Bill Text: IA HF2215 | 2023-2024 | 90th General Assembly | Introduced
Bill Title: A bill for an act relating to the reporting of serious reportable events, and providing penalties.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2024-01-30 - Introduced, referred to Health and Human Services. H.J. 156. [HF2215 Detail]
Download: Iowa-2023-HF2215-Introduced.html
House
File
2215
-
Introduced
HOUSE
FILE
2215
BY
BRADLEY
(COMPANION
TO
SF
2038
BY
LOFGREN)
A
BILL
FOR
An
Act
relating
to
the
reporting
of
serious
reportable
events,
1
and
providing
penalties.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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Section
1.
NEW
SECTION
.
135S.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
“Director”
means
the
director
of
inspections,
appeals,
4
and
licensing,
or
the
director’s
designee.
5
2.
“Facility”
means
a
hospital
as
defined
in
section
135B.1,
6
an
ambulatory
surgical
center
as
defined
in
section
135R.1,
or
7
a
pregnancy
resource
center.
8
3.
“Health
care
professional”
means
an
individual
licensed
9
under
chapter
148
to
practice
medicine
and
surgery
or
10
osteopathic
medicine
and
surgery,
a
physician
assistant
11
licensed
under
chapter
148C,
a
podiatrist
licensed
under
12
chapter
149,
an
advanced
registered
nurse
practitioner
licensed
13
under
chapter
152,
an
advanced
practice
registered
nurse
under
14
chapter
152E,
or
a
pharmacist
licensed
under
chapter
155A.
15
4.
“Pregnancy
resource
center”
means
a
nonprofit
entity
16
that
provides
pregnancy
support
services
as
defined
in
section
17
217.41C.
18
5.
“Serious
injury”
means
any
of
the
following:
19
a.
A
physical
or
mental
impairment
that
substantially
limits
20
one
or
more
of
the
major
life
activities
of
an
individual
or
a
21
loss
of
bodily
function,
if
the
impairment
or
loss
lasts
more
22
than
seven
days
or
is
still
present
at
the
time
of
discharge
23
from
an
inpatient
health
care
facility.
24
b.
The
loss
of
a
body
part.
25
6.
“Surgery
or
other
invasive
procedure”
includes
the
26
treatment
of
disease,
injury,
or
deformity
by
manual
or
27
operative
methods,
including
invasive
testing.
28
Sec.
2.
NEW
SECTION
.
135S.2
Facility
reporting
29
requirements.
30
1.
a.
Each
facility
shall
report
to
the
director
the
31
occurrence
of
an
applicable
serious
reportable
event
described
32
in
this
section
as
soon
as
is
reasonably
and
practicably
33
possible,
but
no
later
than
fifteen
working
days
after
34
discovery
of
the
event.
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b.
The
report
shall
be
filed
in
a
format
specified
by
1
the
director
and
shall
identify
the
facility
but
shall
not
2
include
any
identifying
information
for
any
of
the
health
care
3
professionals,
facility
employees,
or
patients
involved.
4
c.
The
director
may
consult
with
experts
and
organizations
5
familiar
with
patient
safety
when
developing
the
format
for
6
reporting
and
in
further
defining
serious
reportable
events
in
7
order
to
be
consistent
with
industry
standards.
8
2.
Serious
reportable
events
under
this
section
include
all
9
of
the
following:
10
a.
Surgical
events
including
all
of
the
following:
11
(1)
Surgery
or
other
invasive
procedure
performed
on
a
wrong
12
body
part
that
is
inconsistent
with
the
documented
informed
13
consent
for
that
patient.
Serious
reportable
events
under
this
14
subparagraph
do
not
include
situations
requiring
prompt
action
15
that
occur
in
the
course
of
surgery
or
situations
whose
urgency
16
precludes
obtaining
informed
consent.
17
(2)
Surgery
or
other
invasive
procedure
performed
on
the
18
wrong
patient.
