DoD Patient Safety Course

DoD Patient Safety Course

Handbook (Draft 06/01)

Table of Contents

Foreword

Purpose

Scope

Definitions

Goals

Event Identification and Reporting

Review and Analysis of Reported Events

Informing Patients about Events

Tort Claims

Appendices

1. Close Call/Adverse Events

2. Reporting Sentinal Events to JCAHO

3. Aggregated Reviews

4. Safety Assessment Code (SAC) Matrix

5. Root Cause Analysis (RCA)

Chartering an RCA Team

Aggregated Review Logs (PDF Format)

RCA Team Charter Member (PDF Format)

RCA Blank Form (PDF Format)

Near Miss/Adverse Events/Sentinel Event Summary Reporting Form 12/00

Printable Word Version

Return to Course TOC

Foreword

According to estimates in the medical literature, as many as 150,000 deaths may occur in the United States each year due to errors in medical care; as many as 50% of such deaths may be preventable. With recent international attention focused on improving patient safety, the Department of Defense (DoD) military health system (MHS) must renew its commitment to delivering high quality health care by revitalizing and enhancing our patient safety program.

Present efforts, although well intentioned, are incomplete. We must focus our efforts on preventing errors through a "systems approach" to patient safety. We must emphasize process improvement and initiate a shift in the underlying culture that surrounds how we deal with errors and those that report errors. And, we must establish accurate methods of gathering and analyzing data from the field so we generate practical information that can be used for meaningful change.

Ultimately, this effort can succeed only if emphasis on patient safety and responsibility resides at all levels of the organization. A team effort involving both practitioners and managers is essential. Practitioners on the front line are in the best position to identify issues and potential solutions; managers are in the best position to widely implement and disseminate the lessons we learn. We must create and maintain open lines of communication -- up, down, and across the organization – so that input from every person counts; so that all individuals know they are responsible for safety.

Building a "culture of safety" requires commitment on everyone’s part. We must constantly question how we can perform clinical tasks in a safer, more efficient manner. By forcing ourselves to ask "why" an error occurred and by identifying every contributing factor and underlying cause, we can prevent future occurrence. We must find innovative ways to "spread" the lessons we learn, so we spare others from repeating a problem. We must be relentless in our pursuit of safety.

The Military Health System has the opportunity to be a leader through its Patient Safety Program. The impact can be enormous, but we must have the resolve to change. Admitting mistakes and near misses requires personal courage and trust. Without an environment of mutual trust, the quest for improved patient safety will be significantly impaired. I am counting on our leaders to cultivate a "safe environment" so we can improve patient safety. I am confident that we will succeed.

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Health Affairs

1. Purpose

The purpose of this handbook is to operationalize the DoD Patient Safety Program. This handbook provides clear guidelines for identifying and reporting actual and potential problems in medical systems and processes within the Military Health System (MHS). Establishing and incorporating standard procedures, methods, and feedback loops at all levels of the MHS ensures clear, rapid communication of information throughout the organization and speeds the process of safety improvement. For optimal success, training of personnel must occur in conjunction with program implementation. Reading the handbook alone is not sufficient.

2. Scope

This handbook delineates the types of events to be considered when identifying and reporting safety problems; describes how each event should be handled; and defines the disposition of events not addressed here. This handbook also specifies the method for determining when a root cause analysis should be conducted and the procedure for communicating related findings throughout the organization. This handbook addresses both management components and frontline needs in establishing the DoD Patient Safety Program.

3. Definitions

a. Close Calls/Near Miss – A close call is an event or situation that could have resulted in harm to a patient but did not, either by chance or through timely intervention. Such events have also been referred to as "near miss" incidents.

All close calls/near misses require reporting and documentation on the near miss reporting tool and sent to the Registry. An example of a close call is a surgical procedure almost performed on the wrong patient but caught before harm occurred or caused increased length of stay. See Appendix 1, Close Calls.

b. Adverse Events – Adverse events are occurrences or conditions associated with care or services provided, which cause unexpected harm to a patient in the provision of, care or services. Adverse events may be due to acts of commission or omission. Examples of adverse events include patient falls, medication errors, and other procedural errors/complications. Adverse events do not include intentional unsafe acts. Categorization of adverse events is defined in Appendix 4, Safety Assessment Code Matrix. The method for categorizing events may be changed by the Assistant Secretary of Defense (ASD/Health Affairs) by Memorandum.

