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[Lec] QUAILE > Lesson 1 > Flashcards

Lesson 1 Flashcards

Introduction to LQMS

1
Q

A degree to which an object or entity (process, product, or service) is excellent

A

Quality

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2
Q

T/F: Achieving a 99% level of quality means accepting a 1% error rate

A

True

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3
Q

Free from error or consistent with a standard or rule

A

Accurate

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4
Q

Trustworthy or of good quality

A

Reliable

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5
Q

Right time

A

Timely

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6
Q

How to achieve excellent performance in the laboratory?

A

Through QMS

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7
Q

coordinated activities to direct and control a organization with regard to quality (ISO, CLSI)

A

Quality Management System

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8
Q

All aspects (equipment, workflow, etc.) of the lab operation need to be addressed to assure quality; this constitutes a quality management system

A

Quality Management System

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9
Q

What are the different phases of a QMS?

A

Pre-examination phase
Examination phase
Post-examination phase

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10
Q
  • patient preparation & sample collection
  • personnel competency & test evaluation
  • sample receipt & accessioning
  • sample transport
A

Pre-examination phase

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11
Q
  • centrifuge and aliquoting
  • making sure sample is free from hemolysis
  • serum/ plasma
A

Pre-examination phase

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12
Q

-FBS/ Lipid profile
- clear and quality instructions to patient
- verbal / written instructions
- ask for patient’s last meal (underfast/ overfast)

A

Pre-examination phase

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13
Q

uses reagent that resembles human sample

A

Quality control testing (Examination phase)

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14
Q

Control samples: Normal and Abnormal

A

Clinical Chemistry

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15
Q

Control samples: Low, Normal, High

A

Hematology

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16
Q

T/F: Quality control testing can be done daily

A

True

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17
Q

T/F: If values are outliers, reagents may be expire already

A

True

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18
Q

T/F: If values are within range, it is not safe

A

False; it is safe!

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19
Q
  • reporting
  • record keeping
A

Post-examination phase

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20
Q

T/F: Manual record keeping are prone to errors and used by primary laboratories

A

False; it is used by secondary laboratories

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21
Q

Quality control can be the basis of the result explanation

A

Laboratory Information System (LIS)

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22
Q

This is when previous test results are compared to recent one

A

Delta checking

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23
Q

Path of workflow

A

Patient -> Test selection -> Sample collection -> Sample transport -> Lab analysis examination phase -> Report creation -> Report transport

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24
Q

What influences laboratory tests?

A
  • reagents and equipments
  • communications
  • process management
  • lab environment
  • knowledgeable staff
  • competent staff
  • quality control
  • occurrence management
  • record keeping
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25
Q

T/F: Some reagents do not require aircon temperature

A

False; they require

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26
Q

T/F: Communications in the laboratory also includes non-verbal communications

A

True

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27
Q

How to make Turn-Around Time (TAT) quicker?

A

Process management

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28
Q

A set of coordinated activities that function as building blocks for quality management

A

12 Quality System Essentials/ Management

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29
Q

12 Quality System Essentials

A
  1. Organization
  2. Personnel
  3. Equipment
  4. Purchasing & Inventory
  5. Process Control
  6. Information Management
  7. Documents & Records
  8. Occurrence Management
  9. Assessment
  10. Process Improvement
  11. Customer Service
  12. Facilities & Safety
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30
Q

QSE:
- quality policy
- shared responsibilities, authorities
- provision of resources
- communication

A

Organization

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31
Q

QSE:
- human resources
- job qualifications
- job descriptions
- orientation
- training
- competency assessment
- professional development (CPD: continuing professional development)
- continuing education

A

Personnel

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32
Q

QSE:
- acquisition
- installation
- validation
- maintenance
- calibration
- troubleshooting
- service and repair
- records

A

Equipment

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33
Q

conducted by suppliers or product engineer

A

Maintenance

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34
Q

reagent must be in room temperature

A

Calibration

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35
Q

must be recorded

A

Service & Repair

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36
Q

must be kept

A

Records

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37
Q

QSE:
- vendor qualification
- supplies and reagents
- critical services
- contract review
- inventory management

A

Purchasing & Inventory

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38
Q

QSE:
monthly; must take census

A

Purchasing & Inventory

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39
Q

QSE:
- quality control
- sample management
- method validation
- method verification

A

Process Control

40
Q

QSE:
- confidentiality
- requisitions
- logs and records
- reports
- computerized laboratory information system (LIS)

A

Information management

41
Q

Documents/ Records: creation

42
Q

Documents/ Records: collection

43
Q

Documents/ Records: revisions and review

44
Q

Documents/ Records: review

45
Q

Documents/ Records: control and distribution

46
Q

Documents/ Records: storage

47
Q

Documents/ Records: retention

48
Q

T/F: Histopathology samples are kept indefinitely

49
Q

QSE:
- complaints
- mistakes and problems
- documentation
- root cause analysis
- immediate actions
- corrective actions
- preventive actions

