Root Cause Analysis and its application Order Instructions: Review the case at the U.S. Department of Health and Human Services, Agency for Healthcare Quality and Research, “Getting to the Root of The Matter” at https://psnet.ahrq.gov/webmm/case/98/getting-to-the-root-of-the-matter

Prepare a 4-page paper that responds to the following:

1. Define a root cause analysis and when it is used.
2. In the case study identify the incident and explain the problem that might trigger a root cause analysis.
3. Do you agree that the problem should not be investigated? Explain why or why not?
4. Discusses the goals and limitations of root cause analysis;
5. Outline the steps to conduct a root cause analysis.

Root Cause Analysis and its application Module Overview

This module addresses a variety of legal reporting requirements mandated by both federal and state regulatory agencies. These reporting requirements serve several purposes: 1) they help to safeguard the health of the nation’s population; and (2) they help to reduce and eliminate medical errors by identifying problems and implementing solutions to improve patient safety.

The module will examine state and federal legal reporting requirements including state/federal legislative reporting requirements for child abuse, elder abuse, incident reporting, and diseases that pose a threat to public health and safety (e.g., sexually transmitted diseases, anthrax, smallpox).

Managers must be aware of specific state reporting requirements. Hospital procedures for reporting patient care incidents must comply with state and federal regulations.

Incident Reporting on Root Cause Analysis and its application

Patient safety event reporting systems are pervasive in hospitals and a central part of efforts to deter and detect patient safety events and quality problems. Incident reporting is used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information.

Studies show that initial incident reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals.

Incident reports contain statements made by employees and physicians regarding a deviation from acceptable patient care. Some state health codes mandate that hospitals and nursing facilities must investigate incidents regarding patient care and require that certain incidents must be reported in a manner prescribed by the regulation.

Reportable incidents often include such things as those incidents that have resulted in a patient’s serious injury or death, an event such as fire or loss of emergency power, certain infection outbreaks, and strikes by employees.

Generally, based on case law incident reports should not be placed in the medical record. They should be directed to counsel for legal advice. This will help prevent discovery on the basis of client-attorney privilege. There is conflicting case law. In some states, courts will not permit incident reports to be discovered, whereas others will allow discovery.

Public health departments in 25 States and the District of Columbia operate adverse events reporting systems. (see Adverse Events in Hospitals: Overview of Key Issues: http://oig.hhs.gov/oei/reports/oei-06-07-00471.pdf )

States may also have systems targeted toward specific events; for example, the Government Accountability Office reported in 2008 that 23 States require mandatory reporting of healthcare-associated infections in hospitals. As of April 2007, more than half of states (27) had passed legislation or created regulations related to hospital reporting of adverse events (26 are mandatory systems, one is voluntary).

States typically require that adverse events be reported within a specific timeframe. They may also require that hospitals submit the RCA results along with the adverse event report and a corrective action plan that outlines how the hospital plans to address the problem.

States use information in a variety of ways, including issuing periodic alerts to caution providers about specific problems and trends, reporting to the public as a hospital quality measure, and routing information about the most egregious adverse events to State oversight agencies.

At the national level, regulations implementing the Patient Safety and Quality Improvement Act became effective on January 19, 2009. The legislation provides confidentiality and privilege protections for patient safety information when healthcare providers work with new expert entities known as Patient Safety Organizations (PSOs). Healthcare providers may choose to work with a PSO and specify the scope and volume of patient safety information to share with a PSO

In 1995, hospital-based surveillance was mandated by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) because of a perception that incidents resulting in harm were occurring frequently. The Joint Commission encourages healthcare organizations to self-report sentinel events. Although The Joint Commission encourages but does not require the reporting of sentinel events, it does expect organizations to conduct a root cause analysis when sentinel events occur.

JCAHO employs the term sentinel event in lieu of critical incident and defines it as follows: An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.

As one component of its Sentinel Event Policy, JCAHO created a Sentinel Event Database. The JCAHO database accepts voluntary reports of sentinel events from member institutions, patients and families, and the press. The particulars of the reporting process are left to the member healthcare organizations. JCAHO also mandates that accredited hospitals perform root cause analysis (RCA) of important sentinel events. Data on sentinel events are collated, analyzed, and shared through a website, an online publication, and its newsletter Sentinel Event Perspectives.

