MTLBE Chapter III
BSF (Blood Service Facility)
It is a unit, agency or institution providing blood products
Transfusion-Transmitted Infections
TTI
REPUBLIC ACT NO. 7719 REPUBLIC ACT NO. 1517
two major laws of the Philippine Blood Bank Law
1. MINIMUM NUMBER AND QUALIFICATION OF PERSONNEL 2. STAFF DEVELOPMENT PLAN 3. PHYSICAL FACILITIES, EQUIPMENT AND SUPPLIES 4. BIOSAFETY 5. QUALITY CONTROL 6. RECORDING, REPORTING AND DOCUMENTATION REQUIREMENTS 7. BLOOD DISTRIBUTION AND TRANSPORT REQUIREMENTS 8. BLOOD TRANSFUSION COMMITTEE 9. PREVENTIVE SERVICES 10. NETWORKING
A Blood Bank/Center may be granted a license to operate only if it shall have complied with the following minimum requirements:
PRC-registered medical technologist
A Blood Station shall be under the responsibility of a ______
twenty-four (24) hours
A Blood Station shall have at least one properly functioning blood refrigerator with ______ power supply
CHD
A LTO/ATO shall be suspended or revoked by the ______ Director upon violation of the National Blood Services Act
(a) Recruitment and screening of blood donors (b) Collection of blood for transfusion (c) Processing and/or storage of blood (d) Transport and/or issuance to hospitals (e) Compatibility testing of blood
A blood bank or blood processing center is an institution or laboratory in which any three (3) or more of the following are done (referred to as blood bank):
a. Recruitment of voluntary donors b. Health education and counseling c. Donor screening and selection d. Blood collection e. Basic blood processing and testing f. Provision of whole blood and packed RBC g. Issuance, transport and distribution of blood/blood products h. Storage of blood/blood products
A blood bank/center shall be considered non-hospital based category A when it can and is performing the following
2
A certified Pathologist or Hematologist may be authorized to head and manage not more than ______ blood banks
Authority to Operate
ATO
BSF (Blood Service Facility)
All ________ are required to comply with the standards and technical requirements embodied in the inspection tools
service fees
All blood banks/centers shall operate on a non-profit basis: provided, that they may collect ________ not greater than the maximum prescribed by the Department which shall be limited to the necessary expenses entailed in collecting and processing of blood
Upgrading of Services and Facilities
All blood banks/centers shall provide preventive health services such as education and counselling on blood transfusion transmissible diseases. All government hospitals, including those that have been devolved, shall be required to establish voluntary blood donation programs and all private hospitals shall be encouraged to establish voluntary blood donation programs.
RA 7719
Also known as The National Blood Service Act of 1994
REPUBLIC ACT NO. 1517
An Act Regulating the Collection, Processing and Sale of Human Blood, and the Establishment and Operation of Blood Banks and Blood Processing Laboratories
any time
Applications for new license may be submitted _______
2
Applications for renewal of license should be submitted within the_______ months prior to the expiration date of the current license
a. Preparation and distribution of blood components for other hospitals b. Training and supervisory function over the other Blood Banks/Centers c. Research
At least one Blood Bank/Center in every geographical region shall be designated as the Regional Blood Center and shall be developed to perform special functions such as, but not limited to
Basic and Comprehensive Emergency Obstetrical and Neonatal Care
B/CEmONC meaning
BB
Blood Bank
1. Recruitment of voluntary blood donors 2. Screening of blood donors 3. Provision of health education and counselling 4. Collection and transport of blood to Blood Banks/Centers
Blood Banks/Centers shall organize and establish Blood Collection Units (BCU) which is authorized to perform the following:
"Blood Banks/Centers operating without a license"
Blood Banks/Centers which fail to submit an application for renewal within the prescribed two-month period shall be considered as _________
BC
Blood Center
BCU
Blood Collection Unit
BSF
Blood Service Facility
BS
Blood Station
hospital premises (government or private) ; Philippine National Red Cross
Blood Stations may be located only within _______ or within the premises of the ________ chapters
BSF (Blood Service Facility)
Blood and blood products for transfusion shall be obtained from licensed and authorized _____ only
non-profit
Blood banks and processing laboratories shall be operated on a _______ basis
non-profit
Blood collecting or processing by other blood collectors or processors or by individual physicians shall also be on a _______ basis
1. That the medical/surgical condition poses an immediate threat to the patient's life 2. That the collection and transfusion is done under the direct supervision and with the full responsibility of the attending physician 3. That the existing standards and specifications for donor screening including history and physical examination are complied with 4. That the required test for hemoglobin, syphilis, HIV, hepatitis and for presence of malarial parasites and compatibility testing including cross-matching are also performed before transfusion.
