Cases & Commentaries

The Inside of a Time Out

Commentary By David L. Feldman, MD, MBA

The Case

A 65-year-old man was scheduled for an elective
endovascular repair of an abdominal aortic aneurysm. The patient
had an allergy to "IV contrast dye" that was noted during his
preoperative clinic visit with an anesthesiologist. The surgical
physician assistant (PA) documented in a preoperative note that
hydrocortisone should be used before surgery, but no such order was
written. On the day of surgery, a different anesthesiologist
expressed concern about the reported allergy and planned to discuss
with the surgeon—mostly to understand the nature and severity
of the allergy. Fighting time pressures, driven at least in part by
a new policy that tracks and reports delays into the operating room
(OR), the anesthesiologist and his resident induced general
anesthesia, and the resident remained in the room as the attending
left the OR to address an issue regarding another patient.

In the OR, the patient was surrounded by an
attending surgeon, two surgical residents (but not the PA), two
medical students, nursing staff, and a surgical device sales
representative. A "time out" was conducted, during which a nurse
raised concern about the alleged allergy. Everyone else in the room
looked to the anesthesia resident for input. The resident, probably
intimidated by the situation he found himself in, haltingly began
to discuss the allergy, but the surgeons in attendance quickly came
to a "consensus" to administer hydrocortisone and proceed. The
anesthesiology attending returned to the room, upset not to be
included in the time out. He felt that his resident didn't speak up
to adequately address the allergy concern, in part because of the
atmosphere in the OR. While the patient did well during the
surgery, with no evident allergic reaction, the experience raised
concerns about whether time out procedures were serving their
intended role.

The Commentary

In 2003, the Joint Commission made the
elimination of wrong site surgeries a National Patient Safety Goal
and the following year required compliance with a Universal
Protocol.(1,2)
The Universal Protocol requires three separate steps: the proper
preoperative identification of the patient by the three members of
the team (surgeon, anesthesiologist, nurse), marking of the
operative site, and a final "time out" just prior to the surgery or
procedure regardless of where it is being performed.(2) Despite the spirit of these guidelines, controversy
surrounds the Universal Protocol, and in particular the time out
portion of it, since there continues to be little scientific
evidence of its ability to eliminate wrong site surgery.(3-5)

Wrong Site
Surgeries

Debate over the exact incidence of wrong site
surgery cases in the United States stems from conflicting data,
which suggest rates varying from 1 in 5,000 to 1 in 113,000
surgical cases.(1,3,4)
Most would agree that determining a true number is difficult due to
underreporting, difficulties in defining exactly what constitutes a
wrong site surgery, and understanding what is the "denominator for
potential opportunities."(1)
Regardless of the actual numbers, public opinion, regulatory
agencies, and organized medicine have all identified the reduction
of wrong site surgeries as a high priority patient safety
initiative. Past analyses of wrong site surgeries reveal that most
emanate from the OR itself, but it is clear that mistakes made
prior to the day of surgery also account for some of these
errors.(3)
Therefore, even an optimal time out will not prevent all wrong site
surgeries, forcing physicians and institutions seeking to reduce
the incidence of these events to look outside of the OR. This may
include addressing what happens in physicians' offices as well as
in radiology and laboratory settings.

Anatomy of a Time
Out

From a practical perspective, the exact manner in
which the time out is conducted varies considerably from
institution to institution—in timing, content, and
documentation. The time out portion of the Joint Commission
Universal Protocol requires an "[a]ctive communication among all
members of the surgical/procedure team, consistently initiated by a
designated member of the team, conducted in a 'fail-safe' mode," so
that the planned procedure is not started if a member of the team
has concerns.(2) In
some institutions, the time out occurs just prior to induction,
since it is at that time that the anesthesia team is most attuned
to that patient's particular needs. Unfortunately, in many teaching
facilities, the surgical attending may not yet be physically
present, and performing the time out at induction leaves potential
for error between induction and incision. For this reason, New York
State now requires that the time out take place immediately prior
to the incision, a practice performed in many other institutions
across the country as well.(6) In
this scenario, the entire surgical team is present, but the
anesthesia attending, who may be "double covering" more than one
operating suite (as occurred in the present case), may be in an
adjacent room supervising the induction of another patient. This
creates two problematic issues. The first is a delay waiting for
the anesthesiologist to arrive, potentially pushing the busy
surgeon to begin without the attending (as in the case presented).
Second, when the anesthesiologist does arrive, s/he is hurried and
potentially thinking more about the patient who s/he just intubated
rather than the patient in question.

