Hospital Internal Risk Management Survey Worksheets
Name of Facility
Date of Survey
Address
City
Licensed Risk Manager
State
License Number
Zip
Date of Appointment as Risk Manager
Risk Manager Designee
Date of Appointment as Designee
Administrator/CEO’s Name & Title
Date of Appointment
59A -10.002 F.A.C. (14) “Risk management” means the identification, investigation, analysis, and evaluation of risks and the selection of the most
advantageous method of correcting, reducing or eliminating identifiable risks.
HOSPITAL
Licensed Beds:
Acute:
Psych:
Number of Operating Rooms:
SNU:
Program
H0401
Every licensed facility shall, as a
part of its administrative functions,
establish an internal risk
S. 395.0197 (1), F.S.
R.59A-10.002(15),
F.A.C.
R.59A-10.002 (2),
F.A.C.
R.59A-10.002 (3),
F.A.C.
AHCA FORM 3020- 0031
Yes
Tag Number
Legal Authority
Program Requirements
Such program shall include:
Total:
Average Daily Census:
Does the hospital operate outpatient surgical center under its license?
management program.
Child/Adol. Psych:
, June 2010
No
Interpretive Guidelines
Met
Not
Met
Licensed Hospital and Ambulatory
Surgical Centers are required to have
an Internal Risk Management
Program.
PROBE
- Review the Risk Management
Program/Plan to determine
compliance
HQA Bureau of Field Operations
Page 1
R.59A-10.002(14),
F.A.C.
- Interview the Licensed Health Care
Risk Manager responsible for the
program.
Comments:
- Review personnel file of the Risk
Manager for appropriate licensure(&
any Risk Manager designees)
Program Requirements
The internal risk
management
program shall include:
(a) The investigation and analysis
of the
frequency and causes of general
categories and specific types of
adverse incidents to patients.
Tag Number
Legal Authority
H0402
S. 395.0197(1)(a), F.S.
S. 395.0197(5), F.S.
Interpretive Guidelines
The Risk Management Program must
establish the general categories and
specific types of incidents. Further,
the program must contain the
investigative process and analysis of
the incidents.
Met
Not
Met
Comments:
Does the plan establish the incident
categories?
- Are the incidents specific to this
facility?
- Review 5 Monthly Logs and 4
Quarterly Summary Reports
The internal risk
management
program shall include:
(b) The development of
appropriate measures to minimize
the risk of adverse incidents to
patients.
H0403
GUIDANCE TO SURVEYORS
S. 395.0197(1)(b), F.S.
1. Review the Risk Manager's role in
the development and implementation
of risk reduction and risk prevention
strategies.
S. 395.0197(5), F.S.
Comments:
2. Consider evidence that patient and
non-patient department staff have
involvement in the process.
3. Review previous incidents
identified as risk/process
improvement opportunities including
the analysis of the incident and
trends.
PROBES
- Review identified incident trends
- Review measures put in place to
correct
- Verify correction measures are
systematic and facility-wide.
AHCA FORM 3020 - 0031, June 2010
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Page 2
- Has the facility minimized the risk to
other patients?
- Validate implementation of
measures in departments or units of
facility.
The development of appropriate
measures shall include:
1. Risk management and
H0404
S. 395.0197(1)(b)1, F.S.
risk prevention education
and training of all nonphysician personnel as
follows:
a. Such education and training of
all non-physician personnel as part
of their initial orientation; and
b. At least 1 hour of such
education and training annually for
all personnel of the licensed facility
working in clinical areas and
providing patient care, except
those persons licensed as health
care practitioners who are required
to complete continuing education
coursework pursuant to chapter
456 or the respective practice act.
GUIDANCE TO SURVEYORS
Review orientation program(s) for
documentation that the incident
reporting system and adverse incident
reporting (Code 15 and Annual
Incident Reporting) is included.
Comments:
Select a sample of new employees, 5
new and 5 existing employees, and
Agency (contract) personnel for
evidence of training at orientation and
annual review.
Interview 5 employees in regard to
their education and training.
(Example: RN's, CNA's, PT's, RT's,
etc.)
PROBES
- Review 5 new and 5 existing clinical
staff for education and training as
required.
- Interview 5 clinical staff to ascertain
the knowledge of how to report an
incident.
How do you report an incident?
Program Requirements
The development of appropriate
Tag Number
Legal Authority
Interpretive Guidelines
H0404
Are all incidents reported the same
way (fall, elopement, allegation of
abuse, rape)?
