Quality Control

Question 1

_________________(ISO)

the ___________________ (CLSI)

Answer 1

International Organization for Standardization

Clinical and Laboratory Standards Institute

Question 2

quality management system can be defined as “ _______ to ________ an organization with regard to quality”.

Answer 2

coordinated activities

direct and control

Question 3

ISO standards group laboratory processes into ______,______, and ________ categories.

Comparable terms in current laboratory use include: ______,______, and _______ processes; or _______,______, and _______ processes.

Answer 3

pre-examination, examination and post-examination

pre-analytic, analytic and post-analytic

pre-test, test and post-test

Question 4

entire set of operations that occur in testing is called the __________

Answer 4

path of workflow.

Question 5

The path of workflow begins with the ______ and ends in ________________

Answer 5

patient

reporting and results interpretation

Question 6

The concept of the path of workflow is a key to the _________ or ________, and must be considered when developing quality practices.

Answer 6

quality model or the quality management system

Question 7

quality management system model was developed by _____

Answer 7

CLSI

Question 8

quality management system model is not compatible with ISO standards.

T/F

Answer 8

F

It is fully compatible with ISO standards.

Question 9

Implementing a quality management system guarantees an error-free laboratory

T/F

Answer 9

F

It may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring.

Question 10

Organization
In order to have a functioning quality management system, the structure and management of the laboratory must be organized so that quality policies can be established and implemented.
There must be a strong ___________ (_____________ is crucial) and there must be a mechanism for _______ and _______

Answer 10

supporting organizational structure

management commitment

implementation and monitoring.

Question 11

Personnel

The quality management system addresses many elements of personnel _______ and _______, and reminds us of the importance of ______ and _____

Answer 11

management and oversight

encouragement and motivation.

Question 12

The most important laboratory resource is ____________

Answer 12

competent, motivated staff.

Question 13

Equipment

Many kinds of equipment are used in the laboratory, and each piece of equipment must be functioning properly.
________ the right equipment, _____ it correctly, ensuring that new equipment works properly, and having a system for _______ are all part of the equipment management programme in a quality management system.

Answer 13

Choosing

installing

maintenance

Question 14

Purchasing and inventory
The management of ______ and ——— in the laboratory is often a challenging task.
However, proper management of purchasing and inventory can produce _____ in addition to ensuring ________

Answer 14

reagents and supplies

cost savings

supplies and reagents are available when needed.

Question 15

The procedures that are a part of management of purchasing and inventory are designed to ensure that all reagents and supplies are _______, and that they are ___________________

Answer 15

of good quality

used and stored in a manner that preserves integrity and reliability.

Question 16

Process control

These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation.
The elements of process control are very familiar to laboratorians; ______ was one of the first quality practices to be used in the laboratory and continues to play a vital role in ensuring accuracy of testing.

Answer 16

quality control

Question 17

Information management
The product of the laboratory is _____, primarily in the form of ______.

Information (data) needs to be carefully managed to ensure ______ and ______, as well as accessibility to the laboratory staff and to the health care providers.
Information may be managed and conveyed with either paper systems or with computers.

Answer 17

information

test reporting

Question 18

Documents and records
Many of the 12 quality system essentials overlap. A good example is the close relationship between “Documents and records” and “ ________ “.

Documents are needed in the laboratory to inform how to do things, and laboratories always have many documents.
Records must be meticulously maintained so as to be accurate and accessible.

Answer 18

Information management

Question 19

Occurrence management

A system is needed to ______ these problems or occurrences, to ______ them properly, and to ____ from mistakes and ———— so that __________

Answer 19

detect; handle

learn

take action so that they do not happen again.

Question 20

An “occurrence” is ______________

Answer 20

an error or an event that should not have happened.

Question 21

Assessment
The process of assessment is a tool for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories.
Assessment may be internal ( ______________ ) or it may be external (__________).
Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory.

Answer 21

performed within the laboratory using its own staff

conducted by a group or agency outside the laboratory

Question 22

Process improvement
The primary goal in a quality management system is __________ of the laboratory processes, and this must be done in a systematic manner.
There are a number of tools that are useful for process improvement.

Answer 22

continuous improvement

Question 23

Facilities and safety
Many factors must be a part of the quality management of facilities and safety.
These include:
Security—which is the process of _______________

Containment—which seeks to minimize risks and prevent _____________

Safety—which includes policies and procedures to prevent ___________

Ergonomics—which addresses facility and equipment ______ to allow safe and healthy working conditions at the laboratory site.

Answer 23

preventing unwanted risks and hazards from entering the laboratory space.

hazards from leaving the laboratory space and causing harm to the community.

harm to workers, visitors and the community.

adaptation

Question 24

laboratory is a service organization

T/F

Answer 24

T

Question 25

The principles of statistically analyzing QC were initially applied to the clinical laboratory in the —-s by _________

Answer 25

1950

Levey and Jennings

Question 26

QC material

Variation between vials should be (minimal or maximal?) so that differences seen over time can be attributed to the ________ and not variation in the _____

Answer 26

Minimal

Analytic method itself

QC material

Question 27

Specimens analyzed for QC purposes are known as _______ and must be available in sufficient quantity to last at least ____ and aliquoted in ___ form.

Answer 27

QC material

A year

Stable

Question 28

QC materials should be the same _—— as the specimens actually to be tested. For example, a glucose assay performed on serum should have QC materials that are prepared in serum.

