AGREEMENT BETWEEN
OPO
AND
HOSPITAL
This Agreement is made this
day of
, 20___, by and (“Hospital”) and
OPO (referred to hereafter as “Agreement”).
WHEREAS, OPO is an Organ Procurement Organization and Organ Procurement
Agency within the meaning of 42 U.S.C §273 and 42 U.S.C. §1320b-8;
WHEREAS, OPO is a member of the Organ Procurement and Transplantation Network
established under 42 U.S.C. §274;
WHEREAS, OPO has been designated by the United States Department of Health and
Human Services as the Organ Procurement Agency for the state of “State X” and the western
half of the state of “State Y” (“the Area”);
WHEREAS, the Hospital is within the Area and is located at XX, “State X” City, “State
Y” 64111;
WHEREAS, the Hospital is required by 42 U.S.C. §1320b-8(a) to have an agreement
with OPO in order to participate in the Medicare and Medicaid programs; and
WHEREAS, the Hospital wishes to cooperate with OPO in facilitating the wishes of
organ and tissue donors and families of patients who die at the Hospital.
NOW THEREFORE, in consideration of the mutual covenants contained herein and for
other good and valuable consideration, the parties agree as follows:
1.
Unless otherwise stated in this Agreement:
a.
“Effective Date” means the date, stated in the first paragraph of this
Agreement, on which the Agreement is binding on the parties.
b.
“Organ” means a human kidney, heart, lung, intestine, pancreas, liver, and
any other human organ and “Tissue” means eyes, corneas, tendons, bone, skin, blood
vessels, heart valves and body parts that are recoverable for use in human transplantation,
therapy, or research.
2.
Hospital shall, consistent with federal regulations, make available to OPO
information from all patients who die in the Hospital.
3.
Hospital shall notify OPO in a timely manner of every death that occurs at the
Hospital. Notification is “timely” if given to OPO:
a.
When death is imminent for a patient who:
(i) is ventilator dependent, has a non-survivable injury, or from whom the
Hospital plans to withdraw ventilator support; or who
(ii) meets other agreed clinical criteria for making a referral to OPO.
Hospital may not withdraw ventilator support until Hospital has
notified OPO, as provided in this Agreement.
b.
At the time of death, for all other non-ventilator dependent patients, notice
shall be deemed not timely if given later than one hour after cardiac death has occurred or
in the case of imminent death, within 60 minutes of patient meeting agreed upon criteria.
4.
The notification shall be given by telephone and shall include, at a minimum,
the following information; the patient’s identifier number, the patient’s age, the cause of death,
and any medical history available. Hospital shall enter a notation in Hospital’s patient record
(“Medical Record”) when OPO is notified. OPO is entitled to review the medical records of
potential donors and shall determine suitability for donation.
OPO shall document in the
Medical Record the suitability for donation of all patients for whom they have been notified,
except that when suitability for donation is determined at the time of notification, or after
completion of screening, Hospital shall record this determination in the Medical Record. OPO
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shall serve as the tissue recovery organization for all tissues, unless Hospital has an existing
agreement with an eye bank for recovery of eye and cornea tissues. In the event Hospital has an
agreement with an eye bank, OPO shall provide timely notification to the eye bank of all deaths
reported by Hospital that meets the criteria set forth by the eye bank.
5.
The determination of the death of a potential donor shall be made by the
potential donor’s attending physician or by another physician at the Hospital, both referred to
herein as (“Physician”). No Physician or member of Hospital staff, including Hospital nursing
staff, shall ask a patient or a patient’s family to authorize donation, unless they have been trained
as a “designated” requestor by OPO. Physician and/or Hospital personnel may participate in a
request for authorization for tissue donation when such personnel have participated in a training
program and are determined to be a Designated Requestor, or such personnel are trained to make
an introduction to the subject of tissue donation as a participant in OPO’s Bridge Builder
program. Further, the Physician involved in a request for authorization shall not participate in
any procedure relating to removal or transplantation of the organ. The authorization for organ
donation is a discussion with the next of kin conducted by OPO staff. Hospital staff and/or
physicians may participate with OPO in this discussion, only after a plan is agreed upon in
advance of the discussion with the next of kin.
6.
OPO shall supervise all the procedures relating to the procurement of a
donated organ.
OPO shall provide qualified medical and other personnel with specialized
training in transplantation, donor evaluation and management, donation request, medical/social
history interview techniques, and organ recovery and preservation to perform organ procurement
activities at the Hospital. OPO assures Hospital that it assumes total responsibility for the
actions of OPO personnel, and that OPO shall indemnify, defend and hold Hospital, and its
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directors, partners, officers, employees, representatives, agents, and affiliates, harmless from and
against any and all liabilities, suits, damages, and claims arising from the sole negligence or
willful misconduct of OPO personnel. OPO further assures Hospital that OPO personnel are
covered by organ and tissue professional liability insurance.
Hospital with appropriate OPO identification.
OPO personnel will present
The Hospital shall cooperate with OPO by
permitting the personnel provided by OPO to use its facilities and by providing necessary
support personnel for them.
