Sumber : Eileen Corley MSN, RN, CNOR
Ms.
J, born on 3/14/1951, saw a physician assistant (PA) in early January
with pain in both knees (right greater than left). Following several
weeks of physical therapy, the pain was still present, so Ms. J
scheduled another visit. This time, she saw an orthopedic surgeon at a
satellite office. The surgeon examined the knee and felt that
arthroscopy of the right knee was indicated. The surgeon directed his
office staff to schedule an arthroscopy, but the chart was at the
downtown office, so the note wasn't entered in the patient record until
the next day. A few days later, the case was scheduled. Ms. J reported
to the hospital as instructed on February 28. The registration desk was
busy, and the clerk forgot to verify the date of birth on the armband,
which incorrectly read 3/14/1961. The surgery schedule read
"arthroscopy," but didn't indicate which knee. The surgeon was running
behind with his first case, so the PA stopped by the holding area to
mark the knee before he left to go back to the office. The patient was
medicated with midazolam in the holding area. When the PA asked Ms. J if
her left knee hurt, she responded yes, and the left knee was marked.
The circulating nurse transported her to the OR, checked the consent,
positioned the patient, and prepped the knee that was marked. The
surgeon scrubbed and came into the OR. When the circulating nurse
reminded the surgeon it was time to perform the time out, he said, "I'm
already late enough," asked for the scalpel, and made an incision in the
left knee. After surgery, Ms. J was dressing to go home and asked the
discharge nurse "Why don't I have a bandage on my right knee? That's
where I was supposed to have surgery."
Changes
in healthcare and advances in technology have made every aspect of
healthcare more difficult to navigate than ever before. Having the
ability to offer various types of surgery with multiple points of entry
into the system has created a complex environment that's a breeding
ground for errors. Add to that the increasing need for speed in most
ORs, and a perfect storm emerges.
A
wrong-site surgery event isn't just an increased risk for a malpractice
claim. Performing a procedure at the wrong site or on the wrong side is
a violation of the patient's trust in their healthcare providers.
Safety is one of the implicit promises to the patient. Wrong-site
surgery is also a devastating event for the healthcare providers
involved. The cost to reputations and possibility of fines, malpractice
claims, and consequences to licensure are also concerns. In 2005,
six-to-seven figure sums were paid on malpractice claims resulting from
wrong-site surgery, and one report found a wrong-site surgery suit filed
every 5 to 10 years at any given hospital.1
What's wrong-site surgery?
Wrong-site
surgery is defined as surgery on the wrong patient, wrong procedure (a
procedure other than what was intended), on the wrong side (for
structures that are bilateral), or on the wrong structure or body part
(digit, limb, and the like).1 Clarke and colleagues found that surgery on the wrong side is the most common.1
The
Joint Commission (TJC) considers wrong-site surgery a sentinel event.
TJC has designated prevention of wrong-site surgery as one of their
national Patient Safety Goals.2 Some states have instituted a mandatory reporting system for wrong-site surgery.
Occurrence
It's
difficult to determine the exact rate of occurrence because wrong-site
surgery can be reported in several ways. Increased awareness may also
improve reporting of wrong-site surgery events and near misses, so it's
reasonable to assume that recent focus on prevention of wrong-site
surgery has had some effect on reporting.
Statistics
regarding the incidence of wrong-site surgeries vary. Studies indicate
that wrong-site surgery may occur in as many as 1 in 5,000 cases or as
few as 1 in 113,000.3
The Veterans Affairs reviewed reports of wrong-site surgery from 2001
to 2006 and found 209 wrong-site surgeries. This equals averages of 1
wrong-site event in every 18,955 surgical procedures.4
In
surgery, the highest number of wrong-site procedures involves cataract
surgery. This is understandable because both eyes may have cataracts
present and the wrong eye may be operated on. Inguinal hernia repair is
the second highest procedure with reports of wrong-site surgery.5
Regardless
of the numbers reported, wrong-site surgery is defined by TJC as a
"never event," recognizing that any occurrence of a wrong-site surgery
is life changing for the patient involved.6 It should be the goal of any OR, hospital, and procedural area to never have a wrong-site surgery.
Consequences
The
consequences for patients who have undergone a wrong-site procedure
range from life-threatening and debilitating to minor and
inconsequential. The error in the OR could be something as minor as a
small incision where none should exist to removal of a healthy organ or
limb.
There
are also consequences for the staff and surgeons involved. Some state
licensure boards impose penalties, and insurers may cancel coverage for
practitioners involved. Involvement in a wrong-site surgery event may
also lead to legal action to those involved.3
The
punishment those involved inflict on themselves may be even worse.
