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Lesson 1 Flashcards

Introduction to LQMS (96 cards)

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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
T/F: Some reagents do not require aircon temperature
False; they require
26
T/F: Communications in the laboratory also includes non-verbal communications
True
27
How to make Turn-Around Time (TAT) quicker?
Process management
28
A set of coordinated activities that function as building blocks for quality management
12 Quality System Essentials/ Management
29
12 Quality System Essentials
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
30
QSE: - quality policy - shared responsibilities, authorities - provision of resources - communication
Organization
31
QSE: - human resources - job qualifications - job descriptions - orientation - training - competency assessment - professional development (CPD: continuing professional development) - continuing education
Personnel
32
QSE: - acquisition - installation - validation - maintenance - calibration - troubleshooting - service and repair - records
Equipment
33
conducted by suppliers or product engineer
Maintenance
34
reagent must be in room temperature
Calibration
35
must be recorded
Service & Repair
36
must be kept
Records
37
QSE: - vendor qualification - supplies and reagents - critical services - contract review - inventory management
Purchasing & Inventory
38
QSE: monthly; must take census
Purchasing & Inventory
39
QSE: - quality control - sample management - method validation - method verification
Process Control
40
QSE: - confidentiality - requisitions - logs and records - reports - computerized laboratory information system (LIS)
Information management
41
Documents/ Records: creation
Documents
42
Documents/ Records: collection
Records
43
Documents/ Records: revisions and review
Documents
44
Documents/ Records: review
Records
45
Documents/ Records: control and distribution
Documents
46
Documents/ Records: storage
Records
47
Documents/ Records: retention
Records
48
T/F: Histopathology samples are kept indefinitely
True
49
QSE: - complaints - mistakes and problems - documentation - root cause analysis - immediate actions - corrective actions - preventive actions
Occurrence Management
50
Laboratory assessment
- Internal QC - External QC
51
- quality indicators - audit program - audit review - daily QC
Internal QC
52
- proficiency testing (EQAS) - Interlab QC - inspections
External QC
53
National Reference Laboratories (NRLs)
- 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
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
RITM
55
NRL: - HIV/AIDS - hepatitis - syphilis - other STI
SACCL
56
NRL: - environmental and occupational health - toxicology - micronutrient assay
EAMC
57
NRL: - hematology - immunohematology - immunopathology - anatomic pathology - anything related with blood
NKTI
58
NRL: - cardiac disease
PHC
59
NRL: - atomic pathology for pulmonary disease - Clinical Chemistry (monthly submission of QC)
LCP
60
NRL: - newborn
UP NIH
61
QSE: - opportunities for improvements (OFIs) - stakeholder feedback - problem resolution - risk assessment - preventive actions - corrective actions
Process Improvement
62
QSE: - customer group identification - customer needs - customer feedback
Customer Service
63
QSE: - safe working environment - transport management - security - containment - waste management - laboratory safety - ergonomics
Facilities & Safety
64
must be implemented from one management to another
Waste management
65
T/F: Implementing quality management do guarantee and error-free lab, but it detects errors that may occur and prevents them from happening
False; it does not guarantee
66
Company provides, __________ cooperates
personnel
67
coordinated activities to direct and control an organization with regard to quality
Lab QMS
68
International Standard Organization - to direct and control an organization - not for medical field only
ISO 9001:2000
69
History: Statistical process control
Walter A. Shewhart (1920s)
70
History: Continual improvement
W. Edwards Deming (1940s)
71
History: Quality toolbox
Joseph M. Juran (1950s)
72
History: Quality by requirement
Philip B. Crosby (1970s)
73
History: Micro Scale Error Reduction
Robert W. Galvin (1980s)
74
ISO/CLSI: Guidance for quality in manufacturing and service industries
ISO
75
ISO/CLSI: Standards, guidelines, and best practices for quality in medical laboratory testing
CLSI
76
ISO/CLSI: Broad applicability; used by many kinds of organizations
ISO
77
ISO/CLSI: Detailed; applies specifically to medical laboratories
CLSI
78
ISO/CLSI: Uses consensus process in developing standards
ISO
79
ISO/CLSI: Uses consensus process in developing standards
CLSI
80
ISO
International Organization for Standardization (International Standard Organization)
81
CLSI
Clinical and Laboratory Standards Institute (formerly known as NCCLS)
82
ISO: Model for QA in design, development production, installation, and servicing
ISO 9001:2000
83
ISO: Quality Management System Requirements
ISO 9001:2000
84
ISO: General requirements for the competence of testing and calibration laboratories
ISO/EC 17025:2005
85
ISO: Quality management in the clinical laboratory
ISO 15189:2007
86
ISO: The foundation of international medical laboratory quality management
ISO 15189:2007
87
ISO: Medical laboratories particular requirements for quality and competence
ISO 15189:2007
88
CLSI: describes quality system model, 12 essentials
CLSI HSI-A2
89
CLSI: aligns to ISO 15189 and parallels ISO 9000
CLSI HSI-A2
90
CLSI: applies to all health care systems
CLSI HSI-A2
91
CLSI: A quality management system model for health care
CLSI HSI-A2
92
CLSI: describes laboratory application of quality system model
CLSI GP26-A3
93
CLSI: relates the path of workflow to the quality system essentials
CLSI GP26-A3
94
CLSI: assists the laboratory in improving processes
CLSI GP26-A3
95
CLSI: relates to HSI-A2 and ISO 15189
CLSI GP26-A3
96
CLSI: A patient is required to spell their last name for identification
CLSI GP33-A

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