SIA Root Cause Analysis

Linda Ohler. MSN, RN, CCTC, FAANQAPI and Regulatory Manager, George Washington University, D.C

Cassandra Smith Fields. MSN, MBA, RNAdministrative Director Transplant, Phoenix Children’s Hospital, Phoenix, AZ

Tim Stevens. BSN, RN, CCTCTransplant Administrator, Providence Sacred Heart Medical Center &

Children’s Hospital, Spokane, WA

Lessons learned from Reviewing Program RCA’s

Objectives

Differentiate Root Cause Analysis from Morbidity and Mortality Reports

Describe three challenges in defining and implementing RCAs in transplant programs

Analyze the demonstration of a Root Cause Analysis

AgendaOverview

Root Cause Analysis (RCA) and SIA evaluation

RCA’s in the hospital and the transplant center

Sample RCA Tools

Case Study

Other Methods for RCA

Performance Improvement Tools

OVERVIEW

Motto for Root Cause Analysis

If you lose the patient or lose the graft….do not lose the lesson

Thomas E. Hamilton

Director, Survey & Certification

Centers for Medicare & Medicaid Services

What’s in a Name?Morbidity and Mortality Review

Surgeon Summary

Case Review

Causal Analysis

Root Cause Analysis

RCA & SIA Evaluation

What does CMS ask for in an SIA?

Review the program’s causal analysis of patient deaths and graft failures during the most recent 36-months. The in-depth analysis should include at a minimum:

SIA RCA Requirements The factors associated with these deaths and graft

failures as well as an analysis of other adverse events that the Independent Peer Review Team considers relevant to the causal analysis of the graft or patient survival outcomes data

Review the transplant program’s own analysis of the root causes of the deaths or graft failures to evaluate the thoroughness and comprehensiveness of the analysis and the identification of all systemic factors, including, but not limited to, human factors, technical issues, equipment factors, communications systems, and policies and procedures missing or not followed

Evaluation of any trends or patterns in the factors associated with the deaths or graft failures

RCA Contributing Factors Analysis of program activities across all three phases

(pre, during, and post) of transplantation including: Staffing levels and training: Numbers and skills across

disciplines sufficient to adequately meet the needs of patients;

Patient selection criteria: The content, its application and efficacy, and the program’s adherence to its selection criteria;

Donor selection criteria: The content, its application and efficacy, and the program’s adherence to donor selection criteria;

Wait-list management: Effectiveness of policies and procedures, obtaining updated evaluations, routine candidate follow-up, and review of candidate status changes;

RCA Contributing Factors Surgical protocols: Effectiveness of protocols and systems

to develop policies and protocols (i.e. are there effective systems to research and base practices on current practice evidence);

Multi-disciplinary care: Evaluate if care is provided in a multi-disciplinary manner allowing input from all specialty areas during all three phases of transplantation and including but not limited to – transplant surgeons, physicians, transplant coordinators, transplant administrator(s), nurse(s), social worker(s), dietitian(s) and pharmacist(s) and other important disciplines such as anesthesia and cardiology;

Program’s policies and procedures: Analysis of program policies, procedures, and protocols to identify possible opportunities for improvement; and,

Post-transplant follow-up: Assess whether post-transplant follow-up care is provided in a safe, timely, and effective manner.

Contributing Factors by Discipline

Discipline Phase Reference

Contributory Factors / Root causes

MD/Surgeon/SWTC/FC/Pharm

Referral/Eval/Waitlist/Peri/

Post

Policy/ProcedureGuid

eline/Benchmark

Missing require-ment

Patient

Individual Staff

Team and/or Com-

mittee

Out-side

Source

Educa-tion and

training

Equip-ment /

Resource

Communi-cation

Working Conditio

n

Organizational and

strategic

                   

   

   

   

   

   

                     

   

   

   

   

   

                     

   

   

Contributing FactorsCase # 1 2 3 4 5 6 7 8 9 10

Donor ID                    

Date of Transplant                    

Recipient Initials                    

Communication                    

Immunosuppression                    

Donor Selection                    

Recipient Selection                    

Waitlist Mgmt                    

Surgical Protocols/Technical

                   

