MIDTERMS: QA & LABORATORY'S PATH OF WORKFLOW Flashcards

1
Q

A degree to which a set of inherent characteristics fulfills the requirement (ISO 9000 [3.1.1])

A

Quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Other term for QA and Laboratory’s Path of Workflow

A

Phase of the Laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

CLSI

A

Clinical and Laboratory Standards Institute

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

ISO

A

International Organization for Standardization

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What are the stages of Quality? (highest to lowest)

A

Total Quality Management
Quality Cost Management
Quality Management System
Quality Assurance
Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

It is a ladder synthesized from the concepts of acknowledged quality experts. A laboratory can best obtain the next higher stage by mastering the preceding one, ultimately reaching the top rung.

A

Stages of Quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

It is an operational process control technique to fulfill quality requirements for regulatory compliance and accreditation.

A

Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

It is planned and systematic activities to provide confidence that an organization fulfills requirements for quality.

A

Quality Assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

It is a systematic process-oriented approach to meeting quality objectives.

A

Quality Management System

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

It is a measurement system for the economic aspects of the “cost of quality”

A

Quality Cost Management

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

It is a management approach centered on sustained high quality, by focusing on long-term success through customer satisfaction.

A

Total Quality Management`

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

It is part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000 [3.2.11])

A

Quality Assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

A comprehensive set of policies, procedures, and practices are followed to ensure that laboratory results are reliable (accuracy and precision)

A

Quality Assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

It also includes record keeping, maintenance, and calibration of equipment, proficiency testing, quality control, and training of personnel.

A

Quality Assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

A sequential process in laboratory activities transforms a request for examination into the laboratory information that is captured in the report of results.

A

Path of workflow, laboratory

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What are the three phases under the Path of Workflow?

A

Pre-analytical
Analytical
Post-analytical

17
Q

The process starts, in chronological order, from the request for examination and including the transportation to or within the laboratory, and ends when the analytical examination procedure begins (modified from ISO 15198)

A

Pre-analytical/Pre-analytics/Pre-examination procedure

18
Q

What are the different individuals that are involved in the pre-analytical phase?

A

Receptionist/Clerk of the Laboratory
Medical Technologist
Clinician
Patient

19
Q

A set of operations, described specifically, used in the performance of examinations according to a given method (ISO 15198)

A

Analytical/Analytics/Examination procedures

20
Q

Processes following the examination include systematic review, formatting and interpretation, authorization for release, reporting, and transmission of the results, and storage of samples of the laboratory examinations. (ISO 15189[3.9])

A

Post-analytical/analytics/examination procedures

21
Q

Phlebotomy –> Send to the lab. –> Reception –> Centrifuge –> Aliquot –> Distribute –> Load

A

Pre-analytical

22
Q

Pre-order/order entry –> Collection –> Register and ID –> Automated routing –> Device connectivity

A

Pre-analytical

23
Q

Ordering –> Blood collection –> Transport/scan –> Pre-analytics –> Analytics –> Validation –> Sample archiving –> Reporting

A

Quality

24
Q

Automation of complex processes –> Production monitoring –> Quality assurance –> Open connectivity

A

Quality

25
Q

Analysis –> Re-run

A

Analytical

26
Q

QC and monitoring –> Sample tracking –> TAT monitoring

A

Analytical

27
Q

Unload samples –> Archive samples

A

Post-analytical

28
Q

Auto-validation –> Host connectivity –> Reporting

A

Post-analytical