Troponin I testing in a Level 1 Pediatric Trauma Center. Kerstin Halverson BA, MS Point of Care Coordinator

Transcription

1 Troponin I testing in a Level 1 Pediatric Trauma Center Kerstin Halverson BA, MS Point of Care Coordinator

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3 AACC Disclosure Kerstin Halverson Have documented that they have no financial relationships to disclose or Conflicts of Interest (COIs) to resolve

4 Point of Care Testing

5 Objectives Describe implementation of Troponin I (ctni) testing in a pediatric hospital system Describe standardized clinical practice guidelines developed for ctni testing Discuss post-implementation experience and impact on pediatric clinical care

6 Children s Hospitals and Clinics Minneapolis St. Paul

7 Level 1 Trauma Children s began looking at the steps needed to become a Level 1 Trauma center in 2009 United Healthcare gave a $17.5 million dollar gift to Children s in 2010, earmarked to help with readiness activities for Level 1 Trauma designation Children s received designation as a Pediatric Level 1 Trauma Center in 2013, becoming 1 of 2 hospitals designated as such in Minnesota

8 Level 1 Trauma Many changes were implemented to achieve this distinction: Ensuring we had properly trained staff available 24/7/365 Expanding available hospital services - surgery Expanding the ambulance bay Building a helipad Ancillary service availability 24/7/365 One test that was requested: Troponin I

9 Current Situation Current testing scenario: a send out test 3 hour TAT just to get the result back

10 Where to Start? Literature review of ctni in a pediatric population

11 Finding a Solution Essentially a lack of evidence regarding ctni reporting in pediatric and neonatal patients Implementing it wasn t going to be as simple as implementing a glucose test The trauma development team requested it

12 Finding a Solution A team was created which included POCT Technical Specialist Medical Director of POCT Cardiologists Emergency Room Physicians Neonatologists Critical Care Intensivists Laboratory Information Systems Supervisor Respiratory Therapy A Troponin expert

13 Finding a Solution Needed ctni result Quick Reliable Trusted

14 Finding a Solution Options: In house, the current chemistry analyzer was too old On track to be replaced soon, but not soon enough Purchase a stand alone instrument and interface it Deemed too expensive Utilize instrumentation already in place (istat) with experienced operators Only expense/outlay was cartridge cost and additional minimal training

15 POCT instrument choice Worked with our vendor and outside experts to devise a method validation protocol in order to meet standards and requirements: 20 day QC check Calibration Verification Normal Reference Interval Study

16 Precision Precision Statistics SD Goal: 0.25 ng/ml Obs Standard Dev (SD) Pass/Fail/Uncertain Yes 95% Confidence for Obs SD to Obs Coef of Variation (CV) 6.5% Obs Mean ng/ml Number of Specimens (N) 32 of 32 95% CI for Obs Mean to Obs 2 SD Range to Precision Statistics SD Goal: 0.25 ng/ml Obs Standard Dev (SD) Pass/Fail/Uncertain Yes 95% Confidence for Obs SD to Obs Coef of Variation (CV) 5.8% Obs Mean ng/ml Number of Specimens (N) 32 of 32 95% CI for Obs Mean to Obs 2 SD Range to

17 Calibration Verification 30 Scatter Plot 130 Percent Recovery Measured (ng/dl) Percent Recovery Acceptable Range Assigned (ng/dl) Acceptable Range Assigned (ng/dl) 30 Statistical Analysis and Experimental Results Target (1) Range Midpoint Measured Values Accuracy (2) Rpt. Range to Pass Pass to Pass to Pass Pass (1) Accuracy passes if all measured values lie within the Target Range. 'x' indicates an excluded result

18 Normal Reference Interval Reference Interval Proposed 0 to 0.08 ng/ml Results (Total/Excl) 20 / 0 Max/Obs outside 10.0% / 0.0% Passes Yes Results Distribution Interval Percent Count < > Statistical Analysis Mean ng/ml SD Median Range 0.00 to 0.02 C % Reference Interval Histogram Percent < ng/ml >

19 Training and Go-Live Respiratory staff (RT), ED RNS and EMT training included: Differences of running the ctni cartridge as compared to the other cartridges already in use Proper sample collection Proper sample introduction technique Operation of the cartridge Only the istats in Emergency Department (ED), Cardio-Vascular Care Center (CVCC), Lab and Pediatric Intensive Care Unit (PICU) were validated for ctni cartridge use

20 Standardized Protocol Because no external pediatric reference range data was available, the verified adult reference range of ng/mL would be utilized, as this represents 99% of healthy adults We began performing ctni testing in house on the istat point of care analyzer as a diagnostic test to look for acute changes over time (0,6 hours), as well as for chronic elevations