With respect to the "content" of a time out, the
Joint Commission requires confirmation of the correct patient,
correct side and site, agreement on the procedure to be performed,
correct patient position, and availability of needed
equipment/supplies/implants. Some states, including New York, also
require the presence and review of relevant radiologic images (if
applicable).(6)
Furthermore, many institutions have begun to include broader
patient safety practices into the time out, since it's an opportune
time for the entire team to confirm that important (and often
preventive) steps have been taken. The so-called expanded time
out
(7) can
include procedures to ensure the administration of prophylactic
antibiotics, venous thromboembolic prophylaxis, beta-blockers, the
use of a neutral zone (a designated container used to pass sharps,
rather than from hand to hand) and blunt suture needles, and other
pertinent patient and staff needs depending on the nature of the
procedure. Clearly, this process may be more complicated and
lengthy for an open heart surgery case than for a routine
tonsillectomy. While the typical time out (whether limited or
expanded) may essentially be the review of a checklist, some have
argued that asking open-ended questions, such as those that occur
in a briefing (or if at the end of a procedure, a debriefing), may
help make "operative hazards more visible."(8,9) As an example, in a briefing the surgeon might ask
the anesthesiologist if there are any particular patient care
issues or concerns, and ask the circulating nurse if there are any
supply issues. While the Universal Protocol currently mandates that
a time out occur immediately prior to the procedure, some have
suggested that a debriefing occur after the procedure as
well.(1)

Finally, documentation of time outs also poses
difficulties, particularly given the wide number of variations on
the theme. If the time out occurs at the time of incision, the
surgeon is already scrubbed in, leaving only the anesthesiologist
and nursing staff available to document that the time out has taken
place. This places responsibility for the time out in the hands of
the designated documenter, who may later be blamed if a subsequent
retrospective chart review discovers that one was not performed.
The intent of the time out is for the team to collectively discuss
the case, but, given the requirements to ensure it occurs, best
practices must also address the issue of who documents the
communication—the individual responsible for having it (e.g.,
a surgeon) or the one already documenting other aspects of the
case.

Are Time Outs Actually
Happening?

Time outs are mandated by the Joint Commission,
and hospitals have an obligation to ensure they are being
performed. The simplest way to ensure this is through retrospective
chart review. Most hospital charts contain a special form, which
includes all components of the Universal Protocol with the final
time out signed-off on by a member of the team. Unfortunately,
complying with the letter of the law can be radically different
than complying with its spirit. Furthermore, in hospitals where
time outs occur regularly and with meaning, it is the attending
surgeon who initiates the process with the active involvement of
the anesthesia and nursing staff.(10)

It is likely that the traditional culture found
in surgical settings does little to enable the kind of
communication that the Universal Protocol and time out encourage.
Lingard and colleagues point to three cultural barriers to
effective time outs, including that the members of the OR team are
used to working independently, that they embrace individual
excellence, and that they are "overwhelmed by chronic staff
shortages, educational duties, and economic pressures."(11)
Others suggest that the need for respect amongst the members of the
team is a crucial determinant of the success of time outs; without
it, the ability of people lower on the totem pole to speak up may
be lost.(12) At
selected institutions, a process is being put into place that
addresses the issue of respect and frustrations that cause members
of the team to lash out at one another.(12; D. Dull, Spectrum
Healthcare, oral communication, February 6, 2008) In one example, a
surgeon became angry and disrespectful when a scrub nurse, upon
relieving another, spent valuable OR time reorganizing a set of
complicated orthopedic instruments on the back table. The surgeon
was confronted about his behavior and apologized to the nurse, but
was also told that the nursing staff would be establishing new
guidelines to ensure standardization of the orthopedic tables so
that nurse exchanges could be more efficient.

