Quality and Patient Safety in

Respiratory CareCindy Bravo-Sanchez, PhD, MPA, BSRT, RRT-NPS

Lecture Objectives Discuss the six domains of quality care from the

Institute of Medicine (IOM)

Discuss the characteristics of a high reliability organization

Review and demonstrate quality improvement tools and methodologies

Institute of Medicine (IOM) Domains of Quality Care

Safe care: Avoiding harm to patients from the care that is intended to help them.

Effective care: Providing evidence-based care to all who could benefit, and refraining from providing services to those not likely to benefit (avoiding underuse and misuse, respectively).

Patient-centered care: Providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.

Timely care: Reducing waits and sometimes harmful delays for both those who receive and those who give care.

Efficient care: Avoiding waste, including waste of equipment, supplies, ideas, and energy.

Equitable care: Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.

Institute of Medicine. (2001). "Crossing the quality chasm: A new health system for the 21st century". Washington, D.C.: National Academy Press. doi:10.17226/10027

High-Reliability Organizations (HRO) in Healthcare

High risk industries – All efforts towards reaching a state of zero failures When applied to healthcare: care that is safe, equitable, effective, efficient, timely and

patient-centered.

5 characteristics of HROs: Preoccupation with failure – Always monitoring for possible threats to safety (pts., staff,

etc.) Sensitivity to operations – Recognize early indicators of threats to organizational

performance Reluctance to simplify – Resist the temptation to simplify observations – Threats to safety

may be complex Commitment to resilience – Recognize and contain errors, avoiding harm Deference to expertise – Include knowledgeable experts (including front line staff) in

order to find a solution

Weick, K.E., and K.M. Sutcliffe. 2007. Managing the Unexpected. 2nd ed. San Francisco: Jossey-Bass.

High-Reliability Organizations (HRO) in Healthcare

HROs stay safe by:

Creating an environment of collective mindfulness – All workers monitor and report problems/unsafe conditions early (easier to fix), before they become substantial threats to patients and the organization.

Creating an inclusive/safe environment – No tolerance for intimidating behaviors within or between teams (including team leaders and front line staff). This helps to increase reporting of safety concerns and avoids the perpetuating of unsafe conditions.

Practicing transparency – Errors should be seen as valuable information and essential to a hospital’s ability to improve patient safety. No news is bad news when it comes to occurrence reporting.

Chassin, M, Loeb, J., 2013, High – Reliability Health Care: Getting There from Here, The Milibank Quarterly, 91.3. Wiley Periodicals Inc.

High-Reliability Organizations (HRO) in Healthcare

Transitioning healthcare organizations towards high reliability requires: Leadership’s commitment to zero harm

Incorporation of an organization-wide culture of safety

Widespread implementation of process/quality improvement tools and methods

Chassin, M, Loeb, J., 2013, High – Reliability Health Care: Getting There from Here, The Milibank Quarterly, 91.3. Wiley Periodicals Inc.

Process/Quality Improvement Methodologies

Change Management – Assisting people with organizational change Planning for change (communication) Managing change (communication, training) Reinforcing change (communication, resistance

management)

PDSA/PDCA – Plan, Do, Study/Check, Act

Lean – Six Sigma DMAIC – Define, measure, analyze, improve, control DMADV – Define, measure, analyze, design, verify Reduce errors/costs and waste/inefficiencies: Continuous rapid quality performance improvement

IHI – Institute for Healthcare ImprovementNAHQ – National Association for Healthcare Quality

Process/Quality Improvement Tools

SMART goals

Plan-Do-Study-Act worksheet

Lean – A3 Improvement plan

Project planning form

Failure Modes + Effective Analysis

Process map (flow chart)

Cause and effect diagram

Run chart and control chart

Organize your Improvement Project

Evaluate and Analyze the

Problem and Solution

Failure Modes and Effective Analysis (FMEA)

A systematic, proactive analysis of a process in which harm may occur Evaluate a new process, or

A proposed change to an existing process

Prioritize improvement needs

ihi.org/ImprovementCapability

FMEA• List all steps in the process

Steps in process:

• What could go wrong?Failure mode

• Why would the failure happen?Failure Effects

• *What would be the consequences of the failure? (1 – 10)Likelihood of occurrence

• *What is the likelihood the failure will occur? (1 – 10) Likelihood of detection

• *Likelihood that the failure mode (if it occurs) will cause severe harm (1 – 10)Severity

• Multiply each *failure mode togetherRisk profile number (RPN)

• List possible actions to improve safetyActions to reduce occurrence of failure

ihi.org/ImprovementCapability

FMEA: External Patient Transport

Steps in process:

Failure mode

Failure Effects

Likelihood of occurrence (1 – 10)

Likelihood of detection (1 – 10)

Severity

(1 – 10)

Risk profile number (RPN)

Actions to reduce occurrence of failure

Initial report (diagnosis,vent settings, etc.)

