QUALITY CONTROL

- is a system used to maintain a determined level of accuracy and precision .

- helps ensure that reported results of patient laboratory testing are correct
- Applies not only to specimen testing, but also to collection , storage and transportation.
- Use standards/controls to check the precision and accuracy of laboratory equipments
- Disposed of outdated reagents
- Follow the standard operating procedure (SOP) exactly
- Checking the accuracy of the results with laboratory references at intervals
- Maintaining the laboratory equipments
 PURPOSE OF QUALITY CONTROL

1. To make sure that the test result represent the status of the patient’s condition
2. To make sure the test results are reliable and valid
3. To make sure that any possible errors that can interfere are detected and eliminated
 QUALITY

- means the worth of service

- the key measurable characteristics of a product or process whose performance standards
or specification limits must be met to satisfy the customer
- may be upper or lower specification limits or other factors

In Clinical Laboratory - assessment of quality results for various analysis is critical and is an
important component of the operation of a high quality laboratory.
 CONTROL

- QC programs require the same sample to be tested every day . This type of sample is
called a CONTROL.
- often purchased form manufacturers, use a human base to ensure the analytes being
tested parallel human ranges
- Manufacturers pool together many human blood samples to create the large volume
needed for a lot number of control
LABORATORY WORKFLOW

AREA JOB DESCRIPTION:

Pre Analytical- Test request
-Specimen Collection
- Specimen Transport
- Specimen Receipt
Analytical – Testing Review
- Laboratory Interpretation
Post Analytical- Results Report
- Specimen Management
AUTOMATION WORKFLOW
 QUALITY CONTROL OVERVIEW

1. Clinical Laboratory Improvement Amendments

2. Voluntary Accrediting Organizations
3. Quality Assessment Considerations
4. Quality Assessment Descriptors
5. Quality Control Statistics
6. Monitoring Quality Control
7. Testing Outcome
 CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS (CLIA)
1988 – first CLIA enacted Laboratory testing errors
January 24, 2003 – Final CLIA rule, Laboratory requirements relating to Quality Systems
and Certain Personnel Qualifications
April 24, 2003 – All laboratories are required to meet and follow the final QC requirements
January 2004 – EQC ( Equivalent Quality Control) which is the controversial regulation
was published.
- this allows (CMS) Centers for Medicare and Medicaid Services to consider
acceptable alternative approaches to QC practices
 QUALITY ASSESSMENT

- Reduce and potentially eliminate laboratory errors

- Current sources of Laboratory errors:
1. Pre –analytical:
a. Specimen related errors
b. Major problem
c. Increases cost - $400 M/yr
2. Post Analytical
- QA considerations are in two major components
1. Non- analytical
2. QC (Analysis of quantitative data)
ERRORS ECOUNTERED
 ACCREDITATION OF HOSPITAL
LABORATORIES
1. JCAHO – Joint Commission on Accreditation of Health Care Organizations
2. COLA -Commission on Office Laboratory Accreditation
3. CAP - College of American Pathologists
 JCAHO ( JOINT COMMISSION ON ACCREDITATION
OF HEALTH CARE ORGANIZATION)

- Was formed to set standards and to focus on quality assessment programs

- Requirements:
1. Periodic Performance Review (PPR)
- a formal standard evaluation tool intended to support continuous compliance
2. JCAHO accredited organizations must participate in PPR options (non waived test), moderate or
high test -CLIA certificate is needed
3. Laboratories in JCAHO accredited organizations that are accredited by cooperative partner (COLA
or CAP) are not required to complete PPR
4. JCAHO accredited organizations that only provides waived-testing addressed in organizational PPR.
 CAP (COLLEGE OF AMERICAN PATHOLOGISTS )
QUALITY ASSESSMENT CONSIDERATIONS
1. Supervision
2. Procedure Manual
3. Specimen Collection and Handling
4. Result Reporting
5. Reagents, Calibration and Standards Controls
6. Instruments and Equipments
7. Personnel
8. Physical Fascilities
9. Laboratory Safety
IQLM ( THE INSTITUTE QUALITY FOR LABORATORY
MEDICINE)
- Developed 12 measures to evaluate quality in the laboratory based on the phase of
testing:
a. Pre-Analytical
b. Analytical
c. Post Analytical
 PROPOSED QUALITY ASSESSMENT
MEASURES FOR (IQLM)
Pre- Analytical Phase: Test system/Analytical Phase:

