Cases & Commentaries

Failure to Report

Spotlight Case
Commentary By Patrice L. Spath, BA, RHIT

Case Objectives

  • List common causes of medical
    errors.
  • Appreciate the magnitude of
    underreporting of adverse events.
  • List the common barriers to reporting
    adverse events and near misses.
  • Discuss steps that individuals and
    institutions can take to increase reporting.

Case & Commentary: Part 1

A well-appearing 9-month-old infant weighing 8
kg presented with urinary frequency and white cells in her urine.
The emergency department (ED) physician ordered Rocephin (the brand
name for the antibiotic ceftriaxone), 450 mg intramuscularly (IM),
for empiric treatment of a urinary tract infection (UTI) to be
given immediately.

Several hours later, when removing another
vial of ceftriaxone from the automated dispensing cabinet (Pyxis),
the nurse noted that there were two vials in the drawer instead of
the expected one. In the medicine administration area, the nurse
found a partially empty vial of parenteral cefazolin, a different
antibiotic that had not been ordered for any patient that night. On
the top of the vial was a chalky dried substance, and the admixture
remaining in the bottle was cloudy. In this institution,
ceftriaxone is routinely mixed with 1% lidocaine to decrease
postinjection pain. The resulting mixture is clear and colorless.
It was concluded that the infant most likely received 450 mg of IM
cefazolin instead of the intended 450 mg of ceftriaxone.

The medications are routinely ordered by the
ED physicians as "Rocephin" and "Kefzol" but stocked as
"ceftriaxone" and "cefazolin" (Figure). The vials, in the three sizes used to make
the admixtures, are all contained in the same Pyxis drawer.

The error-producing conditions that most likely
contributed to this mistake—similarly named medications
stored in close proximity and an environment predisposed to
distractions—should be recognizable to caregivers, as these
factors are common causes of medication administration
mistakes.(1)
These conditions increased the likelihood that the nurse would get
the wrong medication from the automated dispenser. Retrieving
medications is something nurses do many times during a shift, and,
most of the time, it goes as planned. In the few instances when the
wrong medication is obtained, it is most often recognized and
corrected before administration occurs. In this case, the usual
safeguards such as double-checks and read-backs failed, allowing
the error to reach the patient. What was different this time? An
interview with the nurse involved might provide a clear answer,
although the mistake would most likely be attributed to an
unexplainable lapse in following procedures.

The nurse's failure to confirm the medication's
identity prior to administration falls into the category of an
"unsafe act." Merely telling the nurse to be more careful next time
does little to improve the safety of the system, especially when
the nurse involved in this event is probably the least likely
person to repeat the error. To prevent unintentional unsafe
acts—slips, lapses, mistakes, or procedure
violations—the contributory factors and latent conditions
must be resolved.

The contributory factors in this event fall into
the environmental category. Some hazards in this category are
easier to overcome than others. Periodic pharmacy inspections of
all drug storage areas, including automated dispensing cabinets,
can be used to identify and resolve unsafe conditions.(2)
Separation of inventory will reduce mix-ups caused by
look-alike/sound-alike drugs.(3)

The safety hazards caused by a distracting
environment are not as easily fixed. Interruptions during drug
retrieval may be minimized by creating a zone of safety around the
medication storage area. This can be done by either moving
medication storage to a quieter location or creating some type of
"Do Not Disturb" signage that is posted by the storage area during
times when medications are being retrieved. Facilities using this
strategy have found that people are less likely to disturb a nurse
preparing a medication for a patient when there is a visual
reminder.(4,5)

The latent conditions underlying this event must
be understood by asking why these situations were allowed to exist.
In other words, why are sound-alike drugs stored in close proximity
and why haven't steps been taken to reduce cognitive overload on
caregivers even though it is well known that both of these factors
contribute to medication errors? Often, complacency is the culprit.
When the work environment is normally reliable, safe, and accurate,
it is easy for people to become complacent—a belief that past
experiences will repeat themselves in current situations. Trusting
that "the process will not fail" or "a problem will not happen to
me" is a latent condition that causes individuals to let down their
guard. This trust in the system can also contribute to
organizational complacency, creating an environment that lacks a
sense of urgency about patient safety.

