe and effective provision of services are available and are properly maintained. a. There is an adequate number of operational equipment to provide the Blood Service Facility procedures the Blood Service Facility is licensed for. b. There is a program for calibration, preventive maintenance and repair for the equipment. c. There shall be a contingency plan in case of equipment breakdown, especially of Blood Service Facility cold storage equipment. d. All reagents and glass wares to be used by the BSF shall be based on the minimum requirement for sensitivity and specificity of testing reagents as the Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 19  testing procedures as recommended by the technical committee of the NVBSP. 5. Reagents and Supplies. All reagents and glassware to be used by the BSF shall be based on the minimum requirement for sensitivity and specificity of testing reagents as well as the testing procedures as recommended by the technical committee of the NVBSP. a. There is an adequate supply of properly stored and inventoried reagents and supplies. b. There are adequate storage facilities such as refrigerators for perishable reagents and supplies. c. There is appropriate storage area/ technique for flammable, combustible and hazardous chemicals/ reagents. e. There shall be a system of reporting and recording of results of BSF examinations. Blood Collection Blood Center Blood Bank Blood Station Unit 6. Reporting and Reporting and There shall be a Records Records system of There shall be a Management. There Management. There reporting and system of shall be a system of shall be a system of recording of reporting and reporting and reporting and blood and blood recording of recording of results of recording of results of products stored blood and blood bank blood bank collected and blood products. (immunohematology) (immunohematology) issued. examinations. examinations. a. There shall be a There shall be a documented documented There shall be a There shall be a procedure for procedure for documented documented reporting of results. reporting of results. procedure for procedure for Reports bearing the Reports bearing the reporting and reporting and name and facsimile name and facsimile recording of recording of signature of the head signature of the head blood and blood blood and blood and signed by the and signed by the products products medical medical collected and collected and technologists who technologists who issued. issued performed the performed the examinations examinations There shall be a There shall be a documented documented There shall be a b. procedure for procedure for system of reporting retention of retention of and recording of records which records which blood and blood shall follow shall follow products collected standards standards and issued. promulgated by promulgated by the DOH and/ or the DOH and/ or Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 20  competent competent professional professional organizations. organizations. c. There shall be a documented procedure for reporting and recording stored and issued blood and blood products d. There shall be There shall be documented documented procedure for procedure for retention of records retention of records which shall follow which shall follow standards standards promulgated by the promulgated by the DOH and/ or DOH and/ or competent competent professional professional organizations. organizations. e. There shall be a There shall be a There shall be a There shall be a designated area for designated area designated area designated area for storage of records. for storage of for storage of storage of records. records. records. f. The BSF shall put into practice a quality assurance program a. There shall be a policy on quality assurance program and continuous quality improvement b. The BSF shall participate in an External Quality Assessment Program administered by the designated National Reference Laboratories (NRL) or other external assessment program approved by the DOH-NVBSP. 7. Quality Assurance Program. The Blood Center shall put into practice a quality assurance program. a. There shall be a policy on Quality Assurance Program and Continuous Quality Improvement. b. The Blood Service Facility shall participate in an EQAP administered by the designated NRL or other External Quality Assessment Program approved by the DOH-NVBSP. g. There shall be a system in outsourcing of examinations and blood components. h. All hospital-based BB, BCU, and/or BS shall establish a Hospital Blood Transfusion Committee. i. All BSF shall comply with policies and guidelines of the NVBSP. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 21  B. TECHNICAL REQUIREMENTS Blood Center 1. Administrative/ Technical Procedures. There shall be a system for the provision and processing of safe blood and blood products. a. There shall be a policy for advocacy and promotion, donor recruitment, retention and care of voluntary donors. b. There shall be a policy for collection of blood from qualified voluntary donors, both mobile and facility based. c. There shall be a policy for the processing of blood and blood products. d. There shall be a policy for the storage and distribution of whole blood/ components and specialized immunohematology services. e. There shall be a policy to ensure blood safety by screening and testing for the five (5) TTIs namely: HIV1/2, HBsAg, HCV, Malaria, Syphilis and other TTIs mandated for screening by the technical committee of the NCBS. f. There shall be a policy for confirmation of blood/blood products initially reactive to any of the 5 TTImarkers namely: HIV1/2, HBsAg, HCV, Malaria, Syphilis. g. There shall be a policy for the management of inventory of blood products. h. There shall be a policy for specialized immunohematology examinations. Blood Bank 1. Administrative/ Technical Procedures. There shall be a system for the provision and processing of safe blood and blood products. a. There shall be a policy for the provision of blood products and blood banking services. b. There shall be a policy for the proper issuance of compatible and tested blood products. c. There shall be a policy for the collection, preparation, storage and provision of apheresis derived blood products, if the BSF has the capability for this procedure. d. There shall be a policy for specialized immunohematology examinations. e. There shall be a policy for compatibility testing to provide safe blood components. f. There shall be a policy for investigation of transfusion reactions. Blood Collection Unit 1. Administrative/ Technical Procedures. There shall be a system for advocacy, promotion, recruitment, retention and donor care, and collection and transport of units of blood collected from voluntary donors. