SUBJECT : ESTABLISHMENT
OF A NATIONAL PROGRAM FOR
SHARING OF
ORGANS FROM DECEASED DONORS
I. RATIONALE
Transplantation
has allowed the improvement and prolongation of lives of patients in need of
organ replacement. The traditional source of organ grafts has been deceased
donors, i.e. individuals who suffer severe irreversible brain injury with the
rest of the body remaining practically intact and “healthy”. However, the
perennial lack of deceased organ donors has continually hampered the widespread
application of transplantation. The imbalance of supply and demand has created
the need to resort to other resources of grafts, such as living donors. Organ
donation from living donors, albeit a noble act of charity has been beset by
numerous ethical issues and has unfortunately lent itself to abuse and has been
tainted with commercialism in many areas of the world, including the
Philippines. While the Department of Health (DOH) finally addressed the
situation and established mechanisms to curtail organ sale and protect the
living kidney donor through A.O. No. 2002 – 0124 and A.O. No. 2008 – 0004 – A,
deceased donor organ transplantation had not been given enough attention. While
the National Kidney and Transplant Institute (NKTI) – based Human Organ
Preservation Effort (HOPE) has been functioning since 1983, the deceased
donation rate in the Philippines has remained at way below 1 per million populations
per year.
The
2008 Declaration of Istanbul on Organ Trafficking and Transplant Tourism
strongly encouraged governments, in collaboration with health care institutions,
professional and non–governmental organizations to take appropriate action to
increase deceased organ donation, remove obstacles and disincentives to
deceased organ donation, enact legislation and create transplantation
infrastructure so as to fulfill each country’s deceased donor potential (Istanbul
Declaration 2008). Tackling the issue of human organ and tissue transplantation
in the 63rd World Health Assembly, it was reported that
“Experience in countries with the most successful
deceased donor program has shown the advantage of having strong national
organizations that can stimulate, coordinate and regulate donation and
transplantation. Such organizations can inform the public about the importance
of sustaining a community resource that is built on voluntary, unpaid donation
of organs, tissues and cells rather than on the exploitation inherent in organ
purchases and that provides equitable access to all.”
(63rd World Health Assembly provisional agenda item 11.21).
In
response to this, the DOH is spearheading the development of a national system
of promoting organ donation from deceased donors and sharing of grafts through
the Philippine Network for Organ Sharing (PHILNOS). The potential of deceased
donor organs is yet to be maximized in our country where the estimated number
of deaths due to accidents is about 8000 per year (ADB – ASEAN Regional Road
Safety Program, Accident Costing Report AC7: Philippines). This network will
implement a system of timely referral and processing of potential multiple
organ donors, equitable allocation and efficient procurement and
transplantation of organs from them. Furthermore the DOH has developed an
online database, the Philippine Organ Donor and Recipient Registry System
(PODRRS) that will support the implementation of the PHILNOS guidelines.
II. OBJECTIVES
This
Order sets policies and guidelines for the efficient and equitable sharing of
organs from deceased donors.
Specific
Objectives:
1. To
establish the Philippine Network for Organ Sharing (PHILNOS).
2. To
initiate and maintain the Philippine Organ Donor and Recipient Registry System
(PODRRS).
3. To
promote organ donation from the deceased.
III. COVERAGE
The
policies and guidelines contained herein shall apply to all government and
private hospitals and health facilities, Organ Procurement Organizations,
medical and allied medical practitioners involved in organ and tissue
transplantation in the Philippines.
IV. DEFINITION
OF TERMS
1. Brain
Death (BD) is the irreversible cessation of all
functions of the entire brain, including the brain stem.
2. Death
(as per R.A. 7170 definition) is the irreversible
cessation of circulatory and respiratory functions or the irreversible
cessation of all functions of the entire brain, including the brain stem, which
is determined in accordance with the acceptable medical practice and diagnosed
separately by the attending physician and another consulting physician, both of
whom must be appropriately qualified and suitably experienced in the case of
such patients.
3. Decedent
is a deceased individual, and includes a still–born infant or fetus.
4. Donor
Allocation Scoring System (DASS) is the national
scoring system by which allocation of kidney grafts from deceased donors shall
be based.
5. Graft
is an organ that has been removed from the body of
an organ donor for transplantation into a recipient.