All adverse events require reporting and documentation in the Armed Forces Institute of Pathology Patient Safety Registry (Referred to as the "Registry").

c. Sentinel Events – As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), sentinel events are unexpected occurrences involving death or serious physical or psychological injury or risk thereof.

Serious physical injury includes loss of limb or function. The phrase "risk thereof" includes any process variation for which a recurrence would carry a significant chance of serious adverse outcomes.

Sentinel events require immediate investigation and response. Sentinel events include: death resulting from a medication error; suicide of a patient in a setting where they receive around-the-clock care; surgery on the wrong patient or body part; and hemolytic transfusion reaction involving the administration of products having major blood group incompatibilities.

Sentinel events are included in Appendix 2, JCAHO, and the catastrophic cells of Appendix 4, Safety Assessment Code Matrix and require reporting and documentation in the Registry.

d. Intentional Unsafe Acts – An Intentional unsafe act is any alleged or suspect act of omission of a provider, staff member, contractor, trainee, or volunteer pertaining to a patient that involves a criminal act; a purposefully unsafe act; patient abuse; or an event caused or affected by drug or alcohol abuse. Intentional unsafe acts are matters for law enforcement, the disciplinary system, or administrative investigation.

e. Root Cause Analysis (RCA) – Root Cause Analysis is a process for identifying the basic or contributing causal factors associated with adverse events and in some cases close calls.

NOTE: Root Cause Analysis documents are considered confidential quality assurance records and are protected from discovery under Title 10, United States Code (U.S.C.) 1102, and its implementing regulations and DODI 6043.37.

A Root Cause Analysis includes the following characteristics:

The review is interdisciplinary in nature with involvement of those closest to the process;

The analysis focuses primarily on systems and processes rather than individual performance;

The analysis digs deeper by asking "what" and "why" until all aspects of the process are reviewed and all contributing factors are identified;

The analysis identifies changes that could be made in systems and processes through either redesign or development of new processes or systems that would improve performance and reduce the risk of adverse events or recurrence of close calls.

To be thorough, an RCA must include:

A determination of the human and other factors most directly associated with the event or close call and the processes and systems related to its occurrence (there is rarely only one underlying cause);

Analysis of the underlying systems through a series of "why" questions to determine where redesigns might reduce risk;

Identification of risks and their potential contributions to the event or close call; and

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 credible, an RCA must:

Include participation by the leadership of the organization (this can range from chartering the RCA team to direct participation on the RCA team or to participation in the determination of the corrective action plan) and by individuals most closely involved in the processes and systems under review;

Be internally consistent (i.e., not contradict itself or leave obvious questions unanswered); and

Include consideration of relevant literature.

f. Aggregated Review Analysis: Aggregated review analysis is a type of review designed for specific types of events which occur frequently but where the level of harm to the patient is minimal. Types of events reviewed by this method include falls and medication errors that ARE NOT SCORED as a SAC 3. See Appendix 3, Aggregated Reviews.

g. Action Plan: The action plan is the end product of an RCA and identifies the risk reduction strategies the facility intends to implement to prevent recurrence of similar events in the future. The action plan addresses responsibility for implementation, oversight, pilot testing if applicable, timelines, and strategies for measuring the effectiveness of the actions.

4. Goals

The primary goal of the DoD Patient Safety Program is to prevent or minimize the occurrence of untoward outcomes consequent to medical care and ultimately to improve patient safety and health care quality. Collateral goals are to provide a safe environment for patients, visitors and staff; to prevent injuries; and to manage injuries that do occur so as to minimize negative consequences. Overall, the program strives to enhance safety performance through comprehensive monitoring, standardized reporting, and thorough analysis of untoward events in order to continuously learn and improve error prevention, clinical practice, and environmental safety. Through all these efforts grounded in a systems approach, the MHS can develop an environment of trust and establish a "culture of safety" throughout the organization.

The key building blocks for accomplishing these goals are:

An integrated system throughout the organization.

Comprehensive identification and reporting of all close calls, adverse events, Sentinel Events (see paragraph 5).

Review and analysis of close calls, adverse events, and Sentinel Events, in order to identify underlying causes and system changes that can reduce the potential for recurrence (see paragraph 6). The requirements for initiating a review are determined by the priority scheme defined by the Safety Assessment Code (See Appendix 4, SAC).

Determination of cause aimed at system and process issues rather than individual blame and punishment.

Effective dissemination of patient safety alerts and lessons learned throughout the organization.

Prospective analysis of service delivery systems before an adverse event occurs to identify system redesigns that will reduce the likelihood of error.

