Patient Safety Tip of the Week
December 13, 2016
More on Double-Booked Surgery
It’s only been two weeks since our last column on
double-booked surgery (see our November 29, 2016 Patient Safety Tip of the Week
“Doubling
Down on Double-Booked Surgery”)
but already there have been two significant publications regarding the
practice.
We previously noted the paucity of evidence in the
literature for or against the practice of double-booked surgery. In our November 10, 2015 Patient Safety Tip of
the Week “Weighing
in on Double-Booked Surgery” we noted Massachusetts General Hospital’s
review of its own cases. And in our November 29, 2016 Patient Safety Tip
of the Week “Doubling
Down on Double-Booked Surgery”
we highlighted the study done by Zhang and colleagues at UCSF comparing
overlapping cases with non-overlapping cases for a variety of orthopedic
surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). The latter
found no difference in patient operating room time, procedure time, and 30-day
complication rates between overlapping and non-overlapping surgery.
Now a new retrospective review has compared overlapping
surgery with nonoverlapping surgery at the Mayo Clinic (Hyder
2016). Over 10,000 cases of overlapping surgery were matched to a similar
number of nonoverlapping surgeries. Adjusted
odds ratio for inpatient mortality was greater for nonoverlapping procedures
(adjusted odds ratio, OR = 2.14 vs overlapping procedures) and length of stay
and morbidity were no different.
That’s reassuring in that it likely means that the overall
occurrence of adverse events related to double-booked or overlapping cases is
small. The frequency of retained surgical items or wrong-site surgery is also
small but that doesn’t mean we don’t need to take steps to prevent such adverse
events. The same applies to double-booked or overlapping surgery. The Hyder
review also cannot conclude that there were no adverse events related to
overalapping surgery since they did not do full case reviews on all cases. And,
while they did the best they could in matching overlapping cases to
nonoverlapping cases, we don’t know why the latter were done without
overlapping. There may well have been a selection bias in which some factor not
accounted for in the risk adjustment led the surgeons to schedule these cases
as nonoverlapping. And you’ll recall in our November 29, 2016 Patient Safety
Tip of the Week “Doubling
Down on Double-Booked Surgery”
we also described a scenario where as complication that could have been
prevented had a post-op debriefing been done for one case of an overlapping surgery
actually gets attributed instead to a nonoverlapping case. And, lastly, the
results from a single academic center may not be generalizable to other
academic centers or to non-teaching venues.
In addition, the
Boston Globe (Saltzman
2016) recently noted an unpublished study by an assistant professor of
surgery at the University of Toronto found an increased risk for postoperative
complications in concurrent surgery for hip fractures. The study, which used
data from about 100 hospitals, compared about 1,000 concurrent hip surgeries
with 1,000 that were not performed simultaneously from 2009 to 2014. They noted
that the longer the overlap, the greater the rate of complications. From the
Globe article, however, it is not clear whether these surgeries were concurrent
or overlapping, an important distinction as we’ll note below under definitions.
The second, and perhaps
more significant, publication comes not from traditional medical literature but
rather from the Senate Finance Committee! You may recall that, after the
2015 Boston Globe investigative report (Abelson
2015) on the practice of
double-booked surgery, the Senate Finance Committee, which oversees CMS
(Centers for Medicare & Medicaid Services), launched an investigation into
double-booked surgery. It has just released a report on the findings of that
investigation (Senate
Finance Committee 2016). That committee solicited responses from 20
academic medical centers regarding a variety of issues surrounding
double-booked surgery plus received testimony from CMS, The Joint Commission, the American College of Surgeons (ACS), AHRQ, the HHS OIG, and
multiple other stakeholders.
After the American College of Surgeons issued its position/guidance
on concurrent and overlapping surgery (ACS 2016) all of
the 20 medical centers responding to the Senate committee had either modified
their existing policies, adopted new policies, or were in the process of
adopting new policies on double-booked surgery. The Senate committee reviewed
those policies and other key issues and, while generally comfortable with the
progress made to date, had some additional recommendations.
