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Our August 2016 What's New in the Patient Safety World column “Home Infusion Therapy Pitfalls” highlighted a fatal case related to intravenous vancomycin therapy in the home reported by ISMP Canada (ISMP Canada 2016). The case described was a diabetic patient with a foot ulcer who was receiving IV vancomycin at home after a hospital stay. Recommended bloodwork, including trough vancomycin levels, was not done due to a faulty lab requisition. The patient developed a rash, thrombocytopenia, and high serum vancomycin levels as well as rising creatinine. He was rehospitalized but despite IV fluids and platelet transfusions, he developed hypertensive episodes, epistaxis and mental status changes and developed intracerebral bleeding and ultimately died. The acute kidney injury was attributed to vancomycin toxicity and the thrombocytopenia was also felt possibly related to the vancomycin.
That’s the only case of a vancomycin error we could find in our 14-year patient safety archive. But the Pennsylvania Patient Safety Authority just published an extensive review of safety hazards associated with intravenous vancomycin (Krukas 2020). The authors begin with the complexities of IV vancomycin use: dosing is weight-based and management requires monitoring of drug levels (peak and trough), attention to renal function, and dosing at regularly scheduled intervals. They reviewed the literature and analyzed cases involving vancomycin reported to the Pennsylvania Patient Safety Reporting System (PA-PSRS).
Their literature review identified the following issues:
They then analyzed 143 reports of event reported over a 3-month period related to IV vancomycin (they excluded many more reports if there was no harm or just an unsafe condition that did not reach the patient).
Events occurred in multiple phases of the medication use process: administration (38.5%), monitoring (27.3%), ordering/reviewing (19.6%). The most frequent errors identified were dose omission/delay or receipt of partial dose (41.3%), improper dose (29.4%), and monitoring errors (18.2%).
Workflow and communication issues often contributed to missed doses, delays in doses, or suboptimal doses. Monitoring medication-use process stage issues were mostly related to timing of troughs. Difficulties were especially noted when doses and/or timing needed to be adjusted, including starting, restarting, and stopping IV vancomycin.
Workflow and communication issues typically involved handoffs and transfers, especially related to the ED and OR and transfer from these units to other units. Order sets were sometimes confusing and in other cases paper orders, faxed orders or verbal orders contributed.
Monitoring issues included lack of awareness that trough levels were ordered but not drawn, results of trough levels not promptly transmitted, or trough levels not acted upon.
They provide a terrific self-assessment tool that any organization using vancomycin should download and use. They stress the need to increase clinician awareness and developed an infographic to help promote that. But, recognizing that education and training are of limited value, they focus on potential interventions using health information technology. They note studies showing that use of a weight-based vancomycin EHR order set, specifically in ED settings, resulted in a 20% increase in appropriate dosing (Hall 2015). Other interventions included automatic ordering of a trough level 30 minutes before the fourth dose when a new vancomycin order was placed, or an alert in the nurse’s barcode administration of vancomycin if no trough level had been drawn. One of our own recommendations would be to use clinical decision support to generate an alert when a specified increase in serum creatinine is seen after vancomycin is started.
This is a really good study that has valuable lessons. Issues related to errors in IV vancomycin use probably are underreported and “fly under the radar” in many healthcare organizations. This study should be a wakeup call for all.
ISMP Canada. Gaps in Transition: Management of Intravenous Vancomycin Therapy in the Home and Community Settings. ISMP Canada Safety Bulletin 2016; 16(4): 1-5 June 28, 2016
Krukas A, Franklin ES, Bonk C, et al. Identifying Safety Hazards Associated With Intravenous Vancomycin Through the Analysis of Patient Safety Event Reports. Patient Safety 2020; 2(1): 17
PPSA (Pennsylvania Patient Safety Authority). IV Vancomycin Safety Assessment Tool. PPSA 2020; March 2020
PPSA (Pennsylvania Patient Safety Authority). Vancomycin Inforgraphic. PPSA 2020; March 2020
Hall AB, Montero J, Cobian J, Regan T. The Effects of an Electronic Order Set on Vancomycin Dosing in the ED. Am J Emerg Med 2015; 33(1): 92-94
When we review cases of wrong site surgery (wrong site, wrong patient, wrong side, wrong procedure), we often find that the surgical “timeout” was either not performed or was performed without the full attention of the entire OR team (or team in the procedure room). Every member of the team is expected to take an active role in the timeout. Responses should not be passive nods of assent. Verification should rely upon primary source documentation and not be second-hand. And any member of the team who has questions should be empowered to stop the procedure. The timeout should take place in accord with the “sterile cockpit” concept we’ve adopted from the aviation safety movement.
