Root Cause Analysis (RCA)

Instructors Guide and Exercise

John Gosbee, MD VA National Center for Patient Safety

<John.Gosbee@med.va.gov> 734-930-5893 www.patientsafety.gov

##### Background and Rationale

Most introductory training efforts in patient safety include a section
where teams analyze patient safety case studies. Many of the recurring
columns in medical journals about patient safety are essentially case
studies with reflection and root causes analysis. We at the VA National
Center for Patient Safety began our efforts by developing and
implementing an RCA method. Thus, we have a mountain of lessons learned
and training material (Bagian, et al 2001) that resulted in the guidance
below. Most RCA teams fail unless the tools presented below are used.
This is a human and team decision making issue, not unique to healthcare
learners or practitioners.

In other words, the "cognitive aids" of the five rules of causation and
the Triage Questions are a necessary part of introductory training. This
avoids a superficial treatment of the case studies and concrete tools to
help them lead teams in the future.

Many people (Columbia VA, Dartmouth) have had positive experience when
they tried this small group RCA exercise. In one version, groups of
residents do an abbreviated root cause analysis of one case study. They
are then taught about RCA triggering questions (similar to ROS) and the
5 rules of causation. The same teams then analyzed a second case study.
In another version, the team leader is prepared with the case and
references to read weeks ahead of time. Then teams are asked to focus on
one area of the case during a 1-2 hour small group RCA simulation.

##### Objectives

1\) Create teachable moment for systems thinking

2\) Introduce them to a tool/process that they will be part of in the
future

3\) Demonstrate common pitfalls when trying to do critical safety
analysis

##### Applicability

All residents, medical students, nursing students, and other learners
who are very likely to become key RCA team members within VA or wherever
they go on to practice.

##### Constraints and Lessons Learned

This exercise takes time to prepare for and carry out. It often
frustrates both student and teacher!!! Even experts can easily find
themselves falling into many "traps", including premature "diagnosis",
"knee-jerk" treatment plans, and missing opportunities to "flip the
trainees brain around". There are now literally books written on the
huge number of well-intentioned professionals doing RCAs wrong! The
National Center for Patient Safety will readily acknowledge we are still
learning the best way to learn about and carry out an RCA.

##### [Procedure (Outline) for Exercise]{.underline}

> **Version One (120 minutes)**

1)  Provide one of the attached cases to each mock RCA team at the
    > beginning of class

    a.  Just the first two pages, the rest is the instructor's guide

2)  Each team completes a table with two or more root cause/contributing
    > factors and actions

    a.  This could take hours, but has to be compressed to 20-30 minutes

3)  The class is shown the tools and how to use them

    a.  30 minutes

4)  The teams reconvene, and are given another case to analyze

    a.  Now they use the triage cards

    b.  This could also take hours, but should be compressed to 20-30
        > minutes

5)  Teams report the findings from each of the two cases and discuss
    > differences

> **Version Two (60-90 minutes)**

1)  Each learner is given the first case as homework to bring to class

2)  Learners are given a chance to report their homework (10 min)

3)  Same as steps #3, #4, and #5 above over 50-70 minutes

> **Version Three (60 minutes)**

1)  The class is shown the tools and how to use them

2)  The teams use the tools and one case and they work through with
    > instructor guidance focusing on one or two key root cause pathways

> **Version Four (240 minutes)**
>
>  See RCA training class for VA- Day Three at vaww.ncps.med.va.gov
> (internal VA web site)
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> **Working Tools and Just-In-Time-Training Materials**

1)  Root Cause Analysis Tools Guidebook (pocket-sized and laminated)

> \- With special sections on cause and effect and developing actions

2)  NCPS Triage Cards for Root Cause Analysis (pocket-sized and
    laminated)

> \- The "Review of Systems" for safety diagnosis
>
> \- Organizational tool to keep from jumping ahead

3)  CD-ROM for using Triage Cards and Human Factors Introduction

**[Annotated References]{.underline}**

Bagian, JP, Lee C, Gosbee, JW, DeRosier, J, Stalhandske, E, Eldridge, N,
Williams, R, Burkhardt, M. (2001). Developing and Deploying a Patient
Safety Program in a Large Health Care Delivery System. *The Joint
Commission Journal on Quality Improvement.* Vol. 27, No. 10, pp.
522-532.