6. Hospital
Transplant Candidate Waiting List is the database
of all potential organ recipients of a particular Transplant Center. This shall
be administered by the Clinical Transplant Coordinator of the hospital’s
Transplant Program.
7. National
Transplant Candidate Waiting List is the
Philippine database of all potential organ recipients. The candidates who will
be registered in this list shall come from the waiting lists of the different
accredited Transplant Centers of the Philippines.
8. Organ
Procurement Organization (OPO) is a DOH
accredited non–profit organization, independent or hospital–based, composed
primarily of transplant coordinators and transplant specialists (internists and
surgeons), who can identify, evaluate and maintain potential organ donors and
retrieve organs from them.
9. Host
OPO is the particular OPO responding to an organ
donor call from a referring hospital.
10. Organ
Transplant Candidate (OTC) is a patient with
end–stage–organ–disease (ESOD) who is qualified to receive an organ graft.
a. Kidney Transplant Candidate
(KTC) is a patient with end–stage–renal–disease
(ESRD) who is qualified to receive a kidney graft.
b. Liver Transplant
Candidate (LTC) is a patient with end–stage–liver–disease
(ESLD), acute liver failure, or specific metabolic disease who is qualified to
receive a liver graft.
11. Philippine Organ Donor
and Recipient Registry System (PODRRS)
is the system that shall contain the national computerized database of all
organ transplant candidates, transplant recipients, and organ donors.
12. Potential Multiple Organ
Donor (PMOD) is any patient who will imminently become
brain dead, or who currently meets the criteria for brain death.
13. Referring Hospital (RH)
shall be any hospital that identifies and refers potential deceased organ
donors to PHILNOS.
14.Transplant Center (TxC)
shall be hospitals with transplant facilities duly accredited by the Department
of Health (DOH).
15. Transplant Coordinator
(TC) is the designated trained health care
professional who takes the central role and acts as liaison among the donor
hospital, retrieval and transplant team members in processing a potential organ
donor.
a. Procurement
Transplant Coordinator (PTC) is the TC who shall
have the responsibility of coordinating the donor’s evaluation, management, and
recovery or organs and/or tissues for transplantation.
b. Clinical
Transplant Coordinator (CTC) is the TC who shall
have the responsibility of coordinating the transplant candidate’s evaluation,
management, and follow–up care.
16.Transplant Recipient (TR)
is a patient who has received an organ graft.
V. GENERAL
GUIDELINES
1. The
Philippine Network for Organ Sharing
(PHILNOS) shall be the organization that will facilitate and oversee organ
donation and organ transplantation involving deceased donors in the country. It
shall serve as the central coordinating body of all deceased organ/tissue
donation and transplantation activities. It shall replace the National Human
Organ Preservation Effort (NHOPE) which was established by virtue of A.O. No.
2008 – 0004.
2. The
specific objectives of the PHILNOS are the following:
a. To
manage the national deceased donor program, ensuring effectiveness, efficiency,
equity and transparency in the national system of allocation of deceased
organs.
b. To
initiate and implement programs that will increase awareness and acceptance of
deceased organ donation and transplantation and increase the number of deceased
donors who will donate organs for transplantation.
c. To
formulate, recommend and implement policies that will promote the ethical
practice of deceased organ donation and transplantation.
d. To
maintain a national waiting list of transplant candidates and a national
registry of transplant recipients.
e. To
make policy recommendations to the DOH for legislation and other related
matters pertaining to the deceased donor program.
f. To
perform such other functions as may be ordered by the Secretary of Health in
relation to its primary function.
3. The
function of the PHILNOS shall be carried out through special organ procurement
service units called Organ Procurement Organizations (OPO) that need to be DOH
accredited.
4. Each
region shall have its own designated OPO. The National Capital Region (NCR),
where transplant activity in the country is concentrated, shall be further
divided into several areas of responsibility and each area of responsibility
shall be serviced by a designated OPO. All OPOs shall be mandated to serve
their designated areas of responsibility and other regions to be assigned by
the Program Manager on an annual basis.
a. Upon
issuance of this A.O., all existing memoranda of agreement between an OPO and a
referring hospital or transplant center shall be terminated.
b. All
existing OPOs shall be given privileged accreditation for a period of one year,
provided that they fulfill the minimum requirements of such organizations (see
Appendix B).
c. After
the initial year of accreditation, the existing OPOs shall be subjected to a
review of performance and renewal of accreditation which shall be every 3
years.
d. Accreditation
of new OPOs shall be initially for a period of 1 year. Thereafter, they may
apply for reaccreditation every 3 years.
