Department of Veterans Affairs
 

Office of Inspector General
 

Healthcare Inspection
 

Radiation Safety in
 

Veterans Health Administration
 

Facilities
 

Report No. 10-02178-120 March 10, 2011

VA Office of Inspector General
 

Washington, DC 20420
 
To Report Suspected Wrongdoing in VA Programs and Operations:
 

Telephone: 1-800-488-8244
 

E-Mail: vaoighotline@va.gov
 

(Hotline Information: http://www.va.gov/oig/contacts/hotline.asp)
 
Radiation Safety in VHA Facilities 

Contents
 

Page

Executive Summary ..............................................................................................i

Introduction ..........................................................................................................1

Purpose............................................................................................................................. 1

Background...................................................................................................................... 1

Scope and Methodology .................................................................................................. 3

Radiation Modalities and Review Results .........................................................4

Radiation Therapy............................................................................................................ 4

Computed Tomography ................................................................................................... 6

Fluoroscopy ..................................................................................................................... 8

Nuclear Medicine........................................................................................................... 10

Conclusions........................................................................................................12
 

Recommendations .............................................................................................12
 

Comments...........................................................................................................13
 

References ..........................................................................................................14
 

Appendixes
 

A. Sites Visited for Radiation Safety Review .............................................................. 16

B. Under Secretary for Health Comments.................................................................... 17

C. OIG Contact and Staff Acknowledgments............................................................... 22

D. Report Distribution .................................................................................................. 23

VA Office of Inspector General 
Radiation Safety in VHA Facilities 

Executive Summary
 

As requested by the U.S. House of Representatives Committee on Veterans’ Affairs, we

evaluated program oversight and quality assurance (QA) processes for diagnostic and

therapeutic radiation procedures at Veterans Health Administration (VHA) facilities. The

review focused on four areas associated with the greatest potential for harm—radiation

therapy (RT), computed tomography (CT), fluoroscopy, and nuclear medicine. We

excluded brachytherapy as this has been examined in detail in a recent OIG report.

To evaluate RT care, we queried 32 VHA facilities about processes pertaining to

physician peer review (PPR) and conducted onsite inspections at 26 facilities. Site visits

focused on compliance with American College of Radiology QA requirements for RT.

For the 41 linear accelerators at the 26 facilities we inspected, there were 1,092 treatment

days during April–May 2010. We found a day for one linear accelerator on which a daily

machine check was not documented. All but 1 of the 771 treatment records reviewed for

patient-specific QA demonstrated full compliance. For PPR, we found that the 32 RT

programs varied widely with respect to the frequency of peer reviews.

VHA has disseminated information to hospital radiology departments in an effort to

reduce CT dose variability, but we found no oversight of actual doses being delivered. In

our review of patients with the highest cumulative radiation doses from CT scans, we

found that neither patients nor providers had data about cumulative radiation exposure

available to them at the time of clinical decision making. We also found that patients

were not informed that CT scans may cause cancer. To explore the issue of radiation

exposures which may confer a particularly high risk of cancer, we identified patients who

had undergone multiple CT scans. Based on published estimates of radiation levels

associated with each type of CT study, we enumerated those patients with the greatest

cumulative radiation exposure.

For nearly 2 years, VHA has been developing, but has yet to publish, guidance regarding

the use of fluoroscopy. In nuclear medicine, VHA monitors data provided by all facilities

and proficiency assessments are accomplished annually.

We recommended that the Under Secretary for Health: (1) clarify the current expectations

for frequency of PPR in RT, (2) develop a process for monitoring delivered radiation

dose to ensure that patients do not receive excessive doses from CT scans, (3) develop

risk-based criteria for informed consent prior to CT scans, (4) plan for the development

of a mechanism by which patients and providers have information about prior radiation

exposure available to them at the time of clinical decision making, and (5) ensure that the

fluoroscopy handbook is implemented.

The Under Secretary for Health agreed with our findings and recommendations. The

implementation plans are acceptable, and we will follow up on the planned actions until

they are completed.

VA Office of Inspector General i 
Radiation Safety in VHA Facilities 

Introduction
 

Purpose

On January 28, 2010, the U.S. House of Representatives Committee on Veterans’ Affairs

requested that the VA Office of Inspector General (OIG) investigate “quality assurance

and program management of all nuclear medical care, patient safety, and oversight at the

Department of Veterans Affairs.”

This review evaluated program oversight

and quality assurance (QA) processes for

diagnostic and therapeutic radiation

procedures at Veterans Health

Administration (VHA) facilities,

with a focus on areas with the greatest

potential for harm to patients—computed

tomography (CT), fluoroscopy, nuclear

medicine, and radiation therapy (RT).

RADIATION 

THERAPY 

COMPUTED 

TOMOGRAPHY 

FLUOROSCOPY 

QUALITY 

ASSURANCE 

OVERSIGHT 

PATIENT 

SAFETY NUCLEAR 

MEDICINE 

Background

Radiation has been used for more than a century to diagnose diseases and conditions,

contributing greatly to advances in medical care. While any exposure to radiation entails

the possibility of harm, the benefits from more accurate diagnosis are generally

considered to exceed the risks inherent in radiation exposure. However, with the

increased application of sophisticated technologies involving radiation, concerns have

arisen about whether radiation is being used appropriately.