Root Cause Analysis and its application Required Reading

Advancing Patient Safety through State Reporting Systems June 2007 Agency for Healthcare Research and Quality http://webmm.ahrq.gov/perspective.aspx?perspectiveID=43#ref1

Voluntary Patient Safety Event Reporting (Incident Reporting). U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality; Patient Safety Primers. http://www.psnet.ahrq.gov/primer.aspx?primerID=13

Patient Safety. Minnesota Department of Health Web site. Available at: http://www.health.state.mn.us/patientsafety/ae/index.html

Rule R380-200. Patient Safety Sentinel Event Reporting. The Utah Administrative Code. (March 2013) Patient Safety Initiatives. Utah Department of Health Web site. Available at: http://www.rules.utah.gov/publicat/code/r380/r380-200.htm

Root Cause Analysis. Agency for Healthcare Research and Quality. October 2012 http://www.psnet.ahrq.gov/primer.aspx?primerID=10

Joint Commission for the Accreditation of Healthcare Organizations’ ” Sentinel Events” – January 2011″ found at http://www.jointcommission.org/assets/1/6/2011_CAMLTC_SE_(2).pdf

Patient Safety States. National Academy for State Health Policy http://www.nashp.org/pst-map

Root Cause Analysis and its application Sample Answer

Question 1: Root Cause Analysis and its application

Root cause analysis refers to the process of identifying the causal factors of variation in nursing activity, which leads to adverse, undesired and unexpected outcomes or even lead to a sentinel event. The process focuses on primarily on processes or systems with the aim of understanding the potential causes of the variation that lead to error and identify the most effective changes that will mitigate such failures in the future.  Root cause analysis is often performed to probe bad failures that may arise in nursing practice. It is also used to probe a near miss event or as a process of performance improvement so as to redesign initiatives and to gain an understanding of variations in nursing practice (Holdsworth et al., 2015).

Question 2: Incident that might trigger Root Cause Analysis

In this case study, a patient was placed at the intensive care unit to manage septic shock which required vasopressors suffered a myocardial infarction (MI) during his treatment regimen. The cause of MI was associated with a prescription error, where the patient was given a higher dosage of vasopressin. Medication errors are common, especially in a critically ill patient. The magnitude of these medication errors led to adverse effects. To understand the causative factors of this incident and approaches to mitigate such incidences from occurring again, there is a need to conduct a root cause analysis. In this context, RCA would be used to assess the environment in which the incidence occurred. This includes assess the staffing levels in the healthcare setting, product storage, patient identification process, labeling and also prescription ordering process (Lee, Mills, and Watts, 2012).

Question 3: Is it necessary to conduct RCA for this case study?

In my perspective, it is vital to investigate the incidence in order to prevent such occurrences from occurring. The RCA should be conducted in order to investigate what happened, why it did, and what strategies can be done so as to prevent the incidence from re-occurring. The benefits of RCA, it does not solely focus on an individual who wrote the wrong order, but broadens the investigation to focus on the “root causes” of the incidence.  The underlying theory of RC is to move the understanding of these failures from human mistakes to human factors that trigger the mistakes in order to engineer an approach that identifies the systems vulnerabilities, and addresses the gaps identified (Grissinger, 2011).

Question 4: RCA goals and limitations on Root Cause Analysis and its application

RCA process provides a systematic approach of investigating performance problems in healthcare settings instead of relying in unverified assumptions and perceptions about the causative factors. Secondly, RCA ensures that the healthcare facility inspect the identified issue from broad perspectives with the aim of establishing a range of causative agents that led to the undesired performance. RCA process opposes the idea that causes of the adverse effects are well known and are agreed upon by people involved. In most incidences, the RCA tool has the capacity to identify the systems components that are blocking the desired performance and parts of systems that promotes desired performance. This result in improved performance due to the routine fixing of issues and expansion of ideas that needs to be done right (Lee, Mills, and Watts, 2012).

