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LABORATORY MANAGEMENT > TOPIC 6: 12 Quality System Essentials > Flashcards

TOPIC 6: 12 Quality System Essentials Flashcards

1
Q

Set of 12 core elements that define the key areas.
Required to establish and maintain an effective laboratory management system.
Ensure that the lab’s processes are reliable.
Based on global standards and are integral to laboratory accreditation

A

THE 12 QUALITY SYSTEM ESSENTIALS

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2
Q

The 12 QSEs ensure that each step of the laboratory workflow is efficiently managed.
This comprehensive quality system enhances accuracy, reliability, and safety, ultimately delivering high-quality patient care and outcomes.

Sample collection (pre-analytical)
Testing (analytical)
Reporting (post-analytical)

A

THE ROLE OF QSE IN LABORATORY WORK PATHFLOW

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3
Q

12 QSE
Establish a clear structure.
Guides the lab’s overall operation.
Making sure everyone understands their role.
Resources are effectively managed

A

ORGANIZATION

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4
Q

12 QSE: Ensure that all lab staff are well-trained, competent, and continually improving.
Guarantees accurate and reliable lab results by having qualified personnel performing tasks.

A

PERSONNEL

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5
Q

12 QSE:
All equipment is properly acquired, maintained, calibrated, and functioning correctly.
Reliable equipment minimizes errors and ensures consistent test performance

A

EQUIPMENT

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6
Q

EQUIPMENT

________: Choosing the right tools.
_________: Proper setup of equipment.
_________: Proving the equipment works as needed.
________: Routine care to ensure function.
________: Adjusting instruments for accuracy.
________: Fixing equipment issues.
________: Getting professional help.
_________: Keeping logs of maintenance activities.

A

Acquisition: Choosing the right tools.
Installation: Proper setup of equipment.
Validation: Proving the equipment works as needed.
Maintenance: Routine care to ensure function.
Calibration: Adjusting instruments for accuracy.
Troubleshooting: Fixing equipment issues.
Service and Repair: Getting professional help.
Records: Keeping logs of maintenance activities.

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7
Q

12 QSE:
Manage the procurement and inventory of supplies and reagents efficiently.
Proper inventory management prevents shortages and ensures that materials used meet quality standards.

A

PURCHASING AND INVENTORY

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8
Q

PURCHASING AND INVENTORY
__________: Ensuring suppliers are reliable.
__________: Keeping stock of necessary materials.
__________: Ensuring crucial services are available.
__________: Checking agreements with suppliers.
__________: Tracking supplies to prevent shortages.

A

Vendor Qualifications: Ensuring suppliers are reliable.
Supplies and Reagents: Keeping stock of necessary materials.
Critical Services: Ensuring crucial services are available.
Contract Review: Checking agreements with suppliers.
Inventory Management: Tracking supplies to prevent shortages.

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9
Q

12 QSE:
-Control of the activities employed in the handling of samples
-Examination processes to ensure accurate and reliable testing.

A

PROCESS CONTROL

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10
Q

PROCESS CONTROL
Tools and Techniques
● _______ - process mapping
● _______ - identify priority analysis
● _______ - for problem-solving
● _______ - monitoring process stability

A

Tools and Techniques
● Flowcharts - process mapping
● Pareto analysis - identify priority analysis
● Root cause analysis - for problem-solving
● Control Charts - monitoring process stability

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11
Q

12 QSE: A system for effectively managing incoming and outgoing patient information.
May be paper-based, computer-based, or a combination of both.

A

INFORMATION MANAGEMENT

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12
Q

12 QSE: Addresses the use and maintenance of documents and records, ensuring information can be accessed whenever needed

A

DOCUMENTS AND RECORDS

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13
Q

Provide written information about policies, processes, and procedures.
Must be updated and maintained.
Communicate information to all relevant personnel.

A

Documents

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14
Q

ORGANIZATION
________: A formal statement that defines the lab’s commitment to high-quality work.
________: Systems for effective information exchange.
______: Clear designation of who does what.
________: Making sure the lab has what it needs.

