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مشروع إعتماد معمل الكمياء الإكلينيكيه – مستشفى الطوارئ.

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Presentation on theme: "مشروع إعتماد معمل الكمياء الإكلينيكيه – مستشفى الطوارئ."— Presentation transcript:

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2 مشروع إعتماد معمل الكمياء الإكلينيكيه – مستشفى الطوارئ

3 Role of clinician in lab result accuracy Prof/Azza abd al baky

4 Introduction Three phases of laboratory testing: pre-analytical, analytical and post-analytical Three phases of laboratory testing: pre-analytical, analytical and post-analytical Pre-analytical—specimen collection, transport and processing Pre-analytical—specimen collection, transport and processing Analytical—testing Analytical—testing Post-analytical—testing results transmission, interpretation, follow-up, retesting. Post-analytical—testing results transmission, interpretation, follow-up, retesting.

5 Pre-analytical errors Pre- and post-analytical errors are estimated to constitute 90% of errors Pre- and post-analytical errors are estimated to constitute 90% of errors Errors at any stage of the collection, testing and reporting process can potentially lead to a serious patient misdiagnosis Errors at any stage of the collection, testing and reporting process can potentially lead to a serious patient misdiagnosis Errors during the collection process are not inevitable but can be prevented with a diligent application of quality control, continuing education and effective collection systems. Errors during the collection process are not inevitable but can be prevented with a diligent application of quality control, continuing education and effective collection systems.

6 The steps of the preanalytical phase Preparation prior to sampling Sampling/handling Storage/transport Preparation prior to analysis

7 Implications of errors and compromise the diagnosis and treatment of the patient and compromise the diagnosis and treatment of the patient may influence the quality of the final measured results... Errors made in the period prior to the analysis of the sample... No result is better than bad result

8 Complex and labor intensive The more steps involved in a process, the more likely there will be errors committed The more steps involved in a process, the more likely there will be errors committed % of all test errors occur in the preanalytical phase % of all test errors occur in the preanalytical phase Stankovic 2008 “Quality Improvements in the Preanalytical Phase: Focus on Urine Specimen Workflow”

9 Paying close attention to the preanalytical variables associated with blood collection is critical in ensuring accurate test results in all areas of the clinical laboratory. Paying close attention to the preanalytical variables associated with blood collection is critical in ensuring accurate test results in all areas of the clinical laboratory. Effects of Pre-analytical Variables on the Quality of Laboratory Testing

10 The Pre-Analytical process Patient Identification Patient Identification Sampling Technique Sampling Technique Test Collection Procedures Test Collection Procedures Specimen Transport Specimen Transport Specimen Processing Specimen Processing

11 Collect Sample: Locate Patient Locate Patient Prep Patient Prep Patient Draw Sample Draw Sample Label Label Dispose of supplies Dispose of supplies The Pre-Analytical process

12 When identifying the patient, have them provide their full name, address, identification number and/or date of birth. Hospital No inpatients should be wearing an identification band with the above information, which the phlebotomist should confirm before the venipuncture. Patient identification

13 Patient Identification: It is important to identify a patient accurately so that blood is collected from the correct person. Drawing blood from the wrong person, or labeling the correct patient’s sample with a different patient’s label can certainly contribute to laboratory error. (Mislabeling ???) Patient Identification: It is important to identify a patient accurately so that blood is collected from the correct person. Drawing blood from the wrong person, or labeling the correct patient’s sample with a different patient’s label can certainly contribute to laboratory error. (Mislabeling ???) Effects of Pre-analytical Variables on the Quality of Laboratory Testing

14 Factor affecting lab result Some patient variables that affect test results Some patient variables that affect test results Age Genetic variation Gender Nutrition status Diet Diagnostic and therapeutic Drugs procedures(PR&endoscopy) Exercise Obesity Posture Biorythm Haemolysis,lipemia Special habits & icterus & icterus

15 Test Collection Timing of Collection Timing of Collection Therapeutic Drug Monitoring Therapeutic Drug Monitoring Peak and trough collection times Peak and trough collection times Basal State Collections Basal State Collections Fasting requirements—no food or liquid except water(10-12h) Fasting requirements—no food or liquid except water(10-12h) 2h postprandial, from the start of food. 2h postprandial, from the start of food. Specimens affected by time of day, for example, cortisol, iron and TSH. Specimens affected by time of day, for example, cortisol, iron and TSH.