1. Test order accuracy 1. Diabetes monitoring

2. Patient Identification 2. Hyperlipidemia screening

3. Blood Culture

4. Contamination Post Analytical Phase:

Test System/Pre-Analytical Phase: 1. Critical Value reporting

1. Adequacy of specimen 2. Turnaround time

2. Information

Analytical Phase: Test system/Post Analytical Phase:

1. Accuracy of point of care testing 1. Clinician satisfaction

2. Cervical cytology/biopsy correlation 2. Clinician follow- up

 NON-ANALYTICAL FACTORS IN QUALITY
ASSESSMENT

1. Qualified Personnel
2. Established Laboratory Policies
3. Laboratory Procedure Manual
4. Testing Requisitioning
5. Patient Identification, specimen procurement and labeling
6. Specimen transportation and processing
7. Preventive maintenance of equipments
8. Appropriate testing methods
 QUALIFIED PERSONNEL

1. A thorough orientation to the laboratory procedures and policies is vital for new laboratory
personnel
2. Periodic opportunities for personal upgrading of technical skills and for obtaining new relevant
information should be made available – by in service training classes, opportunity to attend CE
courses, encouraging study habit by scientific journals and audio-visual materials
3. Personnel performance by periodic evaluation and reports
4. Quality assessment demands – supervisor must monitor results of the daily work and reports
produced during the shift be evaluated for the errors and omissions
5. Only properly qualified personnel can perform non-waived assays
QUALIFIED PERSONNEL GUIDELINES
CONT’N….
6. CLIA 88 requirements must be followed for laboratory personnel, level of education
and experience /training for laboratory doing moderately complex or highly complex
testing.
7. Competent laboratory personnel must be able to perform QC activities, maintain
instruments, keep accurate and systematic records of reagents and control specimens
equipment maintenance and patient and analytical data.
 ESTABLISHED LABORATORY POLICIES

1. Laboratory policies should be included in a laboratory reference manual and should be available to all laboratory/ hospital personnel
2. Must have up to date safety manual
3. Manual should contain:
a. Comprehensive listing of approved policies
b. Acceptable practices
c. Precautions - Standard blood and body fluid
4. Safety regulations that conform to current state and general requirements in manual:
a. Occupational Safety and Health Administration (OSHA) regulations
b. Other sources of mandatory and voluntary standards
- JCAHO, CAP, CDC ( Center for Disease Control and Prevention)
 LABORATORY PROCEDURE MANUAL

- Has a complete Laboratory Procedure manual for all analytical procedures performed
with in the laboratory
- Must be reviewed regularly ( some cases- annually) by supervisory staff and updated
- CLSI ( Clinical and Laboratory Standards Institute ) recommends to follow a specific
pattern how procedures are organized in manual
- Each assay done in the laboratory must be included in the manual
 MINIMUM COMPONENTS OF THE
LABORATORY PROCEDURE MANUAL
1. Title of the assay
2. Principle of the procedure and statement of the clinical applications
3. Protocol for specimen collection and storage
4. QC information
5. Reagents, supplies and equipments
6. Procedural protocol
7. “Normal” reference ranges
8. Technical sources of error
9. Limitation of the procedure
10. Proper procedure for specimen collection and storage
 TEST REQUISITIONING

1. Laboratory Test can be requested by a primary care provider (physician)

2. Request can be hard copy or electronic
3. Must include:
a. Patient’s identification data
b. Time and date of specimen collection
c. Source of specimen
d. Analysis to be performed
4. Information on the accompanying specimen container must match exactly the patient identification on test request
5. Handbook or database must have information needed by physician to assist in ordering test
 PATIENT IDENTIFICATION, SPECIMEN
PROCUREMENT AND LABELLING
1. Maintaining an electronic database or handbook or specimen requirement information is
one of the first step in establishing a quality assessment program for the clinical laboratory
2. Database must include:
a. Current information for obtaining appropriate specimen
b. Special collection requirement for various types of tests
c. Ordering tests correctly
d. Transporting and processing specimens appropriately
3. Patient must be carefully identified –OHIP
 PATIENT IDENTIFICATION, SPECIMEN
PROCUREMENT AND LABELLING CONT’N…..
4. Using established specimen requirement information, the clinical specimen must be
properly labelled or identified once they have been obtained from the patient.
5. Computer generated labels assist in making certain that proper patient identification is
noted on each specimen container sent to the laboratory