19
(3)
The
wrong
surgery
or
other
invasive
procedure
performed
20
on
a
patient
that
is
inconsistent
with
the
documented
informed
21
consent
for
that
patient.
Serious
reportable
events
under
this
22
subparagraph
do
not
include
situations
requiring
prompt
action
23
that
occur
in
the
course
of
surgery
or
situations
whose
urgency
24
precludes
obtaining
informed
consent.
25
(4)
Retention
of
a
foreign
object
in
a
patient
after
surgery
26
or
other
invasive
procedure,
excluding
objects
intentionally
27
implanted
as
part
of
a
planned
intervention
and
objects
present
28
prior
to
surgery
that
are
intentionally
retained.
29
(5)
Death
during
or
immediately
after
surgery
or
other
30
invasive
procedure
of
a
normal,
healthy
patient
who
has
no
31
organic,
physiologic,
biochemical,
or
psychiatric
disturbance
32
and
for
whom
the
pathologic
processes
for
which
the
operation
33
is
to
be
performed
are
localized
and
do
not
entail
a
systemic
34
disturbance.
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b.
Product
or
device
events
including
all
of
the
following:
1
(1)
Death
or
serious
injury
of
a
patient
associated
with
the
2
use
of
contaminated
drugs,
devices,
or
biologics
provided
by
3
the
facility
when
the
contamination
is
the
result
of
generally
4
detectable
contaminants
in
drugs,
devices,
or
biologics
5
regardless
of
the
source
of
the
contamination
or
the
product.
6
(2)
Death
or
serious
injury
of
a
patient
associated
with
the
7
use
or
function
of
a
device
in
patient
care
in
which
the
device
8
is
used
or
functions
other
than
as
intended.
“Device”
includes
9
but
is
not
limited
to
catheters,
drains,
and
other
specialized
10
tubes,
infusion
pumps,
and
ventilators.
11
(3)
Death
or
serious
injury
of
a
patient
associated
with
12
intravascular
air
embolism
that
occurs
while
being
cared
for
13
in
a
facility,
excluding
deaths
associated
with
neurosurgical
14
procedures
known
to
present
a
high
risk
of
intravascular
air
15
embolism.
16
c.
Patient
protection
events
including
all
of
the
following:
17
(1)
Discharge
to
the
wrong
person
of
a
patient
of
any
age
18
who
does
not
have
decision-making
capacity.
19
(2)
Death
or
serious
injury
of
a
patient
associated
with
a
20
patient
disappearance,
excluding
events
involving
adults
who
21
have
decision-making
capacity.
22
(3)
Suicide,
attempted
suicide
resulting
in
serious
injury,
23
or
self-harm
of
a
patient
resulting
in
serious
injury
or
death
24
of
the
patient
while
being
cared
for
in
a
facility
due
to
the
25
patient’s
actions
after
admission
to
the
facility,
excluding
26
the
death
of
a
patient
resulting
from
self-inflicted
injuries
27
that
were
the
reason
for
admission
to
the
facility.
28
d.
Care
management
events
including
all
of
the
following:
29
(1)
Death
or
serious
injury
of
a
patient
associated
with
a
30
medication
error
including
but
not
limited
to
errors
involving
31
the
wrong
drug,
the
wrong
dose,
the
wrong
patient,
the
wrong
32
time,
the
wrong
rate,
the
wrong
preparation,
or
the
wrong
route
33
of
administration,
excluding
reasonable
differences
in
clinical
34
judgment
on
drug
selection
and
dose.
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(2)
Death
or
serious
injury
of
a
patient
associated
with
1
unsafe
administration
of
blood
or
blood
products.
2
(3)
Maternal
death
or
serious
injury
associated
with
labor
3
or
delivery
in
a
low-risk
pregnancy
while
being
cared
for
4
in
a
facility,
including
events
that
occur
within
forty-two
5
calendar
days
postdelivery
and
excluding
deaths
from
pulmonary
6
or
amniotic
fluid
embolism,
acute
fatty
liver
of
pregnancy,
or
7
cardiomyopathy.
