Discussion

Prior to beginning work on this discussion, read through the following webpages and resources to understand the purpose of documenting sentinel events as well as methods and reporting requirements:

· Sentinel Event Policy and Procedures (Links to an external site.)

· PSNet Search (Links to an external site.)

· Sentinel Events Download Sentinel Events

· Sentinel Events (SE) (Links to an external site.)

· Topic 6: Understanding and Managing Clinical Risk Download Topic 6: Understanding and Managing Clinical Risk

Your initial discussion post must be a minimum of 250 words. All referenced materials must include citations and references in APA format. Please see directions for including APA Style elements on these Writing Center pages: APA: Citing Within Your Paper (Links to an external site.) and Formatting Your References List (Links to an external site.) .

Sentinel events occur in nearly all health care organizations. According to the Maine Department of Human Services,

facilities that are vigilant about identifying and reporting errors…foster an organizational culture where staff members feel comfortable reporting patient safety concerns without fear of reprisal. Healthcare facilities that embrace this safety-focused culture look at adverse events as opportunities to learn and improve. (2018, p. 5)

Based on your assigned topic, research a sentinel event, or create your own scenario. You will use this sentinel event for other assignments later in class.

Sentinel Event Topic

First Initial of Last Name

Suicide events

From a health care provider perspective (e.g., hospital, physician’s practice, long-term care, hospice, home health, surgery center, etc.), write a brief description of the sentinel event in your own words.

In addition, address the following:

· Identify the sentinel event, who was involved, what occurred, and where it occurred.

· Describe the applicable accrediting agency’s requirements for reporting the event (e.g., OSHA, ACHA, CMS, CDC, CLIA, The Joint Commission [TJC], AHCA, state agencies).

· Discuss the probable cause that may have contributed to the sentinel event (e.g., process failure, human error, policy error, systems error, technology failure, etc.).

· Create a recommendation that will reduce the risk of future events from occurring.

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Sentinel Events (SE)

I. Sentinel Events The Joint Commission adopted a formal Sentinel Event Policy in 1996 to help hospitals that experience serious adverse events improve safety and learn from those sentinel events. Careful investigation and analysis of patient safety events, as well as strong corrective actions that provide effective and sustained system improvement, is essential to reduce risk and prevent patient harm. The Sentinel Event Policy explains how The Joint Commission partners with hospitals that have experienced a serious patient safety event to protect the patient, improve systems, and prevent further harm.

* Severe temporary harm is critical, potentially life-threatening harm lasting for a limited time with no permanent residual, but requires transfer to a higher level of care/monitoring for a prolonged period of time, transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the condition. Adapted from: Healthcare Performance Improve- ment. The HPI SEC & SSER Patient Safety Measurement System for Healthcare, rev. 2. Throop C, Stockmeier C. May 2011. Accessed Jan 16, 2020. https://www.pressganey.com/docs/default-source/ default-document-library/hpi-white-paper—sec-amp-sser-measurement-system-rev-2-may-2011.pdf? sfvrsn=0.

Definition of Sentinel Event A sentinel event is a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in any of the following: n Death n Permanent harm n Severe temporary harm*

An event is also considered sentinel if it is one of the following: n Suicide of any patient receiving care, treatment, and services in a staffed around-the-

clock care setting or within 72 hours of discharge, including from the hospital’s emergency department (ED)

n Unanticipated death of a full-term infant n Discharge of an infant to the wrong family n Abduction of any patient receiving care, treatment, and services

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† If a clinical determination warrants the use of Rho(D) positive blood to a Rho(D) negative recipient or uncrossmatched blood in emergent or lifesaving interventions, this would not be considered a sentinel event to be reviewed. ‡ Administration of blood or blood products where the safety, potency, or purity has been compromised while the blood product in question was in the laboratory’s control. Source: Food and Drug Administration, Center for Biologics Evaluation and Research. 21 CFR 606.171. § Sexual abuse/assault (including rape) as a sentinel event is defined as nonconsensual sexual contact including oral, vaginal, or anal penetration or fondling of the individual’s sex organ(s) by another individual. One or more of the following must be present to determine that it is a sentinel event: n Any staff-witnessed sexual contact as described above n Admission by the perpetrator that sexual contact, as described above, occurred on the premises n Sufficient clinical evidence obtained by the hospital to support allegations of unconsented sexual

contact

n Any elopement (that is, unauthorized departure) of a patient from a staffed around- the-clock care setting (including the ED), leading to death, permanent harm, or severe temporary harm to the patient

n Administration of blood or blood products having unintended ABO and non-ABO (Rh, Duffy, Kell, Lewis, and other clinically important blood groups) incompati- bilities,† hemolytic transfusion reactions, or transfusions resulting in severe temporary harm, permanent harm, or death‡

n Sexual abuse/assault of any patient while receiving care, treatment, and services while on site at the organization/facility or while under the supervision/care of the organization§

n Sexual abuse/assault of a staff member, licensed independent practitioner, visitor, or vendor while on site at the organization/facility or while providing care/supervision to patients/clients

n Physical assault of any patient (leading to death, permanent harm, or severe temporary harm) while receiving care, treatment, and services while on site at the organization/facility or while under the supervision/care of the organization

n Physical assault (leading to death, permanent harm, or severe temporary harm) of a staff member, licensed independent practitioner, visitor, or vendor while on site at the organization/facility or while providing care/supervision to patients/clients

n Homicide of any patient while receiving care, treatment, and services while on site at the organization/facility or while under the supervision/care of the organization

n Homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the organization/facility or while providing care/supervision to patients/clients