People go into healthcare to help, and it's often devastating to them
when they've been a participant in a harmful event. A wrong-site surgery
shakes the team member's confidence in their abilities and stays with
them forever.
Causes of wrong-site surgery
It
goes without saying that a great deal of planning goes into any
surgical procedure. The perioperative staff need to demonstrate
satisfactory performance in specific procedural competencies. There are
surgeon preference cards that provide information on what instruments,
supplies, and suture are required. With so many people rushing around
and attending to smaller details, it's easy for the most important and
seemingly obvious items to be overlooked.
Understanding
what type of surgery is being done at what site seems to be a
relatively uncomplicated task until one looks at the number of people
the information passes through before the patient reaches the OR. The
World Health Organization recommends verification at every step in the
process of a surgical case and has developed a safe surgery checklist
that details what information should be confirmed. The checklist
contains preinduction, preincision, and postprocedure details. Patient
identification, procedure, and side/site confirmation are included at
each of these points.7
Any
information that's received verbally (for example, scheduling a case by
phone) should be read back and confirmed for clarity. All written
information should be checked against any documentation provided by
either the surgeon or patient. Information on the surgical schedule must
be compared with what's written on the consent form and checked against
the surgeon's history, physical, and orders. Ideally, there will be
agreement among all of these. If at any time, anyone, including clerical
staff, nurses, certified registered nurse anesthetists (CRNAs), or
physicians, notices a discrepancy, the patient's progress should halt
immediately until variances are resolved. Only then can the patient
continue toward the OR.
The
team as a whole shares responsibility for making sure they're doing the
right thing. The traditional culture in the OR is a barrier that's
slowly falling but still exists.8
Although the personnel involved in a case must function as a team,
there has been a long-standing perception of power differences that
often inhibits some team members from feeling that they can be heard.
For a time out to truly be a team effort, all members of the team must
have a level of comfort and feel that they're empowered to speak up.
Culture
doesn't change overnight, but it's important that everyone involved in a
case has a true understanding of proposed procedures and the ability to
stop the process if there is even the possibility of an error. The
required culture change requires active support from the top and a clear
expectation from administrators that speaking up isn't just an option,
it's a requirement. A clear and defined process for reporting deviance
from policy auditing performance helps assure that progress is being
made. Management presence provides support and underscores commitment to
patient safety.
Strategy for prevention
Several
strategies have been developed to help reach that goal. Among these are
correctly identifying the patient, identification of the intended
surgical site, and the time out prior to any procedural intervention.
Step back and take a look at site marking and the time out, and it'll
become evident that these strategies are truly just communication tools
aimed at increasing effective communication among all team members.
Communication has been identified as the most often recognized cause of wrong-site surgery sentinel event.9 TJC reported that poor communication was the cause of nearly 70% of sentinel events in 2005.10
When
any project involves potential harm to a person, it's essential that
the communication is clear at all times. Any time there is more than one
person involved in a project, the potential for poor communication
exists. The additional barriers of having new perioperative team members
who may not know each other involved in a complex and stressful
situation heightens the risk and demonstrates the need that a plan must
be in place to decrease the chance of a bad outcome.
Every
step leading into the OR involves communication between patients,
nurses, and physicians. Assuring that cases are posted correctly, that
all pertinent and required documentation is present, and that the
operative site is correctly identified and marked is a collaborative
effort. Before the patient reaches the OR, there are multiple
opportunities to identify discrepancies and prevent irreversible harm
from occurring. Once the door is closed and the patient is asleep, the
circumstances narrow the chances of stopping an error. This is where the
time out comes in.
TJC recommends that when possible, the patient should be involved in the surgical verification process.11
Each facility is charged with developing its own procedures, and many
ORs decide to perform the time out immediately prior to the incision. If
the time out is performed after the patient is anesthetized, it's
essential that a complementary process be developed to include the
patient in the surgical site identification prior to being medicated.6
The
time out communication, then, is actually an opportunity for the team
to speak on behalf of the patient. The OR team becomes the patient's
advocate by implementing the time out. The time out is intended to be
the ultimate communication tool between members of the team before an
irreversible and potentially life-changing mistake is made.
What should the time out look like?
The
time out should be exactly that. Every member of the team should take
time to focus attention on the patient. This is easier said than done.
The immediate preoperative period is, by nature, a period when there are
multiple tasks that must be accomplished to start a surgical procedure.
The daily flow of a typical OR usually requires that these tasks take
place efficiently in a relatively short period of time. This compressed
time period leaves little opportunity for most team members to think
about much other than their unique role in the upcoming case.
