All management systems are focused on getting the job done.

More efficient and effective management guarantees the job to be done in the proper way.

Larger profit Better serviceVs

STAGE ACTIVITIES PERFORMED1. TOTAL QUALITY MANAGEMENT Management approach centered around

“Customer Satisfaction”2. QUALITY MANAGEMENT All of the below plus the economic

aspects of “Cost of Quality”3. QUALITY SYSTEM “Comprehensive and Coordinated”

efforts to meet quality objectives4. QUALITY ASSURANCE Systematic activities to provide

“Confidence” that the organizationmeets requirements for quality

5. QUALITY CONTROL Operational techniques applied to“Specific Tasks” for quality andregulatory compliance.

Quality : degree to which a set of inherent characteristics fulfills requirements

Quality control: part of quality management focused on fulfilling quality requirements

Quality assurance: part of quality management focused on providing confidence that quality requirements will be fulfilled

Quality management: coordinated activities to direct and control an organization with regard to quality

1942-521942-52 US Military develop requirements for contractors for shell, aircraft, missile US Military develop requirements for contractors for shell, aircraft, missile suppliers suppliers (Quality without 100% inspection)(Quality without 100% inspection)

19471947 International Organization for Standardization (ISO) International Organization for Standardization (ISO) created to adopt industrial created to adopt industrial standardsstandards

19591959 US Department of Defense established US Department of Defense established MIL-Q-9858MIL-Q-9858 quality management quality management

19631963 MIL-Q-9858 is internationalized as anMIL-Q-9858 is internationalized as an ABCAABCA standardstandard

19681968 NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (AQAP-1AQAP-1))

19791979 British Standards Institute (BSI) developed AQAP-1 for civilian use British Standards Institute (BSI) developed AQAP-1 for civilian use BS 5750BS 5750

Calibration: the process of testing and adjustment of an instrument, kit, or test system to provide a known relationship between the measurement response and the value of the substance measured by the test procedure

Effectiveness: the extent to which planned activities are realized and planned results achieved

Efficiency: the relationship between the results achieved and the resources used

Non-QMS processes – processes that are not contained in either the QSEs or in the laboratory’s path of workflow, such as those within the finance, sales, or marketing functions.

Path of workflow: the sequential processes in a laboratory’s activities that transform a request for examination into the laboratory information that is captured in the report of results.

Plan: written account of intended future course of actions aimed at achieving specific goal(s) or objective(s) within a specific timeframe and explains in detail what needs to be done, when, how, and by whom.

 OrganizationCustomer FocusFacilities and SafetyPersonnelPurchasing and InventoryEquipmentProcess Management

 Pre-examinationExaminationPost-examination

Documents and RecordsInformation ManagementNonconforming Event ManagementAssessmentsContinual Improvement

Pree-xaminationExaminationPost-examinationInformation

Management

Quality System Essentials - those elements which must be applied to all operations in the service’s path of workflow

Path of Workflow - as it relates to the processes involved in the pre-, during and post- phases of delivery of services with the laboratory as an example

! Internal Quality Control (IQC) Procedures

! External Quality Assessment (EQA)

! Quality Management

Internal Quality Control

⇒ Done during daily routine work⇒ Provides an immediate control⇒ Errors are corrected immediately⇒ Routinely collect and analyze data

from every test run or procedure

Why do we need Internal Quality Control?

! Ensure that test results are reliable (trustable)

! Ensure that test results are reproducible (Closeness of the results of assays of the same test carried under changed conditions)

! Control quality of daily routine work

Monitoring quality of laboratory testing, accuracy and precision of laboratory

results

Precise and Inaccurate

Precise and Accurate

Imprecise and Inaccurate

Imprecise and ?? Accurate

It ensures continual check that the laboratory’s work does not fluctuate and that reports are validated before they are released.

It is based on monitoring the procedures which are actually used for the tests in the laboratory. It includes:

· Control charts with tests on control materials· Duplicate tests on all specimens or on a proportion

of the specimens· Delta check, comparing current test results with

previous results· Consistency of mean values of patient data

Use 2-3 levels of controls covering the medical decision points

At least 20 control values over a period of 20-30 days for each level of control

Perform statistical analysis Develop Levey-Jenning chart Run -regularly- with patient samples Monitor control values on chart using

Westgard rules Take immediate corrective action, if

needed Record actions taken (if any)

QC material must be available in large quantities stored in small aliquots (Ideally should last for at least 1 year)

Always consider as Biohazardous Requires very accurate reconstitution if

needed Always deal with and store as

recommended by manufacturer

Need data set of at least 20 points obtained over 20-30 days better by different operators in different times of day

Calculate mean, standard deviation, Coefficient of variation and determine target ranges

Develop Levey-Jenning charts Plot –on the chart- control values each

run/ day Make decisions regarding acceptability

of run using Westgard rules Monitor over time and at defined

intervals

1. 192 mg/dL2. 194 mg/dL3. 196 mg/dL4. 196 mg/dL5. 160 mg/dL6. 196 mg/dL

7. 200 mg/dL8. 200 mg/dL9. 202 mg/dL10. 255 mg/dL11. 204 mg/dL12. 208 mg/dL13. 212 mg/dL