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||Surgeries or other invasive procedures performed at the wrong site, on the wrong patient, or that are the wrong (unintended) procedure for a patient are reviewable under the policy, regardless of the type of procedure or the magnitude of the outcome. Invasive procedure is defined as a procedure in which skin or mucous membranes and/or connective tissue are incised or punctured, an instrument is introduced through a natural body orifice, or foreign material is inserted into the body for diagnostic or treatment-related purposes. Examples of invasive procedures include central line and chest tube insertions, biopsies and excisions, and all percutaneous procedures (e.g., cardiac, electrophysiology, interventional radiology). Exclusions include venipuncture, which is defined as a collection of blood from a vein. Note:Note: These exclusions are still considered patient safety events and should be reviewed by the appropriate local quality and safety teams. # “After surgery” is defined as any time after the completion of final skin closure, even if the patient is still in the procedural area or in the operating room under anesthesia. This definition is based on the premise that a failure to identify and correct an unintended retention of a foreign object prior to that point in the procedure represents a system failure, which requires analysis and redesign. It also places the patient at additional risk by extending the surgical procedure and time under anesthesia. If a foreign object (for example, a needle tip or screw) is left in the patient because of a clinical determination that the relative risk to the patient of searching for and removing the object exceeds the benefit of removal, this would not be considered a sentinel event to be reviewed. However, in such cases, the organization shall (1) disclose to the patient the unintended retention, and (2) keep a record of the retentions to identify trends and patterns (for example, by type of procedure, by type of retained item, by manufacturer, by practitioner) that may identify opportunities for improvement. ** Fire is defined as a rapid oxidation process, which is a chemical reaction resulting in the evolution of light and heat in varying intensities. Source: National Fire Protection Association. NFPA 901: Standard Classifications for Incident Reporting and Fire Protection Data. Quincy, MA: NFPA, 2016.

n Surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong (unintended) procedure for a patient||

n Unintended retention of a foreign object in a patient after an invasive procedure, including surgery#

n Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter) n Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any

delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose

n Fire, flame, or unanticipated smoke, heat, or flashes occurring during direct patient care caused by equipment operated and used by the hospital. To be considered a sentinel event, equipment must be in use at the time of the event; staff do not need to be present.**

n Any intrapartum (related to the birth process) maternal death

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†† Severe maternal morbidity is defined, by the American College of Obstetrics and Gynecology, the US Centers for Disease Control and Prevention, and the Society of Maternal-Fetal Medicine, as a patient safety event that occurs from the intrapartum through the immediate postpartum period (24 hours), requiring the transfusion of 4 or more units of packed red blood cells (PRBC) and/or admission to the intensive care unit (ICU). Admission to the ICU is defined as admission to a unit that provides 24-hour medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support. Ongoing vigilance to better identify patients at risk and timely implementation of clinical interventions consistent with evidence-based guidelines are important steps in the ongoing provision of safe and reliable care. Appropriate systems improvements can be informed by identifying occurrences of maternal morbidity, reviewing the cases, and analyzing the findings. ‡‡ This definition applies to all staffed-around-the-clock care settings. For care settings not staffed around the clock, the fall must occur during a time when staff are present in the setting for the definition to apply.

n Severe maternal morbidity (not primarily related to the natural course of the patient’s illness or underlying condition) when it reaches a patient and results in permanent harm or severe temporary harm††

n Fall resulting in any of the following: any fracture; surgery, casting, or traction; required consult/management or comfort care for a neurological (e.g., skull fracture, subdural or intracranial hemorrhage) or internal (e.g., rib fracture, small liver laceration) injury; a patient with coagulopathy who receives blood products as a result of the fall; or death or permanent harm as a result of injuries sustained from the fall (not from physiologic events causing the fall)‡‡

TheThe aboveabove listlist isis consistentconsistent acrossacross allall JointJoint CommissionCommission accreditationaccreditation programs,programs, thoughthough somesome ofof thesethese eventsevents maymay bebe unlikelyunlikely toto occuroccur inin certaincertain settings.settings. In cases in which the hospital is uncertain that a patient safety event is a sentinel event as defined by The Joint Commission, the event will be presumed to be a patient safety event and not a sentinel event unless determined otherwise through further investigation or the presentation of relevant information. Patient safety events require analysis and should be shared with the Office of Quality and Patient Safety through an organization response (see the “Patient Safety Systems” [PS] chapter).

AllAll sentinelsentinel eventsevents mustmust bebe reviewedreviewed byby thethe hospitalhospital andand areare subjectsubject toto reviewreview byby TheThe JointJoint Commission.Commission. Accredited hospitals are expected to identify and respond appropri- ately to all sentinel events (as defined by The Joint Commission) occurring in the hospital or associated with services that the hospital provides. An appropriate response includes all of the following: n A formalized team response that stabilizes the patient, discloses the event to the

patient and family, and provides support for the family as well as staff involved in the event

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n Notification of hospital leadership n Immediate investigation n Completion of a comprehensive systematic analysis for identifying the causal and

contributory factors n Strong corrective actions derived from the identified causal and contributing factors

that eliminate or control system hazards or vulnerabilities and result in sustainable improvement over time

n Time line for implementation of corrective actions n Systemic improvement with measurable outcomes

Sentinel events are one category of patient safety events. A patient safety event is an event, incident, or condition that could have resulted or did result in harm to a patient. A patient safety event can be, but is not necessarily, the result of a defective system or process design, a system breakdown, equipment failure, or human error. Patient safety events also include adverse events, no-harm events, close calls, and hazardous conditions, which are defined as follows:

n An adverse event is a patient safety event that resulted in harm to a patient. n A no-harm event is a patient safety event that reaches the patient but does not cause

harm. n A close call (or “good catch”) is a patient safety event that did not reach the patient. n A hazardous (or “unsafe”) condition(s) is a circumstance (other than a patient’s own

disease process or condition) that increases the probability of an adverse event.

The hospital determines how it will respond to patient safety events that do not meet the Joint Commission’s definition of sentinel event. Adverse events shall prompt notification of hospital leaders, investigation, and corrective actions, in accordance with the hospital’s process for responding to patient safety events that do not meet the definition of sentinel event. An adverse event may or may not result from an error.