7.
OPO shall:
a.
assist Hospital to implement its protocols for identifying potential organ
donors by, where appropriate, informing families of their option to donate organs or to
decline and requesting them, in accordance with applicable law and with discretion and
sensitivity, to make a donation.
b.
provide twenty-four (24) hour availability of a recovery coordinator
(“OPO Coordinator”). The OPO Coordinator shall perform or manage the preparation of
a donor evaluation and, at the discretion of the OPO Coordinator, a request to the next of
kin for authorization of organ and tissue donation; preparation of a medical/social history;
assistance in the clinical management of the donor; providing the surgical teams for
organ recovery; and initiating organ preservation and allocation.
c.
provide “designated requestor” training programs or programs designed to
train hospital staff and physicians to serve as “bridge builders” who will introduce the
subject of eye and tissue donation to the next of kin. Such training programs must be
developed in cooperation with the Hospital’s contracted eye bank, if different from OPO.
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d.
provide documentation of the request for organ donation from the next of
kin when the OPO Coordinator is on-site at Hospital (including whether the family
agreed or declined to donate) in the Medical Record. If the OPO Coordinator is not onsite at Hospital, any request for authorization made by the OPO Coordinator shall be
documented in a record maintained by OPO which record shall be made available to
Hospital upon reasonable request.
e.
provide in-service training of Hospital personnel concerning death
notification and organ procurement procedures.
f.
supervise the management of a
deceased donor prior to the time of
procurement of an organ.
g.
arrange for, coordinate, and supervise surgical recovery teams.
h.
provide qualified personnel, materials, and equipment for procurement and
preservation of organs.
i.
utilize or make arrangements for the disposition of organs procured at the
Hospital in accordance with applicable legal and regulatory requirements.
j.
document which organs/tissue/eyes were recovered.
k.
provide the Hospital with information as to the outcome of the recovery.
l.
maintain records pertaining to each potential donor identified, each organ
retrieved, each recipient transplanted and such other transplantation-related matters as
required under 42 C.F.R. § 121.11(a)(2). OPO shall maintain these records for as long as
required under the appropriate regulations.
m.
reimburse the Hospital for certain goods and services used in connection
with the recovery of organs under this Agreement. OPO shall pay for each of these
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goods and services in the amount set forth in Attachment A, which is incorporated in this
Agreement by reference.
8.
Hospital shall:
a.
establish protocols to implement Sections 3 and 4 above. The protocols
also shall provide that if a patient has agreed to be an organ donor, Hospital staff shall
comply with the patient’s wishes and take all steps necessary and consistent with
Hospital’s legal obligations, to give effect to those wishes. Further, the protocols shall
provide that only OPO or a person designated by OPO may inform families of potential
organ donors of the option of organ donation and their option to decline.
b.
cooperate with OPO to develop and maintain a protocol to provide for the
recovery of donated organs after circulatory death (i.e. a “DCD Protocol”).
c.
collaborate with OPO to ensure that OPO is given timely notice of all
deaths and imminent deaths occurring at the Hospital as provided in section 3 above.
d.
comply with the requirements of 42 U.S.C. §1320b-8, the “State Y”
Revised Uniform Anatomical Gift Act (R.S.Mo. § 194.210 et seq.), the “State X”
Revised Uniform Anatomical Gift Act (K.S.A. 65-3220 et seq.), and other legal
requirements applicable to organ donation.
e.
provide laboratory testing of organ function, blood typing, and other
indicated clinical studies of potential donors directed by OPO.
f.
provide intensive care or other clinical support for maintenance of
potential organ transplant donors prior to procurement surgery
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g.
in a timely manner, provide physicians to determine death of potential
organ donors, in compliance with state laws and in accordance with standard medical
practice.
h.
in a timely manner, provide an operating room and staff (including
surgical, anesthesia, and nursing) and supplies deemed appropriate by OPO for
performing organ recovery.
i.
permit OPO to review, on a periodic basis, the medical records of all
patients who die at the Hospital.
j.
provide OPO personnel with access to a wired or wireless high-speed
internet connection.
k.
carry out obligations under this Agreement as expeditiously as reasonable
under the circumstances to ensure that OPO has the opportunity to recover the maximum
number of transplantable organs and tissues from the maximum number of donors at the
Hospital.
9.
To the extent applicable, each party agrees to comply with the Health
Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. §1320d
(“HIPAA”) and any amendments thereof, and with any regulations promulgated there under,
including without limitation, the Privacy, Electronic Transaction, and Security Standards
contained in 45 C.F.R. Parts 160, 162 and 164, all collectively referred to herein as “HIPAA
Requirements.” Pursuant to 45 C.F.R. §164.512(h), the parties acknowledge that Hospital may
disclose Protected Health Information (“PHI”) about Individuals who are patients of Hospital to
OPO without the consent or authorization of the Individual, for the purpose of facilitating
cadaveric organ donation and transplantation. Capitalized terms used in this paragraph, if not
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defined in this agreement, shall have the same meaning as when used in the HIPAA
Requirements.
10.
