Accreditation Elements

1. Accreditation Elements Establishing and Maintaining Accreditation Comparing ACR and IAC

2. Objectives • Briefly describe ACR and IAC Accreditation processes. • List basic requirements of ACR and IAC Accreditation. • List key comparisons and contrasts between ACR and IAC Accreditation.

3. Accreditation shows a commitment to quality care to payers, regulatory agencies, physicians, and patients. Accreditation is a sign to patients that the practice has taken steps to provide the highest quality health care available. Accreditation can be a powerful tool in the recruiting of the best and brightest physicians, technologists and sonographers. Accreditation at the present time is a voluntary process, however Medicare and other payers in the United States have enacted reimbursement legislation that adversely effect practices that are not Accredited. Medicare Improvements for Patients and Providers Act of 2008 – Bill requires that by 2012, providers of advanced diagnostic imaging services, inclusive of Nuclear Medicine, MR, CT, and PET, must obtain accreditation as a condition of reimbursement. The importance of Accreditation

4. Medicare Improvements for Patients and Providers Act • The portion of the legislation requiring accreditation stipulates that the accreditation programs must evaluate that physicians and staff maintain the proper level of training and education; that laboratories use imaging equipment which adheres to strict standards of performance and operates under proper safety guidelines; and that all laboratories establish and maintain a quality assurance program, thereby upholding the standards of quality care for patients, particularly senior citizens. • This powerful legislation (which was just ratified by the house and senate) includes a provision requiring the accreditation of imaging facilities as well as the elimination of a scheduled 10.6% payment cut for physicians.

5. IAC – Intersocietal Accreditation Commission (consisting of four bodies). ICVL – Intersocietal Commission for the Accreditation of Vascular Laboratories. ICANL – Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories. ICAEL - I Intersocietal Commission for the Accreditation of Echocardiography Laboratories. ICACTL - Intersocietal Commission for the Accreditation of Computer Tomography Laboratories.

6. IAC • Founded in 1990 • IAC was created by uniting physicians, technologist, and sonographers from the sponsoring organizations (Intersocietal approach).

7. ACR (American College of Radiology) Ultrasound – Includes all modalities (Gen, OB, OB (trimester specific), GYN, and Vascular. Breast Ultrasound Mammography Computer Tomography Magnetic Resonance Imaging (MRI) Stereotactic Breast Biopsy Radiation Oncology Nuclear Medicine and PET The Diagnostic Modality Accreditation Program (DMAP) incorporates all the ACR accreditation programs (except mammography and radiation oncology) under one application process.

8. ACR • Ultrasound Program founded in 1995 • Membership organization – 34,000 members includes radiologist, radiology oncologist, medical physicists, interventional radiologist, and nuclear medicine physicians.

9. Process OverviewIAC • Download and review the “Standards” (guidelines and requirements) • Make necessary modifications for compliance • Complete online application - Accreditation components: Extracranial Cerebrovascular, Intracranial Cerebrovascular, Peripheral Arterial, Peripheral Venous, Visceral, and screening. - Deadlines: Applications Will Now Be Accepted At Any Time Throughout The Year

10. IAC • Accreditation Application - IAC Submit Online Accreditation Agreement - Application Fee - Attachments (organizational chart, personnel certifications/licenses, ACLS or BLS cards, NRC license/State registration and inspection reports, specific policies and protocols, case studies) • Internal review by IAC application processor • Application review: Medical and Technical Director confirming completeness or requesting more data

11. IAC • On site or audit request - Site Visit: Random selection of statistically significant number of labs each quarter - Paper Audit: Notified by “Certified mail” • Board review and decision - Grant Accreditation (3 years) - Provisional Grant (1 year) - Delay - Denied • Notified by mail when to reapply

12. IAC Fee Schedule • Application Fees - $1500 includes base fees and one testing area - $300 for each additional testing area over one - $750 for each additional site area over one - $200 for each mobile unit

13. Process OverviewACR • The online application contains three separate sections. • • Section 1 collects demographic, contact and general modality information for the overall practice site location. It also involves the completion of a legal agreement that may be completed using electronic signatures (if available) or by faxing it to the ACR. Instructions will be provided during the application process. All of section 1 must be completed before section 2 will become available. • • Section 2 collects modality-specific contact, unit and exam selection information. All of section 2 must be completed before section 3 will become available. • • Section 3 collects personnel and payment information for the application. If multiple practice sites apply under the same user’s account using the online application, they will be able to share their personnel list. For example, facility 1 applied for accreditation using the online application and entered all of their personnel. If facility 2 is entered under the same user’s account, facility 2 will have the option to select their personnel from the list that is already on file and/or to enter additional personnel. This eliminates the need to enter the same personnel more than one time. Once personnel and payment information are entered, the application is ready to submit to the ACR for processing.

