Patient Safety Issues

Where Does the Lab Professional Fit In?

Mary Ann McLane, PhD, CLS(NCA)Region II Director

The patient must come

first!

ObjectivesAt the conclusion of this seminar, the

participant will be able to: Describe the components of the

Institute of Medicine’s 1999 “To Err Is Human” document which relate to the clinical lab.

Compare and contrast the programs offered by JCAHO’s Speak Up” initiative.

List at least 5 examples of errors involving patient safety and pre-analytical/post-analytical error.

Unsafe acts are like mosquitoes…You can try to swat them one at a time,

but there will always be others to take their place. The only effective remedy is to drain the swamps in which they breed. In the case of errors and violations, the "swamps" are equipment designs that promote operator error, bad communications, high workloads, budgetary and commercial pressures…

Unsafe acts are like mosquitoes……procedures that necessitate their

violation in order to get the job done, inadequate organization, missing barriers, and safeguards . . . the list is potentially long but all of these latent factors are, in theory, detectable and correctable before a mishap occurs.

James Reason, To Err Is Human

Americans harmed by medical error

Two studies of large samples of hospital admissions New York using 1984 data Colorado and Utah using 1992 data

adverse event (injuries caused by medical management) were 2.9 and 3.7 percent respectively

adverse events attributable to errors (i.e., preventable adverse events) was 58 percent in New York, and 53 percent in Colorado and Utah

extrapolated to the over 33.6 million admissions to U.S. hospitals in 1997 44,000 to 98,000 Americans die in hospitals

each year as a result of medical errors exceed the number attributable to the 8th-

leading cause of death exceed the deaths attributable to motor

vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516)

Total national costs lost income, lost household

production, disability, health care costs $37.6 billion to $50 billion for adverse

events $17 billion to $29 billion for preventable

adverse events slightly higher than the direct and indirect

costs of caring for people with HIV and AIDS.

Lives lost more than 6,000 Americans die

from workplace injuries every year in 1993 medication errors are

estimated to have accounted for about 7,000 deaths one out of 131 outpatient deaths one out of 854 inpatient deaths

Medication-related errors occur frequently in hospitals; not all result in actual harm, but those that do are costly. 2% admissions at two large hospitals:

preventable adverse drug event average increased hospital costs of $4,700 per

admission about $2.8 million annually for a 700-bed

teaching hospital.

Medication-related errors not all result in actual harm those that do are costly Preventable: $2 billion for the nation

as a whole.

Not just hospital patients In 1998: ~2.5 billion prescriptions

were dispensed by U.S. pharmacies at a cost of about $92 billion. errors in

prescribing medications dispensing by pharmacists unintentional nonadherence on the part of

the patient.

Definitions Adverse event

injury caused by medical management rather than the underlying condition of the patient.

Preventable adverse event adverse event attributable to error

Definitions Error

the failure of a planned action to be completed as intended (i.e., error of execution)

the use of a wrong plan to achieve an aim (i.e., error of planning)

Definitions Negligent adverse event

the care provided failed to meet the standard of care reasonably expected of an average physician qualified to take care of the patient

Discussion point: expected of an “average physician” only?

Why focus on medication-related error? One of the most common types of

error Substantial numbers of individuals

are affected Accounts for a sizable increase in

health care costs

Why focus on medication-related error? Easy to identify an adequate sample of

patients who experience adverse drug events

The drug prescribing process provides good documentation of medical decisions, residing in automated, easily accessible databases Case of Comfort and Caring, Inc

Deaths attributable to medication errors are recorded on death certificates.

Important note!

“There are probably other areas of health care delivery that have been studied to a lesser degree but may offer equal or greater opportunity for improvement in safety.”

That is us!!

What the literature shows

1. How frequently do errors occur?2. What factors contribute to errors?3. What are the costs of errors?4. Are public perceptions of safety in health care consistent with the evidence?

Harvard Medical Practice Study >30,000 randomly selected discharges 51 randomly selected hospitals in New

York State in 1984 Adverse events, manifest by prolonged

hospitalization or disability at the time of discharge or both = 3.7%

Preventable adverse events = 58% Negligence = 27.6%

Harvard Medical Practice Study 13.6% resulted in death 2.6% caused permanently disabling

injuries

Type of adverse event drug complications = 19% wound infections = 14% technical complications = 13%

First instinct? Blame someone! However… due most often to the

convergence of multiple contributing factors

blaming an individual does not change these factors and the same error is likely to recur

Case of Charles Thompson, deathrow inmate from TX

What would work better? Preventing errors and improving safety

for patients requires a systems approach to modify the conditions that

contribute to errors which recognizes people working in

health care are among the most educated and dedicated workforce in any industry

What would work better? The problem is not bad people The problem is that the system

needs to be made safer.

