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What’s New in the
Patient Safety World
May 2020
· PPSA
on IV Vancomycin Safety
· Poor
Timeout Compliance: Ring a Bell?
· A
Takeoff on the Patient Safety Scavenger Hunt
· The
Aging Surgeon Paradox
PPSA on IV
Vancomycin Safety
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:
- Overdosing
- Underdosing
- Failure to adjust dose
based on trough levels or renal function
- Failure to monitor renal
function
- IV access issues
(infiltration, extravasation, need for PICC’s or other more advanced
access)
- Reactions to IV vancomycin
such as hypotension, chills, fever, and red man syndrome (RMS)
- Additive nephrotoxic
effects when combined with some other antibiotics or other nephrotoxic
medications
- Organizational barriers to
maintaining special dosing intervals
- Workflow issues
- Communication 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.
References:
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
https://www.ismp-canada.org/download/safetyBulletins/2016/ISMPCSB2016-04_Vancomycin.pdf
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
https://patientsafetyj.com/index.php/patientsaf/article/view/vancomycin
PPSA (Pennsylvania Patient Safety Authority). IV Vancomycin
Safety Assessment Tool. PPSA 2020; March 2020
https://patientsafetyj.com/index.php/patientsaf/article/view/vancomycin/125
PPSA (Pennsylvania Patient Safety Authority). Vancomycin Inforgraphic. PPSA 2020; March 2020
https://patientsafetyj.com/index.php/patientsaf/article/view/vancomycin/127
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
https://www.ajemjournal.com/article/S0735-6757(14)00704-9/fulltext
Print “May 2020 PPSA on IV Vancomycin Safety”
Timeout Compliance:
Ring a Bell?
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 2017 “Another
Success for the Safe Surgery Checklist”
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”
References:
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
https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.12898
Print “May 2020 Poor Timeout Compliance: Ring a
Bell?”
A Takeoff on the
Patient Safety Scavenger Hunt
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:
- Alarms disabled (or
otherwise manipulated to make them less likely to alert staff to dangerous
situations)
Suicide risk hazards - Hand hygiene patrol
(identify instances where a healthcare worker goes from one patient room
to another without washing his/her hands)
Delirium risk - Catheter patrol
- Dangerous abbreviations
- Look alike/sound
alike drugs (LASA’s)
- BMV workarounds.
Identify examples where the safety mechanisms in a bedside medication
verification (barcoding) system are purposefully bypassed
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.
References:
Bell J. Ideas That Work: Secret Room. Help Staff Spot
Mistakes in Seconds. Outpatient Surgery Magazine 2020; XXI(2):
February 2020
Print “May 2020 A Takeoff On The Patient Safety
Scavenger Hunt”
The Aging Surgeon
Paradox
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:
- July 7, 2015 “Medical Staff Risk
Issues”
- May 28, 2019 “The Older Physician”
- February 2020 “The Older Physician: A
Practical Approach?”
References:
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
https://www.bmj.com/content/361/bmj.k1343
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
https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2706484
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
https://www.cmaj.ca/content/192/15/E385
Katlic MR, Coleman J, Russell MM. Assessing
the Performance of Aging Surgeons. JAMA
2019; 321(5): 449-450
https://jamanetwork.com/journals/jama/article-abstract/2721291
Katlic MR, Coleman J. The aging
surgeon. Ann Surg 2014; 260(2): 199-201.
https://journals.lww.com/annalsofsurgery/fulltext/2014/08000/The_Aging_Surgeon.1.aspx
Frellick M. Screen Aging Physicians for Competency, Report Asks. Medscape
Medical News June 15, 2015
http://www.medscape.com/viewarticle/846497
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
https://www.medpagetoday.com/meetingcoverage/ama/76334
ACS (American College of Surgeons). Statement on the Aging
Surgeon. January 1, 2016
https://www.facs.org/about-acs/statements/80-aging-surgeon
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
https://jamanetwork.com/journals/jamasurgery/fullarticle/2733041
Weinacker A. Staffing: How Do You
Deal With Aging Surgeons? Outpatient Surgery Magazine
2018; XIX(6): June 2018
LifeBridge Health. Aging Surgeon
Program
http://www.agingsurgeonprogram.com/AgingSurgeon/AgingSurgeon.aspx
Cooney L, Balcezak T. Cognitive
Testing of Older Clinicians Prior to Recredentialing. JAMA 2020; 323(2): 179-180
https://jamanetwork.com/journals/jama/article-abstract/2758602
Print “May 2020 The Aging Surgeon Paradox”
Print “May
2020 What's New in the Patient Safety World (full column)”
Print “May 2020 PPSA on IV Vancomycin Safety”
Print “May 2020 Poor Timeout Compliance: Ring a
Bell?”
Print “May 2020 A Takeoff On The Patient Safety
Scavenger Hunt”
Print “May 2020 The Aging Surgeon Paradox”
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What’s New in
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