Infection                    

Follow Up Care                    

Psychosocial                    

Policies and Procedures                    

VAD                    

RCA’s in the hospital and the transplant center

The Alphabet Soup Sentinel Events

Adverse Events

Safety Event

Near Miss

Serious Safety Event

Start at the beginning

COP’s for TransplantX102 (b) Standard: Adverse Events

A Transplant Center must establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case. These policies must address the process for the identification, reporting, analysis, and prevention of adverse events

(Interpretive Guideline) Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk therof

The Big 4Serious medical complications or death caused

by living donation

Unintentional transplantation or organs of mismatched blood types

Transplantation of organs to unintended recipients

Unintended transmission of infectious disease to a recipient

X103 (2) The transplant center must conduct a

thorough analysis of and document any adverse event Interpretive Guideline: A “thorough analysis” is

expected to include (but are not limited to): A description of the key facts of the event..the

severity of the event, and how the patient was affected

A review of whether or not similar events have occurred

An analysis of related systems and processes that contributed to the events occurrence..Human Factors, Environment, Equipment, Policies, Procedures, Organizational

X104And must utilize the analysis to effect

changes in the transplant center’s policies and practices to prevent repeat incidents

Focused QAPI goes on to ask the following: Are there written adverse event (AE) policies and

procedures specific to transplant?

Are AE’s evaluated according to policies and procures?

Can transplant staff describe what is meant by an adverse event (AE) in transplant?

Can transplant staff explain how and/or to whom they report an adverse event (AE)?

Does the hospital/program employ methods, in addition to staff incident reporting, to identify possible adverse events?

Can the program provide evidence that adverse events identified through staff reports are being addressed?

Focused QAPI continued:Does the written AE policy address the

following communication and reporting structures?: For each organ type Staff reporting and communication methods within

the transplant program and hospital Process for disclosure of AEs to the patient/family Process and timeline for reporting adverse events

to required public, state and federal agencies Is there evidence that the transplant program has

adopted policies supporting a non-punitive approach to staff reporting of events and situations they consider unsafe?

Focused QAPI continued: Does the written policy address/categorize the severity of

events that are tracked and analyzed?

Does the program have a defined analysis method/process for AE? Who What Actions taken to prevent similar events Method for follow up

Describe which method(s) will be utilized to analyze AE?

Has the program/hospital conducted any causal analyses in the past 24 months?

Did the analysis of the adverse event address all appropriate areas across the continuum of care?

Now ask yourself the following: Is death and graft loss within the first year an

Adverse Event?

Should these events be subject to the same level of analysis as the Big 4?

If you are subject to an SIA – how will you ensure that your deaths and graft losses have a “root cause analysis”

Then do your research:

What is your organization’s Safety Event, or Incident Reporting Policy?

Read the definitions

Common Definitions Safety Event: A deviation from generally

accepted practice or process that includes near misses, precursor safety events and serious safety events

Near Miss: A deviation in generally accepted practice that passes through error detection barriers and does not reach the patient because it is caught by a detection barrier designed into the system or by change or barrier not designed into the system, sometimes referred to as a Good Catch or Close Call

Common Definitions ContinuedPrecursor Safety Event: A deviation from

generally accepted practice or process that reaches the patient and causes no harm, no detectable harm, minimal temporary harm or minimal permanent harm

Serious Safety Event: A deviation from generally accepted practice or process that reaches the patient and causes harm that includes moderate temporary harm, severe temporary harm, moderate permanent harm, severe permanent harm and death

Common Definitions ContinuedSentinel Event: An unexpected occurrence

involving death or major permanent loss of limb or loss of function (including recognized complications) such as serious sensory, motor, physiological or psychological injury, or the risk thereof, not related to the natural course of the patient’s illness or underlying condition and not present on admission, requiring continued treatment or lifestyle change

Safety Event

Near Miss

Precursor Safety Event

Serious Safety Event

Sentinel Event

Death of a Living Donor

Unintentional transplant of a B Liver into an O recipient

Transplant of organs to unintended recipients

Transmission of Rabies to a recipient from a deceased donor

Death of a tx recipient in the OR

Loss of a kidney graft at day 265

Tools to analyze and review eventsApparent Cause Analysis: A limited investigation

of an event that may be performed instead of a root cause analysis that identifies inappropriate acts and detects weaknesses in systems and processes and results in implementation of remedial corrective actions

