▪ Contact information of requesting physician

LECTURE 5
or authorized individual
PROCESS CONTROL: SAMPLE MANAGEMENT
• Collection Requirements
" The result of any laboratory examination is only as
▪ Patient preparation
good as the sample received in the laboratory "
▪ Patient identification
▪ Type of sample required
o Good Sample Management
▪ Type of container needed
• Directly affects patient care and outcome
▪ Labelling
• Influences therapeutic decisions
▪ Special handling
• Essential to accurate laboratory diagnosis
▪ Safety precautions
• Influences laboratory efficiency

• Labelling
o Sample Management Components
Each sample should be labelled with:
• Laboratory Handbook (Policies and Practices)
▪ Patient's name
-contains information needed by those who
▪ Patient's unique ID number
collect samples
▪ Test ordered
-available to all sample collection areas
▪ Time and date of collection
-must be understood by all laboratory staff
▪ Collector's initials
-referenced in the quality manual
Use computer – generated bar codes when possible
• Collection, preservation
• Outcomes of Improper Collection
• Labelling
▪ Delays in reporting test results
• Assessing, processing, tracking
▪ Unnecessary re-draws/ re-tests
• Retention, storage, disposal
▪ Decreased customer satisfaction
• Transport
▪ Increased diagnosis/ treatment
• Information Needed
▪ Injury
• Collection, preservation
▪ Death
• Laboratory Handbook Contents
• Pre-examination Steps
▪ Name and address of laboratory
o Verify
▪ Contact names and telephone numbers
▪ Completeness of test request
▪ Hours of operation
▪ Appropriateness of sample
▪ List of tests that can be ordered
▪ Information on label
▪ Sample collection procedures
o Record in register or log
▪ Sample transport procedures
o Enforce sample rejection criteria
▪ Expected turn-around times (TAT)
▪ How urgent requests are handled
• Actions for Rejected Samples
▪ Inform authorized person
• Laboratory's Responsibilities
▪ Request another sample
▪ Provide sample collection information
▪ Record rejected samples
(what, when, how)
▪ Retain rejected sample based on preset
▪ Provide appropriate containers and
criteria
supplies
▪ Extraordinary circumstances may require
▪ Define a good labelling system
testing suboptimal samples
▪ Assess all samples- pre-examination

