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Preanalytical errors are said to be the reason for up to 62 % of all errors in laboratory medicine [1]. Here are some tips on how to avoid the most frequent errors.

High Five for venous blood collection for immunoassays

1. Carraro P et al. Errors in a stat laboratory: Types and frequencies 10 years later. Clin Chem 2007; 53,7: 1338-42.

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This presentation tells you about the venous blood collection process for immunoassays

Immunoassays are used to detect biomarkers that are generally only present in small amounts in the blood; therefore correct venous blood collection is pivotal for reliable, accurate test results.

Radiometer provides immunoassays for cardiac markers, infection, hemostasis and pregnancy on the AQT90 FLEX analyzer platform.

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Quality results begin with a quality specimen

Agenda

Why the preanalytical phase is important High Five for safe venous blood collection Blood collection tubes

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The preanalytical phase of venous blood collection

“The errors that can occur during the collection and handling of blood specimens are potentially numerous, and the complications to the patient potentially harmful. Standards for venipuncture can reduce or alleviate many of these errors…” [2]

CLSI

Preanalytical errors are said to be the reason for up to 62 % of all errors in laboratory medicine [1].

Analytical phase

Preanalytical phase

Postanalytical phase

15 %

62 %

23 %

Error rate

1. Carraro P et al. Errors in a stat laboratory: Types and frequencies 10 years later. Clin Chem 2007; 53,7: 1338-42.2. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.3. www.clsi.org.

CLSI: “Vision: To be the leader in clinical and laboratory standards to improve the quality of medical care.” [3]

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Path of workflow:

1. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.2. CLSI. Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition. CLSI document GP39-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.

This workflow is based on CLSI international guidelines [1,2]

High Five for safe venous blood sampling:

1. Patient preparation – patient assessment and correct data registration to maximize patient safety

2. Blood collection device – greater sample integrityand operator safety

3. Sample collection – maximum safety for patient and operator

4. Sample handling – key steps for greater sample integrity

5. Sample transport and storage – minimum time to patient results

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1. Patientpreparation

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Accurate patient identification is fundamental for patient safety

Use at least 2 patient identifiers [1]

Proper sample labeling ensures the right result for the right patient

Attach patient ID label to the sample tubes before you leave the patient

Carefully select a sampling site with optimal access and blood flow

The preferred venipuncture site is the area of either arm that is in front of and below the bend of the elbow with a number of superficial large veins [3]

When the preferred veins are not acceptable or available, veins on the back of the hand are also acceptable [3]

Patient assessment and correct data registration to maximize patient safety

1. Patient preparation

Proper specimen labeling practices are critical components of effective and accurate patient identification [2]

Tips!Establish a dedicated procedure for identifying patient and sample.

1. Joint Commission: National Patient Safety Goals Effective January 1, 2014 (Hospital Accreditation Program, Goal 1). 2. Kahn S. Specimen mislabeling: A significant and costly cause of potentially serious medical errors. www.acutecaretesting.org Apr 2005.3. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.

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Correct data registration to maximize patient safety

1. Patient preparation

Errors can be caused by:

Lack of patient identification and/or sample labeling

Transcription errors due to manual data entry

Lack of a dedicated procedure for identifying patient and samples

Errors can lead to:

Non-compliance Misdiagnosis Incorrect treatment Resampling Lost billing opportunities

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2. Blood collection device

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Dedicated collection tube ensures greater sample integrity Select a self-filling vacuum tube prefilled with an

anticoagulant If pre-evacuation by the end user is required, evacuate

the tubes immediately before use Choose an anticoagulant that is compatible with the

specific assay(s) to be used

Anticoagulants and assay compatibility for the AQT90 FLEX analyzer EDTA

TnI, TnT, CKMB, Myo, NT-proBNP, D-dimer, βhCG, CRP

Lithium heparin TnI, TnT, CKMB, Myo, NT-proBNP, D-dimer, βhCG, CRP

Citrate 3.2 % D-dimer

Do NOT use tubes that contain a gel Do NOT use serum tubes

All blood collection equipment (tube, adaptor, needle) should come from the same manufacturer to ensure compatibility

Greater sample integrity and operator safety2. Blood collection device

1. Ball J et al. Needlestick injury in 2008. Results from a survey of RCN members. Royal College of Nursing 2008.2. Sharps safety. RCN guidance to support implementation of the EU Directive 2010/32/EU on the prevention of sharps injuries in the health care sector. Royal College of Nursing 2011.

11Version 20141113A1. Unpublished data performed on the AQT90 FLEX.

Greater sample integrity and patient safety with the AQT90 FLEX analyzer

Do NOT use gel tubes

Blood collection tube gels are thixotropic polymers.

A thixotropic gel is semi-solid under static conditions — it becomes fluid when stirred or shaken and returns to the semi-solid state upon standing.

2. Blood collection device

Risk of wrong results

Whole-blood samples in gel tubes• If a tube with a gel is placed on the AQT90

FLEX analyzer and mixed by the inlet wheel, we risk that part of the gel is mixed with the blood when the sample is aspirated

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Plasma samples from gel tubes• If the aspirated sample contains gel droplets,

then the actual volume of sample will be too low and the result will of course be affected

• Highly increased imprecision has been seen when plasma from gel tubes were used [1]

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3. Samplecollection

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Stop infusionA sample from a limb receiving infusion: Always stop infusion for a period of at least 2 minutes before you

start to collect a sample [1]

Using a tourniquetTourniquet application should not exceed 1 minute [1]

Indwelling lines – sample collection procedure Removing sufficient flush solution prevents sample contamination.Note: Without complete, thorough, and documented training, phlebotomists should not collect blood from indwelling lines [1].

