MS: I think it’s the first of its kind in the nation, in terms of its comprehensive nature. A multitude of states have started to move in the direction of reporting health care associated infections, but we’ve taken it to the next level. The bill requires that certain provisions be included in health care facilities’ infection control plans - nursing homes and hospitals, as well as ambulatory surgical facilities - reflecting that this is a public health issue across the continuum of care. There is a requirement for notification of transfer between facilities or within facilities, so that if you know that the patient that has an active infection, there has to be a notification so the facility that will be receiving can take appropriate action.

From the hospital community’s vantage point, the most significant component of the law is the adoption of the Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) for the purposes of reporting health care associated infections within hospitals. At this point the CDC doesn’t have modules that are complimentary to the types of things that go on in nursing homes - they’re working on that - but I don’t believe any other state requires nursing homes to report health care associated infections. Unlike other states, Pa. hospitals will be reporting all infections that are included in the CDC’s system, as opposed to one or two selected infection types, which many other states have done. It’s a very comprehensive list, and the CDC has taken the time to look at key sentinel infections - those that are most significant from a clinical vantage point and have the most significant impact in a facility in terms of prevalence or complexity. By utilizing a standard system, with standard definitions, the law will allow for hospital-to-hospital comparisons within Pennsylvania, as well as nationally. There are quality improvement incentive payment components to the law. Beginning January 2009, hospitals that achieve at least a 10 percent reduction in the total number of reported infections would be eligible for that payment, and beginning in calendar year 2010 our Department of Public Welfare and Department of Health will establish what that benchmark will be.

Another provision mandates a strategic assessment that all hospitals are required to conduct to look at the utility and efficacy of using an electronic surveillance system. An electronic surveillance system is a back-end system that compiles data from the various systems within the hospital, develops a profile and flags cases where there may be an infection. For years, infection control practitioners have been doing such surveillance manually. One thing that was very important during negotiations for this bill was the point that a one-size-fits-all approach isn’t going to work. Nearly 26 percent of Pa. hospitals have some form of an electronic surveillance system - so you didn’t want to have a mandate for a single system, and there are many small rural facilities with 25 beds or less and - based on their inpatient case mix - it may not be in their best interest to put out a large sum of money for an electronic system. The law requires hospitals to do a strategic assessment on whether or not an electronic surveillance system will be an effective tool in helping to reduce infections within their facilities and, if not, then to look at what the barriers are. That assessment has to be conducted by all facilities and turned in by December 31st of this year. If a facility is able to determine that it is beneficial to implement such a system, they will have until 2008 to implement it. If a facility determines that they are not yet going to implement an electronic surveillance system, until they do so, they have to put together a written plan of surveillance process elements that includes definitions, data collection, data reporting, identification of personnel to be used, identification of information and technological support that would be needed, and a process for periodic evaluation and validation of the surveillance system’s accuracy. The Department of Health will review hospitals’ strategic assessments, looking for barriers cited that might be of a technical or financial nature, and then discussions would take place on whether or not there are opportunities for any kind of grant or other means of financial or technical assistance for the facilities.

There is a provision that requires a facility’s infection control plan to delineate their screening and culture process, and the law mandates that hospitals screen all nursing home patients that would be admitted to the facility for Methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant organisms. A lot of hospitals are already doing that, because we know that’s a high risk population and a lot of the infections that they’re bringing in have been undetected and manifest during their course of stay. The law also says that hospitals have to have a plan for culturing and screening other targeted high-risk populations, allowing facilities to identify where to best focus their resources based on their own patient population mix.

The Department of Health is also charged with developing a public health awareness campaign that would inform health care providers and health care workers in the field about infections, as well as the public in general about what to expect from your providers - simple things like hand-washing, all the way up to how to make sure you’re not having antibiotics used in inappropriate ways, to insure that patients understand that they also have a role in what takes place when they walk into a facility.

MS: Pretty significantly. I think one of the goals of this legislation was to establish some uniform definitions. While there are definitions for reporting to the PHC4, they were not complete, and there was some uniqueness in the approach taken. Once Pa. hospitals begin reporting health care associated infections to the NHSN, reporting of health care associated infections directly to PHC4 will cease, and Pennsylvania will have an apples-to-apples comparison in our own state, and also establish national comparisons for trending patterns and benchmarks. The NHSN has a very specific clinical process for identifying a health care associated infection. Once hospitals begin reporting to the NHSN, they must grant to the PHC4, the Pa. Department of Health and the Patient Safety Authority access to their NHSN health care associated infection data.

