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May 2007
Volume 71
Number 5

Antibiotics Within One Hour: The Clock Is Ticking

Gary J. Kanter, M.D.
Neil R. Connelly, M.D.
Jan Fitzgerald, M.S., R.N., C.P.H.Q.


t is estimated that evidence-based care is provided to patients less than 50 percent of the time in this country.1 In an attempt to improve this, performance measures with comparative outcomes are increasingly used by: the national government (Centers for Medicare & Medicaid Services [CMS]) via core measures with publication of results on “Hospital Compare” www.hospital compare.hhs.gov; the Joint Commission; the many comparative databases (Maryland Indicators, University Health System Consortium, Premier); state governments (i.e., Massachusetts, New York and Pennsylvania); and the Leapfrog Group (which is sponsored by employers that provide costly health insurance to their employees whose goal is to initiate breakthrough improvements in health care).

Why do they do this, and how does the use of comparison measures help health care?

Competing for Customers

The thought is that by collecting and publicizing comparative quality data (and relative costs in some cases), competition among hospitals will lead to improved care, decreased costs and avoidance of preventable complications. Where government and the Joint Commission are involved, the public reporting of process and outcome data are thought to drive improvement by giving consumers information to make informed choices and fostering competition among hospitals to attract “customers.” “Pay for Performance” (increased payments for higher quality, scaled copayments and deductibles) has been used by the Leapfrog Group as well as Premier with its three-year demonstration project with CMS known as the Hospital Quality Incentive Demonstration. In December 2006, Congress enacted law that, for the first time, directly linked Medicare physician payment to quality data reporting. What had been the Physician Voluntary Reporting Program in 2006 became the Physician Quality Reporting Initiative (PQRI) in 2007, and an incremental 1.5-percent payment (beginning July 1, 2007) for Medicare services was linked to reporting data on a group of 66 quality measures covering most medical specialties (details of which can be found at www.cms.hhs.gov/PVRP). Incentive programs are proliferating among private health plans, and Medicare has linked hospital payments to quality measurement for several years, but this is the first federal program-wide physician pay-for-reporting action.

Even ASA has recently considered performance measures, as have many other specialty societies. One of ASA’s performance measures concerns the administration of perioperative prophylactic antibiotics, namely, on-time administration of prophylactic antibiotics within 60 minutes prior to incision (see www.ASAhq.org/Washington/P4P%20Antibiotics%20for%20Healthplans.pdf). This topic has appeared with increasing frequency in the anesthesia literature.3,4,5,6 and was derived from a set of performance measures put forth by the Surgical Infection Prevention Project (SIPP) in 2002.7 Many specialties, including anesthesiology, have additional quality measures awaiting adoption by CMS in 2008 and future years. It is possible that, over time, more substantial monetary linkages will occur and that data reported in the first phases of the PQRI will lead to performance thresholds subsequently.

Surgical infection is a leading cause of patient injury, mortality, excess length of stay and increased costs.8 It has been estimated that up to 50 percent of these infections are preventable with appropriate interventions.8 In 2002, SIPP — which evolved into the Surgical Care Improvement Project (SCIP) in 2005 — started a nationwide quality improvement initiative with the goal of optimizing the outcomes of patients undergoing surgery by improving the use of evidence-based practices shown to reduce the incidence of surgical infections.7 Three of these measures involved antibiotic prophylaxis: appropriate selection, appropriate timing (within 60 minutes prior to incision) and discontinuation within 24 hours of surgery end time.7 It has become evident that administration of the drugs in a timely fashion is critical to their efficacy and that anesthesiologists are well positioned to accomplish this task. The measure is designed to focus on timeliness as distinct from drug choice or indications for prophylaxis, the latter forming the basis for a companion set of measures for surgeons.

Room for Improvement

This article presents a how-to guide to improve on-time administration of prophylactic antibiotics, which has evidence-based support9 but poor compliance as only 56 percent of Medicare patients undergoing major surgery receive antibiotics within the one-hour time interval.8

For any quality improvement project, a number of elements must be in place before undertaking the actual change. Initially an area for improvement must be identified. It can range from a simple problem with an easy fix to a complex systemwide redesign. In this case, administration of prophylactic antibiotics within 60 minutes before incision was chosen. Appropriate leadership support is essential to the success of larger projects because of the ability of leadership to dedicate resources and provide the authority to effectively implement any needed changes.

