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November 29, 2016
Doubling Down on Double-Booked Surgery
A year ago, we did our first column on double-booked surgery (see our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery”). The practice, also known as concomitant or concurrent surgery or overlapping surgery (though subtle differences will be noted below), typically but not exclusively occurs in teaching hospitals. When it occurs in non-teaching hospitals it would be where a physician assistant, specifically credentialed and privileged by the hospital, is delegated to perform specific portions of a surgical procedure. Policies on such require the attending surgeon to be present during the critical portion of the surgery in each of the two cases.
Our 2015 column followed a Boston Globe investigative report (Abelson 2015) on double-booked surgery at the MGH (Massachusetts General Hospital) which raised serious concerns about the practice of attending surgeons in academic medical centers having two surgical cases ongoing simultaneously. Though the report was as much about hospital politics and power struggles and the manner in which we educate and train our next generation of surgeons, it exposes a controversial patient safety issue in addition to the ethical issue that patients are seldom told that their surgeon might not be in the room for the who procedure. In our prior column we also noted comments from multiple other sources and the MGH’s review of its own cases.
Since that time the American College of Surgeons (ACS) has revised its policy statements pertaining to concurrent, simultaneous, or overlapping operations (American College of Surgeons 2016). That revision has some good points but leaves some others in limbo. First, it clearly states that the primary surgeon bears responsibility for the patient’s welfare throughout the operation. It notes that in true “concurrent” surgery, where the critical portions of two surgeries are being performed at the same time, it is not appropriate for the primary surgeon to be responsible for two patients in two different rooms. It then notes 2 forms of “overlapping” operations. The first is when the critical portions of the first surgery are complete and only the more routine procedures (such as wound closure), the primary surgeon may go to another room to initiate another operation, leaving a qualified practitioner in the first room to finish the procedure. The second would be when the primary surgeon leaves the first room (after completion of the critical portion) and begins performing the critical portion of the second case. In that circumstance, the primary surgeon must assign a second surgeon to be immediately available to the first case. It notes that the patient must be informed in either of the above circumstances.
In discussing “overlapping” surgeries it states that the primary surgeon must be present for the “critical or key components” of the operation. But it leaves determination of “critical or key components” up to the primary surgeon.
The ACS policy statement also notes that performance of overlapping procedures should not negatively impact the seamless and timely flow of either procedure.
The ACS policy statement also discusses delegation of part of the operation to qualified practitioners including, but not limited to residents, fellows, anesthesiologists, nurses, physician’s assistants, nurse practitioners, surgical assistants or another attending under his or her personal direction. However, the primary attending surgeon’s personal responsibility cannot be delegated. It also has statements about cases with multidisciplinary teams, circumstances when a surgeon might temporarily leave a room, and unanticipated circumstances.
The ACS policy statement notes that as part of the pre-operative discussion, patients should be informed of the different types of qualified medical providers that will participate in their surgery (assistant attending surgeon, fellows, resident and interns, physician assistants, nurse practitioners, etc.) and their respective role explained. If an urgent or emergent situation arises that require the surgeon to leave the operating room unexpectedly, the patient should be subsequently informed.
A viewpoint from Mello and Livingston (Mello 2016) took a generally favorable view of concurrent surgery but did a nice job of pointing out some of the risks involved. They note that problems may arise when responsibilities are not delegated to surgeons with appropriate skill or experience or when the supervising surgeon cannot reach the patient in a timely fashion to prevent an unexpected crisis from escalating. They note that some surgeries are too complex or risky or specialized to hand off and that not all surgeons are equally able to carry out the cognitive and physical demands of such multitasking.
Along those lines of thought, hospitals should really determine which types of surgery should never be allowed to be double-booked and should also consider which surgeons should be allowed to double-book. One might consider requiring demonstration of proficiency for new surgeons in the credentialing and privileging process before double-booking is allowed. But at the other end of the spectrum, the older surgeon whose surgical skills are still good but whose ability to multitask may be starting to deteriorate (you all know this surgeon but no one is willing to speak up), is a much more difficult situation. What objective criteria would you use to tell that surgeon he/she can still do surgery but can no longer double-book?
There is actually a paucity of evidence in the literature for or against the practice of double-booked surgery. A recent retrospective review compared overlapping cases with non-overlapping cases for a variety of orthopedic surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). Of 3640 cases done between 2012 and 2015 about two-thirds were overlapping and one-third non-overlapping. Patient characteristics were comparable between the two groups. They found no difference in patient operating room time, procedure time, and 30-day complication rates between overlapping and non-overlapping surgery.