5. Identification and Reporting of Adverse Events, Sentinel Events, and Close Calls

a. Each MTF will ensure that its designated representative reports (manually or electronically, to be determined by local capability and service policy) at least the following events:

Close Calls (See Definitions, paragraph 3a).

Adverse Events (see Definitions, paragraph 3b).

Sentinel Events (see Definitions, paragraph 3c).

b. Close Calls, Adverse events, and Sentinel Events, shall be reported within the facility to the Risk Manager (or designee) within 24 hours of their detection. The Risk Manager (RM) will then use the Safety Assessment Code (SAC) Matrix to determine what action is required. This action could range from reporting to the DoD Service, Armed Forces Institute of Pathology (AFIP) and JCAHO with associated RCA performed and corrective action plan identified, to a decision to do nothing at the present time due to the low priority accorded the event from its SAC score. Appendix 4, SAC, details how the SAC score is used. Paragraph 6 (Page 8) shows the procedure for reporting events along with the associated time constraints and products required as well as to which organization reports will be sent. If a safety alert to other facilities is required, this should be indicated (this is covered in the Appendix 5, RCA).

c. If, in the course of conducting an RCA, it appears that the event under consideration is the result of an Intentional Unsafe Act, the RCA team will refer the event to the facility Commander for appropriate action as described in DODI 6025.xx, para 4.4, 4.4.1 and 4.4.2. In such a situation, the RCA team will then discontinue their review efforts, since the MTF Commander will have assumed the responsibility for any further fact finding or investigation. The RCA team still maintains the information they have already collected as confidential per Title 10, United States Code (U.S.C.) 1102 and DODI 6040.37. This means that members of the RCA team in question could not serve on an investigation team that might be convened by the MTF Commander to consider this particular issue (non-RCA issues, i.e., the criminal investigation or other administrative, legal reviews). Under these circumstances, officials should be notified as soon as possible. To the extent possible, the surrounding area should not be disturbed so that evidence is available for review by the police and other authorities. However, emergency care needed by the patient should always be provided as quickly as possible, regardless of its effect on the site. Facility security and medical staff may need to assist law enforcement agencies with preserving evidence (e.g., blood alcohol levels, weapons, controlled substances). Local policies and procedures for maintaining the chain of custody of evidence apply in those instances.

d. Staff who submit close call and adverse event reports will receive feedback on the actions being taken as a result of their report. The feedback should be of a timely nature and come from the Patient Safety Manager/Risk Manager (PSM/RM) (or designee). Prompt feedback to reporters has been credited in other reporting systems with being one of the cornerstones that establishes trust in the system since it demonstrates the seriousness and commitment on the part of the system regarding the importance of the reporting effort. The objective is for the reporters to be made acutely aware that their effort of reporting was not just a paperwork drill. The nature of this feedback can range from a simple acknowledgement that the event is under consideration to providing information about the corrective action that is planned or has been accomplished. See tool kit and information on completing the RCA form which gives options for communicating with the reporter.

e. Each MTF will adopt strategies to motivate and facilitate staff identification and reporting of close calls and adverse events, even when staff errors contributed to the event. Emphasis should be placed on the value of close calls in identifying needed system redesigns. Identification and reporting of close calls and adverse events, including those that result from practitioner error, need to be a routine part of everyday practice. Employees need to understand that human errors are commonly due to systems and process related problems. They especially need to understand that the most conscientious, knowledgeable, and competent professionals can make unintentional errors.

f. The AFIP Registry will be used to track and monitor reported events. The Patient Safety/Risk Manager or designee will accomplish initial entry of data into the Registry to facilitate the accuracy of the data recorded and avoid translation and transcription errors that could occur.

g. The Patient Safety/Risk Manager will promptly refer close calls or adverse events related solely to staff, visitors or equipment/facility damage to relevant facility experts or services for assessment and resolution of those situations.
6. Review and Analysis of Reported Events

a. A process has been designed so that the review and analysis system for handling reports proceeds in a logical manner and takes into account the various requirements of the DoD and accrediting organizations. This process can be schematically outlined in Figure 1.

The following description will ‘walk you through’ the previous diagram. The first step taken by the PSM/RM after any required immediate action is to assign a SAC score (see Appendix 4, SAC) that defines further actions that are necessary.

Events receiving a score of 1 or 2 will be acted on as deemed appropriate by the facility. The facility will need to eliminate, control, or accept the risks associated with these events. Actions can range from performing an RCA to no further action required.

