Bad News for Devotees of Process-Oriented Quality Assurance (Part 1)

The Surgical Care Improvement Project (SCIP) and its antecedent, the Surgical Infection Prevention project, have been around for several years. In short, these consist of several rules issued by various self-appointed agencies with important-sounding names and the Centers for Medicare and Medicaid Services (CMS), a federal agency. The main rules are (1) administer the correct prophylactic antibiotic before surgery, (2) give the antibiotic within one hour before the skin is incised and (3) discontinue the antibiotic within 24 hours of the end of the operation. The stated goal of these initiatives was to reduce the rate of surgical wound infections by 25% by the year 2010. It didn’t happen.

Surgeons and administrators have been obsessively following the rules and documenting their activities with squads of internal auditors (thought police). There are numerous papers showing a remarkable increase in the levels of compliance over the years to well over 90% in many hospitals. Compliance data have even been posted on line so that patients can compare institutions. CMS is thinking of linking hospital reimbursements to SCIP compliance rates. Unfortunately, a recent large study in the Journal of the American Medical Association (JAMA) has shown that SCIP has not only not decreased the rate of wound infections by 25%, it actually has had NO IMPACT at all on the infection rate.

So what happened? Why didn’t the rules work? They were based on some sound research. There are several theories. In order to comply with the “within one hour” rule, antibiotics are being given in the operating room and on many occasions, have not been completely infused as of the incision time. Thus, they will not have arrived at the wound in time to prevent the infection from occurring. Mary Hawn, MD, MPH, a surgeon and author of an editorial that accompanied the JAMA article, suggested that perhaps prophylactic antibiotics, which had been given for many years before the advent of SCIP, have already reduced the rate of infection as much as possible, and tweaking the timing may not make that much difference. She also pointed out that there are many other variables that influence the infection rate, such as the surgeon, the condition of the patient and type and duration of the procedure.

I asked Dr Hawn if SCIP should be changed or abandoned. She said, “SCIP is likely too narrow to have a meaningful effect on surgical outcomes. One response would be to add significantly more measures, but at that added burden one wonders if we really shouldn’t collect what we all care about – outcomes.” Of course, one reason that process metrics* are so popular is that processes are much easier to define and measure than outcomes. But would you as a patient rather choose a hospital that has a high rate of compliance with SCIP or a very low wound infection rate?

What we have here is the inevitable disconnect between process (the rules) and outcome (the infection rate). It’s not the first time, nor will it be the last. There will be more to come on the topic of process vs. outcome in future blogs.

*Metric: A metric is a measure for quantitatively assessing, controlling or selecting a person, process, event, or institution, along with the procedures to carry out measurements and the procedures for the interpretation of the assessment in the light of previous or comparable assessments. (Author’ note: Even the definition of a metric is convoluted. I promise I will not use the word “metric” again.)