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Legal Incident Reporting Requirements

Prepare a four page paper that responds to the following:
Define a root cause analysis and when it is used.
In the case study identify the incident and explain the problem that might trigger a root
cause analysis.
Do you agree that the problem should not be investigated? Explain why or why not?
Discusses the goals and limitations of root cause analysis;
Outline the steps to conduct a root cause analysis.
Assignment Expectations
Limit your responses to a maximum of four pages, not including title and reference list
Be sure to utilize at least 3-4 scholarly references to support your discussions.
Be sure to properly cite your references within the text of your assignment and listed at the
Be sure to apply critical thinking skills to the write-up of your assignment, especially in
regard to #3 above.

Legal Incident Reporting Requirements

  1. Definition of a root cause analysis and when it is utilized
    A root cause analysis refers to the process in which the major factors underlying variation in
    performance are identified, leading to the possible or actual occurrence of an adverse health
    event (Utah Department of Administrative Services, 2014). A root cause analysis is utilized when
    an adverse health event has occurred. The analysis is carried out to establish the root causes of
    the adverse event and the corrective action plan to help in preventing future recurrence of the
    same event (Flanders & Saint, 2005).
  2. Overview of the incident in the case study and explanation of the problem that might
    trigger a root cause analysis
    The case study involves a 65-year old man with septic shock who was admitted to the
    intensive care unit for vasopressors. In addition to the fluid resuscitation, the blood pressure was

supported with phenylephrine and vasopressin. Due to computer error and nurses’ lack of
oversight, the patient received 0.4 units/min of vasopressin instead of the required 0.04 units/min
for 16 hours. As a result, the patient suffered a myocardial infarction while undergoing
treatment. The error was found out after one of the intensive care unit nurses brought a group of
nursing students to the bedside of the patient for an introduction to critical nursing. The nurse
informed the students that the patient was receiving vasopressin medication at a dose of 0.4
units/min. The ICU fellow overheard her instruction and corrected her that the patient was on a
0.04 units/min dose. The fellow confirmed the dose with the nurse to the patient and discovered
that, in fact, the patient was on a higher dose (Flanders & Saint, 2005).
A root cause analysis is carried out in case of an adverse health event. An adverse health
event involves an event which has led to a major permanent loss of function or an unanticipated
death, unrelated to the natural course of the patient’s underlying illness or condition. An adverse
event also includes a sudden death or major psychological or physical injury, or any variation in
process for which a recurrence would significantly provide a chance for an adverse outcome. The
case study is typical of a variation in process likely to result in an adverse outcome if not
corrected. The fact that the patient suffered a myocardial infarction during treatment indicates
that an adverse health event had occurred, and this should trigger a root cause analysis (Flanders
& Saint, 2005).

  1. Do you agree that the problem should not be investigated? Explain why or why not?
    The problem should be investigated because it consists of a serious adverse event, as well as
    the risks of serious injury to the patient in case of recurrence. The risk posed by the error is very
    serious and it is prudent not only to focus on the person who wrote the incorrect order, but on the
    broader perspective of the root causes of the error. The facility is supposed to investigate the role

of different factors that might have resulted in the event such as organizational culture, training,
equipment, staffing, and communication (Wu, Pronovost & Morlock, 2002).
The facility should investigate the manner in which the orders for vasopressin were given and
how the information was entered into a computerized physician order entry system. It is also
important to investigate the factors that caused the error to go undetected for more than sixteen
hours, and how the error persisted through the following day’s multidisciplinary rounds, which
included nurses, physicians, and possibly pharmacists. Vasopressin medication has a narrow
therapeutic window and is known for causing serious adverse cardiovascular effects in cases of
overdose (Malay, Ashton & Dahl, 2004; Mutlu, 2004).

  1. The goals and limitations of root cause analysis
    The goal of root cause analysis is to find out what happened, why it happened, and what
    should be done to prevent it from recurrence. A proper root cause analysis involves the
    assessment of the environment, such as the medication ordering process, product storage and
    labeling, lighting, staffing levels, and time of day in which the error occurred. The rationale
    behind a root cause analysis is to shift the apprehension of adverse health event analysis beyond
    individual human errors that are less actionable to a human factors engineering perspective
    which looks for the vulnerabilities of systems (Flanders & Saint, 2005).
    Though the value of root cause analysis has not been confirmed in thoroughly conducted
    clinical tests in a healthcare setting, it is perceived that this analysis serves a useful purpose in
    reducing errors when used applied appropriately. Root cause analysis is very effective in the
    assessment of rare events rather than common patient safety issues that are more amenable to
    dimensions based on principles of clinical epidemiology such as re-evaluation, intervention,
    benchmarking, and surveillance. Another limitation to the success of a root cause analysis is

inappropriate management by clinical leaders who, sometimes, do not involve themselves in the
performance of some work in the clinical settings they manage. This destroys the good will of
staff and makes useful-error reduction strategies challenging, and even impossible to implement
(Flanders & Saint, 2005).

  1. The steps involved in conducting a root cause analysis
    The first step in the root cause analysis is for the facility to designate a competent team to
    carry out the investigation. The root cause analysis team is mostly led by a member of the
    facility’s quality or patient safety improvement program with expertise in conducting such
    analyses. The team leader ensures that the process concentrates on systems, rather than
    individual, actions. For a case like this, other team members may include an ICU physician and
    representatives from the emergency department, the pharmacy, and the ICU nursing (Wu,
    Pronovost & Morlock, 2002). At least all members of the team should be professionals in the
    area being investigated.
    After establishing a team, the next step is for that team to generate a differential diagnosis
    for systems factors that may have caused the medical error. The domains of investigation are
    tailored in line with the specific circumstances of the case. For instance, the case study consisted
    of various factors within the pharmacy, nursing, physician practice, and the entire facility that
    could have resulted in the error. Accordingly, each domain is inspected for the contribution to
    the adverse health event and priority for change. This process is also divided into various steps.
    The first process involves the development of a timeline of events connected to the care of the
    patient. As much as possible, every test, every response to a test, every order, and every contact
    with the patient must be highlighted. The timeline is important for the observation of all steps

utilized in the patient’s care and for better evaluation of the significant contributions to the
administration of an incorrect dose (Flanders & Saint, 2005).
The third step involves the analysis of contributing factors. In the intensive care unit
setting, preventable adverse drug events are very common. A recent study found that medication
errors are the most common mistakes associated with long ICU work hours. The team is required
to review each event to make sure that the root cause analysis and corrective action plan meet all
standards, and that the facility is taking necessary steps toward the reduction of the risk. Lastly,
the facility obtains feedback from the review team, and submits responses and alterations to their
plan until review criteria are fulfilled (Flanders & Saint, 2005).


Flanders, S. A. & Saint, S. (2005). Getting to the Root of the Matter: Spotlight Case. Agency for
Healthcare Research and Quality.
Malay, M. B., Ashton, J. L., & Dahl, K. (2004). Heterogeneity of the Vasoconstrictor Effect of
Vasopressin in Septic Shock. Critical Care Medication, 32: 1327-1331.
Mutlu G. M. (2004). Role of Vasopressin in the Management of Septic Shock. Intensive Care
Medication, 30(1): 1276-1291.
Utah Department of Administrative Services. (2014). Utah Administrative Code.

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