Important Rule:
The analytical results can only be as good as the specimen received.
 SPECIMEN TRANSPORTATION AND
PROCESSING
- Specimen must be efficiently transported to the laboratory
- Must be handled specially as per assay requirement:
a. Placing the specimen in the ice immediately after collection
b. Specimens should be tested within 2 hours of the collection to produce
accurate results
- The documentation of specimen arrival in the laboratory as well as other specific data is an
important aspect of the quality assessment process
- Specimen status can be determined by at anytime, e.g. where in the laboratory processing
system a given specimen can be found
 EXAMPLES OF PRE-ANALYTICAL ERRORS

1. Specimen obtained from wrong patient

2. Specimen procured at the wrong time
3. Specimen collected in the wrong tube or container
4. Blood specimen collected in the wrong order
5. Incorrect labelling of specimen
6. Improper processing of specimen
 PREVENTATIVE MAINTENANCE OF
EQUIPMENT
1. Monitoring of the temperature of the heat blocks or refrigerators is important to the
quality of the test performance. Failure to monitor equipment regularly can produce in
accurate test results and lead to expensive repairs
2. Preventative maintenance schedule should be followed for all automated equipments
-Clinical Laboratory must follow CLIA or manufacturer’s requirements for
instrument calibration. CLIA requires that laboratories re calibrate an analytical method
at least every 6 months
 PREVENTATIVE MAINTENANCE OF
EQUIPMENT CONT’N
3. Must be cleaned and checked for accuracy
a. Microscope
b. Centrifuge
c. Other equipments
4. Manufacturers will recommend a calibration frequency determined by
a. Measurement system stability
b. Communicate in product inserts the specific criteria for mandatory re- calibration of instrument system
- Reagent lot change
- Major component replacement
- Instrument maintenance
- New software installation
 APPROPRIATE TESTING METHOD

- Each laboratory must have an assessment routine for all procedures,

performed on a daily , weekly, or monthly basis to detect problems like trends
or shifts in the established mean values.
- If such problem indicated – correct ASAP
- QC program concerns that New procedure are validated before they are
included among the methods routinely used by the laboratory
 APPROPRIATE TESTING METHOD CONT’N

-Each Laboratory must determine for control specimens:

a.The reproducibility (Confidence limits) for each procedure
b. Establish acceptable limits of variation
- The QC program includes:
a. Calculation of Mean (Average Value)
b. Standard Deviation (SD)
c. Generation of control chart for each procedure
 QUALITY ASSESSMENT PROCEDURES

1. Test request procedures

2. Patient Identification
3. Specimen procurement and labelling
4. Specimen Transportation and processing procedures
5. Laboratory personnel performance
6. Laboratory instrumentation, reagents and analytical test procedures
7. Turnaround times
8. Accuracy of final results

- Complete documentation must be maintained and monitored

 PROFICIENCY TESTING (PT)
- Monitoring of quality control between laboratories – CLIA regulations
- Use internal QC programs, each laboratory should participate in external (PT) program as a means of verification of
laboratory accuracy
- Each laboratory has to test a specimen at interval that has been provided by:
a. Government agency
b. Professional society
c. Commercial Company
- At regular intervals during the year, the PT agency sends blind samples to the laboratory.
- A Blind Sample is an assayed sample that is provided as an unknown to laboratories participating in proficiency
programs
- The subscribing laboratory analyzes these blind samples and sends the results to the PT agency
 PROFICIENCY TESTING (PT)

