2nd EFLM-BD European Conference on the Pre-analytical Phase. Preanalytical quality improvement - in quality we trust Pediatric blood collection

Transcription

1 2nd EFLM-BD European Conference on the Pre-analytical Phase Preanalytical quality improvement - in quality we trust Pediatric blood collection Anne Vassault Biologiste des hôpitaux Pôle de BIOLOGIE MEDICALE 2013 MARCH 1st Departments for children Specialized Paediatrics Paediatric Surgery (neurosurgery, transplantation, cardiac surgery) Obstetrics Paediatric Cardiology Intensive care, Emergencies, Anaesthesiology Haematology, Immunology Nephrology Infectious diseases

2 Hôpital Universitaire Necker Enfants Malades 600 beds: Paediatrics : 2/3 of its activity -400 beds Staff: 700 medical / 3200 paramedical personnel Care (numbers per year) Hospitalizations Emergency visits Deliveries Consultations 240 Organ transplants (adults and children) Imaging analyses Laboratory examinations EN ISO Pre-analytical process is a part of laboratory examination: Medical laboratory services include: >arrangements for requisition, >patient preparation, >patient identification, >collection of samples, >transportation, >storage, >processing and examination of clinical samples, >together with subsequent validation, interpretation, >reporting and advice, >in addition to the considerations of safety and ethics in medical laboratory work.

3 ISO EN st edition: ISO EN 15189: nd edition: ISO EN 15189: rd edition: ISO EN 15189: 2012 re-organised to take into account observations Organisation and quality management system: 4.1, 4. 4, 4.15, et 4.2, 4.3, 4.13 RESSOURCES 5.1 Personnel 5.2 Accommodation and environmental 5.3 Equipment, reagents, consumables 5.10 Information system 4.6 Supplies PreanalyticalProcess: 5.4, 4.5,4,7 EVALUATION and CONTINUOUS IMPROVEMENT 4.8 Claims 4.9 Control of non conformities 4.10 Corrective actions 4.11 Actions Preventive actions 4.12 Continuous improvement 4.14 Internal audit 4.15 Review of direction 5.6 Quality insurance Request Analytical process: 5.2, 5.6 Postanalyticalprocess: 5.7, 5.8, 5.9 CLINICIANS REQUIREMENTS/ SATISFACTION Reports of the results PATIENTS 6

4 Pre-analytical (pre-examination) process P Prescription Request form clinical data N N et Preparation of the patient Collection of the sample Identification Conditionnement and handling Materials Documents (5.4.4) T Transport R Reception and registration Acceptance? criteria no NC form T Pretreatement yes Phone/Fax Paediatric collection: specific issues (1) 1. To take into account the pain during blood collection 2. Difficulties for blood collection 3. Small sample volume to handle: Total blood volume: 80 ml/kg small sample volume <0.2 ml 4. Quality of blood samples: Haemolysis, hyperbilirubinaemia, microclots, bubbles 5. Identity monitoring and labelling: Change of identity for new-borns Reduced space for labelling the tubes Risk of misidentification of plasma or serum after separation 6. Order of sampling 7. Reference ranges according to the age 8. Difficulties for automatic analysers and robotics with paediatric tubes. 8

5 Paediatric collection: specific issues (2) Impact on analytical process: Appropriate method and analyser for small volume (reduce dead volume): examples: Check up using < 100 μlplasma or serum Haemolytic samples frequent: (bilirubin assay) Icterus samples (neonatal period) Impact on post-analytical process: Interpretation depends on age and sex Communication between laboratory responsible and clinicians 9 Specificity in pediatrics: to deal with Emergency :50% of the examination requested are «urgent»(results within 1 hour) Communication between laboratory and pediatricians is required Management of small sample volume Providing age-specific reference ranges Newborns Hematocrit> 50 % to 60% plasma or serum: < 0,2 ml => choice of priority test with the collaboration of the clinicians Neonatal icterus => interferences of bilirubin => choice of the methods according to Haemolysis => interference => comments 10

