Auditing The Preanalytical Phase: Lessons from 40+ Audits

Transcription

1 Auditing The Preanalytical Phase: Lessons from 40+ Audits Stephen Church Oxford, UK Dr. Kathrin Schlüter BD Diagnostics, Preanalytical Systems

2 Laboratory Analysis

3 The Preanalytical Phase Order Test Collect sample Transport sample to lab Receive sample in lab Prepare sample for testing Sort sample in lab Receive test order Complete order form Deploy staff for collection Note urgency level Collect supplies Locate patient Identify patient Prep patient Draw sample Location (bedside, home, doctor s office, draw station) Phlebotomy technique (catheter draws, tourniquet time, order of draw, mixing of tubes) Prioritise sample for transport Send sample to lab Pneumatic tube Robot Hand carry courier Accession Apply/verify sample label Barcode for testing Identify STAT tests Rack Sample Centrifuge Aliquot Pre-treat Re-rack Send sample to appropriate lab section Main lab Reference lab Re-rack Label Disposal of supplies PA Phase outside the laboratory PA Phase outside the laboratory

4 Factors Effecting the Preanalytical Phase

5 Literature Reviews of Errors in Laboratory Analysis Processing Phases Preanalytical Analytical Post Analytical Reference Time % % % Goldschmidt and Lent 6y Whole laboratory: total 133 errors Nutting et. al. 6m Primary care: 160,714 patients: error 0.11% of patients 4.4% Referal lab 40% POCT Plebani and Carraro 3m STAT laboratory: 40,490 tests; error 0.47% of test results Stahl et. al. 3y Whole laboratory: 676,564 tests; error 0.61% of test results Hofgartner and Tait 1y Molecular genetic tests: 88,394 patients; error 0.33% of test results Errors in laboratory medicine; Pierangelo Bonini, Mario Plebani, Ferruccio Ceriotti, Francesca Rubboli Clin Chem. 2002; 48:5:

6 Growing Awareness 50 ER Samples Collection with incorrect equipment Potential for sample contamination Call for more training to improve blood tests in A&E, BBC News, 23 September 2011, last accessed 22 nd July 2013.

7 Errors in the PA phase Warehouse PAE Expired tube Emergency department Haemolysed sample Doctor s office PAE Incorrect label Ward Unsafe sharps disposal PAE Lab Incorrect centrifuge settings Clinic PAE Insufficient sample volume NSI PAE Ward Order of draw error Ward No tube mixing PAE PAE

8 What Does Auditing Do For US? Identifies Warehouse the causes of PAEs Expired tube Order of draw error Where PAEs occur Unsafe Ward sharps Warehouse disposal NSI PAE Ward Expired tube Ward Haemolysed sample Emergency department Unsafe sharps disposal PAE Lab PAE No tube mixing Storage Incorrect centrifuge settings Blood Collection Doctor s office Incorrect label Haemolysed sample No mixing Clinic Doctor s Incorrect centrifuge office settings PAE Clinic PAE Incorrect label Insufficient sample volume Insufficient sample volume Emergency department Transport Order of Ward No tube draw error mixing Courier Hand carry Pneumatic tube system PAE Lab PAE

9 Methodology Analysis Storage Blood Collection Transport Sample Preparation Sample Quality Trained Observers Standardised Collection Forms

10 Key Quality Measures 40 Key Measures: Sample Storage Patient and specimen ID procedure Infection control procedures Collection Site & Device Phlebotomy technique Healthcare worker safety Sample management Sample preparation Sample quality

11 Preanalytical Review/QC Driven by data & expert observation Highlights areas for optimising work procedures & practices Identifies potential areas for improving operating efficiency Propose & prioritise potential solutions

12 Completed PA Reviews Data from 48 standardised reviews from 2004 to 2012 in 13 countries : Austria Belgium Canada Czech Republic France Germany Hungary Lebanon 22 Sweden Switzerland The Netherlands Turkey UK Extract from Using BD LABORATORY CONSULTING SERVICES to Understand the Impact of the Preanalytical Phase on Sample Quality and Safety, a Multi Country Perspective, Schlueter K, Church S, Euromedlab 2013

13 Completed PA Reviews - Nordic 14 PA Reviews (On-going & Completed)* Denmark 3 Finland 7 2 Latvia 1 1 Lithuania Sweden * 1 included in the data presented

