qc ii lecture handout combined 10-11

CLS 431 Clinical Laboratory Management II - Quality Management IIQuality Control II Lecture Handout 1

Quality Control II

CLS 431 Clinical Laboratory Management IIy gQuality Management II

QC Basics: What You Know

QC is a statistical tool used to ensure reliability of laboratory measurements Reliability = precision and accuracy

QC value must fall in its acceptable range Acceptable range = 95% confidence interval Within acceptable range: accept results Outside of acceptable range: reject results

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Why are we here today? Clarify terminology

Control materials Control programs Internal controls External controls Instrument Performance Controls Batch and Random Access Assays

Discuss troubleshooting strategies3

Quality Control Procedure for monitoring work processes,

detecting problems, and making corrections prior to delivery of products and services

The CONTEXT QC is used in is very The CONTEXT QC is used in is very important, and can be misinterpreted

Must differentiate: Internal/External Quality Control Material Internal/External Quality Control Programs

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What is CLSI?

CLSI provides guidelines for quality control The Clinical and Laboratory Standards

Institute (CLSI) is a global, nonprofit, standards-developing organization that p g gpromotes the development and use of voluntary consensus standards and guidelines within the health care community

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Quality Control Material Clinical and Laboratory Standards Institute

(CLSI) Definition: A device, solution or lyophilized

preparation intended for use in thepreparation intended for use in the quality control process to monitor the reliability of a test system and to maintain its performance within established limits.

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Components of a QC Program

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How are QC Ranges Established? Assay new lot number of QC through

parallel testing to collect data

Current lot number of QC validates the run Current lot number of QC validates the run Do not use new lot QC values to accept/reject

a run

Do not accept new lot data point if current QC failed

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How are QC Ranges Established? If the current lot number of QC is within

acceptable limits, the new lot value is valid and saved for statistical analysis

If the current lot number of QC is not within acceptable limits, the new lot value is invalid (rejected) and not saved for statistical analysis

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Establish QC Acceptable Range The laboratory establishes its own means

and acceptable ranges based on the saved data of the new lot QC

Acceptable ranges should be establishedAcceptable ranges should be established using N=30 (tentative limits N=10 or N=20) Ideal: one data point per day

The laboratory should not rely solely on the means and ranges from the manufacturers package insert (these must be verified)

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Is Documentation Really all that Important?

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Document Changes to the Test System

Document any changes or processes to help troubleshoot future issues New lot # reagents opened/put into use

New lot # standards opened/put into use New lot # standards opened/put into use New calibration curve put into use New lot # of QC material opened Maintenance or when instrument repairs

occur

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Documenting QC Results All technologists are responsible for

identifying, correcting and documenting QC problems as they occur

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Failed QC results are never deleted/discarded

Documentation of ALL QC is reviewed by supervisor or designee according to SOP

Documentation of QC Failures All unacceptable control results should be

documented by indicating: If run is not acceptable If patient results cannot be reportedp p Corrective action(s) taken

If QC failure cannot be resolved in a timely manner, you may need to notify your customers (ER, oncology, OR, etc.) of the potential delay in reporting patient results

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Leaving a trail: QC Documentation #1

CLSI provides recommendations for when quality control should be performed on commercially prepared microbiological media

Due to high failure rate in some commercially prepared media, a higher frequency of testing is performed (not needed for media that have low failure rates)

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Leaving a trail: QC Documentation #1 Upon receipt in the laboratory, QC is

performed on the commercially prepared media just received We want to ensure that media after shipment

will support growth of the suspected organismg g

Growth of Campylobacter species is used to QC the CVA agar Campylobacter species also require the correct

gas mixture and temperature to support growth on the CVA agar

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Leaving a trail: QC Documentation #1Incubation Technique Protocol A fresh subculture of a known Campylobacter

species is subbed from frozen on Sunday On Tuesday a new subculture is made from

Sundays culture growth On Thursday a new subculture is made from

Tuesdays growth

All subcultures are incubated in the same manner as patient samples and are checked for growth the following day

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Example of the Campylobacter Quality control documentation:

S M T W Th FIndicate day C. jejuni was


j jsubbed

Check for growth

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Does anything appear wrong with documentation?


