COMPLIANCE GUIDE
For
Hospital Joint Commission, CMS or Department of Health Surveys
SELF ASSESSMENT CHECKLIST
STANDARD/GUIDELINE
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NO
PARTIAL
EXAMPLE OF COMPLIANCE
ACTION NEEDED
COMPLETION
DATE
Written agreement with appropriate
organ procurement organization
(OPO); must include the following :
 Criteria for referral, including
the referral of all individuals
whose death is imminent or
who have died in the hospital;
 Definition of “imminent
death”;
 Definition of “clinical trigger”
(clinical trigger is developed
jointly with hospital staff and
OPO);
 Definition of “timely
notification” (ideally within
one hour of clinical trigger);
 Referral will occur prior to the
withdrawal of any lifesustaining therapies including
medical or pharmacological
support;
 Addresses the OPO’s
responsibility to determine
medical suitability for organ
donation;
October 2010
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STANDARD/GUIDELINE
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PARTIAL
EXAMPLE OF COMPLIANCE
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Specifies how the tissue and/or
eye bank will be notified about
potential donors;
Ensures that the designated
requestor training program
offered by the OPO has been
developed in cooperation with
the tissue and eye banks
designated by the hospital;
Permits the OPO, tissue bank
and eye bank access to the
hospital’s death record
information according to a
designated schedule;
Includes that the hospital is not
required to perform
credentialing reviews for, or
grant privileges to, members of
organ recovery teams as long as
the OPO sends only “qualified,
trained individuals” to perform
organ recovery;
Interventions the hospital will
utilize to maintain potential
organ donor patients so that the
patient organs remain viable;
Did the hospital governing
body approve the hospital’s
organ procurement policies?
Is hospital staff aware of the
hospital’s policies and
procedures for organ, tissue and
eye procurement?
October 2010
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STANDARD/GUIDELINE
YES
NO
PARTIAL
EXAMPLE OF COMPLIANCE
ACTION NEEDED
COMPLETION
DATE
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Are the organ, tissue and eye
donation programs integrated
into the hospital’s QAPI
program?
Written agreement with at least one
tissue bank and at least one eye bank
to cooperate in the retrieval,
processing, preservation, storage and
distribution of tissues and eyes.
Procedures, developed in
collaboration with the OPO, for
notifying the family of each potential
donor of the options to donate
organs, tissues, or eyes, including the
option to decline to donate.
 Does the hospital have QAPI
mechanisms in place to ensure
that the families of all potential
donors are informed of their
options to donate?
The individual designated by the
hospital to initiate the request to the
family must be an organ
procurement representative or a
trained designated requestor.
 How does the hospital ensure
that only OPO, tissue bank, or
eye bank staff or trained
designated requestors are
approaching families about
donation?
 Written documentation by the
organization’s designated
requestor indicates that the
October 2010
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STANDARD/GUIDELINE
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NO
PARTIAL
EXAMPLE OF COMPLIANCE
ACTION NEEDED
COMPLETION
DATE
patient or family accepts or
declines the opportunity for the
patient to become an organ or
tissue donor.
 Training schedules and
personnel files are accessible to
verify that all designated
requestors have completed the
required training.
Staff education includes training in
the use of discretion and sensitivity to
the circumstances, beliefs, and
desires of the families of potential
donors.
 Does the designated requestor
training program address the
use of discretion?
 Does the hospital complaint file
contain any relevant
complaints?
Ensure that the hospital works
cooperatively with the designated
OPO, tissue bank and eye bank to
educate staff on donation issues.
 Training should be conducted
with new employees, annually,
whenever there are
policy/procedure changes, or
when problems are determined
through the hospital’s QAPI
program.
 Are in-service training
schedules and attendance sheets
accessible?
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STANDARD/GUIDELINE
YES
NO
PARTIAL
EXAMPLE OF COMPLIANCE
ACTION NEEDED
COMPLETION
DATE
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How does the hospital ensure
that all appropriate staff has
attended education regarding
donation and how to work with
the donation agencies?
Review death records to improve
identification of potential donors.
 Determine by review of
policies and records that the
hospital works with the
donation agencies in reviewing
death records.
 Verify that the effectiveness of
record reviews is monitored as
part of the hospital’s QAPI
program.
Ensure that the necessary testing and
placement of potential donated
organs, tissue and eyes takes place, in
order to maximize the viability of
donor organs for transplant and
maintain potential donors while
preliminary suitability is determined.
 Review hospital brain death
policy to ensure brain death is
declared within an acceptable
time frame by an appropriate
practitioner.
 Develop a donation policy that
addresses opportunities for
asystolic recovery (donation
after cardiac death, i.e. DCD),
based on an organ potential for
donation that is mutually
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STANDARD/GUIDELINE
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PARTIAL
EXAMPLE OF COMPLIANCE
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agreed upon by the designated
OPO, hospital, and medical
staff.
If the organization performs
transplants, it must be a member of
the Organ Procurement and
Transplantation Network (OPTN).
 Confirm membership by
contacting the CMS regional
office or by calling UNOS at 1804-330-8500.
 One year of reports submitted
to OPTN are available for
review.
Create a donation friendly
environment and a culture of
accountability.
 What evidence can you provide
to show that donation is a
mission at your hospital?
 Does your hospital have a selforganizing OPO/hospital team
or committee?
 Are hospital leaders and
medical staff actively involved
in problems that prevent
potential donors from being
converted to actual donors?
The conversion rate data are
collected and analyzed and, when
possible, steps are taken to improve
the rate.
 What is your hospital’s
conversion rate?
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STANDARD/GUIDELINE
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PARTIAL
EXAMPLE OF COMPLIANCE
ACTION NEEDED
COMPLETION
DATE
If your hospital’s conversion
rate is less than 75%, what is
the plan for improvement?
What is your hospital’s referral
rate?
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What is your hospital’s timely
notification rate?
 What is your hospital’s
appropriate requestor rate?
The organization uses standardized
procedures to acquire, receive, store
and issue tissues.
 Who is responsible for
overseeing the tissue program
throughout the organization
including storage and issuance
activity?
The organization’s records permit
tracing of any tissue from the donor
or source facility to all recipients or
other final disposition.
The organization has a defined
process to investigate adverse events
to tissue or donor infections.
October 2010
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