Russell County Hospital
Laboratory Department
Timeline of Troponin I Issues

September 2004 – Troponin I assay performed on Bayer ACS180SE.
Range: 0.0.35ng/ml (negative)
0.35-1.5ng/ml (intermediate)
>1.5ng/ml (positive for myocardial damage)

October 2005 – Troponin I assay moved to new instrumentation, Beckman Access II
Range: 0.00-0.04ng/ml (normal reference range)
0.05-0.49ng/ml (clinical risk assessment (CRA) indicated)
>0.50ng/ml (values >0.50ng/ml are consistent with AMI)

May 2005 – First medical staff meeting Dr. Lozano attended after being named new medical director. The medical staff had numerous questions and comments concerning the “new”
Troponin I range. Prior to MS meeting, Dr. Shane Rice had requested a report of all Troponin I results since new instrument in use. Discussion was primarily centered on adjustment of range.
MS felt the range was too sensitive. Dr. Lozano was to look into range issue and report back to
MS. Beckman was contacted concerning our issues with the range.

July 2005 – Dr. Lozano reported to medical staff that the new range was based on the new methodology, and was set by the manufacturer, thus not subject to change. RCH lab had verified that other laboratories using the same instrument were reporting on the same range that was recommended by the manufacturer.

November 2005 (11/29/05) – A patient of Dr. Gibson’s (Dr. Ibrahim was a surgical consult on this patient) was transferred to Audubon Hospital in Louisville, KY. After the patient was assessed at
Audubon for 48hrs, the cardiologist that was caring for the patient at Audubon determined that the patient had not had an AMI. RCH results for Troponin I had indicted an AMI (1.30ng/ml).
The Troponin I results at Audubon (drawn 12 hours later) were not positive for an AMI. Dr.
Ibrahim and Dr. Gibson discussed this issue with both Dr. Lozano and Lisa Johnson. Audubon
Hospital performs the Troponin I assay on a Dade Behring instrument. The reporting range is similar to our “old” range.

December 2005 – Beckman was contacted again concerning our issues with the Troponin I.
Beckman suggested that Dr. Merabet (a PhD who works for Beckman) come and provide more information and education (to offer CEU’s) for our medical staff. Dr. Lozano has contacted the cardiology group that serves RCH (Dr. Lash) and invited them to participate in the forum. We are in the process of finalizing this meeting. We are trying to work out a date to schedule. Dr.
Lozano has also discussed our Troponin I issues with Dr. Lash to get his opinion of this issue.

December 2005/January 2006 – After discussions with members of the medical staff and reviewing
Troponin I result data, we have noticed a “trend” in that we do seem to have a increased number of Troponin I results in the CRA range, particularly just right above the reference range (0.05,
0.06, 0.07ng/ml). This trend was noticed due to the sometimes inconsistent results with repeat testing.

January 2006 (1/5/06) – Dr. Lozano and Lisa Johnson contacted Jewish Hospital in Louisville, KY.
Spoke with Dr. Jevans. Jewish Hospital uses Beckman Access II analyzers to perform Troponin I.

Jewish Hospital was an alpha site for Beckman Coulter that helped develop the Troponin I assay that is performed on the Beckman Access II analyzers. The study for the normal reference range published by Beckman Coulter to be used on their Access II analyzers was done at Jewish
Hospital in Louisville. After discussing with Dr. Jevans our issues, he suggested we might have a specimen integrity issue. We collect our Troponin I samples in heparinized gel tubes and spin the sample for 5 minutes at 1300rpm’s. Dr. Jevans said that they had found that the use of gel tubes caused interferences with troponin, even though there was not enough data to support this for
Beckman to publish. He also said that they had much better results using ultracentrifugation
(13000rpm’s or greater) when processing the Troponin I samples. He suggested we change our collection tubes and processing method o help with the intermittent erratic results that we are seeing.

January 2006 (1/5/06) – Dr. Lozano met with Dr. Gibson concerning Troponin I prior to the medical staff meeting. Dr. Lozano and Lisa Johnson met with Mark Schagne, Beckman Coulter representative, concerning Troponin I issues.

January 2006 (1/5/06) - At the medical staff meeting, Dr. Lozano updated the medical staff concerning our ongoing Troponin I issues and our action plan on following up this issue.
1) Change collection tubes to plain (no gel added) heparinized tubes.
2) Purchase a Stat Spin (ultra) centrifuge to better process Troponin I samples.
3) Set up an inservice/meeting with Beckman’s PhD and a member of our cardiology group for the medical staff members.
4) Change report comment to the following:
The AMI cut off is 0.05 ng/ml
The normal reference range is 0.00-0.04ng/ml
Patients with skeletal muscle injury or renal failure may show levels as high as 0.18 or 0.25 ng/ml and thus results in the 0.05-0.49ng/ml range require clinical risk assessment (CRA).

January 2006 (1/5/06) – Started collecting Troponin I samples in non-gel heparinized tubes.
Requested quotes for purchase of an ultracentrifuge. Instructed laboratory staff to increase spin time to 10 minutes for processing Troponin I samples.

January 2006 (1/9/06) – Ordered Stat Spin 2 Express centrifuge. Expected delivery 1/25/06.

Currently in process –
1) Dr. Lozano developing new comments to add to Troponin I report format.
2) Awaiting dates to proceed with the meeting.
3) Possible development of a cardiac protocol for RCH.
Note: Throughout this time frame, the QC for Troponin I has been acceptable and the PT results have also been acceptable. We have had service look at the issue and have had 2 PM’s on the instrument during this time.