This organism had actually failed to grow on Monday The technologist suspected a problem with the

organism and subbed another from frozen On Tuesday: failed to grow subbed from frozen


On Tuesday: failed to grow subbed from frozen On Wednesday: failed to grow subbed from frozen On Thursday On Friday..

Failure of the organism to grow (M F) was never documented, nor was it investigated

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On Saturday the technologist questioned why the new lot of media had not been QCd with the subbed Campylobacterspecies Found a sticky note saying:


Found a sticky note saying: QC organism not growing

A considerable amount of time was spent investigating the issue After piecing together verbal reports from

several other technologists, the problem was identified 20

Problem Identified 7 days earlier the wrong gas mixture was

delivered to the laboratory

Consequence of inadequate documentation


Consequence of inadequate documentation Patient samples from the past 6-7 days

were compromised Medical director instructed technologist to

notify providers of the problem and the need to resubmit samples if clinically indicated 21

Documentation is Important Several technologists had been on the bench

No clear communication between technologists Lack of documentation delayed identification of

problem


Time and resources wasted = $$$ lost Angry physician(s) Patient diagnosis delayed Patient inconvenience (recollect sample )

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TB Quantiferon Testing Protocol: Manual test with strict QC requirements for

run to pass (std in duplicate; duplicates must agree; ABS value of STD cannot vary)


Run failed because the standards did not meet these strict requirements QC failure not documented The technologist tossed the worksheet (thought

he/she made a pipetting error and did not want anyone to know)

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What are the potential issues with not documenting the failed run? Next run, standards again failed requirements

Run was repeated and again the standards failed


requirements After two failed runs, the issue was investigated:

Pipette used to dilute the standards appeared to be sticking, the pipette was checked and failed QC

After the pipette was cleaned, the pipette passed QC

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Important to document If the original run had been documented as a

failure, troubleshooting would have been done after the second run failed, rather than the 3rd

V i t t t ( $500) b t


Very expensive test to run (~$500), but even more so since it was run four times before results could be reported

Time, resources, money, patient care!!

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Troubleshooting Strategies

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Troubleshooting QC for Manual vs. Automated Tests

Usually there are fewer potential sources of error in an automated method, as the instrument does not vary the analytic y yprocess from specimen to specimen

With manual methods, there is variation between CLSs, and possibly between runs performed by the same CLS

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Troubleshooting for Manual Tests Begin with the processing steps that are

more prone to human error: Was the proper SOP followed? Were proper techniques employed? Were the proper control materials selected?Were the proper control materials selected? Had any of the materials used expired? Was there a calculation/transcription error?

Manual methods are more frequently corrected by simply repeating the test

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Basic Troubleshooting Steps Was the proper procedure followed?

Check the controls: Expired? Correct control? (level) Current/new lot number?

Check the reagents: Expired? Contaminated? (cloudy, bacteria) Correct reagents? Properly prepared? Current/new lot number? 29

Basic Troubleshooting Steps Check the instrument:

Mechanical malfunction? Required maintenance performed? Calibration current?

Check for calculation or transcription errors

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QC Troubleshooting Flow Chart

Flow charts may be used by some laboratories in an effort to streamline the troubleshooting process

It i i t d d t di t t f It is intended to direct you to perform a series of defined steps in response to a QC failure

This way, all technologists follow this same series of steps

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QC Troubleshooting Flow Chart Intended to minimize use of controls,

recalibration procedures, tech time and frustration

Often helps inexperienced technologists work through the troubleshooting process What should I do in response to a QC failure?