Answer 28

Matrix

Question 29

General chemistry assays generally use ____ levels of control, while immunoassays commonly use ____.

Answer 29

two

three

Question 30

Nowadays, which happens more?

laboratories purchase control materials from companies that manufacture products for QC
Or

prepare the materials themselves.

Answer 30

Today, laboratories more often purchase control materials from companies that manufacture products for QC, instead of preparing the materials themselves.

Question 31

QC materials

Control material concentrations should span the _____ range of the analyte at appropriate decision levels.

Answer 31

clinically important

Question 32

QC materials

These materials are often ______ (______ to ——— ) for stability and can be reconstituted

Answer 32

lyophilized

dehydrated to powder

Question 33

Control materials must be purchased with previously assayed ranges.

T/F

Answer 33

F

Control materials can purchased with or without previously assayed ranges.

Question 34

common method to assess the determination of control materials over time is by the use of a ____________

Answer 34

Levey-Jennings control chart.

Question 35

Control charts graphically represent the ________ values of a control material over time in the context of the _____ and _____ control limits. And when that value falls with the control limits, it can be interpreted that _____________
Points falling outside the control limits may suggest that —————-

Answer 35

observed; upper and lower

the method is performed adequately.

problems may be developing.

Question 36

Imprecision is the __________ about the mean due to ______.
Inaccuracy is the difference between a _______ value and its _____ value

Answer 36

dispersion of repeated measurements

analytic error

true

Question 37

Systemic error: error always in ______

Answer 37

One direction

Question 38

Constant error: type of systemic error in the _____ direction and magnitude. The magnitude of change is _______ and not dependent on the ________

Answer 38

sample; constant

amount of analyte

Question 39

Proportional error: type of ________ where the magnitude changes as ___________

Error is depending on _________

Answer 39

systemic error

a percentage of the analyte present

analyte concentration

Question 40

Total error = ________ + _______

Answer 40

Random error

Systemic error

Question 41

Operation of a Quality Control System
The QC system in the clinical laboratory is used to monitor the analytic variations that can occur.
The QC program can be thought of as a three-stage process:
1. Establishing ________ of variation for each analytic method
2. Using these limits as criteria for ______ the QC data generated for each test
3. Taking action to ______ when indicated a. ___________
b.________
c.__________

Answer 41

allowable statistical limits

evaluating

remedy errors

Finding the cause(s) of error

Taking corrective action

Re-analyzing control and patient data

Question 42

In general, monitoring of analytic methods is performed by assaying __________ materials and comparing the lab’s _______ values with the manufacturer’s _____ values.

Answer 42

stable control

determined; expected

Question 43

The expected values are represented by intervals of acceptable values with upper and lower limits, known as _______

Answer 43

control limits.

Question 44

When the expected values are within the control limits, the operator can be assured that __________________

However, when observed values fall outside of the control limits, the operator ——————- and _________ before potentially erroneously reporting patient results.

Answer 44

the analytic method is properly reporting values.

can be notified of possible problems and further analysis of the method can be made

Question 45

The “multirule” procedure was developed by __________ to further judge whether control results indicate _________ situations.

Answer 45

Westgard and Groth

out-of-control

Question 46

Multi rule procedure

These rules established a criterion for judging whether an analytic process is out of control.
To simplify the various control rules, Westgard and Groth used abbreviations for the various control rules.
Control rules indicate the number of ____________, followed by the _____ in subscript.

Answer 46

control observations per analytic run

control amount

Question 47

Multi rule procedure

If a method is in control, ideally _______ control rules should be violated and the analytic run will not be rejected.

Answer 47

none of the

Question 48

In addition to daily QC practices, laboratories are required to participate in _______________ programs which is another tool in the ongoing process of _________.

Answer 48

external proficiency testing

monitoring test performance

Question 49

External Quality control: Proficiency testing

For a proficiency test, a series of (known or unknown?) samples are sent to the laboratory from the program offering this analysis, such as ____.
The samples are analyzed in the same manner as patient specimens, and the results are reported to the proficiency program.

Answer 49

Unknown ; CAP

Question 50

External Quality control: Proficiency testing

The program then compiles the results from all of the laboratories participating in the survey and sends a ______ back to each participating laboratory.

Each analyte has a defined performance criteria (e.g., ______ to peer mean), where laboratories using the same method are graded by comparing them with the group.

Answer 50

performance report

+/- 3 SDs

Question 51

Proficiency testing allows each laboratory to compare its test results with those of other laboratories that use the ____________ and ________

Answer 51

same or similar instruments and methods.

Question 52

External Quality control: Proficiency testing

Laboratories may be asked to submit information that could include ______ and _____ proficiency testing reports, QC and equipment monitoring, analysis and _____ action of the problem that caused the failure, and the steps taken to ________ of patient test results.

Answer 52

current and historical

corrective

ensure the reliability

Question 53

External Quality control: Proficiency testing

If the laboratory cannot resolve analyte testing discrepancies, the testing facility may be at risk of ________________

Besides meeting required accreditation standards, proficiency testing allows the laboratory to objectively ensure they ________________

Answer 53

losing the authority to perform patient testing for the analyte(s) in question.

report patient results accurately

Question 54

Diagnostic sensitivity is also known as ????

Diagnostic specificity is also known as ????

Answer 54

True positives

True negatives

Question 55

_________ can mimic pseudohyponatremia

Answer 55

Hyperlipidemia

Question 56

Quality ______ is a subset of Quality _____

Answer 56

Control

Assurance