If nothing is done to reduce complacency, it will
undermine the effectiveness of tactics aimed at resolving the
contributory factors. Overcoming individual and organizational
complacency requires an ongoing dialogue about patient safety with
the goal of creating greater awareness of what can go wrong and
greater willingness to reduce potential risks and safety
hazards.(6)

Case & Commentary: Part 2

The nurse who had given this medication was
very upset and spoke with the ED physician on duty about the event,
as 450 mg of IM cefazolin is an overdose for an 8-kg baby. The
nurse was informed that the medications were essentially equivalent
and did not pursue the matter further or report the error to her
supervisor or through the institution's incident reporting
system.

When the physician failed to acknowledge the
potentially harmful medication error, caregivers missed a chance to
protect future patients from harm. Undoubtedly, this was not the
physician's intention, yet this is a common "knee jerk" reaction
following an error. While some observers have attributed this
reaction to the medical profession's "conspiracy of silence"
(7,8),
it is actually a very natural human impulse to hide mistakes so
that potential problems or conflicts can be avoided. Couple this
natural impulse with professional attitudinal barriers and
individual feelings of helplessness, fear, and anxiety, and we have
a situation in which it is difficult to admit that a mistake
occurred. Without interviewing the physician in this case, the
reason for not acknowledging the error is unknown. Because health
care professionals often treat their mistakes as personal failures,
I'd speculate that the physician may have wanted to protect the
nurse and him- or herself from feelings of guilt.(9)

This is an unfortunate case from two
perspectives. First, the child received an overdose of antibiotics.
By not acknowledging the mistake, the health care team made no
attempt to inform the parent of what happened so that potential
effects could be mitigated. Second, and just as important, a
learning opportunity was lost. How many other patients must be
harmed by similar mistakes before the factors that led to the
mistakes are fixed?

Learning could have occurred at two levels. Even
if a formal incident report was not completed, the physicians and
nurses in the unit could have participated in a frank discussion
about what had happened and how future mistakes of this type could
be averted. One tool drawn from crew teamwork training in aviation
is self-critiquing, a team activity that involves debriefing of
recently completed activities.(10,11)
Such discussions also foster a team awareness of failures, which
can help reduce complacency—a probable latent condition in
this case. Instead, the message that may have been imparted is,
"When things don't go right, hide the mistake" rather than "When
things don't go right, openly discuss how to keep it from happening
again."(12) By
completing an incident report for this event, the learning
opportunity would have been expanded to the entire
organization.

It is impossible to determine the rate of
unacknowledged medical mistakes, especially in the absence of an
untoward outcome. Even when caregivers concede that a mistake has
been made, it often goes unreported—impeding organizational
learning and often individual learning. Underreporting of adverse
events is estimated to range from 50% to 96% annually (13,14), and underreporting of no-harm or "near miss"
errors is even greater.(15)
How to improve reporting has become a much-researched question in
recent years, with the reasons for nonreporting found to be many
and varied.(16)

How can health care organizations make reporting
a regular part of individual practice? It is tempting to persuade
compliance with arguments such as:

  • "It's your professional duty."
  • "The incident database will help
    identify improvement opportunities."
  • "We can see if our safety improvement
    efforts are making a difference."

While these are convincing reasons to report
incidents, they may not be persuasive enough. For an individual to
report an incident, the most important factor is safety—not
the patient's, but his or her own. The people must feel safe from
undeserved disciplinary action or retaliation. A study of hospital
nursing units found that higher reporting rates were correlated
with unit members' perception of the risk of discussing mistakes
openly.(17)
Where there was a climate of fear, willingness to report mistakes
was reduced. Other factors that are known to influence reporting
(18)
are:

  • uselessness (perceived attitudes that
    management would take no notice and was not likely to do anything
    about the problem);
  • acceptance of risk (incidents are part
    of the job and cannot be prevented); and
  • practical reasons (too time consuming or
    difficult to submit a report).