5. All
tertiary hospitals and trauma centers are required to have a PTC, working full
time or part–time, in order to optimize the identification and referral of
potential deceased organ donors throughout the country. All TxCs are mandated
to have a PTC.
a. All
PTCs shall be trained and duly certified by PHILNOS to perform their duties and
responsibilities.
b. In
the absence of a hospital PTC in the referring hospital, the PTC of the
designated OPO shall be called.
6. All
patients deemed to be brain dead or in a state of imminent brain death must be
referred to the PTC for evaluation as a PMOD in all hospitals.
7. All
transplant candidates shall be enlisted according to established criteria per
organ. They shall be registered in PODRRS through their respective TxCs.
8. All
donor referrals shall be registered in PODRRS. Required donor data shall be
provided by the Host OPO.
9. Protocols
for donor evaluation, management and procurement including organ acquisition
fees shall be standardized by PHILNOS.
a. The
organ acquisition fee shall include the following:
i. Brain death assessment
and certification costs
ii. Donor evaluation costs
iii. Donor management costs
iv. Organ recovery and
delivery costs
v. Professional fees of specialists
involved
vi. OPO administrative costs
b. Funeral
assistance to the family of the deceased shall be optional.
10. Policies
and guidelines for non–renal solid organ donation and transplantation shall be
developed.
VI. ORGANIZATIONAL
STRUCTURE (See Appendix A)
1. The
PHILNOS shall have a head in the person of the Program Manager who shall be
appointed by the DOH secretary.
2. The
PHILNOS shall be governed by an Executive Committee composed of:
a. One
(1) Program Manager
b. One
(1) Assistant Program Manager
c. Committee
Heads
d. Three
(3) Medical Advisers (Consultants)
All
members of the Executive Committee shall be appointed by the DOH secretary.
3. The
Executive Committee will oversee the day to day operations of PHILNOS; will handle
membership concerns: will formulate and recommend policies to the Philippine
Board for Organ Donation and Transplantation (PBODT).
4. It
shall have an administrative staff that comprise of the following personnel who
will operate the PHILNOS office:
a. One
(1) Administrative Officer
b. Four
(4) Nurses – PHILNOS Transplant Coordinators
c. Three
(3) IT specialists
d. One
(1) Utility Man
5. It
shall be composed of the following working committees with specific functions:
a. Accreditation
and Training Committee will handle quality assurance and standardization; will
handle accreditation of OPOs; will provide training and certification of TCs.
b. Ethics
and Legal Affairs Committee will handle ethical and legal concerns.
c. Finance
Committee will handle costs and other financial matters.
d. Information
and Advocacy Committee will handle lay education, information dissemination,
and media concerns.
e. OPO
Committee will handle OPO concerns in relation to operations and implementation
of PHILNOS guidelines.
f. Registry
Committee (PODRRS) will handle registry and research.
6. The
heads and members of each committee shall be appointed by the DOH secretary,
upon the recommendations of the PHILNOS Program Manager.
7. The
External Audit Committee will be composed of members with no conflict of
interest, to be appointed by the DOH secretary as recommended by PBODT. This
committee shall conduct a periodic review and audit of the allocation
procedures of PHILNOS. It shall submit its reports to the PHILNOS Executive
Committee, the Philippine Organ Donation and Transplantation Program (PODTP),
the PBODT and the DOH secretary.
8. Organizations,
or centers with interest in organ donation and transplantation may become
members of the PHILNOS.
a. Organ
Procurement Organizations (OPO) – DOH accredited
b. Transplant
Centers (TxC) – DOH accredited
c. Medical
Scientific Organizations – PMA accredited
d. Patient
Organizations / Support Groups – SEC registered
e. Histocompatibility
Laboratories – DOH accredited
f. Other
groups that have relevance to the program
Representatives
from the above groups will be tapped as members of the PHILNOS working
committees except the External Audit Committee.
