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Senate
File
581
-
Introduced
SENATE
FILE
581
BY
COMMITTEE
ON
HEALTH
AND
HUMAN
SERVICES
(SUCCESSOR
TO
SF
48)
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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1455SV
(2)
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lh/ko
S.F.
581
Section
1.
NEW
SECTION
.
135S.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
“Department”
means
the
department
of
inspections,
4
appeals,
and
licensing.
5
2.
“Director”
means
the
director
of
inspections,
appeals,
6
and
licensing,
or
the
director’s
designee.
7
3.
“Facility”
means
a
hospital
as
defined
in
section
135B.1,
8
an
ambulatory
surgical
center
as
defined
in
section
135R.1,
or
9
a
birth
center
as
defined
in
section
10A.711.
10
4.
“Health
care
professional”
means
an
individual
licensed
11
under
chapter
148
to
practice
medicine
and
surgery
or
12
osteopathic
medicine
and
surgery,
a
physician
assistant
13
licensed
under
chapter
148C,
a
podiatrist
licensed
under
14
chapter
149,
an
advanced
registered
nurse
practitioner
licensed
15
under
chapter
152,
an
advanced
practice
registered
nurse
under
16
chapter
152E,
or
a
pharmacist
licensed
under
chapter
155A.
17
5.
“Serious
injury”
means
any
of
the
following:
18
a.
A
physical
or
mental
impairment
that
substantially
limits
19
one
or
more
of
the
major
life
activities
of
an
individual
or
a
20
loss
of
bodily
function,
if
the
impairment
or
loss
lasts
more
21
than
seven
days
or
is
still
present
at
the
time
of
discharge
22
from
an
inpatient
health
care
facility.
23
b.
The
loss
of
a
body
part.
24
6.
“Serious
reportable
event”
or
“event”
means
an
event
on
25
the
list
of
serious
reportable
events
endorsed
by
the
national
26
quality
forum.
27
7.
“Surgery
or
other
invasive
procedure”
includes
the
28
treatment
of
disease,
injury,
or
deformity
by
manual
or
29
operative
methods,
including
invasive
testing.
30
Sec.
2.
NEW
SECTION
.
135S.2
Facility
reporting
31
requirements.
32
1.
Each
facility
shall
report
to
the
director
the
occurrence
33
of
a
serious
reportable
event
as
soon
as
is
reasonably
and
34
practicably
possible,
but
no
later
than
fifteen
working
days
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after
discovery
of
the
event.
1
2.
The
report
shall
be
filed
in
a
format
specified
by
2
the
director
and
shall
identify
the
facility
but
shall
not
3
include
any
identifying
information
for
any
of
the
health
care
4
professionals,
facility
employees,
or
patients
involved.
5
3.
The
director
may
consult
with
experts
and
organizations
6
familiar
with
patient
safety
when
developing
the
format
for
7
reporting
and
in
further
defining
serious
reportable
events
in
8
order
to
be
consistent
with
industry
standards.
9
Sec.
3.
NEW
SECTION
.
135S.3
Root
cause
analysis
and
10
corrective
action
plan.
11
1.
Following
the
occurrence
of
a
serious
reportable
event,
a
12
facility
shall
conduct
a
root
cause
analysis
of
the
event.
13
2.
Following
the
analysis,
the
facility
shall
do
one
of
the
14
following:
15
a.
Implement
a
corrective
action
plan
to
address
the
16
findings
of
the
analysis.
17
b.
Report
to
the
director
any
reasons
for
not
taking
18
corrective
action.
19
3.
If
the
root
cause
analysis
and
the
implementation
of
a
20
corrective
action
plan
are
already
completed
at
the
time
an
21
event
is
required
to
be
reported,
the
findings
of
the
analysis
22
and
the
corrective
action
plan
shall
be
included
in
the
report
23
of
the
event.
24
4.
If
the
root
cause
analysis
is
completed,
but
25
implementation
of
a
corrective
action
plan
is
not
completed
at
26
the
time
an
event
is
required
to
be
reported,
the
findings
of
27
the
root
cause
analysis
and
a
copy
of
the
proposed
corrective
28
action
plan
shall
be
filed
with
the
director
within
sixty
29
working
days
of
the
event.
30
Sec.
4.