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Using QC Failure Flowchart

You have just completed the daily maintenance on the urinalysis dipstick reader. Control results follow:

Level 1: within 2SD of meanLevel 2: outside 3SD of mean

You have already rerun the same level 2 control and results remain outside 3SD

What is your next step?34

How QC Policies May Vary

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How is QC Used in the Lab? Contingent on the type of testing performed

Qualitative assay Quantitative assay Batch assay Batch assay Random Access assay Laboratorys SOP

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Qualitative Assay Positive or negative results

Reactive or nonreactive resultsGrowth or no growth

Control(s) must yield the expected results before reporting patient results

Can be manual or automated assay If QC result(s) fails for manual assay, suspect

human error first37

Qualitative Assay Examples Screening procedures

Pregnancy Strep throat Antigen typing Hemoglobin S Monospot

Identification tests: catalase, oxidase Media checks: growth/no growth Test reactivity: Rh-hr, Coombs control cells

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Using 1 Control: Control Fails Blood Bank Antibody Screen

SC AHG CCI 0 3+II 0 0III 0 3+

QC for Screen Cell (SC) II failed Coombs Control Cells did not yield the expected positive result

Patient results can not be reported Test must be repeated on SCII

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Using 2 Controls: 1 FailsBlood Bank Antigen Typing

Anti-Fya

AHG CC

Positive Control Cells 0 3+

Negative Control Cells 0 3+

Positive Control Cells failed Patient had positive reactivity Coombs Control Cells worked

g

Patient Cells 2+

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Using 2 Controls: Both FailBlood Bank Antigen Typing

Neither control gave expected result Look for problems with:

Reagent Reagent Method used Cells selected for controls

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Quantitative Assay Numerical results

Glucose = 185 mg/dl Potassium = 3.2 mmol/L

Si i l l bt i d Since numerical values are obtained, we can calculate QC statistics (mean, SD, CV) Control acceptable ranges can be stored in

computer memory or we can manually prepare Levey-Jennings charts for visual review of QC data

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Quantitative Assay Most often 2 levels of control are analyzed

Westgards rules are often used as minimal acceptable standards to accept/reject QC

Some laboratories and/or departments may choose to use stricter guidelineschoose to use stricter guidelines

Even one QC value 2-3SD from mean = QC failure

Examples: Batch assay (instruments or manual testing) Random access instruments

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What is a Batch Assay? Can be a manual or automated test

Can analyze multiple specimens at one time (per run) but can only analyze ONE analyte(per run) but can only analyze ONE analyte per run

Each run requires validation of calibration using standards and/or controls

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Example of a Manual Batch Assay

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Example of Automated Batch Assay

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QC Evaluation: Batch Assay Before patient results are released, QC is

evaluated: If QC fails, the entire run fails:

Reject all test results (controls, patients)

If you reject the run, troubleshooting should occur. After the problem has been corrected, the entire run will need to be re-analyzed

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What is a Random Access Assay? Automated instrument that is capable of

analyzing any test at any time Mary Jones: TSP, BUN, Creatinine Joe Smith: Glucose, Na, K, Cl, BUN, TSP, , , , ,

Capable of interrupting the instruments current work list to analyze STAT specimens out of sequence

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Current work list Mary Jones: TSP, BUN, Creatinine Joe Smith: Glucose, Na, K, Cl, BUN, TSP

What is a Random Access Assay?

STAT order John Doe: Amylase, Lipase

Work list continued after STAT testing completed 49

Examples of Random Access

Vitros Beckman Centaur Sysmex Sysmex Provue Galileo Stago

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QC Evaluation: Random Access Usually QC for all analytes on the

instruments test menu are run at the start of the shift or once per day (follow SOP)

Before you can analyze and/or reportBefore you can analyze and/or report patient test results, QC is evaluated If QC is acceptable, patient samples can be

analyzed, evaluated and reported

If QC fails, patient samples cannot be analyzed until troubleshooting is performed and QC is acceptable 51

Evaluation of QC Failures: Random vs Batch Assays,

RAE vs SAE

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Review of RAE vs SAE

Determine if the QC failure is caused by a RAE or SAE

Only one control >3SD: RAEy Both controls >3SD: SAE Shift: SAE Trend: SAE Second consecutive control value 2-3SD

from the mean: SAE

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Chemistry Random Access Assay #1

You are running the required two controls for a random access chemistry assay. The level 1 control value is within 2SD of the mean and the level 2 control is >3SD from the mean

What is the next appropriate action?

A. Report both controls and patientsB. Rerun a new vial of the level 2 control onlyC. Rerun the same vial of both controlsD. Recalibrate the assay

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You are running the required two controls for a chemistry batch assay. Both levels of control are >3SD from the mean

What is the next appropriate action?

