STS Intermacs and Pedimacs

1. STS Intermacs and Pedimacs Web-based Data Entry Training

2. Logging Inwww.uab.edu/medicine/intermacs/ The User’s Guide for Intermacs (Appendix M) and Pedimacs (Appendix N) User’s Guides provide step by step instructions for each field and may be found here Click ‘Ctrl + F’ to quickly ‘Find’ a term or form in the User’s Guide. Log in to the system here

3. Reset Password Reset your password by clicking here

4. Screening a Patient-Adding a PatientSee User’s Guide section 2.1Refer to Appendix K for a device brand list of included and excluded devices. Click here to be guided through the questions to determine if patient is included or excluded in the database.

5. Screening a Patient-Screening Log FormSee User’s Guide section 2.1 If patient is included, save the form and the system will guide you to the demographics form next. Data entry tip: Heartmate 3 implants for commercial use for all indications are to be entered in Intermacs as of 8/28/17. Data entry tip: If a patient is implanted as a child and entered in Pedimacs, they will continue being followed in Pedimacs unless they receive a new implant as an adult. The new implant would be entered in Intermacs. If the patient is excluded, a few required questions will need to be completed before the form can be saved.

6. DemographicsSee User’s Guide section 2.2 Data Entry Tip: The patient’s HICN is the Medicare number issued by CMS. If the patient does not have one or your center does not allow you to report it for privacy reasons, select ‘unknown’.

7. Pre-Implant Form-Navigating the FormsSee User’s Guide section 2.3 The sections of the form that have been completed have a green check mark next to them. Submit form at the bottom is not available until each section of the form is complete and has a green check by it.

8. Pre-Implant FormSee User’s Guide section 2.3 Data entry tip: If the patient had a prior LVAD, RVAD, TAH, or ECMO – please select the appropriate box here. This would include any temporary devices.

9. Pre-Implant FormSee User’s Guide section 2.3 Data entry tip: Answer yes only if this is the first FDA-approved durable device that has been implanted in this patient. Otherwise, answer no. Data entry tip: For patients who have had an exchange and do not fit exactly into any of the profiles, please select the profile that most closely reflects the patient’s status while they were on the device before the exchange.

10. Pre-Implant Form-MedicationsSee User’s Guide section 2.3 Data entry tip: Only select currently using if the patient was taking the medicine the day of implant. Data entry tip: For outpatient (prior to admission) inotrope infusion: Answer yes if the patient was on an inotrope infusion at any time within the pre-implant window of 60 days before the implant. Otherwise, answer no.

11. Pre-Implant Form-Submitting a FormSee User’s Guide section 2.3 Once all the sections of the form are completed (they all have green check marks next to them), the submit option becomes available. Select Submit Form to complete this form.

12. Implant FormSee User’s Guide section 2.4 Data Entry Tip: Carefully check the device type and implant date before submitting this form. One common error is to select LVAD alone or to enter LVAD and RVAD as separate implants. Select BIVAD as device type if both and LVAD and an RVAD were implanted during the same surgery. Another common error is entering the wrong implant date. The implant date and device type fields need to be accurate because follow-up form information is based off of these key fields. Errors in these fields are not easily corrected.

13. Implant FormSee User’s Guide section 2.4 Data Entry Tip: Record the time the patient left the operating room as the end of surgery time if the chest was left open. Data Entry Tip: Answer yes if total cross clamp used, not partial cross clamp.

14. Follow-Up DatesSee User’s Guide section 2.5 and 2.6If patient seen in hospital or outpatient within the date range, complete follow-up form with all available information. See examples below in blue. If patient was not seen during the date ranges above, select unable to obtain follow-up and enter reason.

15. Follow-Up Zone InformationIf the patient was seen within the date range described in previous slide, use these guidelines for determining what information to include on the follow-up form.

16. 1 Week and 1 Month Follow-UpSee User’s Guide section 2.5 Answer yes if intubated at any time after leaving the OR. If extubated in the OR and no reintubation required before 1 week follow-up, answer no.

