Result Authorisation – Correct or Not? Julie RYAN FAACB Chair SRAC AACB Healthscope Pathology

 Background Information  Staff Result Validation Training in Biochemistry  Competancy evaluation  Process of Continuing Education Welcome

 Pre Analytical Issues  Analytical Issues  Post analytical Issues  Focus on Potassium el al Plan of Action

 Right result  Right Sample  Right Patient  Right Time Result Authorisation

 Patient Identifiers  Sample Identifiers  Sample Suitability  Test suitability Pre Analytical Requirements

Example 1  75 y o female, in ward.  Date: 4,12 4,12 4,12  Time 03:00 06:00 08:35  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  Sample collected from IV site ? Dextrose infusion

Example 2  45 y o male, in ward.  Date: 27,3 27,3 26,3  Time 11:36 08:55 18:35  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  eGFR 79 >90 63 ml/min/1.73m2  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Sample collected from IV site. Hb Change from 143 to 109 g/L also.

Example 3  86 y o male, in ward.  Date: 5,12 5,12 5,12  Time 23:00 06:54 02:24  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Sample collected from IV site Mg infusion

Example 4  59 y o male, in ward.  Date: 21,11  Time 13:31  Sodium 164 ( ) mmol/L  Potassium >30.0 (3.5 – 5.2) mmol/L  Chloride 151 ( ) mmol/L  Bicarbonate 4 ( ) mmol/L  Urea >107 ( ) mmol/L  Creatinine >1000 ( ) umol/L   Sample specimen check - Urine

Example 5  64 y o Female, in ward.  Date: 14,04  Time 11:22  Sodium 125 ( ) mmol/L  Potassium 7.2 (3.5 – 5.2) mmol/L  Chloride 94 ( ) mmol/L  Bicarbonate 22 ( ) mmol/L  Urea 6.1 ( ) mmol/L  Creatinine 61 ( ) umol/L  TProtein 49 (60 – 80) g/L  Albumin 28 (35 – 50) g/L  Haemolysis 1+  Icterus 0  Lipaemia 3+   Sample specimen check – Intralipid Infusion

Example 6  55 y o male, in AE  Date: 14,4  Time 11:23  Sodium 143 ( ) mmol/L  Potassium 4.0 (3.5 – 5.2) mmol/L  Chloride 109 ( ) mmol/L  Bicarbonate 28 ( ) mmol/L  Urea 5.2 ( ) mmol/L  Creatinine 59 ( ) umol/L  Calcium 2.10 (2.10 – 2.60)mmol/L  Magnesium 0.69 (0.70 – 1.10)mmol/L  Phosphate 0.87 (0.80 – 1.40)mmol/L  Albumin 38 (35 – 50) g/L   Sample issue ?

Example 7  15 y o Female, in AE. Abdominal Pain  Date: 11,03  Time 14:15  Sodium 138 ( ) mmol/L  Potassium 10.7 (3.5 – 5.2) mmol/L  Chloride 105 (101 – 110) mmol/L  Bicarbonate 28 ( ) mmol/L  Urea 2.9 ( ) mmol/L  Creatinine 57 ( ) umol/L  Glucose 2.6 (3.5 – 8.0) mmol/L  Calcium 2.43 (2.10 – 2.60)mmol/L  Albumin 28 (35 – 50) g/L  BhCG <2.0 (0 – 5.0) IU/L  Haemolysis 1+  Icterus 0  Lipaemia 0

Example 8  41 y o Female, in AE.  Date: 15,12  Time 03:10  pH 7.13 (7.35 – 7.45)  pCO2 24 (35 – 45) mmHg  pO2 33 (101 – 110 mmol/L  Bicarbonate 8 ( ) mmol/L  Sodium 138 (135 – 145) mmol/L  Potassium 4.5 (3.5 – 5.20 umol/L  Chloride 111 (101 – 110) mmol/L  Glucose 27.0 (3.5 – 8.0) mmol/L  Cooximetry no results  Sample specimen check – Lipaemic Sample

Example 8  41 y o Female, in AE.  Date: 15,12  Time 03:10  Sodium 133 ( ) mmol/L  Potassium 4.2 (3.5 – 5.2) mmol/L  Chloride 104 ( ) mmol/L  Bicarbonate 8 ( ) mmol/L  Urea 4.2 ( ) mmol/L  Creatinine 81 ( ) umol/L  TProtein 46 (60 – 80) g/L  Albumin 36 (35 – 50) g/L  Haemolysis 1+  Icterus 0  Lipaemia 4+   Sample specimen check – Lipemia

