Michael A Noble MD FRCPCChair – Clinical Microbiology Proficiency Testing

Chair – Program Office for Laboratory Quality Management

University of British Columbia

Counting the Costs of Poor Quality

By way of introduction…

Michael Noble� Medical Microbiologist and Internal Medicine by training

� Laboratory physician by profession

� Medical Qualitologist by evolution and avocation

� Qualitology

� The body of knowledge pertaining to Quality.� Standards development

� Research and Development

� Education

� Application

Useful References for Cost and

Error

Healthcare’s Biggest Challenges (Including medical laboratories)

The Quality – Error Dynamic

Pressures Drive Error and Quality

Costs

Risk

Stress

Staffing

Culture

Urgency

Liability

Litigation

Regulation

Quality–Error-Pressure

� Pressures drive up Error and drive down Quality.

� Error drives up Pressures and drive down Quality.

� Poor Quality drives up both Pressures and Error

Quality-Error-Cost Dynamic

AND… Errors, Pressures and Poor Quality

ALL Drive up Costs

To know and understand the dynamic of Quality and Costs, FIRST know and understand ERROR

Eight things we know about Laboratory Error

1. Most errors are unrecognized or unreported

2. Systemic structures tend to stop most error from showing

3. Of the errors that are detected and studied, they are common and

frequent and occur during every phase of laboratory testing

4. Many personal errors have systemic causes.

5. Most errors have benign causes that are difficult to control

6. Many errors are seemingly benign with respect to Patient Care,

but are dire when viewed in the context of other stakeholders.

7. Even if an error appears benign, the outcome may be far reaching

or catastrophic.

8. Intact mitigation and continual improvement programs can

prevent dire consequences resulting from significant errors

Analysis of laboratory patient safety event reporting in BC: Identifying opportunities to enhance data collection, support learning and promote quality improvement

Veronica Restelli; Michael Noble; Annemarie Taylor; D. Douglas Cochrane

In a population of approximately 4 million people with 105 medical laboratories

12,278 laboratory patient safety events reported75 laboratories - 18 months

On Average about 9 events were reported per month per laboratory

True number of occurring events is probably much higher40-100

Why Most Errors are NOT

ReportedThe Wrong

Thing

Happens

There is

Inconvenience

or Harm

Someone is

Aware and Wants

to Report

A Reporting

Mechanism

Exists

The Reporting

Mechanism is

Available

The Reporting

Mechanism is

Easy to Use

No Negative

Reporting

Consequences

The Report

gets

Submitted

Six Reasons Why Most Errors are NOT Reported

The Wrong

Thing

Happens

There is

Inconvenience

or Harm

Someone

Wants to

Report

A Reporting

Mechanism

Exists

The Reporting

Mechanism is

Available

The Reporting

Mechanism is

Easy to Use

No Negative

Reporting

Consequences

The Report

gets

Submitted

Why most errors are not associated with observed inconvenience or harm

!James Reason1990

The other reason that error goes undetected…

Downstreaming or

Butterfly effectsmall initial error leads to large unforeseen consequences over time

Occurrence

Effect

Distribution of Reported

Patient Associated Medical Laboratory Error

80% 15%

5%

Errors Impact More than Patient Care

Extended Definition for Critical ErrorAn error that results in inconvenience or harm involving

any or all:

PatientsFamily

Clinical care staffLaboratory staff

InstitutionCommunityEnvironment

Medical Laboratory Error is the single greatest risk to:

� Patient Care� Work Flow

� Financial stability

� Worker satisfaction

� Credibility

� Investigation

� Litigation

� Regulation

The Most Common Causes of Error are both benign and human

(probably also including medical laboratory error)

Slips: errant missteps or distractions

Mistakes: errant knowledge or errant judgements

Slips and Mistakes become addressable

when they occur over and over and over

James Reason

Sydney Decker

The Most Common Factors that

Cause Slips and Mistakes

System FactorsPoor Work Distribution

Undue Time Constraints

Excessive Noise

Distractions

Confused instruction

Personal

FactorsRushing

Attitude

Stress

Injury

Health

Briggs Phillips

1986

What we know about Error

� Common and Frequent

� Often missed or unreported

� Usually inadvertent and seemingly benign

� Can cause considerable wide spread harm and

inconvenience

� Drives down Quality

� Drives up Cost

What we know about Cost

Accounting Calculations for

Costs of Poor Quality

Prevention Costs� Standards� Equipment� Supplies� Training� Continuing Education� Implementing Quality