Common Cause Analysis: An aggregating analysis of safety events to identify process or cultural problems leading to events. The goal is to identify elements that contributed to the known events and select behavior-based expectations and error prevention techniques for staff to reduce human error and safety events

Tools ContinuedProtected Case Review: A conference held

under case review protection where a case is presented and discussed for the purpose of education and system improvement

Root Cause Analysis: Process for identifying the factors that underlie variation in performance that focuses primarily on systems and processes, not on individual performance. The analysis identifies potential improvements in theses processes or systems that would tend to decrease the likelihood of such events in the future or determines, after analysis, that no such improvement opportunities exist

RCA’s allow us to: Implement a corrective action

Track the change

Determine if the change is effective

Demonstrate the effective change is sustainable

Establish a system to prevent the problem from occurring again

Challenges with using RCA’s Hospital policy often prescribes when an RCA

methodology can be utilized

Done in accordance with Joint Commission guidance and hospital policy – very labor intensive and time consuming

Requires the time and effort of hospital resources

Morbidity and Mortality

Morbidity refers to the state of being diseased or unhealthy within a population

Mortality is the term used for the number of people who die within a population

A retrospective review of a case evaluating the physiologic and pathologic causes of either death or illness

M&Ms report on a single case Discussion among colleagues States what you think may have happened Usually does not involve a comprehensive data analysis

RCA’s for transplantMay or may not be a sentinel event

Should always be more than an M&M

Utilizes components of the RCA methodologies

May not require reporting to TJC

Is not discoverable

Must be doable

Suggestions The Big 4

Sentinel Events and referred to Hospital for full RCA Hedge on transmission of disease?

Death of a transplant recipient in the OR Serious Safety Event Quality will direct methodology – probably protected

case review or some level of RCA

Death or graft loss within the first year post transplant Serious Safety Event? Defined Apparent Cause Analysis tool specific to

transplant with MDT review

Be Reasonable UCLA

Liver Expect 27 graft losses in adults and 4 in peds Expect 16 patient deaths in adults and 1.5 in peds

Kidney Expect 12 graft losses in adults and .79 in peds Expect 3.7 patient deaths in adults and 0 in peds

Heart Expect 3.42 graft losses in adults and .56 in peds Expect 2.97 patient deaths in adults and .62 in peds

Lung Expect 5.62 graft losses in adults Expect 4.98 patient deaths in adults

Plus pancreas and intestine

If your Observed Events are increasingBefore you become O>E

Start converting the graft losses and/or death analysis to a more robust RCA process

If you are going to flag Go back and do the more robust RCA process on

all graft losses and/or deaths in the cohort

Always, always Track your events in QAPI and evaluate for trends

Root Cause Analysis

What are the goals of RCA?

Determine the best approach to preventing adverse events Not a tool for punishment

of individuals Avoid culture of blame Build a culture of safety.

Identify what can be done to prevent the adverse event or near miss from occurring again

Measure and track outcomes based on changes made.

Important concepts in RCAAvoid culture of blame

Focus on systems issues

Lessons learned: if you lose the patient/graft, do not lose the lesson

Three Common Mistakes: Assuming!

Assuming you know what the problem is without seeing what is actually happening.

Assuming you know how to fix a problem without finding out what is causing it.

Assuming you know what is causing the problem without confirming it.

Demonstration of an RCA

The Joint CommissionROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

Template has 24 analysis questions

Provides a template for answering the analysis questions

Aids organizing the steps in a root cause analysis. Not all questions will apply in every case and there may be findings that emerge during the course of the analysis.

Be sure however to enter a response in the “Root Cause Analysis Findings” field for each question #

For each finding continue to ask “Why?” and drill down further to uncover why parts of the process occurred or didn’t occur when they should have.

Significant findings that are not identified as root causes themselves have “roots”.

Case Report

September 2010

35 year old mother of 3, healthy until this event. Allergies to Vancomycin and Heparin.