Many imaging procedures are employed in current medical practices, but most radiation

exposure associated with diagnosis occurs with CT, fluoroscopy, and nuclear medicine

studies. Because these procedures involve repeated or extended exposure to radiation,

they are associated with a higher radiation dose. Although CT, fluoroscopy, and nuclear

medicine studies account for only 26 percent of imaging performed annually in the U.S.,

together they comprise 89 percent of the total yearly exposure of patients to radiation.1

While the magnitude of increased cancer risk from exposure to diagnostic radiation is

debated, some degree of increased risk is implicit.2 Patient safety is optimized when

clinical practice guidelines are followed, equipment is functioning properly, staff adhere

to standardized procedures, shielding and engineered safety features are employed, and

radiation doses are as low as reasonably achievable.3,4

VA Office of Inspector General 1 
Radiation Safety in VHA Facilities 

In October 2009, officials at Cedars-Sinai Medical Center in Los Angeles notified the

Food and Drug Administration (FDA) that more than 200 patients had received excessive

radiation while undergoing CT perfusion scans. Because these studies require multiple

scans during intravenous injection of a contrast agent, they entail substantially more

radiation exposure than more typical CT scans. The FDA subsequently identified

additional patients at other hospitals who were exposed to excessive levels of radiation

and in February 2010 issued interim recommendations to address ongoing concerns about

CT perfusion imaging.5

In December 2009, a VHA survey found that 12 facilities performed CT brain perfusion

scans.6 None of the 984 brain scans reported by these 12 facilities were described as

exceeding the maximum recommended radiation dose. Subsequently, VHA instructed

radiology service chiefs and chief technologists on calculation of CT radiation dose,

methods to control dose, target dose levels, and levels that would require disclosure to the

patient.

In contrast to diagnostic radiology, such as CT and fluoroscopy, which uses x-rays from

outside the body, nuclear medicine makes use of radioactive materials which are

ingested, inhaled, or injected into the body. The use of radioactive materials in nuclear

medicine provides an assessment of metabolic function and may be diagnostic or

therapeutic in nature.

According to the American Nuclear Society, an estimated 10 to 12 million diagnostic and

therapeutic nuclear medicine procedures are performed each year in the U.S. In fiscal

year (FY) 2008, VHA’s Nuclear Medicine and Radiation Service (NMRS) program

reported that VHA facilities performed 602,895 procedures. Cardiac procedures

comprised about 75 percent of the workload while positron emission tomography/CT

(PET/CT) studies grew at the fastest rate (an average of 25 percent in each of the

previous 3 FYs).7

Radiation can also be used therapeutically to treat cancers and other abnormal cell growth

while protecting normal cells as much as possible. In the most common form of RT,

conventional or external beam RT, intense radiation from linear accelerators is directed at

tumors. With intensity modulated RT (IMRT), higher doses can be delivered to

abnormal tissue while reducing exposure of adjacent non-target structures.8

With higher doses and better targeted delivery of radiation, IMRT offers the possibility of

more effective treatment with fewer side effects. However, its use also carries an

increased risk of harm to patients when practice guidelines and patient safety systems are

not in place or are not followed. On January 27, 2010, the New York Times reported that

36 cancer patients at the East Orange campus of the VA New Jersey Health Care System

had been over-radiated and that 20 more had received inappropriately low doses of

radiation.

VA Office of Inspector General 2 
Radiation Safety in VHA Facilities 

Scope and Methodology

For this evaluation, we considered all diagnostic and therapeutic uses of radiation but

excluded brachytherapy because this form of treatment has been examined in detail in a

recent OIG report.9 We explored issues pertinent to radiation safety with VHA and

private sector experts and focused this review on four areas of medical imaging

modalities considered to involve the greatest potential for harm to veterans—RT, CT,

fluoroscopy, and nuclear medicine.

To evaluate RT care, we queried 32 VHA facilities about processes pertaining to

physician peer review and conducted onsite inspections at 26 facilities from

August 10 through September 3, 2010. Prior to site visits, we developed and pilot-tested

our inspection measurements at an academically affiliated VHA facility. Site visits

focused on compliance with key elements of American College of Radiology (ACR)

machine- and patient-specific QA requirements for RT9,10 as well as compliance with

required physician peer review activities.10,11

We inspected all 23 RT programs that performed IMRT as of May 2010. In addition, we

visited a probability-based random sample of three of the nine facilities that provided

conventional RT only. Appendix A lists the facilities inspected.

For onsite inspections of patient-specific QA documentation, we statistically and

randomly selected 30 patients who had undergone treatment during

October 2009–May 2010 from each of the 26 VHA facilities. For the 23 IMRT sites, we

selected IMRT patients for onsite QA documentation inspection because the

documentation to be reviewed for conventional patients was included in the

documentation to be reviewed for IMRT patients.

All IMRT patients were included in our review if the facility had 30 such patients or

fewer. For the IMRT sites with fewer than 30 patients, we sampled additional

conventional RT patients.

For onsite machine-specific QA documentation inspection, we verified the existence of

each machine’s QA documentation for the daily and monthly checks for April and

May 2010, annual machine calibration during July 2009–August 2010, and biennial

dosimetry system check during July 2008–August 2010.

To evaluate CT, fluoroscopy, and nuclear medicine procedures, we reviewed VHA

documents and interviewed VHA radiology and nuclear medicine leaders. We also

reviewed requirements and guidelines published by various regulatory and professional

organizations, including the Nuclear Regulatory Commission (NRC), the FDA, the ACR,

and the American Association of Physicists in Medicine (AAPM).

