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By Arnold Mackles, MD, MBA, LHRM

By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

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Page 1: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

By Arnold Mackles, MD, MBA, LHRM

Page 2: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

The Sullivan Group

- Author of on line CME courses

- Volunteer member of Advisory Board

Innovative Healthcare Compliance Group, Inc.

- CME speaker

- Consultant

Page 3: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

State mandated Florida Medical Board to require a two hour CME in “Prevention of Medical Errors.”

Page 4: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Course to cover

1) Root Cause Analysis

2) Error Reduction and Prevention

3) Patient Safety

4) Frequently Misdiagnosed Conditions

Page 5: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

MD course:

1. Cancer related conditions

2. Surgery complications

3. Respiratory related issues

4. Ob/Gyn related conditions

5. Cardiology related conditions

DO course:

1. Inappropriate prescribing of controlled substances;

2. Failure to monitor the safety of prescribed medications;

3. Retained foreign objects in surgery and wrong site/patient surgery;

4. Surgical complications/errors and pre-operative evaluations,

including obtaining informed consent; and

5. Failure to timely diagnose sepsis.

Page 6: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

November 1999

Published report entitled:

“To Err is Human”

Cited magnitude of medical error problem

Kohn, Corrigan and Donaldson. Institute of Medicine; To Err is Human: Building a Better Health System; National Academy Press:2000

Page 7: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Injury in 1:25 hospitalized patients

Estimated 44,000-98,000 deaths per year

Cost 17-29 billion $ per year

Kohn, Corrigan and Donaldson. Institute of Medicine; To Err is Human: Building a Better Health System; National Academy Press:2000

Page 8: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Adverse event:

“An injury caused by medical management rather than the underlying condition of the patient.”

Page 9: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Sentinel event:

“An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.”

Joint Commission

http://www.jointcommission.org/SentinelEvents/ Accessed January 22, 2007

Page 10: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Wrong site surgery 12.8 % Retention foreign body 12.4 % Delay in treatment 10.7 % Suicide 10.4 % Op / post op complication 9.3 %

The Joint Commission.”Summary Data of Sentinel Events Reviewed by the Joint Commission.” SE Statistics as of: 1/13/2017

https://www.jointcommission.org/assets/1/18/Summary_4Q_2016.pdf Accessed May 27, 2017.

Page 11: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Patient falls 8.7 % Other unanticipated events 6.4 % Medication errors 4.8 % Criminal event 4.4 %

Perinatal death / injury 3.7 %

The Joint Commission.”Summary Data of Sentinel Events Reviewed by the Joint Commission.” SE Statistics as of: 1/13/2017

https://www.jointcommission.org/assets/1/18/Summary_4Q_2016.pdf Accessed May 27, 2017.

Page 12: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

1. Patient Falls

2. Unintended Retention of a Foreign Body

3. Wrong-patient, Wrong-site, Wrong-procedure

The Joint Commission “Summary Data of Sentinel Events Reviewed by The Joint Commission” SE Statistics as of 1/8/19 https://www.jointcommission.org/assets/1/6/Summary_4Q_2018.pdf Accessed April 10, 2019

Page 13: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

2013 (N=887) 2014 (N=764) 2015 (N=936)

Human Factors Human Factors Human Factors

Communication Leadership Leadership

Leadership Communication Communication

Assessment Assessment Assessment

Most Frequently Identified Root Causes of Sentinel Events Reviewed by The Joint Commission by Year

The Joint Commission. “ Sentinel Event Data - Root Causes by Event Type.”

http://www.jointcommission.org/assets/1/18/Root_Causes_by_Event_Type_2004-2015.pdf

Accessed April 30, 2016

Page 14: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 15: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 16: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

2016 Report: “Free From Harm: Accelerating Patient Safety Improvement Fifteen Years after To Err is Human.”

“Patient safety concerns remain a serious public health issue.”

National Patient Safety Foundation “Free From Harm: Accelerating Patient Safety Improvement Fifteen Years after To Err is Human” National Patient Safety Foundation. 2016 http://www.npsf.org/?page=freefromharm Accessed February 29, 2016

Page 17: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

2016 Report Made Eight Recommendations:

#1. “Ensure that leaders establish and sustain a safety culture.”

National Patient Safety Foundation “Free From Harm: Accelerating Patient Safety Improvement Fifteen Years after To Err is Human” National Patient Safety Foundation. 2016 http://www.npsf.org/?page=freefromharm Accessed February 29, 2016

Page 18: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Simplistic Definition:

It’s what you do if nobody is watching.

But in reality, it is much, much more…

Page 19: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

.

A more specific definition for use in healthcare has the following characteristics: • Understanding of the organizations “high risk”

activities. • Constant striving for safe operations. • Blame-free environment. • Transparent reporting of mistakes without fear of

punishment and reprisal.

Agency of Healthcare Research and Quality(AHRQ). “Safety Culture.” Patient Safety Primers http://psnet.ahrq.gov/primer.aspx?primerID=5 Accessed February 16, 2016

Page 20: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Collaboration across all hierarchies and specialties to create patient safety safeguards and to resolve safety issues.

• Encouragement by top leadership. • Commitment of the organization to provide resources and

to effectively address safety issues.

Agency of Healthcare Research and Quality(AHRQ). “Safety Culture.” Patient Safety Primers http://psnet.ahrq.gov/primer.aspx?primerID=5 Accessed February 16, 2016

Page 21: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Initial concept taken from “High Reliability Organizations.” - Tasks are complicated and dangerous. - Emphasis on safety; minimizing errors, adverse events, and catastrophic situations. - Commitment of safety throughout organization.