All actual events receiving a SAC score of 3 must receive a traditional RCA. The initial report of the event will be entered into the Registry where de-identified information will be available to DOD and the Services.

A quarterly Aggregated Review may be used for two types of events: falls and medication errors (see Appendix 3--Aggregated Reviews). The use of aggregated analysis serves two important purposes: first, wider use of the analysis (i.e., trends or patterns not noticeable in individual case analysis are more likely to show up as the number of cases increases) and, second, wiser use of the RCA team's time and expertise. The AFIP will use this information to compare all MHS reported data to determine if any immediate action (issuance of alerts, etc.) is indicated. It must be noted that any event may be subject to a traditional RCA even though it is in a category that is permitted to use the aggregated approach if this course of action is considered appropriate. Further, events that are eligible for Aggregated Review but received a SAC score of 3 based on what has actually occurred will have an RCA performed and may not use the aggregated approach.

If the event in question is an actual adverse event that meets the JCAHO definition of a Reviewable Sentinel Event, the MTF will then report it to the JCAHO within the designated timeframe after becoming aware of the occurrence in accordance with applicable DOD and Service policies and procedures. If the adverse event is a major/high (SAC 3) which does not meet the JCAHO definition of a sentinel event, the PSM/RM will forward the RCA to AFIP and follow Service-specific policy for reporting. The RCA will be completed within 45 calendar days and forwarded as described above.

Note: Only two reports result after the initial notification. Those include the initial RCA and the six-month follow-up report. In cases of aggregated reviews, only one report is required.

To summarize, the MTF must report to JCAHO per DOD and Service policy. The RCA report tool included in the tool kit will be used and will be retained by the facility even after the results have been entered into the Registry so that they can be made available for future review as required.

The benefit of this entire process will be realized after the RCA is completed and the corrective actions to prevent the future occurrence of similar events are defined and implemented. These corrective actions will fall into the categories of eliminate, control, or accept, and the rationale for selecting one approach over another will be documented. Once implemented, a plan for evaluating the effectiveness of the implemented change must be enacted to insure that this change has the desired effect and the subsequent results are communicated to the Service/MTF and AFIP through entry in the Registry or other appropriate means. This process can be schematically outlined in Figure 2.

As noted above, all events will be entered into the Registry. Sentinel events will be reported to the DoD Service as well in accordance with their policies and procedures. In this way, all events reported will be captured in the Registry even if they have SAC scores less than 3 while remembering that 3s will receive RCAs as described above. Accordingly, the opportunity will then exist to better understand the system and appropriately focus our attentions in the future.

b. The AFIP will be responsible for disseminating the lessons learned and alerts from the RCAs and aggregated reviews in the Registry. The AFIP will also develop methods that the field may find advantageous to implement based on this and other information.

c. The Patient Safety Council (PSC) members will include, as a minimum, representatives from each of the Services, DOD (HA & TMA), USUHS, DOD Office of General Counsel, AFIP, and Safety Centers. The Council shall review the reports from the MHSPSC, patient safety initiatives within MHS, other federal agencies and the private sector. The Council will review other patient safety issues in the MHS and report to ASD(HA) no less than once per year on medical safety improvements and recommended policy changes.

d. The Office of the Assistant Secretary of Defense (Health Affairs) shall designate which group provides oversight to patient safety if desired or warranted. Such groups will provide reports to the Office of the Assistant Secretary of Defense (Health Affairs) as requested.

7. Informing Patients About Adverse Events

a. General Policy. In cases where serious medical errors (or adverse events) cause unexpected harm to a patient, a qualified health care provider will inform the patient or appropriate family members. This information is provided as a matter of clinical policy and does not affect any rights or obligations in legal or administrative proceedings. The Patient Safety Program endorses Opinion 8.12 of the American Medical Association, which provides:

(1) It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free from any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.

(2) Ethical responsibility includes informing patients of changes in their diagnosis resulting from retrospective review of test results or any other information. This obligation holds even though the patient’s medical treatment or therapeutic options may not be altered by the new information.

(3) Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with the patient.

b. Confidentiality of Medical Quality Assurance Information.

(1) Every MTF will ensure that their facilities have a process in place to promptly inform patients and their families, consistent with the foregoing legal requirements and restrictions.

