This
page
is
part
of
the
FHIR
Specification
v6.0.0-ballot3:
Release
6
Ballot
(3rd
Draft)
(see
Ballot
Notes
).
The
current
version
is
5.0.0
.
For
a
full
list
Continuous
Integration
Build
of
available
versions,
see
FHIR
(will
be
incorrect/inconsistent
at
times).
See
the
Directory
of
published
versions
Note
to
Implementers:
This
module
page
describes
the
context
and
usage
of
the
Biologically
Derived
Product
and
related
resources.
This
module
supports
and
clarifies
the
traceability
requirements
for
a
biologically
derived
product,
and
more
specifically,
for
medical
products
of
human
origin
that
represent
a
subset
of
biologically
derived
products.
HL7
seeks
specific
feedback
on
the
usefulness
of
this
module
page
and
the
implementability
of
the
referenced
resources.
The
future
location
and
navigation
links
to
this
module
are
outstanding
items
to
be
revisited
in
a
future
FHIR
version.
16.1
13.0.1
Introduction
This
module
outlines
the
resources
and
functionality
used
to
model
biologically
derived
products
(BDP)
that
have
specific
requirements
for
traceability
and
allocation.
The
Biologically
Derived
Product
is
used
to
track
biological
products
of
human
or
non-human
origin
intended
to
be
transplanted
or
infused
into
a
human.
Examples
of
products
of
human
origin
(referred
to
as
Medical
Products
of
Human
Origin,
or
MPHO)
include:
blood
for
transfusion;
blood
and
marrow
for
cellular
therapy;
organs,
cornea,
vascular
tissue,
bone,
tendons,
and
other
tissues
for
transplantation;
banked
human
milk;
and,
serum
eye
drops.
Examples
of
non-human
derived
products
include:
porcine
dermis
and
porcine
heart
valves.
In
most
countries
BDP
are
regulated
separately
from
medicines
and
medical
devices
and
have
specific
traceability
requirements
including
the
need
to
be
able
to
trace
back
to
the
donor,
and
the
need
to
retain
traceability
records
for
very
long
periods
(e.g.
(e.g.,
30
years
from
time
of
use
for
tissues
and
cells
clinically
applied
in
the
EU).
Some
BDP
are
regulated
as
medical
devices
in
some
jurisdictions
and
these
may
need
to
be
managed
through
the
Medical
Devices
module
in
FHIR.
Traceability
and
lookback
functionality
will
need
to
take
into
account
that
material
from
a
single
donation
event
may
result
in
products
that
are
managed
as
both
biologics
and
medical
devices.
Care
will
need
to
be
taken
when
products
cross
international
boundaries
as
the
regulatory
framework
may
change,
thus
a
product
regulated
as
a
medical
device
in
the
US
may
be
regulated
as
Tissues
and
Cells
in
the
EU.
For
BDP
derived
from
a
human
donor
(an
MPHO)
bi-directional
traceability
is
essential.
A
profile
for
MPHO
has
been
developed
that
specifies
that
essential
traceability
identifiers
are
required.
For
BDP
derived
from
a
human
donor,
traceability
between
donor
and
recipient
has
to
be
maintained.
Models
described
in
this
module
support
traceability.
If
alternative
models
are
used
then
care
must
be
taken
to
ensure
the
traceability
pathway
is
maintained.
The
diagram
below
illustrates
the
information
flow
associated
with
BDP
use
from
clinical
request
and
provision
from
supplier
through
to
clinical
application
into
the
patient.
This
example
demonstrates
how
traceability
and
allocation
requirements
can
be
supported
with
responsibility
for
the
BDP
being
maintained
by
a
custodial
entity.
The
BiologicallyDerivedProduct
resource
(BDP)
is
the
resource
that
carries
the
information
specific
to
an
individual
product
of
biological
origin.
This
resource
carries
a
unique
identifier
together
with
elements
for
the
donation
identification
number,
product
description
code
and
the
division
number.
These
are
essential
for
BDP
of
human
origin
to
ensure
globally
unique
identification
and
to
meet
traceability
requirements.
The
BDP
carries
information
on
important
characteristics
of
the
product
(e.g.