- Each laboratory analyzes the specimen, reports results to agency and is

evaluated and graded on those results in comparison to results from other
laboratories
- The subscribing laboratory’s results are then compared to the PT agency’s
assayed values and to the results of peer laboratories participating in the PT
program. Participating laboratories receive a report evaluating their
performance.
- JCAHO (Joint Committee on Accreditation of Health Care Organizations)
requires ORYX (Outcome Research Yield Excellence)
 ACCURACY IN REPORTING RESULTS AND
DOCUMENTATION
- Critical Values or Data check system to monitor individual patient results:
a. Highly abnormal test results
b. Significant different from previous results
- Alert technologist of a potential problem
- Continuous Quality Improvement (CQI) – define as the ongoing process of making certain that the correct
laboratory result is reported for the right patient in a timely manner and at the correct cost
- Assures clinician – test done at best possible way to provide the most useful information in diagnosis
- Each laboratory set own quality assessment indicators to monitor the performance of the laboratory under the
CQI process
 QA DOCUMENTATION (CLIA)

- Problem or situation affecting results must be recorded and reported

- Incident – collection, labelling, transportation turnaround times must be documented in writing with
changes proposed, implementation and follow –up monitored, all steps must be documented
- Another QA tech is to look at the data generated for each patient and inspect the relation between
them – include mathematician association, correlation, relationship or appearance.
- Use of Computer systems and record keeping can assist in documentation when control results are
within the acceptable limits , these data provide link between control and patient data, thus re assure that
patient results are reliable, valid and reportable.
- Information helps document that uniform protocols have been established and followed and support the
proper functioning of the test system
 CLIA REGULATION FOR MODERATE
COMPLEX TESTS
- Perform and document control procedures using at least two levels of control material
each day of testing
- Follow the manufacturer’s instructions for QC
 QUALITY CONTROL

- QC consists of procedures used to detect errors that results from:

1. Test system failure
2. Adverse environmental conditions
3.Variance in the operator performance
4. Procedure to monitor accuracy and precision
- CLIA regulation
1. Monitoring and documentation of quality assessment records
2. Laboratory must establish and follow written QC procedures for monitoring and
evaluating the quality of the analytical testing process to assure accuracy and reliability of patient test results and
reports
 QC DOCUMENTATION INCLUDES:

1. Monitoring of laboratory instruments, reagents, equipments, etc.

2. Written record of QC activities for each procedure or function including details of
deviation from usual results, problems, or failure in functioning, corrective action
3. Preventative maintenance records, temperature charts and QC charts for specific assays
4. Reagents and other product records
5. Record of use of QC specimens, proficiency testing and standards are as per agency
requirement
6. In the case of the hospital , may be asked for QC measures in other departments like
blood bank, effectiveness of the autoclave , pharmacy and dialysis
 CONTROL SPECIMENS

- Is a material or solution with a known concentration of the analyte being measured in the
testing procedure.
1. Multi-constituent Control – more use, less storage space, offer ease for inventory
and increases manufacturer services through peer laboratory comparison
2. Lyophilized and Liquid Control – offer good stability, reasonable expiry
Liquid Controls – more reproducibility as no pipetting
3. Lot sequestering Control – continue to receive the same lot for long time,
no storage problem
 CONTROL SPECIMEN

- A control specimen must be carried through the entire procedure and treated in exactly the
same way as any unknown specimen. It must be affected by all the variables that affect the
unknown specimen
- Many factors can produce variations in the laboratory analysis in properly designed control
system and can be monitored
- CLIA regulations – a minimum of two control specimens (-ve and +ve) must be run in every
24 hrs period when patient specimens are being run
- When automated instruments are in use, the bilevel controls are run once every 8 hrs of
operation once per shift
 CONTROL SPECIMEN CONT’N

- Use of QC specimens – reliability of the results

- If QC specimen value is not within pre determined acceptable range, unknown specimen
values are incorrect, no reporting.
- Procedure reviewed for error, error found, corrected. Testing repeated until control value
falls within acceptable range
- Reliability determination- when evidence of errors more than permitted amount – reject
results
 QUALITY CONTROL DESCRIPTORS

