Standards and Guidelines for the Accreditation of Ultrasound Practices

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Standards and Guidelines for the Accreditation of Ultrasound Practices
Approved December 17, 2010
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. These Standards
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:
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Abdominal/General Ultrasound (may include thyroid/parathyroid ultrasound and
musculoskeletal ultrasound)
Breast Ultrasound (diagnostic and/or interventional)
Fetal echocardiography
Gynecologic Ultrasound
Obstetric or Trimester-Specific Obstetric Ultrasound
Dedicated Thyroid/Parathyroid Ultrasound
Dedicated Musculoskeletal 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:
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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
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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).
If the practice is applying for accreditation in dedicated musculoskeletal
ultrasound, each physician must have been involved in the performance,
interpretation and reporting of 150 musculoskeletal ultrasound
examinations.
Must maintain documentation of appropriate continuing education:
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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
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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 fetal echocardiography
must obtain a minimum of 10 AMA PRA Category 1 Credits™ in fetal
echocardiography every 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 dedicated musculoskeletal
ultrasound, must obtain a minimum of 30AMA PRA Category 1 Credits™
in musculoskeletal ultrasound every 3 years.
If the practice is applying for accreditation in any category other than
breast ultrasound, dedicated thyroid/parathyroid ultrasound, or
dedicated musculoskeletal 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*:
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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.
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For dedicated musculoskeletal ultrasound accreditation, each
participating physician must meet a minimum of 50 diagnostic
musculoskeletal ultrasound procedures annually.
For fetal echocardiography accreditation, each interpreting physician
must meet a minimum of 100 fetal echocardiograms annually. Indicated
detailed fetal anatomic examinations (CPT code 76811) which include
extensive evaluation of the fetal heart may be counted towards this
minimum.
*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:
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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:
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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.
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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.
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The following certifications are acceptable:
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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
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Many patients have similar-sounding names. The practice must verify the name of
each patient before performing an ultrasound examination.
Precautions for Invasive Procedures
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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).
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Specimens
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The practice must take steps to ensure that specimens are correctly
labeled.
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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.
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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.
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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:
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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
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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.
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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
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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.
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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.
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