• Sample Register or Log

• Test Requisition
A register should include:
▪ Patient ID
▪ Date and time of collection
▪ Tests Requested
▪ Date and time of receipt
▪ Time and date of sample collection
▪ Sample type
▪ Source of sample, when appropriate
▪ Patient name
▪ Clinical data, where indicated
▪ Demographics as required
 ▪ Laboratory assigned identification
▪ Tests to be performed
• Sample Tracking-Manual
▪ Confirm receipt of samples, include date
and time
▪ Label samples of appropriately; keep with
the test requisition until laboratory ID is
assigned
▪ Track aliquots-traceable to the original
sample
• Sample Tracking-Computer
Database entries include:
▪ Identification number
▪ Patient information
▪ Collection date and time
▪ Type of sample
▪ Tests to be performed
▪ Name of health care provider
▪ Location of patient, e.g., ward, clinic,
outpatient
▪ Diagnostic test results
▪ Time and date results are reported
• Sample Handling
▪ Handle all samples as if infectious
▪ Universal Precautions
• Sample Storage Written Policy
▪ Describe samples to be stored
▪ Determine retention time
▪ Determine location
▪ Describe proper conditions
▪ Establish method of organizing samples
• Sample Retention
▪ Set policy for retention
▪ Monitor stored samples, including freeze/
thaw cycles
▪ Maintain an organized, accessible system
▪ Establish a schedule to review all stored
samples
▪ Establish tracking procedures
• Sample Referral
o Record:
▪ Samples referred
▪ Date of referral
▪ Name of person referring test
o Monitor/ Track, and Record:
▪ Turnaround time
▪ Results delivery (from referral
laboratory, to requestor)
▪ Problems with referral
• Sample Disposal
▪ Set policy for sample disposal
▪ Compliance with local and country
regulations
▪ Disinfection procedures
• Sample Transport
o Maintain integrity of sample:
▪ Temperature
▪ Preservation of sample
▪ Special transport containers
▪ Time limitations
o Assure safety regulations are met
• Transport Regulations
o Where do they come from?
o Who develops them?
▪ National transport regulations
▪ ICAO/IATA transport regulations (air)
▪ Rail, road, and sea traffic agencies
▪ Postal services
▪ Private couriers
o Mandatory Compliance
▪ Violation
▪ Deal with accidents and spills
-reduce biohazards
▪ Safety: couriers, laboratory staff,
passengers, carriers
• Classification of Infectious Substances
New Classification in 2005: based on two
transport categories
Category A: infectious substances capable
of causing
o Permanent disability
o Life – threatening or fatal disease to
o Humans or both human and animals
Packaging: most durable triple packaging
with full dangerous goods documentation
Training of transport staff
Category B: infectious substances not
included in Category A
o Less stringent triple packaging
 o No dangerous goods documentation
required
• Managing Sample Transport
o Meet all applicable regulations
o Train personnel in all transport procedures
o Assure sample is protected
▪ Temperature
▪ Transport time
▪ Packaging and preservation
LECTURE 6
PROCESS CONTROL: INTRODUCTION TO QUALITY
CONTROL
Definition
Quality Control (QC) - is part of quality management
focused on fulfilling quality requirements ISO 9000:2000
(3.2.10)
QC is examining "control" materials of known
substances along with patient samples to monitor the
accuracy and precision of the complete examination
(analytic) process.
Purpose
The goal of QC is to detect errors and correct them
before patients' results are reported
Quantitative Examinations
Measure the quantity a particular substance in a
sample
Measurements should be both accurate and precise
Qualitative Examination Methods
Examinations that do not have numerical results:
• Growth or no growth
• Positive or negative
• Reactive or non-reactive
• Color change
Semi-quantitative Examination Methods
Results are expressed as an estimate of the measured
substance:
• "Trace amount", "moderate amount", or "1+, 2+, or
3+"
• Number of cells per microscopic field
• Titers and dilutions in serologic tests
QC Program Steps
• Establish written policies and procedures – include
corrective actions
• Train all staff
• Assure complete documentation
• Review QC data
PROCESS CONTROL: QUALITY CONTROL FOR
QUANTITATIVE TESTS
Quantitative Tests
• Measure the quantity of a particular substance in a
sample (numeric result)
• Quality control for quantitative tests is designed to
assure that patient results are:
▪ Accurate
▪ Reliable
Implementation Steps
• Establish policies and procedures
• Assign responsibility, train staff
• Select high quality controls
• Establish control ranges
• Develop graphs to plot control values – Levey-
Jennings Charts
• Monitor control values
• Develop procedures for corrective action
• Record all actions taken
What is a Control?
• Material that contains the substances being
analyzed
▪ Include with patient samples when performing
a test
• Used to validate reliability of the test system
▪ Run after calibrating the instrument
▪ Run periodically during testing
Calibrators (sets the instrument)
• A substances with a specific concentration
• Calibrators are used to set (calibrate) the measuring • Run each control 20 times over 30 days
points on a scale. • Calculate mean and +/- 1,2,3 Standard Deviations

Controls Measurement of Variability

• A substance similar to patient's samples that has an • Variability is a normal occurrence when a control is
established concentration. tested repeatedly
• Controls are used to ensure the procedure is • Affected by:
working properly. ▪ Operator technique
▪ Environmental conditions
Characteristics of Control Materials ▪ Performance characteristics of the
• Appropriate for the diagnostic sample measurement
• Values cover medical decision points (low or high) The goal is to differentiate between variability due to
• Similar o test sample (matrix) chance from that due to error
• Available in large quantity; ideally enough for one
year Measures of Central Tendency
• Can store in small aliquots Although variable, sets of data are distributed around a
central value
Types of Control Materials
• May be frozen, freeze-dried (lyophilized), or
chemically preserved
• Requires very accurate reconstitution if this step is
necessary

Sources of Control Materials

• Commercially prepared
• Made "in house"
• Obtained from another laboratory, usually central
or reference laboratory