NEW
SECTION
.
135S.4
Electronic
reporting.
31
1.
The
director
shall
design
the
serious
reportable
event
32
reporting
system
to
allow
a
facility
to
file
the
reports
33
required
under
this
chapter
by
electronic
means.
34
2.
The
director
shall
encourage
a
facility
to
use
the
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electronic
filing
option
when
that
option
is
feasible
for
the
1
facility.
2
Sec.
5.
NEW
SECTION
.
135S.5
Relation
to
other
law
and
3
duties
——
confidentiality
of
data.
4
1.
Upon
the
occurrence
of
a
serious
reportable
event,
5
if
prior
to
or
during
a
root
cause
analysis
of
the
serious
6
reportable
event
a
facility
determines
the
serious
reportable
7
event
may
constitute
child
abuse
or
dependent
adult
abuse,
8
the
facility
shall
inform
persons
within
the
facility
who
are
9
mandatory
reporters
of
child
abuse
under
section
232.69
or
10
dependent
adult
abuse
under
section
235B.3.
11
2.
a.
If
a
serious
reportable
event
is
reported
by
a
12
facility
in
compliance
with
this
chapter,
no
other
state
agency
13
or
licensing
board
is
required
to
conduct
an
investigation
14
of
or
obtain
or
create
investigative
data
based
upon
other
15
reports
of
the
same
event.
This
paragraph
does
not
preclude
16
the
department
from
requiring
additional
reports
as
deemed
17
necessary
by
the
department.
18
b.
If
a
facility
is
required
to
report
a
serious
reportable
19
event
pursuant
to
another
state
law
that
meets
the
requirements
20
for
compliance
with
this
chapter,
the
department
shall
21
recognize
the
report
as
compliance
with
this
chapter
in
lieu
of
22
a
report
made
under
this
chapter
if
the
department
is
provided
23
a
copy
of
the
report.
24
3.
a.
Data
contained
in
the
following
records
are
25
confidential
records
under
section
22.7:
26
(1)
Reports
of
serious
reportable
events
made
to
the
27
director
by
a
professional
licensing
board.
28
(2)
Serious
reportable
event
reports,
findings
of
root
29
cause
analyses,
and
corrective
action
plans
filed
by
a
facility
30
under
this
chapter.
31
(3)
Records
created
or
obtained
by
the
director
in
reviewing
32
or
investigating
the
reports,
findings,
and
corrective
action
33
plans
under
subparagraph
(2).
34
b.
For
purposes
of
this
subsection,
the
reporting
facility
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is
the
subject
of
the
report
or
data
under
chapter
22.
1
Sec.
6.
NEW
SECTION
.
135S.6
Director
duties
and
2
responsibilities
——
penalties.
3
1.
The
director
shall
establish
a
serious
reportable
event
4
reporting
system
designed
to
facilitate
quality
improvement
5
in
the
health
care
system.
The
reporting
system
shall
not
6
be
designed
to
punish
errors
by
health
care
professionals
or
7
facility
employees.
8
2.
The
reporting
system
shall
require
and
consist
of
all
of
9
the
following:
10
a.
Mandatory
reporting
by
facilities
of
serious
reportable
11
events.
12
b.
Mandatory
completion
of
a
root
cause
analysis
and
a
13
corrective
action
plan
by
the
facility,
and
the
reporting
of
14
the
findings
of
the
analysis
and
the
plan
to
the
director,
or
15
the
reporting
of
reasons
for
not
taking
corrective
action.
16
c.
Analysis
of
reported
information
by
the
director
to
17
determine
patterns
of
systemic
failure
in
the
health
care
18
system
and
successful
methods
to
correct
the
failures.
19
d.
Sanctions
against
facilities
for
failure
to
comply
with
20
reporting
system
requirements.
21
e.
Communication
from
the
director
to
facilities,
health
22
care
consumers,
and
the
public
to
maximize
the
use
of
the
23
reporting
system
to
improve
health
care
quality.
24
3.
In
establishing
the
serious
reportable
event
reporting
25
system,
the
director
shall
not
select
from
or
between
alternate
26
acceptable
medical
practices.
27
4.
The
director
shall
do
all
of
the
following:
28
a.