8
(4)
Death
or
serious
injury
of
a
neonate
associated
with
9
labor
or
delivery
in
a
low-risk
pregnancy.
10
(5)
Stage
3
or
4
or
unstageable
ulcers
acquired
after
11
admission
to
a
facility,
excluding
progression
from
stage
2
to
12
stage
3
if
stage
2
was
recognized
upon
admission.
13
(6)
Artificial
insemination
with
the
wrong
donor
sperm
or
14
wrong
egg.
15
(7)
Death
or
serious
injury
of
a
patient
associated
with
a
16
fall
while
being
cared
for
in
a
facility.
17
(8)
The
irretrievable
loss
of
an
irreplaceable
biological
18
specimen.
19
(9)
Death
or
serious
injury
of
a
patient
resulting
from
the
20
failure
to
follow
up
or
communicate
laboratory,
pathology,
or
21
radiology
test
results.
22
e.
Environmental
events
including
all
of
the
following:
23
(1)
Death
or
serious
injury
of
a
patient
associated
24
with
an
electric
shock
while
being
cared
for
in
a
facility,
25
excluding
events
involving
planned
treatments
such
as
electric
26
countershock.
27
(2)
Any
incident
in
which
a
line
designated
for
oxygen
or
28
other
gas
to
be
delivered
to
a
patient
contains
the
wrong
gas
29
or
is
contaminated
by
toxic
substances.
30
(3)
Death
or
serious
injury
of
a
patient
associated
with
31
a
burn
incurred
from
any
source
while
being
cared
for
in
a
32
facility.
33
(4)
Death
or
serious
injury
of
a
patient
associated
with
the
34
use
or
lack
of
restraints
or
bedrails
while
being
cared
for
in
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a
facility.
1
f.
Potential
criminal
events
including
all
of
the
following:
2
(1)
Any
instance
of
care
ordered
by
or
provided
by
someone
3
impersonating
a
health
care
professional.
4
(2)
Abduction
of
a
patient
of
any
age.
5
(3)
Sexual
assault
on
a
patient
within
or
on
the
grounds
of
6
a
facility.
7
(4)
Death
or
serious
injury
of
a
patient
or
staff
member
8
resulting
from
a
physical
assault
that
occurs
within
or
on
the
9
grounds
of
a
facility.
10
g.
Radiologic
events
including
death
or
serious
injury
of
a
11
patient
associated
with
the
introduction
of
a
metallic
object
12
into
the
magnetic
resonance
imaging.
13
Sec.
3.
NEW
SECTION
.
135S.3
Root
cause
analysis
and
14
corrective
action
plan.
15
1.
Following
the
occurrence
of
a
serious
reportable
event
as
16
specified
under
section
135S.2,
a
facility
shall
conduct
a
root
17
cause
analysis
of
the
event.
18
2.
Following
the
analysis,
the
facility
shall
do
one
of
the
19
following:
20
a.
Implement
a
corrective
action
plan
to
address
the
21
findings
of
the
analysis.
22
b.
Report
to
the
director
any
reasons
for
not
taking
23
corrective
action.
24
3.
If
the
root
cause
analysis
and
the
implementation
of
a
25
corrective
action
plan
are
already
completed
at
the
time
an
26
event
is
required
to
be
reported,
the
findings
of
the
analysis
27
and
the
corrective
action
plan
shall
be
included
in
the
report
28
of
the
event.
29
4.
If
the
root
cause
analysis
is
completed,
but
30
implementation
of
a
corrective
action
plan
is
not
completed
at
31
the
time
an
event
is
required
to
be
reported,
the
findings
of
32
the
root
cause
analysis
and
a
copy
of
the
proposed
corrective
33
action
plan
shall
be
filed
with
the
director
within
sixty
34
working
days
of
the
event.
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Sec.
4.
NEW
SECTION
.
135S.4
Electronic
reporting.
1
1.
The
director
shall
design
the
serious
reportable
event
2
reporting
system
to
allow
a
facility
to
file
the
reports
3
required
under
this
chapter
by
electronic
means.