Control Materials Mode – the value which occurs with the greatest
• Assayed frequency
▪ Target value predetermined Median – the value at the center or midpoint of the
▪ Verify and use observations
• Unassayed Mean – the calculated average of the values
▪ Target value not predetermined
▪ Full assay required before using
• "In-House"
▪ In-house pooled sera
▪ Full assay, validation

Choosing Control Materials

• Values cover medical decision points
• Similar to the test sample
• Controls are usually available in high, normal, and
low ranges

Preparation and Storage of Control Material

• Adhere to manufacturer's instructions
• Keep adequate amount of same lot number
• Store correctly

Steps in Implementing Quantitative QC

• Obtain control material
Normal Distribution
• All values symmetrically distributed around the
mean
• Characteristics "bell-shaped" curve
• Assumed for all quality control statistics

Quality Control is used to monitor the accuracy and

the precision of the assay
Accuracy – The closeness of measurements to the true
value
Precision – The amount of variation in the
measurements
Bias – The difference between the expectation of a test
result and an accepted reference value
Statistics or Quantitative QC
• Assay control material at least 20 data points over a
20-30 day period
• Ensure procedural variation is represented
• Calculate mean and +1,2 and 3 SD

Number of Controls
Interpretation depends on number of controls run with
patients' samples.
• Good: If one control
▪ Accept results if control is within + 2SD unless
shift or trend
• Better: If 2 levels of controls
▪ Apply Westgard multirule system.

Detecting Error
• Random Error: variation in QC results with no
pattern – only a cause for rejection if outside 2SDs.
• Systematic Error: not acceptable, correct the source
of erroe Measurement Uncertainty
Examples: • Represents a range of values in which the true value
▪ Shift – control on one side of the mean 6
is reasonably expected to lie
consecutive days • Estimated at "95% coverage"
▪ Trend – control moving in one direction-
• More precise the method, the smaller the range of
heading toward an "out of control" value values that will fall within 95%
• Most instances, a range of + or – 2SDs is accepted
Random Error as measurement uncertainty that is explained by
• Bubbles in reagents
random variation.
• Inadequately mixed reagents
• Unstable temperature and incubation
• Unstable electrical supply
WESTGARD RULES
• Individual operator variation
• 1981 Dr. James Westgard published laboratory
quality control basis for evaluating analytical run
Systematic Error quality for medical laboratories.
• Change in reagent lot
• Based on principles of statistical process control
• Change in calibrator lot
used in industry nationwide since the 1950's.
• Wrong calibrator values
• Improperly prepared reagents
Six Basic Rules in Westgard scheme.
• Deterioration of reagents
• These rules are used individually or in combination
• Deterioration of calibrator
to evaluate the quality of analytical runs.
• Inadequate storage of reagents or calibrators
• Change in sample of reagent volumes – equipment
Westgard Notation
failure • Westgard devised a shorthand notation for
• Change in temperature of incubators
expressing quality control rules.
• Change in procedure from one operator to another
• Most of the quality control rules can be expressed
as NL .
• Where N= represents the number of control
observations to be evaluated.
• L= represents the statistical limit for evaluating the
control observation.
Rule 12s
• Warning rule Rule 41s
• Violates a single control observation is outside the • Four consecutive results are greater than 1s on the
+2s limits same side of the mean
• 4.5% of all quality control results will fall between
the 2s and 3s limits.
• Warns that random error or systematic error may Rules 7x/ 8x/ 9x/ 10x/ 12x
be present in the test system. • 7 or 8, or 9 or 10, or 12 control results
• On the same side of the mean regardless of the
specific standard deviation in which they are
located.

When a rule is Violated

• Warning rule = use other rules to inspect the
control points
• Rejection rule = "out of control"
▪ Stop testing
▪ Identify and correct problem
Rule 13s ▪ Repeat testing on patient samples and controls
• Unacceptable random error ▪ Do not report patient results until problem is
• Possibly the beginning of a large systematic error solved and controls indicate proper
• Any QC result outside 3sd violates this rule. performance

