Here are some typical
examples that we as authors and working in the industry for many years have
been involved with as a consultant and/or expert witness that explain the role
of IIP’s/medical physicists in legal (or at least potentially legal) disputes
and show how you can be better prepared as a professional to anticipate
potential legal proceedings.
(Herman):
1.Disputes between
vendors and providers – These types of disputes
are almost always caused by a mismatch of vendor capabilities and provider
expectations. If there is a detailed RFP that spells out the requirements then
the dispute is relatively easy to settle. In one case, a provider did not want
to pay for the PACS delivery as it argued that the PACS did not meet the
requirements. I did an onsite audit checking each RFP item and concluded in my
final report that the vendor had complied with 95% of all items and was due
full payment.
In another case, the
vendor did NOT meet even 50% of the requirements, which forced them to pull out
the system and pay for a replacement. If there is not a detailed RFP to go back
to, it gets hard to find out what the expectations would have been, in which
case there is often a settlement reached in-between.
Lesson learned; make
sure you have very well defined requirements when purchasing a PACS including
performance, features, functionality etc. so you are covered.
2. Technical issues – A radiation therapy
vendor installed both the planning system and the therapy delivery system
(linac). A programming error in the DICOM interface sent the treatment
parameters to the therapy system with the ISO-center inverted, causing patients
who were supposed to be treated for throat cancer to be radiated on their spine
which caused them to become paraplegic. One patient became so depressed that he
took his life. There was an FDA warning issued for the device and it was
eventually corrected, but not after several patients were incorrectly treated.
Lesson learned; never trust a vendor, make sure you check all
settings, parameters, etc. especially if it potentially can cause direct
patient harm.
3. Misdiagnosis – “I did not see that lesion,” is unfortunately still a common
event. Humans are not perfect, but some professionals are just incompetent, and
the general public should be protected from those that do not deserve to be
treating patients. In one case, a radiologist argued that the monitor was
defective, and he could not see the lesion (even I could see the hemorrhage in
the brain). The dispute required the calibration files to be pulled for that
workstation. In another case a radiologist flatly denied that he saw the chest
image to check the tube placement, which was refuted by showing the audit trail
proof that he himself indeed (or someone with his login-password) looked at the
image. In both cases the patient died, in the first case they gave blood
thinner to a patient with a bleed in the brain, in the second case the patient
was in the ICU and died because of incorrect tube placement.
Lesson learned; keep
your calibration files for your monitors safe and also all your audit trails as
they might be needed for a case.
4. QA/QC policies not
being followed – A technologist selected
the wrong study and the report which indicated a terminal disease was connected
to the wrong patient. The good news was that the terminally ill patient already
knew about the disease, but the patient who was perfectly healthy got the bad
news that her days were numbered. After the discovery of the error, you can
imagine the stress and agony she went through, causing her to sue the hospital.
Lessons learned; have
very well defined QA policies in place that require the technologist to double
check the patient demographics, defining these policies typically is the job of
an IIP.
5. Privacy violations – A radiologist was fired because his “supervisor,” i.e. medical
director looked at his brain CT and deemed him to be unfit for practicing
radiology as he had an apparent brain cancer. The medical director argued that
it was her “duty” to perform regular QA checks on all of the department
studies, however, the radiologist argued that his privacy was violated and
should not have been fired for that reason as he had sought medical attention
and was treated accordingly.
Lesson learned; again,
make sure you keep your audit trails available, in this case for proving it was
indeed a privacy violation.
(Jeff)
6. Commercial grade vs.
medical grade displays for diagnostic interpretation – During an evaluation of a radiologist’s home set of 5 MP displays
used primarily for mammography reporting, I was asked to look at her > 5 MP
Apple display as well for comparison. The question she brought to my attention
was “are these satisfactory for mammography interpretation”? The AAPM TG18-QC
test pattern was brought up and looked great (all details supposed to be
observed were observed). However, further measurements of the luminance patches
across the entire dynamic range showed that there was gross non-conformance to
the GSDF curve.
Lessons learned; never
make assumptions regarding the calibration status of your displays, even
if an image looks acceptable for interpretation and/or review. Use of
calibration software with the front sensor and/or external photometer
measurements should occur on a regular basis with documentation and records retention.
7. Phantom image
retention – Routine quality control imaging of phantoms
and/or other test objects can be of value, not only for
compliance/accreditation requirements, but also as a form of documentation to
prove that some sort of constancy evaluation of the image quality is being performed
for your imaging unit. Regulatory officers/inspectors may decide to audit a
facility to show that these phantom images have been retained and are consistent.
