4th (Regional Administrative Order)

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Republic of the Philippines

DEPARTMENT OF HEALTH
CENTER FOR HEALTH DEVELOPMENT BICOL
Legazpi City
Trunk line (052) 824-0371 FAX No. (052) 824-0371 local 104
Website: www.chd5.net.ph Email address: chd_bicol@yahoo.com

28 August, 2008

REGIONAL ADMINISTRATIVE ORDER


No. _________ s. 2008

SUBJECTS : RULES AND REGULATIONS GOVERNING THE ESTABLISHMENT AND OPERATION OF THE
BLOOD SERVICES FACILITIES (BLOOD CENTERS, BLOOD BANKS, BLOOD STATIONS, BLOOD
COLLECTION UNITS) AND END USERS IN BICOL REGION.

POLICIES AND GUIDELINES ON AVAILING BLOOD AND BLOOD PRODUCTS FROM THE BICOL
REGIONAL CENTER.

I. RATIONALE

Republic Act 7719, the National Blood Services Act of 1994 was promulgated to ensure safe and
efficient blood service and transfusion practices in the Philippines through the creation of the
National Voluntary Blood Services Program whose major functions are: 1) Program
Development and Management: which include the conceptualization, planning, and
coordination of core activities such as promotion of voluntary donation, public education and
advocacy, upgrading of blood services and facilities, and effective and equitable collection and
distribution of blood, and other resources, and 2) Regulation and Quality Control: which include
mainly licensing and authorization of Blood Service Facilities and ensuring compliance with
national specifications, standards and quality.

Regulation is one of the main thrusts of current health sector reforms under FOURmula One
(F1) for health. The main objective of which is to ensure access to quality and affordable health
products, devices, facilities, and services. It is envisioned that the goals of the National
Voluntary Blood Services Program shall be better achieved through sound policies and
guidelines.