Chemistry Batch Assay #2

A. Report all control and patient resultsB. Rerun all controls and patients againC. Rerun only the controls, but use fresh vialsD. Recalibrate the assay, then rerun controls and all

patients55

Types of Control Materials

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Internal Control Materials Instrument Performance Controls

Checks that are performed to ensure instrument is operating as expected

Electronics Voltage Voltage Optics Fluidics Pneumatics/hydraulics Pumps Pipette alignment

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Internal Control Materials

Controls that are built into the test platform Control line: pregnancy, Rapid-Strep pH indicator : Rapid-Strep, EluKit

Background clearing: pregnancy Rapid Strep Background clearing: pregnancy, Rapid-Strep Color change: back of glucose strip turns

blue, Low Ionic Strength Solution (LISS) changes color when patient plasma is added

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Internal Control Materials

Example: pregnancy screen

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External Control Materials

Control material that is tested in a manner identical to patient testing

Thi t i th b lk f QC f d This category is the bulk of QC performed in laboratory testing Daily controls Level 1, Level 2 Abnormal, Normal

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One Level of Control

Not common practice to use only one control

May run only one level of control to verify an instrument problem has developed (seeing multiple bad patient CBC results) Troubleshooting can begin sooner

Alternatively may rerun a previously reported sample, and compare to see if results match Patient sample acts as a free control Used in conjunction with, not instead of low, normal or

high liquid control material61

Two Levels of Control:Coagulation Instrument

Normal and Abnormal controls are used

Labs SOP states: troubleshooting required for any control value exceeding 2SD of the mean PRIOR TO REPORTING ti t ltPRIOR TO REPORTING patient results. Differentiate a control problem from an

instrument/reagent problem, and once problem is corrected.

Determine if control material, patient samples or both need to be repeated

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Two Levels of Control:Coagulation #1

When entering QC, the Laboratory Information System (LIS) shows the following SDs from the mean

What test(s) are reportable? What test(s) require troubleshooting prior to reporting patient results?

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Do you suspect a control vial problem or instrument/reagent problem?


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Once the APTT controls are in range, do the patient samples need to be repeated as well as the controls?


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When entering QC, the LIS shows the following SDs from the mean

What test(s) are reportable? What test(s) require troubleshooting prior to reporting


require troubleshooting prior to reporting patient results?

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Do you suspect a control vial problem or instrument/reagent problem?


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Once the control is in range for PTs and APTTs, do the patient samples need to be repeated?


repeated?

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Causes of Control/Reagent Problems

Manufacturers instructions should alwaysbe followed Most reconstituted control or reagents need

an equilibration time at room temperature prior to use (e g 30 minutes)prior to use (e.g., 30 minutes)

Frozen controls should be thawed by following manufacturers instructions

Room temperature 37 C water bath or heat block

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Recommended stability times should be strictly followed

Always write a date and time on controls and

Causes of Control/Reagent Problems

yreagents when they are reconstituted, thawed or opened

Remember, documentation is invaluable when troubleshooting an out of range control result

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Low, normal, high controls

Manufacturer instructions should always be followed:

Three Levels of Control:Cell Counter

followed: Warm at room temp for 15 minutes Mix thoroughlybut GENTLY (these are cells!)

Proper documentation is essential Date opened Be aware of expiration date (cell stability) 71

Labs SOP states: All directly measured parameters must be 2SD

from the mean on at least two of three levels of control

Three Levels of Control: Cell Counter

A result on a directly measured parameter can be between 2-3SD IF the same parameter is 2SD on the other two levels

Calculated parameters can be between 2-3SD if the directly measured parameters used in their calculation are 2SD from the mean 72


When entering QC results, your LIS shows the following SD from the mean. On this instrument, the RBC and Hgb are directly measured; others are calculated.

What action should be taken?

Three Levels of Control: Cell Counter #1


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Analyze the following control results from the same analyzer the next day. On this instrument, the RBC and Hgb are directly measured; others are calculated.Wh t ti h ld b t k ?

Three Levels of Control: Cell Counter #2


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The manufacturer of reagents and instruments often have controls that are formulated to match the reagent, standard and/or a specific instrument

Manufacturer Controls

How do you compensate for a possible bias caused by the manufacturers formulation?

