© 2016 ECRI Institute. May be disseminated for internal educational purposes solely at the subscribing site. For broader use of these copyrighted materials, please contact ECRI Institute to obtain proper permission.

2016 Federal Tort Claims Act (FTCA) Risk Management Virtual

Conference

Key Resources

© 2016 ECRI Institute. For complete Virtual Conference resources, including slide handouts, session recordings, and more tools, go to https://www.ecri.org/components/HRSA/Pages/virtualconference2016.aspx.

Addressing Disruptive Provider Behavior in a Culture of Safety Learning Objectives

Introduce concepts of a culture of safety State the proactive ways that can be used to avoid disruptive behavior Clearly outline what to do and how to manage an identified behavior issue Discuss the concepts of conflict resolution and managing violence in the workplace

Identifying and Preventing Behaviors that Endanger Patient Safety

Fundamental components of a culture of safety include teamwork across disciplines and the ability to discuss safety issues in a blame-free environment. When a health center identifies red flag issues related to provider or staff behavior (e.g., patient complaint about inappropriate conduct, employee report of disruptive behavior, suspected drug diversion), it should take immediate action to address that complaint or behavior.

Behaviors such as intimidation, sexual harassment, and drug diversion undermine a culture of safety. They may contribute to patient harm, undermine staff morale, result in resignation by qualified employees, fuel malpractice suits, and injure the organization’s reputation.

Health centers and free clinics can refer to the checklist and resources below for guidance in addressing disruptive, inappropriate, and unprofessional provider or staff behavior.

Establish a culture of safety within the health center and free clinic and be certain that staff are able to identify and react to inappropriate or disruptive behavior (see the Safety Climate Survey and the Agency for Healthcare Research and Quality’s [AHRQ] Safety Culture and example and article on setting the standard for professional behavior).

Develop a code of conduct that defines disruptive or inappropriate behavior (harassment, sexual misconduct, offensive behavior, inappropriate relationships). Policies and procedures should complement the code of conduct and outline specific processes for addressing violations. The Joint Commission recommends a “zero tolerance” approach to any behaviors that undermine a culture of safety (see the Joint Commission’s Sentinel Event Alerts on Behaviors that Undermine a Culture of Safety and Leadership Committed to Safety).

Develop procedures and practices for investigating all complaints of inappropriate or disruptive behavior and formalize appropriate standardized corrective actions.

Train all personnel about staff-patient boundaries, chaperone use, and staff members’ responsibility to immediately report all concerns related to sexual or behavioral misconduct to designated leadership.

Provide training to managers on conflict resolution and collaborative practice techniques. Coaching and mentoring are ways to implement interventions and

address behaviors (see the AHRQ patient safety primer on Disruptive and Unprofessional Behavior).

Ensure that evaluations and assessments of professional competence include evaluation of interpersonal activities and skills. Disruptive behavior can be fueled by a high-stress environment; increased productivity demands; failure to address unprofessional conduct; a lack of interpersonal, coping, or conflict management skills; intense emotions; personal problems; or substance abuse. Address these triggers as appropriate.

Maintain a confidential reporting system where employees can report confirmed or suspected instances of inappropriate or disruptive behavior including controlled substance diversion. Protect employees from retaliation for reporting or identifying inappropriate behaviors (see also the Event Reporting Toolkit).

Alert staff to drug diversion behaviors, encourage that staff use “see something, say something” protocols, and encourage prompt reporting internally and to appropriate agencies (see also CDC’s Risk of Healthcare-Associated Infections from Drug Diversion and Nurse Drug Diversion and Nursing Leaders' Responsibilities).

Make staff aware of the possible consequences associated with drug diversion, including providing substandard patient care; loss of license, credentials, or employment; litigation; imprisonment; and potentially loss of life.

Put systems in place to guard against prescription drug theft and diversion, and ensure compliance with protocols (see DEA’s Office of Drug Diversion Rx Abuse Online Reporting and Investigations of Employee Behavior).

Make pharmacists aware that they have a corresponding responsibility to prescribers to identify red flags and comply with state pharmacy board regulations (see Red Flags-Warning Signs-Rx Diversion).

Want to learn more? Refer to the guidance articles Disruptive Practitioner Behavior and Human Resources and the sample policy Professional Office Standards for Employees on the Clinical Risk Management Program website. All resources are provided for FREE by ECRI Institute on behalf of HRSA. Don't have access or want to attend a free, live demonstration of the website? E-mail Clinical_RM_Program@ecri.org or call (610) 825-6000 ext. 5200.

Information provided by ECRI Institute is intended as guidance to be used consistent with the internal needs of your organization. This information is not to be viewed as required by ECRI Institute or the Health Resources and Services Administration.

Published 3/1/2013

Clinical Risk Management Services ‐ Guidance

Disruptive Practitioner Behavior

Disruptive behavior by physicians, nurses, and other staff can undermine a healthcare organization’s culture of

patient safety and may cause or contribute to patient harm, fuel malpractice suits, injure the organization’s

reputation, undermine staff morale, and result in resignation by qualified employees, among other burdens on

the medical office. Even patients can be caught up in provider disruptive behavior. Witnessing or overhearing

disrespectful treatment of a healthcare provider by another provider can be a devastating experience for patients

and their families. Disruptive practitioner behavior is reported to occur frequently and in all clinical practice

settings. According to survey reports by the American College of Physician Executives, almost 98% of more than

2,100 physician and nurse respondents reported witnessing disruptive behaviors occurring frequently (30%

reported observing such behavior weekly) among physicians and nurses. Insults, degrading comments, yelling,

cursing, inappropriate joking, and refusing to work with one another were reported as common occurrences.

Healthcare organizations must be equipped to identify and effectively address disruptive practitioner behavior.

Defining Disruptive Behavior

Barriers to Addressing Disruptive Behavior

Tips for Confronting Disruptive Behavior

Disruptive behavior by physicians, nurses, and other staff can undermine a healthcare organization’s culture of

patient safety and may cause or contribute to patient harm, fuel malpractice suits, injure the organization’s

reputation, undermine staff morale, and result in resignation by qualified employees, among other burdens on the

medical office. Even patients can be caught up in provider disruptive behavior. Witnessing or overhearing

disrespectful treatment of a healthcare provider by another provider can be a devastating experience for patients

and their families (Johnson). Disruptive practitioner behavior is reported to occur frequently and in all clinical

practice settings. According to survey reports by the American College of Physician Executives, almost 98% of more

than 2,100 physician and nurse respondents reported witnessing disruptive behaviors occurring frequently (30%

reported observing such behavior weekly) among physicians and nurses. (Johnson) Insults, degrading comments,

yelling, cursing, inappropriate joking, and refusing to work with one another were reported as common occurrences.

Healthcare organizations must be equipped to identify and effectively address disruptive practitioner behavior.

