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Patient Safety Tip of the Week
Wrong Knee
Again!
Wrong
site surgery continues despite all our efforts to prevent it. Joint Commissions
Sentinel Event Data (TJC
2024) showed there were 112
sentinel events classified as wrong surgeries in 2023 - a 26% increase from
2022. Most wrong surgery sentinel events (62%) were surgeries or invasive
procedures performed at the wrong site. Undoubtedly, there are likely many
other cases not reported to the Joint Commission.
As with accidents in any industry, in most healthcare
incidents with untoward outcomes there is typically a cascade of errors or
missteps that contribute to wrong-site surgery. Our many columns on wrong site
surgery (listed below) have discussed in detail the many factors that
contribute to such incidents. A case from the California Department of Public
Health (CDPH
2024) illustrates multiple
factors involved in a case of wrong knee surgery.
A 73 y.o. man was
scheduled for an arthroscopic meniscectomy on his right knee. Instead, the
procedure was incorrectly performed on his left knee. The error was only
detected when the patient was in the post-op recovery area.
The surgeon used a
marking pen and marked the patient's right knee with his (the surgeon's)
initials indicating the correct surgical site before the patient went into the
Operating Room. The nurse assigned
to this patient in the
pre-operative and post-operative areas stated she verified the physician orders
and reviewed the consent form for right knee arthroscopic procedure with the patient,
who verbalized understanding of the planned procedure. The nurse further stated
that the surgeon met with the patient prior to surgery and used a marking pen
to mark his right knee with his (the surgeon's) initials. The nurse stated she
gave a written report to the OR nurse and the patient was transported to the
OR.
Another nurse transported the patient into
the OR and OR staff prepped him for surgery. They applied a tourniquet to the
left leg and drape to the patients left knee. That nurse stated, "I don't
remember seeing the [surgical] marking. Yet another nurse, who was assisting
the OR nurse with the application of the tourniquet stated she did not verify
the surgical site marking when she assisted the OR nurse with the tourniquet.
A timeout was apparently done with the
surgical team in the operative area immediately before surgery and the surgical
procedure was reviewed. A nurse stated the surgical team confirmed the patient
was scheduled for a right knee arthroplasty but failed to verify the correct
site was marked and prepped. That nurse stated she did not see the surgical
site marking on the right knee during the timeout procedure. She stated,
"I don't know how the event happened; it was process fatigue." The "Intraoperative
Record: signed by that nurse indicated, "... Preop [preoperative]
diagnosis... Right Medial [middle] and Lateral [side] Meniscal Tears... Time-
Out Type Procedure... Time Out 12/21/18... 9:03 a.m... All members of Surgical/
Procedure Team Verbally Confirm... Consent form is accurate... yes... Agreement
on the procedure / side/ site... yes..."
A progress note signed by the
Anesthesiologist said, "Patient scheduled for right knee arthroplasty.
Consent signed. Right knee marked. Time-out performed in the usual manner for
procedure to be done for right knee... Wrong site (left knee) realized by the
recovery room nurse...".
The surgeon was interviewed. He stated he
marked the patients right knee (correct site) in the pre-operative area. He
stated the patient's left knee (wrong site) was prepped and draped for surgery
before he entered the operating room. He stated he did not visualize the site
marking during the timeout procedure but decided to proceed with the scheduled
surgery. He stated it was common for the surgical site
markings to erase when the patients' operative sites were disinfected with
antiseptic prior to surgery. He stated he was not aware he performed surgery on
the wrong site (left knee) until he was notified by the hospital's recovery
room nurse. He stated he returned to the hospital and explained the mistake to the
patient.
In sum, the surgeon, anesthesiologist, and
multiple nurses failed to recognize the procedure was being performed on the
wrong knee.
Obviously, multiple factors contributed. One
nurse stated the OR was busy that day, and the surgical team appeared rushed. That
the surgeon had to return to the hospital might indicate that he had left the
hospital shortly after the procedure.
It was said that a timeout was performed in
the OR and there was documentation of a timeout. Obviously, any such timeout
was not performed correctly or was performed in a perfunctory fashion. There
was no verification of the site marking by anyone in the OR. Even someone who
might not usually look for the site marking (such as the anesthesiologist)
should still be confirming concordance between the consent form and the side of
the body being operated on.
There are several questions wed be asking
the hospital about its quality and patient safety program. Was this an isolated
timeout failure, or have timeouts been routinely being
performed in a perfunctory manner by this or other OR teams? Do all staff actually review the consent forms, booking/scheduling
information, and look for site markings? Was there any veracity to the surgeons
comment about it being common for the surgical site markings to erase when the
patients' operative sites were disinfected with antiseptic prior to surgery?
