Loud wake-up call: Unlabeled containers
lead to patient's death
From the December 2, 2004 issue
Problem: As we began our Thanksgiving holiday last week,
we were saddened to hear the news of yet another tragic medication
error that claimed the life of a 69-year-old Seattle woman,
caused in large part by unlabeled basins of solution in the
interventional radiology procedure room. During coil placement
under cerebral angiography to repair a brain aneurysm, a patient
was accidentally injected with an antiseptic skin prep solution,
chlorhexidine, instead of contrast media. Both solutions were
clear and available on the sterile field in unlabeled basins.
The hospital's recent decision to switch antiseptics from a
brown povidone-iodine solution to a clear chlorhexidine solution
resulted in a latent failure - two look-alike, clear solutions
on the sterile field that were previously distinguished by color.
This latent failure was revealed when the unlabeled solution
basins were mixed up.
During the procedure, the clear chlorhexidine solution was
placed in an unlabeled basin identical to that used to hold
the contrast media. Neither basin was labeled, so both solutions
looked exactly the same. At the end of the procedure, contrast
media was supposed to be injected into the patient's artery
for radiographic visualization. Unfortunately, the chlorhexidine
was drawn into the syringe, and the patient received the antiseptic,
which is highly toxic when injected intravascularly. Within
2 hours, the patient suspected that something was very wrong.
Acute, severe chemical injury to the blood vessels of the
leg restricted circulation to the muscles, causing profound
injury and swelling of her leg. During the following 2 weeks,
the patient's condition deteriorated. She underwent a leg
amputation, and then suffered a stroke and multiple organ
failure, which led to her death.
What went wrong during the procedure was detailed in a staff
memo from the hospital's quality committee and chief of medicine,
and was subsequently released to the public (and posted on
its website) in what the Seattle news media described as an "unusual step of publicly explaining, and apologizing
for, the error." According to hospital leaders, the decision
to publicly disclose the error was part of a broader initiative
started 5 years ago to create a culture of safety and to make
harmful medical errors more transparent. The apology states
that, while no single individual is responsible for the tragedy,
the mistake is due to a larger systems problem that allowed
two clear solutions to be confused, for which all hospital
staff assume responsibility. The apology further states, "Talking
about these issues openly is painful and difficult, but only
in doing so can we acknowledge the reality of the flawed systems
that exist in healthcare today - and arm ourselves with information
to do something about it." Apparently, these are not
hollow words intended to placate the patient's family and
the public; according to the Washington Department of Health,
the hospital has been commendable with reporting adverse events
during the past 3 years. The patient's family also reports
that they've been treated well, and that they appreciate the
hospital's full disclosure of the error.
Unlabeled medications and solutions on the sterile field
have caused many other errors, some with tragic outcomes.
One of our earliest reports appeared in the July 1989 Medication
Error Reports column in the journal Hospital Pharmacy. A news
reporter for the Miami Herald died during a surgical procedure
to remove a cancerous eye. An unlabeled specimen cup filled
with glutaraldehyde, to preserve the patient's enucleated
eye, was misidentified as spinal fluid that had been removed
to reduce cerebral pressure because the malignancy had spread
to the brain. The spinal fluid was in an identical unlabeled
cup. Near the end of the procedure, an anesthesiologist accidentally
injected the glutaraldehyde intrathecally, believing it was
the patient's spinal fluid. In our June 18, 1997 newsletter,
we reported several errors in which unlabeled cups or basins
on the sterile field led to errors. In one case, the patient
was injected with hydrogen peroxide instead of lidocaine for
local anesthesia, but suffered no adverse reaction. Three
other cases involved errors with unlabeled medication or solution
containers in settings outside the operating room (OR). One
patient received lidocaine instead of contrast media during
angiography, leading to a grand mal seizure. In a similar
setting, contrast media was infiltrated around an injection
site instead of lidocaine for local anesthesia just prior
to angiography. Local tissue damage resulted. Another patient
being treated in a hospital-based physician's office sustained
severe burns to his genitals when the physician mistakenly
applied TBQ (a cationic germicidal detergent with a pH of
13) from an unlabeled bottle, believing it contained vinegar,
which was needed to bleach the wart to improve visibility.
