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Accreditation & SOPs Flashcards

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1
Q

What is accreditation?

A

The formal third party recognition of the competence of an organisation to carry out specific tasks

Accreditation assures the quality and competence of services and products provided by an organisation worldwide.

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2
Q

Why is accreditation important for medical laboratories?

A

It provides assurance on the integrity and accuracy of laboratory results and outputs, and is a formal recognition of its technical competence

This is crucial for patient safety.

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3
Q

Who is designated as the sole accreditation body for Ireland?

A

INAB (Irish National Accreditation Body)

Designated by DBEI (Department of Business, Enterprise and Innovation) as per EU 765/2008.

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4
Q

What does the accreditation hierarchy consist of?

A

Global, Regional, and Economy levels

Global: ILAC, IAF; Regional: EA; Economy: INAB, CAB.

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5
Q

What legislation requires each EU member state to appoint a National Accreditation Body?

A

EU Directive EC/765/2008

This legislation aims to ensure uniformity in accreditation across Europe.

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6
Q

When was INAB appointed in Ireland?

A

2010

This appointment was in accordance with EU Directive EC/765/2008.

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7
Q

What was the status of CPA certificates issued by the UK accreditation body?

A

All CPA certificates were valid to their expiry date but were not to go past 31/12/2014

This indicates a transitional arrangement post-appointment of INAB.

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8
Q

Is there a legal requirement for all other disciplines to comply with the accreditation standard?

A

No, but all do comply

Indicates the widespread recognition of the importance of accreditation even in the absence of legal mandates.

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9
Q

What is the Blood Directive 2002?

A

A regulation related to blood safety and quality in the EU

This directive sets standards for blood and blood components to ensure safety for transfusions.

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10
Q

What does ISO15189:2003 refer to?

A

International standard for medical laboratories

It specifies requirements for quality and competence in medical laboratories.

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11
Q

What is the significance of EU Directive EC/765/2008?

A

Regulates the requirements for accreditation and market surveillance of products

It establishes the framework for the accreditation of conformity assessment bodies.

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12
Q

What was established by the Health Act 2004?

A

The Health Service Executive (HSE)

HSE is responsible for delivering health and personal social services in Ireland.

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13
Q

What does the Safety, Health & Welfare at Work (Biological Agents) 2013 regulate?

A

Health and safety regulations for biological agents in the workplace

This regulation aims to protect workers from exposure to biological agents.

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14
Q

What is the Health & Social Care Professionals Act 2005?

A

Legislation that regulates health and social care professions in Ireland

It establishes the framework for the registration and regulation of health and social care professionals.

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15
Q

What is HIQA 2017?

A

Health Information and Quality Authority’s standards and regulations

HIQA ensures that health and social care services are safe and of high quality.

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16
Q

What became an offense for Blood Transfusion labs?

A

Not being accredited

Unaccredited labs cannot issue blood products to patients.

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17
Q

What resources were made available to achieve compliance with ISO15189:2007 Standards?

A

Resources & finance

Funding and resources were allocated to help laboratories meet these standards.

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18
Q

What are Quality Management Systems (QMS)?

A

Systems to ensure quality in laboratory processes

QMS help in achieving compliance with various standards and regulations.

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19
Q

What is the role of INAB?

A

Enforces compliance with accreditation standards in Ireland

INAB stands for Irish National Accreditation Board.

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20
Q

How often are medical laboratories inspected by INAB?

A

Annually

This regular inspection helps ensure ongoing compliance with standards.

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21
Q

What must be addressed within 4 weeks of an inspection?

A

Non-compliance / Non-conformances

Laboratories are required to rectify any issues identified during inspections promptly.

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22
Q

What is the validity period of the accreditation certificate?

A

5 year cycles

Laboratories must undergo re-evaluation after this period.

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23
Q

What must every laboratory in Ireland comply with?

A

ISO15189:2012

This standard ensures quality management and competence in medical laboratories.

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24
Q

What is a key requirement for laboratory staff in Ireland?

A

Detailed Job Descriptions

Job descriptions help clarify roles and responsibilities within the laboratory setting.