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Manufactured by an independent company other than the instruments manufacturer Provides an independent, unbiased

assessment of your laboratory method

What Are Third Party Controls?

These can be the controls that are usually run with your assay every day

Biorad: Lyphocheck I, Lyphocheck II Dade: Level 1, Dade Level 2 Streck: Low, Normal, High

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Advantages: Long-term QC monitoring: manufacturer controls

expire when standards or reagents expire

Different formulation than standards or reagents

Use of Third Party Controls

Same control can be used over multiple reagent or calibration changes

Some controls are used on multiple instruments

Disadvantage: costs money77

Use of Third Party Controls:Detecting a Problem

Labs SOP: After instrument preventative maintenance

(PM) is performed, the manufacturers controls AND third party controls must be

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controls AND third party controls must be analyzed

Results of both controls (manufacturer and third party) must be within acceptable limits for the system to be in control


QC Results after PMTest Units

3rd party Level 1

Expected Range

3rd party Level 2

Expected Range

Triglyceride mg/dl 214 147-209 109 74-108

Cholesterol mg/dl 267 200-265 113 84-111

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Test UnitsManufacture Level 1

Expected Range

Manufacture Level 2

Expected Range



QC Results after PM Both levels of the manufacturers controls

were within the expected range, but both levels of the 3rd party control were out high

Additional troubleshooting was performed on

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Additional troubleshooting was performed on the instrument and it was discovered that the sampling probe was out of alignment and needed adjustment

After the probe adjustment was made, another set of both controls (manufacturer and 3rd party) were run

QC Results after Re-alignmentTest Units 3rd party

Level 1Expected Range

3rd party Level 2

Expected Range



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Test Units Manufacture Level 1

Expected Range

Manufacture Level 2

Expected Range



QC Results After Re-alignment Both the manufacturers controls and the 3rd

party controls were within the expected limits

The 3rd party control was able to detect the

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problem that occurred after the PM

The manufacturers controls did not detect the sampling probes misalignment

The sampling probes shift out of alignment could have affected patient results

Types of Control Programs

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External/Interlaboratory QC Program

Example:Mandatory Proficiency Testingy y g

84


Proficiency Testing CLIA regulations require clinical laboratories

participate in a proficiency testing program for regulated analytes

Testing an unknown using the same methods Testing an unknown using the same methods, reagents, and personnel as used to perform patient testing

Samples usually provided by an outside vendor College of American Pathologists (CAP)

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Proficiency Testing Comparison is made between the results the lab

obtained and the referee results, as well as with the results of other laboratories in the nation

Allows the laboratory to monitor its performance Allows the laboratory to monitor its performance in relation to that of its peers using the same test method, and those using different test methods

Proficiency Testing will be discussed further as a component of the CLS431 course, in the Compliance and Regulatory Issues unit

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Resources Used www.biorad.com www.cap.org www.jointcommission.org www.clsi.org

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McKenzie, S.B. & Williams, J.L., Clinical Laboratory Hematology, 2nd edition, Pearson Education, Inc., 2010.

Westgard, James O., Basic QC Practices, 3RDEdition, Westgard QC, Inc., 2010

Policy 6.001 Attachment 1

Quality Control Failure Troubleshooting Flowchart

Control Within Limit Control Not within Limit Control Within Limit Control Not within Limit Control Within Limit

Control Not within Limit Control Within Limit Control Still Not within Limit Document all remedial action on appropriate log sheet.

Control falls outside the satisfactory control limit

Repeat the control

Use control from another bottle

Open another reagent with the same and/or new lot number and repeat with the first vial

Using the new reagent, repeat with the new vial of control

CANNOT USE FOR PATIENT TESTING. If instrumentation, call the Customer Service Hotline of the Manufacturer for assistance. If they are unable to help correct the problem, have it checked and repaired if necessary by Biomedical Instrumentation. If kit, discontinue using kit and open another kit.

PROCEED

WITH PATIENT

TESTING

Contact Lab Consultant

QCII Lecture Handout 10-11.pdfQuality Control Failure Flowchart.pdf

qc ii lecture handout combined 10-11

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