Hereafter, we’ll refer to “overlapping” surgery. The
definition of “concurrent” surgery is a practice in which a surgeon is
participating in the “critical portion(s)” of 2 cases simultaneously. The ACS
and the Senate committee and pretty much all parties agree that “concurrent” surgery should never be
performed.
The Senate committee specifically looked to see if the
hospital policies conformed to the ACS guidance on the following:
- Defining concurrent and
overlapping surgeries.
- Defining the critical
portions of an overlapping surgery.
- Disclosing information to
patients.
- Defining immediately
available.
- Arranging for a backup
surgeon.
- Ensuring compliance with
the new policies.
Under the definitions
of concurrent and overlapping surgeries, they wanted to see that “concurrent”
surgery was defined and specifically prohibited. They also looked to see that
hospitals used the ACS definitions for the 2 types of “overlapping” surgeries
(see our November 29, 2016 Patient Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
for those definitions from the ACS). Half the respondent hospitals used
the ACS definitions but several had used definitions that were more vague.
They drew special attention to one hospital policy that
required department chairs allow surgeons to conduct overlapping surgery only
after reviewing the surgeons’ outcome and quality data. In our November 29,
2016 Patient Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
we recommended that such review be conducted as part of both the credentialing
and privileging process for new surgeons and for continuation of
privileges for “overlapping” surgeries for current surgeons, keeping in mind
that some older surgeons may maintain their surgical skills even as their
ability to multitask deteriorates.
As you might expect,
there was more variability when it came to defining “critical portions”
of overlapping surgeries. Basically, both CMS and the ACS guidance leave that
definition up to the individual surgeon. Most of the hospital policies reviewed
by the Senate committee either did not define the critical portions or left it
up to the attending physician. A few hospitals, however, did develop lists of
procedures (usually by department) and their critical components. The report
also notes that discussion of the “critical portions” could be part of the
pre-op “huddle” or surgical “time out” and could also be written on the OR
white board.
The Senate report
notes that both CMS and the ACS generally consider opening and closing of the
surgical site as not critical. But in our November 29, 2016 Patient
Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
we gave real-life examples of some instances where circumstances identified
after wound closure would likely merit return of the attending surgeon, with
resultant increases in patient time under anesthesia.
The Senate report
recognizes that the optimal manner of defining “critical portion” is wanting.
But it does find merit in the approach where “surgical departments within a
hospital’s medical staff develop guidelines that identify critical components
of particular procedures while accounting for the individualized clinical
judgment of the surgeon”. We feel strongly that there must be definitions that
are uniform for each of the surgical procedures done within a department and
across departments when the same procedure is done by multiple departments.
(Definitions set by the “hospital” would really have to rely upon the expertise
of department chairs, anyway.) Likewise, we would hope that each specialty
society will help develop such definitions so that regulatory bodies don’t have
to step in and develop such for them.
When overlapping
surgery is performed, there should be designation of a backup surgeon
who will be “immediately available” to intervene if the original attending
surgeon is doing other surgery. Defining “immediately available”, as
anticipated, was controversial. There was wide variation in the timeframes and
locations in the policies of respondent hospitals. A third simply stated the
surgeon must be “on campus”, which does not specify how readily he/she could
respond. Some did not define immediately available at all. Others noted
specific timeframes, such as 5 minutes or 15 minutes. The Senate report notes
that neither CMS nor the ACS defined the term adequately. The ACS guidance does
state the surgeon should be “reachable through a paging system or other electronic
means, and able to return immediately to the operating room.”
The Hyder study (Hyder
2016), in describing overlapping surgery as performed at the Mayo Clinic,
noted that “Each surgical specialty
operates in dedicated operating room cores with multiple surgeons of the same
specialty present throughout the business day; therefore, second surgeons are
available to assist when needed.” That’s simply not good enough. A specific
surgeon needs to be designated for each such overlapping case and that surgeon
must not be doing activities that would preclude him/her from immediately going
to the OR case in need of help (nor jeopardizing any other patient he/she may
have been involved with prior to the call for help).