17. 1 Week and 1 Month Follow-UpSee User’s Guide section 2.5 Answer yes to this question if alarms are accompanied by physical signs and symptoms or findings (hematuria, elevated plasma-free hemoglobin, arrhythmias, other patient symptoms, etc.). Answer no for low flow or power spike alarms if the patient is asymptomatic with no other abnormal test findings. ‘Save for later’ can be used when you are interrupted when entering data and want to save the information you have entered, but you are not completely finished with the form and need to come back to it to complete. ‘Validate and Save’ can be used when you have entered everything needed on the form, validate and save must be used before you can submit a form. If you are changing any information on a form that has already been submitted, you will need to ‘validate and save’ any changes made in order to update the form.

18. 3 Month and 6 Month Follow-UpSee User’s Guide section 2.6 Answer yes if the patient was on the medicine considering all time since previous visit to the current follow-up date (this includes prn medications). Data entry tip: If patient is on more than 1 diuretic or varying doses (Example: at one week follow-up, patient was given both Lasix and Bumex, Bumex 4.5mg one day, 4.0mg the next day, Lasix 20mg one day and then d/c’d thereafter.) Average the doses of all the Bumex. Since patient was not on Lasix at time of 1 week visit and only had one dose, do not include the Lasix in the average because the Bumex was taken more regularly.

19. Follow-Up - Hemolysis Zone ScenarioSee User’s Guide section 2.6

20. Data entry tip: If a patient has returned to the OR multiple times for irrigation & debridement - on the Implant Discharge Form, please mark Surgical Procedures – Other. Then scroll down to Other Procedures and check Other, Specify. In the text box specify how many times the patient went to the OR for washout and debridement. Implant DischargeSee User’s Guide section 2.7 Reminder: When completing the implant discharge form and the patient has reached an endpoint, the explant form will need to be completed in conjunction with the implant discharge form. Data entry tip: Stays on the regular floor count here too. Count the duration of the post-implant stay after the ICU or CCU stay.

21. Implant DischargeSee User’s Guide section 2.7

22. Re-hospitalizationSee User’s Guide section 2.9 All re-hospitalizations that are 24 hours or greater need to be reported, even if for an elective procedure or an event that is not related to the VAD like a car accident or gallbladder surgery. Rehab facility stays do not need to be reported as re-hospitalizations. Data entry tip: For re-hospitalizations at an outside hospital, answer no to the question ‘Is this re-hospitalization at your hospital?’ and use the date the patient was admitted to the outside hospital as the admit date. Data entry tip: If this re-hospitalization is for the patient’s first neurological dysfunction adverse event, answer no to this question on re-hospitalization form and yes on the Neuro Dysfunction form when the AE is entered. Answer yes at all subsequent follow up if patient had a CVA, TIA, or anoxic brain injury to track the Modified Rankin Scale over time.

23. Reporting Adverse Events and ExplantsSee User’s Guide section 2.10

24. Reporting Adverse EventsSee User’s Guide section 2.10 Is this a device-related event? What is considered device-related? • This is intended to be an early warning system, answer yes if you think the event could be caused by the device in any possible way. It is not a requirement to complete a device malfunction. • How do I delete an adverse event? Go to the adverse event and change the answer for question, “Did the patient have an ‘x’ adverse event?” from yes to no, validate and save. You will then see a “delete adverse event button” near the top. Click that button to delete. How do I enter a patient that was explanted for recovery or transplant, but then later needed another VAD OR a patient that was implanted at another center a year or more ago and is now having a device exchange at our center? • These are the only scenarios where a patient will need to be entered with a separate patient ID number, so you will add a new patient, and enter ‘99999’ for the SSN under the demographics form. All other additional device scenarios (RVAD needed after LVAD implant, device exchange, etc.) will be accounted for under the same patient ID number with the add a device button.

25. ExplantSee User’s Guide section 2.11

26. ExplantSee User’s Guide section 2.11

27. ExplantSee User’s Guide section 2.11 Data entry tip: If the waitlist ID is unavailable, you may enter 99999.

28. Adding a New DeviceSee User’s Guide section 1.3 You will be taken to a new pre-implant and implant form to complete for this patient.