Best Practices for a
Time Out

While real
incorporation of the Universal Protocol's time out into the daily
surgical schedule of a typical American hospital is far from
complete, a few best practices have emerged. With regard to timing,
it seems that the closer to actual incision time the time out
occurs, the less likely a mistake can be made that is irreversible.
This does not preclude having additional time outs at other
critical points prior to incision, such as just prior to placement
of a spinal anesthetic, and this is a practice that truly expert
teams take the opportunity to have. Similarly, when multiple
surgeons are performing different procedures during the same
operative session, multiple time outs should also be occurring.
Expert teams will also tailor the content of their time out to the
specific procedure—using a combination of checklists and
debriefings to maximize the amount of information communicated to
team members before, during, and after a procedure. As more
evidence-based practices become known, an increasing number of
items will be reviewed in these expanded time outs. Finally, it
would seem appropriate for all members of the team to perform
documentation of the time out: nurses and anesthesiologists
documenting its occurrence in their respective records and surgeons
documenting in the operative report. In the future, all
documentation should be electronic, making it easy to confirm
retrospectively that the time out has occurred.

Take-Home Points

  • All health care providers performing
    invasive procedures must adopt the Joint Commission Universal
    Protocol, including performance of a time out immediately prior to
    the procedure.
  • Best practices suggest that the time out
    be led by the physician responsible for performing the procedure
    with active involvement by all members of the team caring for the
    patient during the procedure.
  • A checklist format is acceptable, but
    the use of open-ended questions may be helpful.
  • Each institution should decide how the
    Universal Protocol and time out are documented, but care must be
    taken to not make one member of the team feel responsible for the
    process when it clearly must be a joint endeavor.
  • Every facility needs to examine the
    pervasiveness of traditional cultural barriers that prevent some
    members of the team from speaking up, since this will significantly
    hamper any patient safety effort, especially the performance of a
    quality time out.

David L. Feldman, MD, MBA
Vice President Perioperative Services
Vice Chairman Department of Surgery
Maimonides Medical Center, Brooklyn, New York

References

1. Clarke JR, Johnston J, Finley ED. Getting
surgery right. Ann Surg. 2007;246:395-405. [go to
PubMed]

2. Universal Protocol for Preventing Wrong Site,
Wrong Procedure, Wrong Person Surgery. Oakbrook Terrace, IL: Joint
Commission. Available at: http://www.jointcommission.org/NR/rdonlyres/
E3C600EB-043B-4E86-B04E-CA4A89AD5433/0/universal_protocol.pdf
.

3. Kwaan MR, Studdert DM, Zinner MJ, Gawande AA.
Incidence, patterns, and prevention of wrong-site surgery. Arch
Surg. 2006;141:353-358. [go to
PubMed]

4. Rothman G. Wrong-site surgery. Arch Surg.
2006;141:1049-1050; author reply 1050. [go to
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5. Seiden SC, Barach P. Wrong-side/wrong-site,
wrong-procedure, and wrong-patient adverse events: are they
preventable? Arch Surg. 2006;141:931-939. [go to
PubMed]

6. New York State Surgical and Invasive Procedure
Protocol for Hospitals, Diagnostic and Treatment Centers,
Ambulatory Centers, and Individual Practitioners. Albany, NY: New
York State Department of Health; September 2006. Available at:
http://www.health.state.ny.us/professionals/protocols_and_guidelines/

surgical_and_invasive_procedure/docs/protocol.pdf.

7. Altpeter T, Luckhardt K, Lewis JN, Harken AH,
Polk HC Jr. Expanded surgical time out: a key to real-time data
collection and quality improvement. J Am Coll Surg.
2007;204:527-532. [go to
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8. Pronovost PJ, Makary MA, Rowen LC. Evaluation
of a preoperative checklist and team briefing among surgeons,
nurses, and anesthesiologists to reduce failures in
communication—invited critique. Arch Surg. 2008;143:18.
Available at: http://archsurg.ama-assn.org/cgi/content/extract/143/1/18

9. Makary MA, Mukherjee A, Sexton JB, et al.
Operating room briefings and wrong-site surgery. J Am Coll Surg.
2007;204:236-243. [go to
PubMed]

10. Napolitano LM. Expanding 'Time Out.' Paper
presented at: 2007 Executive Symposium on Surgical Safety; July
15-17, 2007; Beaver Creek, CO.

11.
Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative
checklist and team briefing among surgeons, nurses, and
anesthesiologists to reduce failures in communication. Arch Surg.
2008;143:12-17. [go to
PubMed]

12.
Feldman DL. No room for disrespect: changing attitudes to reduce
operating room risk. Infocus. 2006;2:14-15.