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Acceptance Testing
New York and many other states require that new imaging equipment
be tested before first use on patients. This is also recommended
in the ACR Standard of Practice and in their Accreditation programs.
UMP has extensive experience providing acceptance testing for new
imaging equipment, including radiographic and fluoroscopic X-ray,
C-arms, CT units, Nuclear Medicine cameras, PET and PET/CT units,
MR units, mammography equipment, CR readers and PACS workstations.
Through our thorough testing and measurements, we have been able
to help clients verify that their equipment meets manufacturer specifications
and regulatory requirements, as well as identify any problem areas
that will need to be addressed to ensure that their substantial
investment in new equipment is maximized.
Most of our clients have felt that the cost of acceptance testing
by an independent, experienced physics group is extremely worthwhile
when compared with the overall cost of the new imaging equipment.
They are especially grateful on those occasions when we have discovered
significant problems that require correction before patient imaging
begins (and before full payment is made).
We believe acceptance testing by an independent physics group such
as ours is akin to having your car or house inspected by an independent
party prior to purchase. It’s a relatively small investment
for a fairly complex piece of imaging equipment. In past acceptance
testing for other clients, we have identified issues that had required
corrective action by the vendor. We have built excellent collaborative
relationships with local service engineers, because we work together
to ensure your imaging equipment works at its optimum performance.
Q&A
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Are there any requirements for acceptance testing?
Some states, like New York, require acceptance testing of all medical
diagnostic equipment before first use on patients. “Diagnostic
equipment,” includes Nuclear Imaging Systems (SPECT and PET),
CR readers and plates, and PACS workstation displays. This clarifies
the common misconception that acceptance testing is only required
for x-ray producing equipment.
Click
Here for the link to the NYS regulation
for Acceptance Testing.
Can acceptance testing be done by the manufacturer?
In New York State, the Medical Physics Licensure Law (Article 166
of the Education Law) specifies that acceptance testing is one of
the practices that may only be performed by a licensed medical physicist.
In section 8702, under the “definition of the practice of
medical physics” that “Acceptance testing” is
listed within the scope of practice.
Note that the education law is not typically enforced by NYSDOH
inspectors. The Medical Physics licensure law does not restrict
unlicensed persons from acquiring data, but rather requires oversight
from a licensed medical physicist.
The bottom line is that, in New York State, Part 16 (Health Law)
says that all diagnostic imaging equipment must be acceptance tested,
and Article 166 (Education Law) specifies that acceptance testing
must be performed by a licensed medical physicist.
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Consulting –
Regulatory, Quality Control, Technology
Medical imaging is becoming anything but simpler. Not
only is the technology becoming increasingly complex,
there are a multitude of regulatory requirements and
quality control tests that change continually. We pride
ourselves in providing prompt, professional advice on
regulatory, quality, and technology issues for all our
clients. Your answer is just a short phone call or email
away. When necessary, UMP consults with a network of
colleagues in the regulatory, manufacturing, and physics
communities.
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Computed Radiography
(CR) – PACS Monitors
CR systems are tested for image quality
and dose calibration. Parameters routinely
evaluated by UMP include: image plate uniformity,
dark noise, signal response for linearity,
calibration and beam quality, laser beam
function, high-contrast resolution, distortion,
and throughput.
Image workstation displays are monitored
annually for proper brightness and contrast.
Improperly calibrated displays can obscure
subtle abnormalities.
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Entrance Skin Exposure Analysis/Entrance
Skin Exposure Rates
ESE is the measurement of radiation output at the point
of skin entry for common X-ray examinations. Based on
our measured data and clinical techniques, we periodically
report ESE and ESER, comparing the results with regulatory
or advisory standards. Most importantly, we advise our
clients about whether or not any changes should be made
to provide optimized imaging at ALARA dose levels. With
CR and DR imaging, this has become even more critical,
since images obtained with too little or too much radiation
do not appear light or dark.
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