Dekker S. *The Field Guide to Human Error Investigations.* Burlington,
VT: Ashgate. 2002.

Splaine M. (Dartmouth Medical School). **RCA Small Group Exercise for
Residency Training**. Dartmouth Hitchcock module Family Practice,
Internal Medicine, and Pediatric residents (primary care). Portions
presented at IHI Forum, Dec. 2000, Workshop on residency patient safety
curriculum.

# Heart Monitor in Demonstration Mode

NOTE: This teaching case has elements from many real case studies, but
many details were manufactured to provide enough information to
accomplish the RCA Team exercise

### Summary of the Event

A.B. is a 65 year-old veteran who suffered mild chest pain and was seen
at the emergency room in his small town (on 6/9/02). Tests for possible
MI (heart attack) were inconclusive, his pain diminished, and his vital
signs were stable. It was decided that it was safe to move him 30 miles
to the nearest VA Hospital via contract ambulance.

Previous to this patient transport, the Emergency Medical Technicians
(EMTs) were being shown several functions of a heart monitor by a
company representative. They had only used basic functions for the month
they had the heart monitor device, since the company rep had canceled
two previous presentations.

EMTs placed A.B. into their transport vehicle with a heart monitor that
displays heart rate, EKG waveform, and blood pressure. He was also
receiving oxygen by nasal canula and had an IV in his arm. Half-way
through the trip, the patient complained of some abdominal pain, like
cramps, and the junior EMT thought the patient looked tired from his
vantage point. The monitor showed no change from the very good vital
signs of BP=125/80 and HR=75. The junior EMT told his senior about the
fatigue, but the senior EMT did not seem to hear him. Ten minutes later,
the patient said his lips were numb and the heart monitor showed no
changes in vital signs.

The junior EMT encouraged the senior EMT at the head of the patient to
manually take vital signs. Upon doing so, the senior EMT was shocked to
find a BP=190/110 and a HR=130 with some skipped beats. As they called
in to the VA for advice, they were actually arriving at the VA. The
emergency department team met them at the door and took over the case.
The monitor used by the EMTs was disconnected and new monitor used.

A.B. was diagnosed as having unstable angina and possible MI. He was
taken for emergency cardiac evaluation and eventually had a cardiac
bypass graft operation. Patient was monitored for 10 days after the
bypass operation, before the patient was able to return home for more
cardiac rehabilitation.

**Other Useful Data:**

1)  Senior EMT has been working for 20 years, the junior EMT for less
    than one year

2)  The heart monitor and pulse oximeter were found to have no
    malfunctioning parts

3)  The transport EMT group is not involved in medical device selection

4)  Event has occurred before most recently on 2/2/02. Corrective
    actions at that time included: more in-service training for EMTs on
    the monitor; warning sheets posted in the paramedic coffee room

#### Instructors Guidebook -- Monitor Case

**Began each session by doing the following:**

> **1)** Identify that you will act as *RCA Advisor*(either sitting
> there with them or floating between many teams)
>
> **2)** Assign or confirm who is the *RCA Team Leader* and *RCA*
> *Recorder*

## Gradually let the Team Leader become the Leader...

**1)** [Expect that some RCA Team Leaders will be
reluctant,]{.underline} - be ready to select, train, and support team
leaders

> **2)** When creating interventions, you many need to take the RCA team
> back to root causes that were poorly worded
>
> **3)**Focus on getting one root cause statement and effective and
> relevant intervention (action) rather than a longer list