A

Quality Policy: A formal statement that defines the lab’s commitment to high-quality work.
Communication: Systems for effective information exchange.
Responsibilities, Authorities: Clear designation of who does what.
Provision of Resources: Making sure the lab has what it needs.

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15
Q

PERSONNEL

_______: Managing staff recruitment and employment.
_______: Requirements for each role.
_______: Details on duties and expectations.
_______: Training for new hires.
_______: Ongoing skill development.
_______: Checking if staff are proficient.
_______: Opportunities for career growth.
_______: Keeping up-to-date with new knowledge.

A

Human Resources: Managing staff recruitment and employment.
Job Qualifications: Requirements for each role.
Job Descriptions: Details on duties and expectations.
Orientation: Training for new hires.
Training: Ongoing skill development.
Competency Assessment: Checking if staff are proficient.
Professional Development: Opportunities for career growth.
Continuing Education: Keeping up-to-date with new knowledge.

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16
Q

● Collected information produced by the laboratory in the process of performing and reporting a laboratory test.

Easily retrieved or accessed
Contain information that is permanent and does not require updating

A

Records

17
Q

UNDER DOCUMENT: ● A documented statement of overall intentions and direction.
● Gives broad and general direction to the quality system.
● Tells “what to do” in a broad and general way, including a statement of the organizational mission, goals, and purpose.
● Serves as the framework for the quality system, specified in the quality manual.

A

Policy

18
Q

UNDER DOCUMENT: ● Steps to follow quality policies.
● “How it happens.”
● Use flow charts to show steps over time.
● Defined by ISO 9000 as a set of activities turning inputs into outputs.

Inputs: Test requests, samples, info requests.
Outputs: Data, result reports.

A

PROCESS

19
Q

UNDER DOCUMENT: ● Specific activities within a process (ISO 9000 [3.4]).
● Explains “how to do it” with step-by-step instructions.
● The term Standard Operating Procedure (SOP) is often used to indicate these detailed instructions on how to do it.

A

PROCEDURE

20
Q

● Shortened versions of SOPs.
● Posted at workstations for quick reference.
● They supplement, not replace, SOPs

A

Job Aids/Work Instructions

21
Q

● Refers to the scientific procedure for identifying, recording, analyzing, and solving errors, deviations, or nonconformities in a laboratory context.
● It aims to identify an issue and respond immediately to its elimination in order not to recur, thereby assuring quality and reliability of laboratory results

A

OCCURENCE MANAGEMENT

22
Q

KEY STEPS IN OCCURENCE MANAGEMENT

________
● Recognizing when an error or deviation occurs, whether it’s technical, procedural, or related to equipment.

________
● Writing down what happened.

_______
● Finding the main cause of an issue.

A

Identification
● Recognizing when an error or deviation occurs, whether it’s technical, procedural, or related to equipment.

Documentation
● Writing down what happened.

Root Cause Analysis
● Finding the main cause of an issue.

23
Q

KEY STEPS IN OCCURENCE MANAGEMENT
_________
● Taking immediate actions to address the specific issue.

________
● Long-term solutions to fix problems.

________
● Steps to stop future problems.

________
● Handling negative feedback.

A

Immediate Actions
● Taking immediate actions to address the specific issue.

Corrective Actions
● Long-term solutions to fix problems.

Preventive Actions
● Steps to stop future problems.

Complaints
● Handling negative feedback.

24
Q

12 QSE:
● A critical component that involves evaluating the laboratory’s processes, procedures, and outcomes.
● It aims to identify areas needing improvement, verify compliance with regulatory and quality standards, and validate the effectiveness of the laboratory’s quality management system (QMS).

A

ASSESSMENT

25
Q

KEY POINTS OF ASSESSMENT IN QSE:
_______
● Involve regular self-audits by laboratory personnel to monitor compliance with the QMS.