Management

Appraisal Costs• Quality Control

• PT/EQA

• Accreditation

• Competency Assessment

Failure Costs

Internal Failure

• Recognition• Repeat• Remediation

• IT• QC

• Correction• Prevention

ExternalFailure

• Contact• Recall• Remediation• Repeat• Correction• Prevention• Litigation

Joseph Juran

Costs of Quality

0

5

10

15

20

25

30

35

40

45

50

PreventionAppraisal Internal External

S. Rodchua

ASQ, Quality Management

JourV16-1, 2009

Costs of Quality:Quality Accounting Practices

0

5

10

15

20

25

30

35

40

45

50

PreventionAppraisal Internal External

Line Listed

Budget Adjusted

Directly Traceable

Not Line Listed

General ledger

Difficult to Trace

Calculus of Costs of Quality

`

Calculus of Costs of QualityRise in P/A costs can decrease both FC and TC

13

2

100%

Defective

Quality of Performance 100%

Good

…but overspending can make total costs rise

Noble MA, K. Meghairbi. Proficiency Testing Can Improve

Medical Laboratory Clinical Testing Performance. Quality Management Conference for Medical Laboratories. Vancouver BC. October 2013

When might a laboratory determine Poor Quality Costs

� As a regular or intermittent Quality Indicator for:�Common Error

�Patient recall

� As a special monitor indicator following Significant Error�Multiple analyzer errors

�Individual’s performance errors

�Laboratory safety failure

�Tracking failure costs sheds light.�Highlights costly errors�Assists learning from errors�Benefits continual improvement

Some errors impact more than money

� Poor Quality is NOT just about money.

�Not all costs are financial.�Defining all costs as financial diminishes

impact.�Non financial costs also drive Error.

� Other Costs to consider�Time Costs

�Patient Costs

�Reputational Costs

�Staff Costs

Laboratory Errors Costs Impact Patients� In Vancouver, how much does an out-patient recall

for repeat testing cost?

Out of PocketBus $ 5.00Drive/Parking $ 4.00 plus

Taxi $10.00Time

Home – to – Home: 60-120 minutes

Anxiety ???Management Delay (24 hours) ???

Laboratory Errors Costs impact Staff and FamilyA laboratory proficiency testing program send simulated stool samples to 150 medical microbiology laboratories. The samples contained laboratorized strains of Shigellaflexneri.

7 laboratory technologists and 1 family member reported developing enteric symptoms. None were hospitalized but all required medical care and follow-up

Budget Impacts: Replacement costs

Total impact: Sick time, Healthcare costsCaregiver costs Family member lost work and income.

Reputational Costs:far beyond the laboratory budget

� A Canadian laboratory started testing for hormone sensitivity tumor markers using an unvalidated assay.

� Many false positive and false negative test results

� 78 women died.

� Provincial enquiry (Cameron Commission)

� Millions of dollars spent

� People lost jobs

� People left jobs to work elsewhere.

� Unable to find people who would fill lost positions.

Employee TEEM Costs

� TIME

� EFFORT

� ENERGY

� MONEY

The amount of time lost counted in minutes

The amount of physical effort and potential injury that is experienced.

The amount of mental stress and anxiety that is experienced.

The amount of money that is expended or lost as impact of cost and error.

Impacts of High Effort and Energy Costs

� Ergonomic Challenges

� Repetitive Stress Syndrome

� Repetitive accidents

� Safety complaints and citations

and

� Personal Stress and Infectious Stress

� Deteriorating Culture

TEEM Compounding Impacts

SlipsDistraction

sErrors

Accidents

STRESSENERG

YANXIET

Y

STRAIN

EFF0RT

PAIN

TEEM Warning Signs

Effort Energy� Dexterity discomfort

� Joint Aches and Pains

� Coughing and Breathing Problems

� Frequent Burns and Rashes

� Missing work

� Difficulty Sitting or Standing

� Dizziness or Falling

� Back Pain

� Inattention to Detail

� Distraction

� Rushing

� Headache

� Missing work

� Anxiety

� Anger

� Rage

Failure Costs

ReputationCosts

CommunityEnvironment

Costs PatientFamilyCosts

EmployeeTEEMCosts

The New Dynamic

In summary…

� Pressures, Quality, Costs, and Laboratory Error are intertwined and

feed on each other.

� Laboratory errors continue to be very common. Most are perceived

as causing no harm, but cause inconvenience.

� Small increases in performance and appraisal costs can result in

large decreases in Failure costs

� Laboratories can and should develop better ways to

track and control FAILURE COSTS

� TEEM Factors magnify the problems that

manifest cost and error and poor Quality

ERROR HAS MANY MANY COSTS

Thank you…For more information on Quality and Cost and Error

� Making Medical Lab Quality Relevantwww.medicallaboratoryquality.com

� This Presentation is available at

www.POLQM.ca

The New Dynamic Failure

CostsReputation

Costs

CommunityEnvironment

Costs PatientFamilyCosts

EmployeeTEEMCosts