## Key Problems or Issues with Previous RCA Teams

**1)** They will want to jump to premature solutions

**2)** They might want to spend a lot of time on details of what
happened, not why

**3)** They might not understand why the triggering questions help

**4)** They might get distracted by minor or moderate details about the
"medical" parts of the case

**5)** They might focus on the shortcomings of people
(blaming-training), not systems redesign

## [Key Points to be Covered for this Case Study]{.underline}

**(Your Team Should Focus on These Items and Triggering Questions
First)**

**HUMAN FACTORS/TRAINING:**

> **HF/T 2** -- Is training provided prior to the start of the work
> process?  *(in this case, **no**)*
>
> **HF/T 3** -- Are the results of training provided for the service
> involved monitored over time?
>
> * (In this case, **no**)*
>
> **HF/T 5** -- Are training programs designed up front with the intent
> of helping staff perform tasks without errors?  *(if a monitor stuck
> in demo mode was possible, [was it trained]{.underline}?)*
>
> **HF/T 8** -- If equipment was involved in the event, did it interface
> smoothly in the context of needs, procedures, workload, space,
> location?  **[No]{.underline},** ***see Environment/Equipment
> questions***

**EQUIPMENT:** Heart Monitor and demo mode (these triggering questions
are relevant)

**E7** -- Does the equipment involved meet current codes, specs, and
regs?  *(yes, so continue)*

**??** -- Was the design of the equipment an issue in this event? 
*(demo mode not "seen")*

**E16** -- Was the design such that mistakes of use would be remote?

 *(demo mode did not automatically discontinue)*

> **E19 --** Were personnel trained to appropriately operate equipment
> involved in this event?
>
>  **[No]{.underline},** ***see Human Factors/Training questions***
>
> **E20** -- Were provisions made in the design to enable detection of
> problems and make them apparent in a timely manner  *(there was not
> an obvious marker to highlight demo mode)*

**E22** -- Were equipment displays and controls a factor in this event?
 *(all above comments)*

**Rule 2 -- Negative descriptors (e.g., poorly, inadequate) should not
used in causal statements. (From FIVE RULES OF CAUSATION)**

**1)** Tendency is for the team to say *"EMTs were poorly trained"* or
*"The EMTs should have been trained not to depend on the monitor so
much"*

**2)** You should help them generate phrases similar to these:

"The lack of in-service training on the monitor contributed to the
likelihood that

> the demo mode was not recognized"

"The level of clinical assessment training increased the likelihood that
the EMTs

> would delay in using physical, rather than electronic, assessments"

**Mock Interviews that Support Instructive Root Causes/Contributing
Factors**

Junior EMT Interview

We were meeting with the company representative to receive our
in-service training on the new heart monitor. Normally we get the
training inside in our break room but the training had already been
cancelled two times and we were needed in the transport. The company
representative was passing through our area and had called that morning
to see if he could stop by and catch up on some of his over due work. We
decided to meet in the transport since the equipment was already set up.
We weren't concerned about not having had the training on the monitor,
after all a monitor is a monitor and this was just a newer model from
what we had been working with. The representative had put the monitor in
demonstration mode and was showing us a couple of new features when he
got a telephone call from his office. At just about the same time we got
the call to pick up a patient at the local ER and transport him to the
VA. The company representative had to leave in a hurry and we headed off
to the ER. The patient looked good when he was handed off to us. The ER
staff said his vitals looked good so we loaded him into the transport
and took off. Both the senior and I were in the back with the patient. I
hooked up the monitor, pulse ox and made sure there was enough oxygen in
the cylinder that the patient was hooked up to when we picked him up. We
had at least a 40-minute ride to the VA so I settled in for what I
thought would be an uneventful trip. We kept an eye on the patient the
whole time. The monitor showed his vitals and they looked really good. A
couple of times the patient mentioned that he had some discomfort and I
thought he looked tired so I made a comment about it to the senior. I'm
sure he heard me. I think we were nearly at the VA when the patient said
his lips were numb. The senior and I looked at the monitor again and saw
that they (the vitals) still looked good. I suggested that maybe we
should take manual vitals and saw that senior had already started to do
it. We were both surprised at the results and realized that our patient
was having problems. At this point we both realized that the monitor was
still in demonstration mode. Senior has been beating himself up about
this since this happened. We called the VA for advice but by the time we
heard back we were just a minute or so from their door. We arrived and
transferred the patient to the VAs care.