Defining Disruptive BehaviorIn its 2012 model medical staff code of conduct (see “Web Resources”), the American Medical Association

describes disruptive behavior as a type of behavior that undermines a culture of safety and means “abusive

conduct including sexual or other forms of harassment, or other forms of verbal or non-verbal conduct that harms

or intimidates others to the extent that quality of care or patient safety likely would be compromised.” Also included

in the definition of behavior that undermines a culture of safety is “inappropriate behavior,” defined as “conduct

EXECUTIVE SUMMARY

TABLE OF CONTENTS

© 2016 ECRI Institute

Web ResourcesAMA model medical staff

code of conduct

Disruptive Physician

Behavior

that is unwarranted and is reasonably interpreted by a reasonably prudent person under similar circumstances to

be demeaning or offensive.” Persistent, repeated inappropriate behavior should be treated as “disruptive behavior.”

(AMA)

Bullying behavior, behavior that is demeaning to other healthcare practitioners, and

berating other providers in the presence of patients or their families is another

manifestation of disruptive behavior. Workplace bullying involves repeated health-

harming mistreatment usually directed toward underlings or peers, and it affects the

quality of patient care (Halverson). Workplace bullying falls into one or more of the

following categories: work sabotage, verbal abuse, or conduct that is threatening,

intimidating, or humiliating. Workplace bullying can occur among all levels of staff,

and healthcare organizations should adopt a zero-tolerance policy for such behavior.

The concepts of power and authority in the healthcare hierarchy may play a role as possible causes of disruptive

behaviors. Although women are increasingly taking on positions of authority in healthcare organizations, gender-

based power relationships continue to exist in the healthcare environment. (MacDonald)

Perceptions of how an organization deals with disruptive behavior also differ somewhat by gender. According to a

2011 report, female respondents to an American College of Physician Executives survey were overall less confident

than their male counterparts about how their organizations deal with disruptive behavior. Compared with the male

respondents, nearly twice as many female respondents strongly disagreed that their organization has a clear, well-

enforced policy on disruptive behavior. More than a quarter of male respondents strongly agreed that there was a

structured method to report incidences of disruptive behavior, but only 17% of females answered similarly.

(MacDonald) For more information about the survey, see “Web Resources.”

Barriers to Addressing Disruptive BehaviorOrganizational reluctance to confront practitioner disruptive behavior may be rooted in the following organizational

factors (Rosenstein):

Cultural inertia

History of tolerance

Code of silence

Fear of antagonistic physician reaction

Organizational hierarchy

Conflicts of interest

Lack of organizational commitment

Ineffective structure or policies

Inadequate intervention skills

Tips for Confronting Disruptive BehaviorImplementing four basic steps can help organizations effectively confront disruptive practitioner behavior: (1)

develop and distribute a written code of conduct for all staff members, (2) develop a written policy that defines

behaviors that are unacceptable, (3) implement a nonretaliatory reporting system, and (4) educate all staff about

the code of conduct, policy, and confidential disruptive-behavior reporting system and the facility’s policy of

nonretaliation for reporting in good faith.

Because of the wide range of behaviors that constitute disruptive behavior, healthcare organizations should ensure

that its code of professional behavior states a clear and comprehensive definition of disruptive behavior. The

definition of disruptive should include behaviors (including repeated behaviors) that should be referred for

© 2016 ECRI Institute

Web ResourcesGuidebook for Managing

Disruptive Physician

Behaviour

Federation of State

Physician Health Programs

website

disciplinary action rather than managed through other interventions. Lack of clarity regarding when an occurrence

of disruptive behavior or repeat behaviors should be considered for disciplinary action can impede effective action.

A formal and confidential process for reporting should include a written policy of no retaliation against individuals

who report in good faith, a procedure for investigation with appropriate follow-through, and a mechanism for

resolution. Informal reports and informal “reporting conversations” should be discouraged because of the risk that

individual biases or conflicts of interest may undermine the seriousness of the event and impede appropriate follow-

through (Rosenstein).

Policies and procedures should clearly outline the levels of intervention that will be taken, including incremental

disciplinary measures. For instances when the practitioner accepts responsibility for addressing his or her problem,

facilities should be prepared to offer support in terms of holding meetings with peers and providing mentoring or

coaching services. This support should be coupled with a mutually agreed upon plan of counseling, workforce

reentry, and compliance monitoring goals. These goals may relate to continuing education, expectations of

appropriate behavior, the consequences for lack of compliance, and a mechanism for addressing future conflicts.

All reports of disruptive behavior, including event reports that involve disruptive behavior but are reported in other

reporting systems, should be reviewed and followed up with action that may include referral for disciplinary action

in accordance with the organization’s policy. Health centers and free clinics should ensure that thorough and

objective documentation is made of all attempts to address disruptive behavior.

Healthcare organizations' risk managers may wish to review a sample code of conduct and sample script to use in

discussion with a practitioner whose behavior does not meet expectations. Both resources are available in a

guidebook from the College of Physicians and Surgeons of Ontario (Toronto, Canada). See “Web Resources.”

Practitioners who are confronted with a report of their own disruptive behavior may

respond in ways that demonstrate their commitment to avoiding the behavior in the

future. A practitioner may not have recognized the disruptive nature of his or her

behavior when it occurred, may not have intended for it to be disruptive, may regret

that the behavior occurred, and may agree to take the necessary steps for self-

correction. In other instances, the practitioner may require education and training to

recognize disruptive behavior and modify his or her own behavior. Courses in sensitivity

training, diversity training, stress management, or anger management may be

appropriate. Some practitioners may require more intense individualized counseling or

therapy. Substance abuse, medical illness, or severe personality or psychiatric disorders may be associated with a

practitioner’s disruptive behavior. (Rosenstein and O’Daniel)

The individual(s) charged with intervention should be prepared to describe the problem behavior and to explain the

impact of the behavior with regard to patient safety, staff relations, communication efficiency, team collaboration,

productivity, and other relevant factors. Before the intervention occurs, determine the goals to be accomplished

(e.g., having the offender acknowledge that the behavior is unacceptable and apologize, enroll in a course such as

one for stress management, submit to an interdisciplinary assessment, or enter into a rehabilitation or counseling

program) and identify what assistance the organization is willing to offer the practitioner (e.g., financial support,

medical leave of absence, assistance in finding coverage if the practitioner chooses an inpatient program). The

organization should determine what rehabilitative programs and counselors are acceptable to the organization and

what options the health center has if the practitioner refuses to admit that he or she has a problem and/or refuses

to accept help (Irons). Most states have a physician health program that will provide direct consultation or arrange

for consultation by qualified professionals. Contact information can be found on the Federation of State Physician

Health Programs’ website. See “Web Resources.”

