Standards and Guidelines for the Accreditation of Ultrasound PracticesApproved November 14, 2009
PURPOSE

The AIUM strives to continuously improve the quality of diagnostic ultrasound services by offering a peer review process for providers to demonstrate that they meet nationally recognized standards and guidelines.

Diagnostic medical ultrasound makes important contributions to patient care and may be used in a variety of settings. Ultrasound practice accreditation is designed to set a standard of quality for the performance of basic ultrasound procedures. TheseStandards and Guidelines for the Accreditation of Ultrasound Practices specify minimum training, experience, credentialing, and continuing medical education requirements for medical staff and personnel who perform and interpret diagnostic ultrasound examinations. Furthermore, these Standards specify the requirements for safety, maintenance, and calibration of equipment, staff performance, reports, record keeping, and quality assurance for clinical practices where studies are performed.

Ultrasound practices that meet the standards and guidelines described below will be eligible for ultrasound practice accreditation.

Accreditation
Accreditation may be obtained in 1 or more of the following specialties:
  • Abdominal/General Ultrasound (may include thyroid/parathyroid ultrasound and musculoskeletal ultrasound)

  • Breast Ultrasound (diagnostic and/or interventional)

  • Gynecologic Ultrasound

  • Obstetric or Trimester-Specific Obstetric Ultrasound

  • Dedicated Thyroid/Parathyroid Ultrasound
The completed application and supporting documents are reviewed by the AIUM’s Ultrasound Practice Accreditation Program’s peer reviewers. Reaccreditation is required every 3 years. In case of major changes in personnel or the practice, the AIUM’s Ultrasound Practice Accreditation Department must be notified as soon as possible.

ULTRASOUND PRACTICE PERSONNEL

Physician Director of Ultrasound
The practice must designate a physician director of ultrasound who is responsible for overseeing the quality and appropriateness of ultrasound operations of the practice, including ensuring that appropriate clinical services are provided, that support services are sufficient, and for certifying that the practice continues to meet the Standards and Guidelines for the Accreditation of Ultrasound Practices. The physician director of ultrasound may supervise the entire operation of the facility or may delegate specific operations to associates and sonographers. The physician director of ultrasound must meet all additional requirements for physicians who perform and/or interpret ultrasound examinations.

Interpreting Physicians
All practice physicians who perform and/or interpret ultrasound examinations must meet the following requirements:
  • Must be a physician with a current state license.

  • Must meet the AIUM Training Guidelines for Physicians Who Evaluate and Interpret Diagnostic Ultrasound Examinations, and
    • If the practice is applying for accreditation in diagnostic breast ultrasound, each physician must attest that he/she has participated in 60 nonscreening breast ultrasound cases in the year before the application.
    • If the practice is applying for accreditation in interventional breast ultrasound, each physician must have performed 25 ultrasound-guided interventional procedures. The first 5 of these cases must have been supervised by another physician experienced in interventional sonography of the breast. At least 3 of the first 5 must be core biopsies. A physician documenting that he/she has safely performed 75 interventional cases in the 3 years before the application can also satisfy the requirement.
    • If the practice is applying for initial accreditation in dedicated thyroid/parathyroid ultrasound, the designated physician director of ultrasound must have earned the Endocrine Certification in Neck Ultrasound (ECNU) credential within the past 12 months, and all other interpreting physicians must provide documentation of 15 CME credits in neck ultrasound and signed attestation that they agree to earn ECNU designation by the time of practice reaccreditation (in 3 years).

  • Must maintain documentation of appropriate continuing education:
    • If the practice is applying for accreditation in breast ultrasound, must obtain a minimum of 10 AMA PRA Category 1 Credits™ in breast ultrasound every 3 years. If the practice is applying for accreditation in other ultrasound modalities as well as breast, the 10 CME credits apply toward the requirement of 30 CME credits over 3 years.
    • If the practice is applying for accreditation in dedicated thyroid/parathyroid ultrasound, must obtain 15 AMA PRA Category 1 Credits™ in thyroid/parathyroid ultrasound every 3 years.
    • If the practice is applying for accreditation in any category other than breast ultrasound or dedicated thyroid/parathyroid ultrasound, must obtain a minimum of 30 AMA PRA Category 1 Credits™ in ultrasound every 3 years.

