Sample Quality Assurance Phlebotomy Association of Ireland AGM 2012 Julie Riordan BSc, HDip Arts, MSc, F.A.M.L.S. Talk Outline • Quality Assurance (QA) • Preanalytical Variables (PAVs) & Errors (PAEs) • Effects of PAEs • Solutions What is Quality Assurance (QA)? • Maintenance of a desired level of quality in a service or product. • Planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled1. • Systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention1. • "Fit for purpose“ • "Right first time" • 70-85% of clinical decisions are based upon information derived from lab test result • ( www.asq.org) 1 QA In the Total Testing Process www.futurelabmedicine.org Pre-analytical Phase www.diagnosticsample.com Pre-analytical Error • Errors that occur due to variables within the pre-analytical phase that affect the quality of a specimen before analysis. TTP Error Frequency Pre-analytical errors Plebani M. Exploring the Iceberg of Errors in Laboratory Medicine. Clinica Chimica Acta. 2009;404:16-23. Pre-analytical Error    Can account for up to 93% of the errors currently encountered during the total diagnostic process1. 2002 review of multiple studies also showed similarly high results2. Overall, insufficient specimen quality and quantity may account for over 60% of diagnostic process preanalytical errors3. 1Preanalytical variability: The dark side of the moon in Laboratory testing. G.Lippi et al. Clin CHem Lab Med, Jan 2006; 44(4): 358-65 2Errors in laboratory Medicine. M Bonini et al. Clin Chem 2002; 48: 691 - 698 3Preanalytic Error Tracking in a Laboratory Medicine Department:Results of a 1-year Experience.G.Lippi et al.Clin Chem,Jul 2006; 52:1442–1443. Pre-analytical Variables  Uncontrollable PAVs  Controllable PAVs Uncontrollable PAV’s • • • • • • • • • Biological variability Environmental conditions Smoking Postural changes Diet (fasting/non-fasting) Medication Physical activity Stress Endogenous Interferences – Lipaemic, Jaundice Patient Preparation & Education Controllable PAV’s  • • • • Specimen Collection Specimen Labelling Specimen Transport Specimen Handling Specimen Processing Common Sources of PAVs & PAEs     • • • • • • • • Labelling Poor phlebotomy technique Haemolysed samples Clotted samples Inadequate mixing of tubes Empty/Incorrect tubes Expired tubes Insufficient sample volumes Venipuncture site Contamination Inappropriate transport and storage conditions Inappropriate blood to tube additive ratio Specimen Collection - Patient Identification & Labelling • • • • • • • • • • • Bedside/Patient side labelling is essential No Addressograph labels No pre-labelling Missing test requests Mislabelled Incorrectly Labelled Unlabelled Manual / handwritten Labelling system Electronic Labelling System Blood Transfusion Acceptance Local Laboratory/Hospital Labelling policy Specimen Collection – Sample Container Type & Quality • • • • • • • Incorrect tube type Empty tube Missing Tube Specimen tubes = Lab Reagents Expiration Dates Stability Issues Tube Mixing Specimen Collection – Order of Draw 1. 2. 3. 4. 5. 6. 7. Blood Culture Bottles Sodium Citrate tubes – Coagulation Sodium Citrate tubes – ESR Serum tubes / dry and gel separator Heparin tubes All other Anticoagulants – EDTA Flouride/Oxalate tubes - Glucose Specimen Collection – Phlebotomy Procedure • • • • • Venipuncture site Needle caliber/Gauge Adequate sample mixing Tourniquet Time Fist clenching/grip balls Tourniquet Time • Haemolysis – Potassium and LFT's • Hemoconcentration - Increase in various chemistry analytes, including serum protein, potassium and lactic acid. • Should not be left in situ for more than one minute • Tourniquet >1min = up to 20% increase in haemolysed samples. Clenching & Grip balls • Potassium release from Myocytes • Fist Clenching: – Widely unrecognised cause of pseudohyperkalaemia. – Gambino et al. Ann Clin Biochem 2008; 46:177 :Potassium results >5.3mmol/L reduced from 3.7% to 2.4% with removal of this practice. – Bailey et al. Ann Clin Biochem 2008; 00:1-4 :Percentage fall also. • Grip/Squeeze Ball: – Gambino et al. Ann Clin Biochem 2008; 46:177 :Elimination resulted in decrease in potassium results >5.3mmol/L from 10.5% to 2.6% Sample Volume • • • • Second most common cause of rejection Insufficient Tube additives / anticoagulants Ensure maximum to correct ratio, until vacuum exhausted. • Underfilled – Haemolysis, changes in cell morphology, prolonged coagulation times. • Overfilled – delayed clotting/fibrin formation, inadequate coagulation and creation of microclots. • Anaemia Sample Transport • Location • Length of transport • Transport environment/conditions – Temperature, vibration/aggitation. • Pneumatic Tube System – Blood gas samples, CLL Patient samples • Portering Sample Storage & Stability • • • • • Centifugation protocols Length Temperature Light Freeze-thaw cycles Sample Stability From www.diagnosticsample.com Sample Timing • • • • • Time related concentration changes. Stability of analytes. Diurinal Variation / Circadian rhythm. Fasting or Non-Fasting. Pre- or post- medication (I.V. Antibiotics, TDM). • Pre- or post- Fluids. • Follow timing protocols Sample Contamination      Haemolysis Anticoagulants I.V. Fluids T.P.N. Bacteria Sample Contamination Haemolysis • • • • Red Cell destruction and Haemoglobin pigment release. 