It's a cloudy Thursday morning and the fellowship hall of First Christian Church of Falls Church resembles an emergency room. Near the back are four testing areas hidden by white partitions. The patients, mostly older women, shuttle from station to station. Technologists focus on colorful keyboards and blinking screens.
This is one of many such events held regularly by Life Line Screening of America, a Cleveland-based mobile ultrasound company. The firm provides vascular disease and osteoporosis screenings to identify health problems that might otherwise go undetected.
Lucille Ferrante, 84, has been getting screened annually since learning about the service through a story in a community newspaper. "I've been here about five or six times," the Falls Church resident said. The annual screenings give her peace of mind at an affordable price, she said.
A Life Line brochure mailed to homes in the Washington area proclaims, "We can help you Avoid a Stroke . . . in just 10 minutes. . . . You don't have to wait for a medical problem to be screened for your risk of vascular disease or osteoporosis." And the screenings are "fast, painless, accurate . . . [and] affordable," says the brochure. The firm also promotes its services on its Web site, www.lifelinescreening.com.
Locally, the company charges $109 for the three-test "vascular package" and $129 for a "complete wellness package," which adds the osteoporosis test. Neither Medicare nor most private insurers cover Life Line screenings.
The four tests screen for: plaque buildup in the carotid artery of the neck, which can lead to a stroke; an enlarged abdominal aorta, a higher risk for a potentially deadly rupture; peripheral arterial disease, a hardening of the arteries of the leg; and low bone density in the heel, which can indicate the bone-thinning disease osteoporosis.
Life Line is one of many commercial enterprises providing screening services for a fee to anyone who pays. But most operate from fixed locations. Vans based in Baltimore, Richmond and the District visit about 22 locations each month in the Washington area.
Not everyone thinks these tests are a good idea. A federal panel examining the value of such screenings found that the potential harms of the tests -- including negative psychological effects among those testing positive for aneurysms, and false positives, which often result in unnecessary medication and surgeries -- outweighed the benefits of screening for most groups.
Some experts also expressed concern about screening services that do not require patients to have an elevated risk for the conditions they test for. Typical Life Line screening clients have no symptoms and are over age 40, the firm says.
For "people under age 55 without risk factors, the yield [of vascular disease found] is going to be very low," said William Flinn, head of the division of vascular surgery at the University of Maryland School of Medicine and vice chairman of the American Vascular Association (AVA). "A lot of the [commercial] screening is for the wealthy well," he said.
But Andrew J. Manganaro, Life Line's medical director, said it is not unusual for screenings -- such as mammograms and tests for colon and prostate cancer -- to not "require the presence of specific risk factors."
"It is in the nature of the screening process," said Manganaro in an e-mail interview. "This is precisely because of the ubiquitous nature of the diseases for which the screenings are conducted."
Company-provided data show that for every 100 people screened, seven to nine have abnormal vascular test results. About 35 of every 100 people screened for osteoporosis are found to be at "high risk" for the disease; 65 are at "low to moderate risk."
Manganaro said the company's "incidence of false positives is very low." The firm sees no harm in arming people with additional knowledge about their health.
"We do not believe that accurate knowledge about the status of one's health can produce psychological harm," Manganaro e-mailed. "On the contrary, the failure to learn about previously unrecognized, potentially life- or limb-threatening disease . . . is more likely to cause both physical and psychological injury."
No Doctors on Site
Some physicians also worry that no doctors are on site during the screenings, and the technologists may not be properly credentialed. There are also concerns about allowing a technologist to make potentially critical medical decisions on site, without the aid of a physician.
"They are taking somewhat credible examinations and morphing them in ways that may not be optimal for patient care," said James Borgstede, chairman of the American College of Radiology's board of chancellors. "When a block of images are presented after the fact, the physician who's interpreting them doesn't have the ability" to go back and examine the patient himself or ask additional questions, he said.
Technologists called sonographers conduct the testing, print the images and mail them to physicians -- board-certified cardiologists, vascular surgeons and radiologists -- who interpret the images and send reports of their findings to a processing center, which mails results to patients within three weeks.