Note that, in the post-op recovery area when it was discovered the procedure
was performed on the wrong knee, a nurse noted that the surgeons initials were
indeed visible on the right knee.
There were likely multiple assumptions. Several
nurses who were assisting during the preparation of the surgical site in the
OR likely assumed that the nurse directing that prep had the correct leg.
Similarly, the surgeon likely assumed that the correct leg had been prepped.
The two most important interventions we use
to prevent wrong site surgery the timeout and the site marking and verification
were not performed correctly in this case. The surgical team did not follow
hospital policy and procedure for the completion of a timeout. The Operating
Room Director stated the normal process, after the patient enters the OR, was
for the nurse to view the site marked for the surgical procedure before putting
on the tourniquet and prepping and draping the surgical site for the procedure.
He stated the expectation was for the person initiating the timeout to gather
the attention of everyone in the OR room, read the signed consent, and everyone
in the room to give verbal confirmation that the patient and the surgical site
were correct.
Below is the Joint Commissions Universal
Protocol wording on site
marking:
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.
·
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.
·
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.
·
In limited circumstances, site marking may be
delegated to some medical residents, physician assistants (P.A.), or advanced
practice registered nurses (A.P.R.N.).
·
Ultimately, the licensed independent
practitioner is accountable for the procedure even when delegating site
marking.
·
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.
·
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 (see
examples below): Use your organizations written, alternative process to ensure
that the correct site is operated on. 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
The American Academy of Orthopaedic
Surgeons introduced the "Sign Your Site" safety program in 1998
designed to reduce wrong site surgeries through improved site identification.
Permanent ink should be used to mark the site(s) with the patient's assistance
prior to surgery and confirmed by the surgical team during the 'Time-Out'
immediately prior to starting the surgical procedure (AAOS
2015).
Perhaps the one good thing done in this case
was that the surgeon immediately returned to hospital and explained the mistake
to the patient. Our many columns on disclosure and apology are listed below.
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 WHOs
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 Dont 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 Vanderbilts
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
May
2022 PPSA:
Updated Wrong-Site Surgery Recommendations
June
13, 2023 Preventing Wrong-Site
Surgery
November
2023 Importance
of Timeouts Outside the OR
January 30, 2024 Is Your Surgical Safety
Checklist Working?
September 10, 2024 Scheduling and Informed
Consent Contribute to Wrong-Site Surgery
November 26, 2024 eConsent: Friend or Foe?
December 17, 2024 Can AI Prevent
Ophthalmological Surgery Errors?
Some
of our prior columns on Disclosure & Apology:
July
24, 2007 Serious Incident Response Checklist
June
16, 2009 Disclosing Errors That Affect Multiple
Patients
June 22, 2010 Disclosure
and Apology: How to Do It
September
2010 Followup to Our Disclosure and Apology Tip of the
Week
November 2010 IHI:
Respectful Management of Serious Clinical Adverse Events
April
2012 Error Disclosure by Surgeons
June
2012 Oregon Adverse Event Disclosure Guide
December
17, 2013 The Second Victim
July
14, 2015 NPSFs RCA2 Guidelines
June
2016 Disclosure
and Apology: The CANDOR Toolkit
August
9, 2016 More on the Second Victim
January
3, 2017 Whats
Happening to Im Sorry?
October
2017 More
Support for Disclosure and Apology
April
2018 More
Support for Communication and Resolution Programs
August 13, 2019 Betsy Lehman Center Report
on Medical Error
September 2019 Leapfrogs
Never Events Policy
March 9, 2021 Update: Disclosure and
Apology: How to Do It
November 2021 When
a Radiologist Recognizes He Committed an Error
May 31, 2022 NHS Serious Incident
Response Framework
July 11, 2023 Error Disclosure in the Real
World
Other
very valuable resources on disclosure and apology:
·
IHIs Respectful Management of Serious Clinical
Adverse Events (Conway
2010)
·
The Canadian Disclosure Guidelines (Canadian
Patient Safety Institute 2008)
·
The Harvard Disclosure Guidelines (Massachusetts
Coalition for the Prevention of Medical Errors 2006)
·
The ACPE Toolkit (American
College of Physician Executives)
·
Oregon Patient Safety Commission Oregon
Adverse Event Disclosure Guide.
References:
The Joint Commission. Sentinel Event Data
2023 Annual Review. Published 2024
CDPH (California Department of Public
Health). Complaint Intake Number: CA00617150 Substantiated. Date Survey
Completed 11/25/2024
The Joint Commission. Universal Protocol.
https://www.jointcommission.org/-/media/tjc/documents/standards/universal-protocol/up_poster1pdf.pdf
American Academy of Orthopaedic
Surgeons. Surgical Site and Procedure Confirmation. Adopted March 2015
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