H0405
GUIDANCE TO SURVEYORS
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Met
Not
Met
Page 3
measures shall include:
S. 395.0197(1)(b)2, F.S.
2. A prohibition, except when
emergency circumstances require
otherwise, against a staff member
of the licensed facility attending a
patient in the recovery room,
unless the staff member is
authorized to attend the patient in
the recovery room and is in the
company of at least one other
person. However, a licensed
facility is exempt from the twoperson requirement if it has:
a. Live visual observation;
b. Electronic observation; or
c. Any other reasonable measure
taken to ensure patient protection
and privacy.
Review facility Policy and Procedures
for prohibitions against staff members
attending patients in the recovery
room alone.
Comments:
Review the facility policy, i.e. either
each authorized staff person in the
recovery room is accompanied by at
least one other person or the recovery
room has live visual observation; or
electronic observation; or any other
reasonable measure taken to ensure
patient protection and privacy.
PROBES
1. Request the schedule of recovery
room personnel for all shifts.
2. Review the Policy and Procedures
regarding the two-person
requirement.
3. Tour the recovery room, preferably
in the afternoon.
4. Interview staff regarding recovery
room procedures and staffing
patterns.
5. How does the facility handle live
visual observation, electronic
observation, or any other reasonable
measure to ensure patient protection
and privacy?
6. What type of electronic observation
is used?
7. Who monitors the camera when
patients are present in the recovery
room?
8. What type of documentation is
maintained by the facility?
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 4
The development of appropriate
measures shall include:
H0406
PROBES
S. 395.0197(1)(b)3, F.S.
Does the facility prohibit unlicensed
person from assisting or participating
in a surgical procedure, unless
complete and direct physician
supervision.
Comments:
3. A prohibition against an
unlicensed person from assisting
or participating in any surgical
procedure unless the facility has
authorized the person to do so
following a competency
assessment, and such assistance
or participation is done under the
direct and immediate supervision
of a licensed physician and is not
otherwise an activity that may only
be performed by a licensed health
care practitioner.
Program Requirements
The development of appropriate
Interview surgical staff to ascertain if
unlicensed staff participate/assisting
in surgical procedures - provisions.
Review surgical schedule or records
utilized to record other unlicensed
staff surgical participation.
Review competencies for Private or
Contractual Scrub individuals.
Tag Number
Legal Authority
H0407
AHCA FORM 3020 - 0031, June 2010
Interpretive Guidelines
Met
Not Met
GUIDANCE TO SURVEYORS
HQA Bureau of Field Operations
Page 5
measures shall include:
4. Development, implementation,
and
ongoing evaluation of procedures,
protocols, and systems to
accurately identify patients,
planned procedures, and the
correct site of the planned
procedure so as to minimize the
performance of a surgical
procedure on the wrong patient, a
wrong surgical procedure, a
wrong-site surgical procedure, or a
surgical procedure otherwise
unrelated to the patient's diagnosis
or medical condition.
S. 395.0197(1)(b)4, F.S.
Does the facility have an established
procedure/protocol to prevent wrong
site, wrong procedure, and wrong
patient surgery?
Comments:
How does the facility identify the
correct patient and the correct site for
procedures?
How is the surgical site identified?
How does the facility identify and
confirm the correct procedure(s)?
Does the facility involve the patient
and his/her family members in
identifying the patient, correct site,
and correct procedure? If so, what
systems does the facility have in
place for appropriate communication
techniques for any identified language
or communication barriers?
Does facility staff have a method to
verify that the identification process
contains correct information?
Are protocols and procedures to
prevent wrong
site, wrong procedure, and wrong
patient incidents used facility-wide?
How is education and training of staff
(including physicians) regarding the
facility's procedures and protocols
accomplished? Review
documentation.
How does the facility monitor
compliance with the protocols for
quality control purposes?
PROBES
- Review systems which prevent or
minimize wrong patient, wrong
surgical procedure, wrong site, or a
surgical procedure unrelated.
- If an incident, breaches protocols how is it reviewed to minimize risk to
other patients.
The internal risk management program shall
H0408
AHCA FORM 3020 - 0031, June 2010
GUIDANCE TO SURVEYORS
HQA Bureau of Field Operations
Page 6
include: (c) The analysis of
patient grievances that relate
to patient care and the quality of
medical services.
S. 395.0197(1)(c), F.S.
R. 59A-10.002(10),
F.A.C.
1. Determine if the facility has a
patient satisfaction patient grievance
and a system to analyze the quality of
medical services.