29. AE – Infection Common QuestionsSee User’s Guide section 2.10 • Pre-implant infections: If an infection was present pre-implant, it will not be counted as an adverse event unless the infection was treated and cleared and then recurs at a later time after implant. • Colonization: If a patient is colonized as identified by screening cultures (ex. VRE, MRSA screenings, asymptomatic bacteruria), but is asymptomatic and is not being treated for the infection, do not count it as an infection adverse event. • Multiple organisms: If multiple organisms are identified on cultures from different sources all within the same 1-2 days, if it is the same type of organism (ex. all are different types of bacteria), this may be counted as one bacterial infection and for location of infection select all the locations that apply. However, if there are different types of infections identified (ex. one bacterial and one fungal), a separate infection for each type will need to be entered, and you would select all the locations that were positive for the fungal culture as one infection and all the sites that had a bacterial culture positive for the other infection. • Ongoing infections: If there is an ongoing infection in the same location with the same type of bacteria, enter the infection when it is first identified along with what type of treatment. If the intervention documented when the first infection is entered changes (ex. go from oral or topical to IV antibiotics or surgery is needed), then enter another infection adverse event to document the change in intervention. Once the change in intervention is documented, there is no need to enter the infection again unless the infection is treated and cleared and then recurs. So if multiple debridements are needed and the infection has already been entered with surgery as an intervention, there is no need to enter a new infection adverse event for each debridement. • Can you have an infection adverse event without any positive cultures? Yes, but only if the clinical evidence is strong enough. Example: if the patient is having fevers, has a productive cough, chest consolidations on imaging, and is being treated for pneumonia (as noted in progress notes or I.D. consult notes) even if cultures have been unrevealing, then the clinical evidence would be strong enough for an infection: pulmonary adverse event.

30. AE – Bleeding Common QuestionsSee User’s Guide section 2.10 • How do I enter a bleeding event if the patient receives transfusions for bleeding from the same site on several different days? • Instead of entering each transfusion as a bleeding event, the clinical episode is considered one event and the total number of units transfused for that episode is entered under the event (for example, if a patient was hospitalized 7 days for a GI bleed and received 18 units of blood during the hospitalization, one bleeding adverse event can be entered with 18 units transfused). • If a patient bleeds, is treated and the bleeding stops then a few days later, has another bleeding event, that can be considered a separate event. If bleeding occurs consistently, continues to happen, same source, not resolved, it would be the same event. If > 7 days have passed, may enter as new AE. • Example-GI bleeding: frequent re-hospitalization with source not being identified, but suspected to be the same source should be the same bleeding episode. If an episode does not stop in as much as recurrent transfusions are needed and no intervention has been able to stop it then it should be considered the same episode if: a) there is no break for at least a week between episode b) has prevented discharge from hospital if the bleeding resulted in an admission. If it has stopped for at least a week or an intervention has found a source and it was curative then any bleeding after that should be a new episode.

31. AE – Neurological Dysfunction AE TipsSee User’s Guide section 2.10 • Intracranial bleeds should be entered as neurological dysfunction adverse events, not bleeding adverse events. • After the patient has experienced a TIA, CVA, or anoxic brain injury, on all subsequent follow-ups answer ‘yes’ to the question: “Has the patient experienced a neuro event since the time of implant?” to track the Modified Rankin Scale over time.

32. AE – Device Malfunction/Pump ThrombusSee User’s Guide section 2.10 The patient was re-hospitalized for suspected pump thrombus, does this need to be reported as an adverse event? • If the patient has at least 2 of the 3 following signs and symptoms: presence of hemolysis, presence of heart failure not explained by structural heart disease, abnormal pump parameters AND suspected pump thrombus should be accompanied by 1 or more of the following events or interventions: • Treatment with IV anticoagulation, IV thrombolytics, or IV antiplatelet therapy • Pump replacement, explant, or urgent transplant – UNOS status 1A • Stroke, arterial non-CNS thromboembolism • Death

33. AE – Device Malfunction/Pump ThrombusSee User’s Guide section 2.10 Device Malfunction – Investigation of implant findings • The cause for implant dysfunction was found by manufacturer investigation but is a sensor issue that is not an option. Type investigation findings in text box. When I’m entering a device thrombus, what do I answer to the question, “Did the patient experience a device malfunction?” • This answer will always be yes because a device thrombus meets the definition of major device malfunction because it either directly causes or could potentially cause a state of inadequate circulatory support or death.