© 2016 ECRI Institute

Web ResourcesAHRQ Patient Safety

Primer: Disruptive and

Unprofessional Behavior

Sentinel Event Alert, Issue

40: Behaviors that

undermine a culture of

safety

Some practitioners may refuse to acknowledge their disruptive behavior and may decline recommended education

or counseling. With regard to such individuals, the organization must be prepared to temporarily suspend or

terminate employment, if necessary. In some circumstances, such action may be the only reasonable option a

healthcare organization may take to safeguard patient safety.

The Agency for Healthcare Research and Quality has developed a patient safety primer

that provides resources for preventing and addressing disruptive behavior through

such actions as modeling desired behaviors, maintaining a confidential reporting

system, training managers in conflict resolution and collaborative practice, providing

teamwork training, and developing structured communication protocols. The primer

discusses other key concepts regarding disruptive behavior, such as the Joint

Commission’s leadership standard, and provides links to numerous articles and

resources regarding disruptive behavior. See “Web Resources.”

Although geared toward hospitals, the Joint Commission’s 2008 Sentinel Event Alert

on disruptive behaviors is also a useful resource for healthcare organizations. The

Joint Commission recommended 11 steps that organizations should implement to actively address disruptive

behavior. The alert is available from the Joint Commission (see “Web Resources”).

REFERENCESAmerican Medical Association (AMA). Model medical staff code of conduct [online]. 2012 [cited 2013 Feb 25].

http://www.ama-assn.org/resources/doc/omss/ama-medical-staff-code-of-conduct.pdf.

Halverson D. Abuse in the medical workplace: fact vs. myth [online]. Utah Nurse 2010 Feb 20 [cited 2012 Jul

23]. http://www.workplacebullying.org/2010/02/20/medical-workplace.

Irons R. The behaviorally disruptive professional. Paradigm Summer 2001:6-7.

Johnson C. Bad blood: doctor-nurse behavior problems impact patient care. Physician Exec 2009 Nov-

Dec;35(6):6-11. Also available at http://www.ncbi.nlm.nih.gov/pubmed/19999685.

MacDonald O. Disruptive physician behavior [white paper online]. 2011 May 15 [cited 2012 Jul 24].

http://www.quantiamd.com/q-qcp/QuantiaMD_Whitepaper_ACPE_15May2011.pdf.

Rosenstein AH. The quality and economic impact of disruptive behaviors on clinical outcomes of patient care. Am

J Med Qual 2011 Sep-Oct;26(5):372-9. Also available at http://www.ncbi.nlm.nih.gov/pubmed/21511883.

Rosenstein AH, O'Daniel M. Impact and implications of disruptive behavior in the perioperative arena. J Am Coll

Surg 2006.

RESOURCE LISTAgency for Healthcare Research and Quality

(301) 427-1364

http://www.ahrq.gov

Patient Safety Primer: Disruptive and Unprofessional Behavior. http://psnet.ahrq.gov/primer.aspx?

primerID=15

American Medical Association

(800) 621-8335

http://www.ama-assn.org

© 2016 ECRI Institute

Model medical staff code of conduct. http://www.ama-assn.org/resources/doc/omss/x-pub/ama-medical-

staff-code-of-conduct.pdf

College of Physicians and Surgeons of Ontario

(416) 961-3330

http://www.cpso.on.ca/

Guidebook for Managing Disruptive Physician Behaviour.

http://www.cpso.on.ca/cpso/media/uploadedfiles/cpso_dpbi_guidebook1.pdf

Federation of State Physician Health Programs

(781) 434-7343

http://www.fsphp.org/

Joint Commission

(630) 792-5800

http://www.jointcommission.org

Sentinel Event Alert, Issue 40: Behaviors that undermine a culture of safety.

http://www.jointcommission.org/sentinel_event_alert_issue_40_behaviors_that_undermine_a_culture_of_s

afety/

QuantiaMD

(800) 773-4162

http://www.quantiamd.com/

Disruptive physician behavior. http://www.quantiamd.com/q-

qcp/QuantiaMD_Whitepaper_ACPE_15May2011.pdf

TOPICS AND METADATATopicsCulture of Safety;

Quality Assurance/Risk Management;

Employment Affairs;

Laws, Regulations, Standards

CaresettingAmbulatory Care Center;

Physician Practice

RolesHealthcare Executive;

Nurse;

Clinical Practitioner;

Legal Affairs;

Patient Safety Officer;

Risk Manager

Information TypeGuidance

© 2016 ECRI Institute

© 2016 ECRI Institute. For complete Virtual Conference resources, including slide handouts, session recordings, and more tools, go to https://www.ecri.org/components/HRSA/Pages/virtualconference2016.aspx.

How to Use Credentialing and Privileging to Improve Patient Safety Learning Objectives

Recognize the purposes credentialing, privileging, and renewal of credentials and privileges

Explore how credentialing can identify potential red flags before a provider practices in a health center

Understand how performance reviews and clinical competence assessments performed during renewal of credentials and privileges can identify potential quality and safety concerns

Apply principles of credentialing, privileging, and renewal of credentials and privileges to the case scenario

Assessing Clinical Competence

Privileging is the process that health care organizations employ to authorize practitioners to provide specific services to their patients (see: HRSA’s PIN 2002-22). Assessing clinical competence is an integral part of the privileging process; it assures that providers and staff possess the requisite skills and expertise to manage and treat patients and that they are able to perform the medical procedures required to provide authorized services within the scope of project.

Proper assessment of clinical competence is a critical step in providing safe patient care and in mitigating risk. Health centers and free clinics can use the following checklist and the links to tools as guidance in assessing clinical competence of providers. For more information see: Get Safe! Effective Processes for Granting Clinical Privileges.

Establish a procedure for assessing clinical competence (to include health status), ensuring that competence is evaluated by staff aware of the skills and knowledge required by each job.

Assess clinical competencies based on the area of practice (available resources such as: Adult-Gerontology Primary Care Nurse Practitioner Competencies; Competencies for the Physician Assistant Profession; Federation of State Medical Boards Clinical Competence Assessment Resources) and assure that providers meet the standards of practice and training that allow them to manage and treat patients with a level of proficiency that minimizes the risk of causing harm.

Utilize peer review and/or performance improvement data for privileging and re-privileging providers.

Adopt appropriate tools (such as: Medical Assistant Skills Checklist, Peer Review Checklist, National Health Policy Forum Physician Assessment: Measuring Competence and Performance) and proctoring procedures for continual assessment of clinical competence.

Educate staff about the credentialing and privileging process and about core clinical competencies for their area of practice (i.e. Implementing the ACGME General Competencies Requirements).

As part of the health center’s quality improvement efforts, establish, implement, and routinely review policies and procedures for evaluating and regularly re-

evaluating clinical competencies (see: Developing Policies and Procedures Toolkit on the Clinical Risk Management program website).

Establish an appeals process for licensed independent practitioners in the event that a decision is made to discontinue or deny clinical privileges.

