Troponin I testing in a Level 1 Pediatric Trauma CenterKerstin Halverson BA, MSPoint of Care Coordinator

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Children’s disclaimer

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• Kerstin Halverson• Have documented that they have no financial

relationships to disclose or Conflicts of Interest (COIs) to resolve.

AACC Disclosure

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Point of Care Testing

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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

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Children’s Hospitals and ClinicsMinneapolis

St. Paul

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• 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

Level 1 Trauma

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• 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

Level 1 Trauma

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• Current testing scenario: a send out test

• 3 hour TAT just to get the result back

Current Situation

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Where to Start?• Literature review of cTnI in a pediatric population

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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

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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

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Finding a Solution• Needed cTnI result

−Quick

− Reliable

− Trusted

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• 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

Finding a Solution

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• 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

POCT instrument choice

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Precision

Obs Standard Dev (SD) 0.157Pass/Fail/Uncertain Yes95% Confidence for Obs SD 0.126 to 0.209Obs Coef of Variation (CV) 5.8%Obs Mean 2.718 ng/mLNumber of Specimens (N) 32 of 3295% CI for Obs Mean 2.661 to 2.774Obs 2 SD Range 2.403 to 3.032

Precision Statistics

SD

0.25

0.2

0.15

0.1

0.05

0

Goal: 0.25 ng/mL

Obs Standard Dev (SD) 0.031Pass/Fail/Uncertain Yes95% Confidence for Obs SD 0.025 to 0.042Obs Coef of Variation (CV) 6.5%Obs Mean 0.481 ng/mLNumber of Specimens (N) 32 of 3295% CI for Obs Mean 0.469 to 0.492Obs 2 SD Range 0.418 to 0.543

Precision Statistics

SD

0.25

0.2

0.15

0.1

0.05

0

Goal: 0.25 ng/mL

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Calibration Verification

TargetMeasured ValuesRange Midpoint Accuracy

(1)Rpt. Range

(2)

1 0.34 to 0.64 0.49 0.44 0.41 0.43 0.45 Pass Pass2 1.80 to 3.34 2.57 2.79 2.83 2.40 2.89 Pass --3 15.50 to 40.86 28.18 28.45 28.80 28.52 26.10 Pass Pass

(1) Accuracy passes if all measured values lie within the Target Range. 'x' indicates an excluded result.

Statistical Analysis and Experimental Results

Assigned (ng/dL)302520151050

Mea

sure

d (n

g/dL

)

30

25

20

15

10

5

0 Acceptable Range

Scatter Plot

Assigned (ng/dL)302520151050

Perc

ent R

ecov

ery

130

120

110

100

90

80

70 Acceptable Range

Percent Recovery

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Normal Reference IntervalReference Interval

Proposed 0 to 0.08 ng/mLResults (Total/Excl) 20 / 0Max/Obs outside 10.0% / 0.0%Passes Yes

Interval Percent Count< 0.00 0 00.00 60 120.01 35 7

0.02-0.03 5 10.04-0.05 0 0

0.06 0 00.07 0 00.08 0 0

> 0.08 0 0

Results Distribution

Statistical AnalysisMean 0.004 ng/mLSD 0.006Median 0.000Range 0.00 to 0.02C %

ng/mL

< 0.00 0.00 0.01 0.02-0.03

0.04-0.05

0.06 0.07 0.08 > 0.08

Per

cent

80

60

40

20

0

Reference Interval Histogram

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• 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

Training and Go-Live

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Standardized Protocol• Because no external pediatric reference range data

was available, the verified adult reference range of 0.00-0.08ng/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

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• 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%

Standardized Protocol

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• 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”

Standardized Protocol

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Post-Implementation Data• Chart review since implementation of testing in both

EDs• Data collected monthlyMethodology Charts

reviewedEligible 182Data incomplete

2

Outside Age Criteria

17

Total Charts Reviewed

201

DemographicsAve Age 13Median Age 14.88 (0-18.83)Std Dev 4.77Male n(%) 105 (58)Female n(%) 77 (42)Total 182

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• Chart review tallied up numbers of tests performed:

Post-Implementation Data

First cTnI Check (+) Myocardial Disease

(-) Myocardial Disease

Total

Positive test 25 6 31Negative test 11 140 151Total 36 146 182

Second cTnI Check

(+) Myocardial Disease

(-) Myocardial Disease

Total

Positive test 19 0 19Negative Test 2 41 43Total 21 43 64

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• 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)

Post-Implementation Data

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• 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

Post-Implementation Data

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• For First cTnI Measurement:

Post-Implementation Data

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%

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• For Second cTnI Measurement:

Post-Implementation Data

Sensitivity 90.48%Specificity 100.00%False Positive Rate 0.00%False Negative Rate 9.52%Positive Predictive Value 100.00%Negative Predictive Value 95.56%

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Emerging Trends

010203040506070 66

27

815 14

5 715 9Pe

rcen

t

Presenting complaint

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Emerging Trends

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101214161820 19

9 10

42 2

710

8 8

Perc

ent

History

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Emerging Trends

0102030405060708090

100 9381

37

16 13 9

48

100

Perc

ent

Other Tests Performed

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Emerging Trends

02468

101214161820 18

8

14

19

2

11

1 2 1 25

13

7

20

Perc

ent

Final Diagnosis

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• 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

Unexpected Findings…

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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

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• 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.

Conclusions

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• 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

Summary

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

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• Besides cardiac, which of the following diagnoses were most commonly seen for pediatric patients presenting with chest pain?

a) GERD/GIb) Musculoskeletalc) Pneumonia/Asthmad) Trauma

Self-Assessment Question: