What’s New in the Patient Safety World
September 2017
·
Clinical Decision Rule Success
·
Inpatient Diagnostic Errors and Malpractice
Claims
·
Safe Medication Use in the ICU
·
Weight-Based Dosing in Children
Clinical Decision
Rule Success
Use of clinical
decision rules can have multiple advantages for hospitals, emergency departments,
payers, and patients. For example, use of any of the several clinical decision
rules for CT scanning in cases of minor head trauma may reduce the number of
unnecessary CT scans, reduce ED throughput times, reduce hospital costs, and
even reduce costs of the “diagnostic cascade” that follow discovery of
incidental findings.
In our March 2017 What's New in the Patient Safety World column “Update
on CT Scanning after Minor Head Trauma” we pointed out that there’s no shortage of clinical decision
rules guiding the ordering of CT scans in patients with minor head trauma. We
have the Canadian CT Head Rule (Stiell
2001), the New Orleans Head CT Rule (Haydel 2000),
and the NICE guideline (NICE
2014) in adults. And for children we have CHIP (Smits
2007), CATCH (Osmond
2010), and the NICE guideline (NICE 2014).
Perhaps the most frequently used clinical decision rule is
the Canadian CT Head Rule (CCHR). In that previous column we noted a study
which looked at the appropriateness of head CT scans for minor head trauma
using the CCHR as the guideline (Klang 2017).
The authors retrospective reviewed 955 head CT scans and found 10.9% were not
indicated according to the CCHR. And, for patients under the age of 65, 37.3%
of scans ordered were not indicated according to that rule. The authors
suggested that interventions to reduce the frequency of non-indicated head CT
scanning might include targeted education of staff members, protocol
implementation, and implementation of computerized decision rules.
Well, clinicians at Kaiser Permanente did just that. First,
clinicians and researchers did an electronic health record (EHR) database and
chart review of adult ED trauma encounters receiving a head CT from 2008 to
2013 (Sharp
2017a). They found that about one-third of head CTs performed on adults
with head injury might be avoidable by applying the CCHR and that avoidance of
CT in such patients is unlikely to miss any important injuries. Then they
implemented the CCHR protocol in 13 Southern California ED’s using a
multicomponent intervention included clinical leadership endorsement, physician
education, and integrated clinical decision support (Sharp
2017b). Overall, they noted a 5.3 percent reduction in CT use and an
increase in CT-identified injuries. Twelve of the 13 emergency departments
reduced head CT following the implementation of the intervention.
Though the reduction in CT scans was more modest than they
would have predicted, it certainly is a start in the right direction. Keys to
success were likely the buy-in of clinical leaders, pilot testing, physician
education through an e-learning module, and integration of the protocol into
the electronic medical record (Kaiser
Permanente 2017).
Some of our previous
columns on CT scans in minor head trauma:
April 16, 2007 “Falls
With Injury”
July 17, 2007 “Falls
in Patients on Coumadin or Heparin or Other Anticoagulants”
March 2010 “CATCH:
New Clinical Decision Rule for CT in Pediatric Head Trauma”
November 23, 2010 “Focus
on Cumulative Radiation Exposure”
June 5, 2012 “Minor
Head Trauma in the Anticoagulated Patient”.
July 8, 2014 “Update:
Minor Head Trauma in the Anticoagulated Patient”
January 2017 “Still
Too Many CT Scans for Pediatric Appendicitis”
March 2017 “Update
on CT Scanning after Minor Head Trauma”
References:
Stiell IG, Wells GA, Vandemheen K, et al for the CCC Study Group. The Canadian
CT Head Rule for patients with minor head injury. Lancet 2001; 357: 1391–96
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(00)04561-X/abstract
Haydel MJ, Preston CA, Mills TJ,
et al. Indications for Computed Tomography in Patients with Minor Head Injury.
N Engl J Med 2000; 343: 100-5 (New Orleans Head CT
Rule)
http://www.nejm.org/doi/full/10.1056/NEJM200007133430204
NICE (UK National Institute for Health and Care Excellence).