Page 22: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Adds accountability to the “Blame-Free” environment. • Zero tolerance for behavior that is considered reckless. • Administration response to error is related to associated

behavior, rather than to type or seriousness of event.

Agency of Healthcare Research and Quality(AHRQ). “Safety Culture.” Patient Safety Primers http://psnet.ahrq.gov/primer.aspx?primerID=5 Accessed February 16, 2016

Page 23: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Distinction must be made between: - Human error (ex: slip-up mistake). - At-risk behavior (ex: use of short cuts). - Reckless behavior (ex: refusing to follow safety policies/protocols).

Agency of Healthcare Research and Quality(AHRQ). “Safety Culture.” Patient Safety Primers http://psnet.ahrq.gov/primer.aspx?primerID=5 Accessed February 16, 2016

Page 24: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 25: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Dr. Keith Klein, professor of medicine at the David Geffen School of Medicine at UCLA.

"Medical-Legal Cases That Went South, Costing Over $30 Million”

Health Information and Management Systems Society (HIMSS) Conference, Chicago.

Westgate, A. “Legal Pitfalls to Avoid When Using you’re her.” Physicians Practice. April 13, 2015. http://www.physicianspractice.com/himss2015/legal-pitfalls-avoid-when-using-your-ehr Accessed December 1, 2016

Page 27: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Pitfall #1: Inadequate capture of informed consent electronically.

Failure to locate signed consent in EMR

despite physician’s claim that it was completed.

Providers must make sure that consent signatures are scanned into the record.

Westgate, A. “Legal Pitfalls to Avoid When Using you’re her.” Physicians Practice. April 13, 2015. http://www.physicianspractice.com/himss2015/legal-pitfalls-avoid-when-using-your-ehr Accessed December 1, 2016

Page 28: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Pitfall #2: Misuse/overuse of templates and

cut-and-paste functionality.

In court, Judges and other lay personnel often questioned why physicians “cut and pasted.”

Small template or “cut and paste” errors are red flags.

Westgate, A. “Legal Pitfalls to Avoid When Using you’re her.” Physicians Practice. April 13, 2015. http://www.physicianspractice.com/himss2015/legal-pitfalls-avoid-when-using-your-ehr Accessed December 1, 2016

Page 29: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

What to avoid:

• Gender confusion in notes.

• Lack of personalization or individualization.

• Typos, spacing errors, blanks.

• Overly extensive notes for each encounter (may appear to be enhanced or generated by the computer).

• Repeating same phrases.

Westgate, A. “Legal Pitfalls to Avoid When Using you’re her.” Physicians Practice. April 13, 2015. http://www.physicianspractice.com/himss2015/legal-pitfalls-avoid-when-using-your-ehr Accessed December 1, 2016

Page 30: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Pitfall #3: Misuse of shortcuts, checklists, checkboxes,

and other tools, that pre-populate information.

Don’t overuse shortcuts. You may create

"inadvertent falsification" or "note bloat."

Use auto-complete sparingly.

Instead, use free text to individualize patient information.

Westgate, A. “Legal Pitfalls to Avoid When Using you’re her.” Physicians Practice. April 13, 2015. http://www.physicianspractice.com/himss2015/legal-pitfalls-avoid-when-using-your-ehr Accessed December 1, 2016

Page 32: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 33: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Privitera, M., Plessow, F., Rosenstein, A. “Burnout as a Safety Issue: How Physician Cognitive Workload Impacts Care” National Patient Safety Foundation. Patient Safety Blog. August 24, 2015 http://www.npsf.org/blogpost/1158873/224974/Burnout-as-a-Safety-Issue--How-Physician-Cognitive-Workload-Impacts-Care

3 Factors of Burnout

Exhaustion (physical and Emotional)

Depersonalization - poor coping mechanisms

Cynicism, compassion fatigue, sarcasm

Lack of efficacy

Page 34: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Shanafelt et. al (Annals of Surgery, 2010)

American College of Surgeons Survey

Self-assessment of major medical errors

Depression screening tool

Standardized assessments for

Burnout

Quality of life (QOL)

Shanafelt ,T., Balch , C ., Bechamps, G., et al. “Burnout and Medical Errors Among American Surgeons.” Annals of Surgery 2010;25:995-1000.

Page 35: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Shanafelt et. al.

7,905 surgeons participated

700 (8.9%) thought they made a major medical error (past 3 months).

70% attributed error to individual factor rather than systems error.

Shanafelt ,T., Balch , C ., Bechamps, G., et al. “Burnout and Medical Errors Among American Surgeons.” Annals of Surgery 2010;25:995-1000.

Page 36: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Shanafelt et. al.

Reporting an error in past 3 months had a significant adverse relationship with:

Mental QOL (Quality of Life)

Emotional exhaustion

Depersonalization

Personal accomplishment

Symptoms of depression

Shanafelt ,T., Balch , C ., Bechamps, G., et al. “Burnout and Medical Errors Among American Surgeons.” Annals of Surgery 2010;25:995-1000.

Page 37: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Shanafelt et. al.

A one point increase in Depersonalization (scale 0-33) =

11% increase in error reporting.

A one point increase in Emotional Exhaustion (scale 0-54) =

5% increase in error reporting.

11% increase in reporting an error

Shanafelt ,T., Balch , C ., Bechamps, G., et al. “Burnout and Medical Errors Among American Surgeons.” Annals of Surgery 2010;25:995-1000.

Page 38: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Shanafelt et. al.

Depression and Burnout were independent predictors

of reporting a recent significant error.

