OCCURRENCE MANAGEMENT

IN THE MEDICAL
LABORATORY

By
Calvin BISONG EBAI, PhD
MLS/FHS/UBa
 Objectives
• At the end of this lecture, students should be able to:

1. Understand the meaning of occurrences in the lab

2. Know the various types of occurrences in the lab

3. Know the sources of error

4. Know the procedure for the detection of errors

5. Know the various methods for the correction of errors

6. Know how to prevent errors in the lab

 PLAN

• Role
• Overview of lab process
• Causes of error
• Consequences
• Investigating errors
• Rectifying and Managing errors
• Responsibilities
• Conclusion
 Role in quality management
systems

• Occurrence management, or dealing with laboratory errors, is important

in ensuring good service from the laboratory.

• It is one of the 12 quality essentials and must be addressed in laboratory

quality management.

• This chapter will describe and explain basic elements that are essential
for developing an effective occurrence management program.
 Overview of the process

• Occurrence management is a central part of continual improvement. It is

the process by which errors or near errors (also called near misses) are
identified and handled.

• The goal of an occurrence management program is to correct the errors

in either testing or communication that result from an event, and to
change the process so that the error is unlikely to happen again.
 Overview of the process

• Well-managed laboratories will also review their systems and detect

process problems that could possibly cause error at some time in the
future, allowing for prevention of these errors.
 Definition

• An occurrence is any event that has a negative impact on an

organization, including its personnel, the product of the organization,
equipment, or the environment in which it operates.

• All such events must be addressed in an occurrence management

program.
 Sources and consequences of
laboratory error
• Causes of laboratory error

• Some of the common causes of error in the laboratory are easily

identifiable, and are also readily correctable.

• For example, some errors may occur because staff are unclear about
who is responsible for carrying out a particular task, so it may remain
undone.

• To prevent these types of errors, individual responsibilities must be

clearly defined and communicated.
 Sources and consequences
cont’d
• Other errors occur when procedures are not written or followed, and
staff are not adequately trained.

• Written procedures serve as a guide for all staff, and help to ensure
that everyone knows what to do. It is essential to ensure that these
written procedures are followed correctly.
 Sources and consequences
cont’d
• Staff need to be trained in how to conduct the procedures and, if this
training is neglected, errors can result.

• There are many other sources of error in addition to these, which are
frequently observed. While they often occur during pre-examination
and post-examination processes, errors can occur throughout the
testing process.
 Sources and consequences
cont’d
• Useful studies for understanding sources of laboratory errors include a
retrospective data collection that found Australian pathology laboratories
had a transcription error rate of up to 39%, and an error rate of up to 26%
for analytical results.

• A report from the College of American Pathologists in collaboration with

the Centres for Disease Control and Prevention Outcomes Working Group
describes error stratification in the working process for clinical
laboratories.
 Sources and consequences
cont’d
• In more than 88 000 defects, 41% were observed in the pre-
examination phase of testing, 55% in the post-examination phase and
only 4% in the examination phase.
 Pre-examination errors

• Some examples of pre-examination errors that are frequently seen include:

• Collecting the wrong sample;

• Mis-labelling or failing to label the sample;

• Storing the sample incorrectly prior to testing, so that the sample deteriorates;

• Transporting the sample under conditions that damage the sample or that endanger
staff and public safety;

• Damaging the reagents or test kits by storing them improperly

 Examination errors
• A list of common errors that occur during the testing process include:

• Failing to follow an established algorithm (e.g. For HIV testing);

• Reporting of results when the quality control material tests is out of range;

• Incorrect measuring of the sample or reagents (usually these are dilution or

pipetting errors);

• Using reagents that have been improperly stored, or after their expiration
date.
 Post-examination errors
• Many of the common laboratory errors occur following the testing of the sample, and
some of these may be more difficult to detect.

• Common examples of these kinds of errors include:

• Making a transcription error when preparing the report;

• Producing a report that is illegible, usually caused by poor handwriting, but sometimes by
damage to the report form;

• Sending report to the wrong location, which often results in complete loss of the report;

• Failing to send the report.

 Consequences of laboratory
error
• The laboratory is a critical partner in all health systems, and it must perform its functions
well in order to help ensure good outcomes of health programmes and interventions.

