IOM Committee on Identifying and Preventing Medication Errors: Panel on Reporting Systems

Noel E. Eldridge, MSDepartment of Veterans Affairs (VA)

National Center for Patient Safety (NCPS)noel.eldridge@va.gov

April 14, 2005

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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 battleand 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 Lincoln2nd Inaugural Address

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Veterans Health AdministrationVeterans Health Administration2211 Veterans Integrated Service Networks Veterans Integrated Service Networks

I J 2002

N ANUARY

W ERE INTEGRATED AND

RENAMED

VISN 13 14

VISN 23

S AND

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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

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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

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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

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Increasing Number of Veterans Coming to VA for Rx & More Outpatient Care…

CMOP Workload vs. Capacity

0

20

40

60

80

100

120

1998 1999 2000 2001 2002 2003 2004

Fiscal Years

Rx

s (

mill

ion

)

Workload

Capacity

45 Million Packages Mailed in 2004

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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…

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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

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MonitoringMedication

Effects

AdministeringMedication

DispensingMedication

PrescribingMedication

VA Medication Safety throughoutthe Process of Care

Guidelines / formulary criteria

Medication Eval - Nationally

Computerized Patient RecordSystem (CPRS) – order entry

Standardization

Centralization (ConsolidatedMail Out Pharmacy - CMOP)

CPRS integrated withPharmacy

AutomationConnectivity between sites

Cooperation between sites

Bar CodeVerification

Robotics

Standardization

CPRS integrated with Nursing

Maximized documentation

Automation

Bar Code MedicationAdministration

Home testing / home care

Post Market Surveillance

Epidemiology

Ambulatory Clinical Pharmacy

Telemedicine / Connectivity

Anticoagulation Clinics

Polypharmacy Clinics

Prescriptive Authority

Vitals, etc.

Other Initiatives

DRAFT

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Event(or Close Call)

Select AdverseDrug Reactionsforwarded to VACentral Office

(MEDRA coding)

Pharmacy &TherapeuticsCommitteeevaluates

Individual RCA

Aggregate RCA orSafety Report

Patient SafetyManager

Pharmacyprepares summary

report

Drug Reaction(via VA’s AdverseReaction Trackingsoftware package)

Medication Errorvia incident

reporting systemPharmacy &TherapeuticsCommittee or

Safety Committee

RCA submissionvia NCPS SPOT

(VA RCASoftware)

Facility-levelsystems changes

based on RootCauses

ProspectiveMonitoring System

VA MedsafeDatabase

Merge with Austin(National) Admin /

Clinical Data

Track and TrendInformation

Investigate Locally

VISN FormularyLeaders and

Medical AdvisoryPanel Intervention

FDA MedwatchSubmission

National Learningand Changes

VA Medication Safety Reporting Processes

General overview – specifics may vary. Communication points are simplified.

Quarterly Reviewof Findings and

Potential Actions,e.g., Formulary

Changes orAdvisories

DRAFT

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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.

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The Value of Close Calls in Safety

Close calls can provide “sentinel” information without or before the “Sentinel Event.”

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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)

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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.”

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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.)

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Event(or Close Call)

Individual RCA

Aggregate RCA orSafety Report

Patient SafetyManager

Medication Errorvia incident

reporting system

RCA submissionvia NCPS SPOT

(VA RCASoftware)

Facility-levelsystems changes

based on RootCauses

National Learningand Changes

Reporting at local level isthrough local methods - not

specified by NCPS Decision on RCA or AggregatedReview is based primarily on SACScore (NCPS-defined but locally

determined).

Actions and outcomemeasures in RCAs and Agg.

Reviews are part of thelocally-performed review.

All RCAs andAggregated Reviews

are submitted to NCPSelectronically.

NCPS Reviews all RCAs andAggregated Reviews for Potential

National Action or Education Efforts -Data also Available for Searches on

Topics of Special Interest.

NCPS-led Portion of MedicationSafety Improvement Efforts in VA

DRAFT

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

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20

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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).

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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

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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

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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.

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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.

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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