No-harm events, close calls, and hazardous conditions are tracked and used as opportunities to prevent harm, in accordance with the hospital’s process for responding to patient safety events that do not meet the definition of sentinel event. (See also Leadership [LD] Standard LD.03.09.01LD.03.09.01, element of performance [EP] 1, which states: The scope of the safety program includes the full range of safety issues, from potential or no-harm errors (sometimes referred to as close calls [“near misses”] or good catches) to hazardous conditions and sentinel events. Such opportunities could include comprehen- sive analysis, risk identification, and corrective action implementation and sustainment.

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II. Goals of the Sentinel Event Policy The policy has the following four goals: 1. To have a positive impact in improving patient care, treatment, and services and in

preventing unintended harm 2. To focus the attention of a hospital that has experienced a sentinel event on

understanding the factors that contributed to the event (such as underlying causes, latent conditions and active failures in defense systems, or hospital culture) and on changing the hospital’s culture, systems, and processes to reduce the probability of such an event in the future

3. To increase the general knowledge about patient safety events, their contributing factors, and strategies for prevention

4. To maintain the confidence of the public, clinicians, and hospitals that patient safety is a priority in accredited hospitals

III. Responding to Sentinel Events Standards Each Joint Commission accreditation manual contains standards that relate specifically to the management of sentinel events. (See the Appendix to this chapter for related standards.)

Standard LD.03.09.01LD.03.09.01, EP 4, requires each accredited hospital to define patient safety event for its own purposes and to communicate this definition throughout the hospital. This definition must encompass sentinel events as defined by The Joint Commission. An accredited hospital is encouraged to include in its definition events, incidents, and conditions in which no or only minor harm occurred to a patient. The hospital determines how it will respond to patient safety events that do not meet the definition of sentinel event.

The Medical Staff (MS) Standard MS.05.01.01MS.05.01.01, EP 10, requires hospitals to include sentinel event data among the information used as a part of performance improvement activities to improve the quality of care, treatment, and services and patient safety. EP 11 of that standard requires that patient safety data is also used in those activities.

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Comprehensive Systematic Analysis As indicated above, appropriate response to a sentinel event includes the completion of a comprehensive systematic analysis for identifying the causal and contributory factors. Root cause analysis, which focuses on systems and processes, is the most common form of comprehensive systematic analysis used for identifying the factors that underlie a sentinel event.

A hospital may use other tools and methodologies to conduct its comprehensive systematic analysis. The Joint Commission encourages the hospital to contact the patient safety specialist assigned to the hospital’s event or to call the Office of Quality and Patient Safety at 630-792-3700 if it has questions regarding using the tools discussed above or other tools it is considering. (See the “Review of Comprehensive Systematic Analyses and Corrective Action Plans” section for further discussion of acceptability.)

Corrective Action Plan The product of the comprehensive systematic analysis is a corrective action plan. The corrective action plan identifies the strategies that the hospital intends to implement in order to reduce the risk of similar events occurring in the future. The identified actions should eliminate or control system hazards or vulnerabilities that have been identified by the comprehensive systematic analysis. Analysis teams should identify at least one stronger or intermediate strength action when possible (see Figure 3 on page 17 of the National Patient Safety Foundation [NPSF] RCA2: Improving Root Cause Analyses and Actions to Prevent Harm report at https://c.ymcdn.com/sites/www.npsf.org/resource/ resmgr/PDF/RCA2_v2-online-pub_010816.pdf for more information on strength of action). The plan must address the following: n Identification of corrective actions to eliminate or control system hazards or

vulnerabilities directly related to causal and contributory factors n Responsibility for implementation n Time lines for completion n Strategies for evaluating the effectiveness of the actions n Strategies for sustaining the change

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Reporting a Sentinel Event to The Joint Commission Each hospital is strongly encouraged, but not required, to report to The Joint Commission any patient safety event that meets the Joint Commission definition of sentinel event. A hospital benefits from self-reporting in the following ways: n The Joint Commission can provide support and expertise to the hospital during the

review of a sentinel event. n A review with the Office of Quality and Patient Safety provides the opportunity for

the hospital to collaborate with a patient safety specialist who is educated as a Master’s prepared clinician or human factors engineer, is a certified professional in patient safety (CPPS), is trained in Robust Process Improvement® (RPI), and is likely to have reviewed similar events.

n Reporting raises the level of transparency in the hospital and helps promote a culture of safety.

n Reporting conveys the hospital’s message to the public that it is doing everything possible, proactively, to prevent similar patient safety events in the future.

Further, reporting the event enables the addition of the “lessons learned” from the event to be added to The Joint Commission’s Sentinel Event Database, thereby contributing to the general knowledge about sentinel events and to the reduction of risk for such events in many other hospitals.

The value of this review is reflected by the fact that a vast majority of sentinel events reported to The Joint Commission are self-reported by the organizations that experienced the events. Alternatively, The Joint Commission may become aware of a sentinel event by some other means such as communication from a patient, a family member, an employee of the hospital, a surveyor, or through the media.

Self-reporting a sentinel event is not required and there is no difference in the expected response, time frames, or review procedures whether the hospital voluntarily reports the event or The Joint Commission becomes aware of the event by some other means. If a hospital wishes to report to The Joint Commission an occurrence of a sentinel event or clarify whether an event meets the sentinel event definition, the hospital will be asked to complete a form accessible through its Joint Commission Connect® extranet site. From this site, place the cursor over “Continuous Compliance Tools.” A drop-down list will appear. From this list, select “Self Report Sentinel Event.”

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If The Joint Commission becomes aware of a sentinel event that was not reported by the hospital to The Joint Commission, the hospital’s CEO (or designee) is contacted, and a preliminary assessment of the sentinel event is made. An event that occurred more than one year before the date The Joint Commission became aware of the event will not, in most cases, be reviewed under the Sentinel Event Policy. In such a case, a written response will be requested from the hospital, including a summary of the processes that were designed to prevent similar occurrences.