Want to learn more? Refer to the Credentialing Toolkit, Initial Privileging Process Flowchart, Renewal of Credentials and Privileges Flowchart, and the webinar: Developing and Maintaining an Effective Credentialing and Privileging Program on the Clinical Risk Management program website. All resources are provided for FREE by ECRI Institute on behalf of HRSA. Don't have access or want to attend a free, live demonstration of the website? E-mail Clinical_RM_Program@ecri.org or call (610) 825-6000 ext. 5200.

Information provided by ECRI Institute is intended as guidance to be used consistent with the internal needs of your organization. This information is not to be viewed as required by ECRI Institute or the Health Resources and Services Administration.

Proprietary and Confidential

Copyright ECRI Institute, 2013

Peer Review Checklist

Instructions: Complete this checklist when conducting medical record review or direct observation of a licensed

independent practitioner. Please see below for the key for scores A, B, and C.

Score A: Care provided at a level expected of an experienced and competent practitioner managing the patient’s care within the practitioner’s scope of practice

and in a similar manner as the practitioner.

Score B: Care provided at a level expected of an experienced and competent practitioner managing the patient’s care within the practitioner’s scope of practice,

and whose care might differ somewhat from the care provided, but within accepted standards.

Score C: Care that differs from what an experienced and competent practitioner, managing the patient’s care within the practitioner’s scope of practice, would

have provided with reference to clinical/professional guidelines, peer reviewed literature, standards of care, and/or compliance with health center policy.

SCORE the following issues A B C Comments

Assessment/diagnosis

History/physical examination

Technique/skills (if observed)

Communication with other providers/patient

Patient education

Treatment plan

Plan is prioritized by chief complaint, history, physical

examination

Appropriate diagnostic tests are ordered and addressed

Appropriate medications are ordered

Page 2 of 3

Proprietary and Confidential

Copyright ECRI Institute, 2013

Appropriate non-pharmacologic treatments are identified

Consultation/Referral

Follow-up

Documentation

Legibility/ use of EHR

Completion

Dates and signatures

States healthcare goals and outcomes

Compliance with health center policy and procedures

Adverse event/Adverse outcome/Near miss

Briefly describe:

Supervision – adheres to protocol agreement or other written arrangement

OTHER quality/safety issue: State the issue and briefly describe the basis for

the reviewer’s concern:

________________________________________

________________________________________

System or process problem identified. Circle Yes or No

If yes, briefly state the problem identified:

Adapted from: Georgia Department of Community Health – Division of Public Health Quality Assurance/Quality Improvement for

Public Health Nursing Practice. Quality assurance/quality improvement for public health nursing practice manual: standards and tools

[online]. 2010 Dec [cited 2013 Feb 8]. Available from Internet at: http://health.state.ga.us/pdfs/nursing/QA-QIManual/Tab%204-

Standards%20and%20Tools.pdf

Page 3 of 3

Proprietary and Confidential

Copyright ECRI Institute, 2013

All policies, procedures, and forms reprinted are intended not as models, but rather as samples submitted by ECRI Institute member and nonmember

institutions for illustration purposes only. ECRI Institute is not responsible for the content of any reprinted materials. Healthcare laws, standards, and

requirements change at a rapid pace, and thus, the sample policies may not meet current requirements. ECRI Institute urges all members to consult with

their legal counsel regarding the adequacy of policies, procedures, and forms.

© 2016 ECRI Institute. For complete Virtual Conference resources, including slide handouts, session recordings, and more tools, go to https://www.ecri.org/components/HRSA/Pages/virtualconference2016.aspx.

Adverse Event Analysis: A Staff Training Exercise Learning Objectives

Understand the steps of event analysis Recognize how to gather information about an event Recognize how to conduct interviews Understand how to create a timeline of an event Learn how to analyze data related to an event Identify root cause and contributing factors of an event

Using EHRs to Coordinate Care for Complex Patients

Caring for complex patients demands intensive monitoring, tracking, and coordination to ensure maximum patient safety and the best achievable health outcomes. Providers must identify and incorporate all pertinent medical and non-medical factors in their treatment plans. These factors may include a history of frequent admissions and readmissions to hospitals or other healthcare settings, a behavioral health or substance abuse diagnosis, multiple co-morbidities, limited access to services provided outside of the health center, multiple prescriptions, difficult social situations, and hazardous physical environments. Electronic health records (EHRs) are valuable tools that can help providers monitor and follow up on complex patients’ multiple healthcare needs as well as exchange information with other providers and specialists.

The following checklist and resources can help health centers and free clinics use EHRs to manage complex patients both within the clinic and across the continuum of care. Additional information appears in Get Safe: Managing Complex Patients across the Continuum of Care and Get Safe: Ensuring Care Coordination of the Medically Complex Patient.

Maximize the use of the patient problem list in the EHR. The problem list provides a centralized location where all providers in a health center or free clinic can view a summary of the patient’s status.

Maximize the use of the medication list in the EHR. Reconcile medication lists frequently for medically complex patients and instruct patients to bring medications with them to appointments so the provider can carefully review and document brands, dosages, and frequencies of all current medications. (For more information, see the guidance article Medication Safety.)

Set up reminders in the EHR for diagnostic tests (e.g., repeat bloodwork, imaging studies) so the care coordinator can follow up to ensure that this testing is completed in a timely manner. (For more information, see the Office of the National Coordinator for Health Information Technology’s SAFER Guide: Test Results Reporting and Follow-Up.)

Consider enhancing the EHR to include electronic exchange of clinical information between providers. Ensure that policies are in place that clearly assign responsibilities for accessing, reviewing, and acting on findings in EHRs. (For more information, see case studies from HealthIT.gov.)

Consider measuring key areas related to care coordination of complex patients as part of the health center’s or free clinic’s quality improvement/quality assurance activities. For example, set a metric related to how often complex patients need to be seen by their primary care provider (e.g., every three to four months) and measure the health center’s progress toward this goal. (For more information, see the Agency for Healthcare Research and Quality’s Care Coordination Measures Atlas and the archived webinar The Use of EHRs for Quality Improvement.)

Be aware of Medicare and Medicaid incentive programs for meaningful use of certified EHR technology, including incentives for using EHRs for care coordination functions (additional information is available from HealthIT.gov).

Want to learn more? Refer to the guidance article Medical Records and the archived webinar Electronic Health Records: Emerging Risks on the Clinical Risk Management Program website. All Clinical Risk Management Program resources are provided for FREE by ECRI Institute on behalf of HRSA. Don't have access or want to attend a free, live demonstration of the website? E-mail Clinical_RM_Program@ecri.org or call (610) 825-6000 ext. 5200.

Information provided by ECRI Institute is intended as guidance to be used consistent with the internal needs of your organization. This information is not to be viewed as required by ECRI Institute or the Health Resources and Services Administration.

5 Whys Worksheet

1 Root cause from worksheet

2 Why is that happening

Why is that?

3

Why is that?

4

Why is that?

