Assessment: Norms and Accreditation Flashcards
Recognition as delivering accurate and reproducible results
Laboratory Assessment
Recognition in lab quality
Accreditation
Recognition of compliance with the quality standards and norms used for the assessment
Laboratory Assessment
Implements international or national standards
Laboratory Director
Seeks information about appropriate norms and standards
Laboratory Director
Seeks information about accreditation and certification processes
Laboratory Director
Uses outcomes to provide better service
Laboratory Director
Must have initiative for accreditation
Laboratory Director
Explains the process for meeting standards to staff
Quality Manager
Organizes the laboratory in preparation for assessments
Quality Manager
The one that assesses medtechs/laboratorians
Quality Manager
Aware of requirements
Laboratorian
Contributes to meeting standards
Laboratorian
Aware of assessment processes
Laboratorian
Helps prepare for assessment
Laboratorian
Medtechs are called ______
Laboratorian
Type of document that provides rules, guidelines or characteristics for activities or their results
Normative document
Type of document that contains recommendations ng manufacturer pag bibili ng reagents (insert)
Normative document
Type of document that established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context
Standard document
Type of document
that is developed by ISO and CLSI
Standard document
Type of document
that any standard that is mandated by a governmental agency or authoritative body
Regulation
Own accreditation requirements established by many agencies, organizations, or regions
Self-developed Standards
Give advantages of Self-Developed Standards
optimized for local use, recognized local strengths and weaknesses
can be developed in progressive steps
can lead to full international recognition
Give disadvantages of Self-Developed Standards
may be narrow or biased
may not be recognized by other organizations
International organizations include:
▪ ISO (International Organization for Standardization)
▪ CLSI (Clinical and Laboratory Standard Institute)
▪ CEN (Comité Européen de Normalisation) –European Committee for Standardization
▪ WHO
What organization is the world’s largest developer and publisher of international standards?
International Organization for Standardization (ISO)
What country is ISO located?
Geneva, Switzerland
How many country does ISO serve?
157 countries
What organization promotes the development and use of voluntary consensus standards and guidelines within the health care community
Clinical and Laboratory Standards Institute (CLSI)
National standards bodies in the European Economic Community and associated countries
European Committee for Standardization
(CEN)
What organization has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles
World Health Organization (WHO)
Give criteria for a certain organization to be accredited in WHO
- 150 samples processed annually
- Participates regularly
- Nag rereport palagi ng case sa WHO
National Standards and Technical Guidelines:
Based on international standards
Adapted to the culture and general condition of the country
Country-specific standards
National Standards and Technical Guidelines:
Supplement ISO standards with technical guidance for use in laboratories
Can address a specific kind of testing
Guidelines
National Standard of France
GBEA (Guideline for Good Analysis Performance)
National Standard of Thailand
BLQS (Bureau of Laboratory Quality Standards)
National Standard of U.S
CLIA (Clinical Laboratory Improvement Amendments of 1988)
Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements.
Certification
Procedure by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks.
Accreditation
Granting of ability to practice provided most often by a local governmental agency, usually based on demonstrated knowledge, training and skills.
Licensure
Elements of an Accreditation Process
Accreditation Body
Standards
Assessors
User laboratory
Give examples on commonly used standards on CERTIFICATION
ISO 9001:2000
ISO 14000
Give examples on commonly used standards on ACCREDITATION
❑ ISO 17025
❑ ISO 15189
WHO polio standards
Give examples on commonly used standards on REGULATION
US CLIA Regulations
French GBEA
UN Transport of Dangerous Goods Regulations
Scope of ISO 17025
General
requirements
for competence
Does not cover compliance with regulatory and safety requirements for laboratory operations
Scope of ISO 15189
Medical
Laboratory
Particular
requirements
for quality & competence
Based on ISO
17025:1999
&
9001:2000
What does Accreditation term “Consensus” mean?
general agreement
What does Accreditation term “Normative Statement” mean?
required and essential part of the standard
includes the word “shall”
What does Accreditation term “Informative Statement” mean?
information (often a ‘note’) that may be explanatory, or cautionary, or provide an example
What does Accreditation term “Compliance” mean?
meets both the text and the spirit of a requirement
What does Accreditation term “Non-conformity” mean?
failure to fulfill the requirements of a specified process, structure or service
What does Accreditation term “Verification of conformity” mean?
confirmation by examination of evidence
True or False:
Accreditation DOES NOT guarantee success,
it is only one step along the quality journey
True
True or False:
It is an ACCOMPLISHMENT
to receive accreditation
True
True or False:
It is an ACHIEVEMENT
to maintain accreditation
True