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Mean

+1SD

+2SD

+3SD

-1SD

-2SD

-3SD

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

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Mean

+1SD

+2SD

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-2SD

-3SD

Ideally should have control values clustered around the mean (+/-2 SD) with little variation in the upward or downward direction

Imprecision = large amount of scatter around the mean. Usually caused by errors in technique

Inaccuracy = may see as a trend or a shift, usually caused by change in the testing process

Random error = no pattern. Usually poor technique, malfunctioning equipment

Random Error (RE): Imprecision

Causes:1. Pipetting error2. Temperature error3. Mixing defect4. Machine need

troubleshooting

Systematic Error (SE): Inaccuracy

Causes:1. Deterioration of

control material2. Deterioration of

calibrator3. Deterioration of

reagents

Allows determination of whether an analytical run/s (in control) or (out of control)

October 1, 2008

October 1, 2008

When you're running 2 or 4 control levels, use the rules: 13s/22s/R4s/41s/10x

When you're running 3 control levels, use a set that works for multiples of threes:13s/2of32s/R4s/ 31s/12x

Rejection rule = Out of control=1. Stop testing2. Identify and correct problem3. Repeat testing on pt samples and

control4. Don’t report pt results until problem

is solved and controls indicate proper performance

Change one variable at a time to troubleshoot an out of control test.

The variables are usually common to all instruments or procedure systems and include the following:

1. Try a fresh vial of QC 2. Try a new reagent (same lot) 3. Try a new consumable (water, part, solution, tubing)

if applicable. 4. Try a new reagent (new lot) 5. Recalibrate (current calibrator) 6. Recalibrate (new lot calibrator) If a system cannot be brought into control,

notify senior staff. Do not process patient samples for the test affected.

When changing to a new lot number of control material, ideally there should be an overlap period while the new material is being analyzed to establish the new control limits.

In cases where the overlap period is not sufficient, it is possible to establish the mean value for the new control material in a short time, over say a five-day period, or to start with the manufacturer’s values.

Then apply the previous estimate of SD to establish the control limits.

These control limits should be temporary, until sufficient data is collected to provide good estimates of both the mean and SD of the new material.

New lots of a quality control material should be analyzed for each analyte in parallel with the lot of control material in current use.

Ideally, a minimum of at least 20 measurements should be made on separate days when the measurement system is known to be stable, based on QC results from existing lots.

If the desired 20 data points from 20 days are not available, provisional values may have to be established from data collected over fewer than 20 days.

Possible approaches include making no more than four control measurements per day for five different days

Retained patients samples◦ Original samples must be assayed in the lab under accepted

control run conditions◦ Stored aliquited immediately after finishing 1st analysis◦ Storage conditions must meet the requirements for analytes to

be measured◦ Avoid repeated warming/ thawing◦ Stability of the measurand must be carefully respected◦ Better to be alternating with QC material◦ Result of the 1st assay is used as the base for comparison and

calculation (as if gold value)◦ Allowable analytical imprecision is used for judgment of

acceptance or rejection◦ Data calculated from biological variations/ CLIA limits are used

for the issue

Result comparison with an in-control method/ instrument/ procedure for the measurand◦ The in-control instrument/ method is considered

the reference one◦ Not more than one hour time gap between the

parallel assays◦ Principles of assays must be considered if

different◦ Inaccuracy limits is used for comparison◦ Data calculated from biological variations/ CLIA

limits are used for the issue

Individual Patient Results:◦Clinical Correlations◦Correlation with other laboratory tests◦Intralaboratory duplicates◦Delta check with previous test results◦Limit Check

Multiple Patients:◦Test distribution statistics◦Monitoring patients means

QUESTIONS

External Quality Control

Inter-laboratory comparisons and other performance evaluations that may extend throughout all phases of the testing cycle, including interpretation of results; determination of individual and collective laboratory performance characteristics of examination procedures by means of interlaboratory comparison

A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification, in which 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 laboratory and others

Introduced into laboratory medicine more than 60 years ago to address that results for aliquots of the same sample were different when measured by different laboratories.

PT/EQA programs are now an essential component of a laboratory’s quality management system.

PT/EQA is a component of laboratory accreditation requirements

Ideal samples for a PT/EQA program would fulfill a range of criteria: ◦ Stable for the conditions under which they will be

transported and stored◦ Homogeneous across all the aliquots produced◦ Have analyte concentrations that include the expected

clinical range◦ Include appropriate sample types (e.g., urine, whole

blood, serum)◦ Available in sufficient volume◦ Inexpensive enough for cost not to be an impediment◦ Behave in clinical laboratory measurement procedures in◦ the same manner as patient samples◦ Samples from a single donor or pooled samples from

multiple donors can be used

Samples have traceable reference values (when reference values are used)

Behave like patient samples (commutability) The laboratory may also consider cost Similarity of PT samples to patient samples Method compatibility with peer groups Size of peer groups Frequency of challenges Timeliness and usefulness of reports Educational content Customer service

category 1 programs are limited because of:• Technical aspects such as a lack of reference measurement

procedures, absence of certified reference materials, inability to prepare commutable samples;