- Test results’ value to clinician – a diagnosis, change diagnosis, provide follow-up on patient
management
- Diagnostic usefulness of a test and procedure is assessed by statistical evaluations such as
descriptors of accuracy and reliability (test and methodology)
a. Reliability can be described by accuracy and precision
b.Variance – describes the factors or fluctuations that affect the measurement of a
substance
c. Statistical Methods – used to assess usefulness of a test result in terms of sensitivity,
specificity and predictive value
 CLINICAL QUALITY ASSESSMENT
TERMINOLOGY
1. Accuracy – how close is the test result to the true value
2. Calibration – the comparison of an instrument measure or reading to a known physical constant
3. Control – a specimen with a known value that similar in composition to the specimen (blood, urine,
etc)
4. Precision – how close the test results are to one another when repeated analysis of the same
material are performed
5. Quality Control – process that monitors the accuracy and reproducibility of results through the use
of control specimens
6. Standards – are highly purified substances or a known composition
 ACCURACY VS PRECISION

ACCURACY PRECISION
- Closeness of the results obtained to the true or actual value - Repeatability or reproducibility (ability to obtain the same
value in the subsequent tests on the same sample)
- Aided by the use of properly standardized valid comparison
of new with established reference methods, use of controls - Expressed as Standard Deviation (SD) or Coefficient
and participation in the Proficiency (PT) program Variation (CV
- Ensured by proper inclusion of standards, reference
samples or controls, statistically valid replicate
determinations of single sample and duplicate
determinations of sufficient numbers of unknown samples
- Measured by control run day-to-day between run
 SPECIFICITY AND SENSITIVITY

- Equally important for diagnosis but in different clinical situation one is generally preferred
- Assessing both needs – test positive, test negative, disease present and disease absent
a. True Positive – subjects who have a positive test result and have disease
b. True Negative – subjects who have negative test result and do not have a disease
c. False Positive – subjects who have a positive test result but do not have disease
d. False Negative – subjects who have a negative test results but do have a disease
 SENSITIVITY VS SPECIFICITY

SENSITIVITY SPECIFICITY
- Defined as the proportion of the cases with a specific disease or condition Defined as the proportion of cases with absence of the specific
-

that give a positive result disease or condition that gives a negative test results
- Means assay correctly predicts with a positive result - Means the assay correctly excludes with a negative result
- Sensitivity represents how much the given substance is measured
- Represents what is being measured
- The more sensitive the test, the smaller the amount of assayed substance
that is measured - A highly specific test measures only the assay substance,
does not measure interfering or similar substance

- Sensitivity %= True positive_________x 100

True positive + False negative Specificity % = ________True Negative____ x 100

False positive + True Negative
 PREDICTIVE VALUES (PV)

- Sensitivity, specificity and prevalence of the disease in the population being studied must
be known to assess the PV of a test
- The prevalence of a disease is the proportion of the population who has the disease
 POSITIVE PREDICTIVE VALUE

- Indicates the number of patients with an abnormal test results who have the disease, compared with all patients with an
abnormal results.

Positive PV = Number of patients with disease and with abnormal test results
________________________________
Total number of patients with abnormal test results

Positive PV = True positives

________________________________
True positives + False positives
 NEGATIVE PREDICTIVE VALUE

- Indicates the number of patients with a normal test result who do not have the disease,
compared with all patients with a normal (-ve) result.

Negative PV = ____True Negatives________

True Negatives + False Negative
 QUALITY CONTROL STATISTICS

- Statistically, the reference range for a particular measurement in most cases is related to a
normal bell-shaped curve.
- This Gaussian curve or distribution is correct for all biological, chemical and physical
measurements
- A statistically valid series of individuals who are thought to represent a normal healthy group
are measured and average value is calculated, this mathematical average is called Mean (X)
called X-bar.
- The distribution of all values around the average for the particular group measured is
described statistically by SD ( Standard Deviation)
 NORMAL BELL-SHAPED GAUSSIAN CURVE
(SD)

1. 2.
 MEAN

- Mathematical average calculated by taking sum of the values – dividing by the number of
values in the list
- CLSI recommends – minimum 20 data for mean and precision , if not available
- minimum of 7 runs- 3 replicates per run can be used for provisional mean and
SD but must be replaced when 20 separate runs becomes available.