14. ACR • ACR review of initial application • Laboratory receives testing materials • Sites have 45 days to complete testing materials phase. – Lab submits: Clinical Images and Protocols/Test Image Data sheets; Phantom images/Site scanning data form; Physicist Report (for each unit); Quality assurance questionnaire; Quality Control Form; NRC and/or State inspection • Clinical and Phantom Images reviewed and scored • Pass/Fail determined

15. Application FeesACR • $1200 OB antepartum ultrasound, only • $1200 Trimester Specific Obstetrical, only • $1200 Gynecological ultrasound, only • $1200 General ultrasound, only • $1200 Vascular only • $1400 Combination accreditation (two types) • $1500 Combination accreditation (three types)

16. Personnel QualificationsIAC Medical Director • The Medical Director is responsible for all clinical services provided and for the determination of the quality and appropriateness of care provided. • The Medical Director supervises the entire operation of the laboratory or may delegate specific operations to appropriate laboratory or administrative staff. • The Medical Director is responsible for the approval of medical staff and the supervision of their work. • The Medical Director is responsible for maintaining and assuring compliance of the medical and technical staff to the “standards”.

17. Medical DirectorIAC • The medical director must be a licensed physician and qualified to interpret studies. • The medical director must demonstrate an appropriate level of training and experience by meeting one or more of the following: Formal Training Program – Completion of a residency or fellowship that includes appropriate didactic and clinical vascular laboratory experience as an integral part of the program. Informal training - Appropriate training and experience for proper qualifications to interpret noninvasive vascular laboratory studies can be achieved through formal accredited post-graduate education. A minimum of 40 hours of relevant Category I CME credit must be acquired within the three-year period prior to the initial application. Established practice – Training and experience will be considered appropriate for a physician who has worked in a vascular laboratory for at least three years and has interpreted more than 300 diagnostic studies in the specific areas. Registered Physician In Vascular Interpretation – A physician has successfully obtained the ARDMS RPVI credential or ASN neurosonology certificate for extracranial and/or intracranial test interpretation.

18. Medical StaffIAC • The medical staff interprets and/or performs clinical studies in accord with privileges approved by the Medical Director and in compliance with the standards outlined in the “standards”. • Qualification: Same as Medical Director

19. Technical DirectorIAC • A qualified Technical Director must be designated for the facility. • The Technical Director reports directly to the Medical Director. • Responsibilities include, but are not limited to, and may be delegated to other staff: • All laboratory duties delegated by the Medical Director • Supervision of the technical and ancillary staff • Daily technical operation of the laboratory (e.g., staff scheduling, patient scheduling, laboratory record keeping, etc.) • Operation and maintenance of laboratory equipment • The compliance of the technical and ancillary staff to the Standards. • Quality patient care • Technical training

20. Technical DirectorIAC • The Technical Director must have an appropriate credential in vascular testing. Appropriate credentials include: Registered Vascular Technologist (RVT); Registered Vascular Specialist (RVS); Registered Technologist Vascular Sonography [RT(VS)]; for physician Technical Directors performing only Extracranial and/or Intracranial testing, the American Society of Neuroimaging’s certificate in Neurosonology.

21. Technical Staff • The technical staff must demonstrate an appropriate level of training and experience by meeting one or more criteria. - Credential in vascular testing Appropriate credentials include: Registered Vascular Technologist (RVT); Registered Vascular Specialist (RVS); Registered Technologist Vascular Sonography [RT(VS)]; if applying for visceral vascular only Registered Diagnostic Medical Sonographer in Abdomen [RDMS (AB)]. - Formal Ultrasound training: Successful completion of an ultrasound, vascular technology or cardiovascular technology program that includes verified didactic and supervised clinical experience in vascular testing. The program should be accredited by either the Joint Review Committee on Education in Diagnostic Medical Sonography (JRC-DMS), the Joint Review Committee on Education in Cardiovascular Technology (JRC-CVT), or the Canadian Medical Association (CMA). • - Post secondary education plus experience: 12 months full time (at least 35 hours/week) clinical vascular testing experience plus one of the following: 1) Completion of a formal two-year program or equivalent in another allied health profession 2) Completion of a bachelor’s degree unrelated to vascular technology 3) A MD or DO degree • - Experience only: A minimum of 12 months of vascular testing experience with the performance of at least 600 noninvasive vascular examinations under the supervision of medical or technical staff who meet the above criteria. The noninvasive vascular examinations performed by these technical staff members must be appropriately distributed among the testing areas performed within the laboratory.