Blood collection and immediate transfusion in hospitals without a license as a Blood Bank/Center may be allowed in an emergency situation subject to the following conditions:
confined within the hospital
Blood shall be issued only to patients ________ that houses the station or to hospitals within the area, unless called for by emergency conditions
at cost
Blood shall be sold by such banks and laboratories, other blood collectors or processors, and individual physicians _________
Department of Health
Blood to be sold that is collected from another person must first secure a license from _________
BHFS
Bureau of Health Facilities and Services
A. BLOOD BANK/CENTER (Non-hospital Based Categories A&B and Hospital Based Categories A&B) B. BLOOD COLLECTION UNITS C. BLOOD STATION
CATEGORIES OF BLOOD SERVICE CAPABILITIES
Center for Health Development
CHD
1. Government 2. Private (for hospital-based BSF only)
Classification of BSF according to ownership
1. BS 2. BCU 3. BCU/BS 4. BB 5.BC
Classification of BSF according to service capability
- hospital blood banks - free standing (non-hospital) blood banks depending
Classification of Blood Banks For purposes of institutional character
primary, secondary, tertiary
Classification of Blood Banks For purposes of service extent and level
a) Public Education b) Promotion in Schools c) Professional Education d) Establishment of Blood Services Network e) Walking Blood Donors
In order to ensure adequate supply of human blood, voluntary blood donation shall be promoted through the ff.:
AO 2008-0008-A AMENDMENT TO AO 2008-0008
Issued to strengthen the existing Blood Services Networks an dimprove the delivery of safe adequate accessible and affordable blood supply to health facilities
licensed physician
It shall be the unlawful for any person to establish or operate a blood bank or blood processing laboratory, or to collect or process blood if he is not a ______
License to Operate
LTO
heads of the Blood Bank/Center ; 2
Licenses shall be released only to the ________ or their officially designated representatives not later than _____ weeks after the completion of the inspection visit.
(1) Donor screening and selection (2) Collection and processing of blood (3) Storage of blood (4) Transport and issuance of blood (5) Compatibility testing (for hospital) (6) Transfusion of whole blood (for hospital
Minimum services required in Primary Category Blood Bank
(1) Services required for Primary Category (2) Provision of packed red cells, plasma and platelet rich plasma (3) Investigations for transfusion reaction (for hospitals)
Minimum services required in Secondary Category Blood Bank
(1) Services required for Primary category (2) Services required for Secondary category (3) Provision of blood components, products or derivatives not included in secondary category (4) Investigations of incompatible crossmatches (for hospitals)
Minimum services required in Tertiary Category Blood Bank
National Council for Blood Services
NCBS
- such bank or laboratory be established or operated in accordance with accepted scientific standards - under the administration, direction and supervision of a licensed and qualified physician - blood is collected and/or processed therein by licensed physicians or under their direct supervision and responsibility.
