High Five for venous blood collection for immunoassays 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. 1. Carraro P et al. Errors in a stat laboratory: Types and frequencies 10 years later. Clin Chem 2007; 53,7: 1338-42. 1
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. 2
Quality results begin with a quality specimen Agenda Why the preanalytical phase is important High Five for safe venous blood collection Blood collection tubes 3
The preanalytical phase of venous blood collection Preanalytical errors are said to be the reason for up to 62 % of all errors in laboratory medicine [1]. Error rate 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] Preanalytical phase 62 % CLSI Analytical phase 15 % Postanalytical phase 23 % CLSI: Vision: To be the leader in clinical and laboratory standards to improve the quality of medical care. [3] 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. 4
High Five for safe venous blood sampling: Path of workflow: This workflow is based on CLSI international guidelines [1,2] 1. Patient preparation patient assessment and correct data registration to maximize patient safety 2. Blood collection device greater sample integrity and 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 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. 5
1. Patient preparation 201411138A 6 6
1. Patient preparation Patient assessment and correct data registration to maximize patient safety Accurate patient identification is fundamental for patient safety Use at least 2 patient identifiers [1] Proper specimen labeling practices are critical components of effective and accurate patient identification [2] 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] 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. 7
1. Patient preparation Errors can be caused by: Correct data registration to maximize patient safety 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 8 8
2. Blood collection device 9 9
2. Blood collection device Greater sample integrity and operator safety 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 All blood collection equipment (tube, adaptor, needle) should come from the same manufacturer to ensure compatibility 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 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. 10
2. Blood collection device 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. 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 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] 1. Unpublished data performed on the AQT90 FLEX. 11 11
3. Sample collection 12 12
3. Sample collection Maximum safety for patient Be sure to follow local procedures and guidelines for sample collection Stop infusion A 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 tourniquet Tourniquet 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 anticoagulant Immediately after the sample is collected, gently invert the tube according to recommendations to mix the anticoagulant with the blood. 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. 13
3. Sample collection Maximum safety for patient and operator Sample contamination can be caused by: Operator safety can be compromised 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 Lack of dedicated procedure for operator safety This can lead to: Needle stick injury Operator concern over own safety Infection by blood-borne pathogens 14 14
4. Sample handling 15 15
4. Sample handling Key steps for greater sample integrity 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. 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. 16
4. Sample handling Key steps for greater sample integrity 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 17 17
5. Sample transport and storage 18 18
5. Sample transport and storage Minimum time to patient results with the AQT90 FLEX analyzer Analyze sample immediately for optimal sample 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 NOTE: Analyze TnI whole-blood samples within 2 hours after sample collection Analyze other whole-blood samples within 3 hours after sample collection The ability to run tests directly on whole-blood samples in capped tubes minimizes sample handling time and thereby the time to patient results. Tips! Note time of sample collection. Stay within the specified time range. 1. Sample stability claims validated by internal testing. 19
5. Sample transport and storage Minimum time to patient 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 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 20 20
High Five for safe venous blood sampling: Path of workflow: 1. Patient preparation patient assessment and correct data registration to maximize patient safety 2. Blood collection device greater sample integrity and 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 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. 21
Blood collection tubes for the AQT90 FLEX analyzer 22 22
Venous blood collection tubes Tube manufacturers providing tubes supported by the AQT90 FLEX analyzer 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 % 23
Venous blood collection tubes Venous blood collection tubes supported by the AQT90 FLEX analyzer Tube manufacturers specifications to sample tubes Becton Dickinson Greiner Int. Terumo Sarstedt Tube size: 13 mm 75 mm Cap types: Conventional Hemoguard Anticoagulants: EDTA Li-heparin Citrate 3.2 % Draw volume: >1.8* ml Tube size: 13 mm 75 mm Cap types: Safety cap Anticoagulants: EDTA Li-heparin Citrate 3.2 % Draw volume: >2 ml Tube size: 13 mm 75 mm Cap type: Venosafe Anticoagulants: EDTA Li-heparin Citrate 3.2 % Draw volume: >1.8* ml 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 24
Venous blood collection tubes The AQT90 FLEX analyzer helps prevent the user from choosing the wrong tube for a specific test After installation of an AQT90 FLEX analyzer, the user sets up the analyzer to fit local preferences. NOTE: The tube type is defined as tube cap color and a name that lets users easily and correctly identify the tube 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 25