Laboratory Quality Management System Flashcards
Vital function of Management
Laboratory Quality Management System
What we after?
Quality Assurance
Coordinated activities to direct an organization with regard to quality
Quality Management System
To assure that every step are at utmost accuracy and precision.
After Quality Management System
Quality Assurance
One of the Earliest Concept of quality management movement
Quality Control Pass
He developed a method for statistical process control in the 1920s, forming the basis for quality control procedures in the laboratory
Shewhart
When was quality control were applied in laboratory?
1940s
Most recent method that is of importance to the laboratory
Galvin’s work on
MICRO-SCALE ERROR REDUCTION
Smallest principle applicable to Quality Assurance
MICRO-SCALE ERROR REDUCTION
ISO STANDS FOR
International Organization for Standards
Documents provide guidance for quality in manufacturing and services industries, and can be broadly applied to many other kinds of organization.
ISO 9000
Addresses general quality management system requirements and applies to laboratories.
ISO 9001:2000
Medical Laboratories-particular requirements for quality and competence
ISO 15189:2007
General requirements for the competence of testing and calibration laboratories.
ISO/IEC 17025:2005
Formerly known as NATIONAL COMMITTEE FOR CLINICAL LABORATOY STANDARDS (NCCLS)
Clinical and Laboratory Standards Institute
Uses a consensus process involving many stakeholders for developing standards.
Clinical and Laboratory Standards Institute
Two Documents that are very important for clinical laboratory
A quality management system model for health care: second edition
Application of a quality management system model for laboratory services: third edition
Representation of the Population
Sample
Representative of the Sample
Specimen
TAT
The time that we received the sample
Turnaround Time
Latin: statin (urgent)
Short Turnaround Time
STAT
Sample Management Components
Information needed for requisition forms.
Handling urgent request.
Collection, Labelling, preservation and transport.
Safety practices (leaking or broken containers, contaminated forms, other biohazards)
Evaluating, Processing and Tracking Samples
Storage, retention and disposal
Analytical Phase of Process Control
Quality Control
It monitors the processes related to the examination phase of testing and allows for detecting errors in testing system.
Quality Control
Gives the laboratory confidence that the test results are reliable before patient results are reported
Quality Control
The result is in the prescribed condition
In Control
The result is outside the range
Out of Control
measure the quantity of an analyte present in the sample, and measurements need to be accurate and precise.
Quantitative Test
measure the presence or absence of a substance, or evaluate cellular characteristics such as morphology.
Qualitative Test
For fine tuning
Has a specific concentration
Calibration
It is used to determine if the calibration is okay
The value is a range
Controls
Graphs to plot control values
Levey Jenning’s Test
Substances that contain an established amount of the substance being tested - the ANALYTE
Controls
Purpose of controls
Validate the reliability of the test system.
Evaluate the operator’s performance and environmental conditions that might impact result
Critical Value means
Life Threatening
Types and Source of Control Material
Frozen (0 to -20)
Freeze-dried (lyophilized)
Chemically preserved (liquid form)
Source of Control Material
Purchased (Assayed or unassayed)
Made in House (pooled)
Tempture range of Frozen
0- (-20)
Most preferred Control material since it has longer shelves life
Freeze-dried (Lyophilized)
Points that are distributed around central location
Variability
The number that occurs most frequently
Mode
The central point of the values when they are arranged in numerical sequence
Median
The arithmetic average of results
Mean
Normal Distribution is also called as
Gaussian Distribution
Gaussian Bell Distribution
The closeness of a measurement to it’s true value
Accuracy
The amount of variation in the measurement
Precision
The difference between the expectation of a test and an accepted reference method
Bias
How many percent of the values will fall within -1SD and +1SD of the mean
68.3%
How many percent of the values will fall within -2SD and +2SD of the mean
95.5%
How many percent of the values will fall within -3SD and +3SD of the mean
99.7%
Used to measure precision
Coefficient Variation
The most common method for the graphing of the range controls
Levey-Jennings Chart
Clinical chemist who made rules applied to laboratory to avoid rejecting runs that may be acceptable.
James Westgard
Variation in QC results that show no pattern
Random
Out of SD (Outliers)
Random Error
Not acceptable error and indicates shift or trend
Systematic
Systematic examination if some part (or sometimes all) of the quality management system to demonstrate to all concerned that the laboratory is meeting regulatory, accreditation, and customer requirements.
Assessment (Audits)
Based on ISO, this is a systematic independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which required criteria are fulfilled
Audit
Allows the laboratory to understand how well it is performing when compared to a benchmark or standard.