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25
What must laboratories have in place to ensure compliance?
Standard operating procedures ## Footnote These procedures outline every process and ensure adherence to ISO15189:2022.
26
What is crucially dependent on the effectiveness of any accreditation system?
The standards adopted and the objectivity of assessment of compliance
27
Define a standard.
A level of excellence or quality
28
What is a document established by consensus and approved by a recognized body?
It provides rules, guidelines or characteristics for activities or their results
29
What operational activities should be standardized in a laboratory?
Collection, transport, reception and registration of specimens or samples, their analysis and reporting
30
What is a requirement in all accredited systems?
Extensive documentation
31
What is ISO?
A network of the national standards institutes of 156 countries
32
How many members are there per country in ISO?
1 member per country
33
Where is the Central Secretariat of ISO located?
Geneva, Switzerland
34
What is the world's largest developer of standards?
ISO
35
What are the principal activities of ISO?
Development of technical standards
36
What must medical laboratories comply with?
ISO standards, INAB, CORU
37
What does ISO 15189 pertain to?
Medical laboratories – particular requirements for quality and competence is patient safety
38
How long did it take to develop ISO 15189?
7 years
39
When was ISO 15189 first published?
2003
40
What years were ISO 15189 revised and republished?
2007, 2012, 2022
41
What does Standard 4 cover?
General Requirements
42
What does Standard 5 cover?
Structural and Governance Requirements
43
What does Standard 6 cover?
Resource requirements
44
What does Standard 7 cover?
Process requirements
45
What does Standard 8 cover?
Management system requirements
46
What does the Scope of Accreditation list?
All of the activities that your laboratory is accredited to perform
47
What is the first step in the accreditation process?
User Laboratory applies to INAB assessment manager
48
What type of assessment is performed prior to inspection?
Pre-assessment or self-assessment
49
Who employs assessors for the accreditation process?
INAB
50
What are assessors experts in?
Scientific area and ISO standards
51
What does the assessor do during the inspection?
Decides if the user Laboratory is compliant with the standards
52
What may be made as a result of the assessor's inspection?
Recommendations
53
What must be cleared before a recommendation is made to INAB Board?
Non-conformities
54
What does INAB do after receiving the recommendation?
Refuses or grants accreditation
55
How often is re-assessment conducted?
Every 5 years
56
Define a 'minor' non-conformance.
Failure to comply with standard requirements e.g. training log not updated
57
What is the timeframe to submit evidence of clearance for minor non-conformance?
One month
58
How is minor non-conformance reviewed?
By INAB personnel by correspondence
59
Define a 'major' non-conformance.
Failure to comply with scheme requirements compromising confidence in accredited activity
60
What is the impact of a major non-conformance on patient care?
Clinically significant
61
What is required within 2 weeks for major non-conformance?
Full root cause analysis
62
What corrective action is required following a major non-conformance?
Corrective action required within following 2 weeks
63
What may be necessary to clear a major non-conformance?
A further visit
64
What types of accreditation visits occur before accreditation?
Pre-Inspection
65
What is the purpose of Initial Accreditation?
To assess compliance for the first time
66
What does Annual Surveillance focus on?
Specific clauses
67
What is involved in a Reassessment visit?
All clauses
68
What does Extension to Scope involve?
Add on new tests/change of platform/kit
69
What does Reinstatement refer to?
Restoring accreditation after it has been revoked
70
What does accreditation ensure in laboratory processes?
Quality and reliability ## Footnote Accreditation guarantees that lab processes meet recognized international standards, ensuring accurate and consistent test results.
71
How does accreditation enhance patient safety?
By providing reliable test results critical for correct diagnosis and treatment decisions ## Footnote Reliable test results directly impact patient care and outcomes.
72
What is one of the key benefits of continuous improvement in accredited laboratories?
Regular audits and assessments encourage ongoing development of quality systems ## Footnote This includes staff competence and technological upgrades.
73
Why is accreditation important for building trust and credibility?
It demonstrates competence and trustworthiness to healthcare providers, patients, and regulatory bodies ## Footnote Accreditation serves as a mark of quality assurance.
74
What is a major benefit of standardization across laboratories?
Facilitates uniformity in testing procedures ## Footnote This makes results comparable across different laboratories and healthcare institutions.
75
How does accreditation support legal and regulatory compliance?
Helps meet national and international regulatory requirements ## Footnote This reduces the risk of non-compliance penalties.
76
What is required for supporting staff training and competence in accredited labs?
Documented evidence of staff training, proficiency testing, and continuous professional development ## Footnote Accreditation bodies mandate these requirements.
77
What does international recognition facilitate in the context of accreditation?
Accredited results are more likely to be accepted globally ## Footnote This supports international collaborations or patient transfers.
78
What are Standard Operating Procedures (SOPs)?
A set of instructions provided for standardization ## Footnote SOPs ensure consistent practices in laboratory settings.
79
List the types of SOPs.
* Laboratory procedures * Processes * Quality control * Quality management * Forms & Instructions ## Footnote Different types of SOPs cover various aspects of laboratory operations.
80
Who is responsible for reviewing SOPs and how often?
Quality Manager/officer; reviewed every 2 years ## Footnote Reviews ensure compliance with recent guidelines and best practices.
81
What must training follow according to SOP updates?
SOP updates ## Footnote Training must align with the most current SOPs to ensure proper practices.
82
What is a key component of a Standard Operating Procedure?
Risk assessment ## Footnote This includes health & safety and waste disposal considerations.
83
What is included in the introduction of a SOP?
Purpose of exam, principle of exam, definitions ## Footnote The introduction sets the stage for understanding the SOP.
84
What responsibilities are outlined in a SOP?
Authorising & reporting results ## Footnote Clear responsibilities help in the accountability of laboratory processes.
85
What must be specified regarding specimen requirements in a SOP?
Specimen identification ## Footnote Proper identification is crucial for accurate testing.
86
What types of materials are mentioned in the SOP components?
* Equipment * Reagents * Consumables ## Footnote Specifying materials ensures that all necessary items are available for procedures.
87
What is included in the procedure section of a SOP?
Detailed step-by-step instructions for performing the test ## Footnote This section is critical for standardizing laboratory practices.
88
What does quality control in SOPs include?
IQC, EQA ## Footnote Internal Quality Control (IQC) and External Quality Assessment (EQA) are essential for maintaining standards.
89
What limitations must be noted in a SOP?
Limitations of the Procedure ## Footnote Acknowledging limitations helps in understanding the scope of the SOP.
90
What is involved in the reporting section of a SOP?
Interpretation, critical alert, procedure for reporting ## Footnote Clear reporting guidelines are essential for effective communication of results.
91
What should be included in the references section of a SOP?
Citations of relevant guidelines and standards ## Footnote References support the validity of the procedures outlined in the SOP.

Professional Practice (13 decks)

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