Required Response to a Sentinel Event All sentinel events must be reviewed by the hospital, whether or not they are reported to The Joint Commission. In addition, if The Joint Commission becomes aware (either through voluntary self-reporting or otherwise) of a sentinel event that meets the criteria of this policy and the event has occurred in an accredited hospital, the hospital is expected to do the following: n Prepare a thorough and credible comprehensive systematic analysis and corrective

action plan within 45 business days of the event or of becoming aware of the event. n Submit to The Joint Commission its comprehensive systematic analysis and

corrective action plan, or otherwise provide for Joint Commission evaluation its response to the sentinel event using an approved methodology within 45 business days of the known occurrence of the event. The Joint Commission Office of Quality and Patient Safety will conduct a collaborative review with the organization leadership or designee to determine whether the comprehensive systematic analysis and corrective action plan are acceptable. The optional alternative approaches to this review appear on the following pages.

The fact that a hospital has experienced a sentinel event will not impact its accreditation decision. However, willful failure to respond appropriately to the sentinel event could have such an impact. For instance, if the hospital fails to submit a comprehensive systematic analysis within an additional 45 days following its due date, its accreditation decision may be impacted. In these instances, patient safety specialists in the Office of Quality and Patient Safety, along with the medical director and patient safety officer, would recommend to the chief medical officer and the executive leadership of The Joint Commission to change the hospital’s accreditation status.

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Submission of Comprehensive Systematic Analyses and Corrective Action Plans A hospital that reports a sentinel event must submit the comprehensive systematic analysis, including the resulting corrective action plan with measurement that describes the hospital’s risk reduction strategies as well as how the effectiveness of those strategies will be evaluated. This information is submitted electronically and will be reviewed in a conference call involving Joint Commission staff and hospital staff (Alternative–0). Documents shall not include the names of caregivers and patients involved in the sentinel event.

If the hospital has concerns about sending the comprehensive systematic analysis documents to The Joint Commission, the following four optional alternative approaches to a review of the hospital’s response to the sentinel event are acceptable: 1. A review of the comprehensive systematic analysis and corrective action plan

documents brought to Joint Commission headquarters by hospital staff, then taken back to the hospital on the same day (Alternative–1). This can also be performed via web-based video conferencing with a patient safety specialist who is located at The Joint Commission (Web-Alternative). When the web-based video conference is used, the hospital’s participants remain at the hospital.

2. An on-site meeting at the hospital with a Joint Commission patient safety specialist to review the comprehensive systematic analysis and corrective action plan documents (Alternative–2). This can also be performed via web-based video conferencing with a patient safety specialist who is located at The Joint Commission (Web-Alternative).

3. An on-site review with a Joint Commission patient safety specialist to review the corrective action plan and relevant documentation (Alternative–3). The patient safety specialist may ask questions regarding the comprehensive systematic analysis, but will not review that document itself. For purposes of this review activity, relevant documentation includes, at a minimum, any documentation relevant to the hospital’s process for responding to sentinel events and the corrective action plan resulting from the analysis of the sentinel event. The corrective action plan serves as the basis for determining appropriate follow-up activity. This can also be performed via web- based video conferencing with a patient safety specialist who is located at The Joint Commission (Web-Alternative).

4. An on-site visit by a specially trained surveyor arranged to conduct the following (Alternative–4):

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a. Interview and review of relevant documentation, including, if applicable, the patient’s medical record, to evaluate the following: n The process the hospital uses in responding to sentinel events n The relevant policies and procedures preceding and following the hospital’s

review of the specific event, and the implementation thereof, sufficient to permit inferences about the adequacy of the hospital’s response to the sentinel event

b. A standards-based survey that traces a patient’s care, treatment, and services and the hospital management functions relevant to the sentinel event under review

Each of these options will result in a fee to the hospital to cover the average direct costs of the option. Inquiries about the fee should be directed to the Joint Commission’s Pricing Unit at 630-792-5115.

The Joint Commission must receive a request for review of a hospital’s response to a sentinel event using any of these options within five business days of the self-report of a sentinel event or of the initial communication by The Joint Commission to the hospital that it has become aware of a sentinel event.

§§ National Patient Safety Foundation. RCA2: Improving Root Cause Analyses and Actions to Prevent Harm. Boston: National Patient Safety Foundation, 2015. ||||Department of Veterans Affairs. Veterans Health Administration Patient Safety Handbook 1050.01. Mar 4, 2011. Accessed Jan 16, 2020. http://www.va.gov/vhapublications/ViewPublication.asp? pub_ID=2389.

Review of Comprehensive Systematic Analyses and Corrective Action Plans A comprehensive systematic analysis will be reviewed for thoroughness, credibility, and acceptability. A hospital’s comprehensive systematic analysis should identify system vulnerabilities so that they can be eliminated or mitigated. The analysis should not focus on individual health care worker performance, but should seek out underlying systems- level causations that were manifested in personnel-related performance issues.§§ To help adhere to these characteristics it is recommended but not required that the following guidelines be considered when developing causative factor statements:||||

n Clearly show the cause-and-effect relationship. n Use specific and accurate descriptors for what occurred, rather than negative and

vague words.

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## A senior leader is not necessarily required to be actively involved in the day-to-day work of the comprehensive systematic analysis team. However, the team should report to the senior leader or designee, and he or she should be involved in deciding or approving the actions the hospital will take as a result of the comprehensive systematic analysis. *** National Patient Safety Foundation. RCA2: Improving Root Cause Analyses and Actions to Prevent Harm. Boston: National Patient Safety Foundation, 2015.

n Human errors must have a preceding cause. n Violations of procedure are not root causes, but must have a preceding cause. n Failure to act is only causal when there is a preexisting duty to act.