VA Office of Inspector General 3 
Radiation Safety in VHA Facilities 

To explore the issue of radiation exposures which may confer a particularly high risk of

cancer, we identified VHA patients who underwent CT scans of the chest, abdomen, or

pelvis during 2009. We excluded CT scans of the head because, except for perfusion

studies, these scans entail lower levels of radiation exposure. Adverse effects of

low-dose radiation exposure are believed to manifest over many years; therefore, we

excluded patients older than 40 and for this analysis considered only patients who were

ages 39–40 at the time of their most recent scan. Based on published estimates of

radiation levels associated with each type of CT study,12 we enumerated those patients

with the greatest cumulative radiation exposure from the selected CT scans performed

during 2005–2009, excluding patients for whom scans were associated with a cancer

diagnosis.

We conducted the inspection in accordance with Quality Standards for Inspection and 

Evaluation published by the Council of the Inspectors General on Integrity and

Efficiency.

Radiation Modalities and Review Results

Radiation Therapy

Overview. ACR practice guidelines and standards for RT, in place since 1990, were

revised in 2009.10 RT delivers radiation to targeted tissue while limiting the radiation

dose to surrounding healthy tissue to an acceptable level.

Because of the higher doses of radiation typically delivered, IMRT entails a higher risk of

complications and therefore requires specific QA processes to ensure accurate and

reproducible radiation delivery. An effective QA program for IMRT includes systematic

testing of hardware and software as well as reviews of each patient’s treatment plan and

of the actual implementation of that plan.

Peer review is an organizational function designed to maintain and improve the quality of

care through assessments of individual professionals by other peer professionals or a

committee of professionals. Peer review encompasses various activities, including

evaluations in response to specific clinical incidents and ongoing professional practice

evaluation.11 With respect to IMRT, ACR practice guidelines specify that radiation

oncologists must “participate in the peer review of contours and IMRT treatment plans in

conjunction with other members of the team.”13

Review Results 

Machine-Specific QA. Inspectors examined documentation of the following:

 Daily machine output checks performed on each linear accelerator prior to the

performance of any RT procedure during April and May 2010.

 Monthly verifications by a medical physicist during April and May 2010.

VA Office of Inspector General 4 
Radiation Safety in VHA Facilities 

 Annual calibration analyses performed by a medical physicist during

July 2009–August 2010.

 Biennial dosimetry system check by a certified laboratory during

July 2008–August 2010.

The 41 linear accelerators at the 26 VHA facilities visited provided 1,092 treatment days

during April and May 2010. We found 1 day for one linear accelerator on which a daily

machine check was not documented.

Patient-Specific QA. For this component of the review, we reviewed the treatment

records of randomly selected patients. Review elements included verification that a

treatment plan was in place and that a second, independent verification of plan

calculations had been performed. For conventional (non-IMRT) treatments, inspectors

also sought documentation that the treatment plan had been compared with a phantom*

prior to treatment.

We reviewed a total of 771 patient treatment records (649 IMRT and 123 conventional

RT).† With the exception of one conventional RT patient who was undergoing palliative

treatment, we found that every treatment record at the 26 VHA facilities demonstrated

compliance with patient-specific QA requirements.

Physician Peer Review. For this component of the review, we assessed all 32 VHA RT

programs and found wide variation in the nature and frequency of physician peer review.

All 32 facilities had physician peer review processes in place for RT. Four facilities

within one Veterans Integrated Service Network (VISN) (3) accomplished reviews

collaboratively. We observed paperless systems for peer review documentation at two

facilities—the East Orange campus of the VA New Jersey Health Care System and the

Louis Stokes VA Medical Center in Cleveland, OH. Nine facilities (28 percent)

described substantial dependence on locum tenens contractors, fee basis, and universityand military-affiliated physicians.

We noted variation in the frequency of peer reviews conducted at the 32 facilities,

ranging from weekly in 18 facilities (56 percent) to bi-annually

at 1 facility (3 percent). Six facilities (19 percent) reported that peer reviews occurred at

least monthly, and seven (22 percent) reported that peer reviews occurred at least

quarterly.

* A phantom is an object with mass, composition, and dimensions resembling a body or body part used to measure

absorption of radiation.

† Information was received on 4,308 patients who had undergone external beam RT at 26 facilities; 266 cases

(6 percent) were excluded because therapy type was not specified or therapy was initiated outside of the review

period.

VA Office of Inspector General 5 
Radiation Safety in VHA Facilities 

Summary 

We found compliance with standards of practice for machine- and patient-specific QA

processes in VHA RT programs. However, we found inconsistent physician peer review

practices, which could be improved by clarifying national expectations for frequency of

physician peer review practices in RT.

Computed Tomography

Overview. CT is a radiographic technique that constructs three-dimensional images from

a series of cross-sectional images or “slices.” CT typically requires repeated or extended

radiation exposures with radiation doses higher than other frequently performed x-ray

tests. For example, the radiation dose for an abdominal CT scan is more than 10 times

the dose for a mammogram and more than 150 times the dose for a chest x-ray.12

The number of CT scans performed per year has increased dramatically in recent decades

from 3 million in 1980 to 70 million in 2007. More than 1.5 million CT scans are

performed annually in VHA facilities.14

Two recent studies highlighted the potential consequences of radiation exposure from

commonly performed CT scans, indicating that radiation doses are probably higher than

previously believed and may cause tens of thousands of future cancer cases.15,16 One

publication found a surprising degree of dose variability among CT scanners at four

hospitals in the San Francisco area, with doses generally higher than expected. Within

each type of CT scan, doses varied significantly within and across institutions, with a

mean 13-fold variation between the highest and lowest dose for each study type.16 In

response to those studies, the ACR issued a statement pointing out the established

benefits of diagnostic imaging, the uncertainty regarding associated cancer risk, and the

continuing need to evaluate the appropriate use of imaging in clinical practice.17

Older CT scanners lack displays of dose metrics. Newer CT scanners either display dose

metrics at the operator’s console, or dose metrics are embedded with the image itself.