5

Action

Published 11/1/2012

Clinical Risk Management Services ‐ Guidance

Event Report Interviews

The event investigation process includes interviewing individuals involved in or with knowledge of an event to find

out exactly what happened, to ensure that appropriate management interventions are taken, and to assess the

possible liability impact of the event. Initial responsibility for conducting an event investigation frequently falls to

the immediate supervisor or manager of the department or service involved in the event. However, the risk

manager must be notified of the event as soon as possible using the established event reporting system or, if the

event is serious, immediately by telephone.

Depending on the nature of the event and/or the outcome, staff may be upset. The risk manager must remain

objective and compassionate when interviewing the healthcare providers involved and, at the same time, be able

to assess the situation and determine additional courses of action. The following guidelines can be used by the

risk manager to prepare for, conduct, and follow up on interviews of workers regarding an event. Many of the

principles described in this Guidance Article apply to almost any internal investigation and interview process,

such as investigation of a serious adverse event, an accident, a sexual harassment complaint, or an employee

injury.

Web ResourcesMedically Induced Trauma

Support Services Tools for

Building a Clinician and

Staff Support Program

Start at the Beginning

Interview Planning

Conduct the Interviews

Should Interviews be Recorded?

Documentation

Action Recommendations

The event investigation process includes interviewing individuals involved in or with knowledge of an event to find

out exactly what happened, to ensure that appropriate management interventions are taken, and to assess the

possible liability impact of the event. Initial responsibility for conducting an event investigation frequently falls to the

immediate supervisor or manager of the department or service involved in the event. However, the risk manager

must be notified of the event as soon as possible using the established event reporting system or, if the event is

serious, immediately by telephone.

Depending on the nature of the event and/or the outcome, staff may be upset. The

risk manager must remain objective and compassionate when interviewing the

healthcare providers involved and, at the same time, be able to assess the situation

and determine additional courses of action. (See “Web Resources” for more

information on providing support and counseling to providers involved in adverse

events.) The following guidelines can be used by the risk manager to prepare for,

EXECUTIVE SUMMARY

TABLE OF CONTENTS

© 2016 ECRI Institute

Web ResourcesJoint Commission: Sentinel

Event Policy and

Procedures

Joint Commission:

Framework for Conducting

a Root Cause Analysis and

Action Plan

conduct, and follow up on interviews of workers in health centers and free clinics

regarding an event. Many of the principles described in this Guidance Article apply to almost any internal

investigation and interview process, such as investigation of a serious adverse event, an accident, a sexual

harassment complaint, or an employee injury.

Additional information, resources, and tools on event reporting are available in the Event Reporting Toolkit.

Start at the BeginningWhen deciding whom to interview and what to ask, begin with the event report itself. Obviously, the person who

initiated the report and the individuals directly involved should be interviewed; it may also be a good idea to talk

with others who might have been in the area or who have knowledge of the event. The interviewer should make a

list of key individuals and witnesses and prepare an interview schedule. The decision to interview healthcare

providers who are not covered under the Federal Tort Claims Act or not represented by the organization's defense

counsel should be made on a case-by-case basis, with input from legal counsel and the involved provider.

Nonemployed providers who serve as independent contractors may, by contract, have the right to have their

attorneys present during any such interview but can voluntarily participate without counsel.

Interviews should take place as soon as possible after the event, while the memory of the details is still fresh. It

may be useful to conduct a second round of interviews one or two weeks later to identify any new information or to

clear up questions that may have arisen during the investigation.

Postevent interviews can also yield updated information for a patient or family members being kept apprised of an

ongoing investigation. If the event has resulted in serious patient injury or death and is likely to proceed to litigation

or settlement, it is advisable to involve legal counsel from the beginning to protect information obtained under

attorney-client privilege; the issue of disclosure of the event and the circumstances surrounding the event to the

patient and/or family members should also be discussed with legal counsel.

Investigators should keep in mind the need to comply with any statute granting privilege from disclosure, as well as

applicable organizational policies, accreditation standards, statutory reporting requirements, and patient or family

communication requirements concerning the event. These requirements should be reviewed by the interviewer at

the beginning of the interview so there is no uncertainty regarding whether the information communicated will be

confidential.

Interviews may provide useful information about a sentinel event that could be used in

conducting a root-cause analysis. The Joint Commission’s sentinel event policies

require accredited organizations to conduct a root-cause analysis of all serious

adverse events, implement improvements to reduce risk, and monitor the

effectiveness of those improvements. (See “Web Resources” for more information on

the Joint Commission’s sentinel event policies and an example of a framework for

conducting root-cause analyses. The framework is just one of many examples of

available tools used by organizations to determine the causal factors of an event.)

Regardless of whether a health center is accredited or seeking accreditation by the

Joint Commission, the organization’s standards represent good risk management

practice that all health centers should strive to meet.

Interview PlanningFirst, recognize that relevant facts about the event must be determined. The interviewer may need to acquire some

background information through research or by discussing the technical aspects with other clinical personnel.

Investigating very complex incidents or those involving highly technical equipment may require the services of an

© 2016 ECRI Institute

independent outside investigator.

Next, develop a list of broad, open-ended questions to ask all interviewees. Questions should be phrased to solicit

descriptions and details about the event and may follow the chronological order of the event for clarification of

sequence. A good basis for the list can be the classic fact-finding questions: who, what, when, where, why, and how.

Experienced interviewers and investigators often use a “tell me about this shift” technique in which they prompt the

interviewee to narrate the sequence of events leading up to and throughout the event. The interviewer listens quietly

while this account is given and saves questions until the end.

Keep an open mind during each interview. It is a natural tendency to accept the first account as accurate and to

weigh subsequent versions accordingly. Try not to draw any conclusions until everyone involved has been

interviewed. Note any discrepancies, but defer making judgments. Because each person who was involved in or

had knowledge of the event will have a different perspective, the interviewer should look for a theme that is

consistent throughout all individuals’ accounts of the sequence of events. If discrepancies are discovered, the

interviewer can have follow-up discussions with the individuals who were interviewed to gain additional information.

Conduct the InterviewsInterview every person who was present during or has knowledge of the event, unless it is a very simple case. This

will allow details to be corroborated and the sequence of events to be established. Remember that in critical clinical

situations, participants may have a poor concept of the passage of time and may confuse the sequence of events or

even who was present. Interview one person at a time, starting with the person most directly involved in the

incident. (Interviews should be conducted with only the investigator and the individual being interviewed—and in

some instances, legal counsel—present. Supervisors or managers should not be allowed to “sit in” on the

interviews. When two or more people are interviewed together, the problems of interpersonal relationships, either as

peers or as a subordinate/superior, are added.) Another consideration involves the attorney-client privilege, which

may be applicable in some jurisdictions if the risk manager is conducting interviews of employees in coordination

with legal counsel. Interviewing more than one person at a time could have the potential effect of waiving attorney-

client privilege.