Senior EMT (Statement matches Junior EMT with the following exceptions)

The patient was stable when we picked him up, I talked with the ER doc
about this. I don't recall junior commenting to me that the patient
looked tired but even if he did, he's pretty new to the job. This
particular transport van has quite a bit of road noise since we had the
new tires installed so I guess it's possible that I missed it. I kept a
close watch on the monitor and was surprised to see that the vitals were
different when I took them manually. Both junior and I looked at each
other and knew what the problem was (with the monitor). We both forgot
about the demonstration mode and had been reading bogus vital signs for
over 30 minutes.

Supervisor of Contract Ambulance Service

We purchased the new monitors and I made sure that there was a
requirement in the contract that they provide training to my guys on how
to use it. I set up the training 2 times with company representative and
both times it got cancelled by the rep, we were all set up for it. Some
of the old monitors we were using in the transports were having problems
and I didn't trust them so we installed the new monitors to be safe. The
new and the old monitors operate pretty much the same way. We had a
similar problem with the old model and the demonstration mode deal that
junior and senior ran into to. I had posted a notice on the bulletin
board in the coffee room about it. I can show it to you if you like, the
pages are starting to curl up now, its been there quite a while.

VA Biomedical Engineer

My department has not been involved with equipment used by our contact
service. We don't have that specific monitor in our hospital.

Heart Monitor Company Representative

I cover a large territory and it isn't always possible for me to get to
all of my customers as quickly as I would like. The monitor meets FDA
requirements and has an approved 510K as it it currently designed. I
haven't had any other customers that have purchased this piece of
equipment say anything to me about a problem with the demonstration mode
staying on. We don't have any plans on changing the design of this new
equipment. I had a personal emergency on the day when I met with the
senior and junior EMT to show them how the new monitor is different from
what they are used to using. I left in a hurry and I guess I forgot to
take the monitor out of the demonstration mode. I'm sure sorry this
happened and I'm glad the patient is okay now.

VA Contracting Officer

The contract ambulance service is the only company in our area. We need
to use them. We were not aware that they were using new equipment that
they had not been fully trained on. Our contract stipulates competency
requirements for the employees but we don't have anything that would
address the training issue we just discovered. Since we are a major
client of this company we have quite a lot of pull on how they conduct
their operation. I'm sure that if we have recommendations for them they
will get implemented, if not I'll amend the contract as needed.

# Tracheal-Esophogeal Catheter Misplacement

**NOTE: This teaching case has elements from many real case studies, but
many details were manufactured to provide enough information to
accomplish the RCA Team exercise**

### Summary of the Event

G.S. is a 66 year old man who had major neck surgery for cancer and has
to be fed via a special tracheal-esophogeal tube in his neck. He entered
the Extended Care Therapy Center (ECTC) for prostate surgery on October
20^th^. He had his hollow tube replaced by a "keep-open" tube (Robnel
catheter) by the Ear-Nose-Throat (ENT physician). He then was asked to
eat a soft mechanical diet by mouth. Two days later, he was NPO (no food
by mouth) and had a TURP (Trans Urethral Resection of the Prostate)
surgery under general anesthesia. One day later, he returned to the ECTC
and was placed back on the soft mechanical diet.

After 8 days on this diet, he was not eating or drinking much at the
ECTC. He was also undergoing several days of radiation therapy for his
neck cancer. On November 1^st^, the nurse practitioner (NP) at the ECTC
replaced the feeding tube through the TE stoma (hole in the neck). ENT
physician was not called, and the NP followed the instructions found in
the packaging. The instructions did not call for confirmation of
placement by X-ray.

Before the RN covering this patient was to connect liquid food to the
catheter, she called the physician on call for confirmation of change of
diet and route. A chest X-ray was ordered and found the tube to be only
part of the way in (stopped at the mid esophagus). The tube was advanced
to the stomach before any feeding through the tube was started.