VII. OPERATIONAL
GUIDELINES
1. ENLISTMENT
OF KIDNEY TRANSPLANT CANDIDATES (KTC)
a. Enlistment
of a KTC for a deceased donor graft will be done in the TxC of choice of the
patient
(1) The KTC must at least be
near–ESRD (calculated creatinine clearance < 20 ml/min for diabetic nepropathy/pre–emptive
transplants) or with ESRD (calculated creatinine clearance <15 ml/min for
non–diabetic chronic kidney disease) at a time of enlistment.
(2) Enlistment of the KTC
must be done in person at the TxC of choice.
b. Only
Filipino KTC will be allowed to enlist in a Hospital Transplant Candidate
Waiting List of any accredited TxC in the Philippines.
c. All
requirements must be submitted and the registration fee must be paid.
d. After
enlistment in the Hospital Transplant Candidate Waiting List, the names and required
documents of patients will be forwarded by the TxC to PHILNOS for enlistment in
the National Transplant Candidate Waiting List.
e. KTCs
shall initially be listed as INACTIVE until approved by PHILNOS. After review
and approval of the case, the status shall be changed to ACTIVE.
f. Once
ACTIVE on the waiting list, fresh serum sample from the KTC shall be stored
every month and whenever sensitizing events have occurred (i.e blood
transfusion, pregnancy, failed allograft) at the PHILNOS reference laboratories for use during cross–matching.
g. All
KTC will be allowed to enlist in only (1) one Hospital Transplant Candidate
Waiting List which should be in their TxC of choice. In the event that the KTC
decides to transfer enlistment to another TxC, the Tc shall immediately report
the changes to PHILNOS.
h. If
the KTC resides in an area that is inaccessible, i.e. no telephone or internet
coverage, or living in an island, etc., it shall be required that the KTC
provides a contact person with whom the CTC shall be able to communicate with
anytime on a 24/7 time frame. This contact person must have the capability to
communicate or get in touch with the said KTC at all times.
2. WAITING
LIST STATUS GUIDELINES
a. Only
ACTIVE patients in the National Transplant Candidate Waiting List are eligible
to receive offers of deceased organs.
b. If
at the time a graft is offered, the KTC is found medically unsuitable or
financially incapable, he will be temporarily considered INACTIVE.
(1) KTC
status can be reactivated once the medical or financial problem is resolved.
(2) The
original date of enrollment shall be retained.
c. Enlisted
KTCs who will be out of the country for a certain period should inform their
CTC who in turn will transmit the information to PHILNOS so that the patient
status may be changed to INACTIVE during the period of physical absence from
the country.
(1) As
soon as the patient returns to the Philippines the patient must inform their
CTC so that his/her status may be updated accordingly in the National
Transplant Candidate Waiting List.
(2) If
the KTC who has gone abroad but failed to inform his CTC is offered a deceased
donor graft, he will automatically be delisted.
(3) The
delisted patient will have to register again with the Hospital Transplant
Candidate Waiting List. Consequently, their date of enrollment in the National
Transplant Candidate Waiting List will be reset.
3. IDENTIFICATION
AND REFERRAL OF POTENTIAL MULTIPLE ORGAN DONORS (PMOD)
The
schematic diagram for processing a PMOD from identification to transplantation
is shown in Appendix C.
a. Any
patient found in the Emergency Room (ER), or in the Pediatric or Adult
Intensive Care Unit (ICU) of a RH or TxC who is deemed to be brain dead, or in
a state of imminent brain death shall be referred as a PMOD to the PTC of the
RH.
b. If
the RH does not have an in–house PTC, its designated OPO shall be contacted to
send their PTC to assess and evaluate the PMOD.
c. The
PTC shall assess the eligibility of the PMOD. The PTC shall then perform a
complete clinical evaluation which includes:
(1) Consultation
with the primary Attending Physician (AP) and nurse–in– charge.
(2) Review
of the patient’s medical records.
(3) Review
of all laboratory and diagnostic examination results.
(4) Performance
of physical examination of the patient.
