by Astrid Fiano, reporter

A recent reversal by HHS' Office for Human Research Protections has many medical facilities celebrating the progressive implications for quality improvement programs. Last year the OHRP in Bethesda, Maryland shut down a quality improvement program in Johns Hopkins University that involved hospital personnel which used a procedural checklist. The goal of the program was to reduce the rate of catheter-related infections in intensive care unit settings. The results of the program at the time of the ban had already demonstrated that infections in the hospital were reduced by two-thirds and an estimated $200,000 million was saved. The success of the checklist at Johns Hopkins led to adoption of the protocol at certain Michigan hospitals.

In spite of the program's success, the OHRP closed the program equating the checklist to an alteration in medical care-similar to using an experimental drug. According to the OHRP, the program was closed following a complaint filed with the Agency which alleged the checklist was research conducted without prior review and approval by an Institutional Review Board. Such procedures, the OHRP ruled in late 2007, would fall under regulations governing human research subjects, and required individual patient informed consent.

Upon protests by medical professionals across the country, the OHRP lifted the ban this February. The reversed decision by the OHRP is considered to be a victory for the efforts in hospitals nationwide in maintaining quality improvement innovations. The prior decision banning the program would have likely instituted a two-fold obstacle in similar measures implemented in health care centers: stricter regulation and exhaustive patient releases. In its official statement regarding the reversal of the ban, the OHRP acknowledged the positive implications of the checklist, and concluded that the Michigan hospitals could continue implementing the program, noting the Michigan facilities used the checklist for clinical purposes only, rather than medical research or experimentation. Dr. Ivor Pritchard, Acting Director of the OHRP commented in the February statement that the OHRP did not want to impede any quality improvement actions and activities that held minimal risks to subjects. Dr. Pritchard further stated that the regulations of the Department of Health and Human Services provided enough flexibility that activities such as the Johns Hopkins checklist should not have been curtailed. On its website, the HHS now encourages hospitals nationwide to adopt the checklist to save both lives and millions of dollars.

More information can be found at: http://www.hhs.gov/ohrp/news/recentnews.html