**Other Important Data**

1)  Patient was cared for on 11/1/01 with full physical exam, increased
    IV fluid rate, and cautionary antibiotics

2)  Many procedures at the ECTC were done by nurse practitioners in
    order to meet needs of the many patients in a timely basis

3)  The feeding tube set was new, due to a change in purchasing contract
    that month

4)  This nurse practitioner had missed the in-service training for the
    new feeding tube set

5)  The patient was Do-Not-Resuscitate (DNR)

6)  There were few resources at the ECTC to encourage or assist patients
    if they had difficulty eating or drinking by mouth

7)  Event has occurred before. Corrective actions included more training
    of personnel involved, new procedures for feeding those with tubes,
    and new tubing sets

**[Instructors Guidebook -- T/E Catheter Case]{.underline}**

**Began each session by doing the following:**

> **1)** Identify that you will act as *RCA Advisor*(either sitting
> there with them or floating between many teams)
>
> **2)** Assign or confirm who is the *RCA Team Leader* and *RCA*
> *Recorder*

## Gradually let the Team Leader become the Leader...

**1)** [Expect that some RCA Team Leaders will be
reluctant,]{.underline} - be ready to select, train, and support team
leaders

> **2)** When creating interventions, you many need to take the RCA team
> back to root causes that were poorly worded
>
> **3)** Focus on getting one root cause statement and effective and
> relevant intervention (action) rather than a longer list

## Key Problems or Issues with Many RCA Training Teams

1)  They will want to jump to premature solutions

2)  You will likely have to remind them to use the Triage Cards and Five
    Rules of Causation

3)  They may get distracted by details of the "medical" parts of the
    case

4)  **Overall Questions they will LIKEY ask**

    -   "Why would "this NP" decide to do something unacceptable and
        against written policy?"

    -   "How could this error or oversight lead to TE catheter
        misplacement?"

5)  **Overall, this is the wrong way for the team to frame its thought
    process**

-   Think of any rule violations as the beginning of the story, not the
    cause -- or as a symptom of trouble deeper inside the system

-   Try to see why her actions and judgments made sense to her at the
    time this happened

-   Make the team address what "usually happens" (norm), and is still
    likely happening in that unit and by all NPs and other clinicians

## [Key Points to be Covered for this Case Study]{.underline}

## (A interview guide follows this summary "cheat sheet")

## 

**I) RULES/POLICIES/PROCEDURES:**

> **R2 --** Does management have a feedback system to inform them how
> key processes related to this event are functioning?  ***No***
>
> **R11** \-- Are the relevant policies actually used on a day-to-day
> basis?  **No**
>
> * Which **positive & negative incentives** exist that led to this
> unwritten "Norm")*
>
> * What sort of things does the team think should be in place so that
> they would likely make the same decisions and do what the NP and other
> caregivers did*

**II) HUMAN FACTORS FATIGUE/SCHEDULING:**

**HF-F/S 1** -- Did fatigue due to vibration, noise, or other stressor
play a role in this event?

***** Yes, the Nurse Practitioner had production pressure stress*

**HF-F/S 4 --** Was workload a factor in this event?

> ** Yes**, and were staffing levels appropriate?
>
>  ***Yes***

 **Also**, would different staff preparation made workload not an
issue?

 **Yes,** so see *Human Factors/Training* questions

**HF-F/S 6 --** Was the environment free of distractions?

> * No, it was a busy and loud unit. HOWEVER, no more so than most
> patient units at thousands of hospitals  so, what does the team do
> with this data (discussion)*

**III) HUMAN FACTORS/TRAINING (other HF-Ts are relevant too):**

**HF-T 1 --** Is there a program to identify where and what training is
needed?

>  **No,** discuss how "inadequate training" must always be further
> investigated

**HF-T 3** -- Are the results of the training provided related to this
event monitored?

>  **No**, discuss how recommendations for "more training" needs to
> monitored

**HF-T 5** -- Are training programs for staff involved in this event
designed with the intent of

> helping staff do tasks without errors  **No*,*** *develop root causes
> related to deficiencies of "rote" training and benefits of simulating
> "errors"*

**V) Rule 4 -- Each procedural deviation must have a preceding cause**

**(From FIVE RULES OF CAUSATION)**

 Tendency to name as a cause: *"nurse practitioner did not follow
procedure",* or *blame the nurse*

* See more detail below under NP and NP manager interviews*

**Issues and Answers (General):**

-   Q: The big question...was there an order from the Physician for the
    NP to replace the tube?

    -   A: No, there was not an order

    -   A: No, there is no protocol to double check when nutritional
        status is poor

-   Q: Why did she replace the tube with a *different type*? Doctor's
    order?