(5) Exclusion
of contraindications to organ donation.
d. The
PTC shall record the findings in a checklist a copy of which shall be
incorporated in the patient’s chart and whether the PMOD is eligible or not.
e. Special
situations
(1) In
the event a determination of brain death is being considered in a patient who
is known to be pregnant, obstetrical consultation shall be arranged to ensure
that no harm is inflicted on the fetus, and that the fetal well–being take
precedence over the option or organ donation.
(2) Although
the determination of brain death itself is not an ethical dilemma, ethical
issues commonly coexist in this setting. Consultation with the Hospital Ethics
Committee or the PHILNOS Ethics Committee may be appropriate.
(3) Medical–legal
cases shall be referred to the Medico–legal officer of the RH and/or the
National Bureau of Investigation/local police.
4. REQUEST
FOR ORGAN DONATION
a. When
a patient is determined to be a PMOD, the AP and/or Intensivist shall explain
the current medical status and prognosis of the patient.
b. The
PTC shall then offer to the legal next–of–kin or family of the patient the
opportunity of the gift of life, or the option of organ donation.
(1) When
the family has expressed understanding and agreement to proceed with the option
of organ donation, the PTC shall facilitate the process of BD certification.
(2) When
the family opts out, this decision shall be recorded in the patient’s chart.
Further efforts for organ donation shall be aborted.
c. The
PTC shall alert the Host OPO of the identification of a PMOD, if not yet done
at this point.
5. CERTIFICATION
OF BRAIN DEATH
a. The
AP shall refer the PMOD to another physician with skills and experience in
neurological assessment, for the diagnosis of brain death. Alternatively, the
AP may call on two (2) other qualified physicians to assess brain death.
(1) They
shall determine and establish brain death based on existing guidelines (Ref:
Philippine Neurological Association (PNA); Canada Practice Guidelines for the
Diagnosis of Brain Death).
(2) A
second evaluation by the same two (2) physicians must be performed after an
interval of at least two (2) hours (Ref: Canada Practice Guidelines for the
Diagnosis of Brain Death).
(3) If
the findings remain unchanged and brain death is confirmed, a Declaration of
Brain Death Form shall be signed by these two physicians.
(4) A
Death Certificate shall be signed by the AP. The date and time of death is
recorded on the Death Certificate and in the patient’s chart. The time of death
is when the patient is initially declared brain dead.
(5) The
PTC and the AP shall then inform the family that brain death has been
confirmed.
b. No
member of the transplant team or host OPO shall participate in the
determination of brain death of the PMOD.
6. SECURING
THE CONSENT FOR ORGAN DONATION FROM THE DECEDENT’S NEXT– OF–KIN
a. Securing
the family consent shall be the sole responsibility of the PTC. After the BD
Certificate has been issued, the PTC shall obtain the consent for organ
donation.
b. Consent
for organ donation must be obtained from the legal next–of–kin of the PMOD in
the following order of priority (R.A. 7170):
(1) Legal
spouse
(2) Son
or daughter of legal age
(3) Either
parent
(4) Brother
or sister of legal age
(5) Guardian
over the deceased person at the time of death
c. The
Consent for Organ Donation Form shall be signed by the legal next–of–kin.
d. Consent
of the legal next–of–kin still has to be obtained regardless of a living
legacy, i.e. organ donation card or will, on the part of the decedent.
e. After
the consent for organ donation has been obtained, the PTC shall inform PHILNOS
of the availability of the PMOD. The PTC shall provide all available clinical
data of the PMOD.
7. DONOR
MANAGEMENT
a. The
donor management in the Intensive Care Unit (ICU) or Emergency Room shall
commence after consent for organ donation is obtained.
b. A
donor management physician of the RH/TxC, or of the designated OPO in the
absence of the former, shall attend to the PMOD until the time of organ
procurement.
c. The
donor management physician shall be responsible for the hemodynamic stability
and maintenance of the PMOD.
8. COMPLETION
OF DECEASED DONOR EVALUATION AND ALLOCATION
a. After
consent for organ donation is obtained, the PTC shall facilitate the completion
of medical evaluation or work–up of the PMOD.
b. Initial
laboratory tests shall be requested.
c. The
PTC shall analyze the test results and determine whether the PMOD remains
qualified as a multiple organ donor.
(1) If
not qualified, further efforts for organ donation shall be aborted.
(2) If
qualified, PHILNOS shall be alerted.
(a) Completion
laboratory tests and examinations, including HLA typing, shall then be
performed.