When conducting the interview, be cognizant of body language. Avoid sitting across a desk or table from the other

person; sitting a little to one side, without any physical barriers in between, is more likely to put the interviewee at

ease. Also, leaning forward toward a person while he or she is talking signals interest in what is being said; pushing

a chair away conveys a message of disinterest or disbelief.

Begin the interview with assurances that all those present during or involved in the event are being interviewed in

order to gather facts, not to place blame. Start with nonthreatening questions, such as asking how long the

employee has had his or her current responsibilities, then ask more specific questions related to the event. Save the

toughest or most threatening questions for last. This offers an opportunity to establish rapport with the interviewee

and prevents any hostility that may exist from sabotaging the rest of the interview. If the event involved a serious

injury or death, a great deal of empathy for the witness and concern for his or her well-being should be displayed.

Because interviewees are likely to act in what they perceive to be their own best interests, be mindful of a witness’s

perspective. Does he or she have a reason for hiding or not emphasizing certain information? Does he or she seem

to note and remember events accurately? Does the potential for disciplinary action, criminal or civil liability, or

discharge from employment exist for either the witness or his or her coworkers? Have others spoken to the witness

and influenced his or her recollection of events? There are no easy ways to discern this information, but experience

in interviewing will increase the ability to pick up subtle clues that can distinguish motivations behind the

information being provided by the witness. Effective interviewing technique requires listening for what is said and

not said.

© 2016 ECRI Institute

As stated earlier, interviews should be conducted as soon as possible after an event because individuals will be

able to more accurately remember the details. In cases in which some time has passed since the event, the

interviewer should listen for biases that may have developed (e.g., “I must have performed the procedure that way

because I always do it that way”).

It is best to conduct interviews in person; doing so provides an opportunity to interpret facial expressions and

gestures and gives the person being interviewed the impression that his or her input is valued. A good place for the

interview is a quiet location near the scene of the incident, if possible and if privacy can be ensured; otherwise, any

area that offers privacy and freedom from distractions can be used. Interviewees will often feel more at ease in

familiar surroundings and may be unusually tense and uncommunicative if interviewed in an office or in the

presence of coworkers.

Try to ask open-ended questions (e.g., “What happened next?”) rather than leading questions (e.g., “Did you then

call the pharmacy?”). Allow the interviewee to tell the story at his or her own pace and in his or her own words—even

seemingly irrelevant details may become important later in trying to put together the whole picture—but

unobtrusively guide the conversation toward the important points.

A technique to elicit as much information as possible is to remain silent when the interviewee stops speaking. It is a

natural tendency to want to fill awkward silences in a conversation. Pausing and looking at the person expectantly

can often encourage the individual to begin to talk again. Other ways to encourage someone to continue talking are

using head nods or repeating his or her last statement. Reflective listening also communicates interest, allows

misunderstandings to be clarified, and assures the interviewee that he or she is being listened to.

Try not to interrupt the interviewee’s train of thought by asking for details, especially when he or she is telling a

crucial part of the story. Make notes, and tie up loose ends later in the interview. Be sure there is an understanding

of what the other person intends; the jargon and differing perspectives of various disciplines can lead to false

conclusions. The interviewer should clearly document in his or her notes where information needs further review or

where a question arose during the interviewee’s account of the sequence of events. After the interviewee has

finished the account, the interviewer can then ask for additional information or clarification.

One way to verify the accuracy of statements is to ask the same questions in slightly different ways at different

points in the interview or in subsequent interviews. For example, for an adverse event involving a medical device

failure, investigators may ask whether the device had ever previously failed. If the interviewee answers “No,”

rephrase the question during subsequent interviews (e.g., “Has the device ever stopped spontaneously?”). Because

individuals may not have viewed the device stoppage as a “failure” or may have attributed the stoppage to other

factors, rephrasing the question can help investigators be sure they have all the facts.

If the interview goes into unfamiliar territory even after research, be honest and ask the other person to explain.

Even if there is familiarity with the subject matter on both sides, ask the interviewee to go over it anyway, “for the

record.” Without confirmation, important details may never come to light—for example, that the interviewee was

unaware of a relevant procedure or misunderstood a certain regulation.

Before completing the interview, ask the interviewee if there are any other points that were overlooked or other

things that he or she wants to talk about. Avoid making promises to the interviewee; for example, do not promise

that no disciplinary action will be taken, because later investigations may reveal that employees knowingly violated

the rules and disciplinary action may be necessary. Especially with interviews that have been stressful, try to end on

a positive note—once again, emphasize the interviewer’s role as a fact finder rather than someone looking to assign

blame, and thank the person for his or her time and cooperation. Provide a phone number, and ask the interviewee

to call if anything further occurs to him or her. Advise the interviewee to not discuss the event with others.

© 2016 ECRI Institute

Web ResourcesInstitute for Healthcare

Improvement: Respectful

Management of Serious

Clinical Adverse Events

Institute for Healthcare

Improvement: Leadership

Response to a Sentinel

Event: Respectful, Effective

Crisis Management

(See “Web Resources” for more information and resources on the overall

management of serious adverse events and tips for communicating with both

providers and patients.)

Should Interviews be Recorded?Consult with legal counsel concerning whether taking notes or recording the interview

is advisable. Court rules in some jurisdictions permit the discovery of notes and

recordings of interviews with witnesses and parties to the event; other rules govern

whether any recorded statements are admissible as evidence in court.

There are several issues to consider concerning whether to take notes or record

interviews with those who were involved in or have witnessed an event. One

consideration is how such recordings are treated under state or federal court rules and

rules of evidence. Recorded responses from witnesses may, in some circumstances, constitute “statements,” which

are discoverable in litigation. Statements taken from an individual who is later named as a defendant in a lawsuit

may, under some circumstances, be considered an “admission,” which, under rules of evidence, may be admissible

as evidence in a trial. This issue is discussed more fully in the discussion Documentation.

Aside from legal considerations, practical considerations also come into play. If interviews are to be recorded, it is

best to take notes rather than use an audio or video recorder during the interview. Although use of an audio or video

recorder eliminates note-taking and may allow the interviewer to concentrate more fully on the interview, it can have

an inhibiting effect on the interviewee. And there are problems with recordings from the interviewer's point of view

as well. At the very least, using an audio or video recorder requires that the recording be transcribed. This can be

time-consuming and very difficult if there is any background noise or if the interviewee did not speak clearly and

loudly.

People who are ill at ease may tense up during note-taking, but there are some ways to overcome this problem. If,

at the beginning of the interview, the interviewee seems nervous or hostile, do not immediately pick up the notepad

and pencil; instead, begin with general questions, and try to put him or her at ease. Once the conversation gets

under way, reach for the notepad and casually say, “Let me make just a few notes. I want to be sure I've got your

comments right.” Then make only essential notes. Learning to jot down notes while maintaining eye contact with the

subject is a good practice—staring at the paper and scrawling furiously while the person speaks should be avoided.