Head injury: assessment and early management. Clinical guideline [CG176] Published
date: January 2014
https://www.nice.org.uk/guidance/cg176
NICE imaging algorithm
https://www.nice.org.uk/guidance/cg176/resources/imaging-algorithm-498950893
Smits M, Dippel DWJ, Steyerberg EW, et al. Predicting Intracranial Traumatic
Findings on Computed Tomography in Patients with Minor Head Injury: The CHIP
Prediction Rule. Ann Intern Med. 2007; 146: 397-405
Osmond MH, Klassen TP, Wells GA, et
al. CATCH: a clinical decision rule for the use of computed tomography in
children with minor head injury. Can. Med. Assoc. J., Feb 2010; early release
published February 8, 2010 doi:10.1503/cmaj.091421
Klang E, Beytelman
A, Greenberg D, et al. Overuse of Head CT Examinations for the Investigation of
Minor Head Trauma: Analysis of Contributing Factors. J Amer
Coll Rad 2017; 14(2): 171-176 Published online:
November 8, 201
http://www.jacr.org/article/S1546-1440(16)30808-0/fulltext
Sharp AL, Nagaraj G, Rippberger
EJ, et al. Computed Tomography Use for Adults With Head Injury: Describing
Likely Avoidable Emergency Department Imaging Based on the Canadian CT Head
Rule. Academic Emergency Medicine 2017; 24: 22-30 First
published online January 12, 2017
http://onlinelibrary.wiley.com/doi/10.1111/acem.13061/abstract
Sharp AL, Huang BZ, Tang T, et al. Implementation of the
Canadian CT Head Rule and Its Association With Use of Computed Tomography Among
Patients With Head Injury.
Ann Emerg Med 2017; Published
online: July 21, 2017
http://www.annemergmed.com/article/S0196-0644(17)30785-0/fulltext
Kaiser Permanente. Kaiser Permanente Emergency Department
Intervention for Adult Head Trauma Reduces CT Use. Press Release July 21, 2017
Print “September
2017 Clinical Decision Rule Success”
Inpatient
Diagnostic Errors and Malpractice Claims
We tend to think
about diagnostic errors leading to malpractice claims as primarily problems on
the outpatient side, mainly because most medical care is rendered on the outpatient
side (see, for example, our March 2013 What's New in
the Patient Safety World column “Diagnostic
Error in Primary Care”). However, diagnostic errors occur in all venues of
the healthcare system.
A previous study of types of malpractice claims (Tehrani 2013), using
data from the National Practitioner Data Bank (1986–2010), found that diagnostic
errors were the leading type (28.6%), were more likely to be associated with
death and disability, and accounted for the highest proportion of total
payments (35.2%). More diagnostic error claims were outpatient than inpatient
(68.8% vs 31.2%) but inpatient diagnostic errors were more likely to be lethal
(48.4% vs 36.9%).
Now, a more recent
study looked at malpractice claims resulting from inpatient diagnostic errors (Gupta
2017). Gupta and colleagues looked at over 60,000 paid malpractice claims
in the US National Practitioner
Database and found that 22% were diagnosis-related. Diagnosis-related paid
claims were associated with 1.83 times more risk of disability and 2.33 times
more risk of death compared with other paid claim types. Median
diagnosis-related payments also increased at a rate disproportionate to other claim
types.
Diagnosis-related
paid claims were more likely to be associated with male patients, patient aged
>50 years, provider aged <50 years, and providers in the northeast
region.
A study from the Doctors Company, a large physician
malpractice insurer, reported percentage of diagnosis-related malpractice
claims by specialty (Troxel
2014). It found that 34 percent of nonsurgical specialty claims were
diagnosis related (the number one allegation in these claims). For surgical
specialties, 14 percent were diagnosis related (the third most common
allegation in these claims). That report did not break down inpatient vs.
outpatient claims. But claims for hospitalists, most of which presumably were
on inpatients, 34% of claims were diagnosis-related.
