This presentation was made to the group that produced this report, The Future of Drug Safety: Promoting and Protecting the Health of the Public; which is online at: http://www.iom.edu/reports/2006/the-future-of-drug-safety-promoting-and-protecting-the-health-of-the-public.aspx. This was a big deal for me because it was the first time I presented to an IOM committee after having worked at the IOM's sister organization, the National Reseach Council, for 5 years, earlier in my career. I rmeember meeting my future boss at AHRQ, Dr. William Munier, for the first time at this meeting. Michael Valentino of the VA's Pharmacy Benefits Management Program was kind enough to come along with me that day in case I was asked drug questions that I couldn't answer.

1. IOM Committee on Identifying and
Preventing Medication Errors:
Panel on Reporting Systems
Noel E. Eldridge, MS
Department of Veterans Affairs (VA)
National Center for Patient Safety (NCPS)
noel.eldridge@va.gov
April 14, 2005

2. 2
Mission of the Department of
Veterans Affairs
“With malice toward none, with
charity for all, with firmness in
the right as God gives us to
see the right, let us strive on to
finish the work we are in,
to bind up the nation’s wounds,
to care for him who shall
have borne the battle
and for his widow, and his
orphan, to do all which may
achieve and cherish a just and
lasting peace among ourselves
and with all nations.”
- Abraham Lincoln
2nd
Inaugural Address

3. 3
Veterans Health AdministrationVeterans Health Administration
2211 Veterans Integrated Service NetworksVeterans Integrated Service Networks
I J 2 0 0 2N A N U A R Y
W E R E IN T E G R A T E D A N D
R E N A M E D
V IS N 1 3 1 4
V IS N 2 3
S A N D

4. 4
VA Statistics (FY 2004)
• 7.4M enrollees, 5.0M uniques
• VA Medical Centers (Hospitals): 163
• Admissions: 587,000
• Community Based Outpatient Clinics: 696
• Outpatient Visits: 54M
• Rx Dispensed (30-day equiv): 219.4M
– From VAMCs: 44.5M
– From Consolidated Mail-Out Pharmacies: 175.0M
• Lab Tests: 202.5M
• Total FTE: 192,600

5. 5
VA has Major Efforts in Medication
Safety with Different Approaches
• In VA, the medication safety focus is on
developing systems that reduce or prevent
adverse drug events and/or med errors
– Consolidated Mail Out Pharmacy (CMOP)
– Computerized Patient Record System (CPRS)
– Bar Code Medication Administration (BCMA)
– Post-Marketing Surveillance
– Ambulatory Clinical Pharmacy
• We also have thorough systems to acquire
reports of adverse events and close calls --
and to review and act on them

6. 6
Consolidated Mail Out Pharmacy (CMOP)
Quality and Error Statistics: 2004
• Wrong Medication: 0.0007%
• Labeling problem: 0.0001%
• Wrong Quantity: 0.0015%
• Wrong Patient/Package: 0.0008%
• Damage in Mails: 0.0024%
• Delays in Delivery: 0.0235%
• Pt. Satisfaction Rating: 90-93+% VG/E

7. 7
Increasing Number of Veterans Coming
to VA for Rx & More Outpatient Care…
CMOPWorkload vs. Capacity
0
20
40
60
80
100
120
1998 1999 2000 2001 2002 2003 2004
Fiscal Years
Rxs(million)
Workload
Capacity
45 Million Packages
Mailed in 2004

8. 8
What is VA Patient Safety
Improvement Trying to Achieve?
• What’s the goal?
– The goal is not so much the elimination of
errors but the elimination of unintended
harm to patients while undergoing medical
care.
– If we can see fewer cases with harm that
would be more important than just seeing
fewer cases with errors.
– But fewer cases with errors would seem to
be progress nonetheless…

9. 9
Using BCMA Software to Improve
Patient Safety In VAMCs
Error Type
1993
(%)
2001
(%)
Improve-
ment
(%)
Wrong
Medication 0.00371 0.00091 75.47
Wrong Dose 0.00334 0.00127 61.97
Wrong Patient 0.00138 0.00009 93.48
Wrong Time 0.00143 0.00018 87.41
Omission 0.00917 0.00272 70.34
Journal of Healthcare Information Management — Vol. 16, No. 1

10. 10DRAFT

11. 11
DRAFT

12. 12
Our Terminology
• Adverse Events: untoward incidents, therapeutic
misadventures, iatrogenic injuries, or other
adverse occurrences directly associated with
care or services provided within the jurisdiction
of a medical center, outpatient clinic, or other
VHA facility.
• Close Calls: an event or situation that could
have resulted in an Adverse Event but did not,
either by chance or through timely intervention.
Such events have also been referred to as “near
miss” incidents.

13. 13
The Value of Close Calls in Safety
Close calls can provide “sentinel” information
without or before the “Sentinel Event.”