Solving out-of-control problems

• Identify problem
Rules 22s • Refer to established policies and procedures for
• Systematic error remedial action.
• Two consecutive QC results are greater than 2s on
the same side if the mean Possible Problems
• Degradation of reagents or kits
• Control material degradation
• There are two applications to this rule: • Operator error
▪ Within- run – both controls • Failure to follow manufacturer's instructions
▪ Across run – single control • An outdated procedure manual
• Equipment failure
Rule R4s • Calibration error
• Random error
• If there is at least a 4s difference between control
values within a single run
PROCESS CONTROL: QUALITY CONTROL OF
QUALITATIVE AND SEMI – QUANTITATIVE
PROCEDURES
Each of these rules also has two applications:
• Within control materials application – single area Qualitative or semi- quantitative test examples
• Acros control materials application – broader core • Microscopic examinations
• Dipsticks
Rule 31s • Serologic procedures
• Three consecutive results are greater than 1s on the • Microbiological procedures
same side of the mean • Any reaction that produces non-numeric results

Important Concepts
• Sample management
• Staff competency
• Equipment maintenance
• Control materials
• Stains, media and reagents management
• Record keeping
Quality Control Materials
• Built-in controls
• Control materials that mimic patient samples
• Reference organisms
Built-in Controls
• Integrated into the design of a test kit device
• Automatically run with each test performed
• Assess certain aspects of kit performance
• May not assess entire testing process
Traditional Controls
• Materials with knows reactivity
• Mimic patient samples
• Assess the integrity of the entire test system
Using Traditional Controls
• Test as per patient samples
• Use a positive and negative control
• Include a weak positive control or immunological
procedures
• Choose positive controls close to the cut-off value
• Include control to monitor extraction phase
Stock Cultures for QC
• Reference strains
• In-house developed strains
• Predictable reactions in stains and media
• Ensure media, reagents and supplies work as
intended
Sources for Obtaining Reference Strains
• ATCC- American Type Culture Collection
• NTCC- National Type Culture Collection (UK)
• CIP- Pasteur Institute Collection (France)
Stain Management
• Use established procedure for preparation or
reconstitution
• Label: content, concentration, date prepared and
placed in service, expiration, initials
• Store appropriately
Quality Control for Stains
As appropriate for particular stain:
• Check with known organisms or cells
• Examine for crystal shards or for precipitation.
• Examine for contaminants such as bacteria and
fungi
QC of Microbiology Media
• Verify performance of all media
• In-house prepared: all batches
• Commercially prepared: new lot only
Media Problems to Avoid
• Out-dated
• Dried-out
• Contaminated
Human Blood should not be used because:
• Too much batch to batch variation
• May include inhibitory substances, including
antimicrobials
• May contain biohazard (e.g., hepatitis virus)
BAP- Blood Agar Plate
-should be sheep's blood
Quality Control of Growth Media
• Keep records for media prepared in-house
• Record outcomes in a dedicated media logbook for;
o pH, sterility, ability to support growth using
stock cultures, biochemical response of stock
cultures.
• Frequency
o Test each new batch or lot number
LECTURE 7
ASSESSMENT: AUDITS
• It determines the effectiveness of the laboratory's
quality management system through internal and
external audit.
• Systematic examination of some part (or all) of the
quality management system.
• Conformance with requirements
What is an assessment??
Assessment is an examination, evaluation or inspection
of a laboratory.
Why perform an assessment?
• Learn "where we are" in terms of quality
management
• Measure gaps
• Need information for:
o Planning and implementation Internal Audit
o Monitoring • Allows the laboratory to look at its own processes
o Continuous improvement and its advantage is the laboratory can perform
them as frequently as needed.
Types of Assessment: • Cost less
• Internal Audit • Flexible in time
Assessment within the laboratory • Required by ISO standards
• External Audit • Conducted on a regular basis
Outside the laboratory, it includes: outside group or • Conducted when problems identified
agencies Performing this internal audit is for you to prepare for
o Two types of external audit: the external audit.
▪ 2nd party audit
This are audit performed by personnel not Value of Internal Audits
from the local laboratory • Prepare for external audit
▪ 3rd party • Increase awareness
Performed by accreditation organization • Opportunity for improvements
auditors. • Preventive and corrective actions
• Opportunity for continuing education
Auditing • Meeting quality standards
1. Gather information
• Process, operating procedures Internal Audits: ISO Requirements
• Staff, equipment, test methods *ISO Standards put much emphasis on the Internal
• Environment, handling of samples Audit
• Quality control verification activities • Must have an audit program
• Recording and reporting practices • Must document procedures
2. Compare findings with documented quality • Auditors independent of activity
management system • Results documented and reported to
3. Identify breakdown in system or departure from • Management for review
procedures • Prompt follow-up action
4. Do something with audit results.
Internal Audit Program
External Auditors • Assign responsibility
• Health authorities • Prepare documents checklists forms
• Funding program • Schedule regular audits
• Accreditation body
• Public health program Laboratory Director
Is the one who is responsible for setting overall policies
External Audit Preparation for the internal audit program
• Plan • Determines the internal auditing policy
• Organize • Assigns responsibility for the internal audit
• Gather information and records program
• Schedule with staff • Supports corrective action measures

