# NCPS TIPS -- July/August 2005

### Contents: 1. Helping RCA Teams Be More Successful 

2.  Improving Chemotherapy Safety

3.  A New, Simplified Approach to Medication Close Call Reporting

### 1. Helping RCA Teams Be More Successful By Illustrating Principles of Human Factors Engineering with a "Hands-On Museum"

By Linda Williams, RN, MSI, NCPS cybrarian

**The Challenge**

So, you have a good understanding of the principles behind designing
systems for the way we humans are built and how we function cognitively
and physically. You understand that human factors engineering (HFE)
applies what is known about human capabilities and limitations when
designing products or processes: that the more intuitive the design, the
more user-friendly and safer the end product. You get it.

However, you find RCA teams repeatedly concluding that patient safety
solutions should be based on warning signs, on training, or on asking
clinicians to "be more careful." These weak solutions won't solve the
problem.

You also hear talk that improving human performance can reduce the
likelihood of adverse medical events. You know this isn't the solution
either; maintaining a consistently high level of human performance is an
unrealistic goal, and can never be an optimal solution.

Often, professionals develop clever and creative "work-arounds" when
devices, equipment or architecture are not quite suitable. In other
words, they become accustomed to making "the hand fit the glove." The
ability to make a system work, regardless of poor design, makes people
less willing to criticize and correct systems issues.

One of the best ways we've found to overcome these and other challenges,
and to better understand HFE principles, is to provide a way for
clinicians to pause and think about how a specific system functions.
That's why we created our "Hands-On Museum." Through experiences with
the displays, clinicians easily recognize that problems can arise not
from a lack of skill or ability, but from a dysfunctional system or
device.

**Making HFE principles come alive**

Start with something all humans understand. Everyone has bad days. Less
than optimal human performance can result from sleep deprivation,
physical exhaustion, extreme stress, or other unpredictable aspects of
normal life. Understanding this and accepting it in a patient safety
analysis is just the starting point.

The potential for harm is present at the point of healthcare delivery
when you combine a normal human in a normal condition, such as sleep
deprivation, and the results of engineering and programming by other
normal humans. The purpose of HFE design is to better understand normal
human performance and design things accordingly.

To make this concept clear to those who have not studied this, consider
starting a collection of devices and equipment that illustrates both
good and bad human factors designs.

We at NCPS have found our Hands-On Museum to be a novel and valuable
teaching aid. If a picture is worth a thousand words, an object
conveying the same message --- an object that can be handled and tested
--- is worth even more. Refining observational skills by making
well-designed objects and those with problem designs available for
handling allows one to better draw conclusions on how devices and
equipment function.**^1^**

If an ambu-bag that looks like it should function well fails to recover
its shape sufficiently to deliver a succession of breaths that meets a
minimum tidal volume standard, how much greater the risk in a complex
device such as a perfusion machine?

A hands-on collection need not be extensive or require special storage
space. You don't need to invest a lot of muscle and money to start your
own Hands-On Museum.**^2^** Let a few key people know that you are
interested in collecting exhibits. Explain to them that this will help
RCA teams better understand HFE principles and improve patient safety at
their facility.

**How do you display your museum exhibits?**

Our Hands-On Museum is a permanent fixture at NCPS, but it can also be
used as a traveling exhibit. We have a space dedicated to the testing
and development of the collection. For special training sessions, it is
possible to store and retrieve these portable exhibits as needed. In
limited space, participants have passed the exhibits hand-to-hand; space
permitting, tabletop displays allow visitors to interact with exhibits.

There are two components to each exhibit: the item and a descriptive
placard. The placard narrative has three parts: the challenge that the
item presents to correct use by a human, the HFE design principle(s)
that are illustrated, and a possible solution based on HFE principles.
Here is one example:

**Where do you begin collecting?**

As you consider the following sources, other ideas may come to mind.
Ideally, you should obtain the actual object or its pertinent parts so
that it can be handled and tested.

-   Take a look through RCAs that mention equipment, devices or
    architecture.

-   Revisit NCPS alerts and advisories --- especially those that include
    photos of problem devices, such as the Risperidone oral medication
    syringe (pipette)
    \[[*www.patientsafety.gov/alerts/Pipette.doc*](http://www.patientsafety.gov/alerts/Pipette.doc)\].