To encourage reporting, organizations need to
minimize these factors and create a forgiving environment in
which people feel "psychologically safe" to acknowledge errors.
Strategies that have proven to be effective are summarized in the
Table. These strategies are central to the success of
many incident reporting initiatives. For example, in the 2 years
following addition of a 24-hour call center, incident reports
submitted to the South Australia Department of Health increased by
275%.(19)
The rise in reports was attributed to enhanced reporting
accessibility as well as the new culture of openness. A nonpunitive
culture and assurance of reporter confidentiality are two factors
that have influenced the success of the incident reporting system
at the Veterans Health Administration. In the first 5 years since
its inception, more than 140,000 incident reports were
submitted.(20)
Availability of a secure Internet site for anonymous event
reporting contributed to a high rate of submissions to the neonatal
intensive care incident reporting project sponsored by the Vermont
Oxford Network.(21)
During patient safety executive walkarounds, leaders at Kaiser
Permanente San Diego (CA) Medical Center personally speak with
physicians and staff about the importance of learning from
mistakes. Leaders' ongoing reinforcement of the organization's
"just culture" has contributed to an increase in reporting and
discussion of errors and near misses.(22) Visible improvements are another factor influencing
reporting in the Kaiser Permanente initiative. Physicians and staff
see that when incidents are reported, problems do get
fixed.(23)

Take-Home Points

  • The majority of adverse events go
    unreported.
  • Near misses and adverse events provide
    valuable teaching opportunities for caregivers and
    organizations.
  • Caregivers should incorporate reporting
    into routine practice.
  • Organizations should work to create a
    safe environment that encourages reporting and provides a
    streamlined, user-friendly process.

Patrice L. Spath, BA, RHIT
Healthcare Quality Specialist
Brown-Spath & Associates
Forest Grove, Oregon

Faculty Disclosure: Dr. Spath has
declared that neither she, nor any immediate member of her family,
has a financial arrangement or other relationship with the
manufacturers of any commercial products discussed in this
continuing medical education activity. In addition, the commentary
does not include information regarding investigational or off-label
use of pharmaceutical products or medical devices.

References

1. Committee on Identifying and Preventing
Medication Errors, Institute of Medicine; Aspden P, Wolcott JA,
Bootman JL, Cronenwett LR, eds. Preventing Medication Errors.
Washington, DC: National Academy Press; 2007.

2. Weber RJ, ed. The Handbook on Storing and
Securing Medications. Oakbrook Terrace, IL: Joint Commission
Resources and the American Society of Health-System Pharmacists;
2006.

3. Medication Errors. HRC Risk Analysis: Pharmacy
and Medications 1. Plymouth Meeting, PA: ECRI; November 2004.
Available at: www.ecri.org/Include/Docs/Marketing/HRC_MedErrors.pdf.

4. Pape TM. Applying airline safety practices to
medication administration. Medsurg Nurs. 2003;12:77-93.
[go to PubMed]

5. Hodgkinson B, Koch S, Nay R, Nichols K.
Strategies to reduce medication errors with reference to older
adults. Int J Evid Based Healthc. 2006;4:2-41.

6. Weick KE, Sutcliffe KM. Managing the
Unexpected: Assuring High Performance in an Age of Complexity. Vol
1. New York: John Wiley and Sons; 2001.

