Risk Management in the Clinical Lab

Question 1

Any source of potential damage, harm, or adverse health effects on something or someone

Answer 1

HAZARD

Question 2

the probability and/or amount of contact between the hazard and the entity it is potentially harming

Answer 2

EXPOSURE

Question 3

Chance or probability that a person will be harmed or experience an adverse health effect if exposed to a hazard

Answer 3

RISK

Question 4

source or situation with a potential for causing harm

Answer 4

HAZARD

Question 5

potential cause of an incident which may result in harm

Answer 5

THREAT

Question 6

FOR BIOSAFETY ISSUES

Answer 6

HAZARD

Question 7

FOR BIOSECURITY

Answer 7

THREAT

Question 8

combination of the likelihood of an incident occurring and the severity of the consequences (harm) if that incident were to occur

Answer 8

RISK / BIORISK

Question 9

CORE of biorisk management

Answer 9

RISK ASSESSMENT

Question 10

Basis for risk management

Answer 10

LABORATORY BIOSAFETY MANUAL 4TH EDITION

Question 11

Most incidents were caused by ________ rather than malfunctions of engineering controls

Answer 11

HUMAN FACTORS

Question 12

_______ approach rather than a prescriptive approach

Answer 12

new-risk and evidence-based

Question 13

a systematic approach to identify hazards

Answer 13

risk assessment (risk evaluation)

Question 14

an essential part of shared decision making

Answer 14

risk communication

Question 15

highly personal process of decision making

Answer 15

risk perception

Question 16

systematic application of management policies

Answer 16

risk management

Question 17

several consensus guidelines agencies

Answer 17

ISO 15189
CLSI EP 18, EP 23
CAP (College of American Pathologists)

Question 18

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

Answer 18

RISK MANAGEMENT IN HEALTHCARE

Question 19

process mapping, brainstorming

Answer 19

what can go wrong?

Question 20

severity of harm, esp. w/ downstream events

Answer 20

how bad is it?

Question 21

risk management can be?

Answer 21

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.

Question 22

1. Analyze the laboratory process

Answer 22

RISK IDENTIFICATION (process mapping and identify risk points)

Question 23

CORE PROCESSES
Pre-analytic

Answer 23

Test ordering specimen
-collection
-transport
-receipt/accessioning

Question 24

CORE PROCESSES
Analytic

Answer 24

-hemtology
-chemistry
-special chemistry
-microbio
-immunology
-blood bank
-flow cytometry
-anatomic pathology

Question 25

CORE PROCESSES Post-analytic

Answer 25

-patient reports -specimen storage

Question 26

A graphical representation of all the steps in a testing process

Answer 26

PROCESS MAPPING

Question 27

Outlines the cause and effect of a testing process

Answer 27

FISHBONE DIAGRAM

Question 28

a simple table that lists all errors identified in the different testing phases for a specific test

Answer 28

RISK IDENTIFICATION TABLE

Question 29

PRE ANALYTICAL

Answer 29

Insufficient sample Lack of training Heavy traffic in specimen reception area Calibration overdue No inventory control

Question 30

ANALYTICAL

Answer 30

interfering substances clotted competency assessment not performed temperature fluctuates no mechanism for error detection improper reagent mixing

Question 31

POST ANALYTICAL

Answer 31

Inadequate training in how to report critical values LIS not verified after update

Question 32

2. Evaluate risk points

Answer 32

Risk assessment Based on probability and severity of impact

Question 33

anything in the environment that has the potential to cause harm

Answer 33

HAZARD

Question 34

possibility that something bad or unpleasant will happen

Answer 34

RISK

Question 35

SOURCES OF ERRORS -temp -humidity -light intensity -altitude

Answer 35

ENVIRONMENTAL

Question 36

SOURCES OF ERROR -improper specimen preparation, handling -incorrect test interpretation -failure to follow test system instructions

Answer 36

OPERATOR

Question 37

SOURCES OF ERRORS -bubbles -clots -incorrect tube additive

Answer 37

SPECIMEN

Question 38

SOURCES OF ERRORS -calibration factor incorrect -mechanical failure

Answer 38

ANALYSIS

Question 39

SOURCES OF ERRORS -expired reagents

Answer 39

REAGENTS

Question 40

6 P’s

Answer 40

Pathogen Procedures Personnel Practices Protective Equipment Place

Question 41

3. Control Risks

Answer 41

RISK MITIGATION

Question 42

HIERARCHY OF RISK CONTROL MEASURES

Answer 42

1. ELIMINATION 2. SUBSTITUTION 3. ENGINEERING CONTROLS 4. ADMINISTRATIVE CONTROLS 5. PPE

Question 43

Removing the hazard, not working with the agent or replacing the hazard with something less dangerous

Answer 43

ELIMINATION OR SUBSTITUTION

Question 44

Physical changes to work stations, equipment, materials, production facilities, or any other relevant aspect

Answer 44

ENGINEERING CONTROLS

Question 45

Policies, standards and guidelines used to control risks

Answer 45

ADMINISTRATIVE CONTROLS

Question 46

Processes and activities that have been shown in practice to be effective in reducing risks

Answer 46

PRACTICES AND PROCEDURES

Question 47

Devices worn by the worker to protect against hazards in the laboratory

Answer 47

PPE

Question 48

use the information gathered earlier to assess all the identified risks and their control measures

Answer 48

QCP

Question 49

MSDS The Globally Harmonized System of Classification and Labelling of Chemicals

Answer 49

CHEMICAL HYGIENE PLAN

Question 50

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.

Answer 50

4. Monitor risks

Question 51

* 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.

Answer 51

Monitor Quality Control Plan for Effectiveness

Question 52

can minimize the chance of errors and ensure reliability of test results.

Answer 52

Risk management