These displays provide parameter settings that optimize both the radiation dose and the

alert system when the radiation dose in a given scan exceeds a particular reference level.

Older scanners also lack the ability to calculate cumulative dose and report standardized

dose. This is a concern because cumulative radiation dose information can be used by the

physician to order the most appropriate diagnostic exam.

VA Office of Inspector General 6 
Radiation Safety in VHA Facilities 

Review Results 

Dose Variability. VHA has disseminated program standards which specify methods of

measuring delivered dose and upper limits of acceptable dose.14 However, we found an

absence of oversight to ensure that delivered doses of radiation are not excessive.

Cumulative Dose. Experts have estimated that as many as 800 malignancies will be

caused by the 1.5 million CT scans performed in VHA facilities annually.14 Although the

magnitude of cancer risk from diagnostic imaging is debated, professional consensus is

that the induced risk of cancer from CT scans is substantial. For relatively young people

undergoing multiple scans, the risk probably exceeds 1:500, and disclosure of risk is

warranted.18

In our review of 40-year-old patients who had CT scans of the chest, abdomen, or pelvis

over a period of 5 years, we identified those individuals with the highest cumulative

radiation dose from these procedures. After excluding patients with cancer diagnoses,

who often require multiple imaging procedures, we determined the reason for the most

recent scan in the treatment of 10 individuals. See the table on the next page.

Notably, only four of the requesting providers indicated awareness that their patients had

had multiple prior CT scans, and VHA has no mechanism to inform patients and

providers of cumulative radiation exposure prior to further medical imaging.

Additionally, there was no documentation that any of the patients had been informed

about the risk of or alternatives to CT scans.

We also noted that in 5 of the 10 cases, a provisional diagnosis describing the need for a

scan was not specified by the requesting provider. In our interviews with VHA leaders,

we found that VHA has no mechanism to ensure that CT scans are requested

appropriately. Although appropriateness criteria have been promulgated,19 they are not

readily available to providers at the time of order entry in VHA’s electronic medical

record.

VA Office of Inspector General 7 
Radiation Safety in VHA Facilities 

Reason for Most Recent CT Other Clinical Condition(s) 

Estimated 5-year 

cumulative dose, 

mSv 

1 Chronic inguinal pain Irritable bowel syndrome, 

history of kidney stones 140 

2 Abdominal pain with UTI PTSD, irritable bowel 

syndrome 130 

3 Abdominal pain Adjustment disorder 128 

4 Abdominal pain Recurrent diverticulitis 120 

5 Chronic abdominal pain History of gastric bypass, 

lumbar pain, menorrhagia 120 

6 Follow-up after bowel 

resection for IBD 120 

7 Flank pain PTSD, depression 120 

8 Kidney cyst HIV infection 114 

9 Flank pain Diabetes, hypertension, recent 

stroke 108 

10 Flank pain Chronic back pain, anxiety 108 

Table. Clinical conditions and radiation cumulative dose for chest, abdomen, and pelvis CT scans among 

patients ages 39-40 (eight male, two female) with non-cancer diagnoses and multiple prior CT scans. 

A single CT scan of the abdomen is associated with an effective radiation dose of approximately 10 mSv. 

The effective dose for a single chest x-ray is 0.04 mSv.12 

mSv = millisievert, a measure of the biological effect of absorbed radiation on specific tissues;
 

IBD = inflammatory bowel disease; PTSD = post-traumatic stress disorder; UTI = urinary tract
 

infection; HIV = human immunodeficiency virus.
 

Summary 

VHA needs to ensure that patients undergoing testing with CT scans receive

non-excessive doses of radiation. Better clinical decisions could result if patients and

clinicians were aware of past radiation exposures.

Fluoroscopy

Overview. Fluoroscopy is a technique for generating x-ray images and presenting them

continuously during a diagnostic or interventional procedure. An x-ray beam is

transmitted through the patient and onto a fluorescent screen coupled with an “image

intensifier” that produces real-time or “live” images on a television monitor.

Fluoroscopic imaging devices are widely utilized throughout VHA facilities both within

and outside of radiology departments. The benefit of utilizing fluoroscopy over other

modalities is its ability to transmit live images during the course of a procedure. With

fluoroscopy, the passage of contrast material can be tracked through the gastrointestinal

VA Office of Inspector General 8 
Radiation Safety in VHA Facilities 

system. Fluoroscopy also permits visualization of blood flow to organs and controlled

manipulation of devices.

Common procedures that utilize fluoroscopy are upper and lower gastrointestinal studies,

cardiac catheterization, intravenous catheter placement, orthopedic surgery, angiography

of the leg and cerebral vessels, and urological surgery. Services within a medical facility

that utilize fluoroscopes include but are not limited to radiology, cardiology, RT,

orthopedic surgery, gastroenterology, vascular surgery, and urology.