16 Phlebotomy Phlebotomy is a highly complex skill requiring expert knowledge, and critical judgment Phlebotomy is a highly complex skill requiring expert knowledge, and critical judgment venipuncture is a frequent medical procedure. venipuncture is a frequent medical procedure. Phlebotomy errors may cause harm to patients or result in needle stick injury to the phlebotomist Phlebotomy errors may cause harm to patients or result in needle stick injury to the phlebotomist

17 Error Prevention Phlebotomy Education Phlebotomy Education Phlebotomists should have completed a standard academic course in phlebotomy and undergo thorough on-the-job training under the supervision of a senior phlebotomist Phlebotomists should have completed a standard academic course in phlebotomy and undergo thorough on-the-job training under the supervision of a senior phlebotomist Continuing Education Continuing Education Phlebotomists should participate in regular educational competency assessments (written and observational) Phlebotomists should participate in regular educational competency assessments (written and observational) Professional Licensure Professional Licensure Phlebotomy Staffing Phlebotomy Staffing Adequate staffing to maintain collection standards Adequate staffing to maintain collection standards Technology Technology Use of barcode scanners for patient identification Use of barcode scanners for patient identification

18 1-posture: The patient should be comfortably seated or supine for 20 minutes before sampling.Not standing The patient arm should be extended in a straight line from the shoulder to the wrist. 2- collection site. The median cubital vein is the preferred site. Veins on the hand or at ankle may be used. Avoid the arm with: Extensive scarring or hematoma.,infection, edema,burn, Containing I.V. access for I.V. infusion. On the side of mastectomy.

19 Phlebotomy Technique Correct collection system Correct collection system Evacuated tube system (Vacutainer) for large veins in antecubital fossa Evacuated tube system (Vacutainer) for large veins in antecubital fossa Syringe for small, fragile veins or veins outside antecubital fossa Syringe for small, fragile veins or veins outside antecubital fossa Venous access Venous access Needle entry should be at 15 to 30 degrees depending on depth of vein Needle entry should be at 15 to 30 degrees depending on depth of vein Needle entry should be in same direction as vein, centered over vein Needle entry should be in same direction as vein, centered over vein Anchor vein to prevent movement during needle entry and to reduce pain to patient Anchor vein to prevent movement during needle entry and to reduce pain to patient

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21 Phlebotomy Technique Errors Tourniquet Application Tourniquet Application Tourniquet tied too close to the venipuncture site can cause hematoma Tourniquet tied too close to the venipuncture site can cause hematoma Veins may not become prominent if tourniquet is tied too high (more than 3 to 4 inches above venipuncture site ) Veins may not become prominent if tourniquet is tied too high (more than 3 to 4 inches above venipuncture site ) Tourniquet left on longer than one minute can result in hemoconcentration, affecting some test results Tourniquet left on longer than one minute can result in hemoconcentration, affecting some test results Tourniquet should be released as soon as needle is in the lumen of the vein and blood flow established Tourniquet should be released as soon as needle is in the lumen of the vein and blood flow established

22 Phlebotomy Technique Cleansing of venipuncture site Cleansing of venipuncture site Thorough cleaning with alcohol Thorough cleaning with alcohol Allow alcohol to dry completely to avoid stinging sensation upon needle entry and hemolysis of sample Allow alcohol to dry completely to avoid stinging sensation upon needle entry and hemolysis of sample Samples such as blood cultures should be collected using iodine to cleanse site to ensure sterility of sample Samples such as blood cultures should be collected using iodine to cleanse site to ensure sterility of sample Recollection rate for blood cultures ranges due to contamination is as high as 50% in hospitals with increased costs, patient overtreatment Recollection rate for blood cultures ranges due to contamination is as high as 50% in hospitals with increased costs, patient overtreatment

23 Test Collection Additive : EDTA,citrat, lithium heparin,oxalate,flourid Additive : EDTA,citrat, lithium heparin,oxalate,flourid Hemolysis Hemolysis Blood collected insufficient to amount of additive in tube, Blood collected insufficient to amount of additive in tube, Traumatic venipuncture Traumatic venipuncture Blood collected from area with hematoma Blood collected from area with hematoma Vigorous shaking of tubes after collection Vigorous shaking of tubes after collection Milking the site when collecting capillary samples and blood collected using a small diameter needle. Milking the site when collecting capillary samples and blood collected using a small diameter needle.