The following were NOT associated with error reporting: Hours worked

Frequency of overnight call

Compensation method

Practice setting

11% increase in reporting an error

Shanafelt ,T., Balch , C ., Bechamps, G., et al. “Burnout and Medical Errors Among American Surgeons.” Annals of Surgery 2010;25:995-1000.

Page 39: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

• Survey of 8,774 Physicians • Margin of Error +/- 1.057% • Published on-line September 18, 2018

Page 40: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Impact of Poverty: • Patients with serious health problem linked

to poverty social conditions - 88% • Few patients with social conditions - 11% • No patients with social conditions - 1%

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

Page 41: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

The Opioid Crisis - How physicians are responding: • Prescribing fewer medications - 69% • Prescribing same amount - 31%

Non Compliant Patients: • Number of non-compliant patients - 31%

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

Page 42: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Symptoms of Burnout: • Sometimes, often, always feel burned out - 78% • Rarely, never feel burned out - 12% Which Physicians Feel Burned Out? Sometimes, often, always feel burned out: • Female Physicians - 85% • Male Physicians - 74%

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

Page 43: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Burden of Paperwork: • Time spent on patient care - 77% • Time spent on paperwork - 23%

Time to See More Patients: • Physicians at capacity or overextended - 80% • Physicians able to see more patients - 20%

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

Page 44: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Two Factors Physicians Dislike Most about Medical Practice: • Electronic Health Records (EHR) • Loss of Clinical Autonomy

2018 Survey of America's Physicians | The Physicians Foundation https://physiciansfoundation.org/research-insights/the-physicians-foundation-2018-physician-survey/ September 18, 2018

Page 45: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Year 2015 Annual CRICO Report.

The Risk Management Foundation of the Harvard Medical Institutions Inc.

“Communication failures linked to 1,744 deaths in five years.”

CRICO Strategies “Malpractice Risks in Communication Failures” 2015 Annual Bernchmarking Report. https://www.rmf.harvard.edu/~/media/0A5FF3ED1C8B40CFAF178BB965488FA9.ashx Accessed February 13, 2016

Page 46: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

23,658 malpractice cases from 2009 to 2013 were evaluated.

Identified 7,149 cases where communication failures caused patient harm.

CRICO Strategies “Malpractice Risks in Communication Failures” 2015 Annual Bernchmarking Report. https://www.rmf.harvard.edu/~/media/0A5FF3ED1C8B40CFAF178BB965488FA9.ashx Accessed February 13, 2016

Page 47: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Ambulatory Setting

ED 8%

Inpatient Setting

44%

CRICO Strategies “Malpractice Risks in Communication Failures” 2015 Annual Bernchmarking Report. https://www.rmf.harvard.edu/~/media/0A5FF3ED1C8B40CFAF178BB965488FA9.ashx Accessed February 13, 2016

48%

Page 48: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Miscommunication of the patient’s condition 26%

Inadequate informed consent 13%

Poor documentation 12%

Unsympathetic response to pt. complaint 11%

Failure to read medical record 7%

CRICO Strategies “Malpractice Risks in Communication Failures” 2015 Annual Bernchmarking Report. https://www.rmf.harvard.edu/~/media/0A5FF3ED1C8B40CFAF178BB965488FA9.ashx Accessed February 13, 2016

Key: provider-provider provider-patient

Page 49: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Hospital Value-Based Purchasing (VBP) Program

Hospital Readmissions Reduction Program (HRRP)

Hospital Acquired Condition (HAC) Reduction Program

Medicare.gov “Linking Quality to Payment.”Hospital Compare. Official U.S. Government site for Medicare. http://www.medicare.gov/hospitalcompare/linking-quality-to-payment.html Accessed December 23, 2014

Page 50: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Pays for value or performance

Reimbursement based on - Results of specific quality measures

- Patient outcomes

Affects approximately 3,000 hospitals in USA

Page 51: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

HCAHPS Survey Administered randomly to a sample of discharged patients (48 hours - six weeks post discharge).

Methods of delivery: mail, telephone, interactive voice recognition, or combination.

Asks 27 questions about hospital stay.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-instruments/HospitalQualityInits/HospitalHCAHPS.html Accessed April 22, 2016

CMS.gov “HCAHPS: Patients' Perspectives of Care Survey”

Page 52: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

The HCAHPS Survey Hospital Consumer Assessment of Healthcare

Providers and Systems

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-instruments/HospitalQualityInits/HospitalHCAHPS.html Accessed April 22, 2016

“The HCAHPS survey is the first national, standardized, publicly reported survey of patients' perspectives of

hospital care.” - CMS

CMS.gov “HCAHPS: Patients' Perspectives of Care Survey”

Page 53: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

HCAHPS Survey Dimensions Communication with nurses

Communication with doctors

Responsiveness of staff

Pain management

Communication about medications

Cleanliness, quietness

Discharge information

Overall hospital rating

The Lake Superior Quality Innovation Network. “ Underwtanding Value-Based Purchasing” CMS Quality Improvement Organization Program.

Page 54: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 55: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 56: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“A process for identifying the basic or causal

factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.” - Joint Commission

http://www.jointcommission.org/SentinelEvents/se_glossary.htm?HTTP___JCSEARCH.JCAHO.ORG_CGI_BIN_MSMFIND.EXE?RESMASK=MssResEN.mskhttp%3

A//jcsearch.jcaho.org/cgi-bin/MsmFind.exe%3Fhttp%3A//jcsearch.jcaho.org/cgi-bin/MsmFind.exe%3FRESMASK%3DMssResEN.msk accessed January 23, 2007

Page 57: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Focuses on systems and processes

Not on individual performance

- Joint Commission

Page 58: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Always ask “why?”