II. DEFINITION OF TERMS


Authority to Operate (ATO) A formal permit issued by the DOH-Center for Health Development
to an individual, partnership, corporation, or association to BB, BCU and BS.
Blood Bank (BB) or Hospital Blood Bank (HBB) A BSF in hospital duly licensed by the DOH BHFS
with the following service capabilities: storage of whole blood and blood components obtained
from a blood center, compatibility testing of red cell units; direct Coombs test; red cell antibody
screening; investigation of transfusion reactions; and assist the Hospital Blood Transfusion
Committee (HBTC) in the conduct of post transfusion surveillance (hemovigilance).
Blood Center (BC) It is a BSF licensed by the DOH, Bureau of Health Facilities and Services (BHFS)
classified as Regional, Sub-National & National, as determined by the National Council for Blood
Services (NCBS); Bicol Regional Blood Center (BRBC) is the designated regional blood center by
the National Council for Blood Services (NCBS) with Bicol Medical Center (BMC) as sub center. Its
service capabilities are: donor recruitment/retention and care of voluntary blood donors;
collection of blood (mobile or facility base) from qualified voluntary blood donors; for national
and subnational and selected regional blood centers only; testing of units of blood for five
infectious disease markers (anti HIV ½, anti HCV, HBsAg, syphilis, malaria); processing and
provision of blood components; storage, issuance, transport, and distribution of whole blood
and/or blood products to hospital and other health facilities.
Blood Collection Unit (BCU) A BSF authorized by the CHD to perform the following, such as;
advocacy and promotion of voluntary blood donation and healthy lifestyle; recruitment,
retention and care of voluntary non-remunerated blood donors; clinical screening and selection
of voluntary non-remunerated blood donors; conduct of health education and counseling
services; collection of blood; transport of blood to referral blood center for testing, laboratory
screening, and processing; compatibility testing of red cell units if hospital based.
Blood Component Specific cellular or liquid products of human blood obtained by processing in
the blood bank, such as centrifugation, precipitation. Examples are red blood cells, fresh frozen
plasma, cryoprecipitate, platelet.
Blood Product A therapeutic substance derived from whole blood or plasma. Includes both blood
components and derivatives.
Blood Service Facility (BSF) A unit, agency or institution providing blood products. This could
either be Blood Station, Blood Collection Unit, Blood Bank or Blood Center.
Blood Services Network An informal organization composed of the designated BCs, BS and BBs
and End-User (EU) hospitals established to provide for the blood needs of a specific geographical
area. The objective of the Blood Services Network is the efficient distribution of voluntarily
donated blood by the blood center/s to different BSF, hospitals and other EU to make available
to all patients and avoid wastage.
Blood Station (BS) A BSF authorized by the CHD to perform the following such as: provision of
whole blood, packed red cells and; storage, issuance, transport, and distribution of whole blood
and packed red cells; compatibility testing of red cell units if hospital-based.
Blood Transfusion Services A set of activities 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, administration of
blood/components, investigation of blood transfusion reactions, inventory control and quality
assurance
End-User Hospital (EU) A hospital with a licensed clinical laboratory capable of red cell typing and
crossmatching and which does not have any blood service facility but which only receives blood
and blood components for blood transfusion as needed.
End-User Non-Hospital Health Facility A licensed/accredited non-hospital health facility without
a licensed clinical laboratory but which administers blood transfusion.
Hospital Blood Transfusion Committee (HBTC) A hospital committee primarily responsible for the
formulation of blood bank and blood transfusion policy and guideline for monitoring and audit
of the use of blood and blood components within the facility, provided that they are in
accordance with the manual of standards for service facilities issued by the DOH.
Lead BSF A BSF that acts as referral center, conducts and coordinates training, research and
monitoring activities within the network, supervise all component units of the regional blood
services network and assist in the over-all monitoring and evaluation of the Regional Voluntary
Blood Services Program (RVBSP)
License to Operate It refers to the license to operate. It is a formal authority issued by the DOH
to an individual, partnership, corporation or association to operate a BB and BC.
National Voluntary Blood Services Program (NVBSP) A program chaired by the Secretary of Health
with multi-sectoral sub-committees for advocacy, promotion, programming, monitoring and
evaluation and curriculum development to strengthen voluntary blood donation and blood
service facilities’ networking operations and upgrading.
Qualified Healthy Voluntary Non-remunerated Blood Donor A voluntary non-remunerated blood
donor who possesses the conditions that excludes a person from becoming a blood donor as
provided in the Alphabetical Guide of Medical Assessment of Blood Donors (Annex A).
Transfusion Transmissible Infection (TTI) An infection that is potentially capable of being
transmitted through blood transfusion.
Voluntary Non-Remunerated Blood Donor A person who gives blood, plasma, or other blood
components of their own free will and receives no payment for it, either in the form of cash or in
kind which can be considered a substitute for money. This includes time off work, other than that
reasonably needed for the donation and travel. Small tokens, refreshments, reimbursements of
direct travel costs are compatible with voluntary non-remunerated blood donation.
III. POLICIES AND GUIDELINES
1. Every BSF shall be an integral part of the blood services network and guided by the
administrative issuances governing the establishment and operation of the blood services
networks.
 The BRBC as the designated Regional BC shall have the responsibility for an
authority over the conduct and close supervision of the BSFs affiliated with its
blood service network.
 The head of the BRBC or his designated staff shall conduct on site periodic
inspection of each affiliated BSFs.
2. All BSFs are required to comply with the standards and technical requirements embodied
in the inspection tools.
3. Blood shall be collected ONLY from QUALIFIED HEALTHY VOLUNTARY-NON
REMUNERATED BLOOD DONORS.
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 and screening for TTIs shall be done at the BRBC as designated regional BC by
NCBS pursuant to AO 2005 s. 0002 and BMC as the designated subcenter, until such time
when all testing and screening can already be done by the BRBC.
6. All units of blood issued by the BRBC and BMC SHALL NOT BE RESCREENED for issuing BC
to ensure that all units of blood issued have been screened and found to be negative of
TTIs.
7. Blood and blood products for transfusion shall be obtained DIRECTLY from licensed and
authorized BSF through networking by other blood service facilities.
IV. SERVICE CAPABILITIES OF THE BSFS
1. Blood Station-Non-Hospital Based
 Advocacy and promotion of voluntary blood donation and healthy lifestyle;
 Provision of whole blood and packed red cells;
 Storage, issuance, transport and distribution of whole blood and packed cells;

2. Blood Collection Unit


 Advocacy and promotion of voluntary donation and healthy lifestyle;
 Recruitment, retention and care of voluntary blood donor;
 Clinical screening and selection of voluntary blood donors;
 Conduct of health education and counseling services;
 Collection (mobile or facility based) from qualified voluntary blood donors;
 Transport of blood to BC for laboratory testing, screening and processing;
 Compatibility testing of red cell unit, if hospital based
3. Hospital Blood Bank (Blood Station- Hospital-based)