Another study from the Doctors Company (Ranum
2016) reported on claims against hospitalists and found that 36% of
claims were diagnosis-related. 35% of those cases resulted from an inadequate
initial assessment. Often the cases with patient assessment issues included the
following:
- Failure to establish a
differential diagnosis.
- Failure or delay in
ordering diagnostic tests.
- Failure to consider
available clinical information (lab values, diagnostic tests, symptoms,
nursing observations).
Claims arising from hospitalist care are more likely to have
a higher injury severity than other physician specialties.
The authors ascribe some of the risk to the fact that hospitalists
manage high-acuity patients, have limited access to patients’ past medical
histories, and often receive patients with serious conditions. They note that these
situations require thorough assessments, comprehensive testing, quick
diagnoses, timely referrals, and rapid initiation of treatment. They stress
that some conditions may have similar presentations (eg.
pneumonia and pulmonary embolism) so having a good differential diagnosis is
important. But they also note that some less common conditions (eg. spinal epidural abscess) are beginning to appear more
frequently in claims.
Some of our prior
columns on diagnostic error:
- September 28, 2010 “Diagnostic
Error”
- November 29, 2011 “More
on Diagnostic Error”
- May 15, 2012 “Diagnostic
Error Chapter 3”
- May 29, 2008 “If
You Do RCA’s or Design Healthcare Processes…Read Gary Klein’s Work”
- August 12, 2008 “Jerome
Groopman’s “How Doctors Think”
- August 10, 2010 “It’s
Not Always About The Evidence”
- January 24, 2012 “Patient
Safety in Ambulatory Care”
- October 9, 2012 “Call
for Focus on Diagnostic Errors”
- March 2013 “Diagnostic
Error in Primary Care”
- May 2013 “Scope
and Consequences of Diagnostic Errors”
- August 2013 “Clinical
Intuition”
- January 2014 “Trigger
Tools to Prevent Diagnostic Delays”
- January 14, 2014 “Diagnostic
Error: Salient Distracting Features”
- May 2014 “Frequency
of Diagnostic Errors in Outpatients”
- June 24, 2014 “Lessons
from the General Motors Recall Analysis”
- November 25, 2014 “Misdiagnosis
Due to Lab Error”
- April 21, 2015 “Slip
and Capture Errors”
- And our review of Malcolm
Gladwell’s “Blink” in our Patient Safety Library
References:
Gupta A, Snyder A, Kachalia A, et
al. Malpractice claims related to diagnostic errors in the hospital. BMJ Qual Saf 2017; Published online 9
Aug 2017
http://qualitysafety.bmj.com/content/early/2017/08/09/bmjqs-2017-006774
Tehrani ASS, Lee HW, Mathews SC, et al. 25-Year summary of
US malpractice claims for diagnostic errors 1986–2010: an analysis from the
National Practitioner Data Bank
BMJ Quality & Safety 2013; 22(8): 672-680
http://qualitysafety.bmj.com/content/22/8/672
Troxel DB. Diagnostic Error in
Medical Practice by Specialty. The Doctor’s Advocate (The Doctors Company) 2014; Third
Quarter 2014
Ranum D, Troxel
DB, Diamond R. Hospitalist Closed Claims Study. An Expert Analysis of Medical
Malpractice Allegations. The Doctors Company 2016
Print “September
2017 Inpatient Diagnostic Errors and Malpractice Claims”
Safe Medication
Use in the ICU
Lots of what we do in healthcare still lacks an adequate
evidence based. And some practices may be evidence-based for some healthcare
venues but have never been adequately assessed in other venues. The ICU is one
area often omitted in studies performed on many medication safety
interventions.
So a new “Clinical Practice Guideline: Safe Medication Use
in the ICU” (Kane-Gill
2017) is quite welcome. It addresses many aspects of medication safety in
the ICU and puts in perspective differences that may exist between ICU settings
and non-ICU settings.
It begins with an overview of the epidemiology of adverse
drug events (ADE’s) and medication errors (ME’s) in the ICU setting, noting the
impact in both human and financial terms. It notes that in adult ICU and PICU
patients, the severity or harm associated with ME’s/ADE’s is greater compared
to non-ICUs. It also notes that adult ICU and PICU patients have different risk
factors for ADE’s and ME’s compared to general care (non-ICU) patients.
