HCV tests urged for those transfused before July ’92

PHS look-back part of effort to test risk groups

The Public Health Service (PHS) has begun a national campaign to encourage hepatitis C virus testing among transfusion recipients who received blood prior to the development and subsequent improvement of HCV assays.

HCV testing was developed in 1990, and more sensitive assays were devised in July 1992. Following the introduction of more sensitive and effective HCV blood tests, the risk of transfusion-related infection is now in the range of one in 100,000 units transfused, compared to one in 200 before screening, according to PHS estimates.

Infection control professionals, some of whom are already fielding questions about the testing effort, may become more directly involved in some of the follow-up or educational aspects of the program depending on job duties at their respective facilities. The PHS initiative includes both "targeted" and "general" efforts, with the former encouraging HCV tests for patients who are actually suspected of receiving tainted blood and the latter urging testing for those who simply have a history of blood transfusions prior to July 1992. The national effort includes involvement by the Food and Drug Administration, the Centers for Disease Control and Prevention, the American Red Cross, and other blood banking groups and transfusion services.

HCV-positive donors may have slipped through

"The more precise tests are more sensitive and therefore identify infected individuals who may have actually tested negative on the prior test," explains Miriam Alter, PhD, chief of epidemiology in the CDC hepatitis branch. "If [blood] donors who donated before testing was available — or [who donated] when the less precise test was being used — come back to donate at a later time and test positive, then it is possible that the prior units that they donated might have been infected. "

Beginning on March 23, 1999, blood banks are to identify repeat donors who test positive for HCV and determine when they donated blood in the past back to 1988.

"We aren’t going further back than that because records generally aren’t available in most transfusion services," Alter says.

After reviewing the records of previous donations of HCV-infected donors, blood collection groups are to notify hospital and health care transfusion services where the units were sent. The transfusion services are being asked to determine whether or not the blood units were transfused and to whom. Once the transfusion service gets the name of a donor, staff are to notify the recipient if sufficient patient or physician locating information is available. Then the transfusion recipient is sent a letter of notification either directly — by the transfusion service — or by the physician, apprising the recipient of the situation and urging him or her to be tested for HCV. (See sample letter, above.)

"Many blood collection groups are working with the transfusion services to offer free testing," Alter says. "Not all, but many. I’m fairly positive the American Red Cross is going to be offering free testing and many of the independent blood centers as well."

The response from hospitals where patients may have been transfused HCV-infected blood will vary, but the basic questions will be similar across the board, notes Pamela Parker, RN, MEd, CIC, director of infection control at the University of Cleveland (OH) Hospitals and Clinics.

"The questions everybody is going to be asking is, how do we inform the patient, how do we inform the physician, how do we make sure the patient gets some follow-up?" she tells Hospital Infection Control. "I think a lot of hospitals are going to try to get infection control to do a lot of the triaging of calls and questions, because we’re generally user-friendly. You really just have to look at how large your numbers are and who is best to do this."

For example, her infection control department has not been assigned primary responsibility because the follow-up duties are expected to be considerable at a large teaching hospital where hundreds of patients may need to be contacted, Parker says.

"While we were in on the planning, we are not going to be responsible for doing all of the notification and triaging of questions because we have such a huge number [of former patients] that we are expecting," she says.

In addition to the targeted look-back notification effort, which is triggered by repeat donors testing HCV-positive, the PHS campaign includes a separate general program beginning in May aimed at all patients transfused before the July 1992 testing refinements. The broader initiative is needed because patients who were transfused HCV-infected blood from a one-time donor will not be identified by the targeted program, which is only triggered by repeat donors coming back in to donate blood, Alter explains.

"The targeted notification won’t reach everybody who is at risk," Alter says. "In fact, the longer ago you were transfused, the higher the risk. The risk was higher in the ’60s and ’70s than it was in the ’80s or ’90s. So the general notification is actually an educational campaign directed at both the public and health care professionals. [The goal is] to motivate people to get tested who have been transfused before the more precise tests were widely implemented. It is also to motivate and educate physicians who take care of people with a history of transfusions to identify them and offer them testing."

The outreach efforts will enable clinicians to combat the severity of future liver disease in HCV-infected patients through medical treatment and by advising them to limit alcohol intake and get vaccinated for the hepatitis A virus. While there is no cure or vaccine for HCV, there is increasing evidence that prolonged therapy with a combination of interferon alpha and ribavirin may provide substantial benefit to certain patients. Moreover, knowledge of their infection and education about prevention approaches will help thwart continued transmission from unknown HCV carriers. HCV is spread primarily by direct contact with blood. (See charts, above and p. 53, and recommendations to prevent transmission, p. 50.)

"We’re starting with transfusion recipients, but then we plan to go on and target the other risk groups, which in most instances accounts for many more infections," Alter says. "The biggest risk group is current and former injecting drug users."

ICPs involved in patient or staff education programs can assist in the effort by raising awareness about HCV and the testing programs. For example, educating physicians about the need to encourage HCV testing in their patients with a history of blood transfusions prior to July 1992 could lead to testing opportunities when patients are hospitalized or treated for other medical conditions.

"There are some other specialized patient groups [at HCV risk] such as the chronic long-term hemodialysis patients, and many hospitals have hemodialysis units," Alter adds. "All of those patients should be tested."

Patients with hemophilia and those with abnormal liver ALT levels also should be tested for HCV, she adds.