A

Occurrence Management

50
Q

Laboratory assessment

A
  • Internal QC
  • External QC
51
Q
  • quality indicators
  • audit program
  • audit review
  • daily QC
A

Internal QC

52
Q
  • proficiency testing (EQAS)
  • Interlab QC
  • inspections
A

External QC

53
Q

National Reference Laboratories (NRLs)

A
  • Research Institute for Tropical Medicine (RITM)
  • San Lazaro Hospital (SACCL)
  • East Avenue Medical Center (EAMC)
  • National Kidney and Transplant Institute (NKTI)
  • Philippine Heart Center (PHC)
  • Lung Center of the Philippines (LCP)
  • UP National Institutes of Health (UP NIH)
54
Q

NRL:
- for infectious units
- dengue, influenza, TB, other mycobacteria, malaria, other parasites
- bacterial enteric disease, measles, otherviral exanthems
- mycology, enteroviruses, antimicrobial resistance, and engineering diseases

55
Q

NRL:
- HIV/AIDS
- hepatitis
- syphilis
- other STI

56
Q

NRL:
- environmental and occupational health
- toxicology
- micronutrient assay

57
Q

NRL:
- hematology
- immunohematology
- immunopathology
- anatomic pathology
- anything related with blood

58
Q

NRL:
- cardiac disease

59
Q

NRL:
- atomic pathology for pulmonary disease
- Clinical Chemistry (monthly submission of QC)

60
Q

NRL:
- newborn

61
Q

QSE:
- opportunities for improvements (OFIs)
- stakeholder feedback
- problem resolution
- risk assessment
- preventive actions
- corrective actions

A

Process Improvement

62
Q

QSE:
- customer group identification
- customer needs
- customer feedback

A

Customer Service

63
Q

QSE:
- safe working environment
- transport management
- security
- containment
- waste management
- laboratory safety
- ergonomics

A

Facilities & Safety

64
Q

must be implemented from one management to another

A

Waste management

65
Q

T/F: Implementing quality management do guarantee and error-free lab, but it detects errors that may occur and prevents them from happening

A

False; it does not guarantee

66
Q

Company provides, __________ cooperates

67
Q

coordinated activities to direct and control an organization with regard to quality

68
Q

International Standard Organization
- to direct and control an organization
- not for medical field only

A

ISO 9001:2000

69
Q

History: Statistical process control

A

Walter A. Shewhart (1920s)

70
Q

History: Continual improvement

A

W. Edwards Deming (1940s)

71
Q

History: Quality toolbox

A

Joseph M. Juran (1950s)

72
Q

History: Quality by requirement

A

Philip B. Crosby (1970s)

73
Q

History: Micro Scale Error Reduction

A

Robert W. Galvin (1980s)

74
Q

ISO/CLSI: Guidance for quality in manufacturing and service industries

75
Q

ISO/CLSI: Standards, guidelines, and best practices for quality in medical laboratory testing

76
Q

ISO/CLSI: Broad applicability; used by many kinds of organizations

77
Q

ISO/CLSI: Detailed; applies specifically to medical laboratories

78
Q

ISO/CLSI: Uses consensus process in developing standards

79
Q

ISO/CLSI: Uses consensus process in developing standards

80
Q

ISO

A

International Organization for Standardization (International Standard Organization)

81
Q

CLSI

A

Clinical and Laboratory Standards Institute (formerly known as NCCLS)

82
Q

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

A

ISO 9001:2000

83
Q

ISO: Quality Management System Requirements

A

ISO 9001:2000

84
Q

ISO: General requirements for the competence of testing and calibration laboratories

A

ISO/EC 17025:2005

85
Q

ISO: Quality management in the clinical laboratory

A

ISO 15189:2007

86
Q

ISO: The foundation of international medical laboratory quality management

A

ISO 15189:2007

87
Q

ISO: Medical laboratories particular requirements for quality and competence

A

ISO 15189:2007

88
Q

CLSI: describes quality system model, 12 essentials

A

CLSI HSI-A2

89
Q

CLSI: aligns to ISO 15189 and parallels ISO 9000

A

CLSI HSI-A2

90
Q

CLSI: applies to all health care systems

A

CLSI HSI-A2

91
Q

CLSI: A quality management system model for health care

A

CLSI HSI-A2

92
Q

CLSI: describes laboratory application of quality system model

A

CLSI GP26-A3

93
Q

CLSI: relates the path of workflow to the quality system essentials

A

CLSI GP26-A3

94
Q

CLSI: assists the laboratory in improving processes

A

CLSI GP26-A3

95
Q

CLSI: relates to HSI-A2 and ISO 15189

A

CLSI GP26-A3

96
Q

CLSI: A patient is required to spell their last name for identification

A

CLSI GP33-A

[Lec] QUAILE (3 decks)

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