External Audit Report and Plan of Action Quality Manager

• Auditors closing summary and report Organizes or manages the internal audit program
• Laboratory understands recommendations
• Identify gaps Quality Manager Responsibility
• Plan corrective actions Establish and maintain an internal audit system
• Develop timeline • Develop schedule
• Assign responsibility • Select & train auditors
• Record results and actions • Coordinate the audit process
• Write report • Internal audit outcomes
 o
o
Report to management
Report to staff
LECTURE 8
o Manage corrective actions
EXTERNAL QUALITY ASSESSMENT
• A system for objectively checking the laboratory
Conducting an Internal Audit
performance using an external agency or facility
• Develop plan
• Write checklists
EQA Methods
• Opening meeting
• Proficiency Testing
• Collect and analyze information
External provider will send unknown samples
• Record results
for testing and your laboratory will test that
• Conduct closing meeting
unknown sample and the result will be analyzed
• Report
by the external provider and compare and
report to the laboratory
Establishing an Audit Schedule
• Rechecking Retesting
• Conduct regularly
Slides that have been read are rechecked by a
• More frequent audits for problems or areas needing
reference laboratory
improvement
• On-site Evaluation
• Over time audits should look at all of the quality
Difficult to be done. It is conducted traditional
system essentials
proficiency testing or use of rechecking or
*ISO states that internal audit is normally conducted
retesting.
once every 12 months, this means that every part of the
laboratory should have an inspection annually.
External Quality Assessment (EQA)
• Comparison among different test sites
Documents
• Early warning for systematic problems
• Checklists
• Objective evidence of testing quality
• Develop forms for documenting corrective actions
• Areas that need improvement
and reports
• Training needs

Important skills for Auditors

EQA Benefits
• Attentive to detail
• Helps the laboratory to produce a reliable result
• Trained
• Can also identify problems in the laboratory
• Communicate effectively
practices, allowing for appropriate corrective
• Diplomatic
actions
• Technical/ quality management experience
• Helps to evaluate reliability of the methods,
materials and to also evaluate and monitor the
*Audits Should Lead to Actions
training impact of the staffs.
• It meets the public health oriented objectives
Corrective and Remedial Actions
These actions are the steps taken to improve a process
EQA
or to correct a problem
• In EQA individual laboratory result are kept
Who is responsible?
confidential and generally are only known by the
Quality Manager
participating laboratory and the EQA provider.
• Can either be free or with fee
Taking corrective action
• Can be organized by different levels
• Using problem-solving team:
o Regional
o Investigate root causes
o National
o Develop appropriate corrective action
o international
• Implement corrective action
• Can be a mono test or multi test
• Examine effectiveness
• Obligatory or Voluntary
• Record all actions and findings
• Monitor
▪ EQA is important for improvement
▪ A measure of laboratory performance
Proficiency Testing Rechecking
ISO/ IEC Guide 43-1:1997 ▪ Samples must be collected randomly
"Proficiency testing schemes (PTS) are interlaboratory ▪ Avoid systematic sampling bias
comparisons that are organized regularly to assess the ▪ Statistically significant
performance of analytical laboratories and the ▪ Resolve discrepancies
competence of the analytical personnel. ▪ Effective feedback
-usually the External provider gives unknown samples ▪ Primarily AFB