6 To avoid pain EMLA PATCH 1 hour EMLA PATCH (1 g par patch): same action as cream EMLA (tube). Easier to use, more efficient. The time can be written on the patch. EMLA NEWBORN: The use of EMLA is possible for newborns (>37 weeks) (AMM, 1999) 0,5 to 1g, during 1 hour, minimum interval between 2 applications: 12 hours Interest: better to use venous blood collection with EMLA (without pain) instead of skin puncture which is painful. Premature infant: main requesting tests >Hypoglycaemia(glucose < 1,6 mmol/l-0,30 g/l) observed in 6 to 10 % of premature infant and 0,3 % of mature new-borns. Due to the excess of energetic dispenses (thermoregulation et respiration), too poor storage trop (stock de glycogen) et immaturity of neoglucogenesis. >Hyponatraemia(Na < 130 mmol/l) due to tubular immaturity associated with urinary sodium losses and hormonal insufficiency and/or inactivity of the tubule. It produces an hydric retention in the interstitial sector. It is the reason why restriction of water is recommended. >hypocalcaemia: mild when < 2 mmol/l, severe when < 1,75 mmol/l, due to the action of calcitonine, an initial l'hyperphosphoraemia, a maternal deficit in vitamin D and to the privation of maternal calcium. More than 50 % of premature infants are affected with a mild form.

7 Premature infant: main requesting tests >le premature infant is immunodepressedbecause of the deficit in C3, IgA, IgM, macrophages et lymphocytes actives. Alteration of fighting against infections. >hypovitaminosek1: is responsible to hypoprothrombinaemiawith an hemorrhagic risk. Systematic infusion of 3 to 5 mg of vitamin K1the first hour of life is administrated to all the premature infants to prevent. >icterus(more than 80 % of premature infants): due to a defect of hepatic glucuronoconjugationof bilirubin associated to a decrease of albumin, hypoglycaemia, deficient of enterohepatic cycling. To prevent the risk of encephalopathy due to kernicterus, bilirubinaemiais monitored during phototherapy. > Early anemia: due to > a defect of synthesis of erythropoietin, > a decrease globular mass of the premature infant, > Rapid growing Frequent Blood collection Capillary/venous blood > Most of the blood collection are from venous blood in children hospital >Capillary collection is used for Newborn screening (NBS), follow up of diabetes (glycated Hemoglobin), glycaemia, cell blood count

8 Capillary/venous blood Capillary >Easy to collect >No traumatism for the infant >Frequent haemolysis >Possible depending on the test : - Blood gas - Glycaemia - Hematocrit, CBC >Impossible for - Coagulation tests (clots) - Kaliemia (haemolysis)

9 EVALUATION of the origin of HAEMOLYSIS 7% of the samples (data from Necker evaluation) Characteristics of the samples capillary blood 55 % Sampling using syringe 15 % Handling defect (temperature and/or delay) 6% Infusions 5% Containers, additives 5% Hemolytic anemia 2% Other (unknown) 12 % 17 Identification of samples from newborn with information system >Newborn at birth has no name >So, the first sample collected is identified with the mother name >Some hours or days, the father is involved in the name and the samples collected in a second time are labeled with the new name. >The first results are identified with a different name and cannot be followed as necessary. >The name written on the request form differs from the name reported par LIS

10 Special device EDTA (BD MAP) Space for labelling Geometric ability for use with automatic analysers and robotics Easy to handle But only for EDTA tube 8 cm The support tube is not integrated to the device. Risk of identification defect by inversion /03/2013

11 EN ISO collected Revision of volume The laboratory shall periodically review its sample volume requirements for phlebotomy (and other samples such as cerebrospinal fluid) to ensure that neither insufficient nor excessive amounts of sample are collected. Blood volume collected Depending on body weight: Infants: total blood volume (TVB): ml/kg Ex : 2 weeks old, 3.5 kg: 350 ml Ex: 15 months old, 10 kg: 800 ml Impact of blood sampling: (data from bulletin of the WHO, 2011, 89,: 46-53) Premature neonates (gestational age: weeks) 13.6 ml/kg = 13% of total blood volume Ex: 18 ml/kg (18% of TBV) : 53 % of the infants required transfusion during their neonatal intensive care admission.