Then ask “why?” again

Page 59: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Looks at special cause in clinical process

Looks at common causes in organizational process

- Joint Commission

Page 60: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Identifies improvements that could decrease such events in the future

-Joint Commission

Page 61: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Creates an ACTION PLAN

With recommendations to reduce the risk of similar future events

-Joint Commission

Page 62: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

ACTION PLAN needs to outline

Implementation

Oversight

Pilot testing

Time lines

Means to measure effectiveness

- Joint Commission

Page 63: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Proximate cause

– Direct cause - Near origin of event

• Underlying cause (Systems, Root Cause)

- Far from event

Page 64: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 65: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Acute M. I. (PIAA 2009-2013)

Closed Paid % Paid to Avg.

Claims Claims Close Indemnity

640 205 32.0% $ 342,504

Physician Insurers Association of America. Rockville, MD. Data prepared by request 10/5/15

Page 66: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Chief Factor Closed Claims % Paid $ Indemnity (av)

Error in Diagnosis 224 43.3% $ 364,749

Improper Performance 73 28.8% $ 442,688

Fail to Recognize Complication 31 48.4% $ 364,179

Physician Insurers Association of America. Rockville, MD. Data prepared by request 10/5/15

Page 67: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 68: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Closed Claims Study • Obstetric Malpractice • 882 Claims • 2007 - 2014

Ranum, D., Traxel, D. “Obstetrics Closed Claim Study.” The Doctors Company. www.thedoctors.com

Page 69: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Frequent Allegations: • Delay in Treatment – Fetal Distress 22% (Category II and III FHR decelerations) • Improper Performance – Vaginal Delivery 20% (Shoulder Dystocia – Brachial Plexus injury) • Improper Management of Pregnancy 17% (Failure to test for abnormalities, recognize complications, act on abnormal findings)

Ranum, D., Traxel, D. “Obstetrics Closed Claim Study.” The Doctors Company. www.thedoctors.com

Page 70: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Contributing Factors to Injury:

Therapy / Management 34% Assessment 32% Technical Performance 18% Provider-Provider Communication 17% Patient Factors 16% Poor Documentation 14% Patient-Provider Communication 14%

Ranum, D., Traxel, D. “Obstetrics Closed Claim Study.” The Doctors Company. www.thedoctors.com

Page 71: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 72: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Perforation

Suture Failure

Infection

Bleeding

Page 73: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Joint Commission. Sentinel Event Alert. Issue 12, Feb 4, 2000.

Operative and Post-Operative Complications: Lessons for the Future.

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_12.htm

“Operative & Post - Op.

Complications”

64 cases reviewed

90% of cases were non-

emergent procedures

84% of cases resulted in

death

Page 74: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Joint Commission. Sentinel Event Alert. Issue 12, Feb 4, 2000.

Operative and Post-Operative Complications: Lessons for the Future.

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_12.htm

Accessed May 3, 2008

58% occurred post - operatively

“Two-thirds of the hospitals

identified incomplete

communication among

caregivers as a root cause.”

Page 75: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Effective in reducing errors and…

Improving quality of care

Page 76: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Haynes & Gawande

NEJM

19 item “surgical safety checklist” (WHO, 2008)

8 hospitals located around the world

Haynes , A., Weiser , T., Berry, W…. Gawande, A. et al. “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global

Population.” New England Journal of Medicine. 2009; 360:491-499January 29, 2009

http://www.nejm.org/doi/full/10.1056/NEJMsa0810119#t=article Accessed September 23, 2013

Page 77: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

3,733 surgical patients before implementation of the checklist

3,955 patients after implementation

Haynes , A., Weiser , T., Berry, W…. Gawande, A. et al. “A Surgical Safety Checklist to Reduce Morbidity and Mortality

in a Global Population.” New England Journal of Medicine. 2009; 360:491-499January 29, 2009

http://www.nejm.org/doi/full/10.1056/NEJMsa0810119#t=article Accessed September 23, 2013

Page 78: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

After implementation

of the checklist:

The rate of death decreased from 1.5% to 0.8%

Surgical complications decreased from 11% to 8%

Haynes , A., Weiser , T., Berry, W…. Gawande, A. et al. “A Surgical Safety Checklist to Reduce Morbidity and

Mortality in a Global Population.” New England Journal of Medicine. 2009; 360:491-499January 29, 2009

http://www.nejm.org/doi/full/10.1056/NEJMsa0810119#t=article Accessed September 23, 2013

Page 79: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 80: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Research by Dr. Hardeep Singh • JAMA Internal Medicine, 2013

• Primary care cases • 68 of 190 diagnosis were missed • Most frequently missed : Pneumonia (6.7% of total errors)

Singh H, Giardina T, Meyer A, et al. Types and origins of diagnostic errors in primary care settings” JAMA Intern Med 2013:1–8 http://archinte.jamanetwork.com/article.aspx?articleid=1656540 Accessed February 27, 2916

“Types and Origins of Diagnostic Errors in Primary Care Settings”

Page 81: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Results of Singh Research: • Process breakdowns involving the “patient-practitioner clinical

encounter” contributed to the error in almost 79% of cases. • Breakdowns:

• Obtaining an accurate history • The examination • Ordering appropriate diagnostic tests

Singh H, Giardina T, Meyer A, et al. Types and origins of diagnostic errors in primary care settings” JAMA Intern Med 2013:1–8 http://archinte.jamanetwork.com/article.aspx?articleid=1656540 Accessed February 27, 2916

Page 82: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Recommendation:

• Follow evidence-based protocols, accepted guidelines for patients with pulmonary related signs, symptoms, or issues.