Hindsight bias things that were not seen or

understood at the time of the accident seem obvious in retrospect misleads a reviewer into simplifying the

causes of an accident highlighting a single element as the cause overlooking multiple contributing factors

Hindsight bias things that were not seen or

understood at the time of the accident seem obvious in retrospect information about an accident is spread

over many participants no one may have complete information easy to arrive at a simple solution or to

blame an individual, but difficult to determine what really went wrong.

More definitions Slips

action conducted is not what was intended observable

Mistakes the planned action is wrong

More definitions Slips

physician chooses an appropriate medication, writes 10 mg when the intention was to write 1 mg

Mistakes selecting the wrong drug because the diagnosis

is wrong Important not to equate slip with "minor."

Patients can die from slips as well as mistakes.

Lab definitions? Slips (action conducted is not what was intended)

physician chooses an appropriate medication, writes 10 mg when the intention was to write 1 mgaaaaaaaaaaaaaaaaaaaaaaaaaaaa

Mistakes (the planned action is wrong)

Safety = absence of errors? More! Multiple dimensions

an outlook: health care is complex and risky and solutions are found in the broader systems context;

a set of processes: identify, evaluate, and minimize hazards and continuously improve

an outcome: manifested by fewer medical errors and minimized risk or hazard

Safety definition Freedom from accidental injury

from the patient's perspective, the primary safety goal is to prevent accidental injuries

Safe environment = low risk of accidents reduce defects in the process or departures

from the way things should have been done establish operational systems and processes

that increase the reliability of patient care.

Active vs. latent error Active errors

occur at the level of the frontline operator their effects are felt almost immediately

Latent errors removed from the direct control of the

operator poor design, incorrect installation, faulty

maintenance, bad management decisions, and poorly structured organizations

Active vs. latent error Active errors

the pilot crashed the plane

Latent errors a previously undiscovered design

malfunction caused the plane to roll unexpectedly in a way the pilot could not control and the plane crashed

Active vs. latent error Latent error

greatest threat to safety in a complex system often unrecognized have the capacity to result in multiple types

of active errors. Challenger accident traced contributing

events back nine years Three Mile Island accident, latent errors were

traced back two years

Active vs. latent error Latent error

difficult for the people working in the system to notice

errors may be hidden in the design of routine processes in computer

programs in the structure or management of the organization

people become accustomed to design defects and learn to work around them, so they are often not recognized

Active vs. latent error Latent error

"normalization of deviance" small changes in behavior became the

norm additional deviations became acceptable the potential for errors is created

signals are overlooked or misinterpreted signals accumulate without being noticed

Active vs. latent lab error Active errors

Latent errors

First instinct? focus on the active errors by punishing

individuals (e.g., firing or suing them) retraining or other responses aimed at

preventing recurrence of the active error punitive response may be appropriate in

some cases (e.g., deliberate malfeasance) it is not an effective way to prevent

recurrence

First instinct? Large system failures

latent failures coming together in unexpected ways

appear to be unique in retrospect Same mix of factors is unlikely to

occur again efforts to prevent specific active errors

are not likely to make the system any safer

Focus on active errors lets the latent failures remain in

the system their accumulation actually makes

the system more prone to future failure

Focus on latent errors Discovering and fixing latent

failures, and decreasing their duration, are likely to have a greater effect on building safer systems than efforts to minimize active errors at the point at which they occur

likely to have a greater effect on building safer systems

High reliability theory accidents can be prevented through

good organizational design and management an organizational commitment to safety high levels of redundancy in personnel

and safety measures strong organizational culture for

continuous learning and willingness to change

Correct performance and error "two sides of the same coin”

Complexity and tight-coupling Systems that are more complex

and tightly coupled are more prone to accidents and have to be made more reliable complex and tightly coupled systems

can "spring nasty surprises.“ Guess what type of system

healthcare is????!!!

