CHAPTER 7: MEDICO-LEGAL AND ETHICAL ASPECTS OF PROVIDING BLOOD COLLECTION AND TRANSFUSION SERVICES Flashcards
• Patients who are injured during, or as a result of, transfusion may seek reparation through [?], a complaint that is usually filed by their families.
legal channels
• This has been of particular concern in blood banking and transfusion medicine because of the possibility of disease transmission, especially from previously unknown sources, and because mistakes may mean death. Basing practices on sound ethical principles provides a good foundation to limit [?] when these unforeseen events occur.
liability
SOURCES OF LAW
are laws enacted by legislative bodies such as the U.S. Congress or state legislatures
• Statutes
may override state laws in certain cases, but both can be applicable.
• Federal laws
provide details on how laws are implemented and are established through formal processes like the Administrative Procedure Act (APA).
• Regulations
• Specific regulations govern areas like healthcare, such as the
Clinical Laboratories Improvement Act of 1988 (CLIA 88), Medicare provisions of the Social Security Act, and laws like HIPAA, HITECH Act, and GINA
National Blood Services Act of 1994”
Republic Act No. 7719
Republic Act No. 7719
National Blood Services Act of 1994”
• Declaration of Policy: The state aims to:
• Promote and encourage [?].
• Establish the principle that blood provision is a [?], not a commodity.
• Ensure [?] blood distribution.
• Educate the public on the [?] of voluntary blood donation.
• Mobilize all sectors for [?].
• Establish a [?].
• Provide [?] to institutions promoting voluntary blood donation.
• Mandate [?] of blood collection units and blood banks/centers.
• Set [?] for operation.
• Regulate and ensure the [?] of blood-related activities.
• Require upgrading of blood banks/centers to include [?] on blood transfusion transmissible diseases.
voluntary blood donation
medical service
adequate, safe, affordable, and equitable
benefits
voluntary and non-profit blood collection
National Blood Transfusion Service Network
assistance
non-profit operation
scientific and professional standards
safety
preventive services and education
: Refers to human blood, processed or unprocessed, including blood components, products, and derivatives.
• Blood/blood product
: A laboratory or institution capable of recruiting and screening blood donors, collecting, processing, storing, transporting, and issuing blood for transfusion.
• Blood bank/center
It also provides information and education on blood transfusion transmissible diseases.
• Blood bank/center
: A blood bank operated for profit.
• Commercial blood bank
: A blood bank located within a hospital premises, capable of performing compatibility testing of blood.
• Hospital-based blood bank
: An institution or facility authorized by the Department of Health to recruit, screen donors, and collect blood,
• Blood collection unit
: Someone who donates blood willingly, without monetary compensation.
• Voluntary blood donor
: Refers to the Department of Health.
• Department
: Diseases that can be transmitted through blood transfusion, including AIDS, Hepatitis-B, Malaria, and Syphilis.
• Blood transfusion transmissible diseases
: The Secretary of Health or any individual delegated by the Secretary to carry out the provisions of this Act.
• Secretary of Health
: An individual listed as a qualified voluntary blood donor, ready to donate blood when needed in their community.
• Walking Blood Donor
Section 4:
Promotion of Voluntary Blood Donation
: The Department, PNRC, and PBCC, along with other entities, will conduct a nationwide public education campaign to promote voluntary blood donation.
• a) Public Education
Financial support will be provided to cover costs, and non-monetary incentives will be given to voluntary donors.
• a) Public Education
: Benefits of voluntary blood donation will be included in school health subjects at all levels.
• b) Promotion in Schools
The Department of Education will ensure inclusion in formal and non-formal education curricula.
• b) Promotion in Schools
: Various medical organizations will conduct training on the rational use of blood and the merits of voluntary donation as part of continuing medical education.
• c) Professional Education
: Blood centers will be established nationwide, coordinated by the Department and PNRC.
• d) Establishment of Blood Services Network
Blood collection will be encouraged in various community settings.