________
● This is carried out by third parties or regulatory bodies to verify that the lab meets recognized standards.

_______
● Findings from assessments often require corrective actions to address any non-conformities, followed by preventive measures to avoid future occurrences.

______
● Assessment results drive continuous quality improvements within the laboratory.

A

Internal assessments
● Involve regular self-audits by laboratory personnel to monitor compliance with the QMS.

External assessments or external audits
● This is carried out by third parties or regulatory bodies to verify that the lab meets recognized standards.

Corrective Actions
● Findings from assessments often require corrective actions to address any non-conformities, followed by preventive measures to avoid future occurrences.

Continuous Improvement
● Assessment results drive continuous quality improvements within the laboratory.

26
Q

Examples of Assessments in Laboratory Quality Management

_______
● Laboratory staff routinely checks adherence to standard operating procedures (SOPs) for specimen handling, equipment calibration, or safety practices.

_______
● The lab participates in external proficiency tests where they analyze unknown samples, comparing results with those from other labs to ensure accuracy and consistency.

______
● An external body assesses the lab to verify compliance with international standards, such as those from the College of American Pathologists (CAP) or ISO 15189.

A

Internal Audits
● Laboratory staff routinely checks adherence to standard operating procedures (SOPs) for specimen handling, equipment calibration, or safety practices.

Proficiency Testing
● The lab participates in external proficiency tests where they analyze unknown samples, comparing results with those from other labs to ensure accuracy and consistency.

Accreditation Audits
● An external body assesses the lab to verify compliance with international standards, such as those from the College of American Pathologists (CAP) or ISO 15189.

27
Q

12 QSE:
● A systematic approach to identifying, analyzing, and improving existing processes in the laboratory to enhance quality, efficiency, and compliance.
● It is aimed at ensuring continual improvement in the laboratory’s operations and maintaining high standards of accuracy and reliability in test results.

A

PROCESS IMPROVEMENT

28
Q

12 QSE:
● To understand and meet the needs of the lab’s clients and stakeholders while ensuring high levels of satisfaction.
● Customer service focuses on building trust and improving the lab’s reputation by delivering reliable and timely results.

A

CUSTOMER SERVICE

29
Q

CUSTOMER SERVICE:

_______
● Knowing who uses lab services.

_____
● Understanding service expectations.

______
● Collecting and acting on input.

A

Customer Group Identification
● Knowing who uses lab services.

Customer Needs
● Understanding service expectations.

Customer Feedback
● Collecting and acting on input.

30
Q

12 QSE:
● To maintain a safe and secure working environment that minimizes risks to personnel and ensures compliance with safety regulations.
● Proper facility management ensures the well-being of staff and the safe handling of materials.

A

FACILITIES AND SAFETY

31
Q

FACILITIES AND SAFETY:
__________
● Ensuring safety in the laboratory through proper infrastructure and protocols.

__________
● Safe transportation of materials such as specimens or chemicals within the lab

__________
● Ensuring laboratory premises and equipment are protected from theft or unauthorized access.

A

Safe Working Environment
● Ensuring safety in the laboratory through proper infrastructure and protocols.

Transport Management
● Safe transportation of materials such as specimens or chemicals within the lab

Security
● Ensuring laboratory premises and equipment are protected from theft or unauthorized access.

32
Q

FACILITIES AND SAFETY:
_______
● Preventing contamination or exposure to hazardous substances.

_______
● Proper disposal of hazardous waste to comply with safety regulations.

______
● Implementing safety protocols, including proper personal protective equipment (PPE).

________
● Designing workstations to prevent injury from prolonged use.

A

Containment
● Preventing contamination or exposure to hazardous substances.

Waste Management
● Proper disposal of hazardous waste to comply with safety regulations.

Laboratory Safety
● Implementing safety protocols, including proper personal protective equipment (PPE).

Ergonomics
● Designing workstations to prevent injury from prolonged use.

LABORATORY MANAGEMENT (7 decks)

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