A recent review of surgical timeouts, using direct observation, found that at least 1 member of the operating room team was actively distracted in 10.2% of the time-out procedures (Freundlich 2020). That shouldn’t surprise most of you. That’s a rate we commonly encounter at many hospitals or ASC’s or cath labs. We’ll bet most of you don’t actually know how often this happens because you don’t actually measure this important item. Measuring it by way of OR video monitoring is one of the prime reasons we have long advocated video recording in the OR (see our columns on video monitoring listed below).
In the study by Freundlich et al. the frequent distractions occurred despite the fact that most timeouts were completed in less than one minute. They did perform a timeout before the first incision in 100% of cases and there was a formal announcement that the timeout was about to start in 163 of 166 observed surgeries. 92.8% of their timeouts were completed without interruption (the most common reason for an interruption was to verify patient information). Ten time-out procedures were stopped due to a safety concern. Fortunately, there were no wrong-site or wrong-person surgeries reported at their hospital during the study period.
We once, in a joking manner, brought a gong to a staff meeting and rang it to get everyone’s attention when extraneous conversations got out of hand. Well, staff at one hospital didn’t laugh at the idea – they actually brought the gong into their OR’s! Brenckle and colleagues (Brenckle 2020) reported on how they used the gong to get everyone’s attention at the start of timeouts. They addressed the problem after a consultant noted, during a mock regulatory survey, that multiple members of the OR team were multitasking during the timeout and not paying sole attention to the timeout procedure.
They considered several sound-making devices to use in order to get the undivided attention of all OR staff at the onset of their timeouts. Ultimately, they chose a classic Tibetan gong. Despite some negative feedback and resistance early on, they persevered and incorporated the gong into their timeout routine.
It took almost six months before staff members began consistently using the gong properly. After piloting the gong in the cardiac cath lab, they also implemented it in their endoscopy suite and OR’s. After a year, they report no further negative feedback or improper use of the gong. Even physicians who originally refused to pause and engage in the timeout are now actively engaged in the process. One even not only engages in the timeout, but also personally strikes the gong at the end of his procedure to indicate it was successful.
Interesting and innovative! Timeouts are not to be taken lightly or in a joking fashion. But it is of utmost importance to get the attention of all the OR team (or the team in any venue performing procedures) to focus on the timeout. Whatever works best in your facility to accomplish that is worthwhile.
Some of our prior columns related to wrong-site surgery:
September 23, 2008 “Checklists and Wrong Site Surgery”
June 5, 2007 “Patient Safety in Ambulatory Surgery”
July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons from Ophthalmology”
July 1, 2008 “WHO’s New Surgical Safety Checklist”
January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 2013 “How Frequent are Surgical Never Events?”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
March 15, 2016 “Dental Patient Safety”
May 17, 2016 “Patient Safety Issues in Cataract Surgery”
July 19, 2016 “Infants and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s Electronic Procedural Timeout”
May 2, 2017 “Anatomy of a Wrong Procedure”
June 2017 “Another Way to Verify Checklist Compliance”
March 26, 2019 “Patient Misidentification”
May 14, 2019 “Wrong-Site Surgery and Difficult-to-Mark Sites”
Some of our previous columns discussing video recording:
September 23, 2008 “Checklists and Wrong Site Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
March 2012 “Smile...You’re on Candid Camera!”
August 27, 2013 “Lessons on Wrong-Site Surgery”
March 17, 2015 “Distractions in the OR”
November 24, 2015 “Door Opening and Foot Traffic in the OR”
March 2019 “Another Use for Video Recording”
March 17, 2020 “Video Recording in the OR”
Freundlich RE, Bulka CM, Wanderer JP, et al. Prospective Investigation of the Operating Room Time-Out Process. Anesthesia & Analgesia 2020; 130(3): 725-729
Brenckle EA, Gealer D, Milligan M. Using a Tibetan Gong to Increase Staff Member Engagement During Time Outs. AORN Journal 2020; 111(1): 81-86
Over 10 years ago, we wrote a column on doing patient safety scavenger hunts (see our March 16, 2010 Patient Safety Tip of the Week “A Patient Safety Scavenger Hunt”). In that column we noted you can also make patient safety fun at the same time you are identifying hazards in your organization. We provided the example of the “Patient Safety Scavenger Hunt”. In this exercise you award points for identifying patient safety hazards or risky situations or practices. Give your staff a finite period of time (eg. 2 hours) to look for these and award points for each item identified within that time frame. Use multiple staff and you may need to pair them up for the search for some of the items (like the suicide risk ones). We provided some examples you could award points for:
We provided a sample scorecard in that column.
Jane Bell, from Cityview Surgery Center in Fort Worth, Texas, recently described in Outpatient Surgery Magazine a takeoff on the patient safety scavenger hunt (Bell 2020). She describes a game/exercise in which two staff members stage 20 to 25 errors at a bedside in their PACU. These would include things like a bloody tourniquet left on a patient’s bedside stand, a surgery schedule in full view, an overflowing sharps container, and others.