• d) Establishment of Blood Services Network
: In areas lacking blood banking facilities, the concept of walking blood donors will be encouraged, and lists of qualified donors will be maintained in government hospitals, health centers, and barangays.
• e) Walking Blood Donors
• Section 5:
National Voluntary Blood Services Program
• The Department, in collaboration with PNRC, PBCC, and other entities, will implement a National Voluntary Blood Services Program to meet the country’s transfusion needs.
Section 5: National Voluntary Blood Services Program
Funding will come from government allocations and contributions from organizations.
Section 5: National Voluntary Blood Services Program
Section 6:
Upgrading of Services and Facilities
• All blood banks/centers will offer preventive health services and education on blood transfusion transmissible diseases.
Section 6: Upgrading of Services and Facilities
Government hospitals must establish voluntary blood donation programs, and private hospitals are encouraged to do the same.
Section 6: Upgrading of Services and Facilities
Guidelines for the rational use of blood and blood products will be established.
Section 6: Upgrading of Services and Facilities
Section 7:
Phase-out of Commercial Blood Banks
• Commercial blood banks will be phased out within two years, extendable by the Secretary, promoting the operation of blood banks on a non-profit basis.
Section 7: Phase-out of Commercial Blood Banks
• Section 8:
Non-Profit Operation
• Blood banks/centers must operate on a non-profit basis, with service fees limited to covering necessary expenses.
Section 8: Non-Profit Operation
Blood collection will be exclusively from healthy voluntary donors.
Section 8: Non-Profit Operation
Establishing and operating a blood bank/center without proper registration and license is prohibited.
Section 9: Regulation of Blood Sciences
Blood collection and transfusion during emergencies in hospitals without licenses are allowed under certain conditions.
Section 9: Regulation of Blood Sciences
Compliance with departmental standards is mandatory,with licensed physicians managing the blood banks/centers.
Section 9: Regulation of Blood Sciences
Section 9:
Regulation of Blood Sciences
• Tax and duty-free importation of equipment and supplies for blood screening and processing will be allowed for entities participating in the National Voluntary Blood Services Program.
Section 10: Importation of Blood Bank Equipment, Blood Bags, and Reagents
Section 10:
Importation of Blood Bank Equipment, Blood Bags, and Reagents
• The Secretary will promulgate rules and regulations within 60 days of approval, ensuring compliance with standards and prescribing maximum fees for blood provision and related services.
Section 11: Rules and Regulations
Section 11:
Rules and Regulations
• Penalties are imposed for violations, Including imprisonment, fines, and administrative sanctions.
Section 12: Penalties
Criminal charges may apply for endangering public health by mishandling contaminated blood.
Section 12: Penalties
Administrative sanctions include fines, suspension, or revocation of licenses.
Section 12: Penalties
Section 12:
Penalties
1.Imprisonment and Fines: Any blood bank/center found collecting charges exceeding the maximum prescribed by the Department may have its license suspended or revoked. Individuals responsible for such violations may face imprisonment ranging from [?], or fines ranging from [?], or both, at the discretion of the court.
one month to six months
Five thousand pesos (P5,000) to Fifty thousand pesos (P50,000)
2.Unlicensed Operation: Operating a blood bank without the necessary license from the Department or failing to comply with departmental standards may result in imprisonment ranging from [?], or fines ranging from [?], or both, at the discretion of the court.
twelve years and one day to twenty years
Fifty thousand pesos (P50,000) to Five hundred thousand pesos (P500,000)
- Administrative Sanctions: The Secretary may impose administrative sanctions, such as [?] a blood bank/center. Additionally, the suspension or revocation of the license to practice the profession may be recommended when applicable.
fines, suspension, or revocation of the license to operate
- Handling Contaminated Blood: Those found responsible for dispensing, transfusing, or failing to dispose of contaminated blood within forty-eight hours may face imprisonment for [?]. This penalty is without prejudice to criminal charges under the Revised Penal Code for endangering public health.
ten years
RULES AND REGULATIONS GOVERNING THE REGULATION OF BLOOD SERVICE FACILITIES
DON ADMINISTRATIVE ORDER NO. 2008-0008, May 02, 2008
was enacted to ensure safe and efficient blood banking and transfusion practices in the Philippines.
