Cases & Commentaries

Listen to the Family

Commentary By Darrell Campbell, Jr., MD

The Case

Vascular surgery was consulted for placement of a
dialysis catheter in a patient on the medical floor. The surgical
resident examined the patient, an elderly woman with dementia and
renal insufficiency receiving IV hydration. The resident called the
family to obtain informed consent for the procedure. The daughter
was very surprised by the call, stating that no one had discussed
initiating dialysis; she insisted that it was a mistake. The
surgical resident attempted to convince the daughter that the
patient's life was in danger, but the daughter refused to give
consent. The next morning, the surgeon returned to the bedside,
where the family again refused to provide consent. The medical
attending caring for the patient was ultimately called, and he
verified that the patient had prerenal azotemia related to
dehydration. He was unaware of any request for dialysis catheter
placement in this patient. Because they were worried about her
safety, the family signed the patient out of the hospital and
returned her to the nursing home. Upon further review, the catheter
placement request was for another patient on the same floor with
the same unusual last name, who had chronic renal failure
progressing towards dialysis.

The Commentary

The case presented represents a near miss. In the
absence of an involved family, a surgical procedure might have been
performed on the wrong patient. Two previous and thorough
discussions on this Web site (1,2)
have focused on the problems of patient misidentification, the most
obvious issue here. As Chief of Clinical Affairs at my institution
and also a general surgeon, I want to share my perspective on the
problem of wrong patients, wrong side, or wrong site surgery, and
the daunting task of initiating a successful patient safety policy
in a busy surgical environment.

Wrong side, wrong site, or wrong patient surgery
is no small problem. The most complete data shows a rate of 1 in
15,500 surgical procedures(3),
assuming all events were reported. A review of such cases reported
to JCAHO showed that in 36% of cases the wrong patient was operated
on, in 44% right and left mix-ups occurred, 14% involved the
incorrect implant, and 7% involved the wrong site (not right versus
left but, for example, the wrong level of the spine).(4) The
sites of errors, in order of decreasing frequency, were eye, groin
or genitals, chest, and leg. It has been suggested that a properly
performed "time
out" would have prevented 85% of the errors, proper patient
identification and discussion with the patient would have prevented
75%, proper marking of the site would have prevented 65%, and a
properly completed consent form would have prevented 45% of errors
(J.P. Bagian, MD, of the National Center for Patient Safety,
written communication, March 2004).

Tackling this problem at an institutional level
by developing and implementing a wrong site policy is far from
easy. Early attempts suffered from inconsistency. At our
institution, Orthopedics marked an "X" on the non-operative site,
while other groups marked the operative site, which was worse than
no site marking at all. A colleague of mine at a different hospital
produced "NO" stickers to place on the non-operative site, but soon
realized that "NO" looked like "ON" from the other end of the
table. Many groups marked the right ("R") or left ("L") shoulder to
indicate laterality regardless of the type of case, but this mark
usually couldn't be seen after the patient was prepped.

In 2003, JCAHO published "The Universal Protocol
for Preventing Wrong Site, Wrong Procedure, Wrong Person
Surgery."(5)
Endorsed by 47 professional societies, including the American
College of Surgeons, this document directly addresses JCAHO's 2004
Patient Safety Goal #4: "Eliminate wrong-site, wrong-patient,
wrong-procedure surgery."(6)

The policy is good, but the ramp up period is
difficult. Long-standing policies and procedures have become
ossified, and surgeons resist change, particularly when the changes
aim to prevent relatively low-frequency events. Yet the need for an
unyielding policy is obvious when one looks at what really happens
in a fast-paced, hectic environment. For example, both our medical
center and JCAHO have a strict policy to use an "active" ("What is
your name?") manner to identify patients. One day not too long ago,
an incognito observer noted that in our preanesthesia care unit
(PACU) a minority of patients was identified in the "active"
manner. Instead, most were identified in the "passive" manner ("Are
you Mr. Jones?"), an approach that probably contributed to the near
miss in this case.

Many hospitals, particularly large ones, are
having difficulty implementing the universal policy. At our
hospital, the major hindrance to implementation was deciding on who
should mark the site preoperatively. The universal policy seems
difficult to apply to a menu of highly complex procedures, such as
spinal surgery requiring intraoperative x-ray confirmation of
levels. We predicted much confusion in the PACU, many unnecessary
pages, and a loss of efficiency. There was also consternation among
attending surgeons. Surgeons juggling clinics, rounds, lectures,
and paperwork felt that marking the site personally in the PACU was
an inefficient use of their time, since a long gap often transpires
between when the patient is evaluated in the PACU and when the
patient actually rolls into the OR.