12 Blood volume collection according to the weight of the child Weight (Kg) Maximum amount to be drawn at one time (ml) Maximum amount to be drawn during stay 1 month or less (ml) Pre-analytical issues for pediatric samples Order of filling the tubes To apply whatever the site: capillary, venous, catheter, Contamination with the tube open => less risk with evacuated tubes -from the micro drops of the caps with a compress -contact with interior of the tube with the syringe Risk: contamination from the anticoagulant of the first tube to the second tube. Impact : erroneous results and re-collection necessary => delay

13 Order of collection and/or filling of the tubes 1 Tube without additives Additives no Consequency 2 Haemostasis Citrate liquid Volume to respect 3 Biochemistry: electrolytes.. Dry Li heparin heparin imported TP N TCA 4 Numeration EDTA tri K liquid EDTA complex Ca, Mg, iron imported K => K Electrolytes + cell blood count (WBC) Aspect of Normal Normal Hem+ Normal plasma Na mmol/l K mmol/l Proteins g/l Ca mmol/l Order for collection Type of contamination 1- electrolytes 2- WBC 1- WBC 2- electrolytes 1- WBC 2- electrolytes Micro drop from the cap syringe Tube EDTA

14 Hypokaliemia, hypercalcaemia? Aspect du plasma Normal Normal Na mmol/l K mmol/l Protides g/l Ca mmol/l Order of sampling 1 electrolytes 2 WBC 1 WBC 2 electrolytes Specimen rejection policy The following criteria will be used for specimen rejection: > Unlabelled, mislabelled or incompletely labelled specimens will be discarded by the laboratory and new collection requested. >Discrepancy between the patient identification on the test requisition (request) and on the specimen label will cause specimen to be discarded by the laboratory and a new collection requested. >Specimen(s) deemed unacceptable due to the requirements of test methodology: i.e. haemolysis, lipemia, short samples, wrong tube or wrong specimen type. >Suspected specimen contamination due to result discrepancy > Pre-analytic handling and transport requirements not met

15 Example of non conformities >Non identified container: LCR >Identity of newborn >Discrepancy between request form and containers >Inappropriate container and additives >Insufficient volume >No information about age, sex, clinical data >Haemolysis >Transport condition: delay and temperature Storage temperature and delay Lactate/Pyruvate min 60 min 120 min 4 C 25 C

16 Pré-analytique Anne Vassault DU PARIS 31 VI 2009 Plasmatic creatinin Newborn < 4j µmol/l Child < year Chid < 12 year Adolescent Adult man woman µmol/l µmol/l µmol/l µmol/l µmol/l 32 08/03/2013 Anne Vassault

17 Ketone bodies according to fasting time and age 4 3,5 3 2,5 2 1,5 1 0,5 0 mmol/l Fed state 15 h fasting 20 fasting 24 h fasting 1-12 months 1-7 years 7-15 years Reference interval Lactate (L) (mmol/l) Enfant (0-1 an) Collection with syringe Collectin using catheter (butterfly) Etat nourri, 1h après repas Enfant (1-7 an) 0,9-2,5 0,6-2,2 Jeûne 10 h 0,8-2,2 0,7-1,8 Etat nourri 0,9-2,4 0,9-1,8 Enfant (7-15 an) et adulte Jeûne 10 h 0,9-1,6 0,7-0,9 Etat nourri 1,0-1,9 1,0-1,55 A. Vassault. «lactate, pyruvate, acétoacétate, 3 hydroxybutyrate». in Blau, Duran, Gibson : LABORATORY GUIDE TO THE METHODS IN BIOCHEMICAL GENETICS, SPRINGER 2008.