(b) Once
the HLA typing is obtained, the PTC shall inform PHILNOS and the donor
allocation process is started using PODRRS.
d. The
donor allocation process is governed by the following:
(1) Geographical
location
The
National Transplant Candidate Waiting List is divided into: Areas of
Responsibility (in the NCR), Regional and National
(2) ABO
compatibility
a. Blood Type “O” donors
will be preferentially allocated to Blood Type “O” recipients, before being
allocated to other blood types.
b. Donors of blood types
other than “O” will be allocated to identical or compatible recipients equally.
(3) DASS
for kidney transplantation (see Section No. 9)
e. The
PHILNOS TC shall then run the match on PODRRS and draw a shortlist of the Top
10 KTCs as potential organ recipients within the areas of responsibility/region
of the host OPO and the Top 10 KTCs in the national list.
(1) A
full house match or zero antigens mismatches takes priority regardless of
geographic location of the potential organ recipient.
(2) When
there is no zero mismatched KTC, the DASS shall be used to be used to determine
kidney graft allocation.
(a) If
the PMOD is from a region other than the National Capital Region (NCR), one (1)
kidney graft shall be allocated to the KTC within the region and the other
kidney graft to the national list.
(b) If
the PMOD is from the NCR, one of the kidney grafts shall be allocated to the
KTC within the areas of responsibility of origin and the other kidney graft to
a KTC on the national list.
(c) If there is a negative
tissue cross–match with the top ranked KTC but the organ is refused for any
reason, then the organ will be offered to the succeeding KTCs in the list until
it is placed.
(d) If
after the 10th KTC there is still no suitable candidate, PHILNOS
shall again draw the next 10 potential recipients from the National Transplant
Candidate Waiting List.
(e) In
the event that transport of the second kidney graft matched KTC in the national
list would be inconvenient and threaten graft quality because of prolonged
ischemia time, the second graft may then be allocated to another recipient
within the region of donor origin.
f. PHILNOS
shall also inform or alert the other tissue procurement agencies or tissue
banks of the availability of a PMOD such as the following:
(1) Sta.
Lucia International Eye Bank of Manila (SLIEB)
(2) Bone
Banks
(3) Skin
Banks
(4) Vessel
Banks
9. DONOR
ALLOCATION SCORING SYSTEM FOR KIDNEY TRANSPLANTATION
CRITERIA
|
POINTS
|
NUMBER OF HLA
MISMATCHES
|
|
0 DR MISMATCH, ANY B
|
4
|
1 DR MISMATCH, ANY B
|
2
|
PANEL REACTIVE
ANTIBODIES
|
|
≥50%
|
4
|
<50%
|
2
|
DATE OF ENROLLMENT
|
|
>3 YEARS
|
4
|
>2 AND ≤3 YEARS
|
3
|
>1 AND ≤2 YEARS
|
2
|
≤1 YEARS
|
1
|
RECIPIENT AGE
|
|
<18 YEARS
|
2
|
19 – 65 YEARS
|
1
|
PREVIOUS KIDNEY DONOR
|
15
|
a. The
Donor Allocation Scoring System for kidney grafts includes 5 criteria:
(1) Number
of HLA mismatches
(2) Panel
Reactive Antibodies
(3) Date
of Enrollment at PHILNOS
(4) Recipient
Age
(5) Previous
Kidney Donor
b. Categories
assigned the highest points correspond to those that are associated with the
greatest graft survival advantage.
c. Donors
who have zero HLA mismatches with a potential recipient will preferentially be
allocated to that recipient, without the need of using the DASS.
d. In
the absence of a waitlisted KTC with a zero mismatch to the PMOD, the DASS will
be used. A shortlist of potential KTC ranked from highest to lowest points will
be produced.
e. All
KTC with a greater than zero HLA mismatch will be allocated according to the
points system below, with KTCs with the highest points receiving priority.
(1) Cross–match negative, highly sensitized patients (defined
as PRA >50% on either Class I or Class II PRA) will be assigned a point
advantage in the allocation scoring system due to the extreme difficulty of
these patients in getting a suitable donor. Historical or current PRA
(whichever is highest will be used.