14. 14
Root Cause Analysis in VA
• Root Cause Analysis (RCA): a process for
identifying the basic or contributing causal factors that
underlie variations in performance associated with
Adverse Events or Close Calls.
– interdisciplinary in nature with involvement of those
knowledgeable about the processes involved in the event
– RCA team is comprised of individuals from the facility where the
adverse event occurred
– focuses primarily on improving systems and processes rather
than individual performance.
– not for punishment
(See Handbook at http://www.patient safety.gov)

15. 15
What’s Off-Limits for RCA
• Intentionally Unsafe Acts
– An “intentionally unsafe act” is defined as
“a criminal act; a purposefully unsafe act;
an act related to alcohol or substance abuse
by an impaired provider and/or staff; or
events involving alleged or suspected
patient abuse of any kind.”

16. 16
The SAC Matrix (excerpted from VHA Patient Safety Improvement
Handbook, see http://www.patientsafety.gov/NCPShb.pdf)
Severity & Probability Catastrophic Major Moderate Minor
Frequent 3 3 2 1
Occasional 3 2 1 1
Uncommon 3 2 1 1
Remote 3 2 1 1
How the SAC Matrix Works
When you pair a severity category with a probability category for either an actual event or Close Call, you will get a ranked
matrix score (3 = highest risk, 2 = intermediate risk, 1 = lowest risk). These ranks, or Safety Assessment Codes (SACs) can then
be used for doing comparative analysis, and, for deciding who needs to be notified about the event.
Notes
1. All known reporters of events, regardless of SAC score (1,2, or 3), will receive appropriate and timely feedback.
2. The Patient Safety Manager (or designee) will refer Adverse Events or Close Calls related solely to staff, visitors or equipment/facility damage to relevant facility
experts or services on a timely basis, for assessment and resolution of those situations.
3. A quarterly Aggregated Root Cause Analysis may be used for four types of events (this includes all events or Close Calls other than actual SAC score of 3, since all
actual SAC score of 3 require an individual RCA). These four types are falls, medication errors, missing patients, and parasuicidal behavior. The use of aggregated
analysis serves two important purposes. First it provides greater utility of the analysis as trends or patterns not noticeable in individual case analysis are more likely to
show up as the number of cases increases. Second, it makes wise use of the RCA team's time and expertise.
Of course, the facility may elect to perform an individual RCA rather than Aggregated Review on any Adverse Event or Close Call that they think merits that attention,
regardless of the SAC score.
(See attached documents defining Severity and Probability categories.)

17. 17
DRAFT

18. 18
Screen Shot of SPOT Program Start Menu for RCAs
(and Safety Reports – first 7 Questions)

19. 19

20. 20

21. 21
Typical Item from an Aggregated
Review of Medication Errors (1 of 3)
This Figure was taken from an
Aggregated Review of about 60
events (close calls and adverse
events scoring 1 or 2 on SAC).

22. 22
Typical Item from an Aggregated
Review of Medication Errors (2 of 3)
• Of 60 events studied, 90% (54) were…
– 18 Wrong Patient
• 15 pharmacy, 3 provider
– 17 Wrong Dose
• 6 pharmacy, 4 nursing, 4 provider, 1 other
– 11 Wrong Medication
• 6 pharmacy, 5 provider
– 5 Wrong Route
• 4 nursing, 1 provider
– 4 Wrong Time
• 4 pharmacy
Real numbers
slightly changed

23. 23
Typical Item from an Aggregated
Review of Medication Errors (3 of 3)
• 60% of providers completed the POE complex
medication order on-line training module…only 5
providers entered all the orders correctly.
• The two providers on the RCA team had both
completed the module and felt that it would be
helpful for providers to find out how they did and
what were the correct answers or ways to enter the
orders…
– Patient Safety Managers and Pharmacists will send test
results and correct answers to providers who completed
the tutorial, and information will be sent to Education
office…
– When CPRS POE medication error occurs pharmacist will
contact the provider at the time to ensure 2-way
communication/education, clarify the order, or answer any
questions on order entry… Slight rewording of
an actual report

24. 24
Data on Medication Safety Events
Reported to NCPS
• For an approximately 18-month period currently
being studied there were approximately 100,000
events (adverse events or close calls) reported to
NCPS as RCAs, Safety Reports, or Aggregated
Reviews. About 25% were related to medication
safety.
• Of the approximately 25,000 events reported related
to medication safety, about >95% had an Actual SAC
score of 1, >4% had an Actual SAC Score of 2, and
<0.2% had an Actual SAC Score of 3.
– Note: A (self-)reporting system should not be evaluated primarily
by the number of reports it receives. Fewer reports of adverse
events does not necessarily mean that fewer adverse events are
occurring.

25. 25
What are We (NCPS) Doing
with the Data?
• It is important to determine what actions have been
successful in reducing medication related/adverse
drug events in the VA.
• This project will help by describing the root causes,
actions, implementation success factors and the
effectiveness of actions to reduce medication related
adverse drug events.
• We will read and code the aggregate reviews from
each site for (100+ reports) and all relevant single
case RCAs (100+ reports).
• We will interview each of the (100+) sites about their
reports and ask if they implemented their actions,
how effective these actions were, and what success
factors or obstacles impacted their implementation.

26. 26
Closing Thoughts
• “Insanity: doing the same thing over and
over again and expecting different results”
Albert Einstein
• “They say that time changes things, but
you actually have to change them
yourself”
Andy Warhol