    -   A: No order was written by physician; but TE catheter was
        correct

    -   A: Doing procedures was typical of what was done in the unit

-   Q: Was there a HF issue with instructions?

    -   A: Ask the team to think about how the instructions may have led
        her astray. That is, have them think about what would make the
        oversight a likely occurrence

    -   A: What kind of instructions did not call X-ray confirmation.

        -   Instruction sheet inside the procedure kits

        -   Yes, there are really some kits that would not have this
            step. The manufacturer sees that as hospital procedure

-   Q: Does the reference to "nurse" in the last para. need to be
    clarified?

    -   A: No. It is purposely confusing so that the team has to
        assemble and carefully read a typically partially incomplete
        event report

**Interview Questions/Answers (related to issues above):**

-   **Prostate surgeon:**

    -   Q: Why was the surgery scheduled so close to the neck surgery?

        -   A: It was appropriate for this patient. Exact reasons are
            not relevant to the RCA learning from this case

    -   Q: Why didn't you check the nutrition status of this patient?

        -   A: I thought it was handled by nursing team or ENT physician

-   **ENT Physician:**

    -   Q: Why was the hollow tube replaced by keep-open tube?

        -   A: To allow the patient to eat food through his mouth; this
            type of eating is encouraged

    -   Q: Was the change in eating monitored? How come no intervention
        (8 days)?

        -   A: It is unfortunately common that things decreased food and
            fluid intake are "missed"

        -   A: In hindsight, there could have been an intervention to
            better meet his nutritional needs. We really don't know how
            it happened.

    -   Q: Do you normally order a confirmation x-ray when a new tube is
        being placed?

        -   A: All feeding tubes, yes

        -   A: NG tubes, no, since they "suck" food out

        -   A: If asked directly, tell them some people don't always get
            X-rays for placement (too slow, etc)

        -   A: If asked directly, tell them this TE catheter looks like
            an NG tube...

-   **Nurse Practitioner:**

    -   Q: Have you been trained? If not why?

        -   A: No, I don't remember receiving any communication of a
            training session being offered.

    -   Q: Explain the packaging and instructions for the tube.

        -   A: It was not user friendly, and was not detailed enough,
            nor was there a diagram. I thought I had done it correctly.

    -   Q: If you were not confident on how to replace the tube/hadn't
        been trained, why didn't you get help from another Nurse
        Practitioner?

        -   A: We always try to do things on our own...

        -   A: We get positive feedback for doing things alone

-   **Nurse Practitioner (cont.):**

    -   Q: Why did you replace the tube, did you have a Dr. order?

        -   A: I don't recall

        -   A: We make so many decisions without help or input due to
            multiple, busy clinicians and sick patients, and this
            instance does not stand out

    -   Q: Do you normally confirm the placement of the tube once
        inserted via x-ray?

        -   A: Yes, we get confirmation X-rays for feeding tubes

        -   A: No, I do not recall "not" ordering it for this case

    -   Q: Did the TE catheter look strange or odd in any way

        -   A: I do not know what you mean...

        -   A: If told about the ENT physician's comments, the NP
            remembers that it did sort of look like an NG tube

-   **Nurse Practitioner Manager:**

    -   Q: How did the NP find herself in the position to apply a device
        she hadn't been trained on (address training issues
        here...expand question if necessary)

        -   A: All NPs are supposed to go

        -   A: Our training people are responsible for ensuring when
            training is offered and who is supposed to go

    -   Q: Why is there no written protocol for x-ray confirmation of
        tube placement?

        -   A: We do have a policy in our "big policy book"

        -   A: The NP should have known, it is in the book

-   **Nurse who ordered the X-ray:**

    -   Q: When you called the doctor for confirmation of diet and
        route, why was an x-ray ordered?

        -   A: I saw it was a new feeding tube and we always get X-rays
            for feeding tube

        -   A: We are a good team that double checks each others work

    -   Q: Why did the NP forget the order the X-ray?

        -   A: Again, these instances of doing things to help remind or
            double-check for each other are common -- this one does not
            stand out in my mind

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