Is there a special certification process for PCI-CAMPOS pilot sites or is there only one application form/process for all applicants?
A. There is only one application and certification process for all applicants.
Have there been any updates to the application form since it was originally posted?
A. Yes, the official OSHPD data release consent form has been made available.
How long will certification be issued for?
A. The elective PCI certification will be added to your general facility license. Certification renewal would be synchronized with the general facility license renewal.
Will the recertification process be the same?
A. For recertification a hospital would need to continue to follow SCAI/ACCF/AHA recommendations for offsite PCI. The recertification process will be included in the general facility license renewal process.
Will there be a recertification process? Will there be any relation to The Joint Commission?
A. This certification will be added on to your general facility license; therefore, it will be included in your facility license renewal. There is a potential for a triennial site revisit, but this has not been determined yet.
Are the SCAI/ACCF/AHA guidelines "required" or "recommended" for participation in the Elective PCI program?
A. According to Senate Bill 906, the participant hospitals shall meet all SCAI/ACCF/AHA guidelines.
Is it possible to do elective PCI but not do STEMI? (i.e., support an elective PCI-only program)
A. Most applicants will be "full service." If a facility is not full service, they do not need to operate 24x7x365. However, they must meet the rest of the requirements and must have a plan to handle emergency cases during off hours.
Is there any documentation stating that elective-only, non-full-service programs are permitted?
A. This has not been spelled out directly, but there is a potential for elective-only programs. Such programs must have a plan to address emergency care.
Is there an estimated time that it would take to complete the application review and approval process?
A. It is a multi-step process and therefore not possible to estimate how long the process would take. We will make every effort to process applications as soon as possible.
Are mobile catheterization labs acceptable?
A. Mobile catheterization labs are not permitted in California.
How soon can the application be submitted?
A. The application period is open, and applications can be submitted at any time.
Is there a deadline for applications each year?
A. Applications are open and applications can be submitted anytime. There is no deadline; however, there could be changes in the SCAI/ACCF/AHA guidelines as we go forward.
Will there be any audit requirements?
A. There will be a site visit as part of the application process. We will not be performing audits in the same manner as the pilot program. However, ACC-NCDR does have its own audit process.
In terms of the electronic copy, how would you like the attachments to be sent over? Do you want individual attachments or one index document containing all?
A. The documents in the electronic copy should be separated according to the instructions in the application, which separates each section into a separate file. As far as emailing the files, this will depend on the size of the files and the size limits of the email system. Multiple emails are fine as long as the emails and attachments are labeled accordingly. If you have any issues submitting the application via email, please contact PCI@cdph.ca.gov.
Is there a listing of current Elective PCI-designated sites for California?
A. A list of "Certified" Elective PCI program hospitals can be found using the CDPH Cal Health Find Database advanced search page.
If a hospital has had a PCI program with cardiac surgical back up for several years but they plan to close the cardiac surgery program and participate in the Elective PCI program, will the hospital need to complete the application?
A. Yes, all hospitals planning to participate in the Elective PCI program must complete the application.
Section C3 requests the catheterization lab log from the most recent 12 months. Is that the most recent calendar year or "month to month"?
A. This should be the most recent 12 months that are available.
Can you please clarify what specific ICD codes should be included per the application on page 10, section C5 for "Patient presented to ER with possible IHD"?
A. Specific ICD-10 codes are not required.
Section C5 says 36 primary PCI procedures and section C6 says 200 elective and primary. Could you clarify what the numbers are?
A. 200 total PCI procedures per year (including 36 primary PCI procedures, if your hospital will be performing primary PCI).
Where can the current patient selection criteria be found?
A. The SCAI website has the current patient selection criteria.
Section C7o requests the P&P for obtaining informed consent from patients for all cardiac catheterization procedures as well as potential transport and cardiac surgery services and section C8 requests the consent forms. Must offsite be listed on the consent form?
A. Appropriate informed consent would include full disclosure that the hospital does not have cardiac surgery onsite.
Per the current SCAI/ACCF/AHA guidelines:
"Initial informed consent for PCI discloses that the procedure is being performed without on-site surgical backup and acknowledges the possibility of risks related to transfer. The consent process should include the risk of urgent surgery and state that a written plan for transfer exists. Consent for PCI should be obtained before the procedure and before any sedatives are given. Consent for PCI obtained while the patient is on the table is not informed consent and is unacceptable in non-emergency situations."
Section C6 asks for a detailed plan with supporting data that shows the minimum number of PCI procedures the facility expects to perform annually. For facilities that are starting a new program, what kind of supporting data or proof would be acceptable?