Each
member of the team is, by necessity, concentrating on their individual
role and completing their responsibilities so the case can start.
Because of the attention to the details that make up a surgical case,
it's easy to lose focus on the "big picture." For years, the assumption
has been that everyone knows what they're doing. The occurrence of
wrong-site surgery disputes that assumption.
In
theory, almost everyone agrees that a "time out" before surgery is a
good idea. The surgical time out, first widely implemented in 2001, is
designed to take that last second look at the essentials of each case
and assure that the right people are in place to do the correct
procedure, on the correct patient, at the correct site. The elimination
of wrong-site surgeries became a Joint Commission National Patient
Safety goal in 2003, and in 2004, the Universal Protocol was introduced.
The Universal Protocol provides three redundant checks to assure that the correct procedure is being performed.11
The first is the preprocedure verification and proper identification of
the patient. The second step is marking of the operative site, and
finally, the time out is performed immediately before surgery. If
performed as intended, these steps will assure that the correct surgical
procedure is performed.
In
practice, the time out isn't consistently performed and is often
lacking at least one of the steps defined in a facilities policy. One
study demonstrated only 60% adherence with established requirements
following extensive staff and physician education.1
Although perioperative staff indicated that they felt the time out
would improve patient safety and expressed willingness to undergo
training, France and colleagues observed behaviors in surgery didn't
support this.10
Failure
to complete the time out process was properly implicated in a large
number of surgical observations. Failures included performing the time
out at the wrong time (that is, positioning the patient before the time
out), making the incision before or during the time out, and failure to
complete all elements correctly. In a study investigating surgical site
marking and time out, Johnston et al. found the time out was performed
after the incision in 19% of surgeries and not performed at all in 11%
of the surgeries reviewed.12
Variances
in how the time out is performed are very common. Although most
hospitals and ambulatory surgery centers (ASCs) have well-thought-out
policies and well-designed processes, these are meaningless unless the
surgeons and staff understand their value and follow them consistently.
Staff
may interpret the time out policy and expectations according to their
own understanding. What seems clear to one person may mean something
very different to another. Clarity in writing the policy, along with
education and implementation, can help mitigate the outcome when people
read different things into it.
Many
ORs belong not just to a hospital, but to a hospital system. That makes
it even more important to establish clear, unambiguous rules for the
time out. If a surgeon sees the time out performed in one place, it's
important for him or her to see the same process everywhere else
throughout the system.
Consistency
in practice makes it easier to both understand and enforce the intent
of the policy. Inconsistency not only decreases adherence, but it also
degrades the importance. If there's a feeling among practitioners that
the time out can be done anyway they choose, it lessens the impact and
indicates that there's no real value in the time out.
TJC
and World Health Organization have defined essential elements of the
time out, and most hospitals use these as a starting point for their
time out policy. Many hospitals recognize the value of the last-minute
review and have used the time out as an opportunity to address other
issues to increase adherence to other measures, including the Surgical
Care Improvement Project (SCIP).
TJC requires, at a minimum, that correct patient identity, correct site, and procedure are confirmed during the time out.11 Many hospitals choose to include additional elements, including the following:
* an accurate consent form that contains patient, witness, and surgeon signatures
* correct patient position
* relevant images properly labeled and correctly displayed
* need to administer antibiotics
* availability of necessary supplies and implants.
TJC
has also identified several other elements that make a time out
effective. These include cessation of all other activities by all team
members, full engagement of all team members, and verbal agreement by
everyone involved in the procedure that the correct procedure is
planned.13
While
each institution creates its own policy regarding surgical site
verification, the essential items should be present in all policies.
When the time out occurs, the existing policy should be followed exactly
every time. Studies have shown that in nearly half of observed time
outs, the OR team doesn't follow the facility's policy.14
At
the time designated in the policy, often immediately prior to the
incision, all staff members in an OR, including surgeons, surgeon's
assistants, anesthesia care providers, circulating nurses, and scrub
persons, should cease all activity. Everyone involved turns their full
attention to the time out. A designated team member leads the time out
and includes all items as described in the policy. This leader speaks
loudly enough to be heard by everyone. At least one team member should
have primary source documentation in hand for comparison to the
information provided in the time out.
Each
team member listens to the leader recite the items. Each person should
verbally agree, again, loudly enough to be heard by all. Verbal
agreement means that everyone understands and agrees with the
information provided in the time out. At any point in the process, if a
team member has questions, doubts, or disagreements with the items as
stated, it's his or her duty to voice them. It's then incumbent upon the
team to stop, resolve any questions to everyone's satisfaction, and
begin the time out again. When there's a final agreement among the team
members, the case can begin.