 Storage and issuance of whole blood and blood components obtained from licensed
BC;
 Compatibility testing of red cell units;
 Direct Coombs test;
 Red cell antibody screening;
 Blood transfusion;
 Investigation of transfusion reactions
 Assistance in the formation of HBTC and in the conduct of post transfusion
surveillance (hemovigilance)
4. Blood Center

 Advocacy and promotion of voluntary blood donation and healthy lifestyle;


 Recruitment, retention and care of voluntary blood donor;
 Collection of blood (mobile or facility based0 from qualified voluntary blood donors;
 Conducts health education and counseling
 Testing and screening of units of blood for TTIs
 Processing and provision of blood components
 Storage, issuance, transport, and distribution of units of whole blood and/or blood
products to hospital and other health facilities.
5. End User (Hospital and Non Hospital health facility)

 Advocacy and promotion of voluntary blood donation and healthy lifestyle


 Blood grouping, cross matching, and blood transfusion

V. STANDARDS AND TECHNICAL REQUIREMENTS


1. The BSF allocates personnel who are suitably qualified, trained to assume the
responsibilities, authority, accountability, and functions of the position.
QUALIFICATION FOR HEADSHIP AND STAFFING
BC BB (BS-HB) BS-NHB BCU
Head: Head: Head: Physician, PRC Head: Physician, PRC
*Certified Clinical *Certified Clinical registered with valid registered with valid
Pathologist or Pathologist or professional license professional license
Hematologists who Hematologists who
has at least two (2) has at least two (2) *With at least four *With at least four
years on-the-job years on-the-job (4) months training in (4) months training in
experience s head of experience s head of basic blood basic blood banking
a currently licensed a currently licensed transfusion services services and
blood service facility blood service facility and attendance at attendance at
and attendance at and attendance at continuing education continuing education
continuing education continuing education seminar/workshop in seminar/workshop in
seminar/workshop in seminar/workshop in Blood Transfusion Blood Transfusion
Blood Transfusion Blood Transfusion Medicine sufficient Medicine sufficient
Medicine to maintain Medicine to maintain to maintain to maintain
competency. competency. competency. competency.
In places where a In places where a *Or with at least one *Or with at least one
certified Clinical certified Clinical (1) year on-the-job (1) year on-the-job
Pathologist or Pathologist or experience as head experience as head
Hematologist is not Hematologist is not or associate of a or associate of a
available as available as currently licensed currently licensed
determined by determined by blood service facility blood service facility
PSP/PSHBT PSP/PSHBT and attendance at and attendance at
**Board eligible **Board eligible continuing education continuing education
Clinical Pathologist Clinical Pathologist seminar/workshop in seminar/workshop in
***Anatomic ***Anatomic Blood Transfusion Blood Transfusion
Pathologist Pathologist Medicine sufficient Medicine sufficient
who has training in who has training in to maintain to maintain
Transfusion Transfusion competency. competency
Medicine. Medicine.
Either (**) or (***) Either (**) or (***) One (1) physician
should have at least 3 should have at least 3 with sufficient
years on-the-job years on-the-job background in
experience as head experience as head Transfusion Medicine
of a currently of a currently
licensed blood licensed blood
service facility and service facility and
attendance at attendance at
continuing education continuing education
seminar workshop in seminar workshop in
Blood Transfusion Blood Transfusion
Medicine sufficient Medicine sufficient
to maintain to maintain
competency. competency.
Two (2) physicians Two (2) physicians
with sufficient with sufficient
knowledge and knowledge and
background in background in
Transfusion Medicine Transfusion Medicine

MEDICAL MEDICAL MEDICAL MEDICAL


TECHNOLOGIST: TECHNOLOGIST: TECHNOLOGIST: TECHNOLOGIST:
Twelve (12) Trained Six (6) Trained Six (6) Trained One (1) Trained
Medical Medical Medical Medical
Technologist, PRC Technologist, PRC Technologists, PRC Technologist, PRC
registered with valid registered with valid registered with valid registered with valid
professional license. professional license professional license professional license