Many patients benefit from fluoroscopic procedures, but this use of radiation constitutes a

potential hazard if administered incorrectly.20 Fluoroscopes can deliver large doses of

radiation, increasing the long-term risk of cancer and subjecting patients to the possibility

of immediate harm from skin injury.21,22

The National Health Physics Program (NHPP) provides oversight for radiation safety

throughout VHA. The NHPP’s mission is to assist Radiation Safety Officers (RSOs) and

other personnel working with radiation by making relevant information easily and readily

accessible.23

The Radiology Program Office recommends courses of action to VHA headquarters,

VISNs, and facility staff regarding trends in imaging in order to facilitate timely, cost

effective, and high quality diagnostic care for patients. It also provides guidance for

VHA radiology programs through the Radiology Field Advisory Group.24

Review Results 

Since early 2009, VHA has been developing a fluoroscopy handbook which incorporates

guidance from the AAPM, the ACR, the FDA, and the National Council on Radiation

Protection and Measurements. The VA Online Radiology Guide also provides guidelines

on radiation safety relative to fluoroscopy.25

According to the National Radiation Safety Group, a team of radiation safety experts

within VHA, policies addressing fluoroscopy safety practices have been developed by

each facility.

The Joint Commission considers prolonged fluoroscopy time as a reviewable sentinel

event. Therefore, facilities are required to maintain a log book to record the duration of

fluoroscopy procedures and to have a process to follow if the facility-established

threshold for allowable fluoroscopy time is exceeded.26 In addition, various regulatory

agencies have developed practice guidelines and standards for QA and quality control

(QC).‡

‡ QC is a set of procedures intended to ensure adherence to a defined set of performance criteria.

VA Office of Inspector General 9 
Radiation Safety in VHA Facilities 

Summary 

Patient safety during fluoroscopy procedures could be enhanced by the completion and

implementation of VHA’s fluoroscopy handbook so that specific standards are

established for fluoroscopy care in all VHA facilities.

Nuclear Medicine

Overview. Nuclear medicine diagnostic procedures involve the use of small amounts of

radiopharmaceuticals (also referred to as tracers) to examine organ function and structure.

For these procedures, a tracer is injected into a vein, swallowed, or inhaled as a gas.

After accumulating in the area of the body being examined, the tracer emits energy in the

form of gamma rays. This energy is detected and used for computer-generated images

showing both structure and function of the tissues being examined.

Therapeutic procedures entail the use of radioactive materials to deliver therapeutic doses

of radiation to specific tissues. In a typical procedure for the treatment of thyroid cancer,

radioactive iodine (

131I) is swallowed, absorbed from the gastrointestinal tract, and

concentrated from the blood into the thyroid gland.

Because of their potentially hazardous properties, the use of radioactive materials is

closely regulated by the NRC. The Code of Federal Regulations sets forth requirements

pertaining to the use of radioactive by-product materials for medical use.§ The NRC

ensures that users of radioactive materials keep radiation exposure within the agency’s

specified dose limits and as low as reasonably achievable. Users are required to be

licensed and must undergo inspections by the NRC to ensure safe practices with

radioactive materials and compliance with regulations.

In 2003, the NRC issued a Master Materials License (MML) to the VA. The VA NHPP

manages the MML and issues each VHA facility a Materials Permit for all use of

radioactive materials. Under the guidance of the VA National Radiation Safety

Committee (NRSC), the NHPP provides regulatory oversight for the NRC’s MML,

which entails permitting the use of radioactive materials, conducting onsite inspections,

and investigating allegations and incidents.

As with other imaging modalities, patients undergoing nuclear medicine procedures are

exposed to ionizing radiation. Minimizing the risk of medical radiation requires reducing

unnecessary use of radiation in diagnosis and treatment and ensuring that equipment and

practices meet regulatory standards.

§ Title 10 of the Code of Federal Regulations, Part 35 (10 CFR Part 35).

VA Office of Inspector General 10 
Radiation Safety in VHA Facilities 

Review Results 

In 1991, VHA established the NMRS to advise the Under Secretary for Health on all

matters related to nuclear medicine and radiation safety. The NMRS has issued guidance

to promote and monitor quality of care and safety practices in nuclear Medicine.27

Additionally, the NMRS has instituted annual reporting of nuclear medicine services’

resource utilization and performance with respect to quality and safety. Also, the NMRS

has developed guidelines for screening procedure requests for appropriateness based on

published criteria.28

As authorized under the NRC’s MML, the NRSC has primary oversight responsibility for

all uses of ionizing radiation at all VHA facilities.29 The NRSC maintains and

implements the MML through NHPP. In turn, NHPP directs the day-to-day

implementation of the MML and coordinates NRSC activities. In addition, NHPP

provides consultations and performs reactive and proactive inspections to investigate

incidents and evaluate regulatory compliance.

At the facility level, the Director is the individual responsible for ensuring regulatory

compliance and safe use of radioactive materials. Generally, this responsibility is

delegated to the facility Radiation Safety Committee (RSC) and the RSO. The RSC

develops local policies for the control of the administration of radio-labeled blood

products.30 The RSO completes day-to-day activities and performs an annual review of

the Radiation Safety Program.

Nuclear Medicine Services are required to develop a comprehensive program that

includes daily QC procedures for gamma cameras and other equipment, protocols for

each nuclear medicine procedure, review of scan requests for appropriateness, and

imaging proficiency and radio-bioassay laboratory testing.

To assess proficiency, NMRS contracts with the Society for Nuclear Medicine to provide

VHA facilities with phantom testing materials annually. These exercises are designed to

test each facility’s ability to display images, identify abnormalities, and formulate a

clinical diagnosis.

Clinical laboratories oversee radio-bioassay testing or the measurement of radioactivity in

body fluids, and the College of American Pathologists conducts regular onsite inspections

to ensure compliance with regulatory requirements.

Summary 

Overall, we determined that VHA has appropriate oversight and QA activities to

minimize radiation risks to nuclear medicine patients at VHA facilities.