 Order of Draw  Correct Tube use  Site of Collection  Sample Mixing Post Collection Sample Collection

Sample Tube Result Variation

 Due to Instrument Failure  Due to Sample preparation issues  Due to Calibration issues  Due to QC issues Analytical Issues

Example 1  49 y o Female, in AE.  Date: 29,01 29,01  Time 10:01 09:38  pH * (7.35 – 7.45)  pCO * (35 – 45) mmHg  pO * (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose (3.5 – 8.0) mmol/L  Lactate (<1.3) mmol/L  iCalcium (1.15 – 1.27)mmol/L   Sample speciman check – * Clot Detected in Sample

Example 2  81 y o Male, in AE.  Date: 30,11 30,11  Time 00:40 03:46  pH (7.35 – 7.45)  pCO (35 – 45) mmHg  pO (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose (3.5 – 8.0 mmol/L  Lactate (<1.3) mmol/L  Haemoglobin (117 – 174) g/L  Haematocrit  Sample Speciman check – Mixing of Sample

Example 3  66 y o Female, in ICU.  Date: 01,03 01,03  Time 17:54 07:56  pH (7.35 – 7.45)  pCO (35 – 45) mmHg  pO (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium < (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose < (3.5 – 8.0) mmol/L  Lactate (<1.3) mmol/L  Haemoglobin (117 – 174) g/L   Sample Speciman check – Gas taken from IV site

Example 4  86 y o male, in ward.  Date: 03,06 03,06  Time 23:00 10:45  Sodium 133 ( ) mmol/L  Potassium 4.4 (3.5 – 5.2) mmol/L  Chloride 98 ( ) mmol/L  Bicarbonate 28 ( ) mmol/L  Urea 5.4 ( ) mmol/L  Creatinine 59 ( ) umol/L  Calcium (2.10 – 2.60)mmol/L  Magnesium 0.82 (0.70 – 1.10)mmol/L  Phosphate 0.98 (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Instrument Error. Sample Repeated

Example 5  42 y o Male, in ICU.  Date: 21,01 21,01 21,01  Time 01:56 01:49 01:33  pH (7.35 – 7.45)  pCO (35 – 45) mmHg  pO (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose (3.5 – 8.0) mmol/L  Lactate (<1.3) mmol/L  Haemoglobin (117 – 174) g/L   Blood Gas Repeated ? Why

Example 5  42 y o male, in ICU.  Date: 21,01 21,01 21,01  Time 01:30 22:30 20:15  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  eGFR ml/min/1.73m2  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Post AAA Transfusion Packed Cells.

 15/09/2010 Results as follows:  Digoxin3.1nmol/L(0.6 – 1.0)  16/09/2010:  Digoxin>7.5nmol/L(0.6 – 1.0)  Rx with Digibind Example 6

 Reference Intervals  Reporting Format  Collection Details Post Analytical Issues

Example 1  81 y o Male, in ICU.  Date: 30,01 30,01 30,01 30,1  Time 13:56 12:49 10:33 09:43  pH (7.35 – 7.45)  pCO (35 – 45) mmHg  pO (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose (3.5 – 8.0) mmol/L  Lactate (<1.3) mmol/L  Haemoglobin (117 – 174) g/L   Blood Gas Repeated Note pH K Lactate & Hb changes

Example 2  81 y o male, in ICU.  Date: 27,06 27,06 26,06  Time 23:50 03:50 20:15  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  eGFR 79 >90 63 ml/min/1.73m2  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Report Printed 27,06 09:55

Example 2  81 y o male, in ICU.  Date: 27,06 26,06 26,06  Time 03:50 23:50 20:15  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  eGFR > ml/min/1.73m2  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  Albumin (35 – 50) g/L   Report in Correct order

 Pre Analytical Issues  Important Analyte  Critical values Potassium

 Venepuncture technique  Sample Container appropriate  Transport at correct temperature  Storage at correct temperature Pre analytical Issues K

 Due to Instrument Failure  Due to Sample preparation issues  Due to Calibration / QC issues  Due to Patient Conditions Analytical Issues K