(e.g.,
blood
group;
expiration
date;
red
cell
antigen
profile;
collection
type;
CMV
status).
The
SupplyDelivery
resource
(SD)
carries
information
on
a
consignment
of
BDP
shipped
from
a
supplier
(e.g.
(e.g.,
blood
center;
tissue
bank;
eye
bank;
registry;
manufacturer)
to
a
hospital
BDP
custodian
entity
(e.g.
(e.g.,
transfusion
laboratory;
sterile
supplies).
The
stage
element
of
SupplyDelivery
allows
the
dispatch
and
receipt
events
to
be
captured.
The
SD
references
the
BDP
of
each
of
the
products
in
the
consignment.
The
ServiceRequest
resource
carries
the
request
for
clinical
application
of
a
BDP
from
an
authorized
healthcare
provider
to
the
hospital
BDP
custodian
responsible
for
issuing
the
required
product.
This
resource
may
reference
a
specific
BDP
or
may
request
provision
at
the
generic
level.
This
may
in
the
future
be
modelled
as
a
BDPRequest
resource.
In
response
to
the
ServiceRequest,
the
BDP
custodian
carries
out
any
necessary
testing
and
releases
the
BDP
for
use.
The
BDPDispense
resource
(BDPD)
carries
information
regarding
the
dispense
including
the
BDP
instance
and
the
identification
of
the
intended
recipient.
The
clinical
team
receiving
the
BDP
and
associated
BDPD
performs
the
clinical
application
(e.g.
(e.g.,
transfusion;
transplant;
etc.)
and
the
event
is
recorded
using
the
Procedure
resource.
This
resource
references
the
BDP
and
the
recipient
identifier,
together
with
relevant
information
regarding
the
clinical
application
activity.
There
is
a
degree
of
flexibility
expected
with
this
resource
given
the
wide
variety
of
biologically
derived
products
used
in
different
areas
of
medicine.
For
example,
the
scenario
described
above
includes
the
use
of
the
SupplyDelivery
resource
to
indicate
a
BDP
being
received
from
an
external
provider,
but
the
biologically
derived
product
could
also
originate
through
a
collection
event
in
a
surgical
suite
or
apheresis
unit
in
the
same
facility
where
the
patient
is
receiving
treatment.
16.3
13.0.3
Example
Workflows
16.3.1
13.0.3.1
Cellular
Therapy
It
is
possible
for
a
ServiceRequest
to
specify
a
collection
event
(procedure)
and
then
a
subsequent
ServiceRequest
for
the
BDPDispense
and
infusion
(procedure).
The
procedure
would
collect
from
the
donor
patient
and
result
in
a
BDP
that
could
later
be
dispensed
to
the
recipient
patient.
This
is
a
common
occurrence
for
standard
of
care
blood
and
marrow
transplant
(BMT)
centers
that
find
a
matching
donor
for
an
intended
recipient,
collect
healthy
blood-forming
stem
cells,
and
infuse
those
cells
into
a
recipient
patient.
For
some
indications
it
is
also
common
for
stem
cells
to
be
collected
from
a
patient
prior
to
them
receiving
other
treatments
(e.g.
(e.g.,
chemotherapy,
radiation),
with
the
cryopreserved
cells
later
being
thawed
and
infused
back
into
the
patient.
Example:
Autologous
stem
cell
transplant
that
uses
pre-treatment
healthy
stem
cells
from
a
patient's
own
body
after
a
treatment
has
damaged
their
bone
marrow
BMT
clinical
team
orders
the
Hospital
Transfusion/Cell
Therapy
Laboratory
to
collect
stem
cells
from
the
patient
(ServiceRequest).
This
will
include
specifying
any
regimens
required
such
as
stem
cell
mobilization
drugs
or
scheduling
requirements.
The
stem
cells
are
collected
from
the
patient
(as
many
as
possible)
and
cryopreserved
for
future
use
(Procedure).
This
may
involve
a
surgical
suite
(bone
marrow)
or
apheresis
unit
(peripheral
blood)
but
the
ultimate
chain
of
custody
of
the
product
resides
with
the
laboratory.
There
will
commonly
be
multiple
biologically
derived
product
instances
as
a
result
of
collection.