Audit/Assessment
Assessments conducted by groups or agencies from outside the laboratories
External Audits
Can include assessments for the purpose of accreditation, certification, or licensure
External Audit
Where staff working in one area of the laboratory conduct assessments on another area of the same laboratory
Internal Audit
External Auditors
Health Authorities (DOH, NRL, BRL)
Accreditation Bodies
Agencies or major public health programmes that provide funding for programmes
Set of rules or policies or procedures design to check the processes of the laboratory
Standards
Allows laboratory to look at it’s own processes
Internal audit
A method that allows for comparison of a laboratory’s performance using an external agency or facility
External Quality Assessment (EQA)
External providers sends unknown samples for testing to a set of laboratories, and the results of all laboratories are analyzed, compare and reported to the laboratories.
Proficiency Testing
Slides that have been read are rechecked by a reference laboratory
Samples have been analyzed are retested, allowing for interlaboratory comparison.
Rechecking or Retesting
Usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking or retesting method
On site Evaluation
Management Process
Handling of Samples
Analyses of Samples
Appropriate Record Keeping
Investigation of any deficiencies
Taking corrective action
Communicate
Provides rules, guidelines, or characteristics for activities or their result.
Normative Documents
Document that established by consensus and approved by a recognized body, that provides for common and repeated use, guidlines or characteristics for activities or thier result, aimed at the achievement of the optimum degree of order in a given context.
Standard Documents
Any standard that is mandated by governmental agency or authoritative body
Regulation
Worlds largest developer and publisher of international standards
It is a non governmental organization and it forms between the public and private sectors
ISO (International Organization for Standardization)
Central Secretariat of ISO
Geneva, Switzerland
A global, non profit, standards developing organization that promotes the development and use of voluntary consensus standards and guidlines within the healthcare community
CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE)
Founded in 1961
The general terms includes openness, transparency, consensus, and integration
CEN (EUROPEAN COMMITTEE FOR STANDARDIZATION)
Developed several standards for disease specific diagnostic laboratories
World Health Organization (WHO)
Was established in 1998
A not for profit, private affiliate of the joint Commission.
JCI (JOINT COMMISSION INTERNATIONAL)
Worlds largest association composed exclusively of pathologist certified by the American Board of Pathology
CAP (COLLEGE OF AMERICAN PATHOLOGIST)
Provide accreditation and proficiency testing to medical laboratories through its laboratory quality solution programs
CAP (COLLEGE OF AMERICAN PATHOLOGIST)
Procedure by which an independent body gives written assurance that a product, process, or service conforms to specific requirements
CERTIFICATION
The procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out a specific task
ACCREDITATION
The granting of ability to practice, usually provided by a local government agency.
Usually based on demonstrated knowledge, training, and skills
Licensure
Agreement between delegations representing all the stakeholders concerned
Consensus
Information within a document that is a requirement and essential part of the standard, includes world SHALL
Normative Statement
Information within a document that is information only; often it is in the term of a NOTE
Informative Statement
Meets both the text and the spirit of a requirement
Compliance
Failure to fulfill the requirements of a specified process, structure or service
Non-conformity
Conformation by examination of evidence
Verification of Conformity
Transcribe PDCA
Plan-Do-Check-Act
Identify the problems and potential sources of system weakness or error
Plan
Put plan into actions.
Implement whatever plans have been developed
Do
Refers to the monitoring process
CHECK
Take any corrective action that is required and then recheck to be sure that the solution has worked.
Act
The process of optimizing space, time, and activity in order to improve the physical paths of workflows.
Lean
Consists of a formal structure for project planning in order to implement change and improvement
Six Sigma
Aka Metrics
Quality Indicators
Established measures used to determine how well an organization meets needs and operational and performance expectations
Quality Indicators
It starts that quality objective should be measurable
ISO 9001 [5.4.1]
The evidence can be gathered and counted
Measurable
The laboratory has the capability of gathering the evidence it needs
Achievable
The laboratory can make a conclusion about the information that is useful to the laboratory
Interpretable
The indicator information reports a high or unacceptable level of error, it is possible to do something about the problem identified
Actionable
Consider indicators that examine multiple aspects of the total testing cycle in the pre-examination, examination and post examination phase
Balanced
Indicators should be examine the work of all staff, not just one group
Engaging
Consider indicators with both short term and long term implications
Timed
Use of a quality indicator only as long as it provides useful information.
Retiring a Quality Indicator