Consult with an attorney to determine the legal status of such notes, and determine how they should be

documented and retained (see the discussion Documentation). The event management policies and procedures

should include information about how to take and protect notes and other information obtained during an

investigation. Review of the event management policy periodically will ensure that all investigators are familiar with

the health center’s methods for documenting interviews and investigations.

DocumentationThe potential discovery of risk management information must be carefully considered when recording the results of

interviews or information obtained as part of the event investigation. It is important to consult with legal counsel

concerning the applicable jurisdiction's laws and court rules governing the discoverability of risk management

information in deciding what written material should become part of the file.

In many jurisdictions, the court rules governing civil litigation permit a party to discover any matter, not privileged,

that is relevant to the subject matter involved in the action, regardless of whether it relates to the claims made or

the defenses asserted. Whether notes taken by a risk manager or recordings of interviews made by a risk manager

of witnesses and individuals who are later named as defendants are privileged from discovery may vary from

© 2016 ECRI Institute

jurisdiction to jurisdiction and are often a subject of pretrial motions requesting a court order to compel discovery. In

some jurisdictions, the party making the request or demand for disclosure of materials prepared in anticipation of

litigation (or for trial) must prove to the court that a substantial equivalent of the materials cannot be obtained by

other means. Examples are an audiotape recording, a transcript of the recording, or notes taken during an interview

with a witness or defendant who dies or is otherwise legally unavailable during the duration of the lawsuit. If

discovery is permitted, some jurisdictions provide protection to the mental impressions, conclusions, opinions, or

legal theories of the representative (e.g., the risk manager) or attorney who made the notes or recordings; thus,

disclosure would be limited to facts only.

Another consideration is whether notes or transcripts of audio recordings, or the recording itself, of the individual

who later becomes a defendant must be disclosed or is otherwise discoverable. Many states have adopted

discovery rules similar to federal court rules that require parties to civil litigation to provide to other parties a copy—

or a description by category and location—of all documents, electronically stored information, and tangible things

that the disclosing party has in its possession, custody, or control and may use to support its claims or defenses

(Fed. R. Civ. P. 26). Therefore, the existence of a risk manager’s recorded interview of an individual who

subsequently becomes a party to litigation would have to be disclosed under the broad discovery rule. However, if

the recorded interview is disclosed under a claim of privilege, the court will make a determination as to whether the

recorded information is privileged or must be disclosed.

As indicated earlier, if the event involved a serious injury, it may be best to involve legal counsel before conducting

the interviews in order to invoke any applicable privileges from discovery or admissibility. As a final note, results of

the interview should never be entered into a patient's medical record or an employee's personnel folder.

Interviewing skills are an important tool for determining the facts surrounding an adverse event. There is no doubt

that interviewing is an art—and as with other arts, the main ingredient for improving one’s skills is practice. The

precise methods used, however, are less important than the final result: a clear and complete picture of the event

in question.

Action Recommendations

Emphasize the fact-finder role of the interviewer: someone who is interested in preventing recurrences and

limiting liability for all involved rather than someone attempting to place blame.

Keep an open mind during each interview. Remain objective yet compassionate, and try not to draw any

conclusions until everyone involved in the incident has been interviewed.

Help interviewees feel at ease by interviewing them in person (one at a time) in familiar surroundings,

preferably taking notes rather than using an audio or video recorder, and arranging seating so that there are no

physical barriers between parties to inhibit discussion.

Ask open-ended questions, allowing the interviewee to tell the story at his or her own pace and in his or her own

words. Be sure there is an understanding of what is being said, even if both parties are familiar with the subject

matter.

Consult with legal counsel concerning any applicable privileges or discovery pitfalls that may be avoided in

cases of events involving serious injury. This consultation should ideally occur before a serious event occurs and

should be made part of the health center’s event management policies or procedures.

Know your state's law concerning discovery of information obtained during risk management investigations

when deciding what written or other materials should become part of a file. Ensure that this information is

included in the organization’s event management policies or procedures.

Do not enter results of the interview in a patient's medical record or an employee's personnel file.

Record factual information, not observations or judgments.

© 2016 ECRI Institute

REFERENCESFed. R. Civ. P. 26.

RESOURCE LISTInstitute for Healthcare Improvement

(617) 301-4800

http://www.ihi.org

Leadership Response to a Sentinel Event: Respectful, Effective Crisis Management:

http://www.ihi.org/knowledge/Pages/Tools/LeadershipResponseSentinelEventEffectiveCrisisMgmt.aspx

Respectful Management of Serious Clinical Adverse Events.

http://www.ihi.org/knowledge/Pages/IHIWhitePapers/RespectfulManagementSeriousClinicalAEsWhitePaper

.aspx

Joint Commission

(630) 792-5800

http://www.jointcommission.org

Sentinel Event Policy and Procedures:

http://www.jointcommission.org/Sentinel_Event_Policy_and_Procedures

Framework for Conducting a Root Cause Analysis and Action Plan:

http://www.jointcommission.org/Framework_for_Conducting_a_Root_Cause_Analysis_and_Action_Plan

Medically Induced Trauma Support Services

(617) 232-0090

http://www.mitsstools.org/

Tools for Building a Clinician and Staff Support Program: http://www.mitsstools.org/tool-kit-for-staff-support-

for-healthcare-organizations.html

TOPICS AND METADATATopicsAccreditation;

Accidents;

Administrative and Support Services;

Aging Services;

Behavioral Health;

Culture of Safety;

Employment Affairs;

Falls;

Incident Reporting and Management;

Long-term Care;

Laws, Regulations, Standards;

Medication/Drug Safety;

Occupational Health;

© 2016 ECRI Institute

Pharmacy;

Quality Assurance/Risk Management;

Rehabilitation;

Root Cause Analysis;

Security/Safety;

Transitions of Care

CaresettingAmbulatory Care Center;

Ambulatory Surgery Center;

Assisted-living Facility;

Behavioral Health Facility;

Dialysis Facility;

Emergency Department;

Endoscopy Facility;

Home Care;

Hospice;

Hospital Inpatient;

Hospital Outpatient;

Imaging Center;

Independent Living Facility;

Physician Practice;

Rehabilitation Facility;

Short-stay Facility;

Skilled-nursing Facility;

Substance Abuse Treatment Facility;

Trauma Center

RolesHealthcare Executive;

Insurer;

Legal Affairs;

Patient Safety Officer;

Quality Assurance Manager;

Regulator/Policy Maker;

Risk Manager

Information TypeGuidance

Published November 1, 2012

PUBLICATION HISTORY

© 2016 ECRI Institute

© 2016 ECRI Institute. For complete Virtual Conference resources, including slide handouts, session recordings, and more tools, go to https://www.ecri.org/components/HRSA/Pages/virtualconference2016.aspx.

