Guidelines from the EP lab for accessing CHPS ECGs, Revised 5/11/2017
The eTRACK Billing Plan must be prepared/approved for all research studies requiring ECGs via the CHPS 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 CHPS resources, please contact the appropriate CHPS Core Director for a startup meeting prior to scheduling research subjects.
A CHPS application must be submitted via eResearch for CHPS Cardio Core services via eCHPS system; CHPS (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 CHPS Core. CHPS 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 CHPS nurses can do the ECG test. The CHPS 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 CHPS Resource Request and billing plan.
INSTRUCTIONS FOR ACCESSING CHPS ECGs IN CHPS CARDIOVASCULAR CORE FOR OUTPATIENTS
1) Make sure eTRACK reflects the ECG is being performed by the CHPS
2) Subjects are registered and scheduled in eTRACK
3) Study coordinator sends email each week to Anna May DeCerchio detailing upcoming CHPS ECGs needed (or calls 590-3181 if the ECG is the test is arranged "last minute") Email to Anna May DeCerchio identifies the CHPS project the subject(s) are on including: PI Name, Title of the study, CHPS Protocol Number, and subject demographic information needed for CHPS 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 CHPS census info for each subject to reflect ECG technical as well as professional services provided; invoicing done via CHPS 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. (CHPS staff will be trained to perform the ECG if it is a CHPS 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 CHPS) 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 CHPS study file and give it to Audrey Kamrin, CHPS Nurse Manager.
Administrative Note: If CHPS study, the CHPS staff will record in census that professional interpretation taking place for invoicing purposes.
INSTRUCTIONS FOR ACCESSING CHPS ECGs FOR INPATIENTS
1) Make sure the eTRACK billing plan reflects the ECG is being performed by the CHPS
2) An order for ECG must be placed in EPIC. In the order, complete the "Indications" section to PI Name, Title of project and CHPS 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 (CHPS Category "B"), study coordinator calls RAC to "arrive" subject.
5) If the subject is hospitalized for research only (CHPS 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: CHPS Nurse will complete CHPS census info for each subject to reflect ECG technical as well as professional services provided; invoicing done via CHPS administration (no CHCA forms sent).
Anna May DeCerchio: 215-590-3181 (ECG/MUSE Coordinator)
David Riffe: 215-590-1819 (ECG Lab Supervisor)
Meryl Cohen, MD: 215-590-3354 (CHPS Cardio Core Director)
John Krall: 267-425-1790 (CHPS Administrative Director)