18 Lactataemia: influence of hand exercice and stasis 5 4 Lactate mmol/l 3 2 Normal value hand exercice exercice and stasis min 4 min 6 min 8 min 10 min Non conformities observed Year 2011 SPECIALISED BIOCHEMISTRY NC 2011 No clinical data Insufficient volume 140 No identification 120 No sample Inappropriate container and additives Incomplete request form whole blood "laqué" Inappropriate sample No order form Broken container Inapproriate transportation (safety..) 36

19 Specialized Biochemistry: Main pre-analytical non conformities NC principales Nombre de NC Vol d'échantillon insuffisant Absence de renseignements cliniques Identifiant Type de NC samples received

20 * Justificationimpérative Prescripteur : Réservéau. laboratoire EtiquetePatient GILDA EtiqueteServiceGILDA Préleveur : (Etiquetelabo). A1 Hôpital universitairenecker-enfantsmalades LABORATOIREDUPOLEDEBIOLOGIE- RECEPTIONCOMUNE Tél : 9514/ 19- Fax: BIOCHIMIEGENERALE- Profeseur B. LACOUR Tél : 9514/19- Fax: Datedeprélèvement : Heuredeprélèvement : J J M M A A Microtube TUBEBOUCHONVERT(Héparinatedelithium) TUBEBOUCHONROUGE (Secsansgel) DIALYSAT Renseignementscliniques: DRA FRA Autrerenseignement Sodium-Potasium outemps:. Rens.cliniques:. Chlorure Bilirubinetotale Na-K-Cl-Bicar-Urée Bicarbonate Bilirubineconj. Na-K-Cl-Bicar-Ca Glucose TGO(ASAT) Glucose Proteines TGP(ALAT) Créatinine Protéines Urée GT SELES Créatinine Cholestérol Na-K Calcium Triglycérides Sang(Recherche) Phosphate HDL-Cholestérol PONCTIONS- ASPIRATIONS Urate Fer Magnésium Feritine Renseignementscliniques CRP Transferine Amylase Haptoglobine Ascite Gastrique Plèvre Lipase B2Microglobuline Genou Drain Redon Phosphatasesalcalines Osmolarité(calcul) Autre: Microtube TUBEBOUCHONVERTSUPLEMENTAIRE (1)Al'abri delalumière, (2) danslaglace Na-K-Cl-Bicar-Urée-Créat. TroponineI PCT Vit.C(1+2) Vit.A(1) Vit.E(1) Protéines Vitamines: pasdemicrotube Glucose Microtube TUBEBOUCHONORANGE(Secavecgel) Bilirubine Alpha-Foetoprotéine(AFP) Amylase LDH PSA LCR CK Protéinograme Albumine Chlorure Glucose Préalbumine I munoélectrophorèse/i munofix. Protéines IgG Rech./Typagedecryoglobuline* Lactate(danslaglace) IgA Renseignementscliniques: I munoélectrophorèse IgM Myélome Autre:. CLAIRANCES- EXPLORATIONS Fructosamine * Prélèvement àjeûnstrict. 2Tubesde7ml Prélèvementssanget urinesobligatoires BHCG préchauffésà37 C(Cf. BIBouprocédure) Datedernièresrègles:... * 2tubessecs: 1mère, 1foetus Créatinine Puretédusangfoetal * TRP Microtube TUBEBOUCHONGRIS(Fluorure) Autre:. Heure: h mn Glucose Glucosepost-prandial Lactate Poids( Kg) :. Cycleglycémique- Temps:. (danslaglace) Taile( cm) :. TUBEBOUCHONVIOLET(EDTA- Sangtotal) Temps( h) :. Volume( ml ):. HbA1C HbS HbF Renseignementscliniques: DiabèteI DiabèteI Autre:. EXPLORATIONSFONCTIONELES URINETUBEBOUCHONJAUNE(Sansconservateur) RENALESADULTE(UH941Uniquement) Nepasindiquer devolumeencasdemiction Volumedesurinesde24H: Explo.fonctionelerénale ml Rens.cliniques:... TempsSang:. Sodium-Potasium Protéines Microalbumine Urobiline(rech.) TempsUrine:. Chlorure Calcium ph Amylase Urée Phosphate Acétone(rech) B2Microglobuline CRISTAUX Créatinine Magnésium Densité Sang(rech.) Glucose Urate Osmolarité(calcul) Cristalurie I munoélectrophorèse(5tubes) *:.... REQUEST FORM For use with automatic and robotic device VersionFévrier 2013_19/02 Conclusion To manage and to improve the quality of the this essential phase of the examination, a close cooperation between clinicians, manufacturers, and medical laboratory responsible are necessary /03/2013