Let these and the most recent tragic error serve as a loud
wake-up call to remedy risks with unlabeled medications and
solutions on the sterile field. While you may not have experienced
a serious sentinel event despite poor labeling practices,
you shouldn't wait until a patient is harmed in your facility
to take action. Lest you think the problem is limited to just
a few hospitals, recent findings from the 2004 ISMP Medication
Safety Self Assessment, gathered from more than 1,600 hospitals,
show that less than half (41%) always label containers (including
syringes, basins, or other vessels used to store drugs) on
the sterile field, even when just one product or solution
is present. Eighteen percent do not label medications and
solutions on the sterile field at all, and another 42% apply
labels inconsistently. Although this represents an improvement
from the 2000 findings (25% reported full labeling; 24% reported
no labeling), surprisingly, this rather basic safety measure
is not widely implemented in hospitals. This is particularly
disturbing because patients undergoing a surgical procedure
cannot intervene on their own behalf. They are typically sedated
or anesthetized, and thus, feel more vulnerable to errors
at this time.
Safe Practice Recommendation: Develop and implement
policies and procedures for safe labeling of medications and
solutions used in perioperative settings, including traditional
ORs, ambulatory surgery units, labor and delivery rooms, physicians'
offices, cardiac catheterization suites, endoscopy suites,
radiology departments, and other areas where operative and
invasive procedures may be performed. For reference, consider
the following recommendations, most of which are mentioned
in the Association of PeriOperative Registered Nurses (AORN)
recently published Guidance Statement: Safe Medication Practices
in the Perioperative Practice Settings.
Provide labels. Make labeling easy by purchasing sterile
markers, blank labels, and preprinted labels prepared by the
facility or commercially available (e.g., Healthcare Logistics)
that can be opened onto the sterile field during all procedures.
To minimize staff time, prepare surgical packs ahead of time
with sterile markers, blank labels, and preprinted labels
for all anticipated medications and solutions that will be
needed for the case. (Since providing labels that can be used
effectively on basins and syringes in the sterile field can
be challenging, please contact us if you would like to share your successful ideas with others.)
Require labels. Require labels on all medications,
medication containers (e.g., syringes, medicine cups, basins),
or other solutions on and off the sterile field, even if there
is only one medication or solution involved. Also require
labels on all solutions, chemicals, and reagents (e.g., formalin,
saline, Lugol's solution, radiocontrast media, etc.) that
are used in the perioperative units.
Differentiate look-alike products. If drug or solution
names are similar, use tall man lettering on the labels to
differentiate them, or highlight/circle the distinguishing
information on the label. When possible, purchase skin antiseptic
products in prepackaged swabs or sponges to clearly differentiate
them from medications or other solutions and eliminate the
risk of accidental injection.
Label one at a time. Individually verify each medication
and complete its preparation for administration, delivery
to the sterile field, and labeling on the field before another
medication is prepared. Verify any medication listed on the
physician's preference list with the physician before delivery
to the sterile field, labeling, and/or administration.
Confirm medications and labels. Require the scrub
person and the circulating nurse to concurrently verify all
medications/ solutions visually and verbally by reading the
product name, strength, and dosage from the labels. (If there
is no scrub person, the circulating nurse should verify the
medication/solution with the licensed professional performing
the procedure.) When passing a medication to the licensed
professional performing the procedure, visually and verbally
verify the medication, strength, and dose by reading the medication
label aloud. Keep all original medication/solution containers
in the room for reference until the procedure is concluded.
Re-verify with relief staff. At shift change or relief
for breaks, require the entering and exiting personnel to
concurrently note and verify all medications and their labels
on the sterile field.
Discard unlabeled medications. Don't assume that you
know what is contained in an unlabeled syringe, cup, or basin.
Discard any unlabeled solution or medication found in the
perioperative area (including the sterile field) and report
the event as a hazardous condition. Nothing should leave the
hand unless it is labeled.
Conduct walk-arounds. Perform regular safety rounds
in perioperative areas to observe labeling procedures, promote
consistency, and inquire about barriers to implementing this
important safety practice.
Pharmacy presence in the OR. While an OR is sometimes
considered "foreign ground" for a pharmacist, establishing
close ties between pharmacists and the OR staff (via satellites
or regular on-site presence) could help spur practice changes
that are needed to improve labeling on the sterile field.
Enhance awareness. Tell memorable stories to perioperative
staff about tragic mix-ups that have occurred in other facilities
when medications and solutions were unlabeled on the sterile
field to help motivate practice changes. A multidisciplinary
perioperative safety team comprising nurses, technicians,
pharmacists, and physicians from various sites where invasive
procedures are performed might also help to improve consistent
labeling as well as enhance interdisciplinary relationships.
Oversight form external agencies. Accrediting, regulatory,
and standard setting agencies should consider safe labeling
practices in perioperative settings when developing national
patient safety goals and initiatives.