*With at least one (1) *With at least one (1) *With at least one (1) *With at least one (1)
year on-the-job year on-the-job year on-the-job year on-the-job
experience in blood experience in blood experience in blood experience in blood
transfusion services transfusion services transfusion services transfusion services
in a currently in a currently in a currently in a currently
licensed blood licensed blood licensed blood licensed blood
service facility and service facility and service facility and service facility and
attendance at attendance at attendance at attendance in Blood
continuing education continuing education continuing education Transfusion Medicine
seminar/workshop in seminar/workshop in seminar/workshop in sufficient to maintain
Blood Transfusion Blood Transfusion Blood Transfusion competency to
Medicine sufficient Medicine sufficient Medicine sufficient include training in
to maintain to maintain to maintain quality assurance
competency. competency. competency. management in
**At least one of the **At least one of the **At least one of the transfusion medicine
registered medical registered medical registered medical
technologists must technologists with technologists with One (1) Medical
possess a HIV- training in quality training in quality Technologist, PRC
proficiency certificate assurance assurance registered with valid
***At lest one of the management in management in professional license
registered medical transfusion medicine transfusion medicine shall be under the
technologists with responsibility of the
training in quality Trained Medical
assurance Technologist
management in
transfusion medicine

NURSE: NURSE:
Six (6) Nurses, PRC Two (2) Nurses, PRC
registered with valid registered with valid
professional license professional license
with at least 6 with at least 6
months training on: months training on:
*voluntary donor *voluntary donor
recruitment recruitment
*voluntary donor *voluntary donor
retention and retention and
motivation motivation
*health education *health education
and counseling and counseling
*blood collection *blood collection
*prevention and *prevention and
management of management of
adverse reaction adverse reaction

2. Services are provided in an environment with adequate space; promote safety; meets the
needs of clients, service provider and other stakeholders; and conforms to the current
standards issued by the DOH.
 The physical plant shall be housed in a well-lighted and well ventilated area with
adequate supply of water.
 The space shall be sufficient to accommodate the various activities of the Blood
Service Facility with provisions for accessible and clearly demarcated fire exits.
 The physical arrangement shall allow for the smooth and orderly flow of activities and
movement of people and supplies.
 The technical working area shall be exclusively for the use of the blood services.

3. All equipment and instruments necessary for the safe and effective provision of services
are available and properly maintained.

Blood Collection Unit


 Donor’s Interview Area adequate to conduct clinical screening and physical
examination of the blood donors considering the utmost confidentiality of the
information taken from the blood donors
 Bleeding Area
 Agglutination viewer for ABO/Rh grouping lube method
 Blood Collection Set
 Bleeding couch or bed
 Weighing scale for blood donor
 Forceps
 Scissors
 Tube Sealer
 Blood container with coolants
 Blood collection mixer
 Copper sulfate
 Sphygmomanometer
 Stethoscope
 Thermometer (Clinical and Laboratory)
 Weighing scale for blood unit
Blood Station Non-Hospital Based
 Air conditioning unit
 Automatic emergency light
 Computer with printer, UPS, AVR
 Generator capacity of at least 5 KVA
 Blood Bank Ref at 2°-6° C w/ temperature recorder, alarm system & AVR
 Laboratory thermometer
 Blood container with coolants
Blood Bank (Blood Station Hospital Based)
 Air conditioning unit
 Automatic emergency light
 Computer with printer, UPS, AVR
 Generator
 Blood Bank Ref at 2°-6° C w/ temperature recorder, alarm system & AVR
 Laboratory thermometer
 Agglutination viewer for ABO/Rh grouping tube method
 Autoclave system and AVR
 Plasma thawer or Waterbath at 37°C
 Blood container with coolants
Blood Bank with Blood Collection Unit (Hospital-based BS-BCU)
 All the requirements, equipment and materials included in BCU, BS & BB
Blood Center
 All those stated for BS, non-hospital based, and BCU and with generator capacity
of 20 KVA
 Refrigerated Centrifuge
 Plasma freezer
 Platelet agitator
 At least two (2) units of 3HP air conditioning units
End User (Hospital and Non Hospital health facility)
 Blood Bank refrigerator
 Blood container with coolants

4. All reagents and glass wares to be used by the BSFs 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.
5. There shall be a system of reporting and recording results of BSF examinations. Blood
quarterly monitoring report MUST be submitted to the BRBC regularly every end of the
quarter.
6. The BSF must put into practice a quality assurance program.