VA Office of Inspector General 11 
Radiation Safety in VHA Facilities 

Conclusions

We found compliance with standards of practice for machine- and patient-specific QA

processes in RT. However, we found inconsistent performance of physician peer review,

which could be improved by clarifying national expectations for frequency of physician

peer review practices in RT.

Regarding CT scans, we found an absence of oversight to ensure that delivered doses of

radiation are not excessive. We also found that patients are not routinely informed prior

to imaging procedures which carry a significant risk of induced cancer. Further, we

identified a need for patients and providers to have information about prior radiation

exposure available to them at the time of clinical decision making.

Patient safety during fluoroscopy procedures could be enhanced system wide with

expedited implementation of the VHA fluoroscopy handbook.

We found that VHA has appropriate oversight and QA activities in place to minimize

radiation risks to nuclear medicine patients.

Recommendations

We recommended that the Under Secretary for Health, in conjunction with VISN and

facility senior managers:

Recommendation 1: Clarify the current expectations for frequency of physician peer

review practices in RT.

Recommendation 2: Develop a process for monitoring delivered radiation dose to

ensure that patients do not receive excessive doses during CT procedures.

Recommendation 3: Develop criteria for patient informed consent requirements prior

to CT testing.

Recommendation 4: Include in strategic planning a mechanism by which patients and

providers have information about prior radiation exposure available to them at the time of

clinical decision making.

Recommendation 5: Ensure that the fluoroscopy handbook is implemented.

VA Office of Inspector General 12 
Radiation Safety in VHA Facilities 

Comments

The Under Secretary for Health agreed with our findings and recommendations. The

implementation plans are acceptable, and we will follow up until all actions are

completed.

 (original signed by:)

JOHN D. DAIGH, JR., M.D.

Assistant Inspector General for

Healthcare Inspections

VA Office of Inspector General 13 
Radiation Safety in VHA Facilities 

References
 

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radiation exposure from medical imaging, February 2010. Available at:

http://www.fda.gov/downloads/RadiationEmittingProducts/RadiationSafety/RadiationDoseReduction/UCM200087.pdf. 2

Amis E.S., Butler P.F., Applegate K.E., et al., “American College of Radiology White Paper on Radiation Dose in

Medicine,” J Am Coll Radiol. 2007; 4 (5): 272–284. Available at:

http://www.jacr.org/article/S1546-1440(07)00108-1/fulltext. 3 American College of Radiology. ACR technical standard for diagnostic medical physics performance monitoring

of radiographic and fluoroscopic equipment, October 1, 2006. Available at:

http://www.acr.org/secondarymainmenucategories/quality_safety/guidelines/med_phys/radio_fluoro_equipment.asp. 4 American Association of Physicists in Medicine. Managing the Use of Fluoroscopy in Medical Institutions; AAPM

Report 58; 1998. Available at: http://www.aapm.org/pubs/reports/RPT_58.pdf. 5 U.S. Food and Drug Administration. FDA makes interim recommendations to address concern of excess radiation

exposure during CT perfusion imaging, December 7, 2009. Available at:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm193190.htm. 6 Department of Veteran Affairs Memorandum. CT Perfusion Scan Survey Results, March 2010. 7 Department of Veteran Affairs. Nuclear Medicine and Radiation Safety Services FY 2008 Annual Report,

November 24, 2009.

8 American College of Radiology. ACR practice guideline for intensity-modulated radiation therapy (IMRT), 2003.

Available at:

http://www.acr.org/Hidden/Economics/FeaturedCategories/ManagedCare/resources_common_coverage/IntensityM

odulatedRadiationTherapyIMRT/ACRPracticeGuidelineforIntensityModulatedRadiationTherapyIMRTDoc1.aspx. 9 VA OIG. Healthcare Inspection – Review of Brachytherapy Treatment of Prostate Cancer, Philadelphia, 

Pennsylvania and Other VA Medical Centers. May 3, 2010.

Available at: http://www4.va.gov/oig/54/reports/VAOIG-09-02815-143.pdf. 10 American College of Radiology. ACR Practice Guideline for Radiation Oncology, 2009. Available at:

http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/ro/radiation_oncology.aspx

11 VHA Directive 2010-025, Peer Review for Quality Management, June 3, 2010. 12 Health Physics Society. Radiation exposure from medical diagnostic imaging procedures.

Available at: www.hps.org/documents/meddiagimaging.pdf. 13 American College of Radiology. ACR-ASTRO practice guideline for intensity-modulated radiation therapy

(IMRT), 2007.

Available at: http://www.acr.org/secondarymainmenucategories/quality_safety/guidelines/ro/imrt.aspx. 14 Anderson, Charles M., National Radiology Director, Veterans Health Administration. “Controlling CT Radiation

Dose,” March 2010.

15 Berrington de Gonzalez A, et al. “Projected cancer risks from computed tomographic scans performed in the

United States in 2007,” Arch Intern Med. 2009;169:2071–2077.

16 Smith-Bindman R, Lipson J, Marcus R, et al. “Radiation dose associated with common computed tomography

examinations and the associated lifetime attributable risk of cancer,” Arch Intern Med. 2009;169:2078–2086.

17 American College of Radiology. ACR Statement on recent studies regarding CT scans and increased cancer risk,

2010. Available at:

http://www.acr.org/MainMenuCategories/media_room/FeaturedCategories/PressReleases/StatementonRecentStudie

sRegardingCTScans.aspx. 18 Baerlocker M.O., Detsky A.S. Discussing radiation risks associated with CT scans with patients. JAMA. 2010;

304:2170–1.