(2) The
enrollment date and time is when the KTC considered ACTIVE in the National
Transplant Candidate Waiting List. Patients who have been enrolled as ACTIVE in
the National Transplant Candidate Waiting List for the longest period will be
given a point advantage.
(3) Patients
less than 18 years of age will be given a point advantage as transplantation
affords them the best possible patient survival, followed by patients aged 18 –
65, and lastly patients >65 years.
(4) Previous
kidney donors who developed ESRD will have a point advantage in the scoring
system so that they may receive a kidney transplant immediately. This done to
accord the donor the same gift as himself gave, at the soonest possible time.
(5) OLD
DONORS FOR OLD RECIPIENTS – the cut–off for deceased donors for kidney grafts
is 55 years old. However, exceptions may be made for expanded criteria donors
>55 years old. These donors will be preferentially allocated to recipients
aged 56 to 65 years old who may not have a long life expectancy but desire a
transplant.
f. The
maximum number of points that can be given is twenty–nine (29).
g. The
KTC with the highest number of points using the DASS will be offered the kidney
graft first. If that KTC refuses, then the next one in line will be offered the
kidney graft until it is accepted.
h. Among
equally ranked patients, the following will apply:
(1) The
tie will first be broken by waiting time; priority will be given to the oldest
date of enrollment in months and days.
(2) If
still equally ranked, the tie will then be broken by age; priority will be
given to the youngest recipient age in days.
i. The PHILNOS may
recommend review and revision of the DASS to the PBODT when it is deemed
appropriate.
10. ORGAN
ACCEPTANCE
The
following policies apply to donor and organ acceptance criteria:
a. Donor
Acceptance Criteria
All
OPOs shall have one uniform set of criteria defining what constitutes an
acceptable deceased donor or organ for the OPO or the transplant program(s) it
serves.
b. Renal
Acceptance Criteria
All
renal transplant programs must submit their minimum renal acceptance criteria
annually to PHILNOS. The PHILNOS will not subsequently offer that TxC renal
organs that fail to meet such criteria. The renal acceptance criteria will not
apply to zero antigen mismatched kidney offers.
c. Non–renal
Organ Acceptance Criteria
A
TxC may inform PHILNOS of the criteria according to which that TxC will accept
non–renal organs allocated through PHILNOS. The PHILNOS will not subsequently
offer that TxC non–renal organs that fail to meet such criteria.
d. Time
Limit for Acceptance
A
CTC, or its designee, must access donor information in PODRRS within one hour
of receiving the initial organ offer notification. The PHILNOS TC shall
communicate via phone call and text messaging with the CTC of the TxC of the
KTC.
(1) If
PODRRS is not accessed within one hour by the TxC or its designee, the offer
will be considered refused.
(2) After
review of the available donor data, the TxC shall be allowed one hour from the
time of accessing the donor information, in which to communicate its acceptance
or refusal of the organ. After one hour elapses without a response, the offer
will be considered refused and the PHILNOS may then offer the organ to the next
KTC in priority on the match list.
e. All
communication and exchange of information between the PHILNOS TC and the CTC of
the TxC with the matched KTC shall be properly documented.
f. The
final decision to accept a particular organ will remain the prerogative of the
transplant nephrologist or transplant surgeon responsible for the care of the
KTC. If an organ is declined for a KTC, a notation of the reason for that
decision must be made on the appropriate form and submitted promptly.
g. Once
acceptance is confirmed by the receiving TxC, the final placement will depend
on tissue crossmatching results.
11. ORGAN PROCUREMENT
a. Avoidance
of the Conflicts of Interest
Neither
the AP of the decedent at the time of death nor the physician who determines
and certifies the decedent’s death may participate in the operative procedure
for removing or transplanting an organ from the decedent.
b. If
the PMOD is stable then the organ procurement may be delayed until tissue
crossmatching results of the potential recipients are known.
c. Otherwise,
the organ retrieval team is informed and the organ procurement is scheduled.
(1) The
surgical team of the Host OPO performs the organ procurement either in the RH
if possible, or in another hospital to which the PMOD is transported, if deemed
necessary.
(2) If
the RH is also a TxC and an organ retrieval team is available, then they may
perform the organ retrieval.
d. If
a non–renal organ is to be recovered, the operation is performed by the non–renal
organ retrieval team.
e. If
the organs are not yet placed after the procurement operation, the grafts shall
remain in the custody of the host OPO until placed.
f. The
OPO will then coordinate transport of the graft to the receiving TxC once
placed.
