Ultrasound


Ultrasound Quality Control FAQ

 

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Ultrasound quality control requirements call for an annual survey to be performed by a qualified medical physicist or appropriately trained personnel with ultrasound imaging equipment experience who has been approved by the lead interpreting physician. We also recommend that routine QC be performed by appropriately trained sonographers or service engineers. As part of the accreditation application, facilities must demonstrate compliance with the ACR requirements for QC by providing:

Contact ultrasound-accred@acr.org or breastultrasoundaccred@acr.org if you have questions about ultrasound or breast ultrasound accreditation.

General

Why is ACR requiring that QC be conducted for ultrasound and breast ultrasound as part of their accreditation programs? 
The committees on ultrasound and breast ultrasound accreditation understand that QC is a vital part of quality imaging and patient safety. For many years, the ACR has alerted accredited facilities through the program requirements that “although the ACR will not initially use [QC] information to determine whether a facility passes or fails accreditation, it may be used in the future to set criteria.” Since most facilities are performing QC as a result of the above notification, the committees decided that it was time to begin requiring QC as part of accreditation.

Medical physicist and radiologist members of both committees decided on the tests and frequencies to be performed, as well as who is responsible for their performance. In addition, the committees strongly recommend that QC be done under the supervision of a qualified medical physicist.

Will not having the annual survey prevent a facility from becoming accredited?
Yes. Effective June 1, 2014, the ACR will not grant accreditation if documentation of compliance with ACR QC requirements is not provided.

What is the difference between acceptance testing, annual surveys and routine QC testing? Many of the tests appear to be the same.
Acceptance testing is initial performance testing of newly installed or repaired imaging equipment (or components) and is completed before clinical use. Acceptance testing should be comprehensive and include all tests done for the annual survey to provide complete performance baselines for comparison with future test results.

Annual surveys are complete tests performed once a year by the medical physicist or designee to assess the performance of the equipment. Although annual surveys include all of the same tests conducted during routine QC testing, it is intended to be more extensive. In addition, annual surveys include an evaluation of the facility’s routine QC program, if applicable.

Routine QC testing is less extensive and is recommended to be performed semiannually by the facility’s sonographer (or a service engineer).

Is preventive maintenance required?
Regular preventive maintenance should be performed and documented by a qualified equipment service engineer following the recommendations of the equipment vendor. 

Will the facility be required to purchase a phantom?
No. Tests of uniformity, geometric accuracy, system sensitivity, and contrast and spatial resolutions must be made using an ultrasound phantom or test object. The ACR does not specify the phantom(s) to be used. Phantoms may be obtained from a variety of commercial vendors or may be fabricated by experienced personnel. Other approaches to performance measurement, e.g., the “paper-clip test”, and use of transducer evaluation devices which test the electrical and acoustic characteristics of each individual transducer array element, may also be used, but may not replace any of the required tests. Additional information may be found in the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real-time Ultrasound Equipment.

Annual Surveys

Will facilities  applying for accreditation have to provide proof that “appropriately trained personnel with ultrasound imaging equipment experience” are conducting the annual surveys?
Presentation of documentation of training is not required as part of the accreditation application. However, the facility must be sure all requirements for personnel are met when they apply for accreditation with the ACR. During ACR site visits, surveyors will request to see verifying documentation. Failure to demonstrate that personnel are qualified could adversely affect accreditation status.

Who must provide the training for “appropriately trained personnel with ultrasound imaging equipment experience” conducting the annual survey?
The ACR strongly recommends that the training for the “appropriately trained personnel with ultrasound imaging equipment experience” be provided by a qualified medical physicist. If unable to acquire training by a qualified medical physicist, training can be achieved through the ultrasound equipment manufacturer or through an appropriate course. Documentation of such training is strongly encouraged. Facilities should keep such documentation on file, but should not submit this documentation with accreditation submissions.

If a test is failed during the annual survey, how long do we have until we must contact service and take corrective action?
If
the annual survey test results fall outside of the acceptable limits, corrective action must be taken. Appropriate action must occur immediately if there is imminent danger to patients or staff using the equipment due to unsafe conditions. However, for other cases there is no specific timeframe required by the ACR. You should consult your medical physicist/service person regarding the seriousness of the failure to determine how quickly corrective action should be implemented. In any event, effective June 1, 2014, the ACR will not grant accreditation if documentation of compliance with ACR QC requirements is not provided; if any tests fail, you must provide documentation of corrective action with your accreditation material.
 
Is there an ACR form the medical physicist (or designee) must use to record his/her annual survey test data and results?
The qualified medical physicist (or designee) may use whatever forms he/she deems appropriate for their Annual Survey. However, effective June 1, 2014, the medical physicist (or designee) must also provide a summary of the Annual Survey pass/fail test results. They may complete the ACR-provided Annual Survey Evaluation Report Summary form which can be found here. Alternatively, they can provide their own summary as long as it itemizes the pass/fail results for each required test.

Is acceptance testing mandatory?
While not required, there is value to be gained in doing acceptance testing, if only to verify to the practice that the equipment will perform as expected when purchasing new imaging systems. It would provide a performance baseline for comparison against the annual survey. This may also be used to establish a timeline for completion of the annual survey.

We have had our ultrasound unit for several years prior to the effective date of this new accreditation requirement and did not perform acceptance testing upon installation. What documentation must we maintain for acceptance testing if none was performed?
Since no acceptance testing was performed, no documentation of such testing can be maintained. It is sufficient to perform routine annual surveys and maintain appropriate documentation is maintained.

If the scanner has only one transducer should all the QC tests be repeated in each port or does verifying that the transducer connects properly in each port satisfy the requirement?
Ideally each transducer and port should be tested. In the case of single probe, it is likely left plugged into the same port all the time, and other ports are not used. In this case, not testing the other ports would be acceptable for accreditation purposes.

Routine Quality Control Testing

Must we submit documentation of routine QC performed by the sonographer as part of the accreditation application?
No, the ACR will not ask for documentation of routine QC performed by the sonographer as part of the accreditation application. Although strongly recommended to ensure continual acceptable performance of US equipment, semiannual QC is no longer be required for submission for ACR US accreditation.

Who should perform routine QC tests?
Routine QC tests are typically performed by appropriately trained sonographers or service engineers.

Who must provide training for “appropriately trained sonographers or service engineers” conducting routine QC?
The ACR strongly recommends that training for “appropriately trained sonographers or service engineers” conducting routine QC be provided by a qualified medical physicist. If unable to acquire training by a qualified medical physicist, training can be achieved through the ultrasound equipment manufacturer or through an appropriate course.

Should a facility assign the lead sonographer to perform routine QC tests? If so, do we need to notify ACR who that person will be?
The lead sonographer is not required to conduct routine QC. You do not need to notify ACR of the designated staff performing QC.

Is there an ACR form that we must use to record our data and results from our routine QC tests?
At this time, the ACR does not provide forms to record data from routine QC tests. We suggest working with your qualified medical physicist to help develop your own forms or contacting the equipment manufacturer.

Can the “in air” test (item 2 in the "Routine QC" table on page 8) be considered the replacement for uniformity test?
An in-air only approach to uniformity assessment for the routine QC test is reasonable and acceptable. A good implementation would provide baseline images of the reverberation/interference pattern for comparison to aid in detecting potential uniformity problems. When obtaining uniformity assessment for the physicist's annual survey (item 2 in the "Annual System Performance Evaluation" table on page 7) the potential limitations to the “in-air only” approach (e.g., limited sensitivity, especially for sector/vector probes) do not support use of in-air images only as a valid approach. In-air images could be used in this evaluation along with other assessment data, e.g., phantom images.