CLSI GP27-A2 27:8 On-site Evaluation

"A program in which multiple samples are periodically
sent to members of a group of laboratories for analysis
and/ or identification; whereby each laboratory's results
are compared with those of other laboratories in the
group and/ or with an assigned value, and reported to
the participating laboratories and others".
• To obtain a realistic picture of laboratory practices
• To provide assistance with problem areas
EQA Participation
• Recommended for all laboratories
• Required by ISO

Management Process
• Handle and analyze EQA samples
• Treat EQA samples same as patient
• Monitor and maintain records
• Investigate deficiencies
• Manage corrective action efforts
• Communicate outcomes

EQA performance problem

*If the laboratory performs poorly on the EQA, the
problems may lie anywhere along the path of workflow.
It can be in the pre examination phase, the examination
phase or the post examination phase.
*information received from PT participation must be
National Reference Laboratories
directed toward improvement in the laboratory to
Functions:
receive the full value.
• Maintain a quality assurance program for laboratory
tests
PT Limitations
• Provide laboratory referral services
▪ PT results are affected by variables not related to
• Train laboratory personnel
patient samples
• Evaluate test kits and reagents
▪ PT will not detect all problems in the laboratory
▪ PT may not detect problems with pre- and post-
o Research Institute for Tropical Medicine
examination procedures
▪ Dengue
▪ Influenza
Other EQA Methods
▪ Tuberculosis and other mycobacteria
Rechecking/ Retesting
▪ Malaria and other parasites
▪ Peripheral laboratory – staffs are the one who
▪ Bacterial enteric diseases
sends the sample with the result
▪ Measle and other viral exanthems
▪ Reference laboratory- rechecks the work
▪ Mycology
▪ Enteroviruses
Retesting
▪ Antimicrobial resistance and Emerging Disease
▪ Tested by reference laboratory
▪ Confirmatory testing of blood donors and blood
▪ Performed on dried blood spots or serum
units
▪ Not blinded
▪ Statistically significant
▪ Primarily used to assess HIV rapid testing
o San Lazaro Hospital • Organizes the laboratory in preparation for
▪ HIV/AIDS assessments
▪ Hepatitis
▪ Sexually Transmitted Diseases
SACCL- STI/AIDS Cooperative Central Laboratory Normative Document – Provides rules, guidelines or
characteristics for activities or their results
o East Avenue Medical Center
▪ Toxicology Standard Document – Established by consensus and
▪ Micronutrient Assay approved by a recognized body, that provides, for
common and repeated use, rules, guidelines or
o National Kidney and Transplant Institute characteristics for activities or their results, aimed at
▪ Hematology the achievement of the optimum degree of order in a
▪ Immunology given context.