-   Take this article to your biomedical engineer and ask for ideas and
    exhibit items.

-   View the Institute for Safe Medication Practices' Web site
    ([*www.ismp.org*](http://www.ismp.org/)) --- look for photos of
    potential exhibits.

-   Tour your facility and look for sticky notes attached to devices
    that provide warnings about safe or correct use.

-   For photos and descriptive museum placards from the NCPS collection
    see
    [*www.patientsafety.gov/PSC/HOM/*](http://www.patientsafety.gov/PSC/HOM/)

**How do you make the design issue clear?**

You will need to take potential exhibits in hand, evaluate their
usability, and consider how others will be challenged by them.

When you have identified challenges to correct use of a device, you may
want to cite the HFE principle that is countered.

**How do you connect the HFE principle to exhibits in your collection?**

Start with a checklist of good design. As you handle the potential
exhibit --- considering issues that you've learned from an RCA, an alert
or advisory, or another source --- look for a connection with one or
more of the design principles. Finding that connection will provide
ideas for solving issues with the device.

**Sample HFE checklist items:^3^**

-   \_\_ Does this device look like another device or tool you have used
    before (e.g., ATM machines, calculators); and is that fact helpful?

-   \_\_ Is it obvious how you operate the device?

-   \_\_ Is it obvious what each button or switch will do?

-   \_\_ Do some buttons/switches look too similar to others?

-   \_\_ Is the message display big enough?

-   \_\_ Is the language simple and natural?

-   \_\_ Is the information useful? Do you need more information?

-   \_\_ Are the error messages understandable?

-   \_\_ Are you able to easily see all the important warnings and
    labels?

**How do you get just-in-time information about HFE principles?**

While the lesson of good design can be learned without spelling out the
HFE principles involved, having the principles stated will assist in
documenting the need for changes in devices, equipment or architecture.

If you need more information, consider consulting with HFE experts at
NCPS.

1 Gosbee J, Anderson T. Human factors engineering design demonstrations
can enlighten your RCA team. Qual Saf Health Care 2003;12:0-2.

2 Gosbee J, Williams L, Dunn E (2004). VA Patient Safety Curriculum for
Residents: An Update. Retrieved May 22, 2005 from
[*www.acgme.org/acWebsite/bulletin/bulletin08_04.pdf*](http://www.acgme.org/acWebsite/bulletin/bulletin08_04.pdf)

3 Gosbee J, Lin L (2005). Human Factors Engineering to Improve Patient
Safety. (pp 28-30) Joint Commission Resources.

**2. Improving Chemotherapy Safety -- The Mission of the Patient Safety
Center for Inquiry, Minneapolis, MN**

#### By Anna E. Schorer, MD, director, PSCI for Chemotherapy Safety, associate professor of medicine, University of Minnesota

"To err is human, but to really foul things up requires a computer."

---Farmer's Almanac, 1978

Patient Safety Centers of Inquiry (PSCIs) are programs supported by
NCPS. Each PSCI focuses on a particular safety problem and is charged
with developing, implementing and disseminating innovations to improve
patient safety.

The PSCI for Chemotherapy Safety was established at the Minneapolis VAMC
(MVAMC) in 2003, with formal project partners at the Cincinnati and Iowa
City VAMCs and collaboration with oncology professionals at the Boston,
San Diego, Cleveland, and Syracuse VAMCs.

Our PSCI's mission is to improve the health of veterans with cancer by
reducing preventable adverse events associated with chemotherapy. In
particular, our efforts have examined problems in chemotherapy that are
not addressed -- or are even exacerbated -- by computerized order entry.

For example, CPRS makes it easy to renew medications, but oncologists
report incidents of patients receiving unintended refills of oral
chemotherapy from unauthorized prescribers. As a remedy, we reviewed all
oral chemotherapy agents stocked by our pharmacy and surveyed VA
oncologists to learn which agents should never be refilled or renewed
without oncology staff approval. We presented a recommendation to the
pharmacy and therapeutics committee of the MVAMC that specific drugs
cannot be renewed or refilled unless authorized by a staff oncologist.
This recommendation was successfully implemented as a facility policy in
2004 and subsequently adopted VISN-wide in 2005.