Preparing transportventilator for use (test)

Inaccurate report

Nurse-to-nurse-to-RT verbal hand-off

Consequences:Hyper/hypocarbia, hypoxia, pneumothorax, atelectasis

10

Chance of using Inappropriate vent settings

5 8 = 400

Implement standardized electronic report tool viewable by all (ex. SBAR)

Ventilator not tested prior to use

Ventilator may malfunction while in use

Consequences:hypoxemia, hypercarbia, death

10

Chance of ventilator malfunction or failure

5 5

Chance of severe harm

= 250

Competencies: Implement pre-post transport electronic check-off tool

Total RPN = 650

Compare to other FMEAs

Chance of severe harm

FMEA – Risk Profile Number Comparisons

FMEA RPN

External patient transport 650

Unplanned extubations 850

E-cylinder access and storage 600

Holter monitoring 600

ICU RC supplies 500

Emergency room assignment 650

NICU Bedside PDA Ligation 700

SMART Goals: Unplanned Extubations Specific: Which goal is most specific?

Reduce intensive care unit complications

Reduce unplanned extubations in the PICU to zero within 6 months

Measureable: Which measure will best help to target the outcomes?

Measure each occurrence in real-time using a collection tool designed specifically for the occurrence

Measure each occurrence based on standard electronic record documentation

Actionable: Which actions will best support the specific goal?

Rapid weaning protocol developed and implemented by a multidisciplinary team

Medical staff, nurses and respiratory therapists will be educated regarding the protocol

Respiratory therapist will collect and report the occurrence data

Rapid weaning protocol developed and implemented by one department

Nursing and respiratory therapy receive an email with the protocol

Nursing and respiratory therapy document any occurrences independently

Relevant: Which one of these statements helps to support the specific goal?

There is a clear gap in care since 6% of patients experience unplanned extubations

The average length of stay is 30 days

Time bound: Which one of these statements best supports the specific goal?

The goal will be achieved over the next 4 years, with bi-weekly, monthly, and quarterly meetings

The goal will be achieved over two weeks, with weekly meetings and final report at end of week 2www.decisionskills.comSadowski R, Dechert R. Bandy K, Juno J, Bhatt-Mehta V, Custer JR, et al. Continuous quality improvement: Reducing unplanned extubations in a pediatric intensive care unit. Pediatrics 2004:1.14(3): 628-32

Process Map (Flow chart) Visual presentation of all the steps in a process Current (where are the opportunities to improve?)

Future (what would be the ideal process?)

Involve frontline staff Most healthcare processes are multidisciplinary

ihi.org/ImprovementCapability

Process Map (Flow chart)Current

Randolph, A. G., Wypij, D., & Venkataraman, S. T. (2002). Effect of mechanical ventilator weaning protocols on respiratory outcomes in infants and children: A randomized controlled trial. Journal of the American Medical Association, 288(20), 2561-2568. doi:10.1001/jama.288.20.2561

Ventilated patients

Wean?

Physician’s discretion

9 vent modes

No management recommendations

made

3 or more mode changes

Pressure support 43.3%

Pressure control w/PS

67%

Extubationswith set rate

Process Map (Flow chart)

Future (Ideal)

Therapist-driven protocol

Faster ventilator weaning

Decreased ventilator days

Haas, C. F., & Loik, P. S. (2012). Ventilator discontinuation protocols. Respiratory Care, 57(10), 1649-1662. doi:10.4187/respcare.01895

Cause and Effect (Fishbone) Diagram

People

Policy Environment

Equipment

Staffing

Results/Outcome

(Problem)

Communication

https://www.cms.gov/medicare/provider-enrollment-and-certification/qapi/downloads/fishbonerevised.pdf