Example is 34,35,38,46,40,41,42,42,36,32
 MEDIAN

- Is the middle value of a body of data

- If all the variables are arranged in order of increasing magnitude in a body of data, the
medial is the variable that falls halfway between the highest and lowest variables, means
median equals middle value

Example: Find the median = 34,35,36, 46,40,41,42,42,36

 MODE

- Is the value that is most frequently occurring in a list of numbers

Example: Find the mode = 34, 35, 38, 46, 40, 41, 42, 42, 36
 STANDARD DEVIATION (SD)

- Is a measure of the spread or variability of data set:

- is a statistic that measures the dispersion of a dataset relative to its mean and is calculated as the square root of the variance. ... If the data points
are further from the mean, there is a higher deviation within the data set; thus, the more spread out the data, the higher the standard deviation.

• a number used to tell how measurements for a group are spread out from the average (mean), or expected value. A low standard deviation means
that most of the numbers are close to the average. A high standard deviation means that the numbers are more spread out.

• In any normal population:

- 68% of the values will be clustered above and below the average and defined statistically as falling within the first SD (+ 1SD) ;

- 95% (+ 2SD)

- 99.7% (+ 3SD)

- Variations occur equally above and below the average (mean) for any measurement
GAUSSIAN CURVE
TO CALCULATE THE STANDARD DEVIATION OF
THOSE NUMBERS
1.Work out the Mean (the simple average of the numbers)
2.Then for each number: subtract the Mean and square the result.
3.Then work out the mean of those squared differences.
4.Take the square root of that and we are done!
STANDARD DEVIATION FORMULA
 STANDARD DEVIATION

- In determining reference values for any measurement, a statistically valid series of population are chosen
and assumed to represent a healthy population. These people are then tested and results are averaged.
Thus the term reference value, that includes 95% of the test results for a healthy reference population –
defined in terms of standard deviation from the average value:
a. Individual state of health – values outside the 3 SD value are
clearly Abnormal
b. Reference range under the Gaussian Distribution closely approximates the mean + 2SD are
always in the range
c. Values within the first (68%) and second (95%) – NORMAL
d.Values within the second (68%) and third (99.9%) -
QUESTIONNABLE
 CONFIDENCE INTERVALS

- When the reference range is expressed in 2 SD on either side of the mean, with 95% of the values
falling above and below the mean, the term confidence interval or confidence limits is used.
- The 95% confidence interval is used to account certain unavoidable error caused by sampling variability
and imprecision of the method themselves.
- If the experiment is repeated many times and 95% confidence interval is constructed each time for one
parameter, then 95% intervals includes true population parameter and 5% will not
- Individual lab must establish the mean and QC limits based on the patient population
- New lots of control material should be analyzed for each analyte in parallel with the control material in
current use.
 COEFFICIENT OF VARIATION

- The coefficient of variation (CV) in percent (%CV) is equal to the Standard Deviation divided
by the mean.
- %CV = SD x 100
mean
- Used to compare the SD of two samples
- One QC value falling outside the limit of 2 or 3 SD – marked as out of
control
- If 2 SD is set for the method, makes the test more sensitive to any change
but create problem as this give high false rejection
 SOURCES OF VARIANCE OR ERROR

- Generally, it is impossible to obtain exactly the same result each time a determination is
performed on a particular specimen. Those may be described as the variance or error of a
procedure.
a. Sampling Factors
- time and day when the sample is obtained, patient’s position (lying down or seated),
the patient state of physical activity (in bed, ambulatory or physically active), fasting or not, time and
storage, processing at the lab and aging of sample.
b. Procedural Factors
- aging of reagents, limited experience of person, lab bias-variations in standards,
reagents, environment, methods or apparatus, change in method, instrument and personnel.
 DETERMINATION OF CONTROL RANGE

- After purchasing unassayed solution, it is necessary to for the lab to determine the acceptable control
range for a particular analysis – various methods.
1. To assay and aliquot of the control solution with the regular batch or assays for 15-25 days exactly
like unknown specimen with no more or less care
2. Repeated determinations of the same sample will often not give identical value for any particular
constituent
3. After sufficient number of repeated determinations, all values obtained will fall into a normal bell-
shaped curve.
4. When statistically sufficient number of determinations have been run, the mathematical
mean/average/x value can be calculated.
 DETERMINATION OF CONTROL RANGE