MS: We truly wanted to have a meaningful piece of legislation that is comprehensive - meaning it didn’t focus just on hospitals, and that it didn’t mandate that an electronic surveillance system be implemented, which prior versions attempted to do. We also wanted to clear up disparate reporting. When folks started to compare what was reported to PHC4 and what was being reported to our Patient Safety Authority, the data didn’t always match up, which was an illustration of the need to have uniformity - from a clinical as well as reporting vantage point - so we could streamline and avoid duplication. The only caveat is that the law also says that a health care associated infection that is reported to the NHSN also constitutes a serious event and is thus also reportable to the Patient Safety Authority, which is a separate system which there wasn’t a way to streamline, at least up front.

MS: One of the great things is that CDC’s NHSN system is Internet-based, so there are no costs for the system itself. When our Patient Safety Authority’s reporting system was developed, the law established a surcharge for facilities which equates to $5 million that the hospitals are assessed on their licensure fee. So, there’s no up-front cost like that. Facilities will certainly incur some costs associated with resources and manpower, particularly on the front end as they’re regrouping internally and looking at how they’re going to cull the data out of the system to put it in to NHSN’s database. And there will obviously be manpower issues around review of their infection control plans for compliance with the new provisions. We’ve gone through the growing pains of initial infection reporting that we did to PHC4 and the serious event reporting to the Patient Safety Authority. The structure and framework is already there for our facilities to build upon, and a lot of our facilities are very familiar with NHSN, which up until this law was passed was a voluntary reporting system for Pa. facilities. In a 2006 HAP survey of hospitals, 40 percent were either participating or planning to participate in the NHSN. Also, for the mandatory screening for MRSA and the multi-drug resistant organisms - there’s a provision in the new law that allows for it to be considered a reimbursable cost to be paid by health insurers.

MS: The ones that have highlighted or included in their law the NHSN, approximately nine. According to our due diligence as we were going through the negotiations with this legislation, none of them were as comprehensive. A lot of them said, "You should consider the definitions" or, if they did mandate use of the NHSN and CDC’s definitions, they didn’t say, "You have to do the whole system across the board." Rather, they highlighted certain types of infections or modules within the system.

MS: Beginning in 2010, facilities will be measured against Department of Health-established benchmarks - thresholds on reduction of health care associated infections in their facilities. If the Department does not see a reduction based on these benchmarks, then facilities will be required to submit a plan of correction to the Department and will have a certain amount of time to implement that plan of correction and start to show a reduction in the rate of infections. If, after that point, they are not able to successfully show improvement, they have to do another plan of correction that will be developed in consultation with the Department of Health. Ultimately, after an additional 180 days with that new plan in place, if the facility continues to not show progress, they would be subject to action under our Health Care Facilities Act, which allows for monetary penalties.

MS: I think it will be pretty significant. Because of changes to the definitions for what is reported and what constitutes a health care associated infection under NHSN, it allows a concentration of resources to focus on key sentinel infections - those high-risk, high-impact, high-cost types of infections, such as surgical site infections, catheter associated urinary tract infections, blood stream infections, pneumonia. I think it will have a domino effect and, once facilities are successful in one area, it will to carry over to others.

MS: For quite some time there has been a signal emanating from government officials and the Legislature that there needs to be some governmental interventions. That’s not to say that facilities have not been doing their fair share. What I think it reflects is the philosophy that it truly is a public health issue that requires a public health comprehensive response. There is a commitment from lawmakers, and certainly from our governor’s office, to have this be a priority.

MS: I think they have a significant role, especially when you look at Medicaid, as a significant portion of our Department of Public Welfare’s operating budget is around care. They obviously have a vested interest in it. How it works best, and I think this legislation is a primary example, is through a collaborative effort among stakeholders to have a conversation and develop an actionable law that hopefully will show some results, as opposed to developing something in a vacuum and imposing it on the provider community.