Two weeks after birth of third child she experience severe chest pain and was taken to a local hospital

Diagnosis was dissection of 3 coronary arteries

Put on by pass but could not come off

Placed on Impella pump and transferred to a hospital with a heart transplant program.

9/12 Implanted with BiVad Required 51 units of PRBCs, 3 units platelets and cryo and 14 units of

FFP

9/23 Listed for heart transplantation

Time Line

9/24/2010 Began vaginal bleeding

9/27 D& C done followed by bilateral uterine artery embolization, intrauterine balloon and partial hysterectomy on 10/16

11/26 discharged home, Bilirubin 4.6

1/18/2011 admitted for fibrin in pump, on heparin, discharged in 11 days on Coumadin

2/2 admitted for anemia, GI bleed, Coumadin adjusted

2/15 admitted for fibrin in pump

4/18 admitted for GI Bleed 5/9 admitted for GI bleed 8/18 admitted for GI bleed, 3

units PRBC 12/15 admitted for GI bleed 3/30/2012 Bilirubin rising 7-

8, Renal insufficiency, PRA 98% Heart offer. Donor and recipient crossmatch negative

3/31/2012 transplant (12 hours in surgery)

Time Line

Heart transplant complications 31 units PRBC, 8 Cryo, 60 platelets, 19 FFP 15 minutes of circulatory arrest

Induced hypothermia Difficulty extracting VAD due to adhesions 3rd chest surgery in 18 months

Wound dehiscence, muscle flap Dialysis required starting on day 4 post op Day 9 developed multiple DVTs, positive urine culture Hypotensive, required vasopressors

Developed dry gangrene of both feet Day 26 trached/respiratory failure MSOF 6 weeks post transplant CT of head revealed CVA Patient expired

Most pertinent TJC questions

What were the factors involved?

Length of time on pVAD

?Possible right heart failure (elevated liver enzymes, ascites)

Renal insufficiency

Fibrin clots in VAD

Blood transfusions during implant of pVAD

Multiple blood products during transplant

15 minutes of Circulatory arrest

Immunocompromised

Infections post transplant

Persistent Hypotension requiring vasopressors

Dialysis post transplant

5 Whys

What is the real problem? What is the root cause? Ask why 5 times

Purpose –to discover the root cause

Why did heart transplant surgery require 15 minutes of circ arrest? Surgeons unable to visualize anatomy Severe bleeding during removal of pVAD On coumadin for 18 months Tissue growth around device

Cells adapt to device and grow around it

5 why’s Why was she on a pVAD for 18 months?

Why was she not sent to another facility? Why was she not put on a TAH? Was she still a transplant candidate?

Why did she develop a fungal infection?

Root CauseLength of time on pVAD

Patient selection

Corrective Action Plan

Writing a corrective action plan

Action 1Length of time on pVAD

Not able to control due to availability of suitable hearts for transplantation

Consider transferring complex patients to a larger heart transplant program

Change from pVAD to TAH*

Action 2Patient selection

Develop risk assessment tool Present risk assessments on each patient referred for heart

transplantation Monitor risks for each patient listed for one year to determine

effective use of risk assessment tool Was she still a transplant candidate?

Tracking Demonstrate Sustainability

Tracking ChangesCollect data on changes in action plans

Audit

Analyze and report

Demonstrate sustainability Run Chart

Assuring Effective ChangesAction steps are designed to prevent or correct problems

through the RCA process

Must provide a sound rationale if no changes are made to policies, protocols or procedures/practice

Change must be communicated to staff when implemented Need to maintain documentation of this communication Must measure changes to demonstrate sustainability

Remember QAPI is a continuous process

Tools for performance improvement

Tools for Improving problemsFailure Modes and Effective Analysis (FMEA)

Cause and effect More prospective in prevention

Define, Measure, Analyze, Improve, Control (DMAIC)

Plan, Do, Study/Check, Act (PDSA)

Performance Improvement ToolsFlowcharts

Cause and Effect Diagram Fishbone Pareto Chart

PDCA

Created by Shewhart in the 1930s

Popularized by Deming first in Japan in the 1950s.

At the core of all quality systems.

The foundation for A3

IHI Model for Improvement

Any Questions?