Review form(s):
Comments:
2. Select a sample of patient
grievances/patient satisfaction
responses related to patient care and
the quality of medical services. Trace
the process.
3. Review Policy and Procedures
establishing the process that refers
issues related to quality of care to the
Risk Manager, Quality
Assurance/Performance Improvement
and the facility representative.
4. Review evidence that issues
related to quality of care/medical care
are analyzed including outcomes.
Program Requirements
Tag Number
Legal Authority
H0408
Interpretive Guidelines
Met
Not Met
PROBES
- Is the Risk Manager involved in the
analysis of grievances and quality of
medical services improvement?
- Is there evidence of grievance
analysis in the samples grievances?
- Were corrective measures placed
into facility-wide systems?
The internal risk management
program shall include:
H0409
(d) A system for informing a patient
or an individual identified pursuant
to Section 765.401(1), F.S., that
the patient was the subject of an
adverse incident. Such notice
shall be given by an appropriately
trained person designated by the
licensed facility as soon as
practicable to allow the patient an
opportunity to minimize damage or
injury.
S. 765.401(1), F.S.
S. 395.0197(1)(d), F.S.
S. 395.0197(5), F.S.
GUIDANCE TO SURVEYORS
Review the Policy and Procedures
developed to enable patient
notification (or the patient's healthcare
surrogate) of all adverse incidents.
Comments:
Refer to definition of adverse incident,
s. 395.0197 (5), F.S.
Review all Code 15's and Annual
Report incidents to determine whether
the patient and/or healthcare
surrogate was informed of the
incident.
Verify documentation that the patient
was notified following the adverse
incident.
Interview patient(s) involved in
adverse incident if the patient is
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 7
accessible.
PROBES
Did facility develop and implement a
system for patient notification?
Does facility staff evaluate the system
for informing patients that they have
been the subject of an adverse
incident?
The internal risk management
program shall include:
(e) The development and
implementation of an incident
reporting system based upon
the affirmative duty of all health
care providers and all agents and
employees of the licensed health
care facility to report adverse
incidents to the risk manager, or to
his or her designee, within 3
business days after their
occurrence.
H0410
GUIDANCE TO SURVEYORS
S. 395.0197(1)(e), F.S.
Review the Policy and Procedures for
incident reporting.
R. 59A-10.002(8),
F.A.C.
R. 59A-10.002(9),
F.A.C.
S. 395.0197(5), F.S.
R. 59A-10.002(21),
F.A.C.
Comments:
Interview a sample of staff to
determine their awareness of the
responsibilities, requirements, and
method for incident reporting. – Done
already under H404!!!!
Review a sample of personnel files for
education and training on incident
reporting – Done already under
H404!!!!!.
- Review a minimum sample of
Incident Reports (review period since
the last risk manager survey)
o Hospitals – 30
Review a sample of
Incident/Occurrence Reports for
determining that incidents are
reported within three (3) business
days to the Risk Manager or to the
Risk Manager Designee.
Interview a sample of staff to
determine the facility's method for
reporting within 3 business days.
If there is a Risk Manager Designee,
verify evidence of appointment.
PROBES
What are the guidelines for reporting
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 8
incidents?
Program Requirements
Tag Number
Legal Authority
H0410
Interpretive Guidelines
Met
Not Met
Does staff understand who reports,
what is reported, when and where to
report, how to report, and why to
report?
Can facility staff provide and account
for dissemination of information on
the incident reporting system to all
health care providers, agents and
employees?
Did all new non-physician personnel
receive, within 30 days of
employment, instruction about the
operation of and the responsibilities of
the incident reporting system?
Procedures shall be detailed in
writing and disseminated to all
employees of the facility. All new
employees, within 30 days of
employment, shall be
instructed about the
operation of the incident
reporting system and
H0411
R. 59A-10.0055(2),
F.A.C.
R. 59A-10.002(8),
F.A.C.
responsibilities of it. At least
annually, all non-physician
personnel of the facility working in
AHCA FORM 3020 - 0031, June 2010
GUIDANCE TO SURVEYORS:
Interview the Risk Manager and
determine what the facility considers
annual? Is it calendar year or date of
hire year?
Request a list of non-physician
personnel with their hire dates.
Include private/contract surgical scrub
personnel.
HQA Bureau of Field Operations
Page 9
clinical areas and providing patient
care shall receive 1 hour risk
management and risk prevention
education and training, including
the importance of accurate and
timely incident reporting.
Interview a sample of newly hired and
experienced staff to determine their
awareness of the responsibilities,
requirements, and method for incident
reporting.