The next day staff are divided into two teams. Each team is brought in to view the room for 30 seconds, and members write down all of the errors they can find. (She notes that the 30-second time limit is key because if your staff can spot problems quickly and under pressure, there’s a good chance they’ll do the same during a stressful surgery.)
After the scores are tallied (a point for each mistake noticed), the team that spots the most errors wins. They gave every member of the winning team a Starbucks gift card. The winning team actually correctly guessed all 25 of the errors in their “Secret Room”.
The point is that you can combine fun with learning and identification of patient safety hazards at the same time. Try these exercises in your organizations.
Bell J. Ideas That Work: Secret Room. Help Staff Spot Mistakes in Seconds. Outpatient Surgery Magazine 2020; XXI(2): February 2020
Many studies have demonstrated more adverse patient outcomes when treated by aging physicians, leading to calls for careful evaluation of the older physician in credentialing and privileging programs in healthcare organizations.
But for surgeons, there is a paradox, at least from a statistical perspective. Tsugawa and colleeagues (Tsugawa 2018) found that patients treated by older surgeons actually had lower mortality than patients treated by younger surgeons. There was no evidence that operative mortality differed between male and female surgeons. And, for eye surgeons performing cataract surgery, Campbell et al. (Campbell 2019) found that “late career” surgeons did not have more complications that eye surgeons earlier in their careers. That finding held up even when surgical volume was factored in.
Now another study from Ontario, Canada (Satkunasivam 2020) found that increasing surgeon age was associated with decreasing rates of postoperative death, readmission and complications. And the association was in a nearly linear fashion. These findings persisted after accounting for patient-, procedure-, surgeon- and hospital-level factors. A 10-year increase in surgeon age was associated with a 5% relative decreased odds of the composite outcome. Patients receiving treatment from surgeons who were older than 65 years of age had a 7% lower odds of adverse outcomes.
A strength of this study was that it included a variety of surgical specialties and both
elective and emergent procedures, and the single-payer health care system in Ontario for surgical procedures ensured capture of virtually all procedures and identification of readmissions or complications after surgery that occurred anywhere in the province.
The authors discuss possible reasons for this finding. One is that those older surgeons may be a highly select group. Surgeons with lesser skills or impaired cognitive abilities may have already ceased operating. On the other hand, it may well be that the longstanding experience of this group of surgeons has allowed them to better select patients who will have better outcomes. Older surgeons did have higher volumes so the volume/outcome phenomenon might play a role. We might speculate that perhaps older surgeons might avoid new technologies or new procedures, like robotic surgeries, that have a learning curve. But the Canadian study excluded robotic surgeries.
Their findings definitely suggest that use of mandatory retirement ages for surgeons would be counterproductive. Many geographic areas, particularly rural ones, are already experiencing shortages of surgeons, both in surgical subspecialties and especially in general surgery.
Nevertheless, programs like the Yale New Haven program we discussed in our February 2020 What's New in the Patient Safety World column “The Older Physician: A Practical Approach?” are still likely to be of benefit in determining which older surgeons are likely to practice with high quality.
In our May 28, 2019 Patient Safety Tip of the Week “The Older Physician” we again noted that age, per se, cannot be the sole factor considered in decisions about the status of aging physicians. Katlic et al (Katlic 2019) note that “establishing a mandatory retirement age for surgeons would be a straightforward solution but would be illegal, inappropriate, and unfair because of the variability in function among older individuals of a given age”. They note that some hospitals have adopted a Late Career Practitioner Policy in their medical staff bylaws. These hospitals may require physicians and advanced practice clinicians older than 70 years who apply for recredentialing to undergo physical examination, eye examination, and cognitive screening. Katlic and Coleman previously described the elements of a formal Aging Surgeon Program (Katlic 2014). In both articles they described this as a more comprehensive option for surgeons identified either through screening or performance issues identified by medical staff. Their program is a 2-day, multidisciplinary, objective, and confidential evaluation of a surgeon's physical and cognitive function. It includes physical, neurologic, and ophthalmologic examinations, neuropsychological and physical/occupational therapy testing. A confidential report is then sent to the hospital medical staff that requested the evaluation. Based on the objective information provided in the report, the hospital medical staff may consider options such as continuing full privileges; no privileges; no operating privileges; operating privileges if assisted by another surgeon (routine vs only complex cases); assistant privileges only; focused review of cases (all vs certain number); or decreased work hours (eg, no on-call duties). Katlic et al do discuss surgical simulator testing but note that its validity for privileging issues has not yet been determined. (They also note that surgical simulator testing can be resource intensive, for both equipment and human time, and would need to be specialty specific.)