But the Zhang study was on an ambulatory surgery patient population. Patients in that setting are generally healthier than those having surgery as inpatients and the procedures done in the ambulatory surgery setting are generally less complicated, shorter, and safer than those done in the inpatient setting. Complication rates for orthopedic procedures in the ambulatory surgery setting are historically low. Moreover, the academic institution in the Zhang study (UCSF) had already implemented most of the stricter policies we’ve previously mentioned to make overlapping surgery less risky. You also must take into account the relatively small patient population here. The sort of disastrous adverse events that might arise as a result of overlapping surgery are quite infrequent, regardless of setting. That doesn’t mean they are not important. Wrong-site surgery is also rare but we now use Universal Protocol and other safety practices to avoid wrong-site surgery. We need to similarly use policies and procedures to minimize the chance that overlapping or concurrent surgery will result in adverse patient outcomes.
Also, in aggregate statistics such as those collected by Zhang et al. you can’t identify in which individual cases a complication might have been the result of double-booked surgery unless you do full case reviews on all cases with complications. There are even nuances in attribution when comparing complications in overlapping vs. non-overlapping surgery. Suppose you have a complication in a case in which a piece of faulty equipment contributed. That same equipment had been identified in a previous case as problematic but no post-op debriefing had occurred because the attending surgeon had left early to do an overlapping case. So no one formally flagged that equipment as faulty and it was cycled back into the usual equipment supply. Your current case (the one with the complication) is not a “double-booked” case but the complication will be attributed to this case and not to the previous double-booked case that missed the opportunity to identify the faulty equipment!
So even though we laud Zhang and colleagues for their study, we remain leery of any study that says “double-booked surgery is safe because we found no more complications in our double-booked cases compared to those that were not double-booked”.
In an editorial accompanying the Zhang study, Healy (Healy 2016) offers practical recommendations to help surgeons “do the right thing”. He proposes 5 important steps:
Regarding his point #4, after the Boston Globe article the Massachusetts Board of Registration in Medicine passed a regulation requiring that surgeon presence or absence in the room at various times be documented. In addition, the primary surgeon must identify the backup doctor who would assume responsibility if the first surgeon leaves the operating room.
As we noted above during discussion of the Zhang study, UCSF has already implemented many of these important elements. Practices at UCSF, noted in the Zhang study, require that the attending surgeon be present for the surgical timeout even when trainees are allowed to set up the case. And, most importantly, during informed consent the patient is told about the possibility of overlapping surgeries. That discussion takes place during a clinic visit (typically a week prior to the procedure) or in the preoperative area before any medication is given. And the attending physician identifies a fellow attending surgeon who is readily available where there might be overlap between two rooms.
Though the UCSF policy requires presence of the attending surgeon during the surgical timeout, we are not told anything about the pre-op “huddle” or pre-op briefing. We’ve done many columns on the utility of these. Our concern is that either the pre-op huddle may be skipped in one case in double-booked surgeries or that two pre-op huddles will be done at one time. If the latter is done, there is the risk that information from one patient or case will be transposed to the other case. That is probably actually more likely when the two surgical procedures are similar, as is the case in many if not most double-booked surgeries.
Informed consent must be transparent and presented in a manner that allows patients to understand the potential ramifications of their surgeon being in another room during any portion of their surgery. A recent viewpoint on informed consent in concurrent surgery (Langerman 2016) points 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.
Healy goes on to say, as we have said in our prior columns, that if he were to undergo surgery he would want his attending surgeon to be present in OR for the entire operation, regardless of whether he were performing or supervising various aspects of the procedure.
In our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery” we, of course, focused on the ethical issues involved (such as lack of informed consent) but we also pointed out some of the less obvious potential vulnerabilities that might occur with any form of “double-booked” surgery. We hope that you’ll go back to that column and read the sections on pre-op huddles and post-op debriefings, infection control issues, duration of surgery issues, surgeon focusing on two things at once (multitasking), and others.
We personally do not think that the definition of the “critical or key” components should be left to the discretion of the individual surgeon. Undoubtedly you will get different definitions from different surgeons. And if there is a case with complications that goes to litigation, you can bet that the lawyers will ask surgeon 1 why his/her definition was different from the definitions used by surgeons 2, 3, 4, etc. 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.
And for all you who would delegate wound closure as “routine, not requiring special expertise” what would you do in the following real-life scenarios if the primary surgeon is now in another room doing a “critical” part of that second surgery:
Another gray area is the definition of “immediately available” for the other surgeon covering in case of emergency. (In fact, we suggest that you might as part of your quality management program occasionally try to get hold of that covering physician and see how long it actually takes for him/her to get to the OR.)