• Practical considerations such as the difficulty of preparing samples covering the full measuring interval and the complicated logistics of preparation and distribution of fresh or frozen samples;

• Psychological limitations such as lack of awareness of the quality factors important in PT/EQA or unwillingness to adopt these;

• Economic concerns because distributing commutable samples in sufficient quantity and providing target values with reference measurement procedures is expensive

PT samples should be tested in the same manner as patient samples, to the extent possible

Some laboratories may improperly test PT samples differently from patient samples, by repeat testing of PT samples when patient samples are tested only once, or by having a specific analyst test PT samples rather than rotating PT testing among all the personnel who perform patient testing.

There should be no attempt to produce “best” results by replicate analysis or testing immediately following internal QC or recalibration

The core content of the result report should resemble as closely as possible the content of a routine clinical result report

If the usual report is deemed inappropriate for a PT report, it may equally be inappropriate for a clinical report

A copy of all PT reports should be retained within the laboratory in order to verify the information handling by the PT provider.

Sending a set of samples from an organizing body to a group of participating laboratories for measurement of 1 or more analytes present in the samples

Samples are intended to simulate the clinical samples usually measured

Laboratories are not informed of the analyte concentration or activity in a particular sample

Timely schedules for running and reporting results are included

Laboratory perform measurements in the same manner as for patient samples

Results for the samples are returned to the PT/EQA organizer for evaluation of conformance to the expected results

The organizer prepares a report that includes:◦ the results reported by a laboratory◦ the method used for the measurements◦ the target values expected for each analyte◦ evaluation of whether the individual laboratory’s results

met the performance requirements◦ Reports may also include evaluation of the performance

of the various measurement procedures used by the participants

The laboratory evaluates its performance according to the provider report

Limits or quality standards around the target value are established against which performance can be assessed by:◦ Regulatory: wider like US CLIA, German Rili-BAeK◦ Statistical: ± 2-3 SD◦ Clinically-based: on a difference that may affect clinical decisions or

on biological variation

Total error limits including bias, imprecision, and analytical nonspecificity can contribute to the variation in a single result

Have different limits to separately assess bias and imprecision when replicate samples are included

PT/EQA limits are set as a minimum standard to identify results that indicate poor performance. Thus, meeting these standards may not indicate that performance is optimal nor that performance meets all clinical needs

Determines the accuracy by comparing PT/EQA results to those from a reference measurement procedure or from a designated comparison method or to an all-participant (or all-method) mean/ median. This arrangement is now referred to as accuracy-based evaluation

Assess agreement with other measurement procedures and imprecision among all methods as well as within a method group

Peer group evaluation provides valuable information to assess quality, verifying that a laboratory is using a measurement procedure in conformance to the manufacturer’s specifications and to other laboratories using the same technology

PT/EQA result represents 1 point in time and will occasionally be a random error

Repeat the measurement using a stored aliquot of the PT/EQA sample (assuming the measurand was stable on storage) to confirm if the problem has persisted or to conclude that the problem no longer exists and the original unacceptable result was a random event, and therefore no corrective action is indicated. If the repeated result is still unacceptable, the laboratory conducts further investigation to identify the root cause, and then initiates corrective action

• Gather data related to the testing event to include records of calibration, reagent use, QC results, and maintenance procedures;

• Obtain other data on assay performance, e.g., previous PT/EQA results and relevant patient data;

• Identify the root cause of the error;• Take corrective action and preventive action ifindicated;• Monitor the success of the corrective action;• Document the investigation and the corrective

action.

• Was the testing material received in satisfactory condition?

• Was the appropriate sample tested?• Were procedures for sample preparation followed?• Was the appropriate method used for analysis?• Was the method performed according to

documented procedures?• Were appropriate reagents and controls used?• Was equipment operated according to

documented procedures?

• Was equipment appropriately maintained?• Was QC acceptable at the time of testing PT

samples?• Were results interpreted appropriately?• Has this problem occurred previously with PT

samples? Are data consistent with previous PT distributions? Is there a trend leading to failure or is the current set completely unexpected?

• Did repeat testing on the properly stored residual sample produce similar results?

• Were patient results acceptable at the time of PT testing?

1. Clerical error;2. Methodologic problem;3. Equipment problem;4. Technical problem;5. Problem with proficiency testing materials;6. Problem with evaluation of results; and7. No explanation after investigation: An

investigation fails to reveal an explanation for an unacceptable PT result 19 to 24% of the time

Split-Sample With Another Laboratory Internal Split-Sample Procedures Audit-Sample Procedure Analysis of Manufacturer’s Product Calibrator or

Trueness Control Material Analysis of Interlaboratory Quality Control Data Averages of Patient Data

Reference Intervals Reevaluation of Interpreted Results Direct Observation of Technique-Dependent Tests Clinical Correlation Studies Government and University Interlaboratory

Comparison Programs Analysis of Data From Qualitative Alternative

Assessment Procedures

YOUR VALUABLE QUESTIONS