Example 1  79 y o male, in AE.  Date: 7,06 21,05 20,05  Time 09:50 13:50 10:15  Sodium ( ) mmol/L  Potassium (3.5 – 5.2) mmol/L  Chloride ( ) mmol/L  Bicarbonate ( ) mmol/L  Urea ( ) mmol/L  Creatinine ( ) umol/L  Calcium (2.10 – 2.60)mmol/L  Magnesium (0.70 – 1.10)mmol/L  Phosphate (0.80 – 1.40)mmol/L  AST (35 – 50) g/L   HAEMOLYSED 4+

Example 2  80 y o male, in AE  Date: 15,10  Time 07:23  Sodium 150 ( ) mmol/L  Potassium 9.7 (3.5 – 5.2) mmol/L  Chloride 114 (101 – 110) mmol/L  Bicarbonate 19 ( ) mmol/L  Urea 42.2 ( ) mmol/L  Creatinine 386 ( ) umol/L  Calcium 2.19 (2.10 – 2.60)mmol/L  Magnesium 1.18 (0.70 – 1.10)mmol/L  Phosphate 3.58 (0.80 – 1.40)mmol/L  Albumin 33 (35 – 50) g/L  CRP (<8) mg/L  Haemolysis 3+  Sample Intravascular Haemolysis and Renal Impairment. Hb drop from 105– 64g/L

Example 3  43 y o male, in ICU.  Date: 21,01 20,01  Time 01:01 23:38  pH (7.35 – 7.45)  pCO (35 – 45) mmHg  pO (101 – 110 mmol/L  Bicarbonate ( ) mmol/L  Sodium (135 – 145) mmol/L  Potassium (3.5 – 5.20 umol/L  Chloride (101 – 110) mmol/L  Glucose (3.5 – 8.0) mmol/L  Lactate (<1.3) mmol/L  Haemoglobin (115 – 170) g/L   Patient Post Transfusion

Example 4  80 y o male, in AE  Date: 16,02  Time 09:23  Sodium 144 ( ) mmol/L  Potassium 6.6 (3.5 – 5.2) mmol/L  Chloride 112 (101 – 110) mmol/L  Bicarbonate 20 ( ) mmol/L  Urea 33.4 ( ) mmol/L  Creatinine 276 ( ) umol/L  eGFR 18 ( >90 )  Calcium 2.19 (2.10 – 2.60)mmol/L  Phosphate 2.58 (0.80 – 1.40)mmol/L  Albumin 29 (35 – 50) g/L  CRP 461 (<8) mg/L  WCC ( 4.0 – 11.0) x10^9/L  Sample High WCC. Serum Used

Example 7  48 y o Female, in AE. Muscle Weakness  Date: 28,08  Time 08:55  Sodium 139 ( ) mmol/L  Potassium 1.8 (3.5 – 5.2) mmol/L  Chloride 104 (101 – 110) mmol/L  Bicarbonate 22 ( ) mmol/L  Urea 0.4 ( ) mmol/L  Creatinine 91 ( ) umol/L  Calcium 1.83 (2.10 – 2.60)mmol/L  T Protein 49 (60 – 80) g/L  Albumin 23 (35 – 50) g/L  Lactate 9.3 ( 0.5 – 2.2) IU/L  Haemolysis 0   Patient with Anorexia Nervosa

Example 8  52 y o Female, in AE.  Date: 26,08  Time 09:55  Sodium 125 ( ) mmol/L  Potassium 2.0 (3.5 – 5.2) mmol/L  Chloride 74 (101 – 110) mmol/L  Bicarbonate 35 ( ) mmol/L  Urea 3.8 ( ) mmol/L  Creatinine 68 ( ) umol/L  T Protein 57 (60 – 80) g/L  Albumin 30 (35 – 50) g/L  T Bilirubin 30 ( <18 ) umol/L  GGT 391 ( <40 ) U/L  Haemolysis 0   Patient with Vomiting

 Urine Spot  Na <10 mmol/L  K 7.0 mmol/L  Cl <15 mmol/L Example 8

 Presentation a first look at Issues in Authorisation  Provide some guidance about the common pitfalls of result verification  Comparison with healthy patient results an invaluable tool  Understanding of the processes involved in result production in the Biochemistry Laboratory  All working towards: Final Comments

 Right result  Right Sample  Right Patient  Right Time Final Comments

 Many thanks to the numerous people who have assisted in training Biochemists throughout the industry  This includes representatives from the RCPA, AACB, various companies who produce and maintain the complex instrumentation used, and also the Educational Institutions providing graduates to staff Laboratories  All invaluable to the Industry Acknowledgements