Adverse Incident Reporting Systems Order Instructions: research voluntary versus mandatory incident reporting systems.
Part I: Review the Utah and Minnesota Incident reporting mandates. Compare these points:
1. Who must report incidents at the institution?
2. Discuss whether there is a difference in the types of incidents that must be reported and explain those differences or similarities.
3. Who investigates the incidents at the hospital level?
4. Explain any steps taken to protect incident reports and control who may obtain the information.
5. Explain if and how a root cause analysis is utilized.
Part II: Discuss whether a voluntary or mandatory incident reporting effort is best. List the pros and cons of each kind of system.
Adverse Incident Reporting Systems 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.
Adverse Incident Reporting Systems
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.
Adverse Incident Reporting Systems 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
Adverse Incident Reporting Systems Sample Answer
522 Module 2 SLP: Adverse incident reporting
PART 1
Question 1
According to the Utah Department R380-200, each health facility is mandated to report to the department of health about the 72 hours after patient safety incident had occurred. These include events such surgical procedures that have been performed on a wrong body part or patient, incorrect surgery procedures, neonatal hyperbilirubinemia (<25 milligrams/ per deciliter), hospital-acquired illness, patient harassment or disappearance of a patient with cognitive impairments that have lasted for more than 4 hours. The facility report should include patient information, situation, and facility information, type of occurrence, analysis and corrective actions (The Utah Administrative Code (Rule R380-200), 2014).
Utah Department of health adverse reporting law is similar to Minnesota ‘Adverse Health Events Reporting Law’, in that the healthcare facility must report adverse effects that have occurred in the healthcare facility within 15 days after the incidence has occurred. The law further recommends that it is important to convene a quality team to conduct root cause analysis to investigate the factors that led to adverse effects. The RCA teams are expected to submit their findings and corrective action plan (Minnesota Department of Health Web site, 2014).
Question 2
According to the Utah Department of health, the following incidents are categorized into 3 categories including a) reportable adverse events whose consequences are assessed by harm scale, b) adverse events that result in patient harm or death and c) adverse events as referenced by reporting rules (The Utah Administrative Code ( Rule R380-200), 2014). In general the Utah Department of Health and Minnesota Department of Health adverse events includes surgical procedures performed on wrong body part, wrong patient, incorrect surgical procedures, retention of foreign surgical objects on patients body, neonatal hyperbilirubinemia, discharging infants to a wrong person, abduction of patient, fire, medication errors, use of contaminated drugs, hemolytic reaction and embolism after surgical procedure, radiology to wrong body part, prolonged fluoroscopy, and hospital-acquired illnesses such as patient falls and pressure ulcers. However, the Minnesota Department of Health has additional adverse effects to include criminal adverse events caused through care delivered by someone impersonating nurse, pharmacists, physician, nurse pharmacists or other licensed providers ((The Utah Administrative Code ( Rule R380-200), 2014; Minnesota Department of Health Web site, 2014).
Question 3
Both the Utah Department of Health and Minnesota Department of Health, the risk management teams are responsible for the investigations at hospital levels. The facility designates a leader to lead the investigation and to conduct a root cause analysis. During the review, risk cause factors are identified; solutions to these issues are identified to ensure that reasonable system changes are made to correct the incident, and to prevent similar incidents from occurring. The investigations primarily focus on the system processes (not individual performance) and to identify changes that will lead to reforms or development of new systems so as to prevent these events from re-occurring (The Utah Administrative Code ( Rule R380-200), 2014).
Question 4
In both departments of health, there are steps outlined to control who might obtain the incident reports information. The Utah Department of Health guidelines R380-200-6 highlights the approaches to protect the confidentiality of information which states that the incident reports information should not be released to any pursuant (subsections 26-3-7 (1), because the information produced is highly confidential and privileged under the Title 26, Chap. 25. On the other hand, the Minnesota Department of health promotes sharing of information between the facilities through “data sharing Minnesota Hospital Association” so that the facilities can learn from each other experiences (Minnesota Department of Health Web site, 2014).