Cause and Effect (Fishbone)Prolonged Intubation

Gutsche, J. T., Erickson, L., Ghadimi, K., Augoustides, J. G., Dimartino, J., Szeto, W. Y., & Ochroch, E. A. (2014). Advancing extubation time for cardiac surgery patients using lean work design doi:https://doi.org/10.1053/j.jvca.2014.05.024

Quality and Patient Safety Measures (Data)

Measuring, analyzing, and reporting quality data helps you to: Track the quality of health care services that we provide. Ensure that a health care process/system is delivering effective,

safe, efficient, patient-centered, equitable, and timely care. Examine many aspects of patient care, including:

Patient and family engagement Patient safety Care coordination Population/public health Efficient use of healthcare resources Clinical process/effectiveness

(The Joint Commission Center for Transforming Healthcare, Centers for Medicare & Medicaid Services)

Run/Control Chart Graph of data over time

Determine if changes to processes are leading to improvement

Variations Common-cause (natural or expected)

Special-cause (causes not inherent in the process)

ihi.org/ImprovementCapability

Run Chart

ihi.org/ImprovementCapability

Control Chart

ihi.org/ImprovementCapabilityhttps://www.youtube.com/watch?v=zvp8qmH3Eos

Upper control limit (UCL) +3 Stdev from the mean

Lower control limit (UCL) -3 Stdev from the mean

Average

Run ChartP

eds

CIC

U U

npla

nned

Ext

ubat

ion

Rat

e per

100

Ven

tila

tor

Day

s

Kaufman, J., Rannie, M., Kahn, M. G., Vitaska, N., Wathen, B., Peyton, C., . . . Dobyns, E. (2012). Interdisciplinary initiative to reduce unplanned intubations in pediatric critical care units. Pediatrics, 129(6), 1594-1600. doi:10.1542/peds2011-2642

# UEX x 100 = Rate of UEX# ventilator days

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

1/2009 4/2009 7/2009 10/2009 7/20101/2010 4/2010 10/2010 12/2010

. . . . . . . .

..

. .

.

. ..

. . ..

.Baseline Median

Goal

Months

. .

RT RetapingPolicy

Systematic Review Sheet Implementation

CICU White Board Daily Use

Hand-off ProtocolBaseline

Control ChartP

eds

CIC

U U

npla

nned

Ext

ubat

ion

Rat

e per

100

Ven

tila

tor

Day

s

Kaufman, J., Rannie, M., Kahn, M. G., Vitaska, N., Wathen, B., Peyton, C., . . . Dobyns, E. (2012). Interdisciplinary initiative to reduce unplanned intubations in pediatric critical care units. Pediatrics, 129(6), 1594-1600. doi:10.1542/peds2011-2642

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

1/2009 4/2009 7/2009 10/2009 7/20101/2010 4/2010 10/2010 12/2010

. . . . . . . .

..

. .

.

. ..

. . ..

.

Goal

Months

. .

RT RetapingPolicy

Systematic Review Sheet Implementation

CICU White Board Daily Use

Hand-off Protocol

Upper control limit

(UCL)

Mean 0.74

Mean 0.44

Upper control limit

(UCL)

Pre-implementation Implementation

Post-implementation

PDSA Plan-Do-Study (Check)-Act

Process for testing a change Plan – Develop a plan

Purpose/SMART goal of the test; prediction of the outcome; cause and effect diagram

Who? What? When? Where? Data to be measured (observations, EMR report)

Do – Test the plan Document unexpected occurrences (flow chart) Collect data during test (process measures)

Study (Check) – Observe/analyze test process and outcomes Expected/ideal outcomes compared to actual outcomes (run/control chart)

Act – Decide if modifications are needed prior to next cycle Repeat until all agree on change outcomes Expected/ideal outcomes compared to actual outcomes Review results and decide whether to adopt, adapt, or abandon new process changes

ihi.org/ImprovementCapability

PDSA WorksheetQuestion Your PlanWhat is your planned change?

What outcome do you predict?

When will you implement the change?

Where will you implement the change?

Which patients will be involved?

Who will implement the change?

How will you measure the change?

How will you help the team track the change?

