Guidelines from the EP lab for accessing CTRC ECGs, Revised 12/8/2016
The eTRACK Billing Plan must be prepared/approved for all research studies requiring ECGs via the CTRC Cardiovascular Core. Research subjects must be registered and scheduled in eTRACK; go to the Clinical Trial Financial Management intranet site for eTRACK instructions. To log into eTRACK use your Active Directory User name and password.
*To utilize CTRC resources, please contact the appropriate CTRC Core Director for a startup meeting prior to scheduling research subjects.
A CTRC application must be submitted via eResearch for CTRC Cardio Core services via eCTRC system; CTRC (and IRB) final approval needed prior to use of the Core. ECGs will be provided by our Core during normal business hours Monday through Friday only. Investigators will have to make arrangements on their own. ECG interpretations are available for pediatric subjects via the CTRC Core. CTRC resource request should specify the need for interpretation services where necessary. At time of scheduling, specific request should be made if interpretation is not needed. ECGs using Sponsor's Equipment: If you will be using a Sponsored-supplied ECG machine, the CTRC nurses can do the ECG test. The CTRC is able to provide ECG interpretations if you require; you will be billed for the interpretations as well as the nurse time involved. The interpretations will have to be added to the CTRC Resource Request and billing plan.
INSTRUCTIONS FOR ACCESSING CTRC ECGs IN CTRC CARDIOVASCULAR CORE FOR OUTPATIENTS
1) Make sure eTRACK reflects the ECG is being performed by the CTRC
2) Subjects are registered and scheduled in eTRACK
3) Study coordinator sends email each week to Anna May DeCerchio detailing upcoming CTRC ECGs needed (or calls 590-3181 if the ECG is the test is arranged "last minute") Email to Anna May DeCerchio identifies the CTRC project the subject(s) are on including: PI Name, Title of the study, CTRC Protocol Number, and subject demographic information needed for CTRC reporting purposes to the NIH. These include: race, ethnicity, gender.
4) The Study PI has to place an ECG order in EPIC for Outpatient ECGs. Subjects will not be seen without the physician order. Study coordinator and subject go to the Cardiology Registration Desk. Once the registration is processed the study coordinator will pick up the Cardiology Face Sheet and labels, and proceed to ECG lab.
5) Anna May DeCerchio and/or David Riffe will inform the study coordinator when report is available for pick-up.
6) If an abnormal/critical ECG is identified the PI of the study will be notified.
7) The "original" and "confirmed" reports are given to the study coordinator. Anna May DeCerchio and/or David Riffe sends copy of "confirmed" report to Audrey Kamrin.
Administrative Note: Anna May will complete CTRC census info for each subject to reflect ECG technical as well as professional services provided; invoicing done via CTRC administration (no CHCA forms sent).
If an external ECG machine is being provided by the study sponsor, you are required to do the following:
1) The ECG machine must be submitted to the device committee to be evaluated and the approval letter will be submitted to Dave Riffe. Contact Andrew Rich, Director of Biomedical Engineering, at x41783 for details.
2) Outside ECG machines must be approved by Biomed department and have the appropriate Biomed label.
3) The coordinator must be trained by the company/industry and/or Dave Riffe. (CTRC staff will be trained to perform the ECG if it is a CTRC study).
4) If Dave Riffe is available, he will be present at the Site Initiation Visit and/or the training.
5) The coordinator will need to print 2 copies of the ECG:
a. One will be taken to the ECG lab and dropped off to Anna May DeCerchio or Dave Riffe who will assign it an EP doc to be read.
b. The other copy of the ECG will be placed in the clinic (or CTRC) chart
6) The ECG will be labeled by the coordinator with the following information (not to obstruct the ECG itself):
Study IRB Number
PI name and contact info- phone and pager.
Study Coordinator Name and contact info - phone and pager.
Technician # 000 (Dave Riffe will assign this #)
7) The attending EP cardiologist will sign, date and provide an interpretation
on the ECG; (timing of the reading depends on preliminary interpretation
done by the machine).
8) If an abnormal/critical ECG is identified the PI of the study will be notified. Anna May DeCerchio or David Riffe will contact the study coordinator when the final interpretation report is interpreted, signed and ready for pick up.
9) Study coordinator will need to make copy for CTRC study file and give it
to Audrey Kamrin, CTRC Nurse Manager.
Administrative Note: If CTRC study, the CTRC staff will record in census that professional interpretation taking place for invoicing purposes.
INSTRUCTIONS FOR ACCESSING CTRC ECGs FOR INPATIENTS
1) Make sure the eTRACK billing plan reflects the ECG is being performed by the CTRC
2) An order for ECG must be placed in EPIC. In the order, complete the "Indications" section to PI Name, Title of project and CTRC Number. Also note "BEDSIDE". The order will print out in Cardiology.
3) Subjects must be registered and scheduled in eTRACK
4) If the subject is hospitalized for standard of care purposes (CTRC Category "B"), study coordinator calls RAC to "arrive" subject.
5) If the subject is hospitalized for research only (CTRC Category "A"), subject does not have to be "arrived".
6) Anna May DeCerchio or David Riffe will inform the study coordinator when report is available for pick-up.
7) If an abnormal/critical ECG is identified the PI of the study will be notified.
8) "Confirmed" report is sent by Cardiology to Medical Records. David/Anna May will send Audrey Kamrin Face page and worksheets.
Administrative Note: CTRC Nurse will complete CTRC census info for each subject to reflect ECG technical as well as professional services provided; invoicing done via CTRC administration (no CHCA forms sent).
Anna May DeCerchio: x43181 (ECG/MUSE Coordinator)
David Riffe: x41819 (ECG Lab Supervisor)
Meryl Cohen, MD: x43354 (CTRC Cardio Core Director)
John Krall: x42215, x51790 (CTRC Administrative Director)