Analyze
serious
reportable
event
reports,
corrective
29
action
plans,
and
findings
of
the
root
cause
analyses
to
30
determine
patterns
of
systemic
failure
in
the
health
care
31
system
and
successful
methods
to
correct
these
failures.
32
b.
Communicate
to
individual
facilities
the
director’s
33
conclusions,
if
any,
regarding
a
serious
reportable
event
34
reported
by
a
facility.
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c.
Communicate
with
relevant
health
care
facilities
any
1
recommendations
for
corrective
action
resulting
from
the
2
director’s
analysis
of
submissions
from
facilities.
3
d.
Publish
an
annual
report,
available
on
the
internet
site
4
of
the
department
that
does
all
of
the
following:
5
(1)
Describes,
by
facility
type,
serious
reportable
events
6
reported
by
facilities.
7
(2)
Outlines,
in
aggregate,
the
findings
of
root
cause
8
analyses
and
corrective
action
plans.
9
(3)
Makes
recommendations
for
modifications
of
state
health
10
care
operations.
11
5.
a.
The
director
shall
take
steps
necessary
to
determine
12
if
required
serious
reportable
event
reports,
the
findings
of
13
the
root
cause
analyses,
and
corrective
action
plans
are
filed
14
in
a
timely
manner.
15
b.
The
director
may
do
any
of
the
following:
16
(1)
Sanction
a
facility
for
failure
to
file
a
timely
17
serious
reportable
event
report,
conduct
a
root
cause
analysis,
18
implement
a
corrective
action
plan,
or
provide
the
findings
of
19
a
root
cause
analysis
or
corrective
action
plan
in
a
timely
20
fashion.
21
(2)
Place
conditions
on
the
license
under
which
a
facility
22
operates
if
the
facility
fails
to
develop
and
implement
a
23
corrective
action
plan,
or
report
to
the
director
the
reason
a
24
corrective
action
is
not
needed.
25
6.
The
director
may
collaborate
with
the
department
of
26
health
and
human
services
to
administer
this
section.
27
Sec.
7.
NEW
SECTION
.
135S.7
Reports
from
licensing
boards.
28
1.
The
board
of
medicine,
the
board
of
physician
assistants,
29
the
board
of
nursing,
the
board
of
pharmacy,
and
the
board
of
30
podiatry
shall
maintain
a
record
of
all
complaints
that
come
31
to
the
attention
of
the
respective
board
that
in
the
judgment
32
of
the
board
qualify
as
a
serious
reportable
event.
Within
33
thirty
working
days
of
making
a
determination
that
an
event
34
qualifies
as
a
serious
reportable
event,
the
respective
board
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shall
forward
a
report
of
the
event
to
the
director,
including
1
the
name
and
address
of
the
facility
involved,
the
date
of
the
2
event,
and
information
known
to
the
board
regarding
the
event.
3
The
report
shall
not
include
any
identifying
information
of
4
any
health
care
professional,
facility
employee,
or
patients
5
involved.
6
2.
The
director
shall
forward
a
report
received
under
7
subsection
1
to
the
facility
named
in
the
report.
8
3.
a.
The
facility
shall
determine
whether
the
event
9
has
been
previously
reported
under
this
chapter,
and
shall
10
notify
the
director
as
to
whether
the
event
has
been
previously
11
reported.
12
b.
If
the
event
has
not
been
previously
reported,
the
13
facility
shall
make
a
determination
whether
the
event
is
14
reportable
under
this
chapter.
If
the
facility
determines
the
15
event
is
reportable,
the
date
of
discovery
of
the
event
for
16
purposes
of
this
chapter
shall
be
as
follows:
17
(1)
If
the
director
determines
the
facility
knew
or
18
reasonably
should
have
known
about
the
occurrence
of
the
event,
19
the
date
the
event
occurred
shall
be
the
date
of
discovery
20
of
the
event
and
the
facility
shall
be
considered
out
of
21
compliance
with
this
chapter.
22
(2)
If
the
director
determines
the
facility
did
not
know
23
about
the
occurrence
of
the
event,
the
date
the
facility
24
receives
the
report
from
the
director
shall
be
the
date
of
25
discovery
of
the
event.
26
c.
If
the
facility
determines
the
event
was
not
reportable
27
under
this
chapter,
the
facility
shall
notify
the
director
of
28
that
determination.