Singh H, Giardina T, Meyer A, et al. Types and origins of diagnostic errors in primary care settings” JAMA Intern Med 2013:1–8 http://archinte.jamanetwork.com/article.aspx?articleid=1656540 Accessed February 27, 2916

Page 83: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

PIAA Data Bank (2004 – 2013)

• 1,692 closed claims for Retained surgical foreign body.

• 500 or 29.6% were paid to close.

• The average indemnity per case was $87,631

Physicians Insurer’s Association of America (PIAA) September, 2014

Page 84: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

PIAA Data Bank (2004 – 2013)

Specialty # Closed Claims % Paid to Close

Gen. Surgery 440 33.4 %

OBGYN Surgery 340 29.7 %

Orthopedic Surgery 123 32.5 %

Urological Surgery 104 32.7 %

Cardio/Thoracic Surgery 137 33.6 %

Physicians Insurer’s Association of America (PIAA) September, 2014

Page 85: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

(PIAA 2001-2010)

Closed Paid % Paid to Avg.

Claims Claims Closed Indemnity

970 272 28% $ 332,720

Largest Indemnity was $ 1,780,000

Physician Insurers Association of America. Rockville, MD. Data prepared by request 10/6/11

Page 86: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

(PIAA 2001-2010) TOP 5 ALLEGED CLAIMS CLAIMS % PAID-TO

ERRORS CLOSED PAID - CLOSED

1. Errors in diagnosis 477 170 35.6 %

2. No med. misadventure 171 20 11.7 %

3. Improper performance 126 32 25.4 %

4. Failure to supervise

or monitor case 34 2 5.9 %

5. Failure to instruct or

communicate with patient 31 5 16.1 %

Physician Insurers Association of America. Rockville, MD. Data prepared by request 10/6/11

Page 87: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

201.9 million opioid prescriptions dispensed in the USA (2009).

Sales of opioid analgesics quadrupled between1999 and 2010. (to hospitals, pharmacies, practitioners)

Cantrill, S.MD (Chair) American College of Emergency Physicians Opioid Guideline Writing Panel “Clinical Policy: Critical Issues in the

Prescribing of Opioids for Adult Patients in the Emergency Department” Annals of Emergency Medicine. October, 2012 Vol. 60. No. 4

http://www.acep.org/clinicalpolicies/ Accessed December 2, 2012

Page 88: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

88

Mike Midgley RN JD MPH CPHRM FASHRM. Florida Society of Healthcare Risk Management Webinar September 9, 2015 www.fshrmps.org

Page 89: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Centers for Disease Control and Prevention (CDC ) “Opioid Data Analysis” https://www.cdc.gov/drugoverdose/images/data/od_deaths_bytype.gif Accessed September 25, 2017

Page 90: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

http://www.e-forcse.com

Page 91: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Davis, Lin, Haiyin.

• Examined the relationship between mental health (mood and anxiety) disorders and prescription opioid use.

• Estimate 38.6 million Americans with mental health disorders (MHD)

• 18.7% (7.2 million) take prescription opioids • 51.4% of all opioid Rx. / year

Davis, M., Lin, L., Haiyin, L. et al. “Prescription Opioid Use among Adults with Mental Health Disorders in the United States.” Journal of the American Board of Family Medicine. http://www.jabfm.org/content/30/4/407.full.pdf+html Accessed February 20, 2018.

Page 92: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• “Adults with MHD were significantly more likely to use opioids (18.7% vs 5.0%; P < .001)” • Conclusion: “Improving pain management among this population is critical to reduce national dependency on opioids.”

Davis, M., Lin, L., Haiyin, L. et al. “Prescription Opioid Use among Adults with Mental Health Disorders in the United States.” Journal of the American Board of Family Medicine. http://www.jabfm.org/content/30/4/407.full.pdf+html Accessed February 20, 2018.

Page 93: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Ordering

Transcription

Dispensing

Administering

Monitoring

Page 94: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Look a-like” medications

“Sound a-like” medications

“5 rights” of medication administration

Consider drug interactions

Need for serum levels? (some antibiotics,

anticoagulants, others,etc.)

Page 95: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Institute for Safe Medication Practices (ISMP)

List of High Risk Medications:

www.ismp.org

Institute for Safe Medication Practices. ISMP’s List of High Risk Medications:http://www.ismp.org/Tools/highalertmedications.pdfAccessed November 26, 2011

Page 96: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Time to Treatment and Mortality during Mandated Emergency Care for Sepsis”

• Seymour et. al. NEJM May , 2017 • 49,331 Patients in 149 hospitals studied (April 1, 2014 -

June 30, 2016) • New York State Department of Health Sepsis Protocol • 3 hour ED “Bundle of Care”

• blood cultures, broad spectrum antibiotics, lactate measurement

Seymour, C., Gesten, F., Hallie C. Prescott, H. et al “Time to Treatment and Mortality during Mandated Emergency Care for Sepsis” The New England Journal of Medicine Downloaded from nejm.org on May 22, 2017. https://www.ohiohospitals.org/OHA/media/Images/Patient%20Safety%20and%20Quality/Documents/PFE/NEJM-2017-Time-to-Treat-Sepsis-Associated-with-Lower-Mortality.pdf

Page 97: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Time to Treatment and Mortality during Mandated Emergency Care for Sepsis”

• Median time to complete bundle = 1.3 hours • Median time to completion of antibiotics = 0.95 hours • Medican time to complete fluid bolus = 2.5 hours