24 Test Collection Capillary Collections—finger stick or heel stick Capillary Collections—finger stick or heel stick Appropriate site Appropriate site Heel stick—sides of the bottom surface of the heel Heel stick—sides of the bottom surface of the heel Finger stick—third or fourth fingers, perpendicular to fingerprint lines on fleshy pads on finger surface Finger stick—third or fourth fingers, perpendicular to fingerprint lines on fleshy pads on finger surface Warming—Warm before collection to increase capillary blood flow near skin surface Warming—Warm before collection to increase capillary blood flow near skin surface Cleaning—cleanse site with alcohol and allow to air dry Cleaning—cleanse site with alcohol and allow to air dry Discard first drop of blood. Discard first drop of blood.

25 Recommended order of draw (NCCLS): 1. Blood Culture Bottles (Aerobic-Anaerobic) 2. Coagulation Tube 3. Serum Tube with or without clot activator, with or without gel separator 4. Heparin Tube with or without gel plasma separator 5. EDTA 6. Glycolytic Inhibitor

26 Correct Specimen Volume: All blood collection tubes need to be filled to the correct volume. This will ensure the proper amount of blood for the amount of additive in the tube (blood to additive ratio). For example, if a 5 mL draw heparin tube is only filled with 3 mL of blood, the heparin concentration is erroneously high and may potentially interfere with some chemistry analytes, tube for Coagulation Studies incomplete filling results in specimen dilution and erroneous Prothrombin and aPTT test results. Correct Specimen Volume: All blood collection tubes need to be filled to the correct volume. This will ensure the proper amount of blood for the amount of additive in the tube (blood to additive ratio). For example, if a 5 mL draw heparin tube is only filled with 3 mL of blood, the heparin concentration is erroneously high and may potentially interfere with some chemistry analytes, tube for Coagulation Studies incomplete filling results in specimen dilution and erroneous Prothrombin and aPTT test results.

27 Proper Tube Mixing: All tubes with additives need to be inverted to mix the additive evenly with the blood. Improper mixing of the tube after venipuncture could contribute to sample clotting. Proper Tube Mixing: All tubes with additives need to be inverted to mix the additive evenly with the blood. Improper mixing of the tube after venipuncture could contribute to sample clotting.

28 E) Specimen transport TemperatureLight

29 Transport Errors Temperature Temperature Specimens must be transported at the appropriate temperature for the required test Specimens must be transported at the appropriate temperature for the required test On ice—ABGs, Ammonia On ice—ABGs, Ammonia Warmed -- (37 C), cryoglobulins Warmed -- (37 C), cryoglobulins Avoid temperature extremes if transported via vehicle from other collection site Avoid temperature extremes if transported via vehicle from other collection site Transport Container Transport Container Some samples need to be protected from light, for example, bilirubin Some samples need to be protected from light, for example, bilirubin Transport in leak-proof plastic bags in lockable rigid containers,avoid agitation. Transport in leak-proof plastic bags in lockable rigid containers,avoid agitation.

30 Blood Specimen Transport Transport of blood specimens in the proper manner after collection ensures the quality of the sample Transport of blood specimens in the proper manner after collection ensures the quality of the sample Timing Timing Some specimens must be transported immediately after collection, for example Arterial Blood Gases. Some specimens must be transported immediately after collection, for example Arterial Blood Gases. Specimens for serum or plasma chemistry testing should be centrifuged and separated within two hours Specimens for serum or plasma chemistry testing should be centrifuged and separated within two hours

31 Special Handling of Blood Specimens: Certain chemistry analytes will require the tube of blood to be chilled after collection in order to maintain the stability of the analyte. A slurry of ice and water is recommended for chilling the tubes of blood. Examples : adrenocorticotropic hormone (ACTH), angiotensin converting enzyme (ACE), acetone, ammonia, catecholamines, free fatty acids, lactic acid, pyruvate and renin,PTH Special Handling of Blood Specimens: Certain chemistry analytes will require the tube of blood to be chilled after collection in order to maintain the stability of the analyte. A slurry of ice and water is recommended for chilling the tubes of blood. Examples : adrenocorticotropic hormone (ACTH), angiotensin converting enzyme (ACE), acetone, ammonia, catecholamines, free fatty acids, lactic acid, pyruvate and renin,PTH

32 Blood gases analysis “Collection of a blood specimen, as well as its handling and transport, are key factors in the accuracy of clinical laboratory analysis and ultimately in delivering quality patient care” ”Arterial blood is one of the most sensitive of the specimens sent to the clinical laboratory for analysis” ”Blood gas and pH analysis has more immediacy on patient care than any other laboratory determination” ”In blood gas and pH analysis an incorrect result can often be worse for the patient than no result at all”