Comments:
Review a sample of personnel, both
newly hired and personnel who have
been employed over 2 years, files for
education and training on incident
reporting.
PROBES:
What are the guidelines for reporting
incidents?
Ask staff which incidents are
reportable, who is suppose to report
the incidents, how is it done, when
does it need to be done by, and
where does the report go once they
have completed it?
Did all non-physician personnel
receive, within
30 days of employment, instruction
about the
operation of and the responsibilities of
the incident reporting system?
When was the last annual, 1 hour
Risk Management and Risk
Prevention training conducted?
Whether or not a physician was
called: and if so, a brief statement
of said physician's
recommendations as to medical
treatment, if any;
H0412
(d) A listing of all persons then
known to be involved directly in the
incident, including witnesses, along
with locating information for each;
R. 59A-10.002(19),
F.A.C.
(c)
R. 59A-10.0055(2),
F.A.C.
R. 59A-10.002(18),
F.A.C.
R. 59A.-10.002(20),
F.A.C.
(e) The name, signature and
position of the person completing
the reports, along with date and
time that the report was completed.
GUIDANCE TO SURVEYORS
Review a sample of
incident/occurrence reports filed since
the date of the previous survey.
Comments:
- Review a minimum sample of
Incident Reports (review period since
the last risk manager survey)
o Hospitals – 30
Select a sample of
incident/occurrence reports to
determine compliance with the
incident form requirements.
The sample size is based on the
issues identified.
PROBES
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 10
What are the types of incident reports
used in the facility?
Program Requirements
Tag Number
Legal Authority
Interpretive Guidelines
Met
Not Met
H0412
Does the incident/occurrence report
form contain the required information?
(2) The internal risk management
program is the responsibility of the
governing board of the health care
facility.
H0413
Each licensed facility shall hire a
risk manager, licensed under
Section 395.10974, F.S., who is
responsible for implementation and
oversight of such facility's internal
risk management program as
required by this section.
R. 59A-10.002(12)
S. 395.0197(2), F.S.
S. 395.1097(4), F.S.
R. 59A-10.002(15),
F.A.C.
R. 59A-10.002(2),
F.A.C.
R. 59A-10.002(3),
F.A.C.
A risk manager must not be made
responsible for more than four
internal risk management
programs in separate licensed
facilities, unless the facilities are
under one corporate ownership or
the risk management programs are
in rural hospitals.
GUIDANCE TO SURVEYORS:
Review the facility's organization
chart to see who the Risk Manger
reports to.
When was the Risk Manager
appointed? When was the Risk
Manager approved by the
Board/Governing Body?
Review reporting lines of authority
Verify that the Risk Manager is
currently licensed.
Interview the licensed Risk Manager
and verify the number of current
facilities for which the Risk Manager
currently has responsibility.
Review the Risk Manager's job
description for his/her responsibilities.
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 11
PROBES:
Comments:
Inquire with the Risk Manager and the
Hospital Administrator about the
amount of time that the Risk Manager
spends on-site at each facility for
which the Risk Manager is
responsible.
What is considered enough time in
the facility? Does the Risk Manager
only come to the facility for
administrative and clinical meetings?
Verify the participation in
administrative and clinical meetings,
by reviewing meeting minutes.
(4) The individual responsible for
the risk management program
shall have free access to all
medical records of the licensed
facility.
H0414
GUIDANCE TO SURVEYORS:
S. 395.0197(4), F.S.
Verify that the Risk Manager has
access to all medical records of the
facility by asking the Risk Manager
and the Administrator.
Comments:
Review the Risk Manager's job
description to ensure the Risk
Manager has access to all of the
medical records.
Review the Governing Body Minutes
and the facility's Policy and
Procedures.
(4) As a part of each internal risk
management program, the incident
reports shall be used to develop
categories of incidents which
identify problem areas. Once
identified, procedures shall be
adjusted to correct the problem
areas.
H0415
GUIDANCE TO SURVEYORS:
S. 395.0197(4), F.S.
R. 59A-10.002(7),
F.A.C.
Ask the Risk Manager how they have
determined what incidents to track
and trend? Are the issues being
tracked and trended, facility identified
concerns?
Comments:
Review all tracking and trending
reports for the period since the
previous survey.
How was the root cause of the
concern identified? What
investigation was done?
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 12
Review all pertinent documentation
for the
Program Requirements
Tag Number
Legal Authority
Interpretive Guidelines
verification that the Risk Manager's
recommendations were developed
and the corrective actions(s) were
implemented.