60% of rejected samples1 Pseudohyperkalaemia/Normokalaemia, LFT’s, Coagulation studies. Preanalytical Reasons: – – – – – – – – – – – Low Ambient Temperatures Prolonged Transport times Prolonged Tourniquet use Use of fist clenching/Grip ball Haematoma site draw Small gauge needle Vigorous shaking or mixing Slow blood flow Skill/training issues Fragile Veins Multiple Medical Conditions 1Carrero P, Servidio G, Plebani M. Haemolysed specimens: a reason for rejection or a clinical challenge? Clin Chem 2000; 46:306-307. Sample Contamination Haemolysis • Burns et al (18) - significantly higher rate of haemolysis in samples collected by phlebotomists who had not had formal training and certification. • Bailey et al (19) – Suggests that when more than 9% of potassium results are above the reference range, the possibility of a pre-analytical problem should be considered. Sample Contamination Anticoagulants Heparin: - Coagulation Studies • K2 or K3 EDTA samples: - Potassium - Calcium - ALP, Mg. • Lithium Heparin - Lithium!  Sample Contamination –I.V.Fluid • Always use alternate arm if possible. • Wait for I.V. to be stopped for at least 5 (10 for KCL & Heparin) minutes prior to venipuncture. • Note on request form • Effects: – Saline :- All results diluted + Na&Cl – KCL :- potassium + Chloride – Dextrose :- All results diluted + Glucose Sample Contamination – T.P.N. • SVPH – common problem as patients on T.P.N for extended time periods. • Lipaemia - Elevated lipids • Pseudohyponatraemia • Note on request form Sample Contamination - Bacteria • • • • • Uncommon Bacteria within sample tube Blood samples / Blood films Blood cultures Aseptic / Infection control procedures Effects of PAV/PAEs  • • • • • • Efficiency Patient safety/outcome Wrong diagnosis Unnecessary treatment / procedures / surgery Patient Mistrust Reputations Cost/financial Effects of PAE/PAVs Plebani M, Carraro P. Mistakes in a Stat Laboratory: Types and Frequency. Clinical Chemistry. 1997. 1348-1351. Plebani M, Carraro P. Errors in a Stat Laboratory: Types and Frequencies 10 years later. Clinical Chemistry. 2007. 1348-1351. Cost of PAE • • • • • • Redraw Re-analysis Instrument downtime – labour/parts/repair. Patient treatment/LOS costs Additional procedures/surgery Time and labour re dealing with issues relating to preanalytical errors. • Legal costs Solutions – Quality Control & Assurance • • • • Quality Management System Metric for tracking errors and setting targets Error Tracking and monitoring Define and implement quality indicators and outcome measures. • Reporting systems • Quality Products/reagents • QA Programs – Q-Tracks Q-Tracks • Q-TRACKS monitors reach beyond the testing phase to evaluate the quality of processes both within and beyond the laboratory that can impact test results and patient outcomes. Q-Tracks Q-Track Performance Indicators QT1 - Patient Identification Accuracy Wrist Band Error rate (%) QT2 – Blood Culture Contamination Total Contamination Rate (%) Breakdown of Wristband Error Types (%) Neonate Contamination Rate (%) Other Contamination Rate (%) QT3 – Lab Specimen Acceptability Specimen Rejection Rate (%) Breakdown of rejection Reasons (%) QT7 – Satisfaction with Outpatient Specimen Collection Patient Satisfaction Score QT18 – Specimen Acceptability in Blood Bank Specimen Rejection Rate (%) Percent of Patients “more than Satisfied” Breakdown of rejection Reasons (%) Solutions – Error Prevention • Multidisciplinary approach – Phlebotomy • / clinical / lab staff • Communications / Feedback –-Systematic and managed • Offer Advice and ensure understanding • Continuous quality improvement • Root Cause analysis (RCA) • Good practice/Standardised practice (Guidelines) Solutions - Standardisation & Best Practice • PAI Phlebotomy Guidelines March 2010 • CLSI (formerly NCCLS): Procedures for the Handling and Processing of Blood Specimens for Common Laboratory tests; Approved Guideline—Fourth Edition. CLSI document H18-A4 (ISBN 1-56238-724-3). Clinical and Laboratory Standards Institute. Solutions – Training & Education       Standardised Documented Training Needs Assessments annually Competency Training Re-Training Create “training and competency culture” In Summary     PAV’s and hence PAEs occur through the lack of standardisation and so this is key. PAEs have significant effects on patient outcomes. Sample quality assurance = Improvement to the quality assurance of lab results. Systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention. (www.asq.org) Thank you for your attention