33 What is so special about blood gases? NOT like other blood samples NOT like other blood samples STAT parameters STAT parameters Short Turn Around Time Short Turn Around Time Must be analyzed within a short time Must be analyzed within a short time pO 2, pCO 2, pH, LAC, GLU pO 2, pCO 2, pH, LAC, GLU Valuable results right now Valuable results right now Not in one hour Not in one hour Sample composition changes Sample composition changes Patient status changes Patient status changes

34 Some points to keep in mind - sampling from A-lines Preparation prior to sampling Sampling/handling Label the sampler with patient ID Use dry electrolyte balanced heparin Endeavor to keep the patient’s respiratory condition stable for a certain period prior to sampling Make sure that the a-line has been adequately cleared of flush solution Aspirate the sample slowly to prevent degassing and hemolysis Expel any air bubbles immediately after sampling Mix the sample thoroughly with heparin after sampling

35 Storage/transport Analyze sample immediately If storage is unavoidable, store the sample at room temperature for max. 30 min. Samples with expected high pO 2 values should be analyzed within 5 min. Preparation prior to sample transfer Before transferring the sample into the analyzer mix thoroughly Visually inspect the sample for clots and air bubbles Enter patient ID in analyzer logs

36 To get a true picture of the patient’s respiratory condition the patient should ideally be in a steady state of ventilation Patients should be at rest for 5 min Ventilatory settings should be unchanged for 20 min Pain and anxiety from arterial puncture may influence the steady state of respiration and should thus be minimized Stabilization of the respiratory condition

37 Storage recommendations Storage and transport time should be kept at a minimum Volatile nature of gases Continued metabolism in blood For parameter panels including GLU/LAC, be aware that 30 minutes storage might lead to biased results It is recommended by the NCCLS to avoid cooling of samples when kept in plastic General storage recommendation Do not cool the sample Analyze within 30 minutes For samples with high pO 2 Analyze within 5 minutes For special studies, e.g. shunt Analyze within 5 minutes For samples with high leukocyte or platelet count Analyze within 5 minutes Expected delayed analysis When analysis is expected to be delayed for more than 30 minutes, the use of glass syringes and storage in ice slurry is recommended

38 pO 2 since oxygen will still be consumed pCO 2 since carbon dioxide will still be produced pHprimarily due to the change in pCO 2 and glycolysis cCa 2+ since the change in pH will influence the binding of Ca 2+ to protein cGlusince glucose will be metabolized cLacdue to glycolysis Continued cellular metabolism in sample

39 Slowing down the metabolism Blood gas samples in glass samplers can be cooled Blood gas samples in glass samplers can be cooled Storing the sample at a lower temperature (0-4 °C) will slow down the metabolism by at least a factor of 10 [NCCLS] Storing the sample at a lower temperature (0-4 °C) will slow down the metabolism by at least a factor of 10 [NCCLS] Cool samples in an ice slurry or other suitable coolant Cool samples in an ice slurry or other suitable coolant Never store the sample s directly on ice as this causes hemolysis of the blood cells Never store the sample s directly on ice as this causes hemolysis of the blood cells NCCLS Document C27-A; Blood Gas Pre-Analytical Considerations: Specimen Collection, Calibrations and Controls; Approved Guideline 25 C 0-4 C pO2pO2 Time

40 Potential preanalytical errors Preparation prior to sampling Missing or wrong patient/sample identification Use of the wrong type or amount of anticoagulant - dilution due to the use of liquid heparin - insufficient amount of heparin - binding of electrolytes to heparin Inadequate stabilization of the respiratory condition of the patient Inadequate removal of flush solution in a-lines prior to blood collection

41 Sampling /handling Mixture of venous and arterial blood during puncturing Air bubbles in the sample Insufficient mixing with heparin Incorrect storage Hemolysis of blood cells Storage and transport Prep prior to transfer Visually inspect the sample for clots Inadequate mixing of sample before analysis Failure to identify the sample upon analysis

42 Mixture of venous and arterial blood When puncturing an artery it is important not accidentally to get the arterial blood mixed with venous blood This may, for instance, occur, if you hit a vein before locating the artery Even an admixture of a small amount of venous blood may significantly bias the results This is especially true of pO 2 and sO 2, but other parameters may also be affected Vei n Arter y 40 mmHg / 5.3 kPa 100 mmHg / 13.3 kPa

43 Mixture of venous and arterial blood In arteries the blood pressure is high enough to fill a self-filling syringe If a self-filling syringe does not fill it may be because a vein has been hit In that case a new sample should be taken Vein: Pressure rarely > 10 mmHg Artery: Systolic blood pressure normally > 100 mmHg