The JCAHO Universal Policy allows for some
flexibility in this matter, in that it states that the attending
surgeon "should" (not "must") mark the site preoperatively. We
developed a new algorithm that we believe is very safe and
consistent with JCAHO expectations, in which the PACU nurse is
allowed to mark the site preoperatively depending on the
circumstances. So far, we have not seen a decrease in efficiency
nor any worrisome events.

The algorithm is based on a newly designed
operative permit (Figure
1
). The permit includes diagrams of a patient on which the
operative site can be marked by the team at the time of initial
evaluation in the office. The attending surgeon must initial a box
indicating agreement with the site marking at that time. The
patient signs a statement that says, "I understand the approximate
location of my surgical incision as indicated on the illustration."
When this procedure has been followed during the preoperative
office visit, the PACU nurses need only reconcile the permit with
the patient (and family) and the OR schedule before marking the
site themselves and sending the patient to the OR. Any discrepancy
in the above requires the attending to come to the PACU to resolve
the issue. In other cases, indicated by checking the respective
boxes on the form (Figure
2
), the attending must personally mark the operative site
(lymph node biopsy, breast biopsy), the attending localizes the
site intraoperatively (eg, spinal surgery), or preoperative site
localization is not indicated (eg, midline sternotomy,
C-section).

This procedure has worked very well, but the lost
operative permit has now become the bane of the busy OR, especially
when the permit cannot be found on the morning of surgery. In the
past, the most junior member of the OR team was stat paged to fill
out a new one, and usually this team member knew next to nothing
about the case. This was a major patient safety vulnerability. We
are transitioning to an electronic medical record (after which time
we will be able to scan the permit at the time of the clinic visit
and enter it into the electronic record), but at this point we
still rely on the chart. In any case, because of the vulnerability
of the old system, the days of the stat page to the intern are
gone. If the permit can't be found, the attending must redo the
permit in the PACU.

Back to this case: if the hapless resident had
actually sent this patient to our OR, I believe that several
checkpoints in our new system would have worked to prevent a wrong
patient, wrong procedure disaster. We now require an active patient
identification, made by three separate individuals (PACU nurse,
circulating nurse, and anesthesiologist). The PACU nurse also is
required to confirm the procedure with the family; this step is
particularly valuable in cases like this one in which dementia
diminishes the value of active identification. Finally, the
attending surgeon's presence would be required in the PACU to fill
out the permit, since it had not been completed during a
preoperative clinic visit. Hopefully, the result from all this
effort would be a happy one—a patient sent back to the floor
with an apology, but no operation.

Take-Home Points

  • Of wrong side, wrong site, and
    wrong patient mistakes, 35% involve operating on the wrong
    patient.
  • A
    properly performed "time out" prior to surgery can prevent the vast
    majority of wrong patient errors (85% in some estimates), and it is
    thus a critical piece of any institutional safety
    policy.
  • A national
    policy/guideline to prevent surgical error can be implemented at
    the institutional level. Key recommendations need to be retained,
    but logistical details should be modified at each institution to
    create a system that addresses wrong site, wrong procedure, and
    wrong patient surgery without a loss in
    efficiency.

Darrell Campbell, Jr.,
MD
Henry King Ransom Professor of Surgery
Chief of Clinical Affairs
University of Michigan Health Systems

References

1. Shojania KG.
Patient mix-up. AHRQ WebM&M [serial online]. February 2003.
Available at: [ go to related
commentary ]. Accessed May 14, 2004.

2. Kaplan H.
Transfusion "Slip". AHRQ WebM&M [serial online]. February 2004.
Available at: [ go to related
commentary ]. Accessed May 14, 2004.

3. NYPORTS. The New
York patient occurrence reporting and tracking system annual report
2000/2001. The New York State Department of Health website.
Available at: [ go to related site ]. Accessed May 14,
2004.

4. Sentinel event
alert. Joint Commission on Accreditation of Healthcare
Organizations Web site. December 5, 2001. Available at: [ go to related site ]. Accessed May 14,
2004.

5. Universal protocol
for preventing wrong site, wrong procedure, wrong person surgery.
Joint Commission on Accreditation of Healthcare Organizations Web
site. Available at: [ go to related site ]. Accessed May 14,
2004.

6. 2004 national
patient safety goals. Joint Commission on Accreditation of
Healthcare Organizations Web site. Available at: [ go to related site ]. Accessed May 14,
2004.

Figures

Figure 1. Sample
Operative Permit


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Figure
1
.

Figure 2. Sample
Form for Preoperative Checklist


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Figure
2
.

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