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

http://annals.org/aim/article/733508/predicting-intracranial-traumatic-findings-computed-tomography-patients-minor-head-injury

 

 

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

http://www.cmaj.ca/cgi/rapidpdf/cmaj.091421v1?maxtoshow=&hits=10&RESULTFORMAT=1&author1=osmond+mh&andorexacttitle=and&andorexacttitleabs=and&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT,HWELTR

 

 

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

https://share.kaiserpermanente.org/article/kaiser-permanente-emergency-department-intervention-adult-head-trauma-reduces-ct-use/

 

 

 

 

 

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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:

 

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:

 

 

 

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

http://www.thedoctors.com/KnowledgeCenter/Publications/TheDoctorsAdvocate/Diagnostic-Error-in-Medical-Practice-by-Specialty

 

 

Ranum D, Troxel DB, Diamond R. Hospitalist Closed Claims Study. An Expert Analysis of Medical Malpractice Allegations. The Doctors Company 2016

http://www.thedoctors.com/ecm/groups/public/@tdc/@web/@kc/@patientsafety/documents/article/con_id_004774.pdf

 

 

 

 

 

 

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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

http://journals.lww.com/ccmjournal/fulltext/2017/09000/Clinical_Practice_Guideline___Safe_Medication_Use.32.aspx

 

 

 

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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:

 

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:

  1. 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.
  2. 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

http://pediatrics.aappublications.org/content/139/3/e20163200?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%3a+No+local+token

 

 

ENA (Emergency Nurses Association). Weighing All Patients in Kilograms. Position Statement; September 2016

https://www.ena.org/docs/default-source/resource-library/practice-resources/position-statements/weighingallpatientsinkilograms.pdf?sfvrsn=9c0709e_6

 

 

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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