• Republic Act 7719, known as the National Blood Services Act
• Previous administrative orders, such as [?], addressed the regulation of blood services.
Administrative Order No. 9, 1995, and Administrative Order No. 17, 1998
In January 2005, [?] was formulated to amend pertinent provisions and establish the National Council for Blood Services and the Philippine National Blood Services.
Administrative Order No. 2005-0002
The document emphasizes the importance of regulation in ensuring access to quality and affordable health products and services, particularly in the context of health sector reforms under the [?] for health.
FOURmula One (F1)
• Separating [?] is expected to better achieve the goals of the national voluntary blood services program.
regulatory functions from programming functions
Il. Objective:
• The rules and regulations aim to protect and promote public health by ensuring the availability of licensed blood service facilities with sufficient [?]to perform required functions safely, efficiently, and effectively.
staff, equipment, and resources
III. Scope:
• The rules and regulations apply to [?] engaged in blood banking and transfusion services.
all government and private blood service facilities
: Refers to Republic Act (R.A.) 7719, also known as the National Blood Services Act of 1994, unless otherwise specified.
A. Act
It’s a formal permit issued by the DOH-CHD to individuals, partnerships, corporations, or associations to operate a Blood Collection Unit (BCU) or Blood Station (BS).
B. ATO: Authority to Operate.
C. BB: Short for
Blood Bank.
D. BC: Abbreviation for
Blood Center.
E. BHFS: Refers to the
Bureau of Health Facilities and Services.
: Refers to human blood intended for transfusion.
F. Blood
: Refers to various blood products derived from whole blood or plasma, including but not limited to red cells, granulocytes, plasma, platelets, cryoprecipitate, and cryosupernate, prepared in a Blood Center (BC).
G. Blood Component
H. BCU: Stands for
Blood Collection Unit.
: A therapeutic substance derived from whole blood or plasma.
I. Blood Product
J. BS: Refers to
Blood Station.
K. BSF: Acronym for
Blood Service Facility
Blood Service Facility includes various types such as
Blood Stations (BS), Blood Collection Units (BCU), Hospital Blood Banks (BB), and Blood Centers (BC) at different levels (Regional, Sub-national, and National)
: An organization comprising designated Blood Centers (BCs), hospital Blood Banks (BBs), Blood Collection Units (BCUs), Blood Stations (BSs), end-user hospitals, and other health facilities established to meet the blood needs of a specific geographical area.
L. Blood Services Network
M. CHD: Stands for
Center for Health Development
the DOH Regional Field Office.
Center for Health Development
N. DOH: Abbreviation for the
Department of Health.
: A hospital equipped with a licensed clinical laboratory capavle of red cell tying and cross-matching, which receives blood and blood components for transfusion as needed but does not operate any Blood Service Facility (BSF).
O. End-User Hospital
: A licensed or accredited non-hospital health facility without a licensed clinical laboratory, such as a dialysis clinic or birthing home, that administers blood transfusions under the supervision of licensed physician(s).
P. End-User Non-hospital Health Facility
Q. EQAS: Refers to the
External Quality Assessment Scheme.
R. HBTC:
Hospital Blood Transfusion Committee.
S. LTO:
License to Operate
a formal authorization issued by the DOH to Individuals, partnerships, corporations, or associations to operate a Blood Bank (BB) or Blood Center (BC).
License to Operate,
T. NCBS: Refers to the
National Council for Blood Services.
U. NVBSP:
National Voluntary Blood Services Program.
V. PNRC:
Philippine National Red Cross.
W. TTI: Refers to
Transfusion-Transmitted Infections.
