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What’s New in the
Patient Safety World
May 2022
PPSA: Updated
Wrong-Site Surgery Recommendations
The Pennsylvania Patient Safety Authority has updated its
“Recommendations to Ensure Correct Surgical Procedures and Correct Nerve
Blocks” (PPSA
2022).
PPSA really stresses that it’s everyone’s responsibility to
ensure correct patient, procedure, and laterality. That includes scheduling
staff, registration clerks, ancillary staff, nursing staff, the operating
provider, anesthesia provider, and the patient. All have an obligation to speak
up if they note a discrepancy in any information on the schedule, consent,
history and physical, and any office notes. Reconciliation of discrepancies is
the responsibility of the operating provider prior to the procedure.
It also stresses the importance of having all relevant
documents and imaging studies available. All parties should have reviewed these
themselves rather than relying on others. It also stresses active, rather than
passive, verification by the patient and others.
We’re glad to see an emphasis also on the importance of
including site and side of the procedure at the time of initial scheduling. In
several of our columns we have lamented that sometimes the scheduling is
performed by non-clinical individuals on either side. In our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” we noted the Minnesota Alliance for
Patient Safety created a sample booking form that contains
a section which must be filled out by the physician performing the surgery
(i.e. that cannot be delegated to staff).
The PPSA recommendations have a good section on site
marking. You may wish to also see our May
14, 2019 Patient Safety Tip of the
Week “Wrong-Site Surgery and
Difficult-to-Mark Sites”
regarding sites that are difficult to mark, such as dental, ocular, or spine
sites.
There is one area where we think better clarification is
due. The recommendations state that “The provider performing the procedure
should announce the time-out.” We don’t have a problem with that. But it should
not mean that he/she “leads” the timeout. We like the “Minnesota
Timeout” concept in which someone other than the surgeon leads the time out
process. That helps prevent team members from simply agreeing with the surgeon.
The timeout is supposed to be an active rather than passive process and there
should not be undue deference to the surgeon. Every member of the team needs to
speak up and not be afraid to challenge any aspect.
In the Minnesota Timeout, after the surgeon announces the
timeout, the circulating Nurse reads from the patient’s informed consent the patient name, procedure, and laterality (or level), and
notes the position of the patient. The anesthesia care provider reads patient’s
name from the anesthesia record and states shorthand version of procedure. He/she
also states antibiotic name, dose, and minutes from administration time. The
scrub person states the shorthand version of procedure for which he/she has set
up and verbally confirms he/she sees the surgical site marking (if there is a
site marking). If an anatomical diagram is used in lieu of physical site
marking, the circulating nurse and team use the diagram to verbally acknowledge
the surgical site. The surgeon then states the patient’s name, complete
procedure, and site—from memory. Discrepancies are resolved before procedure
start.
What’s missing from the Minnesota Timeout? There is no
mention of using the other primary source documents (scheduling form, office or hospital notes, history & physical) and no
mention about presence and accuracy of appropriate imaging studies.
Here’s the full list of the PPSA recommendations:
Recommendations to ensure the correct surgical procedure
is performed on the correct site, side and patient
Preoperative verification and reconciliation
1. The site and side of procedure should be
specified when the procedure is scheduled.
2. The procedure, site and side should be noted
in the medical record on the history and physical exam record
or the procedure note.
3. The procedure, site and side should be
discussed and documented on the informed consent form.
4. The individuals, including scheduling staff,
registration clerks, ancillary staff, nursing staff, the operating provider and the patient, have an obligation to speak up if
they note a discrepancy in any information on the schedule, consent, history
and physical, and any office notes. Reconciliation of discrepancies is the
responsibility of the operating provider prior to the procedure.
5. The information to verify the correct
patient, procedure, side and site, including the
patient's or family's verbal understanding, when possible, must be verified by
the circulating nurse/designee, anesthesia provider and operating provider.
This verification shall be documented in a manner determined by the healthcare
facility.
6. Verbal verification with the patient or
their representative should be conducted whenever possible. The verbal
verification must be done using questions that require active response of
specific information rather than passive agreement. Example: Can you tell me
your full name? What is your date of birth? What procedure are you having
performed today?