Met
Not Met
Comments:
How was the corrective action(s)
implemented? Staff educated on
corrective action?
How was the corrective action
measured to determine its
effectiveness? If it did not reduce
the number of occurrences, what new
corrective action(s) was
implemented? Training?
PROBES:
How is information shared with other
departments? How does the Risk
Manager know if problems exist in
other areas?
Ask floor staff if they have ever
submitted an incident report? If yes,
did they receive any feedback after
the incident report was reviewed?
What was the outcome of that
incident report?
Question floor staff regarding how
they were informed of the corrective
actions implemented after an incident.
H0416
AHCA FORM 3020 - 0031, June 2010
GUIDANCE TO SURVEYORS:
HQA Bureau of Field Operations
Page 13
(7) Any of the following adverse
incidents, whether occurring in the
licensed facility or arising from
health care prior to admission in
the licensed facility, shall be
reported by the facility to the
Agency for Health Care
Administration within 15 calendar
days after its occurrence:
S. 395.0197(7), F.S.
R. 59A-10.0065, F.A.C.
S. 395.0197(5), F.S.
Review the facility's Policy and
Procedures regarding reporting death,
brain or spinal damage, wrong
patient/wrong site/wrong surgical
procedure, unnecessary surgical
procedure, surgical repair of damage
resulting from surgical procedure, and
removal of unplanned foreign body
left after a surgical procedure.
Comments:
(a) The death of a patient
Request a list of any discharged
patient that was re-admitted into the
facility within days of being discharge.
(b) Brain or spinal damage to a
patient;
Review a few re-admitted patients’
records to determine if any were
admitted for the previous treatment or
surgical procedure.
(c) The performance of a surgical
procedure on the wrong patient;
(d) The performance of a wrongsite surgical procedure;
Request a list of patients who have
expired in the facility in the past year.
(e) The performance of a wrong
surgical procedure;
Review those deaths which resulted
in an autopsy being conducted. What
was the outcome?
(f) The performance of a surgical
procedure that is medically
unnecessary or otherwise
unrelated to the patient's diagnosis
or medical condition;
Did the Risk Manager file the Code 15
within 15 calendar days?
Review the consent form, signed by
the patient prior to surgery, was the
incident outcome listed as one of the
specific risk of the surgical procedure.
(g) The surgical repair of damage
resulting to a patient from a
planned surgical procedure, where
the damage is not a recognized
specific risk, as disclosed to the
patient and documented through
the informed-consent process; or
PROBES:
Interview the Risk Manager regarding
the facility's process for reporting
Code 15 events.
(h) The performance of procedures
to remove unplanned foreign
objects remaining from a surgical
procedure. The 15-day report shall
be made on AHCA Form 31405001-August 1993, Code 15
Report, which is incorporated by
reference and may be obtained
from the Agency for Health Care
Administration. The Agency may
require an additional final report.
Any reportable incidents pursuant
to this section
Program Requirements
that are submitted more than 15
calendar
days from occurrence by the
facility must be justified in writing
by the facility administrator
Is the Risk Manager following the
facility's Policy and Procedures when
a Code 15 reportable incident occurs?
Tag Number
Legal Authority
H0416
AHCA FORM 3020 - 0031, June 2010
Interpretive Guidelines
Met
Not Met
If it is determined, through interview
that the
Risk Manager was unable to submit
an adverse incident within 15
calendar days, did the Risk Manager
request an extension from AHCA?
Review the extension request.
HQA Bureau of Field Operations
Page 14
(9) The internal risk manager of
each licensed facility shall:
(a) Investigate every allegation of
sexual misconduct which is
made against a member of the
facility's personnel who has
direct patient contact, when the
allegation is that the sexual
misconduct occurred at the facility
or on the grounds of the facility.
H0417
GUIDANCE TO SURVEYORS:
S. 395.0197(9), F.S.
R. 59A-10.002(19),
F.A.C.
Review a list of incidents and chose
those relating to allegations of sexual
misconduct.
Comments:
Was the victim safe from further
sexual
misconduct during the investigation?
How?
What is the facility's Policy and
Procedures regarding the
investigation of an allegation of sexual
misconduct? Was the Policy and
Procedures followed?
(b) Report every allegation of
sexual misconduct to the
administrator of the licensed
facility.
(c) Notify the family or guardian of
the victim, if a minor, that an
allegation of sexual misconduct
has been made and that an
investigation is being conducted.
If the allegation was confirmed, what
corrective action was implemented?
