By Carol A. Kemper, MD, FACP

Transfusion-Associated WNV

Source: CDC. MMWR Morb Mortal Wkly Rep. 2002;51(43):907.

As of October 2002, 47 cases of possible transfusion-associated West Nile Virus (WNV) infection were reported to the CDC. Further investigation determined that 14 of these persons did not have WNV infection or their infection was unrelated to transfusion. Of the remaining 33 cases (from 17 different states), strong evidence suggests that infection was acquired through receipt of blood components in 6 people. The remaining cases are still being investigated.

Meningoencephalitis occurred in at least 3 of these 6 cases, resulting in 1 death. Most of these patients were immunocompromised and/or received multiple units of blood or fresh frozen plasma. In 3 of the cases, donors of the suspect units became ill 2-5 days after donation. WNV was isolated from an untransfused unit of fresh frozen plasma from 1 of these donors, indicating that the virus can survive in stored, frozen product. A quantitative PCR assay was used to identify virus in several other units, although the units tested negative for WNV-specific IgM antibody.

Any case of WNV infection occurring in patients who have received blood transfusions within the previous 1 month should be reported to the CDC. In addition, potential donors should be counseled to report any signs or symptoms of illness within 2 weeks following donation. This preliminary data suggest that transfusion-related infection may be more severe and may result in greater morbidity, although several of these patients were severely immunosuppressed. The results of quantitative assays of viral load on compromised blood components would be of interest.

Patient Privacy Laws—2002

Source: Kulynych J, Korn D. N Engl J Med. 2002;347:1133-1134.

The revised federal medical-privacy rule was finally released for public consumption by DHHS in August (Federal Register 67:53182-53273, 2002)—and is a must-read for any clinical researcher. The new 2002 rules have been (somewhat) streamlined and softened compared with the Clinton administration document initially released in December 2000. For example, the older document required appropriate authorization and approval even for a simple chart review with strict time limitations on how and when data could be used; research could not be conducted past a compliance date, even if informed consent had been previously obtained. The time limitations and the number of forms required have now been somewhat lessened. In addition, the earlier document required that all medical data be stripped of 18 identifiers, including birth dates, zip codes, and hospital discharge dates, virtually prohibiting any meaningful epidemiologic investigation. The current document reduces the criteria for performance of a research project, although access is still limited to a specific data set and must be kept to the "minimum necessary."

Despite these improvements, Kulynych and Korn believe the new rules still "pose serious and ill-advised obstacles to clinical studies and other research." In addition, DHHS estimates that it will cost about $450 million to implement these new rules, not to mention the burden it places on hospitals and clinical researchers. Because of the new rules, some researchers have confessed to limiting the number and scope of their projects during the past 2 years. Some brilliant and creative physicians and investigators, without the knack for paperwork, will not survive the shift in policy (or will purposely choose to bow out). The rules and regulations are too stifling, the paperwork overwhelming, and the risk to reputation too great if somehow you don’t do everything you’re supposed to do. The cost to the public in terms of the loss of meaningful research and valuable epidemiologic investigation cannot be underestimated.

In addition, the public should understand that these so-called "privacy" rules will only bring greater intrusion of administrators and bureaucrats into what was previously largely protected information. For example, one research-related hospital administration, in our area, in an attempt to provide adequate "oversight" and to more closely monitor ongoing research activity, now requires that the names and medical record numbers of every person enrolled in a research project be forwarded to administration on a monthly basis—preferably by e-mail. How private is that?

The deadline for implementation of this rule is April 2003. What are you going to do?