• A failure in the laboratory role can have significant effect, producing:

• inadequate or inappropriate patient care

• inappropriate public health action

• undetected communicable disease outbreaks

• wasting of resources

• death of an individual.
 Investigation of occurrences

• Occurrence cycle includes investigation

• A cycle of events reflects the process of occurrence management. When

occurrences are found, they must all be investigated to find the causes of the
problem.

• The investigation will help to identify the actions needed to correct the
problem and to ensure that it does not occur again.

• All necessary communication must take place, including informing any health
care providers whose clients are affected.
 Detecting occurrences

• Occurrences are detected through a variety of investigative

techniques.
• Monitoring of complaints and satisfaction surveys will yield much
information. Once the laboratory establishes and monitors quality
indicators, deficits will be noted.
 Detecting occurrences cont’d
• The tools of external assessment, such as proficiency testing, external
quality assessment, accreditation and certification processes, will be
very useful in occurrence management.

• A very valuable tool is the internal audit, which can be performed at

any time in the laboratory.

• The laboratory’s process improvement efforts will identify

opportunities for improvement.
 Detecting occurrences cont’d

• It is the responsibility of management to review all the information

that results from use of these tools, and to look for underlying
patterns and potential causes for persistent or repeated error.

• Investigation involves gathering complete and detailed information

about events that led to a problem, and a thorough analysis to
determine all the factors that contributed to the problem occurrence.
 Root cause analysis

• The most aggressive and complete approach to addressing occurrences

is to seek the root cause of the problem.

• This is more than just a thorough examination, but is a planned and

organized approach toward finding not only the superficial causes of a
problem, but also the deeper or core problems.

• With some occurrences, they are likely to recur until such time as the
true root causes are discovered and addressed.
Root cause analysis
 Rectifying and managing
occurrences
Correction of occurrences

• As a reminder, an occurrence is any event that has a negative impact

on an organization, which includes personnel, product, equipment or
the environment.

• There are several levels of action that may be undertaken to rectify

occurrences, including the following.
 Rectifying and managing occurrences

• Preventive actions involve a planned and organized evaluation of processes

and procedures to identify potential error points, so action can be taken to
prevent the errors from ever occurring. Preventive actions require planning
and team participation.

• Remedial action, or remediation, is the fixing of any consequences that

result from an error. For example, if an erroneous result has been reported,
it is essential to immediately notify all persons concerned about this error
and to provide the correct result.
 Rectifying and managing
occurrences
• Corrective actions address the cause of the error. If a test was done
incorrectly, resulting in an incorrect result, corrective actions sort out
why the test was not performed properly and steps are taken so that the
error does not happen again.

• As an example, a piece of equipment may have been malfunctioning,

and the corrective actions would be to recalibrate, repair or otherwise
address the equipment problem.
 Occurrence management process

• The laboratory should develop a system for prompt investigation of every

laboratory problem and error. The management process for dealing with
errors or occurrences involves several steps.

1. Establish a process to detect all problems, using the tools that are
available. Remember that problems may go undetected unless there is an
active system for looking for them.

2. Keep a log of all problem events that records the error, any investigation
activities and any actions taken.
 Occurrence management process
cont’d
3. Investigate the cause of any problem that is detected and carefully analyze the
information that is available.

4. Take the necessary action (remedial and corrective)—if the problem is detected
before the error actually occurs, take preventive action.

5. Monitor and observe for any recurrence of the original problem, keeping in mind
that there may be a systemic problem.

6. Provide information to all those who need it, and to those who are affected by the
error.
 Responsibilities

• The responsibility for monitoring for occurrences belongs to everyone in

the laboratory.

• It is important, however, that someone be designated as the person

responsible for marshalling the energies and activities of all staff into an
effective management process.

• In many instances, this is the responsibility of the laboratory director,

laboratory manager or quality manager.
 Conclusion

• Occurrence management is an integral component of laboratory quality

management.

• It establishes the methods for finding errors and preventing them from
occurring again, and also seeks to identify potential errors and prevent
them from happening.

• The laboratory should employ an active process for occurrence

management and take a positive approach.
 Conclusion cont’d

• Make an effort to detect problems as early as possible, and then take

immediate remedial and corrective action.

• Be proactive and see opportunities to identify potential error, thus

preventing an occurrence.

• Finally, keep good records of all problems, investigations and actions

taken
• JITA