Risk Management in the Clinical Lab Flashcards
Any source of potential damage, harm, or adverse health effects on something or someone
HAZARD
the probability and/or amount of contact between the hazard and the entity it is potentially harming
EXPOSURE
Chance or probability that a person will be harmed or experience an adverse health effect if exposed to a hazard
RISK
source or situation with a potential for causing harm
HAZARD
potential cause of an incident which may result in harm
THREAT
FOR BIOSAFETY ISSUES
HAZARD
FOR BIOSECURITY
THREAT
combination of the likelihood of an incident occurring and the severity of the consequences (harm) if that incident were to occur
RISK / BIORISK
CORE of biorisk management
RISK ASSESSMENT
Basis for risk management
LABORATORY BIOSAFETY MANUAL 4TH EDITION
Most incidents were caused by ________ rather than malfunctions of engineering controls
HUMAN FACTORS
_______ approach rather than a prescriptive approach
new-risk and evidence-based
a systematic approach to identify hazards
risk assessment (risk evaluation)
an essential part of shared decision making
risk communication
highly personal process of decision making
risk perception
systematic application of management policies
risk management
several consensus guidelines agencies
ISO 15189
CLSI EP 18, EP 23
CAP (College of American Pathologists)
an approach in which a specialist addresses the prevention and containment of liability by documenting critical or unusual incidents towards the patient or healthcare worker
RISK MANAGEMENT IN HEALTHCARE
process mapping, brainstorming
what can go wrong?
severity of harm, esp. w/ downstream events
how bad is it?
risk management can be?
a project triggered by an occurrence or finding,
* a proactive project to evaluate potential weaknesses in a new, revised, or complex processes or
* a continuous assessment based on daily events and observation of what is happening in the laboratory.
- Analyze the laboratory process
RISK IDENTIFICATION (process mapping and identify risk points)
CORE PROCESSES
Pre-analytic
Test ordering specimen
-collection
-transport
-receipt/accessioning
CORE PROCESSES
Analytic
-hemtology
-chemistry
-special chemistry
-microbio
-immunology
-blood bank
-flow cytometry
-anatomic pathology
CORE PROCESSES
Post-analytic
-patient reports
-specimen storage
A graphical representation of all the steps in a testing process
PROCESS MAPPING
Outlines the cause and effect of a testing process
FISHBONE DIAGRAM
a simple table that lists all errors identified in the different testing phases for a specific test
RISK IDENTIFICATION TABLE
PRE ANALYTICAL
Insufficient sample
Lack of training
Heavy traffic in specimen reception area
Calibration overdue
No inventory control
ANALYTICAL
interfering substances clotted
competency assessment not performed
temperature fluctuates
no mechanism for error detection
improper reagent mixing
POST ANALYTICAL
Inadequate training in how to report critical values
LIS not verified after update
- Evaluate risk points
Risk assessment
Based on probability and severity of impact
anything in the environment that has the potential to cause harm
HAZARD
possibility that something bad or unpleasant will happen
RISK
SOURCES OF ERRORS
-temp
-humidity
-light intensity
-altitude
ENVIRONMENTAL
SOURCES OF ERROR
-improper specimen preparation, handling
-incorrect test interpretation
-failure to follow test system instructions
OPERATOR
SOURCES OF ERRORS
-bubbles
-clots
-incorrect tube additive
SPECIMEN
SOURCES OF ERRORS
-calibration factor incorrect
-mechanical failure
ANALYSIS
SOURCES OF ERRORS
-expired reagents
REAGENTS
6 P’s
Pathogen
Procedures
Personnel
Practices
Protective Equipment
Place
- Control Risks
RISK MITIGATION
HIERARCHY OF RISK CONTROL MEASURES
- ELIMINATION
- SUBSTITUTION
- ENGINEERING CONTROLS
- ADMINISTRATIVE CONTROLS
- PPE
Removing the hazard, not working with the agent or replacing the hazard with something less dangerous
ELIMINATION OR SUBSTITUTION
Physical changes to work stations, equipment, materials, production facilities, or any other relevant aspect
ENGINEERING CONTROLS
Policies, standards and guidelines used to control risks
ADMINISTRATIVE CONTROLS
Processes and activities that have been shown in practice to be effective in reducing risks
PRACTICES AND PROCEDURES
Devices worn by the worker to protect against hazards in the laboratory
PPE
use the information gathered earlier to assess all the identified risks and their control measures
QCP
MSDS
The Globally Harmonized System of Classification and Labelling of Chemicals
CHEMICAL HYGIENE PLAN
Follow the data until you see a pattern of resolution based on the indicators chosen.
* Bring the risk down to the point where there are constraints (based on available technology, or budget) that prevent you from reasonably bringing it down any further.
* There will always be some residual risk.
- Monitor risks
- Verify that the QCP that is put in place actually works.
- Continue to monitor errors and control failures.
- If an error occurs:
- Taketheappropriatecorrectiveaction.
- Investigatethecauseoftheerror.
- Once the cause is understood, evaluate whether any changes need to be made in the QCP.
Monitor Quality Control Plan for Effectiveness
can minimize the chance of errors and ensure reliability of test results.
Risk management