The Senate report
notes that some hospitals set additional expectations for the backup surgeon.
For example, he/she should be credentialed/privileged to perform the procedure
being done, be willing to serve as backup, and be fully aware of the
responsibility. The ACS apparently testified that some surgical fellows, with
appropriate training, could be qualified to serve as the backup surgeon. We
especially like what some policies require regarding communication about the
backup surgeon:
- Name of the backup surgeon must be communicated to the OR staff (it
could be noted verbally as part of the surgical “time out”, be written on
a white board in the OR, or documented in the patient’s medical record).
- Any member of the surgical team should be able to call the backup
surgeon in to the surgery.
The section of the
Senate committee report dealing with informed consent is quite useful.
It makes it clear that patients must be informed that their surgeon will not be
in the operating room for parts of their surgery. But their review of informed
consent documents found only 3 in which the consent forms explicitly stated the
patient was scheduled to have overlapping surgery and that their surgeon would
not be present for portions of their surgery. Many hospitals used wording too
vague, such as their surgeon “may” be involved in other surgeries. In addition,
6 hospitals had wording that other providers may perform portions of their
surgery without mentioning that their attending surgeon might not be present
for those portions.
Moreover, it
emphasizes that patients must be made aware of this in a manner in which they
fully comprehend the implications and have both the ability to ask questions
and refuse to have overlapping surgery. They cite an informative Health Affairs
Blog by Dr. James Rickert dealing with informed consent in such cases (Rickert
2016). Rickert discusses the problems of ensuring patients truly understand
what is told to them during informed consent and suspects that in discussing
overlapping surgery “Euphemisms, incomplete information, and oblique discussions
will be the norm.” It is clear that this discussion must take place at a time
when the patient would have adequate time to digest the information, ask
questions, and be able to cancel the surgery if desired. So having the
discussion on the day of surgery is a no-go. Some of the hospitals included a
specific time period, such as “at least 24 hours prior to the surgery”, but many
left the wording vague such as “sufficiently prior to” surgery.
Some hospitals
included in their general surgery consent a place for a patient to initial or
sign that he/she understands their surgeon may be absent for a portion of their
surgery. The report provides an excellent example the specific text of a
paragraph one hospital uses on its form that must be signed by patients only in
cases where overlapping surgery applies. Rickert notes that when surgery is
first discussed, surgeons should tell patients if they practice simultaneous
surgery, and explain what this will mean for them in the operating room. Because
surgery schedules for elective procedures are usually done weeks or even months
ahead of time, patients would then have sufficient time to find another surgeon
if they are uncomfortable with the practice of simultaneous surgery. You’ll
also recall from our November 29, 2016 Patient Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
the practice at UCSF in the Zhang study (Zhang 2016) typically involved such discussion during a
clinic visit, typically a week prior to surgery and in the editorial
accompanying the Zhang study, Healy (Healy 2016) recommended
obtaining specific informed consent at least 2 weeks prior to the operation.
Our November
29, 2016 Patient Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
also cited a viewpoint on informed consent in concurrent surgery (Langerman
2016) which pointed out the “information asymmetry” involved, where
“surgeons know much and our patients know little about what will happen during
their operation.” Patients may not understand the implications of potentially
spending extra time under anesthesia in the event their surgeon is delayed in
responding to something in their case because he/she is doing surgery on
another patient. Most patients in academic centers understand that physicians
in training will actively participate in the surgery and likely improve the
quality of their overall care. But they also likely expect that their primary
surgeon will be present to oversee all aspects of their surgery.