One of our safety goals is to support standardization of treatments.
When fully achieved, this will result in all chemotherapy being written
from templates that reflect institutional policy and evidence-based
treatment and have been reviewed by a multi-disciplinary team.

Since October 2003, the PSCI has collected and analyzed all chemotherapy
orders written at its study sites. We document remarkable consistency
between sites in the types of chemotherapy regimens used; but, broad
variation in the use of supportive medications, such as growth factors
and antinausea medicines, between and within institutions.

We identified a core anthology of regimens that are commonly used. Of
the 1,215 orders written during the first year of the PSCI, there were
125 distinct chemotherapy regimens written. The most frequently used
regimens were prescribed dozens of times, while some treatments might be
used only once a year. For each regimen, we have retrieved the original
published clinical trial and reviewed the treatment details to establish
a "gold standard" for dose rules.

To enhance facility-wide standardization of supportive medicines, we
distributed policy papers and guidelines from national bodies for the
use of antiemetics and other supportive medications. We then surveyed
practitioners at each PSCI-participating facility for their preferred
antiemetic sets. These standards are the basis for our efforts to create
facility-specific templates for chemotherapy.

Because CPRS does not compute or restrict dosing of drugs, a
chemotherapy order may exceed the safe and appropriate dose for a drug.
To provide resources that would reduce the chance of a chemotherapy
overdose, we reviewed published trials and pharmacy resources, and then
developed a table listing the usual and maximum doses of each of the
chemotherapy drugs, including individual dose, daily, and cyclic dose
maxima. This table can be accessed by VA employees via our PSCI Web
site: vaww.visn23.med.va.gov/psci.

VA employees often say, "If you've seen one VA . . . you've seen one
VA." They mean, of course, that every facility has unique physical and
human resources with problems that are likewise unique. Despite this,
through visits and conversations, the PSCI is identifying themes that
recur throughout the system. One way to identify the high frequency
safety concerns is to review the compiled data from NCPS.

Early in 2005, NCPS performed a search of their SPOT database using the
key word "chemo" and retrieved 457 incident reports from a four-year
period. We categorized and tabulated these incident reports: falls or
other injuries to chemo patients (92); adverse events related to pumps,
venous access devices or other aspects of drug infusions (66);
medication errors (257); and an assortment of other issues (42).

The reports of chemotherapy medication errors reflect the difficulty of
using CPRS for complex dosing and schedules. We found incidents that
involved drugs being given at the wrong time (87), or patients being
given the wrong dose (71) or the wrong drug (43).

In the reports where it was possible to determine the step when an error
was committed, 37 percent occurred at the administration step and 31
percent at the ordering step. Administration errors frequently were
attributable to confusion about the intended treatment schedule (unclear
communication of orders) or uncertainty about whether an earlier step in
a sequence had been completed (unclear documentation of therapy).
Thirty-seven percent of the ordering errors were due to incorrect drug
doses.

Chemotherapy prescribing problems have plagued the VA since the
introduction of CPRS. Unlike traditional paper orders, computerized
orders are directed either as a pharmacy or nursing order and the
components of an order set are not linked together electronically,
although they must be linked in execution. The fragmentation of the
components of a set of instructions for care has created a daunting
challenge for oncologists who want to order chemotherapy in CPRS. A
chief concern remains that key information about the plan of care will
not be communicated to the clinical staff when using CPRS.

Historically, the VA computer system, VistA, was initially used by
pharmacy to print labels. CPRS, a graphical user interface with
attributes of a browser, was subsequently developed to facilitate
recording and retrieval of clinical information by nurses and doctors.

VistA and CPRS are partial and imperfect images of one another. For
example, all the pharmacists' work is still performed in VistA; but
other orders, such as nursing text orders, are not viewable in VistA. As
a result, the pharmacist, an integral member of the multidisciplinary
care team for a cancer patient, may be unaware of crucial information
about a patient's treatment. The VistA "Print Information" field for IV
orders is limited to 60 characters. Therefore, if a clinician adds
longer text instructions to the CPRS "Comments" section when placing an
IV drug order, no part of this text is placed on the drug label or in
BCMA; essentially, the text is left behind in CPRS.