We admit it – we don’t like the practice of any form of double-booked surgery other than in emergency cases. We’ve heard all the rationales and excuses used by physicians and hospitals for doing double-booked surgery:
Yes, we’re all for cost-effective medicine and understand the importance of training each new generation of surgeons. But when you read between the lines the fiscal incentives are still driving the practice of double-booked surgery.
Sorry, we’re with Healy on this – if we need surgery we want to know that our primary surgeon is going to be in the room for the entire procedure, even if he/she is just supervising the “non-critical” portions delegated to others. We suspect most patients would also want this.
Abelson J, Saltzman J, Kowalcyzk L, Allen S. Clash in the Name of Care. Boston Globe October 26, 2015
ACS (American College of Surgeons). Statements on Principles. Revised April 12, 2016
Mello MM, Livingston EH. Managing the Risks of Concurrent Surgeries. JAMA 2016; 315(15): 1563-1564
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
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
Langerman A. Concurrent Surgery and Informed Consent. JAMA Surg 2016; 151(7): 601-602
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A couple nationwide medication safety campaigns have been in the news lately. Earlier this year ASHP (American Society of Health-System Pharmacists) was awarded a 3-year contract by the FDA to develop standardized concentrations for intravenous and oral liquid medications. ASHP has partnered with ISMP (Institute for Safe Medication Practices), AAMI (Association for the Advancement of Medical Instrumentation), and PPAG (Pediatric Pharmacy Advocacy Group) in this endeavor, the Standardize 4 Safety initiative. The coalition just announced one of its Phase 1 (of 3 Phases) outcomes: a list of recommended standardized concentrations for adult continuous IV infusions. The list includes the standardized concentration(s), dosing units, status of commercial availability, and comments for over 30 of the most commonly infused drugs in adults.
Other activities in Phase 1 will be development and implementation of concentrations and dosing units for compounded oral liquids for adults. Phase II addresses concentrations and dosing units for pediatric continuous IV infusions and standard doses for oral liquid medications. Phase III addresses intermittent IV medications, PCA (patient-controlled analgesia) pumps, epidurals, and standard doses for oral chemotherapy agents.
Another collaborative medication safety campaign, the Just Bag It Campaign, was just launched by the National Comprehensive Cancer Network (NCCN 2016). Vincristine is a chemotherapy agent intended for intravenous use. Yet since the 1960’s there have been numerous incidents where it has been administered intrathecally or via Omaya reservoirs. The results are disastrous, with patients developing quadriplegia, encephalopathy, and usually death. In 2013 ISMP summarized the literature (ISMP 2013) and noted that virtually all cases involved vincristine being prepared in a syringe and that there were no cases when vincristine was prepared in an IV bag. There are, of course, other contributing factors in such incidents. ISMP noted the following contributing factors: mislabeling of syringes; bringing IV and intrathecal medications into a treatment area together; failing to administer vinca alkaloids in a specialty oncology unit or with only experienced, oriented staff familiar with current operational and clinical standards, procedures, or protocols; administering chemotherapy outside of normal hours; not conducting an independent double check or “time out” before intrathecal medication administration; and incomplete or missing warning labels. But, given that all reported incidents occurred when vincristine was in a syringe, ISMP recommended that vincristine instead by diluted in a minibag for infusion and syringes be avoided.
Now the NCCN Just Bag It Campaign has been launched for the safe handling of vincristine, calling for health care professionals to always dilute vincristine in a 50ml mini-IV drip bag and never in a syringe. The campaign comes with Christopher’s Story, the sad story of a patient who died as the result of one of the above vincristine errors. All NCCN member institutions have already adopted this best practice for handling vincristine but the campaign calls on all other oncology providers to do the same.
ASHP (American Society of Health-System Pharmacists). Standardize 4 Safety website.
ASHP (American Society of Health-System Pharmacists). ASHP IV ADULT CONTINUOUS INFUSION GUIDELINES. October 2016
NCCN (National Comprehensive Cancer Network). Just Bag It: The NCCN Campaign for Safe Vincristine Handling. NCCN 2016; accessed November 14, 2016
ISMP (Institute for Safe Medication Practices). Death and neurological devastation from intrathecal vinca alkaloids: Prepared in syringes = 120; Prepared in minibags = 0. ISMP Medication Safety Alert! Acute Care Edition. September 5, 2013
In our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…” we noted the paucity of evidence in the literature about antibiotic stewardship programs in ambulatory care or other outpatient settings. CDC had previously published on the core elements for hospitals (CDC 2014) and nursing homes (CDC 2015). Now CDC has published the “Core Elements of Outpatient Antibiotic Stewardship” (Sanchez 2016).