(2) Information provided to the patient or appropriate family members may not include medical quality assurance records and information prohibited from disclosure by 10 U.S.C. 1102 and DoD Directive 6040.37. For example, any information based on peer review for the purpose of monitoring, assessing, or documenting the quality of the diagnostic or treatment services is confidential medical quality assurance information. In contrast, the patient’s medical records are not confidential medical quality assurance information.

(3) In discussing medical information with family members, MTF personnel shall comply with other applicable restrictions on nonconsensual disclosures, including those under the Privacy Act, 5 U.S.C. 552a, and DoD 5400.11-R, "Department of Defense Privacy Program," and Service regulations. As a general rule under the Privacy Act, information regarding a patient's condition shall not be provided to others without the patient's consent. In addition, in cases in which substance abuse treatment is involved, MTF personnel shall comply with the confidentiality provisions addressed in DoDI 1010.6, "Rehabilitation and Referral Services for Alcohol and Drug Abusers," Mar. 13, 1985.

(4) Claims for Compensation. In cases which patients or their families request information on procedures for filing claims for compensation for personal injury or death arising from medical care provided, MTF personnel shall refer the patient to the MTF Risk Management Office for information on the applicable procedures. These include procedures under the Federal Tort Claims Act (generally applicable to care provided in the United States), Military Claims Act (generally applicable to care provided outside the United States), Disability Evaluation System (for disabling injuries or illnesses of military personnel), and death benefits for survivors of military personnel. Additionally, the MTF Risk Management Office should consult Service-specific procedures and the Staff Judge Advocate for specific information to fully advise patients or their families of the applicable procedures.

8. Torts

Policy concerning quality assurance reviews of potential instances of medical malpractice is established by DoD Instruction 6025.15, "Implementation of Department of Defense Participation in the National Practitioner Data Bank," 12 Oct 00.
Appendices

Appendix 1. Close Calls and Adverse Events

What is a Close Call?

1. A close call is an event or situation that could have resulted in harm to a patient, but did not, either by chance or through timely intervention. Such events have also been referred to as "near miss" incidents.

2. We have all experienced close calls on the job. A few examples are listed below.

Mrs. Smith, a nurse, almost gives an overdose of insulin, but recognizes and prevents the error when double-checking the order. (During the double check, Mrs. Smith realizes that she had confused the "U", for units, with a "0".)

An environmental management employee notices a jug of industrial strength cleaner mistakenly left in the shower stall on a locked psychiatric unit. The employee returns it to proper storage before any patient can use it inappropriately.

On the way to the parking lot, a motor pool employee notices that a barricade, preventing anyone from using a sidewalk under repair, has fallen down and been shoved aside. The employee replaces the barricade and then notifies engineering service of the hazardous situation before anyone trips and falls.

What is an Adverse Event?

An adverse event is an incident that caused some degree of harm but did not meet the definition of a sentinel event. An example would be:

A patient presented a prescription for microzide, a blood pressure medication. It was filled with micronase, a diabetes medication. The patient became ill and was sent to the emergency room and diagnosed with hypoglycemic shock and given an intravenous infusion of glucose. The error was due to misinterpreting the written prescription. The patient was discharged within a few hours with no other significant injury or harm.

What is not a Close Call/Adverse Event?

1. There are a few events or situations that are not close calls nor adverse events but rather situations that must be handled through administrative review or investigation. These excluded events or situations are:

Intentionally unsafe acts |
Criminal acts
Acts related to alcohol or substance abuse, impaired provider/staff
Events involving alleged or sustained patient abuse

Appendix 2. Reviewable Sentinel Events that May Be Reported to JCAHO

The following criteria define the subset of sentinel events that require mandatory reporting to the Joint Commission. Only those sentinel events that affect recipients of care (patients, clients) and that meet the following criteria fall into this category:

1. The event has resulted in an unanticipated death or major permanent loss of function not related to the natural course of the patient's illness or underlying condition, ^1,2 or

2. The event is one of the following (even if the outcome was not death or major permanent loss of function):

a. Suicide of a patient in a setting where the patient receives around-the-clock care (e.g., hospital, residential treatment center, crisis stabilization center).

b. Infant abduction or discharge to the wrong family.

c. Rape.³

d. Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities.