22. Physician QualificationsACR • Radiologist/Physicians must initially meet one of four qualifications. • A. Completion of an approved residency program including three months of training supervised by qualified individuals, and involvement with 500 ultrasound examinations, including a broad spectrum of uses. The physician should have passed written and oral board certification examinations, including sections related to diagnostic ultrasound • B. If residency did not include ultrasound, the physician must have had appropriate fellowship or post graduate training supervised by a qualified physician. • C. Physicians trained prior to 1982 must have performed and interpreted ultrasound examinations for at least 10 years. • D. Physicians without formal fellowship or postgraduate training must have two years of ultrasound experience in which 500 exams must have been performed or supervised and interpreted. They must show documentation and show a history of a quality assurance program.

23. Ultrasound TechnologistACR • Certified or eligible for certification by: American Registry of Diagnostic Medical Sonographers (ARDMS), or American Registry of Radiologic Technologists, Sonography (ARRT) (S). • • All sonographers must be certified and currently registered as RDMS (OB or AB), RT(S), RT (VS), RVT, or RVS at the time of application for renewal of accreditation. (All sonographers should obtain certification within twenty-four months of eligibility or cross training.) • **Sites applying for Vascular Ultrasound Accreditation must have at least one technologist who has an RVT (Registered Vascular Technologist) by the ARDMS, a Vascular Sonographer (VS) by the ARRT, or as a Registered Vascular Specialist (RVS) (also known as RCVT) by Cardiovascular Credentialing International (CCI) credential working on-site during the performance of vascular examinations.

24. Policies and ProtocolsIAC • Protocols should meet that “standards” • They should be written, detailed, lab-specific policies and protocols - Clinical Procedures - Equipment Quality Control - Required Documentation of Examination - Diagnostic Criteria and interpretation - The indication for testing must be documented - Correlation and Confirmation of Results • Required policies and protocols will be reviewed for compliance with Standards. • Missing protocols and detail (reporting) – common problem areas

25. Policies and ProtocolsACR • All sites initially applying for ACR accreditation and all sites renewing their accreditation must actively participate in a physician peer review program that performs the following functions: • Includes a double reading (2 MDs interpreting the same study) assessment. • Allows for random selection of studies to be reviewed on a regularly scheduled basis. • Exams and procedures representative of the actual clinical practice of each physician. • Reviewer assessment of the agreement of the original report with subsequent review (or with surgical or pathological findings). • A classification of peer review findings with regard to level of quality concerns (One example is a 4 point scoring scale). • Policies and procedures for action to be taken on significant discrepant peer review findings for the purpose of achieving quality outcomes improvement. • Summary statistics and comparisons generated for each physician by imaging modality. • Summary data for each facility/practice by modality. • There are several options available to meet this requirement. Sites may develop their own peer review program, use a vendor product or RADPEER, a peer review process developed by the ACR. • Clinical Images • Vascular Exam Diagnostic Criteria • Reporting of Results • Very limited number of case studies

26. Equipment Quality ControlIAC • Instrumentation used for diagnostic testing must be maintained in good operating condition. • The accuracy of the data collected by ultrasound instruments is paramount in the interpretation and diagnostic utilization of the information collected. • Required Characteristics • Guidelines for equipment maintenance include, but are not limited to, the following: • Recording of the method and frequency of maintenance of ultrasound instrumentation and non-imaging equipment. • Establishment of and adherence to a policy regarding routine safety inspections and testing of all laboratory electrical equipment. • You are required to document proper maintenance including calibration of equipment semi-annually, however the facility does not have to submit reports with application. • The reports can be audited as part of the review process.

27. Equipment Quality ControlACR • Continuous Quality Control • Routine quality control testing must occur regularly; a minimum requirement is semiannually. The same tests must be performed during each testing period so that changes can be monitored over time and effective corrective action can be taken. Testing results, corrective action, and the effects of corrective action must be documented and the documentation maintained on site. In the event of a site survey, reviewers will expect to see such documentation. • The QC program must evaluate at least the following items in gray-scale imaging mode: System sensitivity and/or penetration capability. Image uniformity. Assurance of electrical and mechanical safety and cleanliness Photography and other hard-copy recording. • QC Data to be Submitted for Accreditation For each unit, submit a copy of your most recent physicist’s or service engineer’s report. The QC report should document results of the QC testing.