: Describes a donor who freely and voluntarily gives blood without receiving any form of payment.
X. Voluntary, Non-Remunerated Blood Donor
: All Blood Service Facilities (BSF) must be part of a blood services network and adhere to administrative regulations governing their establishment and operation.
- Inclusion in Blood Services Network
are responsible for overseeing and supervising affiliated Blood Collection Units (BCUs) and Blood Stations (BSs)
- Blood Centers (BCs)
- Regular on-site evaluations of affiliated facilities must be conducted by [?].
BC heads or designated staff
- Compliance with Standards: [?] are required to comply with standards and technical requirements outlined in inspection tools, which are posted on the DOH website.
All BSFs
- Donor Criteria: Blood must be collected only from [?]
qualified healthy voluntary non-remunerated donors
- Testing for Transfusion-Transmitted infections (TTIs):
- Testing for TTIs must follow [?].
- The number of infections to be screened and detection methods are determined and reviewed periodically by the [?].
- Testing for TTIs is conducted at designated [?].
DOH-prescribed methodology
National Council for Blood Services (NCBS)
BCs
- Retesting Prohibition: Blood units issued by designated BCs should not be retested for TTIs by [?]. The responsibility for ensuring negative TTIs lies with the Issuing BCs.
end-user hospitals and other health facilities
2.Source of Blood and Blood Products: Blood and blood products for transfusion must be obtained from [?] only.
licensed and authorized BSFs
B. Specific Guidelines:
1. Classification of BSF:
: BSFs can be government-operated or private (for hospital-based BSFs).
1.Ownership
: BSFs can be hospital-based or non-hospital-based
2.Institutional Character
: Different types of BSFs have specific functions and services.
3.Service Capability
- [?] must appoint suitably qualified personnel, provide services in a safe environment, maintain necessary equipment, and adhere to quality assurance programs,
BSFs
includes participation in external quality assessment programs and reporting of examination results.
- Quality assurance
- There must be policies for outsourcing examinations and blood components, as well as the establishment of [?].
Hospital Blood Transfusion Committees (HBTC)
- License/Authorization (LTO/ATO):
- Hospital-based BSFs are licensed or authorized through [?] for Hospitals and are not required to obtain separate LTOs or ATOs.
2.LTOs/ATOs must be displayed prominently, and any changes in management, name, or ownership must be notified to the [?].
One-Stop-Shop Licensure
Center for Health Development (CHD)
- Maximum Allowable Service Fees:
1.BSFs may collect reasonable service fees for blood/blood products issued, not exceeding maximum fees prescribed by the [?].
2.Prescribed fees must be publicly displayed, and basic donor screening and testing procedures are determined by the [?] based on research and consultation.
DOH
NVBSP
1.The applicant requests relevant Information and the prescribed form from the [?] where the proposed Blood Service Facility (BSF) Is located
Center for Health Development (CHD)
2.The applicant completes required documents and submits them to the [?], along with necessary attachments.
CHD
3.The [?] reviews the documents for completeness, authenticity, and compliance with requirements.
CHD
- The applicant pays the appropriate fees to the [?].
CHD
1.LTO/ATO is renewed every [?] for hospital BSFs as part of One-Stop-Shop licensure.
three years, or annually
- Renewal applications are filed from [?] of the last year of validity.
October 1 to November 30
- Renewal depends on compliance with [?].
prescribed standards and technical requirements
VIl. Validity of License to Operate:
• LTO/ATO validity:
• BSF:
• Hospital BSF:
Three years (January 1 to December 31).
One year (January 1 to December 31).
VIll. Monitoring:
• [?] monitors and conducts on-site visits to BSFs.
• [?] must provide access to pertinent records for monitoring.
BHFS/CHD
BSFS
IX. Violations:
• Violations include [?].
false statements, misrepresentation, refusal to provide records, charging fees above maximum, collecting blood from paid donors, and refusal to participate in EQAS