e. Surgery on the wrong patient or wrong body part. ⁴

^{1 A distinction is made between
an adverse outcome that is related to the natural course of the patient's illness or
underlying condition (not reviewable under the Sentinel Event Policy) and a death or major
permanent loss of function that is associated with the treatment, or lack of treatment, of
that condition (reviewable).
^{2 "Major permanent loss of function" means
sensory, motor, physiologic, or intellectual impairment not present on admission requiring
continued treatment or life-style change. When "major permanent loss of
function" cannot be immediately determined, applicability of this policy is not
established until either the patient is discharged with continued major loss of function,
or two weeks have elapsed with persistent major loss of function, whichever occurs first.
^{3 The determination of "rape" is to be based on
the healthcare organization's definition, consistent with applicable law and regulation.
An allegation of rape is not reviewable under the policy. Applicability of the policy is
established when a determination is made that a rape has occurred.
^{4 All events of surgery on the wrong patient or wrong
body part are reviewable under the policy, regardless of the magnitude of the procedure.}}}}
Note: As JCAHO policies are dynamic, it is important to ensure that the most recent JCAHO Sentinel Event Policies and definitions are used in making any determination for reporting.

Appendix 3. Aggregated Reviews--Falls and Medication Errors

(Tools: Logs and MedMarx System)

Background: Quarterly Aggregated Reviews, completed within 45 days of the end of the quarter and conducted by a chartered RCA Team, may be used for two types of reported events or close calls. All actual SAC 3s require individual RCAs. The two types of aggregated reviews are: falls and medication errors.

The use of Aggregated Reviews serves two important purposes: first, wider applicability of the analysis (i.e., trends or patterns not noticeable in individual case analysis are more likely to show up as the number of cases increases) and, second, wiser use of the RCA Team's time and expertise.

Of course, a facility may elect to perform an individual RCA rather than an Aggregated Review on any adverse event or close call they think merits that attention, regardless of the actual SAC score.

A tailored real-time minimum data set (Aggregated Review Log) will be compiled for falls and medication errors by designated staff in follow-up to reported events or close calls during each quarter. Capturing this data may require medical record review, medication administration record review, and brief discussion with staff members most knowledgeable about the events or close calls. The Aggregated Review Logs will be provided to the designated RCA Team as soon as they are convened and will serve as their initial data source. The MedMarx methodology is an additional tool to gather and compile the data. (By using these tools, the RCA Team may not routinely need to retrospectively consult individual patient profiles or individual medical records.)

It is anticipated that by using this aggregated approach and building the reviews over succeeding quarters, common themes may be more readily identified and the effectiveness of actions taken to prevent these events or close calls from happening again may be more easily evaluated.

Descriptions of each Aggregated Review Log are provided below, and copies of the Logs are attached to this Appendix.

Falls: All falls should be reported on the aggregated review form, unless a fall scores a SAC 3, then an individual RCA will be performed for all patients for any reported inpatient or outpatient fall occurring on facility property that results in an actual SAC 3.

Reported falls and close calls on facility property involving patients which do not score a SAC 3 will be included in an Aggregated Review on a quarterly basis (completed by the RCA Team within 45 days after the end of the quarter). These Aggregated Reviews will be entered in the Registry.

The following elements are included in the Falls Aggregated Review Log:

Case (1 … X)

ID# (First Initial, Last Initial, last 4 SSN)

Age

Sex

Event (Day, Date, Time)

OPT or INPT/Unit (designation of inpatient or outpatient status at time of event, and, if inpatient, unit where the patient was assigned at the time of the event)

Functional & Cognitive Factors (a listing of factors related to falls;, requires a "yes"/"no" response for all applicable items: prior fall; designation as "high risk" for falls; needs assistance with ADLs, mobility, transfer, toileting, dressing, eating; gait or balance limitations; incontinent; confused/memory limitations; related medical conditions; medication effect, and other)

Assisstive Devices (a listing of devices related to falls;, requires a "yes"/"no" response for all applicable items: cane; crutches; transfer device; walker; wheelchair; bathing device; mechanical lift; eye glasses; hearing aid, and other)

Communication Issues (a short list of areas where communication or information exchange can break down; requires a "yes"/"no" response for all applicable items: staff to staff; staff to patient, and staff to family/other)

Environmental Factors (a listing of physical plant issues related to falls; requires a "yes"/"no" response for all applicable items: use of restraints; use of protective devices; inadequate footwear; bed siderails; floor condition; obstacles; fall while the patient was reaching for a needed item; inadequate patient or family/other education; unfamiliarity with the environment; inadequate lighting, and other)

What Happened & Treatment Plan Changes (free narrative)

Comments (free narrative)

Medication Errors: A medication error is defined as any preventable event that may cause or lead to inappropriate use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Such events may be related to the professional practice, healthcare products, or procedures and systems which includes the following: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration, education; monitoring; and use.