19 American College of Radiology. ACR’s Appropriateness Criteria®. Available at:

http://www.acr.org/secondarymainmenucategories/quality_safety/app_criteria.aspx. 20 Hirshfeld J.W., et al. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize

patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures. Circulation. 2005;

111:511–32.

VA Office of Inspector General 14 
&

Radiation Safety in VHA Facilities 

21 U.S. Food and Drug Administration. Public Health Advisory: Avoidance of Serious X-Ray Induced Skin Injuries

to Patients during Fluoroscopically-Guided Procedures, September 30, 1994. 22 U.S. Food and Drug Administration. Radiation-Induced Skin Injuries from Fluoroscopy, September 1996.

23 Department of Veterans Affairs. National Health Physics Program.

Available at: http://nhpp.med.va.gov/aboutus.asp. 24 Department of Veterans Affairs. VA National Radiology Program. Available at: http://vaww1.va.gov/Radiology/. 25 Department of Veterans Affairs. Radiology Online Guide.

Available at: http://vaww1.va.gov/RADIOLOGY/Safety.asp. 26 The Joint Commission, Sentinel Events Policy and Procedures.

Available at: http://www.jointcommission.org/Sentinel_Event_Policy_and_Procedures/. 27 VHA Handbook 1105.2, Nuclear Medicine and Radiation Safety Service Guidance, February 15, 2002.

28 Department of Veteran Affairs. Nuclear Medicine Radiation Safety Services Appropriateness Criteria for

Commonly Performed Nuclear Medicine Imaging Procedures, February, 2007.

29 VHA Memorandum Delegation of Authority, Under Secretary for Health, September 21, 1998.

30 VHA Directive 2010–037, Administrative Practices for Ensuring Safe Injection of Radio-Labeled Blood Products,

August 17, 2010.

VA Office of Inspector General 15 
Radiation Safety in VHA Facilities 

Appendix A

Sites Visited for Radiation Safety Review

Name Location VISN 

Samuel S. Stratton VA Medical Center Albany, NY 2 

James J. Peters VA Medical Center Bronx, NY 3 

VA NY Harbor Healthcare System, Brooklyn Campus Brooklyn, NY 3 

VA New Jersey Health Care System, East Orange Campus East Orange, NJ 3 

Northport VA Medical Center Northport, NY 3 

Philadelphia VA Medical Center Philadelphia, PA 4 

VA Pittsburgh Healthcare System Pittsburg, PA 4 

Washington DC VA Medical Center Washington, DC 5 

Hunter Holmes McGuire VA Medical Center Richmond, VA 6 

Durham VA Medical Center Durham, NC 6 

Atlanta VA Medical Center Decatur, GA 7 

Miami VA Healthcare System Miami, FL 8 

James A. Haley Veterans’ Hospital Tampa, FL 8 

Mountain Home VA Medical Center Mountain Home, TN 9 

Memphis VA Medical Center Memphis, TN 9 

Louis Stokes VA Medical Center Cleveland, OH 10 

Dayton VA Medical Center Dayton, OH 10 

VA Ann Harbor Healthcare System Ann Harbor, MI 11 

Richard L. Roudebush VA Medical Center Indianapolis, IN 11 

Edward Hines Jr. VA Hospital Hines, IL 12 

Clement J. Zablocki VA Medical Center Milwaukee, WI 12 

St. Louis VA Medical Center St. Louis, MO 15 

Michael E. DeBakey VA Medical Center * Houston, TX 16 

VA North Texas Health Care System – Dallas VA Medical Center Dallas, TX 17 

VA Greater Los Angeles Healthcare System Los Angeles, CA 22 

VA Long Beach Healthcare System Long Beach, CA 22 

Minneapolis VA Health Care System Minneapolis, MN 23 

* pilot site
 

VA Office of Inspector General 16 
Radiation Safety in VHA Facilities 

Appendix B

Under Secretary for Health Comments

Department of

Veterans Affairs Memorandum

Date:

From: 

Feb 17, 2011

Under Secretary for Health (10)

Subject:	 OIG Healthcare Inspection Draft Report, Radiation Safety in

Veterans Health Administration Facilities (VAIQ 7013978)

To: Assistant Inspector General for Healthcare Inspections (54)

1. I have reviewed the draft report and concur with all five of the of the

report’s recommendations. Attached is VHA’s corrective action plan for

the report’s recommendations.

2. Thank you for the opportunity to review the draft report. If you have

any questions, please contact Linda H. Lutes, Director, Management

Review Service (10B5) at (202) 461-7014.

Robert A. Petzel, M.D.

Attachment

VA Office of Inspector General 17 
Radiation Safety in VHA Facilities 

VETERANS HEALTH ADMINISTRATION (VHA)

Action Plan

OIG Draft Report, Radiation Safety in Veterans Health 

Administration Facilities (VAIQ 7013978) 

Date of Draft Report: December 9, 2010 

Recommendations/ Status Completion 

Actions Date 

We recommended that the Under Secretary for Health, in conjunction with

VISN and facility senior managers:

Recommendation 1: Clarify the current expectations for frequency of

physician peer review practices in RT.

VHA Comments

Concur

VHA concurs about the need for a robust physician peer review process

related to all RT programs; however, VHA also notes that the variation in

the types of practices throughout the country requires that VHA evaluate

what works best in an individual practice depending on its unique

characteristics. This is in the context of the broad expectations included in

the physician peer requirements used in the American College of Radiology

(ACR) accreditation process, and the 2007 Joint Commission medical call

standards that placed a renewed emphasis on measurement of practitioner

competency.