44 Inadequate removal of flush solution Flush solutions used in a- lines must be removed completely from the system to avoid a dilution of the blood sample It is recommended to withdraw a volume equal to three to six times the “dead space” of the catheter system (NCCLS)

45 Inadequate removal of flush solutions Sample B and A are both a-line samples taken from the same patient immediately after each other Sample B and A are both a-line samples taken from the same patient immediately after each other Before taking sample B only 1 mL of saline solution was removed - the tubing, however, looked red Before taking sample B only 1 mL of saline solution was removed - the tubing, however, looked red Before taking sample A saline solution was removed as recommended Before taking sample A saline solution was removed as recommended Sample A ctHb6.2 mmol/L cGlu9.6 mmol/L cK mmol/L cNa mmol/L cCa mmol/L cCl mmol/L pH7.271 pCO mmHg / 6.7 kPa pO mmHg / kPa Sample B ctHb4.6 mmol/L cGlu6.9 mmol/L cK mmol/L cNa mmol/L cCa mmol/L cCl mmol/L pH7.275 pCO mmHg / 4.8 kPa pO mmHg / 17.2 kPa

46 Air bubbles Any air bubbles in the sample must be expelled as soon as possible after the sample has been drawn before mixing the sample with heparin before any cooling of the sample Even small air bubbles may seriously affect the pO 2 value of the sample, normally resulting in increased values An air bubble whose relative volume is 0.5 to 1.0 % of the blood in the syringe is a potential source of a significant error

47 Effect of air bubbles - an example Sample A and B were taken from the same patient immediately after each other Sample A and B were taken from the same patient immediately after each other Sample A without air bubbles was analyzed immediately after collection Sample A without air bubbles was analyzed immediately after collection 100 µL air was added to sample B (1 mL). It was stored cold (0-4 °C) for 30 minutes and mixed for 3 minutes before sample analysis 100 µL air was added to sample B (1 mL). It was stored cold (0-4 °C) for 30 minutes and mixed for 3 minutes before sample analysis Sample A pO mmHg / 38.5 kPa (FIO ) Sample B pO mmHg / 33.8 kPa (FIO )

48 Insufficient mixing with heparin Insufficient mixing can cause coagulation of the sample Insufficient mixing can cause coagulation of the sample It is recommended to mix the blood sample thoroughly with heparin It is recommended to mix the blood sample thoroughly with heparin Invert the syringe 10 times and roll it between your palms Invert the syringe 10 times and roll it between your palms

49 Inadequate mixing - an example Sample A and B were taken from the same patient immediately after each other and stored cold for 10 minutes Sample A and B were taken from the same patient immediately after each other and stored cold for 10 minutes Sample A was mixed in a rotator (14 revolutions/min) for 3 minutes Sample A was mixed in a rotator (14 revolutions/min) for 3 minutes Sample B was mixed in a rotator (14 revolutions/min) for 1 minute Sample B was mixed in a rotator (14 revolutions/min) for 1 minute Sample B ctHb4.5 mmol/L Sample A ctHb 6.2 mmol/L

50 Hemolysis of blood cells The blood cells are relatively fragile, and therefore hemolysis may easily occur during blood sampling Hemolysis may, for instance, occur due to high filling pressure through a narrow entrance (e.g. during too vigorous sample aspiration, sample transfer to the analyzer, etc.) vigorous rubbing or squeezing of the skin during capillary sampling too vigorous mixing of the sample cooling down the sample below 0 °C

51 “The weak link” Blood gas analyzers of today are highly accurate Make sure that sample represents patient status The preanalytical phase is the weak link in the Patient Focus Circle Many potential errors Can be overcome by Training User guidelines Sampling products

52 Specimen Quality Markers for Rejection Clotted Clotted Hemolyzed Hemolyzed Underfilled, overfilled Underfilled, overfilled Insufficient quantity Insufficient quantity Incorrect labeling Incorrect labeling Unlabeled specimen Unlabeled specimen Incorrect patient Incorrect specimen Contaminated Lost sample Too old to process Broken and leaking

53 Finally… The human role in sample collection makes complete elimination of errors associated with laboratory testing unrealistic The human role in sample collection makes complete elimination of errors associated with laboratory testing unrealistic However, good practices and compliance with the new strategies for error prevention can lead to a substantial reduction in pre- analytical errors. However, good practices and compliance with the new strategies for error prevention can lead to a substantial reduction in pre- analytical errors.

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