Question 5
Root cause analysis is utilized during cause analysis of adverse patient’s incidences. RCA is an error analysis tool, used to identify underlying problems that increase the likelihood of adverse incidents by avoiding the common trap of focusing individual’s mistakes. This tool uses a systematic approach to figure out active errors (those that occur at the interface between the complex system and human) and the latent errors (hidden issues within the healthcare system that contribute to adverse events. The RCA tool follows a pre-specified protocol that starts with data collection, holistic analysis of the data collected through reconstructions of the events through observation, staff interviews, and record review. The sequence of events that led to the adverse outcome is analyzed with the aim of identifying ways the event occurred, why they occurred, and the specific interventions to prevent future harm from happening by eliminating active and latent errors (Root Cause Analysis, 2012).
PART II: Voluntary vs. Mandatory reporting systems
Voluntary patient safety reporting systems are important because they help in detecting safety problems and quality issues. The initial reports are obtained from the frontline personnel involved in the actions. This type of reporting is a passive form of surveillance from unsafe situations or near misses (Howell et al., 2015). The benefits of voluntary reporting systems are that it increases acceptability and involvement of the frontline healthcare staff. In addition, the people who have been involved in the incidents make the report, which highlights that the staffs have legitimate concerns regarding quality performance concerns. In most incidences, voluntary reporting systems are confidential which indicates that any person who witnessed the incidence can make the report because there is legal protection unless the incident occurred due to professional misconduct. However, the voluntary reporting system is associated with limitations such as selection in reporting bias and may capture only a fraction of the incident especially if there are conflicts of interest (Voluntary Patient Safety Event Reporting (Incident Reporting), n.d.).
In some States, reporting of adverse events is mandatory. The benefits of adverse reporting are that it acts as a direct acknowledgment of the adverse event. It helps in detecting adverse incidents that would go unnoticed by the relevant governing bodies. This kind of reporting is important because it reinforces the moral obligation of every person to protect the patient from harm and abuse. The challenges of mandatory reporting are that it is usually governed by the States Department of health, increasing the risk of underreporting to avoid punitive actions, legal penalties, and public scrutiny. This implies that some staff will be reluctant to report errors due to external mandatory programs but will report internally. The health systems may make it challenging for staff to report the adverse incidents that have ‘hand down punishments.’ This is because the organization’s first priority is to minimize organizations exposure to public distrust and increased liability. This generally implies that the situation is prone to hindsight bias (Pham, Girard, & Pronovost, 2013).
Adverse Incident Reporting Systems References
Howell, A.M., Burns, E.M., Bouras, G., Donald, L.J., Athanasiou, T., Darzi,A. (2015). Can patient safety incident reports be used to compare hospital safety? Results from a quantitative analysis of the English National Reporting and Learning System data. PloS one 10(12):e0144107. doi: 10.1371/journal.pone.0144107
Minnesota Department of Health Web site (2014). Patient Safety. Retrieved from http://www.health.state.mn.us/patientsafety/ae/index.html
Pham, J. C., Girard, T., & Pronovost, P. J. (2013). What to do With Healthcare Incident Reporting Systems. Journal of Public Health Research, 2(3), e27. http://doi.org/10.4081/jphr.2013.e27
Root Cause Analysis. (2012). Agency for Healthcare Research and Quality. Retrieved from http://www.psnet.ahrq.gov/primer.aspx?primerID=10
The Utah Administrative Code ( Rule R380-200). (2014). Patient Safety Sentinel Event Reporting. Patient Safety Initiatives. Utah Department of Health Web site. Retrieved from http://www.rules.utah.gov/publicat/code/r380/r380-200.htm
Voluntary Patient Safety Event Reporting (Incident Reporting) (n.d.). U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality; Patient Safety Primers. Retrieved from http://www.psnet.ahrq.gov/primer.aspx?primerID=13