Seymour, C., Gesten, F., Hallie C. Prescott, H. et al “Time to Treatment and Mortality during Mandated Emergency Care for Sepsis” The New England Journal of Medicine Downloaded from nejm.org on May 22, 2017. https://www.ohiohospitals.org/OHA/media/Images/Patient%20Safety%20and%20Quality/Documents/PFE/NEJM-2017-Time-to-Treat-Sepsis-Associated-with-Lower-Mortality.pdf

Page 98: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Time to Treatment and Mortality during Mandated Emergency Care for Sepsis”

• Higher mortality: • Noted with each hour of time to complete the bundle

• Patients with bundle completed hours 3 – hour 12 • Had 14% higher odds of in-hospital death

• “More rapid completion of a 3 hour bundle of sepsis care

and rapid administration of antibiotics, but not rapid completion of an initial bolus of IV fluids were associated with lower risk-adjusted in-hospital mortality.”

Seymour, C., Gesten, F., Hallie C. Prescott, H. et al “Time to Treatment and Mortality during Mandated Emergency Care for Sepsis” The New England Journal of Medicine Downloaded from nejm.org on May 22, 2017. https://www.ohiohospitals.org/OHA/media/Images/Patient%20Safety%20and%20Quality/Documents/PFE/NEJM-2017-Time-to-Treat-Sepsis-Associated-with-Lower-Mortality.pdf

Page 99: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 100: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

http://www.jointcommission.org

Page 101: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 102: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Use 2 patient identifiers for:

Obtaining blood

Giving meds

Procedures

Treatments

Label in presence of patient.

The Joint Commission http://www.jointcommission.org/standards_information/npsgs.aspx Accessed September 24, 2015

Page 103: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Develop procedures for reporting results:

Definition of test / procedure

Who to report to

Acceptable time for result

Procedure to manage results of critical tests

Measure of timeliness

The Joint Commission http://www.jointcommission.org/standards_information/npsgs.aspx Accessed September 24, 2015

Page 104: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Hey, who’s on first?

Communication

Page 105: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Readback” phone, verbal orders

“Readback” test results

JCAHO Patient Safety Goals: http://www.jointcommission.org/PatientSafety/National PatientSafetyGoals/ Accessed January 18, 2007

Page 106: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Measure, improve reporting time of results

Standardize communication “handoff”

JCAHO Patient Safety Goals: http://www.jointcommission.org/PatientSafety/National PatientSafetyGoals/ Accessed January 18, 2007

Page 107: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Handoffs are “Prime Time” for communication errors to occur.

Page 108: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 109: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

SBAR

Used in nuclear submarines Adapted for healthcare use (Dr. Leonard, Kaiser Permanente, Oakland, CA).

Can be tailored for various types of handoffs

Pillow, M., Smith, V. (Editors); Joint Commission Resources: Improving Hand-Off Communication; 2007. P.67

Page 110: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

1) Situation: “What is going on with the patient?”

2) Background: “What is the clinical background, or context?”

3) Assessment: “What do I think the problem is?”

4) Recommendations: “What would I do to correct it?”

Pillow, M., Smith, V. (Editors); Joint Commission Resources: Improving Hand-Off Communication; 2007. P.67

Page 111: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Boston Children’s Hospital.

Developed to improve house staff handoffs.

Printed handoff form.

Integrated into EMR

Boston Children’s Hospital “I-PASS: Standardizing patient “handoffs” to reduce medical errors.” Newsroom. April 29,

2012.http://childrenshospital.org/newsroom/Site1339/mainpageS1339P878.html

Page 112: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

I – Illness severity

P – Patient summary

A – Action list for the next team

S – Situation awareness and contingency

plans

S – Synthesis and “read-back”

Boston Children’s Hospital “I-PASS: Standardizing patient “handoffs” to reduce medical errors.” Newsroom. April

29, 2012. http://childrenshospital.org/newsroom/Site1339/mainpageS1339P878.html

Page 113: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Boston Children’s Hospital “I-PASS: Standardizing patient “handoffs” to reduce medical errors.” Newsroom. April

29, 2012. http://childrenshospital.org/newsroom/Site1339/mainpageS1339P878.html

3 Month “before and after” pilot study

After implementation of I-PASS:

- 40% reduction in medical errors (from 32% to

19%).

- More time spent with patients (225 min./24-

hr. vs. 122 min./24 hr).

Page 114: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Boston Children’s Hospital “I-PASS: Standardizing patient “handoffs” to reduce medical errors.” Newsroom. April

29, 2012. http://childrenshospital.org/newsroom/Site1339/mainpageS1339P878.html

After implementation of I-PASS:

- Inclusion of patient “To Do List” went from

29% to 82%.

- Inclusion of “Medication List” went from

3% to 100%.

Page 115: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 116: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Universal Protocol Effective July 1, 2004

The Joint Commission http://www.jointcommission.org/standards_information/npsgs.aspx Accessed

September 24, 2015

Page 117: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Pre-op verification process

Marking operative site

“Time Out” before starting

The Joint Commission http://www.jointcommission.org/standards_information/npsgs.aspx Accessed

September 24, 2015

Page 118: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths
Page 119: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Label on and off sterile field Syringes, Cups, Basins

Label all transferred solutions Med name, strength, quantity, diluent volume

Expiration dates

Verify labels verbally, visually

GOAL: Label all medications, medication containers, and

other solutions on and off the sterile field in perioperative

and other procedural settings.

The Joint Commission http://www.jointcommission.org/standards_information/npsgs.aspx Accessed September

24, 2015

Page 120: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

A Hospital Acquired (Associated) Condition (HAC) • Medical condition or complication • Develops during a hospital stay • Was not present at admission.