No license shall be granted or renewed by the Department of Health for the establishment or operation of a blood bank or blood processing laboratory UNLESS
commercial blood bank
No new license shall be issued for a _________
a. Preparation of special plasma derivatives b. Performance of special confirmatory and reference blood tests c. Conduct of highly technical specialist on-the-job training courses d. Conduct of research and special studies
One Blood Bank/Center shall be designed as the National Blood Center and shall be developed to be able to perform more specialized function such as, but not limited to:
Philippine National Red Cross
PNRC stands for...
six (6) months
Standard Operating Procedure Manual (SOP Manual) shall be developed, pretested and printed by the BRL within _______ after the effectivity of these Implementing Rules and Regulations
1. INITIAL APPLICATION 2. APPLICATION FOR RENEWAL OF LICENSE 3. INSPECTION 4. TIMETABLE FOR APPLICATION AND INSPECTION 5. RELEASE
THE LICENSING PROCESS
1. Philippine National Red Cross (PNRC) 2. Philippine Blood Coordinating Council (PBCC
TWO MAJOR AGENCIES THAT FACILITATE BLOOD DONATION AND EDUCATION
TTIs (Transfusion-Transmitted Infections)
Testing for ______ shall be based on the DOH prescribed methodology
2 ; 2
The Department shall affect the phasing-out of all commercial blood banks over a period of ______ years, extendable for a maximum period of _______ after the effectivity of R.A. 7719
upgrading of provincial and district hospitals
The Department shall assist in the _________ to meet the blood transfusion services requirement in the area especially by providing technical assistance, training and mobilizing resources
PNRC
The Department shall assist the ________ in mobilizing resources and in the upgrading their facilities or chapter by facilitating linkages with private or government hospitals with laboratory facilities and trained personnel.
Hospital Blood Transfusion Committee
The Department shall require the establishment of a ________ as a prerequisite for licensure of teaching/training hospitals and hospitals with blood banks/centers.
National Voluntary Blood Services Program (NVBSP)
The Department, in cooperation with the PNRC and PBCC and other government agencies and non-governmental organizations shall plan and implement a _______ to meet in a revolutionary manner, the needs for blood transfusion in all regions of the country
Voluntary Blood Donation Program Plan
The Department, through the Bureau of Licensure and Regulation, shall require private and government hospitals to submit their ________
a. Formulation of a five-year Directional /Strategic Plan of the NVBSP b. Operationalization and institutionalization of the NVBSP c. Monitoring and evaluation of the NVBSP d. Creation of multi-sectoral sub-committees such as, but not limited to, advocacy and promotion, programming, monitoring and evaluation and curriculum development e. Generation of multi-sectoral and inter-disciplinary support for national activities focused on blood services including the organization of the National Blood Congress
The National Voluntary Blood Services Program Committee shall be responsible for the following (functions) :
PRC
The _____ shall provide equivalent continuing professional education units for all training courses on rational use of blood and blood products
Regional Health Director
The _______ shall be the field representative of the National Voluntary Blood Services Program Committee, and such shall coordinate the Voluntary Blood Services Program activities in the region
Secretary of Health
The _______ shall ensure the conduct of trainings 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
Secretary of Health
The ________ is charged with the responsibility of strictly enforcing this Act (RA 1517)
Professional Regulation Commission (PRC)
The ________ shall encourage all medical and other health professional associations and societies especially those accredited by it 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.
Department of Health
The ________ shall require training hospitals to conduct continuing professional education programs and trainings on the rational use of blood and blood products
yearly
The authority to operate a Blood Station shall be renewed _______, signed by the Regional Health Director
1. the Hospital Blood Banks, 2. the Blood Centers, 3. the Blood Collection Units and 4. Blood Station
The four new categories of Blood Service Facilities according to AO 2008-0008 are ______
BB (Blood Bank), BCU (Blood Collection Unit) and BS (Blood Station)
The head of the BC or his designated staff shall conduct on site periodic evaluation of each affiliated __________
Bureau of Research and Laboratories (BRL)
The licensing and regulatory functions of the Department of Health regulating blood services shall be exercised through the _______ in the Office of Health Facilities Standards and Regulations
NCBS (National Council for Blood Services)
The number of [TTI] infections to be screened as well as the method for their detection shall be determined and reviewed periodically by the ___________
contingency plan
There shall be a written and readily available _______ for all Blood Stations in case of problems such as instrument or equipment breakdown
A. Any material false statement in the application B. Misrepresentation of facts or falsification of documents or records C. Refusal to make available its books, accounts and records of operation to an authorized person from the BHFS/CHD D. Charging of blood service fees above the maximum fees set by the DOH E. Collection of blood from paid or remunerated donor whether payment comes from the hospital or from the patient/relatives F. Refusal to participate in EQAS
Violations of the National Blood Services Act
June 16, 1956
When was RA 1517 approved
May 5, 1994
When was RA 7719 approved?