4
2.
The
director
shall
encourage
a
facility
to
use
the
5
electronic
filing
option
when
that
option
is
feasible
for
the
6
facility.
7
Sec.
5.
NEW
SECTION
.
135S.5
Relation
to
other
law
and
8
duties
——
confidentiality
of
data.
9
1.
a.
Serious
reportable
events
described
under
section
10
135S.2
do
not
constitute
child
abuse
as
defined
in
section
11
232.68
or
dependent
adult
abuse
as
defined
in
section
235B.2,
12
and
are
excluded
from
the
reporting
requirements
of
chapters
13
232
and
235B,
if
the
facility
makes
a
determination
within
14
twenty-four
hours
of
discovery
of
the
serious
reportable
event
15
that
this
chapter
is
applicable
and
the
facility
files
the
16
reports
required
under
this
chapter
in
a
timely
fashion.
17
b.
A
facility
that
determines
a
serious
reportable
event
18
described
in
section
135S.2
has
occurred
shall
inform
persons
19
within
the
facility
who
are
mandatory
reporters
of
child
abuse
20
under
section
232.69
or
dependent
adult
abuse
under
section
21
235B.3.
A
mandatory
reporter
otherwise
required
to
report
22
child
abuse
or
dependent
adult
abuse
is
relieved
of
the
duty
to
23
report
an
event
the
facility
determines
to
be
reportable
under
24
section
135S.2.
25
c.
The
protections
and
immunities
applicable
to
reporting
26
of
child
abuse
under
section
232.73
and
dependent
adult
abuse
27
under
section
232.68
are
not
affected
by
this
section.
28
2.
a.
If
a
serious
reportable
event
is
reported
by
a
29
facility
in
compliance
with
this
chapter,
no
other
state
agency
30
or
licensing
board
is
required
to
conduct
an
investigation
of
31
or
obtain
or
create
investigative
data
based
upon
other
reports
32
of
the
same
event.
33
b.
If
a
facility
is
required
to
report
a
serious
reportable
34
event
pursuant
to
another
state
law
that
meets
the
requirements
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for
compliance
with
this
chapter,
the
department
shall
1
recognize
the
report
as
compliance
with
this
chapter
in
lieu
of
2
a
report
made
under
this
chapter
if
the
department
is
provided
3
a
copy
of
the
report.
4
3.
a.
Data
contained
in
the
following
records
are
5
confidential
records
under
section
22.7:
6
(1)
Reports
of
serious
reportable
events
made
to
the
7
director
by
a
professional
licensing
board.
8
(2)
Serious
reportable
event
reports,
findings
of
root
9
cause
analyses,
and
corrective
action
plans
filed
by
a
facility
10
under
this
chapter.
11
(3)
Records
created
or
obtained
by
the
director
in
reviewing
12
or
investigating
the
reports,
findings,
and
corrective
action
13
plans
under
subparagraph
(2).
14
b.
For
purposes
of
this
subsection,
the
reporting
facility
15
is
the
subject
of
the
report
or
data
under
chapter
22.
16
Sec.
6.
NEW
SECTION
.
135S.6
Director
duties
and
17
responsibilities
——
penalties.
18
1.
The
director
shall
establish
a
serious
reportable
event
19
reporting
system
designed
to
facilitate
quality
improvement
20
in
the
health
care
system.
The
reporting
system
shall
not
21
be
designed
to
punish
errors
by
health
care
professionals
or
22
facility
employees.
23
2.
The
reporting
system
shall
require
and
consist
of
all
of
24
the
following:
25
a.
Mandatory
reporting
by
facilities
of
the
applicable
26
serious
reportable
events
described
in
section
135S.2.
27
b.
Mandatory
completion
of
a
root
cause
analysis
and
a
28
corrective
action
plan
by
the
facility,
and
the
reporting
of
29
the
findings
of
the
analysis
and
the
plan
to
the
director,
or
30
the
reporting
of
reasons
for
not
taking
corrective
action.