5. Acceptable limits or variation from the mean for the control solution are then calculated on
the basis of the standard deviation from the mean using statistical formula
6. Most labs use 2 SD above or below the mean as the allowable range of the control
specimen, others use this as a warning limit
7. According to the normal bell-shaped curve, setting 2 SD as the allowable range for the
control sample means that 95% of all determinations on that sample will fall within the
allowable range and 5% will be out of control
8. Once the range of the acceptable results has been established, one of the control specimen
is included in each batch- if value not in limits established, procedure must be repeated
and no patient results reported until the control value is acceptable.
 MONITORING QUALITY CONTROL

1) Levey –Jennings Chart

2) Westgard rules
 LEVEY-JENNINGS CHART

- Daily quality control specimen values are plotted on the quality control chart
- is a graph that quality control data is plotted on to give a visual indication whether a
laboratory test is working well. The distance from the mean is measured in standard
deviations. ... Westgard rules are commonly used to analyse data in control charts.
- Levey-Jennings QC plots have been used to identify unacceptable runs and then evaluates the
source of magnitude of the deviation to decide if results are to be released to patient charts.
- The purpose of this Levey-Jennings Chart is to aid in maintaining stability of the analytical
measurement system and attempt to detect change (cause of variation) and after that to
restore the system.
 LEVEY-JENNINGS CHART

- There is a software available for LIS and computer to automate the plotting of control
values
- The mean value for the analyte is then indicated on the chart and the acceptable limits-
generally set at + 2SD or + 3SD
- 2 SD values as a warning limit & 3 SD value as an action limit
- Each day the control value is plotted on the chart and any value falling out of control can
easily be seen – these charts serves a visual documentation
- A different control chart is plotted for each substance
EXAMPLE OF A LEVEY JENNINGS CHART
 REGULAR VISUAL INSPECTION OF CONTROL
CHART IS USEFUL FOR:
1. A systematic drift or trend is displayed when the control value direction moves
progressively in one direction from the mean for at least 3 days – suggest
deterioration of reagent or control
2. By comparison, dispersion is observed when random error or lack of precision
increases – indicate instability problem
3. Shift or abrupt change is observed when a problem developed suddenly – indicates
sudden malfunction of an instrument
 WESTGARD RULES

- Helps to analyze data in control charts based on statistical method

- Define specific performance limits for a particular assay and can be used to detect both
random and systematic errors.
- Westgard multi-rule procedure is designed to improve the power of QC methods using
+ 3SD limits to detect trends and shift
- Westgard examines individual values and determines status of the measuring system
maintaining low false rejection rate by upto 85% as with + 2SD
 SIX WESTGARD FOR ANALYSIS OF QC CHARTS

1. 1 point outside 2 SD - If 1 point is outside 2 SD , then reject.

2. 1 point outside 3 SD - reject
3. 2 Consecutive points are outside 2 SD on the same side of the center line
4. Range of 2 points is greater than 4 SD
5. 4 Consecutive points exceed 1 SD on the same side of the center line
6. 10 Consecutive points are above or below the mean
 SIX WESTGARD FOR ANALYSIS OF QC CHARTS

Purpose:
1. 3 warning rules –violation triggers a review of the test procedure, reagent
performance and equipment calibration
2. 3 mandatory rules – if there is a violation, action should be taken
a. Accept the results of the testing run, if only a warning is violated
b. Reject the results of the testing run, when a mandatory rule is violated
c. Increase the re-testing range for a particular assay, if either a warning or a
mandatory rule is violated
EXAMPLE OF VIOLATION OF WESTGARD RULE
POSSIBLE CONTROL PROCEDURE IN CASE OF OUT
OF CONTROL SITUATION
1. Review procedure used
2. Search for recent events that could cause change, such as new reagent kit or lot
component replacement, environmental condition – temperature, humidity
3. Prepare new control materials
4. Follow manufacturer’s troubleshooting guide
5. Contact manufacturers of instruments, reagents materials and condition
 TESTING OUTCOMES

- Reference values will vary with many factors – between labs and geographic location
- Clinician provided with ref value for that lab and must be more refined now
- Reference value must take in to consideration acceptable for a representative population
– same age, sex, gender, ethnicity and the method used – these are the variations
- Biometrics – the science of statistics applied to biological observations – is to describe
these variations