  • Must meet the following procedure volume requirements depending on the type(s) of accreditation for which the practice is applying*:
    • For gynecologic ultrasound accreditation, each interpreting physician must meet a minimum of 170 gynecologic ultrasound procedures annually.
    • For obstetric ultrasound accreditation, each interpreting physician must meet a minimum of 170 obstetric ultrasound procedures annually.
    • For obstetric/gynecologic ultrasound accreditation, each interpreting physician must meet a minimum of 170 obstetric/gynecologic ultrasound procedures annually. Each physician must have no fewer than 50 cases per year in either obstetric or gynecologic ultrasound.
    • For abdominal/general ultrasound accreditation, each interpreting physician must meet a minimum of 300 abdominal/general ultrasound procedures annually.
    • For diagnostic breast ultrasound accreditation, each participating physician must meet a minimum of 60 diagnostic ultrasound procedures annually.
    • For interventional breast ultrasound accreditation, each participating physician must meet a minimum of 12 interventional ultrasound procedures annually.
    • For dedicated thyroid/parathyroid ultrasound accreditation, each participating physician must meet a minimum of 100 thyroid/parathyroid ultrasound procedures annually, 30% of which must be ultrasound-guided fine-needle aspiration procedures.
*Physicians who do not meet the minimum volume of ultrasound procedures on an annual basis can participate in a quality assurance program designed to increase their exposure to ultrasound examinations and ensure quality ultrasound care. Physicians who do not meet the minimum annual ultrasound volume requirements can meet the case study requirements in any 1 of the following ways:
  • They can double read ultrasound studies for quality assurance purposes.

  • They can have their ultrasound studies reread by a physician who does meet the minimum volume requirements and compare their findings with those of the other physician.

  • They can participate in a monthly case study review seminar developed and conducted by physicians in the practice who do meet the minimum annual ultrasound volume requirements.
SONOGRAPHERS AND OTHER NONPHYSICIANS WHO PERFORM ULTRASOUND EXAMINATIONS

Chief Sonographer
A qualified chief sonographer may be designated for the facility. The chief sonographer will report to the physician director of ultrasound and will be responsible for those tasks specified by the physician director of ultrasound for the day-to-day operation of the facility and the maintenance and operation of the equipment. The chief sonographer must meet all additional requirements for sonographers and other nonphysicians who perform ultrasound examinations.

Sonographers and Other Nonphysicians Who Perform Ultrasound Examinations
Qualified sonographers and other nonphysicians who perform ultrasound examinations (hereto referred to as sonographers) will be responsible for those tasks specified by the physician director of ultrasound and the chief sonographer. Sonographers must have appropriate training for the performance of the sonographic examinations they perform. Requirements for sonographers and other nonphysicians who perform ultrasound examinations are as follows:
  • If an interpreting physician is not immediately available at the time a sonogram is being performed, the sonographer must be appropriately credentialed in the specialty area(s) of the examination.

  • All sonographers must be certified in the specialty or specialties for which the practice seeks accreditation or must become certified before reaccreditation. A sonographer required to become certified in multiple specialties must obtain a minimum of 1 additional specialty per accreditation cycle.
    • The following certifications are acceptable:
      • American Registry for Diagnostic Medical Sonography (ARDMS) certification in abdomen, breast, obstetrics and gynecology, and others as applicable.
      • American Registry of Radiologic Technologists (ARRT) certification in breast sonography.

  • Although a sonographer may play a critical role in extracting the information essential to deriving a diagnosis, the rendering of a final diagnosis of ultrasound studies represents the practice of medicine and, therefore, is the responsibility of the supervising physician.
POLICIES AND PROCEDURES SAFEGUARDING PATIENTS, ULTRASOUND PERSONNEL, AND EQUIPMENT

Patient Identification
  • Many patients have similar-sounding names. The practice must verify the name of each patient before performing an ultrasound examination.
Precautions for Invasive Procedures
  • Time-Outs
    Before beginning an ultrasound-guided invasive procedure, the practice must take steps to verify patient identification, the type of procedure planned, and the appropriate procedure site(s).

  • Specimens
    • The practice must take steps to ensure that specimens are correctly labeled.
    • The practice must clearly define the personnel responsible and the steps required to hand off each specimen.
TIMELY REPORTING OF ULTRASOUND FINDINGS

If physicians are not immediately available for the patient at the time of the sonogram, the sonographer must be registered in the specialty area; a mechanism must be in place to address unexpected or emergency findings; sonograms must be finally read within 24 hours, and if the patient is not kept until the physician reviews the images, a callback mechanism must be described.