12. ORGAN TRANSPLANTATION
The
task of organ transplantation shall be carried out at the TxC of choice of the
KTC. The organ transplantation shall also be performed by the transplant team
of choice of the KTC.
13. FINANCIAL CONSIDERATIONS
a. All
hospital expenses of the PMOD not related to organ acquisition, i.e. prior to
obtaining the consent for organ donation, shall be for the account of the PMOD
or his/her next–of–kin.
b. All
charges related to organ acquisition, i.e. from time of BD certification until
transport of the organs to the TxC, shall be for the account of the Host OPO.
Regardless of graft placement, the Host OPO shall be responsible in the
immediate settlement of all bills pertaining to organ acquisition in the
referring hospital.
c. If
the organs are placed, the host OPO shall then be reimbursed by the
recipient(s) through appropriate sources of funds, e.g. personal account,
PhilHealth private insurance, PCSO and others.
d. In
the event that the organs procured are not placed, the Host OPO understands and
accepts the fact that it shall not be reimbursed for the expenses it has
incurred from the process of organ acquisition.
14.POSTMORTEM CARE
a. Postmortem
care shall be provided for the decedent by the hospital where the procurement
was performed. The Host OPO and PTC will assist in providing this service.
b. If
necessary, assistance for funeral arrangements shall be provided by the Host
OPO.
15. PERFORMANCE REPORTS
a. The
PHILNOS Program Manager shall prepare and submit monthly performance reports to
the PODTP, the PBODT and the Secretary of Health.
b. Each
OPO will submit to PHILNOS every 1st week of the month the list of
PMOD that were referred to them in the previous month.
c. Each
TxC will submit to PHILNOS every 1st week of the month the list of
new patients who were transplanted with deceased donor grafts in the previous
month.
d. Each
PTC will submit to PHILNOS on a quarterly basis (i.e. 1st week of
April, July, October, January) the list of PMOD (i.e. regardless of outcome)
who were referred to them in the previous 3 months.
VIII. REPEALING
CLAUSE
All
existing issuances found inconsistent with the provisions of this
Administrative Order are hereby amended and/or repealed.
IX. EFFECTIVITY
CLAUSE
This
Order shall take effect fifteen (15) days after publication in a newspaper of
general circulation.
ESPERANZA
I. CABRAL, MD
Secretary
of Health
Appendix
B
MINIMUM
REQUIREMENTS FOR ORGAN PROCUREMENT ORGANIZATIONS
1. Organ
Procurement Organization is a non–profit organization, independent or hospital
based, consisting of:
a. Procurement
Transplant Coordinator(s)
b. Internists
c. Transplant
Surgeons
d. Allied
Health Professionals
2. Basic
Functions
a. It
can identify and evaluate potential organ deceased donors.
b. It
can stabilize and maintain potential organ donors.
c. It
can conduct and participate in systematic efforts, including professional
education, to procure all viable organs from potential donors.
d. It
can arrange for the acquisition and preservation of donated organs and provide
quality standards for the acquisition of organs which are consistent with the
standards adopted by the PHILNOS, including arranging for testing with respect
to preventing the acquisition of organs that are infected with the etiologic
agent for acquired immune deficiency syndrome.
e. It
can arrange for the appropriate tissue typing of donated organs.
f. It
can provide or arrange for the transplantation of blood specimen to NCR for
crossmatching.
g. It
can provide or arranged for the transport of donated organs to receiving
transplant centers.
3. Operational
Requirements
a. It
has an office where its operation are centralized and services are coordinated
b. It
should have a legal charging capability, accounting and other fiscal
procedures.
c. It
or its source of financial support; e.g. hospital base, foundation; must be
registered with the Securities and Exchange Commission.
d. It
should have financial stability.
e. It
has operational policies and procedures.
f. It
can evaluate annually the effectiveness of the organization in acquiring
potentially available organs.
g. It
can assists hospitals in establishing and implementing protocols for making
routine inquiries about organ donations by potential donors.
h. It
shall participate in the advocacy and information dissemination for organ
donation/sharing.
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