Scenario II
Ms.
J, birth date 3/14/1951, saw a PA in early January with pain in both
knees (right greater than left). Following several weeks of physical
therapy, the pain was still present, so Ms. J scheduled another visit.
This time, Ms. J saw an orthopedic surgeon at a satellite office. The
surgeon examined the knee and felt that arthroscopy of the right knee
was indicated. The surgeon directed his office staff to "schedule an
arthroscopy," but the chart was at the downtown office, so the note
wasn't entered in the patient record until the next day; a few days
later, the case was scheduled. Ms. J reported to the hospital as ordered
on February 28. The registration desk was busy, but the clerk took time
to verify the date of birth on her armband (3/14/1961). The clerk
removed the armband, corrected the birth date, and confirmed the date of
birth with Ms. J. Once it was verified, the clerk placed the armband on
and sent Ms. J to the prep area.
The
surgery schedule read "arthroscopy" without mention of which knee. The
preoperative nurse asked Ms. J to have a seat while she paged the
surgeon to obtain an order for the consent, which specified which knee
would be operated on.
The
surgeon was running behind with his first case, so the PA stopped by the
holding area to mark the correct knee before Ms. J was taken to the OR.
She was medicated with midazolam in the holding area. When the PA asked
if the left knee hurt, she responded yes, but because Ms. J had been
medicated, the PA checked the history, physical, and the surgeon's order
before marking the right knee.
The
circulating nurse took the patient to the OR, checked the consent,
noted that it matched the procedure posted on the surgery schedule,
positioned the patient, and prepped the knee that was marked. The
surgeon scrubbed and came into the OR. When the circulating nurse
reminded the surgeon it was time to do the time out, he said, "I'm
already late enough," and asked for the scalpel. The surgical
technologist, recognizing that the time out had not been completed,
moved the scalpel to the back table and reminded the surgeon again that
the time out must be completed before the scalpel could be handed off.
After
surgery, Ms. J was dressing to go home and said to the discharge nurse
"Everything was great. I felt like everyone was really looking out for
my best interests."
REFERENCES
1. Clarke JR, Johnston J, Finley ED.Getting surgery right. Ann Surg. 2007;246(3):395-403. [Context Link]
2. The Joint Commission. National patient safety goals. 2013. http://www.jointcommission.org/standards_information/npsgs.aspx. [Context Link]
3. Feldman D.The inside of a time out morbidity and mortality rounds on the web. 2009. http://www.webmm.ahrq.gov/case.aspx. [Context Link]
4. O'Reilly KB.Wrong surgeries a product of poor communication. (2009). http://www.ama-assn.org/amednews/2009/12/07/prsf1211.htm. [Context Link]
5.
Seiden SC, Barach P.Wrong-side/wrong-site, wrong-procedure, and
wrong-patient adverse events: are they preventable. Arch Surg.
2006;141(9):931-939. [Context Link]
6.
Mulloy D, Hughes RG.Wrong Site Surgery: A Preventable Medical Error.
In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based
Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and
Quality; 2008:chap 36. [Context Link]
7. World Health Organization. Patient Safety. http://www.who.int/patientsafety/safesurgery/tools_resources. [Context Link]
8. Makary M, Sexton JB, Freischlag JA, et al.Patient safety in surgery. Ann Surg. 2006;243(5):628-635. [Context Link]
9.
Greenberg CC, Regenbogen SE, Studdert DM, et al.Patterns of
communication breakdowns resulting in injury to surgical patients. J Am
Coll Surg. 2007;204(4):533-540. [Context Link]
10.
France D, Leming-Lee S, Jackson T, Feistritzer NR, Higgins MS.An
observational analysis of surgical team compliance with perioperative
safety practices after crew resource management training. Am J Surg.
2008;195(4):546-553. [Context Link]
11. The Joint Commission. The Universal Protocol for preventing wrong site, wrong procedure, and wrong person surgery. http://www.jointcommission.org/assets/1/18/UP_Poster1.PDF.
12.
Johnston G, Ekert L, Pally E.Surgical site signing and "time out":
issues of compliance or complacence. J Bone Joint Surg Am.
2009;91(11):2577-2580.
13.
Altpeter T, Luckhardt K, Lewis JN, Harken AH, Polk HC.Expanded surgical
time out: a key to real-time data collection and quality improvement. J
Am Coll Surg. 2007;204(4):527-532.
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Sunday, June 2, 2013
JURNAL KEPERAWATAN : Time out is just another way to say communicate
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