(d) Report to the Department of
Health every allegation of sexual
misconduct, as defined in Chapter
456, F.S., and the respective
practice act, by a licensed health
care practitioner that involves a
patient.
Interview floor staff to see if they are
aware of the facility's Policy and
Procedures for an allegation of sexual
misconduct?
Were the police, DCF/APS, and the
Department of Health notified?
Review the accused and other
employees' personnel file to
determine if the facility conducted a
background screening, prior to the
employees working in the facility?
What education/training regarding
sexual misconduct and reporting an
allegation of sexual misconduct have
the employees received?
PROBES: Interview the facility's staff,
can they tell you what they would do if
someone accused an employee of
sexual misconduct? Does it meet the
facility's Policy and Procedures?
Review the facility's Policy and
Procedures regarding background
screening.
(10) Any witness who witnessed or who
H0418
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 15
possesses actual knowledge of the
act that is the basis of an allegation
of sexual abuse shall:
S. 395.0197(10), F.S.
S. 794.011(1)(h), F.S.
(a) Notify the local police; and
(b) Notify the hospital risk manager
and the administrator.
not include any act intended for a
valid medical purpose or any act
which may reasonably be
construed to be a normal care
giving action.
Comments:
Review a list of incidents and choose
some incidents regarding allegations
of sexual abuse.
Review the facility's Policy and
Procedures regarding the prevention
and investigation of sexual abuse.
For purposes of this subsection,
"sexual abuse" means acts of a
sexual nature committed for the
sexual gratification of anyone
upon, or in the presence of, a
vulnerable adult, without the
vulnerable adult's informed
consent, or a minor. "Sexual
abuse" includes, but is not limited
to, the acts defined in Section
794.011(1)(h), F.S., fondling,
exposure of a vulnerable adult's or
minor's sexual organs, or the use
of the vulnerable adult or minor to
solicit for or engage in prostitution
or sexual performance. "Sexual
abuse" does
Program Requirements
GUIDANCE TO SURVEYORS:
Was the alleged victim protected from
any further abuse during the facility's
investigation? How? If the allegation
was confirmed, what did the facility do
to rectify the situation which resulted
in the abuse? What preventive
measures have been taken to ensure
this situation does not recur?
What in-service/training was
conducted in order to educate all of
the facility's staff on the new
prevention method?
Were the police, DCF/APS,
Administrator, and/or the Health
Department notified?
Tag Number
Legal Authority
H0418
Interpretive Guidelines
Met
Review the accused and other facility
employee's file to determine if
background checks were conducted
prior to the employee working in the
facility?
Comments:
Not Met
What training have the facility's
employees received regarding
preventing and reporting abuse or
neglect?
PROBES:
Interview facility staff (LPN, RN, CNA,
Maintenance, Housekeeping) to
determine if
they know what to do if someone
reports sexual abuse to them. Is the
information provided by staff
incompliance with the facility's abuse
Policy and Procedures?
Did the investigation into allegation of
sexual abuse comply with the facility's
Policy and Procedures?
What was the outcome of the
investigation?
The risk manager shall be
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GUIDANCE TO SURVEYORS:
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Page 16
responsible for the regular and
systematic reviewing of all incident
reports, including 15-day incident
reports, for the purpose of
identifying trends or patterns as to
time, place or persons. Upon
emergence of any trend or pattern
in incident occurrence, the risk
manager shall develop
recommendations for corrective
actions and risk management
prevention education and training.
Summary data thus accumulated
shall be systematically
maintained for 3 years.
R. 59A-10.0055(3),
F.A.C.
R. 59A-10.002(7),
F.A.C.
Review all tracking and trending
reports for the period since the
previous survey.
Comments:
Review results to ascertain that the
Risk Manager has trended the
information to identify patterns and
any problem areas.
Discuss the guidelines used.
Review all pertinent documents for
verification that the Risk Manager's
recommendations were developed
and the corrective action(s)
implemented.
Discuss and review documentation as
to whether the corrective action(s)
was effective and if not was the plan
revised.
Verify that action has been taken to
reduce and prevent risks to patients.
Review in-service education
documents for programs pertinent to
risk management education and
training relating to the corrective
action(s).Verify that the past 3 years
of accumulated summary data has
been maintained and reviewed.
PROBES
Describe the manner by which the
Risk Manager ensures that staff from
individual departments/units identify
safety hazards and risk exposures in
clinical and facility-wide systems.
Does staff receive feedback regarding
incident reports that they completed?
Has an incident report that you filed
resulted in a change?