The
Hospital
Transfusion/Cell
Therapy
Laboratory
processes
the
stem
cells
based
on
the
unique
needs
of
the
intended
recipient.
In
standard
of
care
applications
this
could
mean
plasma
reduction
while
in
advanced
applications
this
could
include
ex
vivo
expansion
or
further
specialized
processing.
The
Hospital
Transfusion/Cell
Therapy
Laboratory
advises
the
BMT
clinical
team
that
cryopreserved
products
are
available
in
inventory,
are
medically
releasable,
and
have
desired
characteristics
for
purity
and
potency
of
the
stem
cells.
The
BMT
clinical
team
orders
infusion
of
one
or
more
biologically
derived
products
depending
on
the
dosing
needs
of
the
recipient
(ServiceRequest
and
then
BiologicallyDerivedProductDispense).
This
will
be
scheduled
to
occur
within
the
context
of
a
larger
treatment
plan
involving
a
variety
of
allied
health
professionals
in
addition
to
treatment-specific
regimens
such
as
chemotherapy
or
radiation.
The
stem
cells
are
infused
into
the
patient
and
long-term
follow-up
begins
(Procedure).
For
some
kinds
of
transplant
(myeloablative)
the
timing
of
this
is
critical
as
the
patient
will
effectively
have
no
surviving
bone
marrow
until
the
stem
cells
have
engrafted
which
can
take
upwards
of
three
weeks.
Example:
Allogeneic
stem
cell
transplant
that
uses
healthy
stem
cells
from
a
healthy
donor
to
replace
bone
marrow
that
is
not
producing
healthy
blood
cells
BMT
clinical
team
orders
human
leukocyte
antigen
(HLA)
testing
for
intended
recipient
and
potential
donors
to
identify
if
a
suitable
healthy
donor
exists.
The
donor
matching
may
occur
through
the
hospital
network
or
an
international
registry
soliciting
stem
cell
donors
on
a
global
basis.
This
step
is
relevant
for
context
purposes
but
is
out
of
scope
for
the
BDP
FHIR
resources
and
is
not
included
in
the
related
diagrams.
BMT
clinical
team
orders
the
Hospital
Transfusion/Cell
Therapy
Laboratory
to
collect
stem
cells
from
the
selected
donor
(ServiceRequest).
This
will
include
specifying
any
regimens
required
such
as
stem
cell
mobilization
drugs
or
scheduling
requirements.
The
stem
cells
are
collected
from
the
donor
(as
many
as
possible)
(Procedure).
This
may
involve
a
surgical
suite
(bone
marrow)
or
apheresis
unit
(peripheral
blood)
but
the
ultimate
chain
of
custody
of
the
product
resides
with
the
laboratory.
There
will
commonly
be
multiple
biologically
derived
product
instances
as
a
result
of
collection.
The
Hospital
Transfusion/Cell
Therapy
Laboratory
processes
the
stem
cells
based
on
the
unique
needs
of
the
intended
recipient.
In
standard
of
care
applications
this
could
mean
plasma
reduction
or
RBC
depletion
while
in
advanced
applications
this
could
include
ex
vivo
expansion
or
further
specialized
processing.
(not
shown
in
the
diagram)
The
Hospital
Transfusion/Cell
Therapy
Laboratory
advises
the
BMT
clinical
team
that
the
fresh
or
cryopreserved
products
are
available
in
inventory,
are
medically
releasable,
and
have
desired
characteristics
for
purity
and
potency
of
the
stem
cells.
The
BMT
clinical
team
orders
infusion
of
one
or
more
biologically
derived
products
depending
on
the
dosing
needs
of
the
recipient
(ServiceRequest
and
then
BiologicallyDerivedProductDispense).
This
will
be
scheduled
to
occur
within
the
context
of
a
larger
treatment
plan
involving
a
variety
of
allied
health
professionals
in
addition
to
treatment-specific
regimens
such
as
chemotherapy
or
radiation.
The
stem
cells
are
infused
into
the
patient
and
long-term
follow-up
begins
(Procedure).
For
some
kinds
of
transplant
(myeloablative)
the
timing
of
this
is
critical
as
the
patient
will
effectively
have
no
surviving
bone
marrow
until
the
stem
cells
have
engrafted
which
can
take
upwards
of
three
weeks.
