How to guide and prepare the patient and the importance of blood sampling

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1 How to guide and prepare the patient and the importance of blood sampling Mads Nybo Dept. of Clinical Biochemistry and Pharmacology Odense University Hospital

2 My background Clinical biochemist, MD Responsible for routine production in Odense Accreditation assessor for the ISO15189 Member of EFLM-WG on preanalytics And the Nordic WG, too Research in preanalytical issues Potentially worried

3 Preanalytics a complicated area

4 Preanalytics the quick take Analytical variation The civilization Preanalytical variation Biological variation Patient preparation Sampling Sample transportation Preanalytical issues in the lab Stability/storage A jungle!

5 Preanalytics the quick take Analytical variation The civilization Preanalytical variation Biological variation Patient preparation Sampling Sample transportation Preanalytical issues in the lab Stability/storage A jungle!

6 Patient preparation Fasting (whatever the definition may be ) Physical activity Medication

7 Patient preparation FASTING

8 Definition of fasting Does food intake affect our analyses? Does liquid intake affect our analyses? Does smoking affect our analyses? Does medication affect our analyses? YES YES YES YES

9 Definition of fasting Are fasting standardized? Locally? Nationally? Internationally? Mostly, but Some times, but No

10

11 Many investigations were conducted years ago habits have changed Many samples are drawn outside our jurisdiction (GP s etc.) People do in general not understand the impact of the fasting/non-fasting state A job for the laboratory organization!

12

13 Definition of fasting ITEMS?

14 Definition of fasting TIME OF DAY?

15 Preferable time for blood drawing?

16 Reference ranges are most often established from morning samples And there is a wide variety between fasting and noon sampling (e.g. a significant increase in triglycerides) If the analytes alters during the day, a fixed sampling time point should be chosen And the most standardized time of day is in the morning

17 The EFLM WG-PRE therefore recommends Blood should be drawn in the morning from a.m.

18 Definition of fasting DURATION?

19 Many analytes are altered 9-10 hours after a meal (e.g. triglycerides, insulin, C-peptide, glucose, homocysteine) Prolonged fasting (14-16 hours) can however lead to altered gluconeogenesis and renewed rise in triglycerides and should also be avoided

20 The EFLM WG-PRE therefore recommends Fasting should last for 12 hours (perhaps plus/minus half an hour?)

21 Definition of fasting WATER?

22 A certain amount of water intake will always be necessary But excessive water intake will of course affect analysis results So, as it is difficult to recommend an exact volume, it must be a consensus recommendation

23 The EFLM WG-PRE therefore recommends Water consumption should mirror the usual intake during the fasting period

24 Definition of fasting OTHER LIQUIDS?

25 200 ml coffee can cause an 0.5 mmol/l increase in P-Glucose within one hour (and café latte even worse ) Moderate alcohol intake causes significant decrease in P-Glucose for up to 20 hours Severe alcohol intake will affect many analytes acutely (and chronically )

26 The EFLM WG-PRE therefore recommends Caffeine-containing beverage (coffee, tea) should be avoided the morning of the blood sampling Alcohol should be avoided 24 hours prior to blood sampling

27 Definition of fasting SMOKING?

28 Smoking one cigarette increases the triglyceriderich lipoprotein rate significantly Smoking also increases e.g. adrenalin, cortisol, and free fatty acids The effect of smoking on the different analytes is very individual, not dose-dependent and can therefore not be predicted

29 The EFLM WG-PRE therefore recommends The patient should refrain from smoking the morning of the blood sampling

30 If we find out Cancel blood sampling! Or if possible (?) convert to a non-fasting entity If we don t find out Risk for reference ranges being wrong Deduction/diagnosis will be erroneous Patient safety will be compromised

31 Patient preparation PHYSICAL ACTIVITY

32 Physical activity As usual But not peak performances the day before, please Bicycle and PSA? Remember: The recommended 15 minutes rest prior to sampling often fits the queue in the waiting room

33 Patient preparation MEDICATION

34 Medication Must be noted! If the test monitors medication effect, the phlebotomist must ask about intake Time for last dose should be noted What affects the requested tests?

35

36 There is a strong need for harmonization at this area nationally as a minimum! Fasting is not only food, but includes other issues that are just as important! Physical activity and medication are also obligatory aspects Remember: It is those who inform the patients prior to sampling that needs the information (e.g. nurses, GP s)!

37 Blood sampling Patient identification! Is the patient correctly prepared? Tube labelling Hand hygiene ( ) Cleaning of puncture site Stasis Order of draw Mixing of samples

38 Blood sampling Patient identification! Is the patient correctly prepared? Tube labelling Hand hygiene ( ) Cleaning of puncture site Stasis Order of draw Mixing of samples ANALYSIS QUALITY

39 Blood sampling Patient identification! Is the patient correctly prepared? Tube labelling Hand hygiene ( ) Cleaning of puncture site Stasis Order of draw Mixing of samples SAFETY ISSUES ANALYSIS QUALITY

40 Blood sampling Patient identification! Is the patient correctly prepared? Tube labelling

41 Blood sampling Patient identification! Is the patient correctly prepared? Tube labelling Hand hygiene ( ) Cleaning of puncture site Stasis Order of draw Mixing of samples

42 Blood sampling

43 So it s a complex area.. Includes a multitude of items Why multiple instruments are needed Quality indicators (QI s) Sampling quality control Documentation Certification?

44 Quality indicators why? IFCC In order to continuously improve, you need indicators of your performance Measurable, objective, quantitative measures of key system elements performance Documentation of to what extent your laboratory meets the needs and expectations of the customers

45 Quality indicators why? Or: Monitor what we do, so we can assure and increase quality Enable demands to our selves and others (laboratories, GP s, etc.) ISO standardization Benchmarking

46 Possible QI s Identification Missing samples Unlabelled samples Erroneous labelling Sample condition Hemolysis Coagulation To little sample material Turn-around-times Sampling QC! Data extraction on a monthly basis Data extraction on weekly basis

47 Possible QI s

48 Possible QI s Identification Missing samples Unlabelled samples Erroneous labelling Sample condition Hemolysis Coagulation To little sample material Turn-around-times Sampling QC! Data extraction on a monthly basis Data extraction on weekly basis

49 Sampling quality control What does it take to assure sampling quality? A system for continuous control Established demands Time (!) Interest!

50 Sampling quality control Sampling at Odense University Hospital

51 Sampling quality control

52 Sampling quality control Sampling at Odense University Hospital Auditing three samplings from two phlebotomists weekly Alternating at the out-patient clinic and a hospital ward Only observational! A priori QC demands Single person evaluation (vertical) Pattern recognition (horizontal)

53 OUTCOME SO FAR 1) Two examples of wrong patient ID! 2) Focus areas Hand hygiene Order of draw Mixing of samples 3) Accept!

54 Sampling quality control What does continuous sampling QC provide? Visibility and focus Continuous improvement Documentation Demands to others taking samples!

55 Consider use of QI s Continuous sampling auditing! Continuous education Focus on other samplers, e.g. GP s Certification? External quality assessment??

56 The preanalytical phase is complex But there is a number of specific areas with well-defined goals And tools to reach those are available Also, international and Nordic guidelines are emerging So let s start working there s a lot to do!

57 THANK YOU

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