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 22  a. There shall be a policy for advocacy and promotion, donor recruitment, retention and care of voluntary donors. b. There shall be a policy on compatibility testing, if hospital based 1. Administrative/ Technical Procedures There shall be a system for storage, provision, and proper issuance of safe and tested blood and blood products. a. There shall be a policy on storage and issuance of blood and blood products. b. There shall be a policy for compatibility testing for hospital based BS. 2. Referral of Examinations for Rare Blood Types and Outsourcing of Rare Blood/ Blood Components. There shall be a system in outsourcing of rare examinations and blood components. For Blood Center and Blood Bank only a. There shall be a policy on immunohematology examinations for rare blood types and outsourcing of rare blood/ components. E. LTO/ATO 1. Hospital based BBs, BCUs and BS shall be licensed or authorized to operate through the One-stop-shop Licensure for Hospitals and are therefore not required to obtain a separate LTO or ATO. The required documents for the licensure of the BB or the authorization of the BCU or BS shall be submitted to the CHD along with the other documentary requirements for the hospital LTO. 2. The LTO/ATO shall be granted in accordance with the prescribed documentary and technical requirements and on the basis of specific conditions and limitations established during inspection. 3. The LTO/ATO as well as any right under the license/authorization cannot be assigned or otherwise transferred directly or indirectly to any party. 4. The LTO/ATO must be displayed at all times at a prominent place within the premises. 5. The CHD shall be notified within 15 calendar days of any change in management name or ownership. In cases of transfer of location, a new application for LTO/ATO shall be required. 6. A separate LTO/ATO shall be required for each BSF or branch maintained in separate premises even if operated by the same management. F. Maximum Allowable Service Fees 1. The BSF may collect a reasonable service fee for every blood/blood product issued which shall not be greater than the maximum fees prescribed by the DOH. The NVBSP shall periodically review the maximum allowable service fee specifying the basic requirements and special tests covered by the service fee. 2. The prescribed maximum allowable fees shall be placed in an area readily seen by the public. 3. The basic donor screening and blood testing procedures shall be determined by the NVBSP through analysis of research information such as disease prevalence studies and risk estimates, consultation with the technical experts and careful evaluation of the optimum benefits from the expected cost of these tests. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 23  G. Procedural Guidelines 1. Application for LTO for BCs and BBs and ATO for BCU and BS a. Applicant requests for relevant information and prescribed form from the CHD under whose jurisdiction the proposed BSF is located, in person or through mail, e-mail or the internet. b. Applicant accomplishes required documents and submits them to the CHD. Documentary requirements for the issuance of LTO/ATO: i. Certificate of inclusion in the Regional Blood Services Network approved by the identified Lead Blood Center in the region ii. Duly accomplished and notarized application form iii. DTI/SEC registration (initial) iv. List of personnel with photocopy of valid PRC card v. Location map (initial) vi. Floor diagram vii. List of equipment – with serial number, brand, date of purchase, number of units and operational status viii. NVBSP Annual Blood Report (renewal) ix. Certificate of participation in EQAS in previous year (renewal) c. The CHD director or his authorized representative/s reviews documents for completeness, authenticity and compliance with the requirements. d. The applicant pays the appropriate fees based on current prescribed DOH schedule of fees to the CHD cashier in person or through postal money order. BSF operating as BCU/BS shall be charged the corresponding fee for BCU. 2. Inspection a. The CHD director or his authorized representative/s inspects the BSF within 30 calendar days from the time of application to determine compliance with standards and technical requirements. b. The CHD inspection team prepares official summary of findings and recommends approval or disapproval after inspection. 3. Issuance of LTO/ATO a. The CHD director approves or disapproves the issuance of LTO/ATO. i. If approved, the BSF is registered and an LTO/ATO is issued to the applicant within 15 calendar days. ii. If disapproved, a copy of inspection findings and recommendations is provided to the applicant within 15 calendar days from the time of inspection. iii. An application for an LTO/ATO that is not processed within the 30 calendar day period is considered approved. 4. Renewal of LTO/ATO a. The LTO/ATO shall be renewed every 3 years. All hospital BSF shall renew their LTO/ATO annually as part of the One-Stop-Shop licensure for hospitals. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 24  b. Application for the renewal of LTO/ATO shall be filed on the 1st day of October until the last day of November on the last year of the LTO validity period to the CHD under which jurisdiction the BSF is located. c. The LTO/ATO may be renewed only if it complies with the prescribed standards and technical requirements. H. Validity of License to Operate 1. The LTO/ATO to operate a BSF shall be valid for a period of 3 years beginning on January 1 of the 1st year of the validity period to December 31 of the 3rd year of the validity period. 2. As part of the hospital license to operate, the license to operate/authority to operate a BB/BCU/BS shall be valid for a period of 1 year beginning January 1 to December 31. I. Monitoring The BHFS/CHD director or his authorized representative/s is authorized to monitor and conduct on-site visits to the BSF at any given time. The BSF shall make available to the monitoring team all pertinent records to determine the level of compliance with the National Blood Services Act and these rules and regulations. J. Violations Violations of the National Blood Services Act or the rules and regulations issued in pursuance thereto, include the commission of the following acts by individual, corporation, association or organization operating the BSF or people under their authority: 1. Any material false statement in the application 2. Misinterpretation of facts or falsification of documents or records 3. Refusal to make available its books, accounts and records of operation to an authorized person from the BHFS/CHD 4. Charging of blood service fees above the maximum fees set by the DOH 5. Collection of blood from paid or remunerated donor whether payment comes from the hospital or from the patient/relatives. 6. Refusal to participate in EQAS conducted by the designated National Reference Laboratories. K. Transitory Provisions All previously licensed hospital based and PNRC BCs already performing the blood testing and processing shall be allowed to operate as such until December 31, 2009. By 2010, there shall be a nationally coordinated blood service network with only the designated BCs performing the centralized testing and processing. L. Investigation and Hearing of Charges or Complaints 1. Upon filing of charges or complaints duly sworn to by any individual, corporation, association or organization against any BSF or any of its personnel who has violated or is violating the provisions of RA 7719 or any of these rules and regulations, the BHFS/CHD director or his authorized representatives/s shall investigate and verify if the BSF concerned or any of its personnel is guilty of the charges or complaints. Property of and for the exclusive use of SLU. Reproduction, storing in a retrieval system, distributing, uploading or posting online, or transmitting in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise of any part of this document, without the prior written permission of SLU, is strictly prohibited. 25  2. If upon investigation and hearing, the BSF concerned or any of its personnel is found violating the provisions of RA 7719 or any of these rules and regulations, the CHD director shall suspend the LTO/ATO for a definite or indefinite period of time or revoke the LTO/ATO without prejudice to taking the case to judicial authorities for criminal action. M. Suspension/Revocation of License/Authority to Operate An LTO/ATO shall be suspended or revoked by the CHD director upon violation of the National Blood Services Act or rules and regulations issued in pursuance thereto. The CHD director shall notify the BSF concerned or any of its personnel by registered mail the particular reasons for the denial or revocation of LTO/ATO. N. Appeal 1. Any BSF or any of its personnel aggrieved by the decision of the CHD director may, within 30 calendar days after receipt of notice of the decision, file a notice of appeal with the Office of the Secretary through the BHFS and serve a copy of the notice of appeal to the CHD. 2. Thereupon, the CHD director shall promptly certify and file a copy of the decision, including the transcript of the hearings on which the decision is based, with the Office of the Secretary for review. The decision of the Office of the Secretary shall be final and executor. O. Closure The CHD director or his authorized representative/s shall immediately close all BSF without and LTO/ATO and may seek assistance of any government agency to effectively enforce the closure. P. Penal Provision 1. Upon conviction, any BSF that collects service fees greater than the maximum prescribed by the DOH shall have its LTO/ATO suspended or revoked by the CHD director. Any individual, corporation, association or organization who is responsible for the above violation shall suffer a penalty of imprisonment of not less than 1 month but not more than 6 months or a fine of not less than Php 5,000.00 but not more than Php 50,000.00 or both at the discretion of the judicial authority. 2. Any individual, corporation, association or organization who establishes and manages a BSF without securing the necessary LTO/ATO from the CHD or violates any provision of these rules and regulations shall suffer a penalty of imprisonment of not less than 12 years but not more than 20 years or a fine of not less than Php 50,000.00 but not more than Php 500,000.00 or both at the discretion of the judicial authority. 3. The head of the BSF and the personnel responsible for dispensing or transfusing unscreened, incompletely tested and/or contaminated blood or failing to dispose within 48 hours blood that is contaminated with transfusion transmissible infections after receipt of confirmatory testing result from the Research Institute of Tropical Medicine National Reference Laboratory shall be imprisoned for 10 years. This shall be