31
c.
Analysis
of
reported
information
by
the
director
to
32
determine
patterns
of
systemic
failure
in
the
health
care
33
system
and
successful
methods
to
correct
the
failures.
34
d.
Sanctions
against
facilities
for
failure
to
comply
with
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reporting
system
requirements.
1
e.
Communication
from
the
director
to
facilities,
health
2
care
consumers,
and
the
public
to
maximize
the
use
of
the
3
reporting
system
to
improve
health
care
quality.
4
3.
In
establishing
the
serious
reportable
event
reporting
5
system,
the
director
shall
not
select
from
or
between
alternate
6
acceptable
medical
practices.
7
4.
The
director
shall
do
all
of
the
following:
8
a.
Analyze
serious
reportable
event
reports,
corrective
9
action
plans,
and
findings
of
the
root
cause
analyses
to
10
determine
patterns
of
systemic
failure
in
the
health
care
11
system
and
successful
methods
to
correct
these
failures.
12
b.
Communicate
to
individual
facilities
the
director’s
13
conclusions,
if
any,
regarding
a
serious
reportable
event
14
reported
by
a
facility.
15
c.
Communicate
with
relevant
health
care
facilities
any
16
recommendations
for
corrective
action
resulting
from
the
17
director’s
analysis
of
submissions
from
facilities.
18
d.
Publish
an
annual
report,
available
on
the
internet
site
19
of
the
department
of
inspections,
appeals,
and
licensing,
that
20
does
all
of
the
following:
21
(1)
Describes,
by
facility
type,
serious
reportable
events
22
reported
by
facilities.
23
(2)
Outlines,
in
aggregate,
the
findings
of
root
cause
24
analyses
and
corrective
action
plans.
25
(3)
Makes
recommendations
for
modifications
of
state
health
26
care
operations.
27
5.
a.
The
director
shall
take
steps
necessary
to
determine
28
if
required
serious
reportable
event
reports,
the
findings
of
29
the
root
cause
analyses,
and
corrective
action
plans
are
filed
30
in
a
timely
manner.
31
b.
The
director
may
do
any
of
the
following:
32
(1)
Sanction
a
facility
for
failure
to
file
a
timely
33
serious
reportable
event
report,
conduct
a
root
cause
analysis,
34
implement
a
corrective
action
plan,
or
provide
the
findings
of
35
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a
root
cause
analysis
or
corrective
action
plan
in
a
timely
1
fashion.
2
(2)
Place
conditions
on
the
license
under
which
a
facility
3
operates
if
the
facility
fails
to
develop
and
implement
a
4
corrective
action
plan,
or
report
to
the
director
the
reason
a
5
corrective
action
is
not
needed.
6
6.
The
director
may
collaborate
with
the
department
of
7
health
and
human
services
to
administer
this
section.
8
Sec.
7.
NEW
SECTION
.
135S.7
Reports
from
licensing
boards.
9
1.
The
board
of
medicine,
the
board
of
physician
assistants,
10
the
board
of
nursing,
the
board
of
pharmacy,
and
the
board
11
of
podiatry
shall
maintain
a
record
of
all
complaints
that
12
come
to
the
attention
of
the
respective
board
that
in
the
13
judgment
of
the
board
qualify
as
a
serious
reportable
event
14
under
section
135S.2.
Within
thirty
working
days
of
making
a
15
determination
that
an
event
qualifies
as
a
serious
reportable
16
event,
the
respective
board
shall
forward
a
report
of
the
event
17
to
the
director,
including
the
name
and
address
of
the
facility
18
involved,
the
date
of
the
event,
and
information
known
to
19
the
board
regarding
the
event.
The
report
shall
not
include
20
any
identifying
information
of
any
health
care
professional,
21
facility
employee,
or
patients
involved.
22
2.
The
director
shall
forward
a
report
received
under
23
subsection
1
to
the
facility
named
in
the
report.
24
3.
a.