34. Additional Adverse EventsSee User’s Guide section 2.10 • Cardiac arrhythmia (any episodes occurring within 7 days count as one event) • Pericardial fluid collection • Hepatic dysfunction (may only occur beyond 14 days post-implant unless hepatic dysfunction was cause of death within 14 days of implant) • Myocardial infarction • Psychiatric episode (requires intervention, psychiatric meds or consult, or hospitalization, suicide included) • Renal dysfunction (acute if no dialysis pre-implant, chronic if dialysis pre-implant) • Respiratory failure (intubated >6 days post-implant, reintubation, do not include reintubation for re-operation or temporary intubation for procedures) • Arterial non-CNS thromboembolism (acute perfusion deficit, non cerebrovascular) • Venous thromboembolism (e.g. DVT, pulmonary embolus) • Wound dehiscence (excludes infectious cause, requires surgical repair) • Other Serious Adverse Event (an event that causes clinically relevant changes in the patient’s health status, e.g. cancer)

35. DeathSee User’s Guide section 2.12 Data Entry Tip: If a patient dies during the implant operation, if the pump is turned on and blood is flowing through the cannulas, the patient needs to be entered, even if the patient died in the operating room. Data Entry Tip: Select the primary cause of death. Choose one of the listed causes of death when possible, you may be asked to reclassify any ‘other, specify’ causes of death into the appropriate category. For example, if a patient dies from an intracranial bleed, select ‘Nervous System: Neurological Dysfunction’ as the cause of death instead of ‘other, specify: intracranial bleed’.

36. Device ExchangeThings to remember when entering a device exchange I can’t add an LVAD on a patient that had a device exchange. • Before you can add a device on a patient, all forms including the explant related to the most recent implant must be completed and validated. Also, the patient must be alive in order to add a new device. Check to be sure all the follow-up forms on the patient summary screen have been completed. Once the forms are complete, you should be able to add a LVAD.

37. Triggered Adverse EventsSee User’s Guide section 2.10 • How are the zone adverse events (hemolysis, right heart failure, hypertension) counted? • You no longer need to directly enter these adverse events. The system determines if these events occurred based on the follow-up information entered. These events will be analyzed over a period of time as conditions.

38. TransfersSee User’s Guide section 2.13 The transferring center must: • Complete all outstanding data collection forms • Complete the Add Patient Transfer form in the web based data entry system indicating the patient is no longer in their care. • Please notify Jeanne Anne Love (jfowler@uabmc.edu) of the hospital the patient is transferring to so she can contact the center and let them know what paperwork is needed to transfer the patient. The receiving center must: • Provide proper documentation to the Intermacs DCC (A release of info. authorization form found in Appendix C of the Intermacs website must be signed by the patient at the receiving center). • Due to the potential exchange of Protected Health Information (name, date of birth, etc.), all correspondence must be made using a secure method. Contact the DCC (jfowler@uabmc.edu), for access to the Intermacs secure e-mail (NeoCertified) and additional guidance. The DCC staff will: • Verify all data has been entered at the transferring center • Verify the receiving center has completed the transfer documentation • Program the switch from the transferring center to the receiving center • Notify the receiving center that the transfer is complete

39. TransfersSee User’s Guide section 2.13 How is a patient transfer from a non-INTERMACS site or an international patient transfer handled? • If a patient is implanted at a non-INTERMACS site (in or outside the U.S.) and transfers to an INTERMACS site, the patient will not be entered in INTERMACS unless they require a device exchange and receive an implant at the INTERMACS site. • There is no add transfer form button on a patient that needs to be transferred. Check to be sure all the follow-up forms on the patient summary screen have been completed. Once the forms are complete, the transfer form button should appear. Death after Transfer: • If death occurs after transfer and the patient is never picked up by the next site then we will not capture it.

40. Resources and References • The User’s Guide is the best resource for data entry questions - IntermacsAppendix M and PedimacsAppendix N. Go to the form you are working on for detailed instructions on how to enter data. Be sure you are using the latest version of the User’s Guide, it is updated on a quarterly basis to reflect any changes in the system. • Printable forms are available – Intermacs Appendix P, Pedimacs Appendix Q • Email intermacs@uabmc.edu with questions.