16.3.2
13.0.3.2
Cornea
Transplant
The
example
below
follows
the
General
Usage
workflow
shown
above,
but
provides
more
detail
specific
to
cornea
transplantation.
Eye
surgeon
identifies
need
for
cornea
replacement
and
determines
appropriate
cornea
replacement
procedure.
Eye
surgeon
requests
required
cornea
graft
from
eye
bank
and
provides
necessary
specifications.
(ServiceRequest).
Eye
bank
sources
cornea
and
dispatches
to
BDP
custodian
(BiologicallyDerivedProductDispense).
The
tissue
is
delivered
to
the
eye
clinic
BDP
custodian
(usually
an
appointed
nurse,
or
the
chief
nurse
of
the
operating
theatre,
or
transfusion
laboratory
staff).
Surgeon
implants
cornea
(Procedure)
16.3.3
13.0.3.3
Blood
Transfusion
The
examples
below
follow
the
General
Usage
workflow
shown
above,
but
provide
more
detail
specific
to
blood
transfusion.
Example:
Transfusion
of
platelets
Patient's
clinician
identifies
the
need
for
a
platelet
transfusion
and
places
a
request
with
the
transfusion
laboratory
(ServiceRequest).
Transfusion
laboratory
selects
suitable
platelet
units
from
stock
and
allocates
them
for
the
patient
(BiologicallyDerivedProductDispense).
Platelet
units
are
transferred
from
the
transfusion
laboratory
to
the
ward.
Transfusion
practitioners
verify
correct
identification
of
patient
and
units
and
proceed
with
infusion
(Procedure).
Transfusion
laboratory
replenishes
platelet
stock
by
placing
an
order
with
their
Blood
Center.
Blood
center
dispatches
a
consignment
of
products
to
the
transfusion
laboratory
(SupplyDelivery).
Example:
Blood
transfusion
for
patient
with
antibodies.
The
patient's
clinician
identifies
the
need
for
a
blood
transfusion
and
requests
3
units
of
red
cells
(ServiceRequest).
Transfusion
laboratory
orders
blood
specimens
to
be
collected
from
the
patient.
Transfusion
laboratory
performs
blood
grouping
and
antibody
investigation.
Blood
group
B
RhD
positive.
Identifies
the
presence
of
anti-C
and
anti
Jk(a).
Transfusion
laboratory
requests
supply
of
Group
B
or
Group
O
units
that
are
negative
for
both
the
C
antigen
and
the
Jk(a)
antigen.
Blood
center
dispatches
the
requested
units
(SupplyDelivery).
Transfusion
laboratory
crossmatches
the
units
against
the
patient
blood
specimen.
Compatible
units
are
dispensed
for
the
patient
(BiologicallyDerivedProductDispense).
Blood
units
are
transferred
from
the
transfusion
laboratory
to
the
ward.
Transfusion
practitioners
verify
correct
identification
of
patient
and
units
and
proceed
with
transfusion
(Procedure).
16.4
13.0.4
Common
Use
Cases
Representation
of
a
biologically
derived
product
and
its
clinically
relevant
characteristics.
The
BDP
provider/manufacturer
sources
a
donation
of
biological
material
from
a
donor,
allocates
a
unique
identifier
to
the
donation
event,
performs
testing
and
transmissible
disease
screening,
and
performs
processing
steps
to
prepare
one
or
several
BDP
products
from
the
donated
material.
Each
BDP
product
is
uniquely
identified
and
the
BDP
provider/manufacturer
is
responsible
for
maintaining
traceability
links
between
the
BDP
products
and
the
donor.
BDP
products
are
labeled
with
their
unique
identification
and
critical
information
that
varies
by
BDP
type.
BDP
provider/manufacturer
creates
a
BiologicallyDerivedProduct
resource
to
carry
critical
and
other
clinically
important
information.
The
BiologicallyDerivedProduct
resource
is
made
available
to
the
BDP
Custodian
receiving
the
BDP.
The
BiologicallyDerivedProduct
resource
is
referenced
in
the
BiologicallyDerivedProductDispense,
the
Procedure,
and
the
patient
electronic
health
record.