American College of Physicians - https://edhub.ama-assn.org/steps-forward/module/2702507Sadowski R, Dechert R. Bandy K, Juno J, Bhatt-Mehta V, Custer JR, et al. Continuous quality improvement: Reducing unplanned extubations in a pediatric intensive care unit. Pediatrics 2004:1.14(3): 628-32

Our planned change is: To reduce the number of unplanned extubations/dislodgements (UEX)Action plan 1: Assemble and train multidisciplinary team Action plan 2: Expedited weaning protocolAction plan 3: Standardized sedation protocol

Our predicted outcome is: UEX rates will be reduced with the implementation of all action plans

We will implement the change in the following time frame: Phase I: 2 yrs. of pre-protocol data capture; Cause and effect; Development of action plansPhase II: 1 yr. implementation of all action plansPhase III: 1 yr. of analysis-tracking trends – improvement cyclesPhase IV: Post-protocol data capture and communication of findings

We will implement the change in the following location: PICU

We will involve the following patient population: All patients requiring an artificial airway (Orotracheal, nasotracheal, or tracheostomy) will be monitored for any UEX occurrences

The following team members will implement the change: Medical staff, nursing, respiratory care

The following members will be involved in measuring the change by: UEX per 100 days, by age group (Little et al, 1990); RTs will track UEX details (data form used): Root cause analyses

We will track and communicate the results of our planned change by: Bi-weekly, monthly, quarterly meetings

PDSA WorksheetPlan Do Study Act

https://edhub.ama-assn.org/steps-forward/module/2702507

To reduce the number of unplanned extubations/dislodgements (UEX)Phase I: 2 yrs. of pre-protocol data capture; Cause and effect; Development of action plans

Phase II: 1 yr. implementation of all action plans: Action plan 1: Assemble and train multidisciplinary team Action plan 2: Expedited weaning protocolAction plan 3: Standardized sedation protocol

Phase III: 1 yr. of analysis-tracking trends –improvement cycles (focused PDSA cycles)

Results reviewed and the decision was made to adopt the new protocols

Lean – A3Process Improvement Plan

3. Future StateIdeal process (process

map)/outcome (benchmark/target measures)

2. Current StateProcesses (process map), policies, quality metrics?; What can be improved?

1. Reason for Action

Identify issue (SMART goals)

6. Run PilotPilot new process; multiple PDSAimprovement cycles: Who, what when, where, how; quality data

5. Possible Solutions

Best attainable solution; New process (process map)

4. Present Gaps

Cause and effect, 5 whys; Challenges to ideal outcome

9. Continuous Monitoring for Sustainment

Plan for initial and long-term monitoring of system (data);

Feedback loop for all stakeholders

8. Evaluate Outcomes

Expected vs. unexpected outcomes (graphs, run/control charts)

7. Wide Implementation

Stepwise implementation: Unit by unit, floor by floor; feedback loop

https://edhub.ama-assn.org/steps-forward/module/2702507#resource

Project planning formTeam: Nancy, Chris, John Project: Reduce unplanned extubations in the PICU to zero within 6 months

Drivers (planned improvements in process)

Process Measures (data collectedto monitor the improvement steps)

Goal (Outcome data measures monitor the end result of the improvement)

1. Protocol education RTs, RNs, Medical staff

% of pediatric ICU staff will have documented use of education materials.

90% of Peds ICU staff will have documented used of education materials

2. Documentation of UEX events % RTs educated on UEX event documentation

90% of RT Peds ICU staff will have documented education for UEX event data collection

3. Peds ICU white board daily use # days of white board daily use (Unit director)

All improvement implementation dayswill be tracked for white board use –documentation sheet by unit director

4.

Driver # Change Idea Tasks to Prepare for Tests

PDSA LeadPerson

Timeline (T=Test; I=Implement; S=Spread)

Week

1 2 3 4 5

1. Video; pamphlet Coordinate with IT and education department

Staff will be provided with link; pamphlets

Nancy T I S

2. RT schedule for training

Reserve training space and print Ed. material

Schedule training sessions

Chris T I S

3. White boards in PICU and CICU

Purchase and request wall mounting

White board implementation

John T I S

ihi.org/ImprovementCapability

Final Points Always include front line staff representation in all stages of an

improvement project

Include all departments involved in the process in question

Communicate with all stakeholders regarding planning, implementation, and monitoring.

Include feedback from all levels of the organization

Encourage occurrence reporting (incl. near-miss, good catches)

Transparency regarding quality metrics

Close the loop

Improvement efforts never end

Spread mindfulness of quality improvement and patient safety

Thank you!Questions?