The
facility
shall
determine
whether
the
event
25
has
been
previously
reported
under
this
chapter,
and
shall
26
notify
the
director
as
to
whether
the
event
has
been
previously
27
reported.
28
b.
If
the
event
has
not
been
previously
reported,
the
29
facility
shall
make
a
determination
whether
the
event
is
30
reportable
under
this
chapter.
If
the
facility
determines
the
31
event
is
reportable,
the
date
of
discovery
of
the
event
for
32
purposes
of
this
chapter
shall
be
as
follows:
33
(1)
If
the
director
determines
the
facility
knew
or
34
reasonably
should
have
known
about
the
occurrence
of
the
event,
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the
date
the
event
occurred
shall
be
the
date
of
discovery
1
of
the
event
and
the
facility
shall
be
considered
out
of
2
compliance
with
this
chapter.
3
(2)
If
the
director
determines
the
facility
did
not
know
4
about
the
occurrence
of
the
event,
the
date
the
facility
5
receives
the
report
from
the
director
shall
be
the
date
of
6
discovery
of
the
event.
7
c.
If
the
facility
determines
the
event
was
not
reportable
8
under
this
chapter,
the
facility
shall
notify
the
director
of
9
that
determination.
10
Sec.
8.
NEW
SECTION
.
135S.8
Interstate
coordination
and
11
reports.
12
1.
The
director
shall
report
the
list
of
serious
reportable
13
events
described
under
section
135S.2
to
the
national
quality
14
forum,
and
through
the
national
quality
forum
to
other
states.
15
2.
The
director
shall
monitor
communications
by
the
16
national
quality
forum
of
amendments
to
the
list
of
serious
17
reportable
events
maintained
by
the
forum
and
shall
report
any
18
modification
to
the
list
to
the
general
assembly.
19
3.
The
director
shall
also
monitor
efforts
in
other
states
20
to
establish
a
list
of
serious
reportable
events
and
shall
21
make
recommendations
to
the
general
assembly
as
necessary
for
22
modifications
to
the
list
of
serious
reportable
events
under
23
this
chapter
to
maximize
uniformity
with
the
list
maintained
by
24
the
national
quality
forum
and
by
other
states.
25
EXPLANATION
26
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
27
the
explanation’s
substance
by
the
members
of
the
general
assembly.
28
This
bill
relates
to
the
reporting
of
serious
reportable
29
events
by
facilities
including
hospitals,
ambulatory
surgical
30
centers,
and
pregnancy
resource
centers.
31
The
bill
provides
definitions
used
in
the
bill.
32
The
bill
requires
each
facility
to
report
to
the
director
33
(director)
of
the
department
of
inspections,
appeals,
and
34
licensing
(DIAL)
the
occurrence
of
an
applicable
serious
35
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reportable
event
described
in
the
bill
as
soon
as
is
reasonably
1
and
practicably
possible,
but
no
later
than
15
working
days
2
after
discovery
of
the
event.
Reports
shall
be
filed
in
a
3
format
specified
by
the
director
of
DIAL
and
shall
identify
the
4
facility
but
shall
not
include
any
identifying
information
for
5
any
of
the
health
care
professionals,
facility
employees,
or
6
patients
involved.
7
The
director
may
consult
with
experts
and
organizations
8
familiar
with
patient
safety
when
developing
the
format
for
9
reporting
and
in
further
defining
serious
reportable
events
in
10
order
to
be
consistent
with
industry
standards.
11
Serious
reportable
events
under
the
bill
include
surgical
12
events,
product
or
device
events,
patient
protection
events,
13
care
management
events,
environmental
events,
potential
14
criminal
events,
and
radiologic
events
detailed
in
the
bill.
15
The
bill
requires
that
following
the
occurrence
of
a
serious
16
reportable
event,
a
facility
shall
conduct
a
root
cause
17
analysis
of
the
event,
and
following
the
analysis
shall
either
18
implement
a
corrective
action
plan
to
address
the
findings
of
19
the
analysis
or
report
to
the
director
any
reasons
for
not
20
taking
corrective
action.