7. Patient identification must require at least
two unique identifiers, for example, name and date of birth.
8. Discrepancies must be reconciled and documented
by the operating provider prior to the procedure.
Site Marking—Site marking recommendations apply to all
procedures where there is more than one possible location for the procedure.
9. The site must be marked by the provider responsible
for the procedure, for example, surgeon, proceduralist or interventional
radiologist, prior to the patient entering the procedure area. The mark must be
confirmed by the attending nurse/designee. The mark must also be confirmed by
an alert patient or patient representative when possible. The mark must
coincide with the schedule, history and physical, and consent.
10. The site must be marked with the provider's
initials with an indelible marker.
11. The mark must be made as close to the
incision site as possible, so that it is visible in the prepped and draped
field.
Time-out and intraoperative verification
12. Prior to the induction of anesthesia, the
circulating nurse and the anesthesia provider, verify
the patient's identity, procedure, site, side, consent and site marking. The
patient is included in this verification whenever possible.
13. The provider performing the procedure
should announce the time-out. This occurs after the patient is prepped and
draped, and immediately prior to skin incision/puncture.
14. Separate formal time-outs must be done for
separate procedures, including anesthetic blocks, by the person performing that
procedure.
15. The noncritical activities in the procedure
area must stop during the time-out, including music and nonessential talking
that could distract team members.
16. The relevant patient documents should be
available and actively confirmed during the time-out process. Relevant
documents include a history and physical, consent, operating room schedule and
radiographic studies when applicable.
17. The site mark should be referenced in the
prepped and draped field during the time-out.
18. The members of the surgical team should
actively and verbally verify agreement with the surgical site, side and relevant documents. Active participation should be used at all times. For example, ''Which side is the surgery
on?'' instead of ''The surgery is on the left side. Do you agree?''
19. Staff should be engaged in the process and
the operating provider should specifically encourage team members to speak up
with any concerns during the time-out. The operating provider is responsible
for resolving any questions or concerns based on primary sources of information
and to the satisfaction of all members of the team before proceeding.
20. Utilize intraoperative imaging whenever
possible for procedures where exact site is not easily determined through
external visualization, for example, X-ray and fluoroscopy, to verify spinal
level, rib section level or ureter to be stented.
Accountability
21. Incorporate accountability for these
recommendations into the facility's quality assurance and formal evaluation
process. This includes both individual and team performance evaluations,
ongoing professional practice evaluations and focused professional practice
evaluations.
Recommendations to ensure nerve blocks are performed at
the correct site and correct patient
Preoperative verification and reconciliation
1. Confirm patient identity using at least two
forms of patient identification.
2. Reconcile and verify the exact site and
laterality of the surgical procedure and the perioperative nerve block site
using all forms of available primary and confirmatory patient sources,
including surgical consent, patient or representative, or both, operative
provider's notes (if available), surgical schedule, and history and physical.
3. If any sources differ, the process stops and
a member from the anesthesia block team notifies the surgeon to resolve the
conflicting information.
Anesthesia site marking
4. After confirming the information in the
preoperative verification, the responsible anesthesia provider will use a
standardized, institutionally approved mark that is distinct from the one used
for the surgical site to mark the perioperative nerve block site.
5. Place the mark close to the injection site
to ensure it is visible in the prepped and draped field.
6. Repeat the marking process when there are
multiple injection sites.
Time out
7. Secure a block team consisting of at least
two people with independent roles (for example, responsible anesthesia provider
and preoperative or holding area nurse or circulating nurse).
a. Engage the anesthesia provider to initiate
the time-out.
b. The anesthesia provider should be present during
the time out and during the nerve block.
8. Conduct a time-out before:
a. Sedating the patient, when possible.
b. Inserting the needle or as close to the
procedure as possible.
c. Each nerve block.
9. Minimize distractions and stop all unrelated
activity before conducting the time-out.
10. Both the anesthesia provider and block team
member verify the procedure that is documented and on the surgical consent (and
anesthesia consent if used).
11. Locate and visibly confirm the anesthesia
site mark during the time-out.
12. Repeat the time-out process when there are
changes to:
a. Block team.
b. Patient location within the perioperative
area.
c. Patient positioning.
d. Planned nerve block site.