o Lung Cancer of the Philippines Regulation - Any standard that is mandated by a

▪ Anatomic Pathology governmental agency or authoritative body.
▪ Biochemistry
▪ Clinical Chemistry
Self-developed Standards
Many agencies. Organizations, or regions develop their
LECTURE 9 own accreditation requirements rather than using
internationally recognized standards.
• Advantages:
ASSESSMENT: NORMS AND ACCREDITATION
▪ Optimized for local use, recognized local
strengths and weaknesses
Laboratory Assessment- Why?
▪ Can be developed in progressive steps
• Recognition as delivering accurate and reproducible
▪ Can lead to full international recognition
results
• Recognition of compliance with the quality
• Weaknesses:
standards and norms used for the assessment.
▪ May be narrow or biased
*The more recognition in your laboratory, the more
▪ May not be recognized by other organizations
your customer trusts you.
*Successful completion of this process gives the
National Standards and Technical Guidelines
laboratory recognition that it is in compliance with the
• Country-specific standards
quality standards and norms used for the assessment.
▪ Based on international standards
▪ Adapted to the culture and general condition of
Laboratory Director
the country
Needs to be aware of the importance of gaining
• Guidelines
accreditations, certifications and licensure.
▪ Supplement ISO standards with technical
• Implements international or national standards
guidance for use in laboratories
• Seeks information about appropriate norms and
▪ Can address a specific kind of testing
standards
• Seeks information about accreditation and
Certification – Procedure by which a third party gives
certification processes
written assurance that a product, process or service
• Uses outcomes to provide better service
conforms to specific requirements
Laboratorian
Accreditation – Procedure by which an authoritative
• Aware of requirements
body gives formal recognition that a body or person is
• Contributes to meeting standards
competent to care out specific tasks.
• Aware of assessment processes
• Helps prepare for assessment
Licensure – Granting of ability to practice provided most
often by a local governmental usually based on
Quality Manager
demonstrated knowledge, training and skills.
• Explains the process for meeting standards to staff
Elements of an Accreditation Process
• Accreditation Body – the one who oversees the
assessment and granting the accreditation, there
must be set standards that is used for the
assessment process or accreditation process.
• Standards – must be complied by the laboratory in
order to gain accreditation.
• Assessors – knowledgeable assessors or inspectors.
There are the one who seeks to establish the
compliance with the standard by conducting the
assessment.
• User Laboratory
Certification Bodies and Accreditation Bodies
*Is an organization or agency with the authorized right
and authority to inspect a laboratory. They provide
written evidence of its compliance (certification) and
competency (accreditation) with a standard.
*Usually require their own accreditation status.
*They are accredited by the international organizations
like ISO
• Characteristics:
▪ Approved
▪ Knowledgeable
▪ Standards-based
▪ Objective
▪ Competent staff
Standardization Bodies
International organizations include:
• ISO (International Organization for Standardization)
▪ World's largest developer and publisher of
international standards
▪ Standards are applicable to many kinds of
organizations including clinical and public health
laboratories
• CLSI (Clinical and Laboratory Standard Institute)
▪ Global, Nonprofit, standards-developing
organization
▪ Promotes the development and use of
voluntary consensus standards and guidelines
within the health care community
▪ Documents are developed by experts working
on subcommittees or working groups
• CEN (Comite Europeen de Normalisation) -
European Committee for Standardization
▪ National standards bodies in the European
Economic Community and associated countries
▪ General terms include openness and
transparency, consensus, and integration
• WHO (World Health Organization)
▪ Developed several standards for disease-
specific diagnostic laboratories, such as polio,
tuberculosis, influenza, measles.
• Commonly used standards
o Certification standards
▪ ISO 9001:2000
-specifies requirements for a quality
management system
-used by many sectors
▪ ISO 14000
-defined as the "series of international
environmental management standards, rights
and technical reports.
o Accreditation standards
▪ ISO 17025
- which enables laboratories to
demonstrate that they operate
competently and they generate valid and
reliable results
-they promote confidence in their work
both national and international.
-it is a quality standard for testing and
calibration of laboratories
-it does not cover compliance with
regulatory and safety requirements for the
laboratory operations
▪ ISO 15189
-based on the ISO 17025:1999 & 9001:2000
-specific for medical laboratories
-develops there quality management
system
-assesses their own competence
-used for confirming or recognizing
competence of medical laboratories by
laboratory customers regulating authorities
and accreditation bodies
o Regulations – required by the law
▪ US CLIA (Clinical Laboratory
Improvement Amendments) Regulations
-applicable to US facilities
▪ French GBEA (Guideline for good analysis
performance)
-all clinical laboratories in France are
required by law to comply with GBEA
Process for Accreditation
Not one to be taken lightly or without forethought
• Requirements:
 ▪ Commitment
▪ Planning
▪ Knowledge
▪ Resources

Accreditation Terms
• Consensus
– Represents general agreement in the absence of
strong and compelling objection
• Normative Statement
- Required and essential part of the standard
Includes the word "shall"
• Informative Statement
-Information (often a 'note') that may be
explanatory, or cautionary, or provide an example
• Compliance
-Meets both the test and the spirit of a
requirement
• Non-conformity
-Failure to fulfill the requirements of a specified
process, structure or service
-May be categorized as major (complete) or minor
(partial)
• Verification of conformity
-Confirmation by examination of evidence

*Accreditation does not guarantee success, it is only

step along the quality journey

Accreditation outcomes
• Strength and integrity of the quality system are
measured
• Continual monitoring of the quality system
• Recognition for efforts

Accredited laboratories tend to:

• Perform better on proficiency testing
• Have a working quality management system

*It is an Achievement to maintain accreditation.*