They note that there is great variability in the cognitive decline that takes place with aging, but also that clinical experience may offset declines in cognitive performance. As such, mandating retirement at a specific age would undoubtedly remove some competent surgeons from the workforce. But they also note that physicians’ self-awareness of cognitive decline often does not coincide with objective performance measures.
In our July 7, 2015 Patient Safety Tip of the Week “Medical Staff Risk Issues” we noted the AMA had voted to approve a report saying it is time to have a system for assessing the competence of older physicians but there was considerable sentiment expressed that screening physicians at a certain age “is inappropriate and smacks of ageism” (Frellick 2015). The AMA had not yet developed criteria or processes for such assessments. Subsequently, guiding principles for assessing the competency of senior/late career physicians were proposed by the AMA’s Council on Medical Education, but these were not adopted and the report was back to the Council on Medical Education (Firth 2018).
The American College of Surgeons did issue a Statement on the Aging Surgeon in 2016 (ACS 2016). While it was not in favor of a mandatory retirement age, it recommended that, starting at age 65 to 70, surgeons undergo voluntary and confidential baseline physical examination and visual testing by their personal physician for overall health assessment and regular interval reevaluation thereafter for those without identifiable issues on the index examination. It also encouraged surgeons to also voluntarily assess their neurocognitive function using confidential online tools. It also noted that voluntary self-disclosure of any concerning and validated findings is encouraged as part of a surgeon’s obligations. It also noted that colleagues and staff must be able to bring forward and freely express legitimate concerns about a surgeon’s performance and apparent age-related decline to group practice, departmental and medical staff, or hospital leadership without fear of retribution. It stressed the importance of peer-reviewed methods, including ongoing professional practice evaluation, as part of recredentialing and, if a potential issue is identified, additional methods of evaluation may include chart reviews, peer review of clinical decision making, 360-degree reviews and patient feedback, observation or video review of operating room cases, and proctoring.
It acknowledged that there will be occasions were a surgeon will need to be referred to a comprehensive evaluation program, conducted at a number of specialized centers where a battery of tests for neurocognitive function can be conducted in the form of a neuropsychological assessment (the costs of which should be borne by the hospital or medical staff, not the surgeon). But it emphasized that these results cannot be used in isolation to determine continuation or withholding of hospital and surgical privilege but should be incorporated as an additional piece of information.
Recommendations such as those from the Society of Surgical Chairs (Rosengart 2019). and Stanford Health Care’s Late Career Practitioner Policy (Weinacker 2018) are a good starting point. The concept of beginning the discussion with your clinicians long before they are “aging” needs to be ingrained in your programs. Resources such as the Aging Surgeon Program at Sinai Hospital/LifeBridge Health (developed by Katlic and others) may be very helpful to you once have reached an age where their skills and cognitive functions may start to wane. And the Yale New Haven program (Cooney 2020) that we discussed in our February 2020 What's New in the Patient Safety World column “The Older Physician: A Practical Approach?” offers a way to provide an objective assessment in a respectful manner.
Our prior columns dealing with the issue of the aging physician:
Tsugawa Y, Jena AB, Newhouse RL, et al. Age and sex of surgeons and mortality of older surgical patients: observational study. BMJ 2018; 361 Published 25 April 2018
Campbell RJ, el-Defrawy SR, Gill SS, et all Association of Cataract Surgical Outcomes With Late Surgeon Career StagesA Population-Based Cohort Study. JAMA Ophthalmol 2019; 137(1): 58-64
Satkunasivam R, Klaassen Z, Ravi B, et al. Relation between surgeon age and postoperative outcomes: a population-based cohort study. CMAJ 2020; 192 (15): E385-E392
Katlic MR, Coleman J, Russell MM. Assessing the Performance of Aging Surgeons. JAMA 2019; 321(5): 449-450
Katlic MR, Coleman J. The aging surgeon. Ann Surg 2014; 260(2): 199-201.
Frellick M. Screen Aging Physicians for Competency, Report Asks. Medscape Medical News June 15, 2015
Firth S.How Can Competency be Measured in Older Docs? AMA council guidance for testing fails to win over delegates. MedPage Today 2018; November 14, 2018
ACS (American College of Surgeons). Statement on the Aging Surgeon. January 1, 2016
Rosengart TK, Doherty G, Higgins R, et al. Transition Planning for the Senior Surgeon. Guidance and Recommendations From the Society of Surgical Chairs. JAMA Surg 2019; Published online May 15, 2019
Weinacker A. Staffing: How Do You Deal With Aging Surgeons? Outpatient Surgery Magazine 2018; XIX(6): June 2018
LifeBridge Health. Aging Surgeon Program
Cooney L, Balcezak T. Cognitive Testing of Older Clinicians Prior to Recredentialing. JAMA 2020; 323(2): 179-180
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