. American Hospital Directory https://www.ahd.com/definitions/hqi_acq_cond_measures.html

Page 121: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

“Infections that patients acquire during the

course of receiving healthcare treatment for

other conditions.” - The Centers for Disease Control and Prevention (CDC)

Page 122: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• 1 out of 25 hospitalized patients

are treated for an HAI.

• Cost of HAIs: estimated to

be $28 - $33 billion per year.

Health Research & Educational Trust, Chicago “Eliminating Catheter-Associated Urinary Tract Infections.” American Hospital Association. July 2013 http://www.hpoe.org/Reports-HPOE/eliminating_catheter_associated_urinary_tract_infection.pdf

Page 123: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Estimated 1.7- 2.0 million HAIs per

year in USA.

• 99,000 deaths / year estimated.

Health Research & Educational Trust, Chicago “Eliminating Catheter-Associated Urinary Tract Infections.” American Hospital Association. July 2013 http://www.hpoe.org/Reports-HPOE/eliminating_catheter_associated_urinary_tract_infection.pdf

Page 124: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• More deaths from HAIs than total from:

- Breast Cancer,

- Auto Accidents

- AIDS

• Yet, many HAIs are preventable.

Health Research & Educational Trust, Chicago “Eliminating Catheter-Associated Urinary Tract Infections.” American Hospital Association. July 2013 http://www.hpoe.org/Reports-HPOE/eliminating_catheter_associated_urinary_tract_infection.pdf

Page 125: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Many HAI’s are considered “Never Events”

- The term “never event” was first described in

2001 by Dr. Ken Kizer, of The National Quality

Forum (NQF).

- Significant adverse medical errors that should

never have taken place!

Agency for Healthcare Research and Quality (AHRQ) “Never Events” Patient Safety Primer.

http://psnet.ahrq.gov/primer.aspx?primerID=3

Page 126: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Centers for Medicare and Medicaid Services

(CMS):

• “Non-reimbursable serious hospital-acquired

conditions.”

• Non-reimbursement applies to conditions

that should have been “reasonably preventable”

by following evidenced-based guidelines.

Lembitz, A., Clarke, T. Clarifying "never events" and introducing "always events."

BMC Health Services Research .2009. http://www.pssjournal.com/content/3/1/26

Page 127: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Foreign Object Retained After Surgery • Air Embolism • Blood Incompatibility • Stage III and IV Pressure Ulcers,

• Falls and Trauma • Manifestations of Poor Glycemic Control (ex: Diabetic Ketoacidosis) • Catheter-Associated Urinary Tract Infection (UTI) • Vascular Catheter-Associated Infection

CMS.gov https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html Page last Modified: 08/19/2015

Page 128: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Surgical Site Infection Following:

- Bariatric Surgery for Obesity - Certain Orthopedic Procedures - Cardiac Implantable Electronic Device (CIED

- Coronary Artery Bypass Graft (Mediastinitis)

• Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) Following Certain Orthopedic Procedures (Spine, Neck, Shoulder, Elbow)

• Iatrogenic Pneumothorax with Venous Catheterization

CMS.gov https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html Page last Modified: 08/19/2015

Page 129: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

2008 - Federal Steering Committee was established. (US Dept.

of HHS, U.S. Dept. of Defense, U.S. Dept. of Labor, and U.S. Dept. of

Veterans Affairs). Coordinated public / private initiatives.

2009 - “National Action Plan to Prevent Health Care-

Associated Infections: Road Map to Elimination” (HAI Action

Plan).

2011 - “Partnership with Patients” established by HHS.

Health.gov “National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination”

http://health.gov/hcq/prevent-hai.asp Accessed January 17, 2016

Page 130: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• Launched by US Dept. of HHS.

• Private / public collaboration.

• Task: improve the quality of healthcare, reduce costs.

• Goal: protect patients from hospital acquired

conditions!

Department of Health and Human Services “National Action Plan to Prevent Healthcare-Associated Infections:

Roadmap to Elimination” HHS.gov, April 2012 http://www.hhs.gov/ash/initiatives/hai/infection.html

Page 131: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Focused on 4 HAI categories:

1. Catheter-associated urinary tract infections (CAUTI)

2. Central line-associated bloodstream infections

(CLABSI)

3. Surgical site infections (SSI)

4. Ventilator-associated pneumonia (VAP)

Department of Health and Human Services “National Action Plan to Prevent Healthcare-Associated Infections:

Roadmap to Elimination” HHS.gov, April 2012 http://www.hhs.gov/ash/initiatives/hai/infection.html

Page 132: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

• “Multistate Point-Prevalence Survey” • Magill et al. • New England Journal of Medicine 2014 • Surveyed 11,282 patients in 183 hospitals • 4% of patients had 1 or more HAI

Magill, S., Edwards, J., Bamberg, W. et al. “Multistate Point-Prevalence Survey of Health Care–Associated Infections” N Engl J Med 2014; 370:1198-1208March 27, 2014 http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleTop

Page 133: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Results: (504 infections) Pneumonia 21.8% Surgical-site 21.8% GI infections 17.1% Urinary tract 12.9% Bloodstream 9.9%

Magill - Prevalence of HAI

Magill, S., Edwards, J., Bamberg, W. et al. “Multistate Point-Prevalence Survey of Health Care–Associated Infections” N Engl J Med 2014; 370:1198-1208 March http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleTop

Page 134: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Magill - Prevalence of HAI