If
the
root
cause
analysis
and
21
the
implementation
of
a
corrective
action
plan
are
already
22
completed
at
the
time
an
event
is
required
to
be
reported,
the
23
findings
of
the
analysis
and
the
corrective
action
plan
shall
24
be
included
in
the
report
of
the
event.
If
the
root
cause
25
analysis
is
completed
but
the
implementation
of
a
corrective
26
action
plan
is
not
completed
at
the
time
an
event
is
required
27
to
be
reported,
the
findings
of
the
root
cause
analysis
and
a
28
copy
of
the
proposed
corrective
action
plan
shall
be
filed
with
29
the
director
within
60
days
of
the
event.
30
The
director
shall
design
the
serious
reportable
event
31
reporting
system
to
allow
a
facility
to
file
the
required
32
reports
by
electronic
means
and
shall
encourage
a
facility
to
33
use
the
electronic
filing
option
when
that
option
is
feasible
34
for
the
facility.
35
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The
bill
provides
that
serious
reportable
events
under
the
1
bill
do
not
constitute
child
abuse
or
dependent
adult
abuse
and
2
are
excluded
from
the
child
abuse
and
dependent
adult
abuse
3
reporting
requirements,
if
the
facility
makes
a
determination
4
within
24
hours
of
discovery
of
the
serious
reportable
event
5
that
the
provisions
of
the
bill
apply
and
the
facility
files
6
the
reports
required
under
the
bill
in
a
timely
fashion.
7
A
facility
that
determines
a
serious
reportable
event
8
has
occurred
must
inform
persons
within
the
facility
who
are
9
mandatory
reporters
of
child
abuse
or
dependent
adult
abuse.
10
A
mandatory
reporter
otherwise
required
to
report
child
abuse
11
or
dependent
adult
abuse
is
relieved
of
the
duty
to
report
an
12
event
the
facility
determines
to
be
a
serious
reportable
event
13
under
the
bill.
The
bill
does
not
affect
the
protections
and
14
immunities
applicable
to
reporting
of
child
abuse
and
dependent
15
adult
abuse.
16
Additionally,
if
a
serious
reportable
event
is
reported
by
a
17
facility
in
compliance
with
the
bill,
no
other
state
agency
or
18
licensing
board
is
required
to
conduct
an
investigation
of
or
19
obtain
or
create
investigative
data
based
upon
other
reports
20
of
the
same
event.
Also,
if
a
facility
is
required
to
report
21
a
serious
reportable
event
pursuant
to
another
state
law
that
22
meets
the
requirements
for
compliance
with
the
bill,
DIAL
shall
23
recognize
the
report
as
compliance
with
the
bill
in
lieu
of
a
24
report
made
under
the
bill
if
DIAL
is
provided
a
copy
of
the
25
report.
26
Reports
of
serious
reportable
events
made
to
the
director
27
by
a
professional
licensing
board;
serious
reportable
event
28
reports,
findings
of
root
cause
analyses,
and
corrective
action
29
plans
filed
by
a
facility
under
the
bill;
and
records
created
30
or
obtained
by
the
director
in
reviewing
or
investigating
the
31
reports,
findings,
and
corrective
action
plans
are
confidential
32
records
under
Code
section
22.7.
33
The
director
shall
establish
a
serious
reportable
event
34
reporting
system
requiring
and
consisting
of
mandatory
35
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5296YH
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reporting
by
facilities
of
the
serious
reportable
events
1
described
in
the
bill;
mandatory
completion
of
a
root
cause
2
analysis
and
a
corrective
action
plan
by
the
facility,
and
3
the
reporting
of
the
findings
of
the
analysis
and
the
plan
4
to
the
director
or
the
reporting
of
reasons
for
not
taking
5
corrective
action;
analysis
of
reported
information
by
the
6
director
to
determine
patterns
of
systemic
failure
in
the
7
health
care
system
and
successful
methods
to
correct
these
8
failures;
sanctions
against
facilities
for
failure
to
comply
9
with
reporting
system
requirements;
and
communication
from
the
10
director
to
facilities,
health
care
consumers,
and
the
public
11
to
maximize
the
use
of
the
reporting
system
to
improve
health
12
care
quality.