A. Some potential methods of estimating future PCI volume could include the following: calculating the acute coronary syndrome admissions during the past 12 months (assuming about 50% would go for PCI), or diagnostic catheterization cases that are referred for PCI. It would also be helpful to have letters from regional facilities or interventionalists stating their intent to divert PCI cases to your facility (including their estimated annual volume).
We are currently in the process of developing a catheterization lab program and will have a transfer agreement with an academic center with surgical backup. Since this is a startup program, am I able to file for application without current volume?
A. Yes you can file for application, but you need to submit documentation that you can meet the 200 annual volume requirement.
The application requires that we present a plan that shows a total of 200 elective and primary PCI procedures. Does the plan have to show that all the patients come from our Primary (PSA) and Extended Service area (ESA), or only the PSA?
A. No restrictions regarding where your patients will come from.
Recent evidence and trends have shown an overall decrease in the number of PCI procedures being performed nationwide, likely given improvements in preventive care. Do you know if CDPH plans to lower the 200 PCI annual volume requirement in response to the overall decrease in PCI procedures being performed?
A. Not at this time.
Is a center required to have purchased other diagnostic modalities and PCI supplies prior to applying, or can we submit our planned purchases?
A. It would be acceptable, if you can provide a list of your anticipated inventory and a letter of commitment from your hospital administration stating that, if approved, the facility will have the inventory in stock. Inventory and diagnostic modalities will be inspected during the site visit.
Section D14 states: Facility must have high-resolution digital imaging capability and intra‐aortic balloon pump support in the catheterization lab compatible with transport vehicles. Does your facility have these capabilities? If yes, provide details on the systems and a confirmation statement from the emergency medical service (EMS) that their systems are compatible. What digital imaging capability is required in the transport vehicle?
A. If the medical records (including angiography) were not previously transmitted, the patient transport vehicle must be able to carry a digital copy (CD, flash drive, etc.) of the medical records (including angiography) to the receiving hospital.
Question D15 asks about the ability for real-time transfer of images and hemodynamic data to receiving hospitals. Is this capability a requirement for certification?
A. Ideally yes, but a facility should at least be able to provide this information to the receiving facility before the patient arrives or send it along with the patient during transport.
Must all the interventional cardiologist be ABIM board certified in interventional cardiology?
A. Only the interventionalists who will be performing elective PCI procedures under the program. An American Osteopathic Board of Internal Medicine (AOBIM) certification in Interventional Cardiology is also acceptable.
Must the PCI program director be ABIM board certified in interventional cardiology?
A. Yes, if he/she will be performing elective PCI procedures under the Program. An American Osteopathic Board of Internal Medicine (AOBIM) certification in Interventional Cardiology is also acceptable.
Will operators who are not ABIM certified qualify to perform elective PCI procedures under the program?
A. Current guidelines state: "ABIM board certified in interventional cardiology and maintain certification, with the exception of operators who have gone through equivalent training outside the United States and are ineligible for ABIM certification and recertification exams." (An American Osteopathic Board of Internal Medicine (AOBIM) certification in Interventional Cardiology is also acceptable.) These operators must also meet all the other operator requirements as specified in the guidelines. Thus, U.S. trained non-ABIM. Non-AOBIM certified (Interventional Cardiology) interventionalists are not currently eligible.
Are cardiothoracic surgeons required to have privileges at the offsite facilities?
A. Per the current SCAI/ACCF/AHA guidelines: Cardiac surgeons should have privileges at the referring facility to allow review of treatment options as time allows.
Question F1g requires that review and follow up of all patients transferred for cardiac surgery, emergent or non-emergent, with or without the outcome of surgery and identification of any improvement opportunities be identified. How far back should this be done?
A. The most recent 12 months.
Question G2 requires that transport protocols be tested a minimum of twice per year. What would qualify as "testing"?
A. Acceptable "testing" would include actual patient transfers that have occurred or drills that have been run.
Question G8 asks for a letter from EMS noting that their transport vehicles are capable of advanced life support and intra‐aortic balloon pump support that is compatible with the applicant hospital’s systems. Could we just submit a P&P indicating the hospitals IABP and trained RN go with the transfer to satisfy this question?
The statement of understanding and agreement to participate, item #8, states that a certified hospital that cannot demonstrate that it will perform the minimum of 200 PCI procedures (including 36 or more primary PCIs) by the beginning of the second year of implementation may have its status terminated. It also states that there may be an exception per the SCAI/ACCF/AHA guidelines for facilities in underserved areas. Are there any other exceptions that would allow lower volume facilities to continue?
A. The only exceptions would be related to your facility being in a defined health professional shortage area (HPSA), medically underserved area (MUA), or rural area as defined by the California Office of Statewide Health Planning and Development.