The California agency's action constitutes the making of an "underground" rule that "not only leapfrogged its duty to issue its own regulations, but has converted a reporting system designed to be voluntarily scaled to each reporting hospitals priorities, needs and capabilities into a mandatory reporting system of complex reports on broad variety of publicly reported procedures, an extreme example of underground rulemaking," the complaint says.
The Association for Professional Infection Control and Epidemiology (APIC) joined as a co-plaintiff, and the Society for Healthcare Epidemiology of America (SHEA) says it intends to file an amicus brief with the court.
APIC's president Russell Olmsted said his organization joined the fight to block the state law saying there was no prior assessment of the impact the rule would have. Additionally, to provide the necessary NHSN data requires "20 to 30 data elements for each patient" regardless of whether they developed an infection or not, and between 100 to 200 procedural codes.
"The scope of this is breathtaking," he said.
"We're very supportive of transparency, and were on of the early groups to jump in and support public reporting," he said, but the problem is for California hospitals, "most of this data would have to be dug out on a manual basis," he said.
A statement on SHEA's website says its "amicus brief will outline the significant burden that will be imposed on SHEA members and potentially devastating impact on patient care if the mandate is allowed to stand."
While the issue so far has remained exclusive to California, several infection control consultants interviewed indicated a concern that other states may attempt similar rules in a misguided effort to improve safety without understanding the limited benefits of collecting such a huge amount of data.