It then asks a number of questions about medication safety,
reviews the pertinent literature on each question, grades the evidence, and
makes recommendations where there is sufficient evidence to do so, and grades
the recommendations.
Some of the recommendations in the guideline seem rather
obvious (use of CPOE, clinical decision support, drug-dosing software,
protocols/bundles, barcoded beside medication safety systems, smart infusion
pumps, etc.). Others are more general (eg.
establishing a culture of safety, educating all staff on medication safety,
etc.).
The guideline does a good job of presenting pros and cons
even for those practices they recommend. For example, though they note that
most studies show CPOE reduces
medication errors, they note that at least one study showed a paradoxical
increase in ICU patient mortality after implementation of CPOE and they note
that CPOE may introduce its own set of unexpected errors. They also note that
the costs associated with initial implementation of many of the
technology-based practices may be substantial but that many of these costs are
offset in the long run by reductions in unwanted events.
The guideline suggests using the Broselow tape (a tool that measures a patient’s length to estimate a colorcoded weight range) in pediatric emergency situations,
when patient weight is not available to determine the child’s length and then
the associated colorcoded, weight-based dosing for
emergency drug doses to reduce MEs and ADEs. Weight, of course, is critical in
determination of dosing of many medications in pediatric patients (see our September 2017 What's
New in the Patient Safety World column “Weight-Based
Dosing in Children”).
The guideline recommends using validated assessment tools (eg. the
Richmond Agitation Sedation Scale or RASS, the Ramsay Sedation Assessment
Scale, etc.) to achieve therapeutic goals during administration/titration of medications
in the ICU.
The guideline endorses installation of robotic automated
packaging systems and other strategies for automated dispensing of medications
in the ICU.
The guideline also recommends using labeling practices such
as tall man lettering to reduce the
risk of LASA (look-alike, sound-alike) drug pair errors. Note that they use the
acronym SALAD for sound-alike look-alike drugs.
They do also recommend use of independent double checks for dispensing high-risk medications.
While we have pointed out some of the pitfalls of double checks in numerous
prior columns (see, for example, our
October 16, 2012 Patient Safety Tip of the Week “What
is the Evidence on Double Checks?”) we still consider double checks to be
an action of intermediate strength worth using in multiple situations. This
would include using them before preparation, dispensing or administration of
high-risk drugs. But they need to be truly “independent” double checks.
They also recommend compliance with safe medication concentration practices (i.e., use of
premade IV preparations, requirement of pharmacists to prepare all IV
medications) to reduce the number of ME’s and potential ADE’s.
Interestingly, they could make no recommendation about
medication reconciliation, because of lack of rigorously conducted studies on
medication reconciliation in the ICU. They also make no recommendation
regarding pharmacist involvement in medication passes, use of point-of-care
(POC) testing in the ICU, or specific handoff communication techniques.
The guideline has limited discussion about medication monitoring
in the ICU but it does suggest the use of reflex (automatic) ordering of
laboratory values with the addition of a dosing suggestion for heparin orders.
The guideline has mixed recommendations about patient/family involvement. For example
there is no recommendation about patient/family involvement regarding
notification of medication regimens. But it does recommend application of a
patient/family reported outcome interview at or after ICU discharge to improve
ME/ADE reporting.
Regarding the issue of disclosure
of medication errors to patients/families, the authors note they could not
scientifically address the question because of lack of comparator data.
However, they clearly state that “the ultimate goal should be to establish
policies for full disclosure of medical errors to patients and/or family
members as a standard of clinical practice”.
Regarding surveillance
systems for monitoring for ADE’s/ME’s, they had no recommendation on the use of
electronic versus analog systems. They do suggest performing chart reviews for
detecting ADEs as part of a surveillance system, both non-targeted chart
reviews and trigger-initiated target chart review in addition to voluntary
reports to improve the rate of identifying ADE’s.