Mix with anticoagulantImmediately after the sample is collected, gently invert the tube according to recommendations to mix the anticoagulant with the blood.

Be sure to follow local procedures and guidelines for sample collection

Maximum safety for patient3. Sample collection

1. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.

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Sample contamination can be caused by:

Diluting the sample with flush solution if an insufficient amount of flush solution has been removed

This can lead to:

Contaminating the sample with flush solution will alter the sample result so that it no longer represents the patient status

Operator safety can be compromised by:

Lack of dedicated procedure for operator safety

This can lead to:

Needle stick injury Operator concern over own safety Infection by blood-borne pathogens

Maximum safety for patient and operator

3. Sample collection

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4. Samplehandling

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Proper mixing of the sample immediately after collection for a clot-free sample Mix to dissolve the anticoagulant to prevent clots to form Invert EDTA and lithium-heparin tubes at least 5-10

times unless otherwise specified by the tube manufacturer [1]

Invert citrate tubes 3-4 times [1]

Note: An inversion is one complete turn of the wrist, back and forth.

Key steps for greater sample integrity4. Sample handling

1. CLSI. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition. CLSI document GP44-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.

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Microclots can be formed if the sample is not mixed properly immediately after its collection.

Clots in the sample can lead to:

Wrong results Analyzer downtime due to

blocked sample fluid pathway

Key steps for greater sample integrity4. Sample handling

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5. Sample transportand storage

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Analyze sample immediately for optimalsample integrity and short TAT If samples cannot be analyzed immediately, separate

plasma immediately after sample collection Store plasma at 2-8 °C [1] Analyze plasma within 24 hours of collection time

The ability to run tests directly on whole-blood samples in capped tubes minimizes sample handling time and thereby the time to patient results.

NOTE:

• Analyze TnI whole-blood samples within 2 hours after sample collection

• Analyze other whole-blood samples within 3 hours after sample collection

Tips!

Note time of sample collection.

Stay within the specified time range.

Minimum time to patient results with the AQT90 FLEX analyzer

5. Sample transport and storage

1. Sample stability claims validated by internal testing.

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Incorrect storage temperature can lead to:

Incorrect storage temperature can alter the sample result so that it no longer matches the patient’s disease state

Incorrect results

Prolonged storage time can lead to:

Prolonged storage time can alter the sample result so that it no longer matches the patient’s disease state

Incorrect results

Minimum time to patient results

5. Sample transport and storage

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Path of workflow:

1. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.2. CLSI. Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition. CLSI document GP39-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.

High Five for safe venous blood sampling:

1. Patient preparation – patient assessment and correct data registration to maximize patient safety

2. Blood collection device – greater sample integrityand operator safety

3. Sample collection – maximum safety for patient and operator

4. Sample handling – key steps for greater sample integrity

5. Sample transport and storage – minimum time to patient results

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Blood collection tubes for the

AQT90 FLEX analyzer22

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Becton Dickinson (BD) Greiner International Terumo Sarstedt

All the manufacturers have tubes using the American/ international color codes for caps.

NOTE: In addition, Sarstedt also has tubes using the European color codes for caps.

There are minor deviations from the international color codes for citrate tubes in the Japanese market.

Sample tubes with one of three anticoagulants are used: EDTA Lithium heparin Citrate 3.2 %

Tube manufacturers providing tubes supported by the AQT90 FLEX analyzer

Venous blood collection tubes

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Venous blood collection tubes supported by the AQT90 FLEX analyzer

Greiner Int.

Tube size: 13 mm × 75 mm

Cap types: Safety cap

Anticoagulants: EDTA Li-heparin Citrate 3.2 %

Draw volume: >2 mL

Terumo

Tube size: 13 mm × 75 mm

Cap type: Venosafe

Anticoagulants: EDTA Li-heparin Citrate 3.2 %

Draw volume: >1.8* mL

Becton Dickinson

Tube size: 13 mm × 75 mm

Cap types: Conventional Hemoguard

Anticoagulants: EDTA Li-heparin Citrate 3.2 %

Draw volume: >1.8* mL

Venous blood collection tubes

Sarstedt

Tube size: 13 mm × 65 mm 11 mm × 66 mm

Cap type: Monovette

Anticoagulants: EDTA Li-heparin Citrate 3.2 %

Draw volume: >2.6 mL

*1.8 mL for citrate tube containing 0.2 mL of citrate so that final volume is 2.0 mL

Tube manufacturers’ specifications to sample tubes

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After installation of an AQT90 FLEX analyzer, the user sets up the analyzer to fit local preferences.

Tube setup is a vital part of analysis setup.

A tube type is defined for each type of sample tube approved for use on the analyzer, and used locally.

For each tube type it is defined which tests can be done with the tube.

A test cannot be run on a tube if the test is not defined for that tube type

The AQT90 FLEX analyzer helps prevent the user from choosing the wrong tube for a specific test

Venous blood collection tubes

NOTE:• The tube type is defined as

tube cap color and a name that lets users easily and correctly identify the tube