28. Quality AssuranceIAC • There must be a written policy regarding quality assurance for all procedures performed in the laboratory. • Regular Ongoing quality assurance must be performed for all areas of vascular testing performed by the laboratory as outlined in the standards specific to that area. • A minimum of two vascular laboratory quality assurance conferences per year must be held to review the results of comparative studies, address discrepancies and to discuss difficult cases and laboratory issues and minutes maintained. • Quality controls for studies is done by correlation according to the standards for each area of testing. A minimum of 30 correlations must be done for each modality.

29. Quality AssuranceACR • All sites initially applying for ACR accreditation and all sites renewing their accreditation must actively participate in a physician peer review program that performs the following functions: • Includes a double reading (2 MDs interpreting the same study) assessment. • Allows for random selection of studies to be reviewed on a regularly scheduled basis. • Exams and procedures representative of the actual clinical practice of each physician. • Reviewer assessment of the agreement of the original report with subsequent review (or with surgical or pathological findings). • A classification of peer review findings with regard to level of quality concerns (One example is a 4-point scoring scale). • Policies and procedures for action to be taken on significant discrepant peer review findings for the purpose of achieving quality outcomes improvement. • Summary statistics and comparisons generated for each physician by imaging modality. • Summary data for each facility/practice by modality.

30. Case StudiesIAC • Extensive case studies with contemporary staff to include multiple abnormal and one normal exam for each modality. Example: Extracranial Cerebrovascular: Normal, 1-20%, 21-49%, 50-69%, 70-99%, and one showing Occlusion. • Case studies must adhere to the “Standards”. It is preferred to submit case studies with matching correlation data.

31. Case StudiesACR • For Vascular one exam (normal and abnormal) from each category performed at the site: Peripheral, Cerebrovascular, Abdominal, and/or deep abdominal. • OB - there should be 1 first trimester, 2 second trimester and 1 third trimester. • Trimester specific OB - as many as four case studies must be submitted with two of these being transvaginal. • GYN – three endovaginal and one transabdominal even if female pelvis is selected on the GEN application. • GEN – One complete upper abdominal exam. Three different exams from either: Female pelvis, Renal/Urinary, Transrectal/prostate, Pediatric neurosonology, or small parts. • In regards to the ultrasound case studies outside of vascular normal and abnormal are not required. These studies are supposed to be the facilities best studies. • Does not require representative staff and the vascular criteria is far less stringent.

32. Comparisons • Qualified Personnel (similar qualifications) • Interpreting physicians are encouraged to be authorized users • Regular schedule of Quality Control procedures • Random site visits • Opportunity to correct deficiencies • Three year Accreditation

33. No application deadline Organizational structure (IAC Medical and Technical Director) Policy and protocol format and review: site specific, guidelines that adhere to the “Standards Intersocietal approach (representative of many organizations including technologist, physician, surgeons, radiologist, and sonographers), allowing for a comprehensive evaluation of testing in each modality. Case studies – Comprehensive case studies that must adhere to the standards and be representative of staff. Final report format (required components and templates for IAC). Quality assurance: Is focused on correlation of exams to gold standards. Not focused on peer review as laboratories have to have exams read under laboratory specific criteria. Accreditation for Vascular Lab only. Recognized as the highest level of accreditation for Vascular Laboratories. Clinical data is due within 45 days of submission of online application Physician lead, no organizational structure Organizational approach: Member driven: radiologist, radiology oncologist, medical physicists, interventional radiologist, and nuclear medicine physicians. Quality assurance: Is more focused on interpretation not correlation. Accreditation for General, OB, GYN, Vascular, and Small parts. DMAP – The ability to have accreditation of all modalities except mammography and radiation Oncology under one application. ContrastsIAC ACR

34. Which Path? There are many similarities and differences between IAC and ACR accreditation. IAC accreditation is the higher of the two standards; is held in a much higher regard; and will increase the ability of your organization. ACR is a minimum standard accreditation in regard to modalities outside of conventional radiology modalities (Vascular, Cardiac, CT and Nuclear Medicine). In these areas ACR accreditation is viewed as less than the standard. Whichever path you choose to take will impact the clinical quality of an organization and the quality of patient care.