Breakout Session C: Harmonisation of the Alert Table.
RCPA-AACB High Risk Results Working Party Andrew Georgiou Craig Campbell Grahame Caldwell Hans Schneider Penelope Coates Que Lam Rita Horvath Robert Flatman
Alert Table is a list containing: Critical Tests Alert thresholds for Critical-Risk and Significant- Risk Results Laboratories and Clinicians must be confident that these results require notification for timely clinical action. Common goal and common tests lend themselves to Harmonisation. Beyond Harmonisation; evidence-based.
Points of discussion Alert Table must be solid enough to resist customisation. Individual variations are unworkable for the laboratory, and for clinicians who use multiple laboratory services. Choice of analytes & thresholds must be evidence-based. We need to state the source and strength of the evidence. Can we have one value for all methods? Start with analytes with AACB Common Reference Intervals We can t be too simplistic; what conditions do we need to consider? Inpatients vs. Community patients, after hours vs. working hours, patient groups (pregnancy, paediatric), refer to clinical notes, serum vs. plasma. Do we need to be pragmatic? Do we want to look at every analyte abnormality? Should we start with a small list and look to expand later?
Published 12 th April 2015
Risk Management (CLSI GP47) Hazard Identification Risk Analysis Risk estimation Risk Evaluation Risk Control Analyte value Potential harm associated with result Clinical intervention that can reduce the risk of harm Probability: Is there reasonable likelihood of harm in absence of intervention? Severity: Is there reasonable likelihood of severe damage if harm occurs? Urgency: Is immediate intervention necessary to reduce risk of harm? Risk of Process Failure: Is there reasonable likelihood that routine reporting would not permit timely intervention? Is the risk of process failure greater than the clinically acceptable risk, given the estimation of potential harm? Category of abnormal result (critical risk vs. significant risk)
Hierarchy of Evidence Strength of Evidence Laboratory AND clinicians Laboratories OR clinicians Level 1 alert thresholds established by clinical outcome studies 1A 1B Source of Data Level 2 Level 3 Level 4 alert thresholds recommended by professional bodies alert thresholds from surveys of laboratories or clinicians alert thresholds reported by individual institutions 2A 3A 4A 2B 3B 4B Notes 1. Number of studies classification is based on should appear after the classification in ().
Elements of the Alert Table Displayed on Alert Table: Analyte Sample type Alert threshold (including delta) values Clinical setting Accompanying information for laboratory: Risk (potential harm) of this result Probability of Harm Immediacy of Intervention Time to Escalation Level of Evidence Source Strength of Evidence
Laboratory abnormalities identified as High Risk. C. Campbell and consensus. (sample type is serum/plasma unless specified) Potassium Potassium Sodium Sodium Glucose Glucose Calcium(Total) Calcium (Ionised) Calcium (Total) Calcium (Ionised) Magnesium Magnesium Phosphate Phosphate creatinine Urea Uric Acid in Pregnancy CK Cortisol CRP Bicarbonate Bicarbonate ph ph po2 pco2 Lactate Lipase Albumin ALT Ammonia Digoxin Lithium Carbamazepine Phenytoin Gentamicin (pre-dose) Paracetamol Valproate Vancomycin Bilirubin (Total) in neonate Bilirubin (Direct) in neonate freet4 freet4 TSH TSH iron in child iron in adult Urine Total Protein in Pregnancy Triglycerides Troponin Vitamin B12
The Plan Review evidence Define thresholds Ask laboratories if they agree Compare to current list Look at potential rates of notification. Ask clinicians if they agree Does this fit with clinical practice. Seek endorsement from laboratory and clinical groups
Summary Analyte Threshold Notes Sodium Sodium Potassium Potassium >155 mmol/l <120 mmol/l >6.2 mmol/l <2.5 mmol/l Calcium (Total) </= 1.9 mmol/l (corrected T Ca if Alb >20 g/l) Calcium (Ionised)?<0.85 mmol/l Calcium (Total) 3.0 3.4 mmol/l (corrected T Ca if Alb >20 g/l) Calcium (Total) >/= 3.5 mmol/l (corrected T Ca if Alb >20 g/l) Calcium (Ionised) Glucose >1.55 mmol/l <2.5 mmol/l Phenytoin > 25 mg/l trough egfr or Creatinine <12 ml/min/1.73m2 Or M>450, W>350 umol/l Creatinine >150 umol/l woman 15-45 years or child. Creatinine > 150 umol/l & > 50% increase over previous result. Previous result available
Summary of discussions Please read the WP recommendations document Cut down list for most frequent analytes initially Involving other areas of the lab and clinicians using our results POC challenges who is responsible for escalation/communication Do they understand pitfalls (e.g. K and haemolysis) IT flagging of critical risk results on reports
Summary Alert Table design Choice of Tests/abnormalities Hierarchy of Evidence Review of Evidence Clinical consultation Laboratory consultation Endorsement