What type of system does the Risk
Manager utilize to track and trend
incidents?
Program Requirements
(a) At least quarterly, or more often
Tag Number
Legal Authority
Interpretive Guidelines
Met
Not Met
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AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 17
as may be required by the
governing body, the risk manager
shall provide a summary
R. 59A-10.0055(3)(a),
F.A.C.
report to the governing
body, which includes information
R. 59A-10.002(12),
F.A.C
about activities of risk
management as defined herein.
R. 59A-10.002(14),
F.A.C.
GUIDANCE TO SURVEYORS
Comments:
Review the Governing Body minutes
for risk management documentation.
Interview the Licensed Risk Manager
and staff re: methodology.
Who presents the risk management
summary report?
PROBES
Does the Governing Body act on the
quarterly reports?
(3) Each licensed facility shall
annually report to the
Agency for Health Care
Administration and the
H0421
S. 395.0197(3), F.S.
GUIDANCE TO SURVEYORS
Review documentation of reporting.
Comments:
S. 456.001(4), F.S.
PROBES
Department of Health the name
and judgments entered against
each health care practitioner for
which it assumes liability.
Does the facility have a report that
identifies and summarizes judgments,
not actions against practitioners?
Have these identified practitioners
been reported to the Department of
Health and Agency for Health Care
Administration?
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(6)(a) Each licensed facility subject
to this section shall submit an
annual report to the
Agency for Health Care
Administration
summarizing the incident
reports that have been
filed in the facility for that
year. The report shall include:
S. 395.0197(6)(a), (c),
F.S.
R. 59A-10.002(7),
F.A.C.
S. 395.0197(5), F.S.
S. 766.106(1)(a), F.S.
Review the Annual Report(s)
submitted to the Agency for Health
Care Administration for:
--Timeliness
--Verification the AHCA form is being
used.
--Number of incidents reported.
--Types of incidents.
--Number and types of claims.
Comments:
The Annual Report includes:
--Death;
--Brain or spinal damage;
--Permanent disfigurement;
--Fracture or dislocation of bones or
joints;
--A limitation of neurological, physical,
or sensory function which continues
after discharge from the facility;
--Any condition that required
specialized medical attention or
surgical intervention resulting from
non-emergency medical intervention
other than an emergency medical
condition, to which the patient has not
given his or her informed consent;
--Any condition that requires the
transfer of the patient within or
outside the facility to a unit providing
a more acute care level of care due to
the adverse incident, rather than the
patient's
condition prior to the adverse incident;
--Was the performance of a surgical
procedure on the wrong patient;
--A wrong surgical procedure;
--A wrong-site surgical procedure;
--A surgical procedure otherwise
unrelated to the patient's diagnosis or
medical condition;
--Required the surgical repair of
damage resulting to a patient from a
planned surgical procedure, where
the damage was not a recognized
specific risk, as disclosed to the
patient and documented through the
informed-consent process; or
--Was a procedure to remove
unplanned
1. The total number of adverse
incidents.
2. A listing, by category, of the
types of operations, diagnostic or
treatment procedures, or other
actions causing the injuries, and
the number of incidents occurring
within each category.
3. A listing, by category, of the
types of injuries caused and the
number of incidents occurring
within each category.
4. A code number using the health
care professional's licensure
number and a separate code
number identifying all other
individuals directly involved in
adverse incidents to patients, the
relationship of the individual to the
licensed facility, and the number of
incidents in which each individual
has been directly involved. Each
licensed facility shall maintain
names of the health
care professionals and individuals
identified by code numbers for
purposes of this section.
5. A description of all malpractice
claims filed against the licensed
facility, including the total number
of pending and closed claims and
the nature of the incident which led
to, the persons involved in, and the
status and disposition of each
claim. Each report shall update
status and disposition for all prior
reports.
(c) The annual report submitted to
the
Program Requirements
Agency shall also contain the
Tag Number
Legal Authority
Interpretive Guidelines
Met
Not Met
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name and
license number of the risk manager
of the licensed facility, a copy of its
policy and procedures which
govern the measures taken by the
facility and its risk manager to
reduce the risk of injuries and
adverse incidents, and the results
of such measures.
foreign objects remaining from a
surgical
procedure?
Comments:
Review a sample of malpractice
claims filed since the date of the last
survey.
Review a sample of disciplinary
actions and outcomes against
practitioners and the reporting of all
actions to Department of
Health/Medical Quality Assurance.