Distribution
of
a
consignment
of
biologically
derived
products
from
a
supplier
or
manufacturer
to
a
healthcare
organization.
A
healthcare
organization
places
an
order
for
biologically
derived
products
from
their
BDP
provider/manufacturer.
The
BDP
provider/manufacturer
prepares
a
consignment
to
satisfy
the
order.
A
SupplyDelivery
resource
is
created
for
the
consignment.
For
each
BDP
in
the
consignment
a
BiologicallyDerivedProduct
resource
is
referenced
in
the
SupplyDelivery
resource.
The
healthcare
organization
receives
the
SupplyDelivery
resource
and
the
consignment.
Each
BDP
in
the
consignment
is
barcode
scanned
to
verify
receipt
and
crosschecked
against
the
corresponding
resources.
Information
from
the
BiologicallyDerivedProduct
resource
is
used
to
populate
information
in
the
receiving
organization
inventory.
Dispense
of
a
biologically
derived
product
from
the
unit
responsible
for
selection/matching
to
the
team
responsible
for
clinical
application.
The
clinician
responsible
for
the
patient
requests
application
of
a
biologically
derived
product.
Product
is
requested
from
the
appropriate
BDP
Custodian
using
a
ServiceRequest
resource.
The
BDP
custodian
carries
out
any
necessary
matching
or
selection
and
dispenses
the
BDP
using
the
BiologicallyDerivedProductDispense
resource.
The
BDP
is
transported
to
the
ward.
The
patient
wristband
and
BDP
labels
are
scanned
and
electronically
checked
against
the
BiologicallyDerivedProductDispense
resource,
and
referenced
BiologicallyDerivedProduct
resources,
to
confirm
correct
allocation
The
clinical
team
caring
for
the
patient
carries
out
identification
checks
of
the
patient
and
the
products
to
ensure
correct
allocation
prior
to
clinical
application.
Recording
of
clinical
application
of
a
biologically
derived
product
to
a
patient.
Following
all
necessary
identification
and
verification
steps
the
BDP
is
clinically
applied
to
the
patient
A
Procedure
resource
is
used
to
capture
the
event
details
and
includes
links
to
the
BiologicallyDerivedProduct
resources
of
the
products
used.
The
patient
electronic
health
record
is
updated
to
reference
the
Procedure
resource.
Tracking
all
products
derived
from
a
single
donation
event
(all
products
carrying
the
same
donation
identification
number)
from
source
to
final
disposition
(clinical
use
or
disposal).
A
BDP
provider/manufacturer
receives
post-donation
information
about
a
donor
of
biological
material
that
indicates
a
potential
risk
of
harm
to
recipients.
The
BDP
provider/manufacturer
determines
that
it
is
necessary
to
withdraw
all
implicated
products
from
the
supply
chain,
and
notify
the
clinicians
of
any
patients
that
have
already
received
implicated
product.
The
BDP
provider/manufacturer
notifies
the
BDP
Custodian
for
all
healthcare
organizations
that
have
received
implicated
products
and
references
the
relevant
BiologicallyDerivedProduct
resources.
BDP
Custodian
initiates
a
search
of
all
BiologicallyDerivedProductDispense
resources
to
identify
implicated
product
dispensed
to
patients.
For
each
implicated
product
that
has
been
dispensed,
clinical
application
is
confirmed
by
accessing
the
Procedure
resource.
Clinical
staff
responsible
for
each
patient
that
has
received
implicated
product
are
notified
and
referred
to
the
provider/manufacturer
for
more
information.
BDP
Custodian
initiates
a
search
of
inventory
using
the
information
provided
in
the
BiologicallyDerivedProduct
resources.
Any
implicated
product
in
stock
is
immediately
flagged
as
unsuitable
for
use
and
returned
to
the
provider/manufacturer.
Identifying
all
biologically
derived
products
clinically
applied
to
a
patient
within
a
specified
time
period.
Following
a
course
of
BDP
treatment,
a
patient
develops
symptoms
of
an
infection
that
is
known
to
be
transmissible
by
BDP.