DOH website (doh.gov.ph)
Where are the technical requirements embodied in the inspection tools posted?
Quality Assurance Officer
_______ shall organize all documents relating to quality assurance and, in coordination with the head of the blood service facility, shall make sure that the required, recognized standards are instituted and followed according to national specifications
Department of Health
________ provide guidelines for the inclusion of the rational blood and blood products use and the merits of voluntary blood donation
Commercial blood bank
a blood bank that exists for profit
Hospital-based blood bank
a blood bank which is located within the premises of a hospital and which can perform compatibility testing of blood
Voluntary, Non-remunerated Blood Donor
a donor who gives blood freely and voluntarily without receiving money or any form of payment
License to Operate
a formal authority issued by the DOH to an individual, partnership, corporation, or association to operate a BB/BC
End-Use Hospital
a hospital with a licensed clinical laboratory capable of red cell typing and cross-matching and which does not have any BSF but only receives blood and blood components for blood transfusion as needed.
Blood bank/center
a laboratory or institution with the capability to recruit and screen blood donors, collect, process, store, transport and issue blood for transfusion and provide information and/or education on blood transfusion transmissible diseases
End-User Non-hospital Health facility
a license/accredited non-hospital health facility without a licensed clinical laboratory but administers blood transfusion such as a dialysis clinic and birthing home under the supervision of a licensed physician/s
Blood Product
a therapeutic substance derived from whole blood or plasma
Walking Blood Donor
an individual included in the list of qualified voluntary blood donors, referred to in Sec. 4, paragraph (e), who is ready to donate blood when needed in his/her community
Blood collection unit
an institution or facility duly authorized by the Department of Health to recruit and screen donors and collect blood
Blood Services Network
an organization composed of the designated BCs, hospital BBs, BCUs, BSs, end-user hospitals, and other health facilities established to provide for the blood needs of a specific geographical area
1. Hospital-based 2. Non-hospital based
classification of BSF according to Institutional Character
> education > pre- and post-donation counseling on blood transfusion transmissible diseases
preventive health services in line with the guidelines and standards of the National Voluntary Blood Services Unit
Blood/blood product
refers to human blood, processed or unprocessed and includes blood components, its products and derivatives
Blood Component
refers, but not limited to whole blood, red cells, granulocytes, plasma, platelets, cryoprecipitate and cryosupernate prepared in a BC
Center for Health Development
the DOH Regional Field Office
human blood, processed or unprocessed, and includes its products and derivatives
the term "blood" used in the act refers to:
Hospital-Based Category B
when, in addition to those performed under the Hospital -based Category A, it is capable of providing, in addition to whole blood, all blood products and components; and of performing investigation of transfusion reactions and resolution of incompatible cross-matching results
Non-hospital Based Category B
when, in addition to those performed under the Non -hospital Based Category A, it is capable of providing, in addition to whole blood, all blood products and components
Hospital-Based Category A
when, in addition to those performed under the Non- hospital Based Category A, it is capable of performing compatibility-testing
BSF (Blood Service Facility)
Every ______ shall be an integral part of a blood services network and guided by administrative issuances governing the establishment and operation of blood services networks.