We would also like
to point out a surgeon should never refuse to perform surgery on a patient who
refuses to consent to overlapping surgery. It may be appropriate to let a
patient know his/her surgery may not be able to be scheduled as soon if it is
not overlapping. But to refuse to do the surgery as a nonoverlapping case would
be unethical. We feel that including specific wording to that effect in the
informed consent document or the educational materials provided to the patient
should be part of every hospital’s policy on overlapping surgery. And hospitals
obviously need to make it clear to their staff that such refusal would not be
tolerated.
Perhaps the
strongest recommendations in the Senate committee report deal with ensuring
compliance with policies. The report stresses that developing policies on
overlapping surgery are an important first step but that training all staff to
ensure they understand the policies and then overseeing that the policies are
adhered to are critical steps. They liked language
similar to that used by some hospitals:
- Hospitals will conduct quarterly or random audits of adherence to
the overlapping policy and/or of the performance of surgeons performing
overlapping operations.
- Hospitals will conduct audits or monitor reports of overlapping
surgeries to ensure compliance with CMS’s billing requirements for
teaching physicians.
- Staff should report observed violations of the overlapping surgical
policy.
- Violations of the overlapping surgical policies may result in a loss
of a surgeon’s overlapping surgical privileges.
They also liked
language used by some hospitals to describe roles played by others staff in
ensuring compliance with the policies:
- Anesthesiologists may reschedule, delay, or cancel surgical cases in
order to ensure policy compliance and appropriate behavior.
- Fellows, residents, or qualified assistants may initiate a procedure
only if the surgeon is present within the hospital and not involved in the
key portions of another surgery.
Monitoring surgeon
location and tracking the critical portions of the surgical procedures is also
considered important in the Senate committee report. Many hospital policies simply
used the CMS billing requirement that the surgeon document in the medical
record that he/she was present for the critical portion(s) of the surgery. We
previously noted the Massachusetts Board of Registration in Medicine
proposal requiring that surgeon presence
or absence in the room at various times be documented. We like the latter
idea. We actually have proposed hospitals record entry and exit of all OR personnel in attempt to reduce
opening and closing of OR doors (which may predispose to infections) as
described in our July 26, 2016 Patient Safety Tip of the Week “Confirmed:
Keep Your OR Doors Closed”.
In our November
29, 2016 Patient Safety Tip of the Week “Doubling
Down on Double-Booked Surgery”
we also suggested that you might as part of your quality management
program occasionally try to get hold of that “backup” physician and see how
long it actually takes for him/her to get to the OR.
The Senate committee was also concerned that hospitals need
to specify how complaints about surgeries from patients or staff would be
addressed.
Missing from the Senate committee report, from our
perspective, is discussion about pre-op huddles/briefings and post-op
debriefings. We’ve discussed these important issues in our Patient Safety Tips
of the Week for November 10, 2015 “Weighing
in on Double-Booked Surgery” and November 29, 2016 “Doubling
Down on Double-Booked Surgery”.
The Senate committee
report does make mention of the surgical time out only in that the “time out”
should include identification of the backup surgeon. It also notes that
discussion of the “critical portions” could be part of the pre-op “huddle” or
surgical “time out” and could also be written on the OR white board. We also
think that the surgeon should announce during both the pre-op “huddle” and
surgical “time out” that he/she will be doing an overlapping case and when
staff can expect him/her to leave the current case. For the second case, the
surgeon obviously needs to be present for the surgical “time out”. But what
about the pre-op “huddle” for that second case? Is it skipped? Is it done prior
to the first case? And, remember, if you do two pre-op huddles back-to-back you
may be vulnerable to transposing information or intents between cases,
particularly when the cases are similar procedures.
The Senate committee report tried to get an estimate of the
scope of overlapping surgery across the US. But they found such statistics are
difficult to come by. At respondent hospitals the percentages of overlapping
cases ranged from less than 1% to 33% of all surgeries. The percentage of overlapping
cases was even higher for some specific surgeons.
The Senate report also notes that neither CMS nor The Joint
Commission has specifically investigated overlapping surgery in their surveys.