In the performance of the obligations hereunder, the relationship of the
Hospital and OPO shall be that of independent contractors, and neither shall be deemed to be the
partner or agent of the other. Neither party shall withhold or in any way be responsible for the
payment of any federal, state, or local income or occupational taxes, F.I.C.A. taxes,
unemployment compensation, worker’s compensation contributions, or any other payments for
or on behalf of the other party or any person or the payroll of the other party.
11.
Each party shall be insured for professional liability for services and activities
performed under this Agreement, which also shall cover its directors, officers, and employees
providing services hereunder. Such coverage shall survive the life of the Agreement for so long
as there exists professional liability exposure for incidents which occur during the term of this
Agreement.
12.
This Agreement shall remain in effect until terminated by either party.
Termination may be made only upon the occurrence of one or more of the following
circumstances:
a.
Decertification of OPO by the Centers for Medicare and Medicaid
Services (“CMS”) as the designated Organ Procurement Organization for the Hospital;
b.
Upon designation of another Organ Procurement Organization by CMS to
be the Hospital’s designated Organ Procurement Organization;
c.
Upon the granting of a waiver to the Hospital by CMS to work with
another Organ Procurement Organization; or
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d.
Upon a showing by the Hospital that it is no longer subject to compliance
with any federal or state regulation requiring that it refer potential organ and tissue
donors to any Organ Procurement Organization.
Either party desiring to terminate this Agreement as a result of any of the aforesaid
circumstances shall provide as much notice as possible, but in no case less than ninety (90) days
written notice to the other party.
Such notice shall specifically state the reason for the
termination of the Agreement, and such party desiring to terminate the Agreement shall provide
such documentation to the other party supporting the reason so stated. Tissue and eye recovery
services provided by OPO to the Hospital are not subject to the provisions of Sec. 12 and may be
terminated upon written notice, but in no case less than ninety (90) days.
13.
Any written notices required under this Agreement shall be directed to the
signatories below or to the registered agents of the entity signing the Agreement at the address of
those registered agents.
14.
This Agreement may be amended or modified only in writing, signed by both
15.
OPO and Hospital understand that the federal, state and local laws and
parties.
regulations applicable to this Agreement may be amended from time to time. Accordingly, if
any law or regulation enacted, amended or if an interpretation of such law regulation after the
date of this Agreement materially affects or impacts upon the reasonable expectation of the
parties, the parties shall, in good faith, meet and negotiate an amendment to this Agreement to
maintain its compliance with those laws and regulations and to effectuate the intent of the parties
as evidenced by this Agreement.
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16.
This Agreement shall be governed by and construed in accordance with the
laws of the state in which the Hospital is located.
17.
The provisions of this Agreement are severable.
If any one or more
provisions of this Agreement are held invalid, the remaining provisions shall continue in full
force and effect.
18.
This Agreement shall be binding upon and inure to the benefit of the parties
hereto and their successors in interest.
OPO
Hospital
Signature:
Signature:
Printed Name
Printed Name:
Title: Chief Executive Officer
Title:
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ATTACHMENT A
SCHEDULE
OF
GOODS AND SERVICES
FOR WHICH
OPO WILL REIMBURSE HOSPITAL
UNDER PARAGRAPH 7 (L) OF THE AGREEMENT
Hospital agrees to charge OPO for Hospital inpatient and/or outpatient services properly
rendered in connection with each organ donation case coordinated by OPO at Hospital (the
“Services”) and accept as payment in full, an amount that is XXX percent (XX%) of the
Hospital’s usual charge for services of the same or similar type rendered to patients who are not
organ donors. Hospital shall not seek or accept payment for the Services or any part thereof
from any third person.
Hospital shall provide OPO with an itemized invoice for the Services. The invoice shall
set forth the Hospital’s usual charge and the discounted amount payable by OPO.
OPO agrees to pay for the Services, an amount that is XX% of the Hospital’s usual
charge for services of the same or similar type rendered to patients who are not organ donors.
OPO shall pay Hospital promptly after receipt of Hospital’s invoice; except that if OPO disputes
any invoice or part thereof, OPO shall pay the undisputed portion and shall notify Hospital
promptly of the amounts and services that are disputed.
Hospital and OPO shall cooperate to resolve any disputed invoice and shall provide such
additional documentation relating to the invoice or disputed amount as the other party may
reasonably request. When an invoice amount is adjusted, Hospital shall enter the adjustment in
its billing records and, at Hospital’s discretion, provide OPO with a corrected invoice or an
invoice reflecting the adjustment.
For purposes of this Schedule, organ donation means cases of brain death and donation
after cardiac death (DCD) in which kidney, heart, liver, pancreas, lung and/or small bowel are
recovered (or are attempted to be recovered, but which cases are discounted for clinical reasons)
from a deceased donor.
For the recovery of tissue donors at the Hospital, OPO may request access to and use of a
surgical suite. Tissue recovery does not require hospital personnel, supplies or equipment and
will be terminally cleaned at the completion of the case. OPO agrees to reimburse up to $XXX
for access and use of the suite.
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