To be thoroughthorough, the comprehensive systematic analysis must include the following: n The analysis repeatedly asks a series of “Why” questions until it identifies the

systemic causal factors associated with each step in the sequence that led to the sentinel event

n The analysis focuses on systems and processes, not solely on individual performance n A determination of the human and other factors most directly associated with the

sentinel event and the process(es) and systems related to its occurrence n The analysis of the underlying systems and processes through the series of “Why”

questions determines where redesign might reduce risk n An inquiry into all areas appropriate to the specific type of event n An identification of risk points and their potential contributions to this type of

event n A determination of potential improvement in processes or systems that would tend

to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist

To be crediblecredible, the comprehensive systematic analysis must do the following: n Include participation by a process owner who is not a member of the response team;

typically this is a senior leader of the hospital or a designee##

n Each action recommended by a review team should be approved or disapproved, preferably by the CEO or alternatively by another relevant member of top management. If an action is disapproved, the reason for its disapproval should be shared with the comprehensive systematic analysis and action team so that the constraint can be understood and another developed by the team to replace it if the system vulnerability is not otherwise effectively addressed in the corrective action plan.***

n Include patients, family, or patient representatives when appropriate to ensure a thorough understanding of the facts

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†† An example of the Action Hierarchy tool is available at https://www.patientsafety.va.gov/docs/joe/ rca_tools_2_15.pdf, page 28.

n Include individuals most closely involved in the processes and systems under review n Be internally consistent (that is, not contradict itself or leave obvious questions

unanswered) n Provide an explanation for all findings of “not applicable” or “no problem” n Include a bibliography of any relevant evidence-based literature

A corrective action plan will be considered acceptableacceptable if it does the following: n Identifies and implements actions to eliminate or control systems hazards or

vulnerabilities o It is recommended but not required that review teams should attempt to

identify actions that are likely to reduce the risk or prevent the event from recurring and, if that is not possible, reduce the severity or consequences if it should recur.

o It is recommended that the review team use a tool that will assist in identifying stronger actions that provide effective and sustained system improvement. A tool such as the Action Hierarchy can help organizations evaluate the strength of the corrective actions identified in their comprehensive systematic analysis. The US Department of Veterans Affairs National Center for Patient Safety developed this tool in 2001. ††

n Identifies, in situations in which improvement actions are planned, who is responsible for implementation, when the action will be implemented, how the effectiveness of the actions will be evaluated, and how the actions will be sustained

n Identifies at least one stronger or intermediate strength action for each comprehen- sive systematic analysis

All comprehensive systematic analyses and corrective action plans will be considered and treated as confidential by The Joint Commission.

Follow-up Activities After The Joint Commission has determined that a hospital has conducted an acceptable comprehensive systematic analysis (for example, root cause analysis) and developed an acceptable corrective action plan, The Joint Commission will notify the hospital that the comprehensive systematic analysis and corrective action plan are acceptable and will

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assign an appropriate follow-up activity. This will be a mutually agreed-upon documentation of sustained improvement and reduction of risk, which may include one or more Sentinel Event Measure(s) of Success (SE MOS).

IV. The Sentinel Event Database The third goal of the Sentinel Event Policy is to increase the general knowledge about patient safety events, their contributing factors, and strategies for prevention. To achieve this, The Joint Commission collects and analyzes data from the review of sentinel events and their comprehensive systematic analyses, corrective action plans, and follow-up activities. These data and information comprise the content of the Joint Commission’s Sentinel Event Database.

The Sentinel Event Database is a major component of the evidence base for developing and maintaining the Joint Commission’s National Patient Safety Goals. The database also informs the development prevention advice to hospitals through Sentinel Event Alert or other media. For these purposes, The Joint Commission uses de-identified aggregate data relating to root causes, contributing factors, and risk-reduction strategies. The Joint Commission is committed to developing and maintaining this Sentinel Event Database in a fashion that will protect the confidentiality of the hospital, the caregiver, and the patient.

V. Determination That a Sentinel Event Is Subject to Review In order to determine if an event is sentinel, it must be submitted as a self report (see “Reporting a Sentinel Event to The Joint Commission” for a review of the self-report process). Based on available information received about the event, a patient safety specialist from the Office of Quality and Patient Safety (OQPS) will determine whether an event meets the definition in Section I and is, therefore, a sentinel event. Challenges to a determination that an event is a sentinel event will be resolved through discussions between senior Joint Commission staff and senior hospital leaders.

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Shading indicates a change effective July 1, 2021, unless otherwise noted in the What’s New.

VI. Optional On-Site Review of a Sentinel Event An initial on-site review of a sentinel event will usually not be conducted unless it is determined that a potential ongoing Immediate Threat to Health or Safety exists. An Immediate Threat to Health or Safety is a threat that represents the most immediate risk and has or may potentially have serious adverse effects on the health or safety of patients. All potential Immediate Threats to Health or Safety are referred to Joint Commission executive leadership for authorization to conduct an unannounced on-site for-cause survey. If an on-site survey is conducted, the hospital will be billed a sufficient charge, based on an established fee schedule, to cover the costs of conducting such a survey.

VII. Disclosable Information If The Joint Commission receives an inquiry about the accreditation decision of a hospital that has experienced a sentinel event, the hospital’s current accreditation status will be reported in the usual manner without making reference to the sentinel event. If the inquirer specifically references the particular sentinel event, The Joint Commission will acknowledge that it is aware of the event and currently is working or has worked with the hospital through the sentinel event review process.

VIII. The Joint Commission’s Response Patient safety specialists from The Joint Commission assess the acceptability of the hospital’s response to the sentinel event, including the thoroughness and credibility of any comprehensive systematic analysis information reviewed and the hospital’s corrective action plan. (Root cause analysis is the most commonly used method of comprehensive systematic analysis.) If the comprehensive systematic analysis and corrective action plan are found to be thorough and credible, patient safety specialists from The Joint Commission will notify the hospital and assign one or more or other mutually agreed- upon documentation of sustained improvement and reduction of risk, such as SE MOS. (See the “Sentinel Event Measures of Success [SE MOS]” section for more details.)

A patient safety specialist, who is educated as a Master’s prepared clinician or human factors engineer, is a certified professional in patient safety (CPPS), and is trained in RPI will provide consultation to the hospital if the response is unacceptable and will allow an

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the CAMH update.