The HHS OIG has audited billing practices at teaching hospitals and has found
several violations over the years, resulting in fines for those hospitals. So
the Senate Finance Committee has also recommended that CMS and the HHS OIG
review compliance with billing practices related to overlapping surgery. They
also note that the CMS billing guidelines only apply to teaching hospitals. The
Senate committee recommends that CMS also review whether those billing
requirements should also be applied to non-teaching venues where overlapping
surgery may be done (private hospitals, ambulatory surgery centers, etc.).
The recent Boston
Globe article (Saltzman
2016) also included a comment from the chairman of surgery at the
University of Michigan, stating that “the practice benefits only the surgeons
who get to do it by increasing their productivity. It is inefficient for all
other medical staff, he said, including other surgeons who lose operating room
time.” We hadn’t quite thought about it in that way but it is really in keeping
with our conviction that the fundamental driving force for double-booked
surgery is the financial incentive.
As before, we personally would not consent to any form of
double-booked surgery and expect our attending surgeon to be present at our
procedure even when portions of the surgery are being performed by residents,
fellows, or other personnel. While we would hope most hospitals eliminate or
minimize any form of double-booked surgery, we would expect those hospitals
allowing overlapping surgery meet the positive elements noted in this column.
For those of you who plan to allow overlapping surgery at
your institution, we offer the the “Overlapping
Surgery Checklist” to help you plan for safe implementation.
See all our columns
on double-booked, concurrent, or overlapping surgery:
- November 10, 2015 “Weighing
in on Double-Booked Surgery”
- November 29, 2016 “Doubling
Down on Double-Booked Surgery”
- December 13, 2016 “More
on Double-Booked Surgery”
And our “Overlapping Surgery Checklist”
References:
Zhang AL, Sing DC, Dang DY, et al. Overlapping Surgery in
the Ambulatory Orthopaedic Setting. J Bone Joint Surg Am, 2016; 98 (22): 1859-1867
http://jbjs.org/content/98/22/1859.full
Hyder JA, Hanson KT, Storlie CB, et al. Safety of
Overlapping Surgery at a High-volume Referral Center. Annals of Surgery 2016;
Published ahead of print (Post Author Corrections): December 5, 2016
Saltzman J, Abelson
J. Senate committee calls for ban on surgeons conducting simultaneous
operations. The Boston Globe 2016; December 6, 2016
Abelson J, Saltzman J, Kowalcyzk L, Allen S. Clash in the
Name of Care. Boston Globe October 26, 2015
http://apps.bostonglobe.com/spotlight/clash-in-the-name-of-care/story/
Senate Finance Committee. Concurrent and Overlapping
Surgeries: Additional Measures Warranted. A Senate Finance Committee Staff
Report 2016; December 6, 2016
http://www.finance.senate.gov/imo/media/doc/Concurrent%20Surgeries%20Report%20Final.pdf
ACS (American College of Surgeons). Statements on
Principles. Revised April 12, 2016
https://www.facs.org/about-acs/statements/stonprin
Rickert J. A
Patient-Centered Solution To Simultaneous Surgery.
Health Affairs Blog 2016; June 14, 2016
http://healthaffairs.org/blog/2016/06/14/a-patient-centered-solution-to-simultaneous-surgery/
Healy WL. Overlapping Surgery: Do the Right Thing.
Commentary on an article by Alan L. Zhang, MD, et al.: “Overlapping Surgery in
the Ambulatory Orthopaedic Setting”. J
Bone Joint Surg Am, 2016; 98 (22): e101
http://jbjs.org/content/98/22/e101?iss=22
Langerman A. Concurrent Surgery and Informed Consent. JAMA
Surg 2016; 151(7): 601-602
http://archsurg.jamanetwork.com/article.aspx?articleid=2504500
Our own “Overlapping Surgery Checklist”.
http://www.patientsafetysolutions.com/docs/Overlapping_Surgery_Checklist.htm
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