Failing to adhere to imaging phantoms or retaining the images can result in
fines, should an officer decide to enforce this. Furthermore, image retention can
be extremely valuable in the event your facility is hit with a lawsuit and/or
allegation.
Lessons learned; know
your regulatory/accreditation requirements and adhere fully to these. Even if
these requirements do not pertain to some modalities, routine phantom imaging
and retention should still occur for the reasons mentioned previously.
8. Dental facility being
sued – I was called in by a lawyer to act as an expert
consultant regarding a dental facility being sued by one of its staff members.
The staff member claimed that the cause of her breast cancer (resulting in a
double mastectomy) and cataracts was the result of use of the facility’s
panoramic x-ray unit. I had reviewed documentation regarding past service/x-ray
compliance reports, Ministry approval to install the x-ray unit, and other
related documentation. Furthermore, I had conducted a comprehensive evaluation
of the unit according to AAPM TG 175 (Acceptance Testing and Quality Control of
Dental Imaging Equipment). Based on my evaluation, no compliance requirements
evaluated or reviewed failed.
Lessons learned; no
matter if the modality produces a low amount of radiation relative to others
(e.g. dental panoramic to diagnostic CT), ensure that you follow all compliance
requirements and retain such documentation for the required amount of time.
Lawsuits are a real thing and can occur for ANY facility!
9. Accidental exposure –
An x-ray technologist had apparently performed
both AP and LAT views of the tibia/fibula of a two-year old child who was
suspected of a fracture. During the AP view, in the midst of the child crying
and the father restraining the child to remain still for the exam, the
technologist had forgotten to give shielding to both the child and father. Lead
protection was provided prior to the LAT view being taken, however. I was
called in to perform a dose/risk analysis regarding this matter. Output
measurements of the x-ray unit were taken as well as a review of the images in
PACS.
Upon review of the image
headers, including the attributes pertaining to exposure techniques, I asked
the technologist if she was aware of what range the exposure indicator should
be within (the exposure indicator being a way to quantify how much radiation
the detector received). The response given to me was a blank stare. In a
follow-up discussion with the diagnostic imaging manager and chief radiologist,
it was explained that the increased radiation risk to the child and father from
the first exposure without any lead protection was minimal. However, it was
further explained that some training for at least this technologist should
occur regarding how much radiation is to be administered (via the exposure
indicator).
Lessons learned;
accidental exposures, even overexposures, deserve due diligence and use of an
expert to add value to the matter. As an incidental finding performing this
review, there was a knowledge gap revealed for this particular technologist. If
radiation is administered, it’s crucial to be able to know how much radiation
is used. Training in best and latest trends/standards should be
implemented.
10. Investigation of
high radiation badge readings – An x-ray facility had a
general radiography room with a control badge directly behind a glass window.
Since the start of using this room, the badge had not registered anything, but
was kept to monitor the secondary radiation just in-case. However, after about one
year of use, the badge was recording values, which surprised and concerned
staff members, particularly some pregnant x-ray workers. I was asked to
investigate this matter.
The facility had
retained the documentation related to what shielding requirements they have
been approved for. Upon reviewing this as well as taking various radiation
measurements, I had noticed that the glass windows were half of the
lead-equivalent thickness they were approved for (1.6 mm Pb vs. 3.2 mm Pb).
Furthermore, the use of the room had increased by approximately three times
from what they were approved for. Putting two and two together with other
related evaluations, I concluded that the increase in use and inappropriate
glass windows were the cause of the higher badge readings.
Lessons learned; when
planning the design for approval of an x-ray room, be sure to verify and
document what shielding is actually installed. One also should be proactive and
plan ahead if they intend to increase the utilization of their x-ray machine,
which will increase shielding requirements.
In conclusion, there are
several unfortunate events (patient injury and/or death), that might end up in
a legal case. You, as an IIP/medical physicist might be asked to either assist
in providing data, an opinion, or serve as an expert witness to get to the
bottom of a situation so that corrective actions and/or compensation for the
ones impacted can be achieved. If you have any questions, don’t hesitate to
contact us:
- Herman Oosterwijk of OTech Inc. (herman@otechimg.com)
- Jeff Frimeth of JF Medical Physics Inc. (jf@jfmedphys.com)