CAMH Update 1, July 2021SE – 14b

◤Comprehensive Accreditation Manual for Hospitals

Shading indicates a change effective July 1, 2021, unless otherwise noted in the What’s New.

CAMH, January 2021 SE – 15

Sentinel Events◥ additional 15 business days beyond the original submission period for the hospital to resubmit its response. If the response is still unacceptable, the hospital’s accreditation decision may be impacted.

IX. Sentinel Event Measures of Success (SE MOS) The hospital’s follow-up activity may be conducted through the SE MOS process. An SE MOS is a numerical or quantifiable measure, ideally with a numerator and denominator, that indicates whether a planned action was effective and sustained. The SE MOS is due on a mutually agreed-upon date.

If an SE MOS is used, the following information would apply: n If an SE MOS is submitted on time but does not meet pre-established levels of

compliance, the patient safety specialist from The Joint Commission will request an additional four months of data. If the second set of data does not meet pre- established levels of compliance, the hospital’s accreditation decision may be impacted.

n If submission of an SE MOS is 90 or more days late, the hospital’s accreditation status may be impacted.

X. Handling Sentinel Event–Related Documents Handling of any submitted comprehensive systematic analysis and corrective action plan is restricted to specially trained staff in accordance with procedures designed to protect the confidentiality of the documents.

At the time the review of the de-identified comprehensive systematic analysis is entered into the Sentinel Events Database, the original documents will be destroyed, as well as any copies. However, upon request the original documents may be returned to the hospital. The information contained in any electronically submitted comprehensive systematic analysis tool will be de-identified after the review is completed.

The corrective action plan resulting from the analysis of the sentinel event will initially be retained long enough to serve as the basis for appropriate follow-up activities, such as the SE MOS or other mutually agreed-upon documentation of sustained improvement. After the corrective action plan has been implemented and meets the established levels of

CAMH, January 2021SE – 16

◤Comprehensive Accreditation Manual for Hospitals compliance, The Joint Commission will destroy and delete the corrective action plan. If the SE MOS was submitted electronically, the information will likewise be de-identified upon completion of the review.

XI. Oversight of the Sentinel Event Policy The executive leadership of The Joint Commission is responsible for approval of this policy and overseeing its implementation. In addition to reviewing and deciding individual cases involving changes in a hospital’s accreditation decision, Joint Com- mission staff will periodically audit the comprehensive systematic analysis and documentation of follow-up activities. For the purpose of these audits, The Joint Commission temporarily retains random de-identified samples of these documents. Upon completion of the audit, these documents are also destroyed.

For more information about the Joint Commission’s Sentinel Event Policy, visit the Joint Commission’s website at https://www.jointcommission.org/resources/patient- safety-topics/sentinel-event/sentinel-event-policy-and-procedures/ or call the Office of Quality and Patient Safety at 630-792-3700.

XII. Survey Process When conducting an accreditation survey, The Joint Commission seeks to evaluate the hospital’s compliance with the applicable standards, National Patient Safety Goals, and Accreditation Participation Requirements, and to assess the hospital’s performance based on those requirements. Surveyors are instructed not to search for or investigate sentinel events during an accreditation survey or to inquire about sentinel events that have been reported to The Joint Commission. However, surveyors may assess a hospital’s performance improvement practices, such as its processes for responding to a sentinel event.

If during the course of conducting survey activities, a potential serious patient safety event is newly identified, the surveyor will take the following steps: n Inform the hospital CEO that the event has been identified n Inform the CEO the event will be reported to The Joint Commission for further

review and follow-up under the provisions of the Sentinel Event Policy

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Sentinel Events◥ Surveyors are not authorized to review the comprehensive systematic analysis documents and determine credibility, thoroughness, or acceptability because they are limited to applying the related standards and elements of performance to assess performance improvement practices, such as processes for responding to safety events, adverse events, hazardous unsafe conditions, close calls, and sentinel events.

The surveyor makes no determination of whether or not the event is a sentinel event and does not focus on or explore the event further, but rather will hand off further discussion to a patient safety specialist in the Office of Quality and Patient Safety. Surveyors are not authorized to investigate sentinel events. The patient safety specialist will contact the hospital after all survey activity is entirely completed to explore the event and determine whether or not submission of a comprehensive systematic analysis is required. If so, the hospital will proceed with the steps described after an event is determined to be a sentinel event. (See the “Required Response to a Sentinel Event” section in this chapter.)

During the on-site survey, the surveyor(s) will assess the hospital’s compliance with sentinel event–related standards in the following ways (see Standards LD.03.09.01 and MS.05.01.01 in the Appendix): n Review the hospital’s process for responding to a sentinel event n Interview the hospital’s leaders and staff about their expectations and responsibilities

for identifying, reporting on, and responding to sentinel events

Appendix. Accreditation Requirements Related to Sentinel Events The following standards and associated elements of performance (EPs) are related to sentinel events:

Leadership (LD) Standard LD.03.09.01 The hospital has an organizationwide, integrated patient safety program within its performance improvement activities.

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◤Comprehensive Accreditation Manual for Hospitals Elements of Performance for LD.03.09.01 1. The leaders implement a hospitalwide patient safety program as follows:

n One or more qualified individuals or an interdisciplinary group manage the safety program.

n All departments, programs, and services within the hospital participate in the safety program.

n The scope of the safety program includes the full range of safety issues, from potential or no-harm errors (sometimes referred to as close calls [“near misses”] or good catches) to hazardous conditions and sentinel events.

2. As part of the safety program, the leaders create procedures for responding to system or process failures.

Note:Note: Responses might include continuing to provide care, treatment, and services to those affected, containing the risk to others, and preserving factual information for subsequent analysis.

3. The leaders provide and encourage the use of systems for blame-free internal reporting of a system or process failure, or the results of a proactive risk assessment. (See also LD.03.08.01, EP 1; PI.01.01.01, EP 7)

Note:Note: This EP is intended to minimize staff reluctance to report errors in order to help an organization understand the source and results of system and process failures. The EP does not conflict with holding individuals accountable for their blameworthy errors.