13
The
director
shall
analyze
serious
reportable
event
14
reports,
corrective
action
plans,
and
findings
of
the
root
15
cause
analyses
to
determine
patterns
of
systemic
failure
in
16
the
health
care
system
and
successful
methods
to
correct
17
these
failures;
communicate
to
facilities
the
director’s
18
conclusions
regarding
a
serious
reportable
event
reported
by
19
a
facility;
communicate
with
relevant
health
care
facilities
20
any
recommendations
for
corrective
action
resulting
from
the
21
director’s
analysis
of
submissions
from
facilities;
and
publish
22
an
annual
report.
The
director
shall
take
steps
necessary
to
23
determine
if
serious
reportable
event
reports,
the
findings
24
of
the
root
cause
analyses,
and
corrective
action
plans
are
25
filed
in
a
timely
manner.
The
director
may
sanction
a
facility
26
for
failure
to
file
a
timely
serious
reportable
event
report,
27
conduct
a
root
cause
analysis,
implement
a
corrective
action
28
plan,
or
provide
the
findings
of
a
root
cause
analysis
or
29
corrective
action
plan
in
a
timely
fashion;
or
place
conditions
30
on
the
license
under
which
a
facility
operates
if
the
facility
31
fails
to
develop
and
implement
a
corrective
action
plan
or
32
report
to
the
director
the
reason
a
corrective
action
is
not
33
needed.
34
The
director
may
collaborate
with
the
department
of
health
35
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5296YH
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and
human
services
to
administer
the
director’s
duties
and
1
responsibilities.
2
The
bill
requires
the
boards
of
medicine,
physician
3
assistants,
nursing,
pharmacy,
and
podiatry
to
maintain
4
a
record
of
complaints
that
come
to
the
attention
of
the
5
respective
board,
that
in
the
judgment
of
the
board
qualify
as
6
serious
reportable
events.
Within
30
working
days
of
making
a
7
determination
that
an
event
qualifies
as
a
serious
reportable
8
event,
the
respective
board
shall
forward
a
report
of
the
9
event
to
the
director,
including
the
name
and
address
of
the
10
facility
involved,
the
date
of
the
event,
and
information
11
known
to
the
board
regarding
the
event.
The
report
shall
12
not
include
any
identifying
information
of
any
health
care
13
professional,
facility
employee,
or
patients
involved.
The
14
director
shall
then
forward
the
report
to
the
facility
named
in
15
the
report
and
the
facility
shall
determine
whether
the
event
16
has
been
previously
reported
and
shall
notify
the
director
as
17
to
whether
the
event
has
been
previously
reported.
If
the
18
event
has
not
been
previously
reported,
the
facility
shall
make
19
a
determination
whether
the
event
is
reportable
and
if
it
is
20
reportable,
the
date
of
discovery
of
the
event,
depending
on
21
the
circumstances,
is
either
the
date
of
discovery
or
the
date
22
the
facility
receives
the
report
from
the
director.
If
the
23
facility
determines
that
the
event
is
not
reportable
under
this
24
Code
chapter,
the
facility
shall
notify
the
director
of
that
25
determination.
26
The
bill
requires
the
director
to
report
the
list
of
serious
27
reportable
events
under
the
bill
to
the
national
quality
forum
28
and
through
the
national
quality
forum
to
other
states.
The
29
director
shall
monitor
amendments
to
the
national
quality
30
forum’s
list
of
serious
reportable
events
and
report
any
31
modification
to
the
list
to
the
general
assembly.
The
director
32
shall
also
monitor
efforts
in
other
states
to
establish
a
list
33
of
serious
reportable
events
and
shall
make
recommendations
to
34
the
general
assembly,
as
necessary,
for
modifications
to
the
35
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5296YH
(1)
90
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14/
15