licensed physician certified by the Philippine Board of Pathology in Clinical Pathology or Blood Banking of Philippine Board of Hematology and Blood Transfusion
For all categories of blood banks, the head shall be _______
a. Integration and coordination of all voluntary blood service program efforts b. Development of training, information, education and communication (IEC) materials c. Provision of technical assistance and training in designing and implementing a voluntary blood donation program d. Preparation of the blood services operational pan incorporation e. Provision of secretariat services to the National Voluntary Blood Service Program Committee
Functions of the National Voluntary Blood Services Unit
Hospital Blood Transfusion Committee
HBTC
a. Certificate of Inclusion in the Regional Blood Services Network approved by the identified Lead Blood Center in the region b. Duly accomplished and notarized Application Form c. DTI/SEC registration (initial) d. List of personnel with photocopy of valid PRC card e. Location map (initial) f. Floor diagram g. List of equipment - with serial number, brand, date of purchase, number of units and operational status h.NVBSP Annual Report (renewal) i. Certificate of participation in EQAS in previous year (renewal)
Documentary requirements for the issuance of LTO/ATO
External Quality Assessment Scheme
EQAS
once ; head of the Blood Bank/Center
Each Blood Station shall be visited at least _______ a year by the _______ that distributes blood to the station or by a duly designated Blood Bank/Center health staff
BC (Blood Center)
Each _____ shall have responsibility for and authority over the conduct and close supervision of the BCU/BS affiliated with its Blood Service Network
a) To promote and encourage voluntary blood donation b) To lay down the legal principle that the provision of blood for transfusion is a professional medical service c) To provide for adequate, safe, affordable and equitable distribution of supply of blood and blood products d) To inform the public of the need for voluntary blood donation e) To teach the benefits and rationale of voluntary blood donation f) To mobilize all sectors of the community to participate in mechanisms for voluntary and non-profit collection of blood g) To mandate the DOH to establish and organize a National Blood Transfusion Service Network h) To provide for adequate assistance to institutions promoting voluntary blood donation i) To require all blood collection units and blood banks/centers to operate on a non-profit basis j) To establish scientific and professional standards for the operation of blood collection units and blood banks/centers in the Philippines k) To regulate and ensure the safety of all activities related to the collection l) To require upgrading of blood banks/centers to include preventive services and education to control spread of blood transfusion transmissible diseases.
Policies declared in order to promote public health under RA 7719
(1) Collate and review all annual operational plans, proposed budgets (2) Propose priorities for budgetary allocation (3) Prepare the consolidated annual National Voluntary Blood Services Program Plan (4) Coordinate and document all National Voluntary Blood Service Program Committee and sub-committee meetings and activities.
Provision of secretariat services to the National Voluntary Blood Service Program Committee and as such shall
AO 57 S. 1989
REVISED RULES AND REGULATION GOVERNING THE COLLECTION, PROCESSING AND PROVISION OF HUMAN BLOOD AND THE ESTABLISHMENT AND OPERATION OF BLOOD BANKS
ADMINISTRATIVE ORDER NO. 9 s. 1995
RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT No. 7719 OTHERWISE KNOWN AS THE "NATIONAL BLOOD SERVICES ACT OF 1994"
Secretary of Health and the National Director of the Bureau of Research and Laboratories
Reports on violations of R.A. 7719 and these Rules and Regulations shall be addressed to the ________
encouraged to conduct trainings and seminars on the: - rational use of blood and blood products - dangers of commercial blood - benefits of voluntary blood donation for their respective members
Role of Professional Societies and Association
Blood transfusion transmissible diseases
diseases which may be transmitted as a result of blood transfusion, including AIDS, Hepatitis-B, Malaria and Syphilis
ATO (Authority to Operate)
formal permit issued by the DOH-CHD to an individual, partnership, corporation or association to a BCU/BS
attending physician
in cases of emergency, blood transfusion shall be allowed under the responsibility of the ________ without such license
The Head (Chief, Director, Physician-In-charge, etc.)
is the person who assumes technical and administrative supervision and control of activities in the blood bank.
Voluntary blood donor
one who donates blood on one's own volition or initiative and without monetary compensation