For all patients, an individual RCA will be performed for any reported inpatient or outpatient medication error that results in an actual SAC 3,.

Reported medication errors or close calls involving patients will be included in an Aggregated Review on a quarterly basis (completed by the RCA Team within 45 days after the end of the quarter). These Aggregated Reviews will be entered in the Registry.

The following elements are included in the Medication Aggregated Review Log:

Case (1 … X)

ID# (First Initial, Last Initial, last 4 SSN)

Age

Sex

Event (Day, Date, Time)

OPT or INPT/Unit (designation of inpatient or outpatient status at time of event, and, if inpatient, unit where the patient was assigned at the time of the event)

Processes Related to Event (a listing of key steps in the medication process;, requires a "yes"/"no" response for all applicable items: ordering; transcribing, dispensing; administering, and documenting)

What Happened? (a listing of medication errors; requires a "yes"/"no" response for all applicable items: medication given despite known allergy; omission; overdose; incorrect patient identification; incorrect medication identification; incorrect dose; incorrect route; incorrect schedule, and equipment failure)

Medication (name/dose/route/schedule for the correct medication, and the name of the medication involved in the actual/close call medication error)

Treatment Plan Changes (free narrative)

Comments (free narrative)

Appendix 4. Safety Assessment Code Matrix Severity Categories

Safety Assessment Code Matrix

Severity Categories

Key factors for the severity categories are: extent of injury; length of stay; and level of care required for remedy. The four categories below apply to actual adverse events.

For actual close calls/adverse events, assign severity based on the patient's actual condition. Some incidents that occur may have such an overwhelming potential for a catastrophic event that an RCA will also be necessary, but that determination will be left to the discretion of the MTF.

Catastrophic

Major

Patients with Actual Patients with Actual:

Death or major permanent loss of function (sensory, motor,
Physiologic, or intellectual) not related to the natural course

of the patient's illness or underlying condition (i.e., acts of

commission or omission).

Suicide (inpatient or outpatient)

Rape

Hemolytic transfusion reaction

Surgery/Procedure on the wrong patient or wrong body part

Infant abduction or infant discharge to the wrong family
Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual) not related to the natural course of the patient's illness or underlying conditions (i.e., acts of commission or omission).
Disfigurement

Surgical intervention required

Increased length of stay or level of care of 3 days or more

Death or major permanent loss of function that is a
Direct result of injuries sustained in a fall; or associated

With an unauthorized departure from an around-the-clock treatment setting; or the result of an assault or other crime

Moderate

Minor

Patients with Actual: Patients with Actual:

Increased length of stay or higher level of care for less than 3 days No increased length of stay or increased level of care

Probability Recurrence

Like the severity categories, the probability recurrence apply to actual adverse events and close calls.

In order to assign a probability rating for a close call or adverse, it is ideal to know how often it occurs at your facility. Sometimes, the data will be easily available because it is routinely tracked (e.g., falls with injury, medication errors, etc.). Sometimes, getting a feel for the probability of events which are not routinely tracked will mean asking for a quick or informal opinion from staff most familiar with those events. Sometimes it will have to be your best educated guess.

High – Likely to occur immediately or within a short period of time

Medium – Likely to occur several times in 1 to 2 years.

Low –May happen greater than two years.

How the SAC Matrix Looks

Severity & Probability

Catastrophic

Major

Moderate

Minor

High
3

3

2

1

Medium
3

2

1

1

Low
3

2

1

1

How the SAC Matrix Works

When you pair a severity category with a probability category for either a close call or adverse event, you will get a ranked matrix score (3 = highest risk, 2 = intermediate risk, 1 = lowest risk). These ranks, or Safety Assessment Codes (SACs) can then be used for doing comparative analysis, and, for deciding who needs to be notified about the event.

Notes

1. All known reporters of events, regardless of SAC score (1,2, or 3), will receive appropriate and timely feedback.

2. The Patient Safety/Risk Manager (or designee) will refer close calls or adverse events related solely to staff, visitors or equipment/facility damage to relevant facility experts or services on a timely basis, for assessment and resolution of those situations.

3. A quarterly Aggregated Root Cause Analysis may be used for two types of cases (this includes all events or close calls other than actual SAC 3s, since all actual SAC 3s require an individual RCA). These two types are: falls; and medication errors. The use of aggregated analysis serves two important purposes. First, greater use of the analysis (i.e., trends or patterns not noticeable in individual case analysis are more likely to show up as the number of cases increases). Second, it makes wise use of the RCA team's time and expertise.