Review the facility's results of
outcome measures, QA/PI initiatives;
risk prevention and risk reduction
strategies for the year. (Reference s.
395.1097(6)(c), F.S.)
PROBES:
Remind the facility the surveyor has
access to any facility record
necessary to perform the Risk
Management Survey.
Is there a process in place for
determining reportable incidents?
How does it function?
Is there a system developed to report
the required adverse events to the
Agency?
Determine who has the final authority
for determination that an incident
meets the definition of an "adverse
incident" to be reported to the
Agency.
Have any discharged patients
required readmission for previous
treatment or surgical episodes?
Have any current patients required
additional surgery, and/or treatment
interventions as a result of an adverse
incident?
Any transfers to a higher level of
care?
Review the facility's annual reports for
compliance of reporting the following:
Total number of pending and closed
claims;
Claim number for each claim;
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
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Nature of incident;
License numbers of persons involved
in the claim and
Status or disposition of the claim.
(13) The Agency
for Health
Care Administration shall
have access to all licensed
facility records necessary
to carry out the provisions
of this section. Evidence of the
incidents reporting and analysis
system and copies of summary
reports, incident reports filed within
the facility, and evidence of
recommended and accomplished
corrective actions shall be made
available for review to any
authorized representative of the
H0423
GUIDANCE TO SURVEYORS
S. 395.0197(13),
F.S.
All facility records are to be made
available to surveyors upon request.
Comments:
R. 59A10.0055(3)(b),
F.A.C.
AHCA FORM 3020 - 0031, June 2010
HQA Bureau of Field Operations
Page 21
Agency upon request during
normal working hours.
Program Requirements
Tag Number
Legal Authority
Interpretive Guidelines
(19) It shall be unlawful for any
person over whom the facility
exercises control to coerce,
intimidate, or preclude a Risk
Manager from lawfully executing
his or her reporting obligations
pursuant to this chapter. Such
unlawful action shall be subject to
civil monetary penalties not to
exceed $10,000 per violation.
H0424
1) Each licensed facility must
adopt a patient safety plan.
A plan adopted to implement the
requirements of 42 C.F.R. Part
482.21 shall be deemed to comply
with this requirement.
H0425
GUIDANCE TO SURVEYORS
S. 395.1012(1), F.S.
Review the facility's patient safety
plan.
S. 395.0197(19), F.S.
H0425
Ask the Risk Manager if anyone has
ever attempted to interfere with
his/her reporting obligations.
Met
Not Met
Comments:
Comments:
If applicable, review QA/PI
(HOSPITALS ONLY) plan to assure
patient safety issues are addressed
within the QA/PI plan.
PROBES
Does the facility have a patient safety
plan?
How often is the patient safety plan
updated/reviewed?
As relevant, consider information the
facility representatives utilized to
demonstrate compliance with 42 CFR
482.21 (Quality Assurance and
Performance Improvement Plan)
(FOR HOSPITALS ONLY).
(2) Each licensed facility shall
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appoint a patient safety officer and
a patient safety committee, which
shall include at least one person
who is neither employed by nor
practicing in the facility, for the
purpose of promoting the health
and safety of patients, reviewing
and evaluating the quality of
patient safety measures used by
the facility, and assisting in the
implementation of the facility
patient safety plan.
S. 395.1012(2),
F.S.
Determine if facility management has
appointed a Patient Safety Officer.
R. 59A-10.002(15),
F.A.C.
Review position description.
R. 59A-10.002(2),
F.A.C.
R. 59A-10.002(3),
F.A.C.
Comments:
Interview the Patient Safety Officer
regarding roles and responsibilities.
Review the composition of the Patient
Safety Committee.
Determine the eligibility of the
committee member not employed by
the facility, not a contracted employee
of the facility, nor in practice at the
facility.
A review facility documentation of the
Patient Safety Committee activities
such as minutes, reports, QA/PI
projects and outcomes, Patient Safety
Initiatives, etc.
Review the process by which the
committee reviews and evaluates the
quality of patient safety measures
implemented by the facility.
Review the process by which the
committee
assists in the implementation of the
facility's Patient Safety Plan.
PROBES
Do the committee members maintain
records (surveys, evaluations,
monitoring and corrective actions)?
Does the Patient Safety Committee
document the proceedings?
Program Requirements
Tag Number
Legal Authority
H0426
Interpretive Guidelines
Describe the relationship of the
Patient Safety Officer to the Patient
Safety Plan.
Not
Met
Met
Comments:
What are the committee's current
projects/goals?
How well attended are the committee
meetings?
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Page 23