4. The leaders define patient safety event and communicate this definition throughout the organization.

Note:Note: At a minimum, the organization’s definition includes those events subject to review as described in the “Sentinel Events” (SE) chapter of this manual.

5. The hospital conducts thorough and credible comprehensive systematic analyses (for example, root cause analyses) in response to sentinel events as described in the “Sentinel Events” (SE) chapter of this manual.

6. The leaders make support systems available for staff who have been involved in an adverse or sentinel event.

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Sentinel Events◥ Note:Note: Support systems recognize that conscientious health care workers who are involved in sentinel events are themselves victims of the event and require support. Support systems provide staff with additional help and support as well as additional resources through the human resources function or an employee assistance program. Support systems also focus on the process rather than blaming the involved individuals.

7. At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment. (See also LD.03.08.01, EP 1)

Note:Note: For suggested components, refer to the “Proactive Risk Assessment” section at the beginning of this chapter.

8. To improve safety and to reduce the risk of medical errors, the hospital analyzes and uses information about system or process failures and the results of proactive risk assessments. (See also LD.03.08.01, EP 1)

9. The leaders disseminate lessons learned from comprehensive systematic analyses (for example, root cause analyses), system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.

10. At least once a year, the leaders provide governance with written reports on the following: n All system or process failures n The number and type of sentinel events n Whether the patients and the families were informed of the event n All actions taken to improve safety, both proactively and in response to actual

occurrences n ForFor hospitalshospitals thatthat useuse JointJoint CommissionCommission accreditationaccreditation forfor deemeddeemed statusstatus

purposes:purposes: The determined number of distinct improvement projects to be conducted annually

n All results of the analyses related to the adequacy of staffing (See also PI.02.01.01, EP 14)

11. The leaders encourage external reporting of significant adverse events, including voluntary reporting programs in addition to mandatory programs.

Note:Note: Examples of voluntary programs include The Joint Commission Sentinel Event Database and the US Food and Drug Administration (FDA) MedWatch. Mandatory programs are often state initiated.

CAMH, January 2021SE – 20

◤Comprehensive Accreditation Manual for Hospitals Medical Staff (MS) Standard MS.05.01.01 The organized medical staff has a leadership role in organization performance improvement activities to improve quality of care, treatment, and services and patient safety.

Elements of Performance for MS.05.01.01 Information used as part of the performance improvement mechanisms, measurement, or assessment includes the following:

10. Sentinel event data. (See also PI.03.01.01, EPs 2 and 4)

11. Patient safety data. (See also PI.03.01.01, EPs 2 and 4)

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Course: Knowledge is the Enemy of Unsafe Care

Topic: Understanding and managing clinical risk

Summary

Health-care providers are responsible for the treatment, care and clinical outcomes of patients. Personal accountability is important, as any person in the chain might expose a patient to risk. One way for professionals to help prevent adverse events is to identify areas prone to errors. The proactive intervention of a systems approach for minimizing the opportunities for errors can prevent adverse events. Individuals can maintain a safe clinical working environment by looking after their own health and responding appropriately to concerns from patients and colleagues.

Risk management is routine in most industries and associated with limiting litigation cost. In health care, it is usually associated with patients taking legal action against a health professional or institution, alleging harm as a result of their care and treatment. Many health care facilities have systems in place for reporting patient falls, medication errors, retained swabs and misidentification of patients. However, most health facilities are only beginning to focus on all of these. Clinical risk management is relevant to patient safety

Effective risk management involves every level of the health system. It is essential that all health-care providers understand risk management, and its relevance in the workplace. Health- care providers have a responsibility to take corrective action when they observe unsafe situations.

Some important considerations include: • Clinical risk management is relevant because it recognizes that clinical care and treatment

are risky and negative incidents do occur. • Health care itself is inherently risky and although it is impossible to eradicate all risk, there

are many activities and actions that can be introduced to minimize opportunities for errors. • Many health facilities have policies for reporting incidents, but the reporting of these

incidents is often sporadic. • Inadequate reporting may be due to the blame culture in health care being a strong

deterrent to reporting. • Today, most risk-management programmes aim to improve safety and quality, in addition

to minimizing the risk of litigation and other losses to health-care providers.

 

Gathering information about clinical risk

Health-care facilities in most developed and transitional countries use a range of mechanisms to measure harm caused to patients and staff, as well as avoid known problems. Some activities commonly used to manage clinical risk are described below.

Clinical risk management deals mostly with improving the quality and safety of health-care by identifying the circumstances and situations that put patients at risk and then acting to prevent or control those risks. The following process is used to manage clinical risks:

o identify the risk; o assess the frequency and severity of the risk; o reduce or eliminate the risk; o assess the costs saved by reducing the risk or the costs of not managing the risk.

 

 

 

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Incident monitoring

• WHO defines an incident as an event or circumstance that could have or did lead to unintended and/or unnecessary harm to a person and/or a complaint, loss or damage.

• The main benefit of incident monitoring lies in the collection of information useful for the prevention of similar incidents in the future.

• The key to an effective reporting system is for staff to routinely report incidents and near misses. Unless staff members trust that the organization will use the information for improvement and not to blame individuals, they will be reluctant to report incidents.

• Facilitated monitoring identifies and analyses a greater proportion of incidents with a view to making improvements to care. This continuous activity of health-care teams involves: o discussion about incidents as a routine item at the weekly staff meetings; o a weekly review of areas where errors are known to occur; o a detailed discussion about the facts of an incident and follow-up action required—this

discussion should be educational rather than focusing on attributing blame; o identification of system-related issues and problems to be addressed and made known.

Near miss A near miss is an incident that did not cause harm. Some people call near misses “near hits”,

because the actions may have caused an adverse event, but corrective action was taken just in time or the patient had no adverse reaction to the incorrect treatment.