29
EXPLANATION
30
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
31
the
explanation’s
substance
by
the
members
of
the
general
assembly.
32
This
bill
relates
to
the
reporting
of
serious
reportable
33
events
by
facilities
including
hospitals,
ambulatory
surgical
34
centers,
and
birth
centers.
35
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The
bill
requires
each
facility
to
report
to
the
director
1
(director)
of
the
department
of
inspections,
appeals,
and
2
licensing
(DIAL)
the
occurrence
of
a
serious
reportable
3
event
as
soon
as
is
reasonably
and
practicably
possible,
4
but
no
later
than
15
working
days
after
discovery
of
the
5
event.
Reports
shall
be
filed
in
a
format
specified
by
the
6
director
of
DIAL
and
shall
identify
the
facility
but
shall
not
7
include
any
identifying
information
for
any
of
the
health
care
8
professionals,
facility
employees,
or
patients
involved.
9
The
bill
requires
that
following
the
occurrence
of
a
serious
10
reportable
event,
a
facility
shall
conduct
a
root
cause
11
analysis
of
the
event
and
shall
either
implement
a
corrective
12
action
plan
or
report
to
the
director
any
reasons
for
not
13
taking
corrective
action.
14
The
director
shall
design
the
serious
reportable
event
15
reporting
system
to
allow
a
facility
to
file
the
required
16
reports
by
electronic
means
and
shall
encourage
a
facility
to
17
use
the
electronic
filing
option
when
that
option
is
feasible
18
for
the
facility.
19
Upon
the
occurrence
of
a
serious
reportable
event,
if
prior
20
to
or
during
a
root
cause
analysis
the
facility
determines
21
the
serious
reportable
event
may
constitute
child
abuse
or
22
dependent
adult
abuse,
the
facility
shall
inform
persons
within
23
the
facility
who
are
mandatory
reporters
of
child
abuse
and
24
dependent
adult
abuse.
25
Additionally,
if
a
serious
reportable
event
is
reported
26
by
a
facility,
no
other
state
agency
or
licensing
board
is
27
required
to
conduct
an
investigation
of
or
obtain
or
create
28
investigative
data
based
upon
other
reports
of
the
same
event.
29
DIAL
is
not
precluded
from
requiring
additional
reports
as
30
deemed
necessary
by
DIAL.
If
a
facility
is
required
to
report
31
a
serious
reportable
event
pursuant
to
another
state
law
that
32
meets
the
requirements
for
compliance
with
the
bill,
DIAL
shall
33
recognize
the
report
in
lieu
of
a
report
made
under
the
bill
if
34
DIAL
is
provided
a
copy
of
the
report.
35
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Reports
of
serious
reportable
events
made
to
the
director
1
by
a
professional
licensing
board;
serious
reportable
event
2
reports,
findings
of
root
cause
analyses,
and
corrective
action
3
plans
filed
by
a
facility
under
the
bill;
and
records
created
4
or
obtained
by
the
director
in
reviewing
or
investigating
the
5
reports,
findings,
and
corrective
action
plans
are
confidential
6
records
under
Code
section
22.7.
7
The
director
shall
establish
a
serious
reportable
event
8
reporting
system
requiring
certain
information
as
detailed
in
9
the
bill.
10
The
director
shall
take
action
relating
to
serious
11
reportable
events
as
described
in
the
bill.
12
The
director
may
collaborate
with
the
department
of
health
13
and
human
services
to
administer
the
director’s
duties
and
14
responsibilities.
15
The
bill
requires
the
boards
of
medicine,
physician
16
assistants,
nursing,
pharmacy,
and
podiatry
to
maintain
17
a
record
of
complaints
that
come
to
the
attention
of
the
18
respective
board
and
are
determined
to
qualify
as
serious
19
reportable
events.
Within
30
working
days
of
making
a
20
determination
that
an
event
qualifies
as
a
serious
reportable
21
event,
the
respective
board
shall
forward
a
report
of
the
event
22
to
the
director.
The
director
shall
then
forward
the
report
23
to
the
facility
named
in
the
report
and
the
facility
shall
24
determine
whether
the
event
has
been
previously
reported
and
25
shall
notify
the
director
as
detailed
in
the
bill.
26
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