7. Lens P, Van De Wal G, eds. Problem Doctors: A
Conspiracy of Silence. Amsterdam, NLD: IOS Press; 1997.

8. Leven L, Ashton JR. The conspiracy of silence
in health care quality. J Epidemiol Community Health.
2006;60:913.

9. Wu AW. Medical error: the second victim. The
doctor who makes the mistake needs help too. BMJ. 2000;320:726-727.

[go to PubMed]

10. Wilson KA, Burke CS, Priest HA, Salas E.
Promoting health care safety through training high reliability
teams. Qual Saf Health Care. 2005;14:303-309.
[go to PubMed]

11. Risser DT, Simon R, Rice MM, Salisbury ML. A
structured teamwork system to reduce clinical errors. In: Spath PL.
Error Reduction in Health Care: A Systems Approach to Improving
Patient Safety. San Francisco, CA: Jossey-Bass;
1999:235-278.

12. Singer PA, Wu AW, Fazel S, McMillan J. An
ethical dilemma: medical errors and medical culture. BMJ.
2001;322:1236-1240.
[go to PubMed]

13. Committee on Quality of Health Care in
America, Institute of Medicine; Kohn L, Corrigan J, Donaldson M,
eds. To Err is Human: Building a Safer Health System. Washington,
DC: National Academy Press; 2000.

14. Joshi MS, Anderson JF, Marwaha S. A systems
approach to improving error reporting. J Healthc Inf Manag.
2002;16:40-45.
[go to PubMed]

15. Bates DW, Boyle DL, Vander Vliet MB,
Schneider J, Leape L. Relationship between medication errors and
adverse drug events. J Gen Intern Med. 1995;10:199-205.
[go to PubMed]

16. Vincent C, Stanhope N, Crowley-Murphy M.
Reasons for not reporting adverse events: an empirical study. J
Eval Clin Pract. 1999;5:13-21.
[go to PubMed]

17. Edmondson AC. Learning from mistakes is
easier said than done: group and organizational influences on the
detection and correction of human error. J Appl Behav Sci.
1996;32:5-28.

18. van der Schaaf T, Kanse L. Checking for
biases in incident reporting. In: Phimister JR, Bier VM, Kunreuther
HC. Accident Precursor Analysis and Management: Reducing
Technological Risk Through Diligence. Washington DC: National
Academic Press; 2004:119-126.

19. Error Reporting on the Increase—South
Australian Department of Health [news release]. Adelaide, SA,
Australia: Patient Safety International; May 3, 2006. Available at:
http://www.patientsafetyint.com/updates.aspx?ID=7.
Accessed March 1, 2007.

20. McCarthy D, Blumenthal D. Committed to
Safety: Ten Case Studies on Reducing Harm to Patients. New York,
NY: The Commonwealth Fund; April 2006. Publication No. 923.
Available at: http://www.cmwf.org/usr_doc/McCarthy_safetycasestudies_923.pdf.
Accessed March 1, 2007.

21. Suresh G, Horbar JD, Plsek P, et al.
Voluntary anonymous reporting of medical errors for neonatal
intensive care. Pediatrics. 2004;113:1609-1618.
[go to PubMed]

22. Feitelberg SP. 2005 Lawrence Patient Safety
Award Winner: Patient Safety Executive Walkarounds. Permanente J.
Summer 2006;10:29-35.

23. Spath PL. Sustainable patient safety.
H&HN Online. December 12, 2006. Available at:
http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HHNMAG/PubsNewsArticle/data/2006December/

061212HHN_Online_Spath&domain=HHNMAG. Accessed March 1,
2007.

Table

Strategies to Improve Incident
Reporting

Promote and sustain a culture of learning from mistakes.
Make incident reporting an individual performance
expectation.
Have clear definitions for reportable events that everyone
understands.
Make it easy to report and provide several different reporting
methods.
Allow for anonymous error reporting.
Maintain a confidential incident reporting system.
Use reports to identify common error-producing factors, not
just to create incident counts.
Share the learning derived from incident analyses with
physicians and staff.
Communicate and celebrate improvements that result from
analyzing reported events.


Figure

Figure. Example of Similar-Looking
Vials.

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