Two cases of success Aviation Occupational health

growing awareness of safety concerns and the need to improve performance

comprehensive strategies creation of a national focal point for leadership development of a knowledge base dissemination of information throughout the

industry

Two cases of success Aviation Occupational health

designated government agency with regulatory responsibility for safety

carefully constructed research agenda

substantial resources devoted to these initiatives

Third case of success? Healthcare

no cohesive effort to improve safety in health care

resources devoted to enhancing and disseminating the knowledge base are wholly inadequate

“health care is not likely to make significant safety improvements without a more comprehensive, coordinated approach.“

Center for Patient Safety provide leadership for safety

improvements throughout the industry establish goals and track progress in

achieving results expand the knowledge base for

improving safety in health care provide visibility to safety

concerns

Role of professionals Become active leaders in encouraging and

demanding improvements in patient safety. Setting standards, convening and

communicating with members about safety Incorporating attention to patient safety into

training programs Collaborating across disciplines Contribute to creating a culture of safety. As

patient advocates, health care professionals owe their patients nothing less.

Center for Patient Safety should… 4. Define feasible prototype

systems (best practices) and tools for safety in key processes, including both clinical and managerial support systems for… management of diagnostic tests,

screening, and information…

Improve Access to Accurate, Timely

Information

Information about the patient, medications, and other therapies should be available at the point of patient care, whether they are routinely or rarely used. Examples of ways to make such information available are the following

Improve Access to Accurate, Timely

Information• Have a pharmacist available on nursing

units and on rounds.(why just a pharmacist? Commercial minute for the professional DLM doctorate…)

• Use computerized lab data that alert clinicians to abnormal lab values.

• Place lab reports and medication records at the patient's bedside.

• Place protocols in the patient's chart.

Improve Access to Accurate, Timely

Information• Color-code wristbands to alert of

allergies.• Track errors and near misses and report

them regularly.• Accelerate laboratory turn around time.…also noted the importance of involving

the patient in their own care…commercial about the ASCLS consumer webpage

Joint Commission on Accreditation of Healthcare Organizations Speak Up:  Help Prevent Errors In Your Care

Brochures and Poster

Speak Up Poster Hospitals (English) Ambulatory Care Hospitals (Spanish)  Behavioral Health Care Laboratory Services  Health Care Networks  Long Term Care Home Care    

http://www.jcaho.org/general+public/gp+speak+up/speak+up_bro.htm630-792-5800, option 5

So what’s happened since 1999? 2001

Congress: $50E6 for safety research IOM: The Quality Chasm

2004 Congress named Agency for Healthcare

Research and Quality Center for Quality Improvement and Safety

Education, training, dissemination, setting standards

Health and Human Services Agency for Healthcare Research and Quality Quality & Patient Safety Health Information Technology

Electronic health records — innovation — privacy — international standards — data sources — clinical vocabulary

National Quality Measures Clearinghouse™Evaluate health care quality — online database — process — outcome — access — patient experience

CAHPS®—Consumer Assessment of Health PlansConsumer feedback — survey and report tools — fact sheet — impact

Measuring Healthcare QualityStudies and projects — standardized methods — performance measures

Medical Errors & Patient SafetyScope of problem — reducing errors — research program — patient tips

WebM&M: Morbidity & Mortality RoundsPatient safety forum— learning modules — analysis of medical errors

Quality IndicatorsHospital quality measures — prevention — inpatient — patient safety

Quality Information & ImprovementEmployer experience — consumer information — case studies — glossary

TalkingQualityCommunicating with consumers — health care report cards

2005 JAMA (Lucian Leape, Donald Berwick)

Computerized prescribing

Including pharmacists on rounds

Standardizing medication practices

Errors 80%

Preventable adverse events down 78%

Adverse events down 60%

Am J Clin Pathol Volume 120, 18-26, 2003 Classifying laboratory incident reports to

identify problems that jeopardize patient safety

129 incidents 95% potential adverse events 73% preventable

71% preanalytical, 18% analytical, , 11% postanalytical

30% involved cognitive error (incorrect choices caused by insufficient knowledge)

73% involved noncognitive error (lapses in expected automatic behavior)

ADVANCE for MLP 11/7/05 Quashing errors Streamlining… the lab professionals getting

involved in the training of nurses… Cited Clin Chem 1997 paper (Plebani et al)

46% lab errors = preanalytical phase 68.2% of these = specimen collection Note…we usually haven’t a clue if it’s been drawn

correctly unless it’s in the wrong tube…

Comment on the Clin Chem paper 1998, Volume 44: 1066-67, Witte et

al. Analyzed 219,353 clin chem results

and found 98 errors 447 ppm Anesthesia errors = 2.5 ppm Aviation errors = 0.18 ppm We have a ways to go!!

And then there are the blood glucose meters…

11/9/05 Glucose readings done using stix having

glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) as the method

Falsely increases glucose levels in patients receiving parenteral products containing maltose, galactose, d-xylose

Peritoneal dialysis Immune globulin

Our turn!