Continuous Quality Improvement: Learning from Events Learning Objectives

Develop corrective actions that are linked to identified root causes Develop corrective actions that are effective and impactful Develop measures of effectiveness for corrective actions

Employing Data-Driven Quality Improvement (QI) Measures

Data-driven quality improvement (QI) measures are an essential part of improving patient outcomes, managing population health, reducing cost, and increasing the satisfaction of patients and staff. Quality measures focus on structures or processes of care related to positive health outcomes that can be facilitated by the health center or free clinic. Gathering data on measures that are important to the health center and that are valid, feasible, reliable, predictable, and evidence-based will facilitate improved health outcomes for patients.

Health centers and free clinics can use the following checklist and resources to help identify opportunities to use data-driven quality improvement initiatives in their facility.

Recognize the benefit of the data gathered and the role of data in identifying high-risk populations, supporting evidence-based medicine, and improving processes. (See also the National Quality Forum’s ABCs of Measurement.)

Ensure leadership support and commitment for data-driven quality activities. For more information, refer to The Healthcare Executive's Role in Ensuring Quality and Patient Safety.

Set organization-wide, as well as project- or care-level, quality goals and measures. See the HHS Measures Inventory on the Agency for Healthcare Research and Quality (AHRQ) website.

Assemble the appropriate team to champion the measure and develop strong team skills by using tools such as TeamSTEPPS.

Recognize that electronic health records (EHRs) are just one form of technology that allows data to be readily accessed and utilized. Remain cautious of using data from health information exchanges, mobile devices, and personal fitness monitors because these data may require additional steps to standardize before use.

Ensure that the data gathered is the appropriate measure for that health outcome. As an example refer to AHRQ’s Child Healthcare Quality Toolbox which includes Understanding Quality Measurement.

Establish good data governance and a high-quality data warehouse recognizing the difference between static data (such as date of birth) and dynamic data (such as glucose levels), as well as when data maintenance occurs and what version of the

EHR is being used. For more information refer to the American Health Information Management Association’s (AHIMA’s) Data Quality Management Model (Updated).

Use a deliberate and defined improvement process such as Plan-Do-Check-Act (PDCA)/PDSA: Plan-Do-Study-Act (Rapid Cycle Improvement).

Recognize and celebrate successful initiatives and implement them on a larger scale.

Continue to evaluate and monitor initiatives in order to maintain improvement.

Want to learn more? You can learn more about Performance Management & Measurement and obtain help in developing and measuring quality improvement goals by reviewing Managing Data for Performance Improvement.

Additionally you can refer to the QI/QA Plan: Meeting to Facilitate QI/QA Activities from the 2014 Virtual Conference, Data-Driven Quality Improvement, and The Use of EHRs for Quality Improvement in the Webinar Archive, as well as tools and policies in the Quality Improvement/Quality Assurance Toolkit, all available on the Clinical Risk Management Program website. All resources are provided for FREE by ECRI Institute on behalf of HRSA. Don't have access or want to attend a free, live demonstration of the website? E-mail Clinical_RM_Program@ecri.org or call (610) 825-6000 ext. 5200.

Information provided by ECRI Institute is intended as guidance to be used consistent with the internal needs of your organization. This information is not to be viewed as required by ECRI Institute or the Health Resources and Services Administration.

Using Valid Quality Improvement (QI) Methodologies

Quality improvement (QI) consists of systematic and continuous actions that lead to measurable improvement in healthcare services and the health status of targeted patient groups. Quality initiatives in health centers and free clinics can transform the delivery of primary care services and facilitate the triple aim of improved patient experience, improved population health, and reduced costs. An effective QI strategy must incorporate QI methodologies that are tailored to QI activities in the practice. Health centers and free clinics can use the following checklist and resources to help identify and select the QI methodologies that are best suited for their quality activities.

Ensure leadership support and commitment for the QI/QA plan and related activities. Be certain to include quality updates as part of the board’s agenda.

Use a deliberate and defined improvement process such as Plan-Do-Check-Act (PDCA) / PDSA: Plan-Do-Study-Act (Rapid Cycle Improvement).

Set organizationwide as well as project- or care-level quality improvement goals.

Establish quality initiatives in your facility in response to such things as community need, performance of a process over time, or performance of daily health center activities. Refer to suggestions offered in the “Potential Quality Indicators” slides in the handouts for ECRI Institute’s 2014 Virtual Conference presentation, QI/QA Plan: Meeting to Facilitate QI/QA Activities.

Establish a team to set quality initiatives for the year involving key leaders and staff. Refer to Building Quality Improvement Capacity in Primary Care for more information on team approaches to quality activities.

Identify issues for quality analysis and establish a baseline. Develop actions and tasks, prioritizing as you move forward, set benchmarks and targets, develop project plans, implement plans, and monitor outcomes by using data. For more information refer to Performance Management & Measurement.

Use tools such as flow charts, cause and effect diagrams (Fishbone diagrams), Pareto charts, checklists/check sheets, histograms, and scatter diagrams to support QI/QA activities.

Identify triggers (issues/concerns) for a root cause analysis. Use root cause analysis tools to examine the potential root cause of an issue. Identify risk

assessments to focus on by using tools such as the root cause rating form. For an example of an issue for root cause analysis and the steps of the process refer to Root Cause Analysis Workbook for Community/Ambulatory Pharmacy.

Want to learn more? Compare the relationships among various quality improvement tools, learn the Basics of Quality Improvement in Healthcare, and develop Tools and Strategies for Quality Improvement and Patient Safety. You may want to also consider whether a Quality Improvement Strategy | Safety Net Medical Home Initiative is helpful for your health center or free clinic.

Additionally you can refer to the QI/QA Plan: Meeting to Facilitate QI/QA Activities from the 2014 Virtual Conference, The Use of EHRs for Quality Improvement in the Webinar and Audio Conference Archive, tools and policies in the Quality Improvement/Quality Assurance Toolkit, and previous Get Safe! communications such as Improving Provider-Patient Communication and Maintaining Continuous Quality Improvement, all available on the Clinical Risk Management Program website. All resources are provided for FREE by ECRI Institute on behalf of HRSA. Don't have access or want to attend a free, live demonstration of the website? E-mail Clinical_RM_Program@ecri.org or call (610) 825-6000 ext. 5200.

Information provided by ECRI Institute is intended as guidance to be used consistent with the internal needs of your organization. This information is not to be viewed as required by ECRI Institute or the Health Resources and Services Administration.

© 2016 ECRI Institute. For complete Virtual Conference resources, including slide handouts, session recordings, and more tools, go to https://www.ecri.org/components/HRSA/Pages/virtualconference2016.aspx.

Sample Action Tracking Sheet Preventive actions Action strength Root causes

Responsible party/ due date

Measure of effectiveness (process, outcome)

High

Moderate

Low

High

Moderate

Low

High

Moderate

Low

High

Moderate

Low

High

Moderate

Low