The Core Elements of Outpatient Antibiotic Stewardship are:
Regarding commitment, CDC notes that declaring commitment to antibiotic stewardship in a public fashion (eg. posters in examination rooms) has been shown to reduce inappropriate prescription of antibiotics. In larger practices and healthcare organizations, designating a leader for antibiotic stewardship programs is recommended. CDC also recommends not only educating all staff on antibiotic stewardship but also making it part of their job descriptions and evaluation. CDC stresses that all members of the healthcare team have an important role in antibiotic stewardship.
Under Action for policy and practice they recommend adherence to the evidence-based practices recommended in specialty society guidelines. They note that use of delayed prescribing practices or watchful waiting, when appropriate, may be successful strategies. This requires good communication skills and consistent messages. Systems should provide clinical decision support tools for clinicians and have informational printouts available for patients and families. Various triage systems (eg. nurse call lines) should also reinforce principles of appropriate antibiotic prescribing and may help reduce unnecessary office/clinic/ER visits. They also recommend documentation in the medical record of rationale for decisions not to prescribe antibiotics.
Tracking and reporting consists of audit and feedback, which has been shown to reduce inappropriate antibiotic prescribing. Items to track should include whether antibiotics were appropriate, whether the correct antibiotic was prescribed, and whether the duration of therapy recommended was appropriate. Some systems or practices might choose a high priority condition, like acute bronchitis, to monitor. Others might look at percentage of overall visits at which antibiotics are prescribed. Feedback to individual prescribers can be compared to peers. Some systems may also track adverse drug events related to antibiotics.
Education applies both to prescribers and patients. Communication with patients or families should take into account health literacy issues. Continuing educational activities should be available for healthcare providers and timely access to persons with expertise (eg. pharmacists, infectious disease staff) should be made available.
See also our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…” for other recommendations and links to some of the other studies on antibiotic stewardship in the outpatient setting.
Some of our prior columns on antibiotic stewardship:
CDC. Core elements of hospital antibiotic stewardship programs [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2014; last updated May 25, 2016
CDC. Core elements of antibiotic stewardship for nursing homes [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2015; last updated August 18, 2016
Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. Core Elements of Outpatient Antibiotic Stewardship. Recommendations and Reports. MMWR 2016; 65(6): 1-12
The Joint Commission has revised for 2017 NPSG.07.06.01, its national patient safety goal for prevention of CAUTI’s (catheter-associated urinary tract infections).
The elements of performance for NPSG.07.06.01 are:
- Limiting use and duration
- Performing hand hygiene prior to catheter insertion or maintenance care
- Using aseptic techniques for site preparation, equipment, and supplies
- Securing catheters for unobstructed urine flow and drainage
- Maintaining the sterility of the urine collection system
- Replacing the urine collection system when required
- Collecting urine samples
(The NPSG acknowledges that there are certain medical conditions, predominantly neurological ones, that require a prolonged use of an indwelling urinary catheter in order to avoid adverse events and promote patient safety.)
- Selecting measures using evidence-based guidelines or best practices
- Having a consistent method for medical record documentation of indwelling urinary catheter use, insertion, and maintenance.
- Monitoring compliance with evidence-based guidelines or best practices
- Evaluating the effectiveness of prevention efforts
(The NPSG notes that surveillance may be targeted to areas with a high volume of patients using in-dwelling catheters, as identified through the hospital’s risk assessment.)
Of course, we are advocates of incorporating your evidence-based criteria into your CPOE system. That can help ensure appropriate use of catheters and may help you meet some of the documentation requirements. Innovative hospitals will also use barcoding to help create documentation for things like time of insertion, review for continuation, etc.
This NPSG and all the other 2017 National Patient Safety Goals are now available on The Joint Commission website (TJC 2016).
Our other columns on urinary catheter-associated UTI’s:
The Joint Commission. Hospital Accreditation Program. National Patient Safety Goals Effective January 2017. Accessed November 18, 2016
ECRI Institute has published its annual list of its Top 10 Health Technology Hazards for 2017 (ECRI 2016). The full report details the risks of each of the technologies and makes very useful recommendations on what your organization should be doing to minimize those risks. Their 2017 list:
As is our usual practice we don’t go into detail about items on their list because we encourage you to go right to their excellent resources on these topics. We’re happy to see that under alarm management they have highlighted failures to communicate alarms effectively to staff, a topic we discussed in detail in our February 9, 2016 Patient Safety Tip of the Week “It was just a matter of time…”.
Go to the ECRI site to download the full report. It is a free download but you’ll need to register to receive it.
ECRI Institute. Top 10 Health Technology Hazards for 2017.
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