- There must be standard operating procedures (SOP) on quality assurance program


and continuous quality improvement
- The BSF shall participate in the External Quality Assessment Program (EAP)
administered by the designated National Reference Laboratories or other EAP
approved by the DOH-NVBSP.
7. All hospital based BSF shall establish a HBTC.
VI. AVAILING BLOOD/BLOOD COMPONENTS AT THE BRBC
1. The BRBC, BMC and the DOH-accredited Blood Banks, Blood Collection Units and Blood
Stations, Hospital Based (BB) and Non-Hospital Based, in the Bicol Region shall
coordinate for the laboratory screening and acquisition of blood products at and from
the BRBC.
2. Blood stocks will be provided by the BRBC and BMC to all accessible BB, BS, EU. The
blood stocks to be provided depend upon the need and the capability for storage of the
identified BB, BS or EU. Appropriate blood containers with coolants must be provided by
the BB, BS, EU for the transport of the blood products. Proper temperature must be
observed.
3. The BB, BS, EU shall collect blood service fees from their patients for blood products
used. The payments shall be remitted by the BB, BS, EU to DOH-CHD or BMC.
4. The BCU shall pay for the cost of the laboratory screening tests of blood units.
5. The BRBC must be informed by the BB, BS, EU for the need for platelet concentrate,
washed red blood cell and cryoprecipitate at least 24 hours for its preparation and
processing.
6. BB, BS and EU that are not easily accessible to and from the BRBC shall be provided with
blood stocks by other DOH-accredited BCs, particularly BMC.
7. BLOOD ITSELF IS FREE. However; expenses for the collection, processing and testing of
blood and blood products such as the actual cost of blood bags, reagents, supplies and
indirect cost shall be charged as SERVICE FEE as authorized by law and as provided by
AO No. 181 s.2002 for cost recovery