On the other hand, RCA is associated with some limitations. For instance, RCA often identifies many causal factors than anticipated or budgeted for. Therefore, it is important to investigate the relative effect of the identified factors, and address the priorities critical to the patient’s safety and quality of care. In addition, the RCA involves complex procedures that may not be familiar with the healthcare settings. The RCA focus on causes but does not inform one on which interventions or activities best address each of the causal factor (Holdsworth et al., 2015).

Question 5 Steps for conducting RCA

The first step is the investigation phase. This involves the identification of a system failure, and assessing the work environment and staff involved in the error so as to establish the sequential flow of events. In this case study, this stage involves a careful review of the incident reported from the ICU and to check for near misses to allow identify the best practice for a change. The amount of information available in this case study is that a fellow resident staff gave a verbal direction to pharmacist to order for vasopressin, the pharmacist entered the order directly into a computer physician order (CPOE) system that had several lists of possible drug dosages, an error was made which went undetected for more than 16 hours, and it involved multidisciplinary teams rounds including nurses, physicians and resident pharmacist. The error was noted during a practicum session with nurse students who found that the patient was on higher dosage (Joint Commission.org., 2011).

The next stage is to develop a plan to identify the identified need. This involves holding interviews with the staff individually or through focus groups and record or document reviews so as to collect information regarding the causal factors that led to the system failure. In this case, the RC team led by health care facility patient safety and improvement program is established so as to ensure that the process focus on the whole systems. Other team members would include ICU nurse, ICU physician, ED representative and a pharmacist. The RCA team is responsible of generating differential diagnosis data to identify factors that could have contributed to the medication error (Grissinger, 2011).

The third step is an analysis of the causatives factors identified. This stage is comparable to the analogy of onion peeling because RCA involves analysis of many causal factors that underlie many layers. At the first step of the analysis, the causes of failure system seem to be easily identified. In most of ICU, the safety networks emphasis on patient’s quality and safe care and are often committed to a culture of safety. In this case study, the main investigation domain generated includes events timeline, ICU protocols for high risk patients, patient safety culture, communication practices, medication ordering protocol and staff working relationships (U.S. Department of Health and Human Services, Agency for Healthcare Quality and Research, 2005).

The fourth step is identifying system failures solution. Unfortunately, there are no standardized safety solutions that will aid in guiding the changes that should be made. This indicates that the RCA team must research further to identify the key steps that will address the contributing factors, and propose a reasonable system based solutions, implement the evidence based changes and to re-evaluate  the process to ensure that there are no more problems will occur. In this case study, the system errors can be developed such that there is complete medication reconciliation and review the patient entry and exit into ICU. The ICU safety officer should round with team, review medication and non-medication related patient safety. A system should be used to allow the fellow healthcare staff members to discuss medication errors so as to encourage the likelihood of constructive changes (Grissinger, 2011; Anonymous, 2012).

Root Cause Analysis and its application References

Anonymous (2012). Root Cause Analysis. Agency for Healthcare Research and Quality. Retrieved from http://www.psnet.ahrq.gov/primer.aspx?primerID=10 Grissinger, M. (2011). Including Patients on Root Cause Analysis Teams: Pros and Cons. Pharmacy and Therapeutics, 36(12), 778–779.

Holdsworth, M. T., Bond, R., Parikh, S., Yacop, B., & Wittstrom, K. M. (2015). Root Cause Analysis Design and Its Application to Pharmacy Education. American Journal of Pharmaceutical Education, 79(7), 99. http://doi.org/10.5688/ajpe79799

Joint Commission.org. (2011). Joint Commission for the Accreditation of Healthcare Organizations’ ” Sentinel Events” –  Retrieved from  http://www.jointcommission.org/assets/1/6/2011_CAMLTC_SE_(2).pdf

Lee, A., Mills, P.D., and Watts, B.V. (2012). Using root cause analysis to reduce falls with injury in the psychiatric unit.  Gen Hosp Psychiatry  34 (3): 304-311

U.S. Department of Health and Human Services, Agency for Healthcare Quality and Research. (2005).  “Getting to the Root of the Matter.”  Retrieved from https://psnet.ahrq.gov/webmm/case/98/getting-to-the-root-of-the-matter