Technologists are "highly skilled, registered or eligible to be registered sonographers," Life Line says in a booklet describing its services. (Those deemed "eligible" for registration have "fulfilled all guidelines required" to become registered by accreditation groups -- which also grant registrations -- but have not completed the process, said Rena Law, Life Line's director of clinical operations, in an e-mail interview.) Life Line hires technologists who have "completed a formal ultrasound program," but the company does not do its own training of sonographers, Law said.
While there are groups that accredit non-mobile facilities, no group provides oversight or accreditation for mobile ultrasound companies. The Intersocietal Commission for the Accreditation of Vascular Laboratories is working to develop such criteria.
Borgstede said three weeks is too long to wait for results, in comparison to the several-day turnaround time many non-mobile facilities provide. Life Line says three weeks is the maximum wait time; results typically arrive sooner. In potentially life-threatening situations, technologists are told to inform patients on the day of the screening to follow up with their physicians.
Life Line says it takes steps to ensure the quality of its services. Forms are reviewed for accuracy on the day of the screening and all abnormal screenings are reviewed on-site by a second technologist. Every year, physicians review the work of other company doctors.
In 2002 the firm conducted a small study comparing its carotid and aortic artery measurements to similar testing results from the Cleveland Clinic Foundation's Vascular Laboratory. The results showed "remarkably good agreement" between the two groups' aneurysm studies, and an "excellent level of agreement" in the carotid artery studies, according to the study.
Similar tests are often offered in hospital and doctor's office settings, and some organizations, such as the AVA, periodically offer free screenings, some held in hotels, patient-care facilities and other locations. AVA's screenings always have doctors on site.
What the Feds Say
Of the tests Life Line offers, the only one recommended by the government is the aneurysm screening, and then only for certain patients.
The U.S. Preventive Services Task Force (USPSTF), an independent panel of experts that reviews evidence of effectiveness, suggests one-time ultrasound screening -- at an "accredited facility with credentialed technologists" -- for abdominal aortic aneurysms in men ages 65 to 75 who have ever smoked.
The task force acknowledged potential harms from such screening -- including an "increased number of surgeries with associated clinically significant morbidity and mortality, and short-term psychological harms" -- but said the benefits of screening for this group outweigh the risk of harm.
For men ages 65 to 75 who have never smoked, the task force said, evidence suggests that the balance between potential benefits and harm is too close to recommend screening. For women, potential harms outweigh the benefits of screening.
For carotid artery and peripheral arterial disease screening, the USPSTF said, routine screening for those without symptoms is not recommended.
The task force recommends that women 65 and older, and those 60 and older with elevated risk, be routinely screened for osteoporosis. But instead of sonography it suggests a dual-energy X-ray absorptiometry test, also known as DXA. It is the best predictor of hip fracture, the task force said in a 2002 report.
"Further research is needed to determine the accuracy of peripheral bone density testing" -- such as the heel ultrasound Life Line uses -- compared to the DXA test, the report said.
USPSTF "makes no recommendation for or against routine osteoporosis screening in post-menopausal women who are younger than 60" or in women ages 60 to 64 who aren't at increased risk for fractures.
"The best we can do [through heel ultrasound] is determine whether women should be referred" for DXA, said Marc C. Hochberg, head of rheumatology at the University of Maryland School of Medicine. He suggests women at risk for osteoporosis skip the ultrasound and get the DXA test instead.
Still, some patients prefer both. Two years ago, Ferrante's heel ultrasound indicated diminished bone density. Her doctor sent her for the DXA test and then prescribed osteoporosis medication and calcium supplements. Sometimes screening tests have benefits unrelated to the medical conditions they are intended to identify. When Fredericksburg resident Stan Steinberg had the three vascular screening tests done last year, the technologist "kept going around and around in this one spot on my abdomen," he said. A few days later, Steinberg said, he received his ultrasound report in the mail "strongly advising" him to see his family doctor about the results.
After additional tests, Steinberg learned he had a cancerous tumor on his kidney.
"If it weren't for the fact that [Life Line] found this abnormality, I don't know what it would've led to," Steinberg said.