MAXIMUM ALLOWABLE SERVICE FEES


Blood/Blood Component Blood Service Fee Voluntary Non-Remunerated
Walk-in Donor or from
Community- based MBDs*
1. Whole Blood P 1500.00 1
2. Packed Red Cells P 1,100.00 1
3. Washed RBC P 1,600.00 1
4. Platelet Concentrate P 700.00 1
5. Fresh Frozen Plasma P 700.00
6. Cryoprecipitate P 700.00
* Until such time when the regular blood activities have already been fully established in the
LGUs.
8. Standard blood referral/withdrawal form shall be issued by the BRBC to LGU duly signed
by the latter’s authorized official for the availment of blood products at the BS and EU.
9. Guarantor shall shoulder the blood service fee in case patient cannot comply.
10. Networking must be maintained at all times to ensure availability of blood products.
VII. LICENSING AND AUTHORIZATION
1. Hospital-based Blood Service Facilities 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 authorization or
accreditation of the Blood Service Facility shall be submitted to the DOH-CHD V, along
with other documentary requirements.
2. Non-hospital based or free-standing BSFs shall be licensed or authorized to operate in
accordance to the usual procedure set by the Bureau of Health Facilities Services (BHFS)
and Health Regulatory Division.
3. The LTO/ATO shall be granted in accordance with prescribed documentary and technical
requirements on the basis of specific conditions and limitations established during the
inspection.
4. The LTO/ATO shall be issued by the CHD Director and the Chief or OIC of the Health
Regulations Division upon the recommendation of the Chief or OIC of the Bicol Regional
Blood Center with the issuance of the certificate of inclusion in the Regional Blood
Services Network.
5. The LTO/ATO as well as any right under the license/authorization can not be assigned or
otherwise transferred directly or indirectly to any party.
6. The LTO/ATO must be displayed at all times at a prominent place within the premises.
7. The CHD shall be notified within fifteen (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.
8. A separate LTO/ATO shall be required for each BSF or branch maintained in separate
premises even if operated by the same management.
9. The BSF LTO/ATO as part of the hospital licensee to operate shall be valid for one (1)
year, beginning January 1 to December 31.
10. The LTO/ATO of non-hospital based BSF shall be valid for a period of three (3), beginning
on January 1 of the first year of the validity period to December 31 of the third year of
validity period.
VIII. 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 persons under the authority:
1. Any material false statement in the application.
2. Misrepresentation of facts or falsification of documents or records.
3. Change of location, management, name or ownership without informing the CHD in
writing.
4. Refusal to allow survey of BSF by the Bicol Regional Blood Center Assessment Team or
the CHD V- Health Regulatory Division Inspection Team at an appropriate time.
5. Refusal to make available its books, accounts, and records of operation to an authorized
person from the CHD.
6. Charging of blood service fees above the maximum fees set by the DOH.
7. Collection of blood from paid or remunerated donor whether payment comes from the
hospital or from the patient/relatives.
8. Dispensing or transfusing unscreened, incompletely tested and/or contaminated blood.
9. Failure to dispose contaminated blood within appropriate time.
IX. TRANSITORY PROVISIONS
All previously licensed hospital-based and PNRC BCs already performing the blood
testing and processing in the Bicol Region shall be allowed to operate as such until December
31, 2009. By 2010, there shall be a regionally coordinated blood service network, and the BRBC
is tasked to coordinate nationally the blood services network in the region, with only the
designated BCs performing the centralized testing and processing and only the licensed and
authorized BSFs allowed to collect, transport, distribute and dispense blood and blood
products.
X. INVESTIGATION AND HEARING OF CHARGES OR COMPLAINTS
The Director of CHD V, the Chief or OIC of the CHD V-Health Regulatory Division, the
Chief or OIC of the BRBC, or any individual, corporation, association or organization may file
charges or complaints, duly sworn to, against any BSF or any of its personnel who has violated
or is violating the provisions of R.A. 7719, its implementing rules and regulations, the
subsequent administrative orders issued in relation thereto, or any of these rules and
regulations.
Upon the filing of the duly sworn charges or complaints, the DOH Region V-Legal
Division shall investigate and verify if the facility concerned or any of its personnel is guilty of
the charges or complaints. If upon investigation and hearing, the BSF concerned or any of its
personnel is found violating the provisions of R.A. 7719, its implementing rules and regulations,
the subsequent administrative orders issued in relation thereto or any of these rules, the
Director of the CHD V shall suspend the authority to operate for a definite or indefinite period
of time or revoke the authority to operate without prejudice to taking the case to judicial
authorities for criminal action.
XI. SUSPENSION OR REVOCATION OF LICENSE/AUTHORITY TO OPERATE
A LTO/ATO shall be suspended or revoked by the CHD Director upon violation of the
National Blood Services Act or the 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.
XII. APPEAL
Any BSF or any of its personnel aggrieved by the decision of the DOH Legal
Division/BHFS/CHD may within thirty (30) days after receipt of notice of the decision, file a
notice of appeal with the Office of the Secretary of Health, and serve a copy of the notice of
appeal to the DOH Legal Division/BHFS/CHD.
XIII. PENAL PROVISION
A. 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 the penalty of imprisonment of not less than one (1)
month but not more than six (6) months, or a fine of not less than five thousand pesos
(P5,000) but not more than fifty thousand (P50,000), or both at the discretion of the
judicial authority.
B. 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 the penalty of imprisonment of not less than
twelve (12) years but not more than (20) years, or a fine of not less than fifty thousand
pesos (P50,000) but not more than five hundred thousand pesos (P500,000), or both at
the discretion of the judicial authority.
C. 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
forty-eight (48) hours blood that is contaminated with transfusion transmissible
infections after receipt or confirmatory testing result form the Research Institute of
Tropical Medicine – National Reference Laboratory shall be imprisoned for ten (10)
years. This shall be without prejudice to the filing of criminal charges under the Revised
Penal Code.
D. The CHD Director, after due notice and hearing, and upon approval of the Secretary,
may impose the following administrative sanctions:
1. Penalty of five thousand pesos (P5,000) for any BSF that fails to submit the
application for renewal of LTO/ATO to the CHD within three (3) months prior to
the expiration of the existing license;
2. Recommendation to the PRC to revoke the certificate of registration or
invalidate the license of any health professional found violating the provisions of
RA 7719 or of these rules and regulations.
XIV. OPERATING WITHOUT A LICENSE OR AN AUTHORITY TO OPERATE
The CHD V -Director shall motu proprio, or shall, upon the recommendation of the Chief
or OIC of the Health Regulation Division – CHD V and/or the Chief or OIC of the BRBC,
immediately close all BSFs without a license or an authority to operate and may seek assistance
to the regional law enforcement agency to effectively enforce the closure.
XV. PUBLICATION
A list of authorized Blood Service Facilities shall be published by the CHD V annually at a
local newspaper.
XVI. SEPARABILITY CLAUSE
In the event that any section, paragraph, sentence, clause or word of this order is
declared invalid for whatever reason, other provisions thereof shall not be affected thereby.
XVII. REPEALING CLAUSE
These rules and regulations shall repeal and supersede all regional administrative orders
and other issuances inconsistent thereof.
XVIII. EFFECTIVITY
These policies and guidelines shall take effect immediately.

NESTOR F. SANTIAGO, JR., MD, MPHC, MHSA, CESO IV


DIRECTOR IV

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