Results: (504 infections) • Device associated (VAP, CAUTI, CLABSI) = 25.6% • Estimated HACs in acute hospitals in one year = 721,800

Magill, S., Edwards, J., Bamberg, W. et al. “Multistate Point-Prevalence Survey of Health Care–Associated Infections” N Engl J Med 2014; 370:1198-120 2014 http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleTop

Page 135: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Magill – Prevalence of HAI

Clostridium difficile 12.1% Staphylococcus aureus 10.7% Klebsiella pneumoniae* 9.9% Escherichia coli 9.3% Enterococcus species 8.7%

*or K. oxytoca

Magill, S., Edwards, J., Bamberg, W. et al. “Multistate Point-Prevalence Survey of Health Care–Associated Infections” N Engl J Med 2014; 370:1198-1208 http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleTop

Causative Pathogens:

Page 136: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Magill – Prevalence of HAI

Causative Pathogens:

Pseudomonas aeruginosa 7.1% Candida species 6.3% Streptococcus species 5.0% Coag (-)staphylococcus 4.8% Enterobacter species 3.2%

Magill, S., Edwards, J., Bamberg, W. et al. “Multistate Point-Prevalence Survey of Health Care–Associated Infections” N Engl J Med 2014; 370:1198-1208 http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleTop

Page 137: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Bacteria of particular and increasing interest:

• Clostridium difficile - Causes severe diarrhea

- Related to antibiotic use

• Methicillin-resistant Staphylococcus aureus (MRSA) - 94,000 cases of serious MRSA infections per year

- 18,650 deaths per year

AHRQ “Health Care-Associated Infections,” PSNet. Agency for Healthcare Research and Quality(AHRQ). http://www.psnet.ahrq.gov/primer.aspx?primerID=7

AHRQ. “Methicillin-Resistant Staphylococcus aureus.” Web M&M. http://www.webmm.ahrq.gov/perspective.aspx?perspectiveID=57

Page 138: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

700,000 – 1 Million hospitalized Patients fall each year.

11,000 hospital falls result in death each year.

Currie L.” Fall and injury prevention. In: Hughes RG., ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses.” (AHRQ Publication

No. 08-0043). Rockville, MD: Agency for Healthcare Research and Quality; 2008;. http://www.ahrq.gov/qual/nurseshdbk/docs/CurrieL_FIP.pdf.

Accessed May 26, 2014

Page 139: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Hospital Falls:

30-35% result in injuries.

LOS increased by 6.3 days.

Cost per fall = $14,056.

• DuPree, E. Fritz-Campiz, A. ,Musheno, D. “A New Approach to Preventing Falls With Injuries” Journal of Nursing Quality of Cqre. April/June , 2014. V. e29. Issue 2. PP 99-102 • Joint Commission Center for Transforming Healthcare. “Facts about the Preventing Falls With Injury Project.” Joint Commission. 4/14 • Wong, C., Recktenwald, A., Jones, M., et. al. “The Cost of Serious Fall-Related Injuries at Three Midwestern Hospitals.” The Joint Commission Journal on Quality and Patient Safety. Volume 37, Number 2, February 2011 .

Page 140: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Joint Commission Center for Transforming Healthcare:

7 U.S. Hospitals.

Identified causes of falls, created targeted solutions > intervention.

• DuPree, E. Fritz-Campiz, A. ,Musheno, D. “A New Approach to Preventing Falls With Injuries” Journal of Nursing Quality of Cqre. April/June , 2014. V. e29. Issue 2. PP 99-102 • Joint Commission Center for Transforming Healthcare. “Facts about the Preventing Falls With Injury Project.” Joint Commission. 4/14

Page 141: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Examples of targeted solutions: Utilizing a fall assessment tool

Partnering with patients (teach safety)

Hourly rounding

Video monitoring

Scheduled toileting

Patient sitters if necessary

• DuPree, E. Fritz-Campiz, A. ,Musheno, D. “A New Approach to Preventing Falls With Injuries” Journal of Nursing Quality of Cqre. April/June , 2014. V. e29. Issue 2. PP 99-102 • Joint Commission Center for Transforming Healthcare. “Facts about the Preventing Falls With Injury Project.” Joint Commission. 4/14

Page 142: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Results of Intervention:

35% reduction in falls (4 falls/ 1,000 pt. days to 2.61 falls/ 1,000 pt. days).

62% reduction in falls with injury

(1.31 falls-injury/1,000 pt. days to 0.50 falls-injury/1,000

pt. days).

• DuPree, E. Fritz-Campiz, A. ,Musheno, D. “A New Approach to Preventing Falls With Injuries” Journal of Nursing Quality of Cqre. April/June , 2014. V. e29. Issue 2. PP 99-102 • Joint Commission Center for Transforming Healthcare. “Facts about the Preventing Falls With Injury Project.” Joint Commission. 4/14

Page 143: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Interim Data Summary:

Agency for Healthcare Research and Quality (AHRQ)

Preliminary estimates for 2015 show a 21% decline

in Hospital-Acquired Conditions (HACs) since 2010

National Scorecard on Rates of Hospital-Acquired Conditions 2010 to 2015: Interim Data From National Efforts To Make Health Care Safer. Content last reviewed December 2016. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/pfp/2015-interim.html

Page 146: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths

Declines in Hospital-Acquired Conditions from 2014 to 2016. Content last reviewed August 2018. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/data/infographics/hac-rates-decline.html

Page 147: By Arnold Mackles, MD, MBA, LHRMYear 2015 Annual CRICO Report. The Risk Management Foundation of the Harvard Medical Institutions Inc. “ommunication failures linked to 1,744 deaths