Types of issues identified by incident monitoring Type of incident % of

reports a Falls 29 Injuries other than falls (e.g. burns, pressure injuries, physical assault, self-harm) 13

Medication errors (e.g. omission, overdose, underdose, wrong route, wrong medication) 12

Clinical process problems (e.g. wrong diagnosis,inappropriate treatment, poor care) 10

Equipment problems (e.g. unavailable, inappropriate, poor design, misuse, failure, malfunction)

8

Documentation problems (e.g. inadequate, incorrect, incomplete, out-of-date, unclear) 8 Hazardous environment (e.g. contamination, inadequate sterilization) 7 Inadequate resources (e.g. staff absent, unavailable, inexperienced, poor orientation) 5 Logistical problems (e.g. problems with admission, treatment, transport, response to an emergency)

4

Administrative problems (e.g. inadequate supervision, lack of resource, poor management decisions)

2

Infusion problems (e.g. omission, wrong rate) 1

Infrastructure problems (e.g. power failure, insufficient beds) 1

Nutrition problems (e.g. fed when fasting, wrong food, food contaminated, problems when ordering)

1

Colloid or blood product problems (e.g. omission, underdose, overdose, storage problems) 1 Oxygen problems (e.g. omission, overdose, underdose, premature cessation, failure of supply)

1

a An incident may be assigned to more than one category

Source: Runciman B, Merry A, Walton M. Safety and ethics in health care: a guide to getting it right, 2007

 

 

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Sentinel events • An adverse event that is usually unexpected and involving a patient’s death or serious

physical or psychological injury to a patient. The term sentinel event is the designation reserved for the most serious ones.

• Many health-care facilities have mandated the reporting of sentinel events because of the significant risks associated with their repetition. These events are classified into categories (e.g. surgery on the wrong patient or body site, incompatible blood transfusion, medication error leading to death, newborn being given to the wrong mother, etc.).

• Events that do not fit into these categories are referred to as “other catastrophic events”.

The role of complaints in improving care • A complaint is defined as an expression of dissatisfaction by a patient, family member or

carer with the care provided. It helps to identify areas that can be improved. • Complaints highlight problems that need addressing, such as poor communication or

suboptimal decision-making. Communication problems are common causes of complaints, as are problems with treatment and diagnosis.

• Complaints also: o help maintain high standards; o reduce the frequency of litigation; o help maintain trust in the profession; o encourage self-assessment; o protect the public.

• Most health-care providers will receive complaints during their careers and this is not an indication of incompetence. Even the most conscientious and skilful health-care providers make mistakes. Health-care error is a subset of human error; all humans make mistakes.

Coronial investigations Specifically appointed people, called coroners in many countries, are responsible for

investigating deaths in situations where the cause of death is uncertain or thought to be due to unethical or illegal activity. Coroners often have broader powers than a court of law and, after reporting the facts, will make recommendations for addressing any system-wide problems. • Health-care providers must have attributes, such as compassion, empathy and a vocational

aspiration to provide benefit to society. These are necessary for safe and ethical practice. • However, many mistakes leading to adverse events are associated with the fitness of health-

care providers to practise. • Health-care providers are accountable for their actions and conduct when caring for patients.

Related to accountability is the concept of fitness to practise, eg the competence of health- care providers.

• Health-care organizations are required to check that health-care providers have the appropriate qualifications and are competent to practise. The processes are as follows:

o Credentialing The Australian Council on Healthcare Standards defines credentialing as the process of assessing and conferring approval on a person’s suitability to provide specific consumer/patient care and treatment services, within defined limits, based on an individual’s licence, education, training, experience, and competence.

Fitness to practise is an important component of patient safety.

 

 

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o Accreditation Accreditation is a formal process to ensure the delivery of safe, high-quality health care, based on standards and processes devised and developed by health-care professionals for health-care services. It can also refer to public recognition of achievement by a health-care organization of requirements of national health-care standards.

o Registration (licensure) Most countries require health-care providers to be registered with a government authority to help protect the health and safety of the public through mechanisms designed to ensure that health-care providers are fit to practise. This ensures that only properly trained professionals are registered and that registered professionals maintain standards of conduct and competence.

Personal accountability for managing risk

o The role of fatigue and fitness to practise There is strong scientific evidence linking sleep deprivation and fatigue to poor clinical performance. Studies have shown that sleep deprivation can have symptoms similar to those of alcohol intoxication. Fatigue will lead to being less alert and unable to perform as normal in a variety of psychomotor tasks. Fatigue has been linked to increased risk of errors.

o Stress and mental health problems Performance is affected by stress. There is strong evidence that inadequate sleep contributes to stress and depression, rather than the number of hours worked. Other stressors identified include financial status, educational debt, term allocation, emotional pressures caused by demands from patients, time pressures and interference with one’s social life.

o Work environment and organization Certain factors and time periods, such as shift work, overtime, shift changes, nights and weekends, are associated with increased numbers of errors. The factors underpinning these errors can range from lack of oversight and instruction or supervision to tiredness. Health-care providers should be extra vigilant during these times.

o Instruction and supervision The failure of health professionals to provide adequate instruction or supervision to junior staff makes them more vulnerable to making mistakes either by omission (failing to do something) or commission (doing the wrong thing).

o Communication issues Multiple health professionals-nurses, midwives, doctors, dentists, pharmacists, radiologists, and others-must record their communications in health-care records. The role of good communication in the provision of quality health care, and the role poor communication plays in substandard care are both well documented. For example, treatment errors caused by miscommunication and absent or inadequate communication occurs daily in all health-care settings. Checklists, protocols and care plans are ways of better communicating patient-care orders.

 

How to understand and manage clinical risks • Know how to report known risks or hazards in the workplace • Keep accurate and complete health-care records • Know when and how to ask for help from a supervisor or senior health-care professional • Participate in meetings that discuss risk management and patient safety • Respond appropriately to patients and families after an adverse event • Respond appropriately to complaints.

© World Health Organization, 2012. For permission to reprint, reproduce, use extracts or translate please apply at http://www.who.int/about/licensing/en/index.html

 

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