21 Standardized Protocol As a result, ctni testing would no longer be a send out test, resulting in significantly improved turn around time and minimal use of blood for testing The istat ctni method is not as analytically sensitive as some laboratory instrumentation and may have a false negative rate of 15% at initial draw (time 0). At 6 hours, the negative predictive value is 99% and the sensitivity of the assay increases to over 90%

22 Standardized Protocol If there is sufficient clinical suspicion to obtain ctni, a second level at 6 hours is strongly recommended A physician override will be required in order to cancel the 6 hour level In conclusion, ctni is strongly recommended to be ordered minimally at 0 and 6 hours. Please contact Children s Cardiology for further recommendations or questions

23 Post-Implementation Data Chart review since implementation of testing in both EDs Data collected monthly Methodology Charts reviewed Eligible 182 Data incomplete Outside Age Criteria Total Charts Reviewed Demographics Ave Age 13 Median Age ( ) Std Dev 4.77 Male n(%) 105 (58) Female n(%) 77 (42) Total

24 Post-Implementation Data Chart review tallied up numbers of tests performed: First ctni Check (+) Myocardial Disease (-) Myocardial Disease Positive test Total Negative test Total Second ctni Check (+) Myocardial Disease (-) Myocardial Disease Positive test Negative Test Total Total

25 Post-Implementation Data Appropriate use of guideline for testing ctni levels: 87 (47.80%) first level done >6 hours from onset of symptoms 64 (35.16%) repeat done appropriately per guideline 31 (17.03%) no repeat done, despite presentation <6 hours from onset of symptoms (inappropriate based on history)

26 Post-Implementation Data Of the 64 patients who had repeat testing, 19 had positive tests indicating myocardial injury Of the 31 without repeat testing, 15 had clear diagnosis without myocardial disease 5 patients did return to the ED, but only 1 returned with the same complaint, which was cardiac related, but not myocardial injury for either visit No patients had adverse outcomes despite 2 false negative results

27 Post-Implementation Data For First ctni Measurement: Sensitivity 69.44% Specificity 82.97% False Positive Rate 4.11% False Negative Rate 30.56% Positive Predictive Value 80.65% Negative Predictive Value 92.72%

28 Post-Implementation Data For Second ctni Measurement: Sensitivity 90.48% Specificity % False Positive Rate 0.00% False Negative Rate 9.52% Positive Predictive Value % Negative Predictive Value 95.56%

29 Emerging Trends Presenting complaint Percent

30 Emerging Trends History Percent

31 Emerging Trends Other Tests Performed Percent

32 Emerging Trends Percent Final Diagnosis

33 Unexpected Findings There is a group of chemotherapy drugs called Anthracyclines (IE Daunorubicin and Adriamycin), which are used to treat Leukemia, Lymphoma and some solid tumors that can have immediate & serious affects on the heart while treatment is being given Since ctni is only performed as POCT, choreographing the need to have a patient drawn and a ctni run took a bit of work with RT and phlebotomy to create a process that would work

34 Conclusions Overall compliance to protocol: Based on our chart review, the majority of pediatric patients experience chest pain symptoms >6 hours before arrival The vast majority of patients have had prolonged symptoms hours to days prior to testing, and therefore a follow-up ctni test is not indicated Providers should continue to be encouraged to check a 6 hour post symptom onset ctni level or document if the onset of symptoms is more than 6 hours from the time of initial draw to increase specificity and positive predictive value of this test in the pediatric population

35 Conclusions Troponin measurement in pediatric populations is not seeking myocardial damage from coronary artery disease Diagnoses sought are more likely infectious myocarditis, post arrest myocardial injury, post operative myopericarditis and traumatic myocardial disease Nevertheless, ctni is a useful test in evaluation of pediatric chest pain, especially if used as the adult guideline suggests with a 6 hour follow up

36 Summary We will continue to monitor for evidence of the 6 hour follow up test or documentation of why it is not obtained Use of ctni in the ED has increased since we brought it in house; however only by about 17% Use of the ctni test in house has not shown to have a significant effect on a decrease in length of stay in the ED, but it does help in screening for cardiomyopathy, myocarditis, trauma and cardiorespiratory damage in a pediatric environment

37 Thank you! Dr. Greg Wright Dr. Robert Sicoli Dr. Fred Apple Danyel Olson Dr. Kristin Mascotti Dr. Donna Milner

38 Self-Assessment Question: Besides cardiac, which of the following diagnoses were most commonly seen for pediatric patients presenting with chest pain? a) GERD/GI b) Musculoskeletal c) Pneumonia/Asthma d) Trauma