Accountability
13. Incorporate accountability for these
recommendations into the facility's quality assurance and formal evaluation
process. This includes both individual and team performance evaluations,
ongoing professional practice evaluations and focused professional practice
evaluations.
The PPSA recommendations appear to be aimed at those
surgeries and other procedures that are likely performed in an OR or procedural room. Don’t forget that many of the same
principles should apply for those procedures done at the bedside (see our
columns for June 6, 2011 “Timeouts
Outside the OR”, July 2014 “Wrong-Sided Thoracenteses”, and February 15, 2022 “Wrong-Side Chest Tubes”).
We should also mention that a recent article in Outpatient
Surgery (Gapinski-Kloiber
2022) described use of a mobile software application that might help
avoid wrong site surgery. “Surgeons can use the platform to record their
discussions with patients in the clinic about the planned procedure, including
the site and laterality. This cloud-based statement of the intended surgical
plan and verbal confirmation by the patient is accessible leading up to the
procedure, including just before the time out, to help providers confirm the
correct patient and site. The platform also has a visual cue component, which
uses alliteration and colors to help staff identify the correct site of the
surgery. A member of the pre-op team uses the platform’s app to listen to the
recording of the surgeon-patient statement and scans the proper procedure card
into the system. In the OR, members of the surgical team also listen to the
statement before conducting the safety time out, which is recorded by the app.“
“In a study involving use of this technology, researchers
found no incidences of wrong-site surgery in 487 orthopedic procedures.
However, the tool did catch 17 near misses. The researchers were surprised by
how many seemingly small errors occurred, including misspelled names and
laterality mistakes, and that they were caught at various points of care
between surgeons’ offices and operating rooms. The technology can track these
close calls and advance staff education and communication by reporting them
objectively to surgical leadership.”
Some of our prior columns
related to wrong-site surgery:
September 23, 2008 “Checklists
and Wrong Site Surgery”
June 5, 2007 “Patient
Safety in Ambulatory Surgery”
July 2007 “Pennsylvania
PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons
from Ophthalmology”
July 1, 2008 “WHO’s
New Surgical Safety Checklist”
January 20, 2009 “The
WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site
Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site
Neurosurgery”
January 19, 2010 “Timeouts
and Safe Surgery”
June 8, 2010 “Surgical
Safety Checklist for Cataract Surgery”
December 6, 2010 “More
Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts
Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine
Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 2013 “How Frequent are Surgical Never Events?”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
March 15, 2016 “Dental
Patient Safety”
May 17, 2016 “Patient
Safety Issues in Cataract Surgery”
July 19, 2016 “Infants
and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s
Electronic Procedural Timeout”
May 2017 “Another
Success for the Safe Surgery Checklist”
May 2, 2017 “Anatomy
of a Wrong Procedure”
June 2017 “Another
Way to Verify Checklist Compliance”
March 26, 2019 “Patient
Misidentification”
May 14, 2019 “Wrong-Site Surgery and
Difficult-to-Mark Sites”
May 2020 “Poor
Timeout Compliance: Ring a Bell?”
September 14, 2021 “Wrong Eye Injections”
October 5, 2021 “Wrong Side Again”
November 9, 2021 “Ensuring Safe Site Surgery”
February 15, 2022 “Wrong-Side Chest Tubes”
References:
Patient Safety Authority/Department of Health. Final
Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks.
Pennsylvania Bulletin 2022; 52(12): 1591-1724 March 19, 2022
https://www.pacodeandbulletin.gov/Display/pabull?file=/secure/pabulletin/data/vol52/52-12/448.html
Minnesota Alliance for Patient Safety. Sample booking form
Harder KA. Safe Surgery Process Steps (including the
Minnesota Time Out) to Prevent Wrong Surgery. Minnesota Department of Health
https://www.health.state.mn.us/facilities/patientsafety/adverseevents/publications/safesurgery.pdf
Gapinski-Kloiber K. Why Does
Wrong-Site Surgery Keep Happening? Put policies in place to make sure surgeons
always cut where they should. Outpatient Surgery 2022; April 7, 2022
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