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(LEC) QUAILE > 1 - LABORATORY QUALITY MANAGEMENT SYSTEM > Flashcards

1 - LABORATORY QUALITY MANAGEMENT SYSTEM Flashcards

1
Q

The Quality Management System

A

Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety

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2
Q
  • degree of excellence
  • It is essential to all aspects of healthcare are laboratory results that are accurate, reliable, & timely
A

What is Quality?

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3
Q

Laboratory errors cost in:

A

Time
Personnel Effort
Patient Outcomes

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4
Q

Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI)

A

Quality Management System

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5
Q

All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a ?

A

Quality Management System

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6
Q

Patient/Client Preparation / Sample Collection
Personal Competency / Test Evaluations
Sample Receipt and Accessioning
Sample Transport

A

Pre-Examination

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7
Q

Quality Control Testing

A

Examination

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8
Q

Record Keeping
Reporting

A

Post Examination

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9
Q

Path of Workflow

A

THE PATIENT → Test Selection → Sample Collection → Sample Transport → Laboratory Analysis Examination Phase → Report Creation → Report Transport → Post Examination Phase → Result Interpretation

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10
Q

The entire process of managing a sample must be considered:
The beginning: Sample Collection
The end: Reporting and Saving of Results
All processes in between

A

Why is the Path of Workflow Essential to Consider in Health Laboratories?

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11
Q

Laboratory Tests are Influenced by:

A

Laboratory Environment
Knowledgeable staff
Competent staff
Reagents and equipment
Quality control
Communications
Process management
Occurrence management
Record keeping

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12
Q

Set of coordinated activities that function as building blocks for quality management

A

Twelve Quality System Essentials

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13
Q

Responsibilities, Authorities
Provision of Resources
Communication

all entails Quality Policy

A

Organization

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14
Q

Human resources
Job qualifications
Job descriptions
Orientation
Training
Competency Assessment
Professional Development
Continuing Education

A

Personnel

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15
Q

Acquisition
Installation
Validation
Maintenance
Calibration
Troubleshooting
Service and Repair
Records

A

Equipment

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16
Q

Vendor qualifications
Supplies and reagents
Critical services
Contract Review
Inventory Management

A

Purchasing and Inventory

17
Q

Quality Control
Sample Management
Method Validation
Method Verification

A

Process Control

18
Q

Confidentiality
Requisitions
Logs and records
Reports
Computerized Laboratory Information Systems (LIS)

A

Information Management

19
Q

Documents
Creation
Revisions and review
Control and Distribution
Records
Collection
Review
Storage
Retention

A

Documents & Records

20
Q

Complaints
Mistakes and problems
Documentation
Root cause analysis
Immediate actions
Corrective actions
Preventive actions

A

Occurrence Management

21
Q

Internal
Quality Indicators
Audit Program
Audit review

External
Proficiency Testing (EQA)
Inspections
Accreditations

A

Laboratory Assessment

22
Q

Opportunities for improvement (OFIs)
Stakeholder feedback
Problem resolution
Risk assessment
Preventive actions
Corrective actions

A

Process Improvement

23
Q

Customer group identification
Customer needs
Customer feedback

A

Customer Service

24
Q

Safe working environment
Transport management
Security
Containment
Waste Management
Laboratory Safety
Ergonomics

A

Facilities and Safety

25
Q

Coordinated activities to direct and control an organization with regard to quality
ISO 9000:2000

A

Laboratory Quality Management System

26
Q

Statistical Process Control

A

Walter A. Shewhart

27
Q

Continual Improvement

A

W. Edwards Deming

28
Q

Quality Toolbox

A

Joseph M. Juran

29
Q

Quality by Requirement

A

Philip B. Crosby

30
Q

Micro Scale Error Reduction

A

Robert W. Galvin

31
Q

Guidance for quality in manufacturing and service industries
Broad applicability; used by many kinds of organization
Use consensus process in developing standards

A

ISO - International Organization for Standardization

32
Q

Standards, guidelines, and best practices for quality in medical laboratory testing
Detailed; applies specifically to medical laboratories
Uses consensus process in developing standards

A

CLSI - Clinical and Laboratory Standards Institute (formerly known as NCCLS)

33
Q

NCCLS stands for

A

National Committee for Clinical Laboratory Standards Institute

34
Q

Model for QA in design, development production, installation, and servicing

A

ISO 9001:2000 Quality Management System Requirements

35
Q

General requirements for the competence of testing and calibration laboratories

A

ISO / IEC 17025:2005

36
Q

Quality Management in the clinical laboratory

A

ISO 15189:2007

37
Q
  • the foundation of international medical laboratory quality management
  • medical laboratories - particular requirements for quality and competence
A

ISO 15189:2007

38
Q
  • describes quality system model, 12 essentials
  • aligns to ISO 15189 and parallels ISO 9000
  • applies to all health care systems
A

HS1-A2 A Quality Management System Model for Health Care

39
Q
  • describes laboratory application of quality system model
  • relates the path of workflow to the quality system essentials
  • assists laboratory in improving processes
  • relates to HS1-A2 and ISO 15189
A

GP26-A3 Application of Quality Management System Model for Laboratory Services

(LEC) QUAILE (2 decks)

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