They also recommend including direct observation as a component of an active medication
surveillance system since it provides the advantage of detecting more events
and is likely to detect more administration errors than other surveillance methods.
When evaluating suspected drug-induced events, they
recommend use of a reliable and valid ADE causality assessment instrument,
noting that the ADR Probability Scale is the only ADE instrument tested for
reliability and validity in the ICU. They do suggest performing ICU-specific
ADE surveillance and evaluation but feel that evaluation between types of ICU units
seems unnecessary. They also could not find evidence to make any recommendation
on the effectiveness of prospective versus retrospective strategies at
detecting ME’s/ADE’s in medication safety surveillance.
And, interestingly, they lacked evidence to make
recommendations on the effectiveness of benchmarking for patient safety
surveillance strategies on improving outcomes such as ME/ADE rate or on the
effectiveness of strict compliance with patient safety standards set forth by regulatory
bodies on impacting outcomes such as ME/ADE rates.
Note that the guideline does not really go into safety
issues regarding use of individual drugs or medication categories as they
pertain to the ICU. We’ve done many columns on safety of drugs like opioids,
sedative/hypnotics, and neuromuscular blocking agents (NMBA’s) that are widely
used in ICU’s. But these were beyond the scope of the current guideline.
Perhaps the biggest contribution by the new guideline is its
extensive review of the literature. There are 374 references and the pertinent
literature is summarized for each of the questions they asked.
References:
Kane-Gill SL, Dasta JF, Buckley
MS, et al. Clinical Practice Guideline: Safe Medication Use in the ICU. Crit Care Med 2017; 45(9): ee877-e915
Print “September
2017 Safe Medication Use in the ICU”
Weight-Based
Dosing in Children
One factor contributing to many pediatric medication errors
is that dosages of medications often require calculations based upon the weight
of the patient. The fact that a calculation must be done predisposes to both
simple arithmetic errors and to decimal point errors (see, for example, our
September 2011 What's New in the Patient Safety World
column “Dose
Rounding in Pediatrics”).
A recent study looked at an intervention designed to reduce
the likelihood of errors in weight-based dosing (Larose 2017).
Larose and colleagues compared two strategies in a simulation exercise among residents
rotating in the pediatric emergency department. One group of residents used a
reference book providing weight-based precalculated
doses. The other (control) group used a card providing milligram-per-kilogram
doses.
They found that the clinical aid providing precalculated medication doses was not associated with a
decrease in overall prescribing error rates but was highly associated with a lower risk of 10-fold error for bolus
medications and for medications administered by continuous infusion.
Of course, the other big issue in calculating weight-based
pediatric medication dosages is having an accurate weight and one that uses the
appropriate units.
According to the American Academy of Pediatrics (AAP), half
of all U.S. hospitals do not weigh and record in kilograms, according to an
emergency readiness assessment (Korioth 2016).
That simple initiative (requiring all weights be in kilograms) can prevent
drug-dosing errors. There has been an updated AAP-endorsed statement from the
Emergency Nurses Association (ENA) calling for use of kilograms in the ED (ENA
2016, Wyckoff
2017). An error that originates in the ED can follow the patient throughout
a hospital visit.
The ENA position statement recommends:
- Patient weights should be
measured, recorded and displayed in a prominent place in the medical
record in kilograms only.
- Multiple types of scales
should be available in the emergency setting, all configured to record
weights in kilograms only.
- For patients under age 18
years, clinical decision support features should be used to compare weight
with expected weight (such as based on growth charts) and provide
real-time alerts whether under-dose or over-dose is suspected.
- Electronic medical
records (EMRs) should allow for weight entries only in kilograms.
- Institutions should
consider integrating digital scales with the EMR to eliminate or reduce
the need for data entry.
- The patient’s actual
weight is considered part of the mandatory nursing assessment, is taken at
each visit, and is repeated as warranted in response to changes in the
patient’s condition unless life-threatening circumstances do not allow it.
- The patient’s weight in
kilograms should be included on all prescriptions.
