Standards Review

• The ACE Standards will be reviewed annually or as necessary to maintain the most current and optimum patient care standards. Facilities will be notified of any significant changes to the standards.  In addition, updated versions of standards will be available on the ACE website.
• In order to maintain full Accreditation, laboratories must continuously adhere to the most current Standards within 6 months of notification.
• ACE will modify the standards to conform to any changes in CMS statutory requirements. All accredited facilities will be notified of these changes and will have 6 months to validate compliance if necessary.
• Facilities will be required to submit an annual online survey to confirm compliance with current standards and to determine if there have been substantive program changes at the institution.  This will be sent to each facility and completion is required to maintain accreditation.
• All accredited facilities must notify ACE of any major program changes.  These include but are not limited to the following situations.
  • Addition/Deletion of Medical Director
  • Major changes to equipment or procedure
  • Significant changes in outcomes that exceed published threshold levels.
  • Discontinuation of service

Application Process

• Applications are processed upon completion of the online application via the ACE website and receipt of payment.
• Laboratories applying for reaccreditation should submit their application at least three months prior to the expiration date of their current accreditation to avoid a lapse in their accreditation.
• Accreditation is granted for a two-year period. This period begins on the decision date which the ACE board approves and accredits the facility.  Accreditation will not be extended beyond the two year period.

In-House Review

• Each facility will submit an application online via the ACE website.
• All applications will be entered into the ACE database. 
• An in-house review of the application is performed by ACE staff and consists of a review of the application for completeness.  (questions have been answered completely, attachments are included etc.).
• If missing information is identified, the laboratory is notified in writing, via email or fax and/or by telephone. The laboratory will have 20 business days to submit the missing information.
  • If missing information is not submitted within the allowed time, the facility will be required to resubmit an application and pay an additional application fee.
  • Verification of current physician licensure and a check of the OIG website for any providers included in the list of excluded individuals or entities will also be conducted.
• Nurse as well as physician reviewers will be assigned and submitted data reviewed to identify potential issues or items that require further clarification
  • Physician reviewers are selected from a multidisciplinary pool of experienced carotid stent, vascular medicine, and neurologic clinicians that are consistent with the physicians who perform CAS at the institution
• Staff will then contact the facility and schedule a site visit.

Onsite Review

• All facilities will be subject to an onsite review by a team of experienced, trained, objective nurse reviewers.
• The onsite review will include but not be limited to the following activities:
  
  • Inspection of all locations performing CAS within the institution
  • Chart Audit
  • Review of SOPs for CAS
  • Review of operator & staff credentials
  • Interview with Medical Director & Key program personnel
  • Collection of Angiograms for outside review by physician panel
• The site reviewers submit a report detailing their findings to the assigned physician reviewers. 
• Facilities will be reviewed by two independent reviewers and each will render an independent opinion.  
• The nurse and physician reviewers will recommend “accreditation”, “provisional accreditation” until specific improvements have been put in place or “denial”
• A sample of facilities will be required to undergo onsite evaluation conducted by physician experts at the expense of the facility. 
• Outlier facilities will be surveyed by a physician team to validate clinical outcomes, identify specific issues, and assist in developing a corrective action plan or obtain first hand information prior to issuing a denial decision.
• A written procedure for appeal will be available.
• Corrective action plans will be developed to assist facilities when indicated. 

Angiographic Review

• During the site visit a random selection of angiographic studies  will be collected for independent review
• Angiograms related to major complications will also be collected
• These studies will be evaluated for:
  
  • Image quality
  • Compliance with NASCET criteria for lesion assessment
  • Adherence to angiographic standards.

Final Report

• A final report will be issued to each facility within 30 days of completion of the site visit and receipt of all pertinent material
• Accreditation Certificates will be sent to each facility
• When indicated a corrective action plan will be developed for each facility not receiving full accreditation.
• Drafts of press release or marketing information will be available