The current nationally defined expectation regarding the frequency of

physician peer review practice for RT is that they are to be done either

through weekly case conference reviews, or through periodic peer reviews

of each physician. The selection of one system over the other depends

upon available physician staffing, or the association with a university

affiliate. In some cases, facilities do both types of physician peer review.

While periodic physician peer review in RT by a second physician must

occur on at least a semi-annual basis, new case peer reviews occur weekly.

Either of these processes meets the ACR requirement for physician peer

review.

VA Office of Inspector General 18 
Radiation Safety in VHA Facilities 

The 2007 Joint Commission medical call standards do not specifically

quantify a timeframe for ongoing evaluations, but the suggestion has been

that, at a minimum, clinical leadership must be able to demonstrate that it

examines relevant provider data every 6 months and is able to demonstrate

continuous monitoring of important aspects of care on a frequent basis.

In recognition of the OIG concern and to ensure that satisfactory peer

review processes are in place for each RT practice, the National Director

for the Radiation Oncology Program will review and verify by

March 1, 2011, that the frequency for each practice is appropriate. Also,

two methods for providing weekly case conference reviews to every VHA

radiation oncology practice are under consideration. Technical issues

preclude implementation in the near future, but evaluation of these

possibilities will be ongoing.

Completed

Recommendation 2: Develop a process for monitoring delivered

radiation dose to ensure that patients do not receive excessive doses during

CT procedures.

VHA Comments

Concur

VHA’s Radiology Program Office and the National Health Physics

Program will develop guidelines for monitoring computed tomography

(CT) exposures. Statements from professional societies will be utilized in

formulating this guide. The guideline will define the following parameters:

 What radiation dose measurements should be monitored and in what

units the measurements should be recorded.

 Reference and alert values for common CT procedures.

 Resource materials to assist radiology services in reviewing

protocols and choosing acquisition parameters.

 Reporting procedure for doses that exceed reference values.

VHA’s Radiology Program Office and the National Health Physics

Program will collaborate with the Deputy Under Secretary for Health for

Operations and Management (DUSHOM) to test the guidelines at select

field locations. The guidelines will be composed by May 2011. Once

testing has been completed, the guidelines will be converted into Directives

for all facilities to utilize.

In process May 31, 2011

VA Office of Inspector General 19 
Radiation Safety in VHA Facilities 

Recommendation 3: Develop criteria for patient informed consent

requirements prior to CT testing.

VHA Comments

Concur

VHA’s Radiology Program Office, the National Center for Ethics in

Healthcare, and the National Health Physics Program, will develop a

patient information sheet to educate patients on stochastic and deterministic

risk. They will also establish criteria for obtaining signature informed

consent for high-risk CT scans. This criteria will be based on parameters

such as age, life expectancy, and predicted dose. VHA Handbook 1004.01

“Informed Consent for Clinical Treatments and Procedures,” will be

appropriately updated.

In process June 30, 2011

Recommendation 4: Include in strategic planning a mechanism by

which patients and providers have information about prior radiation

exposure available to them at the time of clinical decision making.

VHA Comments

Concur

VHA’s Radiology Program Office has entered a New Service Request for

an information system that will automatically collect procedure radiation

dose from imaging equipment, save the data in a registry, and display the

information at the time of order entry or ad hoc. Patients will be counseled

about the availability of this information and may request a list of

procedures and approximate radiation doses. Completion of this project

will depend on funding. The Veterans Health Information Systems and

Technology Architecture (VistA) Imaging development team has begun

analysis of data extraction from image files which will be completed in

July 2011.

In process July 31, 2011

Recommendation 5: 

implemented.

Ensure that the fluoroscopy handbook is

VHA Comments

Concur

VA Office of Inspector General 20 
Radiation Safety in VHA Facilities 

VHA’s Radiology Program Office, the National Health Physics Program

Office, and the Office of Medical Staff Affairs within VHA’s Chief Quality

and Performance Office will finalize the Fluoroscopy Handbook. The

remaining task is to define what personnel can operate fluoroscopes. State

laws differ on operation and supervision requirements for such individuals

as nurses, nurse practitioners, and physician assistants.

In process May 31, 2011

Veterans Health administration

February 2011

VA Office of Inspector General 21 
Radiation Safety in VHA Facilities 

Appendix C

OIG Contact and Staff Acknowledgments

OIG Contact Daisy Arugay, MT

Los Angeles Office of Healthcare Inspections

Acknowledgments Limin X. Clegg, PhD

Matthew Frazier, MBA

Douglas Henao, RD

Jerome E. Herbers, MD

Simonette Reyes, RN

Kathi Shimoda, RN

Mary Toy, RN

Julie Watrous, RN

Elizabeth Bullock, Program Support

VA Office of Inspector General 22 
Radiation Safety in VHA Facilities 

Appendix D

Report Distribution
 

VA Distribution

Office of the Secretary

Veterans Health Administration

Assistant Secretaries

General Counsel

Veterans Integrated Service Network Directors (1–23)

Non-VA Distribution

House Committee on Veterans’ Affairs

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and

Related Agencies

House Committee on Oversight and Government Reform

Senate Committee on Veterans’ Affairs

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and

Related Agencies

Senate Committee on Homeland Security and Governmental Affairs

National Veterans Service Organizations

Government Accountability Office

Office of Management and Budget

This report is available at http://www.va.gov/oig/publications/reports-list.asp.

VA Office of Inspector General 23