- The patient’s weight in
kilograms should be included in all inter- and intra-disciplinary patient
hand-offs.
Lastly, don’t forget that one of the unintended consequences
of healthcare information technology is that a single error can be propagated
into multiple other errors. The classic error is inputting an incorrect patient
weight into a dedicated field in an electronic medical record. That erroneous
patient weight may then be used to calculate doses of those medications that
use weight-based dosing. This error probably most often happens when the weight
is input in pounds when the EMR is expecting the weight in kilograms. There are
also instances where a patient’s height and weight have been transposed in the
EMR. The other time it occurs is when the weight put into that field is an
estimated weight that turns out to be incorrect or when the weight field is not
updated after a significant gain or loss of weight. Good EMR’s do two things:
- When a weight is input
into a dedicated field the EMR will prompt for input in kilograms or it
will ask whether the input weight is in pounds or kilograms and make the
appropriate adjustment.
- After a certain period of
time (eg. 2-3 weeks) the EMR may prompt the user
to adjust the weight if significant change has taken place.
What safety mechanisms do you have in place to ensure
capture of correct weights?
Some of our other
columns on errors related to patient weights:
March 23, 2010 “ISMP
Guidelines for Standard Order Sets”
September 2010 “NPSA
Alert on LMWH Dosing”
August 2, 2011 “Hazards
of ePrescribing”
January 2013 “More
IT Unintended Conseequences”
December 8, 2015 “Danger
of Inaccurate Weights in Stroke Care”
May 2016 “ECRI
Institute’s Top 10 Patient Safety Concerns for 2016”
Some of our other
columns on pediatric medication errors:
November 2007 “1000-fold
Overdoses by Transposing mg for micrograms”
December 2007 “1000-fold
Heparin Overdoses Back in the News Again”
September 9, 2008 “Less
is More and Do You Really Need that Decimal?”
July 2009 “NPSA
Review of Patient Safety for Children and Young People”
June 28, 2011 “Long-Acting
and Extended-Release Opioid Dangers”
September 13, 2011 “Do
You Use Fentanyl Transdermal Patches Safely?”
September 2011 “Dose
Rounding in Pediatrics”
April 17, 2012 “10x
Dose Errors in Pediatrics”
May 2012 “Another
Fentanyl Patch Warning from FDA”
June 2012 “Parents’
Math Ability Matters”
September 2012 “FDA
Warning on Codeine Use in Children Following Tonsillectomy”
May 7, 2013 “Drug
Errors in the Home”
May 2014 “Pediatric
Codeine Prescriptions in the ER”
November 2014 “Out-of-Hospital
Pediatric Medication Errors”
January 13, 2015 “More
on Numeracy”
April 2015 “Pediatric
Dosing Unit Recommendations”
September 2015 “Alert:
Use Only Medication Dosing Cups with mL Measurements”
November 2015 “FDA
Safety Communication on Tramadol in Children”
October 2016 “Another
Codeine Warning for Children”
January 31, 2017 “More
Issues in Pediatric Safety”
May 2017 “FDA
Finally Restricts Codeine in Kids; Tramadol, Too”
August 2017 “Medication
Errors Outside of Healthcare Facilities”
August 2017 “More
on Pediatric Dosing Errors”
References:
Larose G, Levy A, Bailey B, Cummins-McManus B, et al.
Decreasing Prescribing Errors During Pediatric Emergencies: A Randomized
Simulation Trial. Pediatrics
2017: 139(3): e20163200
ENA (Emergency Nurses Association). Weighing All Patients in
Kilograms. Position Statement; September 2016
Korioth T. FYI: Weigh in kilograms to cut dosing errors. AAP News 2016;
August 19, 2016
http://www.aappublications.org/news/2016/08/19/FYIKG081916
Wyckoff AS. To reduce errors, ED staff should weigh patients
in kilograms AAP
News 2017; August 29, 2017
http://www.aappublications.org/news/2017/08/29/Kilograms082917
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2017 Clinical Decision Rule Success”
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2017 Inpatient Diagnostic Errors and Malpractice Claims”
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