APIC, SHEA Seek to Block Infection Disclosure Rules in CA

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APIC, SHEA Seek to Block Infection Disclosure Rules in CA

Cheryl Clark, for HealthLeaders Media , June 8, 2011

A California lawsuit seeking to block state requirements that acute care facilities report surgical site infections for certain surgical procedures is drawing national support, in part because of concerns that state rules go far beyond the intent of the statute known as "Nile's Law," and did not go through required prior review.

Workforce reports say the California Department of Public Health's rules would require the state's 350 hospitals to hire more than 500 full-time employees to hand-comb through medical records for details on patients who undergo more than 900,000 procedures each year, said CHA senior vice president for health policy Debby Rogers.

As stated in the complaint, "This additional reporting imposes great burdens of manpower and expense on reporting hospitals, which are not called for by the underlying statute including providing extensive information on over 900,000 surgeries per year rather than only on infections and similar statistics," the lawsuit says. That diverts resources away from patient care, the complaint maintains.

"When you're talking about 900,000 surgeries and the use of limited healthcare resources, I think that's a challenge," Rogers said.

Rogers emphasizes that the CHA supports the state law, and was neutral on it when it moved through the legislature. The problem, she says, is that state officials issuing the requirements included far more surgical procedures than the original law intended.

The reporting is ordered to begin for surgeries performed on or after June 1 this year. It would cover a wide range of surgeries from the routine to the complex, from appendectomies and gallbladder procedures to heart, liver and kidney transplants.


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.


For many of the surgical procedures for which patient characteristics would be required to be fully documented, there are extremely few resulting infections at any one hospital.

A San Francisco Superior Court judge declined the plaintiffs' request for an immediate temporary restraining order late last month but agreed to hear arguments on the case June 22. Ralph Montano, spokesman for the CDPH, had no comment. The lawmaker who sponsored the bill, Sen. Elaine Alquist, D-Santa Clara, did not return calls requesting comment.

Alquist named the statute "Niles Law" after the death of 15-year-old Niles Calvin Moss in 2006 because of a hospital acquired infection with a strain of methicillin-resistant staphylococcus aureus.

Rogers says that the CHA supports the state law, but that state officials issuing the requirements included far more surgical procedures than the original law intended.

According to the law, "each health facility shall report quarterly to the department all health-care associated surgical site infections of deep or organ space surgical sites, health-care associated infections of orthopedic surgical sites, cardiac surgical sites, and gastrointestinal surgical sites designated as clean and clean-contaminated, and the number of surgeries involving deep or organ space, and orthopedic, cardiac, and gastrointestinal surgeries designated clean and clean contaminated."

On March 11, CDPH acting deputy director Pam Dickfoss sent hospitals a rule saying they must report surgical site infections for two procedures, hip arthroplasty and heart revascularization procedures, and could choose two others from a list of 14. But on April 27, she sent a correction document that expanded the list to 29 procedures.


Additionally, the law requires hospitals to report monthly rather than quarterly, and send information as required to the National Healthcare Safety Network database of the Centers for Disease Control and Prevention, which requires multiple additional pieces of information not just on the patients who endured the infections, but for patients who underwent all 900,000 procedures safely so the data may be appropriately risk adjusted.

Additionally, the law calls for hospital-by-hospital infection rate reporting to be published online by the state by January 2012, "including information on the number of inpatient days."

Complying with these requirements might be easier of hospitals already had electronic infection surveillance systems, but Olmsted points to a survey published last September in the American Journal of Infection Control that found of 207 responding California hospitals, only 23% had electronic surveillance systems in place.

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