14 Results: Institution Demographics Size of institutions (in number of beds) where reviews have taken place Different institutions used different blood collection systems Sample types to be investigated Consultation with institution Chemistry and/or coagulation Which wards are the samples to be collected from Consultation with institution Wards where there is an increased risk of sample quality issues: Oncology, Emergency, Geriatrics, Intensive Care n< <n <n 6

15 Results: Observation Demographics collections 3597 tubes where PA phase observed 4324 quality assessed serum tubes 3263 quality assessed plasma tubes 3532 quality assessed coagulation tubes Majority (6931; 86%) of chemistry samples collected in tubes with a gel barrier

16 Results: Patient Identification 60% 56% Correct procedure: ask patient to identify themselves using an open question 50% 40% 44% Other locally acceptable procedures may apply 30% Incorrect identification can lead to Test results being associated with wrong person Two patients impact 20% 10% 0% correct procedure incorrect procedure Data from 1076 collections

17 Results: HCW Safety Legal requirements vary from country to country 60% 50% 56% EPINet Data : 21% needle stick injuries associated with blood collection 40% 30% 20% 16% 28% Use of safety engineered devices can reduce incidence of needlestick injuries Reduce exposure Reduce probability of seroconversion Or having to undergo prophylaxis 10% 0% safety devices only in use some safety devices in use Data from 32 reviews no safety devices in use

18 Results: HCW Safety Introducing safety devices only part of the story Full protection from needlestick injuries only results from correct activation of the device after collection, according to manufacturers instructions Eg single handed rather than double handed activation Correct training after introduction Reminder posters Training of new staff due to turnover 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 19% correct activation Data from 469 collections 81% incorrect activation

19 Results Haemolysis: Chemistry All samples, ie both those where PA phase had been observed or had not been observed none slight severe 7,0% 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 0,0% 6,4% slight hemolysis 1,8% severe hemolysis Data from observation of 7384 clinical chemistry samples

20 Results: Haemolysis: Chemistry: PA Phase No significant difference between with prolonged tourniquet or disinfectant not allowed to dry % of hemolysed samples where catheter used much greater than % of catheters used for all samples Use of catheter increases risk of hemolysis Catheter has many edges Turbulence in blood flow during collection Red blood cells more likely to rupture 60% 50% 40% 30% 20% 10% 0% 47% 48% prolonged use of tourniquet 38% 35% disinfectant not dry hemolysed samples 31% 117 PA phase observed samples from 35 reviews were hemolysed 15% catheter collection

21 Results: Fibrin Formation - Chemistry All serum samples, ie those where PA phase had been observed or had not been observed Fibrin formation can block instrument probes Instrument downtime Fibrin formation can lead to a smaller aliquot used for the test by instrument Inaccurate test results 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 94% no fibrin 6% fibrin Data from observation of 7545 clinical chemistry samples

22 Results: Fibrin Formation Chemistry PA Not mixing (patient dependant) Not allowing sufficient time to clot increases risk of fibrin formation So Can We Improve??? 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 81% tubes not mixed 26% insufficient clot time 40 PA phase observed serum samples from 10 reviews had fibrin

23 So Can We Improve? Patient Identification Patient ID Confirmation Specimen Labelling

24 So Can we Improve? Fill Volume Fill Volume Coag Fill Volume Chemistry

25 So Can we Improve? Clotting & Fibrin Clotting & Fibrin Clinical Chemistry Mixing by > 3 Inversions

26 Laboratory & Phlebotomy Partnership Case Study Level of Haemolysis leading to specimen rejections Effectiveness of safety device introduction Haemolysis 22% coagulation tubes, 14% chemistry tubes 33% of collections with catheter or needle & syringe Safety 73% safety device use, 84% not activated Benefits Driver for on-going safety change Improved relationship between lab and nursing

27 Accreditation Case Study

28 Accreditation Case Study ISO requirements

29 New ipad Based Audit Tool BD Laboratory Consulting Services PA QC ipad Based Auditing System Implemented Jan 2013 Can Be Expanded to Cover Other Areas Benchmarking Capability

30 Completed PA Reviews ipad Systems has enabled 69 BD PAQC to be completed in Belgium Bulgaria Croatia Denmark Finland France Germany Hungary Italy Latvia Lithuania Poland Portugal Romania Slovakia

31 Conclusions PA Factors have significant impact on the sample Each Institution will have different areas for improvement A standardised process to enable comparisons By implementing recommendations it is possible to improve

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