The
patients
electronic
health
record
is
analysed
to
identify
all
Procedures
involving
BDP
in
the
last
3
months.
The
BiologicallyDerivedProduct
resource
for
each
product
used
is
identified,
and
from
this
the
provider/manufacturer
is
determined.
All
providers/manufacturer
involved
are
notified
and
given
the
identification
information
for
the
products
used.
Provider/manufacturers
identify
the
donors
from
their
own
records
and
initiate
follow-up
testing
of
donors.
In
the
context
of
blood
transfusion,
observations
based
on
tests
performed
on
specimens
collected
from
the
patient
fulfil
a
number
of
important
roles:
To
help
determine
the
need
for
the
clinical
application
of
a
BDP
(e.g.
(e.g.,
platelet
count
on
patient
specimen
gives
indication
if
platelet
transfusion
is
required)
To
determine
important
serological
information
about
the
patient
prior
to
transfusion
(blood
group
of
patient,
presence
of
atypical
antibodies)
To
ensure
the
selection
of
safe
product
for
the
patient
(e.g.
(e.g.,
blood
crossmatch
using
a
patient
specimen
ensures
compatibility
between
red
blood
cell
units
and
patient)
Follow-up
specimen
collection
can
provide
information
on
efficacy
of
treatment
and
the
need
for
additional
clinical
support
(e.g.
(e.g.,
post-transfusion
platelet
count
can
indicate
effectiveness
of
platelet
therapy)
Investigation
of
suspected
transfusion
reaction
will
involve
the
analysis
of
pre-
and
post-
transfusion
specimens
The
Biologically
Derived
Product
resources
typically
represent
patient-specific
data,
and
as
such
are
susceptible
to
data
breaching.
Necessary
privacy
and
security
provisions
must
be
in
place
when
searching
and
fetching
this
information.
For
more
general
considerations,
see
the
Security
and
Privacy
module
.
16.7
13.0.7
Developmental
Roadmap
The
Biologically
Derived
Product
resource
had
relatively
significant
changes
leading
up
to
the
R5
release,
and
is
still
immature
at
FMM=2.
We
anticipate
that
future
work
could
lead
to
further
refinements
in
the
scope
and
boundaries.
Broader
use
by
implementers
will
help
to
increase
its
maturity
level.
The
Biologically
Derived
Product
Dispense
resource
was
introduced
in
R5.
Further
use
of
this
resource
in
production
tooling
is
needed
for
it
to
reach
a
more
stable
FMM
level.
16.7.1
13.0.7.1
Examples
to
be
created
BDP
A
unit
of
red
blood
cells
for
transfusion.
Essential
information
includes
donation
identification
number,
product
code,
division
identifier,
blood
group,
collection
type,
expiration
date,
collection
or
processing
facility.
A
cornea
for
transplant.
Essential
information
includes
donation
identification
number,
product
code,
date
and
time
of
collection.
An
Achilles
tendon
with
bone
block
for
transplant.
Essential
information
includes
donation
identification
number,
product
code,
division
identifier,
expiration
date.
SupplyDelivery
A
consignment
of
20
x
O
RhD
Positive,
20
Rh
D
Positive,
10
O
RhD
Negative
and
10
RhD
Negative
blood
units
sent
from
Blood
Center
A
to
Hospital
Transfusion
Laboratory
X.
ServiceRequest
Request
for
transfusion
of
3
units
of
red
blood
cells
to
a
specified
patient.
BDP
Dispense
3
units
of
red
blood
cells
of
group
A
RhD
Negative
cross-matched
for
a
specified
patient.
3
units
of
red
blood
cells
group
O
RhD
Positive,
C
Negative,
K
Negative
crossmatched
for
a
specified
patient
with
anti-C
and
anti-K
antibodies.
Procedure
Record
the
transfusion
of
a
specific
unit
of
red
blood
cells
to
a
specified
patient.
The
procedure
records
the
time,
date,
location
of
the
event
and
references
the
patient,
biologically
derived
product,
and
responsible
healthcare
staff.
O&O
welcomes
feedback
to
show
if
the
resource
designs
have
made
a
solution
that
works,
and
is
implementable,
for
users
across
a
range
of
domains.
Biological
Products
|
Propose
a
change