The VistA pharmacy package is being re-engineered with a projected
release near the close of the decade, but it is not certain that all
problems will be resolved.

We surveyed doctors, pharmacists, and clinical applications coordinators
throughout the country to determine how chemotherapy is prescribed at
each facility. Of the 41 facilities that responded, only five use direct
physician order entry for cyclic chemotherapy; all of the others
designate a pharmacist to place the orders. Twenty-three of these
facilities use handwritten orders; ten are written in CPRS using a text
order, pharmacy consult, or progress note. Three facilities are testing
commercial software for prescribing.

A major goal of this PSCI is to determine whether the safety needs of
veterans can be met with CPRS or whether commercial chemotherapy
software is needed. Testing of candidate software is ongoing at
Minneapolis and Cincinnati. This is being compared to order sets
produced at the Iowa City VAMC. Simulated clinical scenarios will
compare the commercial software and CPRS chemotherapy order sets for
their effectiveness, efficiency, flexibility, clarity and precision.

Our PSCI intermediate and long-range goals include: the coordination
between VA cancer experts to propose, publish, and update consensus
guidelines for treatment sets; a review of recurring and unique barriers
to dissemination of innovations in technology; and further development
of the technologies that accurately and effectively order chemotherapy
treatments for VA patients.

**3. A New, Simplified Approach to Medication Close Call Reporting**

*By Noreen Jennings, JD, RN, patient safety specialist, and Dale Ryan,
RN, MSA, informatics nurse specialist, West Palm Beach VAMC*

At West Palm Beach VAMC, staff members in pharmacy, nursing and patient
safety were interested in increasing their ability to capture medication
error close calls.

We had specific goals: to increase reporting, to improve its timeliness
and accuracy, and to increase staff involvement, whether it meant
reporting a close call or an actual event.

With the assistance of Information Resource Management, we developed a
user-friendly, computer-based format that minimizes free text and offers
simplified categories. When a category is chosen, such as a "prescribing
error" or a "dispensing error," another selection is displayed that
allows a second choice from a subcategory, such as "wrong dose" or
"wrong drug." Both steps can be taken by simply pointing and clicking.

**Close calls**: Every computer desktop at our VAMC contains a
"medication incident error" icon that can be accessed by any staff
member. To report, a staff member enters the name and Social Security
number of the patient, the name and dose of the drug, and a brief
summation of the incident. It can take, literally, as little as one
minute to complete and submit the form. Quality Management receives the
information and ensures its confidentiality; even the staff member who
had entered the information can no longer access it.

**Actual events**: The medication incident icon can also be used to
submit a report on an adverse event that in some way affected a patient.
As is the case with close call reporting, the system is built to ensure
that we preserve the database as "confidential and protected" under 38
USC 5705. When an actual adverse event occurs, the patient safety
manager assigns it a Safety Assessment Code score. Depending upon the
situation, either an RCA is conducted or the data is added to the
medication aggregate.

**Results and Benefits**: During the first quarter after the
implementation of this process, our medication close call reporting
increased from 10 to 173. This is a remarkable increase in reporting.
The medication aggregate team has used the information to review trends
and issues, and to develop action plans to prevent future incidents.
Since the report the team uses is formatted in an Excel database, it can
easily be sorted according to categories, making trends readily
apparent.

For instance, the team identified a trend attributed to the staff's
level of knowledge and experience with order entry. A competency
checklist has been developed to serve as a uniform reference for new
providers being trained in order entry. All new providers will also be
asked to complete an electronic self-learning module on CPRS.

Another issue concerned tracking IV-controlled substances by using a
paper-based method versus segregating these medications in an automated
dispensing machine (ADM). The team recommended standardizing our
approach by having all controlled substances delivered directly to an
ADM. They could then be removed individually for administration to
patients.

**Summary**: Our system has dramatically increased close call reporting.
This increase has significantly improved our medication aggregate team's
ability to develop action plans to improve patient safety. Our effort,
though, is a "work in progress." We continue to make changes and
additions based on suggestions from our staff.

VA employees who wish to view screenshots of this system may click to
[vaww.ncps.med.va.gov/frontlines/index.html](http://vaww.ncps.med.va.gov/frontlines/index.html)