Of course, the facility may elect to perform an individual RCA rather than Aggregated Review on any adverse event or close call that they think merits that attention, regardless of the SAC score.

_____________________________________________________________________________________________

*29 CFR 1960.70 requires each federal agency to notify OSHA within 8 hours of a work-related incident which results in the death of an employee or the in-patient hospitalization of 3 or more employees.

**The Safe Medical Devices Act of 1990 requires reporting of all incidents in which a medical device may have caused or contributed to the death, serious injury, or serious illness of a patient or another individual.
Appendix 5. Root Cause Analysis (RCA) Overview

Introduction:

Our goal is to make patient care as safe as possible. To that end, we have to be prepared to learn as much as we can from situations that either do not turn out as we had hoped or come too close for comfort.

Root cause analysis is a method that can help us learn as much as possible from both close calls and adverse events. But, it is not enough to learn the truth about why things happened the way they did. What really counts is applying what we have learned constructively, so we can do things better in the future and ultimately prevent close calls and adverse events from happening again. If we accomplish this we will have accomplished our goal.

This RCA form will help the RCA Advisor (this will usually be the Risk Manager), team leader and team members develop a clear, comprehensive root cause analysis for close calls or adverse events. The form may be used effectively for RCAs on single cases or aggregated review (i.e., aggregated reviews are performed on a group of similar cases in order to find commonalties, trends or patterns within the group). In addition, the form will assist in designing, implementing and measuring actions to eliminate, control or accept the root cause and contributing factors which made things unsafe in the first place. Finally, the form may be used as a stand alone final report that is confidential, privileged and protected under 10 USC 1102 .
Key Terms (Root Cause/Contributing Factors):

Before going any further, it is important to mention key terms that will be used frequently. These terms are root cause and contributing factors.

A root cause is the most basic reason that a situation did not turn out ideally, as planned, or as expected. A RCA team gets to a root cause by asking "why" until it either runs out of questions to ask or decides that there are no new answers to consider. Most often, a root cause is a known or unknown system vulnerability (human weakness is almost never a root cause). In close calls or complex adverse events, there may be more than one root cause.

Contributing factors are additional reasons -- not necessarily the most basic reasons -- that clearly made a situation turn out less than ideally, as planned, or as expected. Contributing factors may apply to individuals, systems operations or the entire organization.

There is nothing to be gained by splitting hairs over whether a factor is called "root cause" or "contributing", because the bottom line questions for the RCA team to consider are: If the factor were eliminated or corrected would there be a real chance to prevent a similar adverse event or close call from happening again, or, to at least substantially reduce the impact of a similar adverse event or close call, and; have we asked all of the "why?"
Chartering an RCA Team

Once the decision to conduct an RCA has been made, the next step is for the MTF Commander to "charter" an RCA team (the formal chartering process serves as an active demonstration of the importance that the Commander holds for the RCA process). The purpose of chartering the team is to provide an initial framework for the team's activity (i.e., membership, resources, and timeframes). It is anticipated that most teams will have three to five members. (Ad Hoc members may temporarily increase the overall number). The team may sometimes have eight members depending upon the scope of the review and services involved.

Aggregated Review Logs (PDF Format)

RCA Team Charter Member (PDF Format)

RCA Blank Form (PDF Format)
Near Miss/Adverse Events/Sentinel Event Summary Reporting Form

Near Miss/Adverse Events/Sentinel Event
Summary Reporting Form-Revised 12/00

DOD Service: Army ___ Navy ___ Air Force ___ Teaching MTF: Yes___ No____

Size of Facility: Ambulatory____ Beds: <50 ____ 51-100 ___ 100-200____ >200____

Categories of Events
Near Miss

No Harm

Adverse Event
Sentinel
Event

SAC 1¹

SAC 2²

SAC 3³

SAC 3³

Transfusion Error

Incomplete/potential/blood verification

Transfusion reaction not recognized

Care planning/no informed consent

Multiple samples being crossmatched

Orientation/training

Staffing levels

Equipment related

Information related

Totals

Patient Falls (preventable within walls of the MTF)

Totals

Patient Elopement (AMA) (Totals)

Delay in Dx/Treatment

Totals

Infant Abduction/Wrong Family (Totals)

Utility/Equipment System Failure

Totals

Fire (Totals)

OR Sponge/Instrument Counts

Totals

Other/Miscellaneous

Totals

Grand Totals

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