FINAL REPORTS

A final report is a written report that has been signed and dated by the interpreting physician. Findings must be recorded and results communicated in a timely fashion to the physician responsible for care.

Reports must specifically address the indication for the study and findings. The final report must meet the requirements specified in the AIUM Practice Guideline for Documentation of an Ultrasound Examination.
  • Verified (signed) final reports must be available within 24 hours of completion of the examination or, for nonemergency cases, by the next business day; exceptions to this time frame must be clarified.
PRELIMINARY REPORTS

A preliminary report is a written or verbal report released before being signed by the physician responsible for giving the final interpretation.
  • If preliminary reports are issued, the reports must be labeled "Preliminary Report."

  • A written policy for communicating the potential differences and changes that may arise between the interpretation of the final report and the preliminary report must be in place for any practice that generates preliminary reports.

  • If the practice permits, preliminary obstetric reports for fetal biometry, biophysical profiles, and viability may be released before review by the interpreting physician if all of the following criteria are met:
    • The examination must be performed by a sonographer who is ARDMS registered in obstetric/gynecologic ultrasound;
    • The preliminary report would only include biometry and/or biophysical profile results and/or fetal cardiac activity;
    • The results are normal; and
    • The final report is complete within 2 hours.

      All other reports must be reviewed by a physician before being released.
INCIDENT REPORTING

A policy/procedure must exist for responding to and reporting any accidents or complications that occur in the facility.

PATIENT CONFIDENTIALITY

All practice personnel must adhere to Health Insurance Portability and Accountability Act regulations and professional ethics and behavior to ensure patient confidentiality.

POLICIES ON PREVENTION OF INFECTIOUS DISEASES

The practice must have procedures and policies on the protection of patients and practice personnel from the transmission of infectious disease as well as the cleaning and disinfection of ultrasound equipment and transducers.

ALARA PRINCIPLE

Personnel must be familiar with and show evidence of practicing the ALARA (as low as reasonably achievable) principle.

QUALITY ASSURANCE

The practice must show ongoing monitoring of the clinical practice’s personnel performance, including all physicians and sonographers.
  • Ultrasound studies must be supervised and interpreted by a physician with training and experience in the specific area of sonography.

  • The practice must show ongoing monitoring of the clinical practice’s personnel performance, including all physicians and sonographers. The practice must demonstrate regular peer review; the diagnostic interpretations and technical merit of images generated by the practice must be independently evaluated for image clarity and diagnostic accuracy.

  • The practice must obtain regular correlation of ultrasound diagnosis of normal and abnormal studies with clinical, radiographic, laboratory, surgical, and pathologic findings; a record of this must be maintained and kept current. Information obtained should be disseminated to both physician and sonographer personnel of the ultrasound practice in a timely fashion.
DOCUMENT STORAGE AND RECORD-KEEPING GUIDELINES AND REQUIREMENTS
  • There must be provisions for the retrieval and storage of examination records of all studies performed.

  • Appropriate documentation of every study must include permanent ultrasound images stored on suitable recording media, as well as a report that indicates the findings obtained by examination.

  • The report and the information included on the images must meet the AIUM Practice Guideline for Documentation of an Ultrasound Examination.

  • Ultrasound images and a report from the interpreting physician must be maintained in a readily accessible fashion for comparison and consultation.

  • Recording media must have a shelf life compatible with the minimum number of years, required by law, for the maintenance of patient records. In most states, this will be for at least 7 years after the patient’s last examination was performed; however, these requirements vary from state to state.
POLICIES PROTECTING PRACTICE PERSONNEL

The practice must be in compliance with all US Occupational Safety and Health Administration regulations.

ULTRASOUND EQUIPMENT MAINTENANCE AND QUALITY ASSURANCE

The ultrasound equipment must meet all state and federal guidelines.

Studies must be conducted with real-time equipment, and transducers must be available with a frequency range that will optimize beam penetration and resolution.

Practices must meet or exceed the quality assurance guidelines specified in Routine Quality Assurance for Diagnostic Ultrasound Equipment.
  • Instrumentation used for diagnostic testing must be maintained in good operating condition and undergo routine calibration at least once a year.

  • All ultrasound equipment must be serviced at least annually, according to the manufacturers’ specifications or, more frequently if problems arise.

  • There must be routine inspection and testing for electrical safety of all existing equipment.