The Universal Protocol is a set of procedures implemented in 2004 to prevent wrong site, wrong procedure, and wrong patient surgery. It includes three key elements: pre-procedure verification, marking the intended site, and conducting a time-out immediately before starting the procedure. The goal is to use data on adverse events collected by JCI to prevent similar errors in other healthcare organizations.

2. UNIVERSAL PROTOCOL
The Universal Protocol is based on
the fact that wrong site, wrong
procedure, and wrong person surgery
can be prevented
It became effective in July 2004

3. UNIVERSAL PROTOCOL
JCI Collects reports
from accredited
organizations that have
experienced a sentinel
event within their
organization
Data from reports are
collected, aggregated,
and analyzed to identify
root causes of adverse
events

4. UNIVERSAL PROTOCOL
The goal is to use the data to prevent
similar errors from occurring in other
health care organizations
The joint commission found the wrong
site surgery to be the third-highest-
ranking event

5. UNIVERSAL PROTOCOL
The protocol includes many
recommended steps but
there are three principal
elements:
a) Pre-procedure verification
b) Site marking
c) Time out prior to incision

6. AT-RISK BEHAVIOR IN THE OR
Not checking equipment before use
Surgeon entering after prep and drape
Surgeon running 2 rooms
Multi-tasking from O.R.
Relying on memory about the
pathology
Unannounced substitutions in mid case
Continuing to close during sponge
search

7. O.R. TEAM
Be Patient- focused
Not surgeon-focused
Not workflow-focused
Not specialty-focused
Not budget-focused
Not break-focused

8. High Reliability Organizations
“ CARE “
Commitment by the Leaders
Attention to the Task
Respond as a Team
Effective Communication
Safety in surgery require the reliable
execution of multiple necessary
steps in care by health team working
together for the benefit of the patient

9. PRE-PROCEDURE VERIFICATION
PROCESS
Verify the correct
procedure, for the
correct patient, at the
correct site.
When possible, involve
the patient in the
verification process.

10. PRE-PROCEDURE VERIFICATION
PROCESS
Identify the items that must be
available for the procedure.
Use a standardized list to verify the
availability of items for the procedure.
At a minimum, these items include:
relevant documentation

11. labeled diagnostic and
radiology test results that
are properly displayed
any required blood
products, implants,
devices, special equipment
Match the items that are to
be available in the procedure
area to the patient.
PRE-PROCEDURE VERIFICATION
PROCESS

12. MARK THE PROCEDURE SITE
At a minimum, mark the site when
there is more than one possible
location for the procedure and when
performing the procedure in a different
location could harm the patient.

13. MARK THE PROCEDURE SITE
For spinal procedures: Mark the
general spinal region on the skin.
Special intraoperative imaging
techniques may be used to locate
and mark the exact vertebral level.
Mark the site before the procedure is
performed.

14. MARK THE PROCEDURE SITE
If possible, involve the patient in the
site marking process.
The site is marked by a licensed
independent practitioner who is
ultimately accountable for the
procedure and will be present when
the procedure is performed.

15. MARK THE PROCEDURE SITE
In limited circumstances, site
marking may be delegated to some
medical residents, physician
assistants (P.A.), or registered
nurses (R.N.). Ultimately, the
licensed independent practitioner is
accountable for the procedure even
when delegating site marking.

16. MARK THE PROCEDURE SITE
The mark is unambiguous and is used
consistently throughout the
organization.
The mark is made at or near the
procedure site.
The mark is sufficiently permanent to
be visible after skin preparation and
draping.

17. MARK THE PROCEDURE SITE
Adhesive markers are not the sole
means of marking the site.
For patients who refuse site marking
or when it is technically or
anatomically impossible or
impractical to mark the site: Use
your organization’s written,
alternative process to ensure that
the correct site is operated on.

18. MARK THE PROCEDURE SITE
Examples of situations that involve
alternative processes:
mucosal surfaces or perineum
minimal access procedures treating a
lateralized internal organ, whether
percutaneous or through a natural
orifice
teeth
premature infants, for whom the mark
may cause a permanent tattoo

19. PERFORM A TIME-OUT
The procedure is not
started until all questions
or concerns are resolved.
'fail-safe' mode
Conduct a time-out
immediately before starting
the invasive procedure or
making the incision.

20. PERFORM A TIME-OUT
The time-out is standardized.
The time-out involves the immediate
members of the procedure team: the
individual performing the procedure,
anesthesia providers, circulating
nurse, operating room technician,
and other active participants who
will be participating in the procedure
from the beginning.

21. PERFORM A TIME-OUT
All relevant members of the
procedure team actively
communicate during the time-out.
During the time-out, the team
members agree, at a minimum, on
the following:
correct patient identity
correct site
procedure to be done

22. PERFORM A TIME-OUT
When the same patient has
two or more procedures: If the
person performing the
procedure changes, another
time-out needs to be
performed before starting each
procedure.
Document the completion of
the time-out.