The most important part of successful implementation is that a group is formed that can share ideas and data and foster teamwork. This team is responsible for the actual work and should be composed of the various stakeholders touched by the process needing change, which could include nurses, pharmacists, support staff, physicians and the physician champion. A physician champion is essential to any quality improvement project that involves changes in clinical care as he or she can lead the educational discussion that can achieve “buy-in” from other physicians (lead with the evidence), especially when they are of the same specialty. The physician champion must be credible, respected and have good communication skills. Use of ad hoc experts, when necessary, can provide content or operational guidance. The team needs to set a meeting tempo with more frequent meetings in the beginning. For our team, this was twice a month. Initially the team will set goals, adopt a formal improvement methodology, do a gap analysis by mapping the existing process compared to the ideal process, and establish baseline measurements. One final advantage of the team approach is that once established, it acts as a template to tackle future projects.

Several quality improvement methodologies can be adopted for health care improvement, including the Six Sigma approach, the Toyota Lean principles, Plan-Do-Study-Act (PDSA) and others. Common to all the effective programs are: the use of data prechange and postchange to describe the problem and measure success (or failure); collaboration with stakeholders who best know the processes underlying the data and therefore how best to change them; the use of frequent, real-time-specific feedback of the data to the stakeholders; and, ultimately, minimization of clinically unjustified variation.10

Always a Work in Progress
At our institution, we have adopted the PDSA cycle for rapid improvement. The advantages of using the PDSA model is that small tests of change can be implemented rapidly, studied to see if they work and changed as needed. Testing in this way allows a process to be worked out in a small pilot population prior to its spread to other populations. Often an impediment to the initial implementation is the idea that one needs to design a perfect system before implementation can take place. One of the mantras we stress is “implementation before perfection.” We do this for two reasons: there are too many circumstances to plan for, and new barriers not thought of during planning will only become apparent after implementation. By using the PDSA cycle, one can rapidly identify the problems and fix them. Other rationale for adopting this methodology is the intuitive simplicity and low costs (compared to Six Sigma) because expert consultants are not needed, although Six Sigma has been used by others to improve adherence for antibiotic prophylaxis administration.5

As mentioned before, the team should map the current process and the ideal process as envisioned by the team. The difference between the two is known as gap analysis. We had multiple “gaps” in our process. One example of this involved our preoperative holding area process. We were often too early in our administration of prophylactic antibiotics because the preoperative nurse in our holding area was responsible for administration based on the printed operating room schedule instead of taking into consideration case over-runs and emergency add-ons that delayed scheduled cases.

After working through several PDSA cycles, including considering the circulating nurse administering the antibiotic, we moved to a system in which the anesthesiologist took the responsibility for administering all antibiotics (except vancomycin and levofloxacin due to their longer infusion time). In fact, initially, an anesthesiologist was not on the original team, but it was soon realized that an anesthesiologist physician champion was integral to successful improvement. Gap analysis can drive change by showing unnecessary steps mapped out in the baseline process, knowing that simplifying a process will decrease the potential for error. Defining the current process also allows one to predict where most errors will occur and mitigate against them by building redundant systems — this is called “failure mode effects analysis” (FMEA). An example of this can be found in the pre-incision “time out,” where potential omissions in care can be remedied.

After the initial implementation is introduced, continual measurement of success (or failure) of process interventions and outcomes is done. One needs to know what worked and did not work. This is the study phase of the PDSA cycle. Studying the results, continuing with successful interventions while acting to change the unsuccessful ones will drive improvement. During this phase, the team will continue to do several tests of change for various processes and system modifications in order to find the ones that work before spreading them across the entire facility.

It Takes a Team

Communication and education via grand rounds, staff meetings, dashboards, e-mails, etc., should be used to publicize the project and create a sense of purpose and togetherness. It is important to celebrate successes when they occur and give credit to the people doing the work on the “front line.” Expect failures as a part of system change; not all interventions will have the desired result. Early on we attempted to have the anesthesiologist mix the antibiotic but realized that compliance would be better achieved if the antibiotic accompanied the patient to the operating premixed, hanging on the patient’s I.V. pole.

The system that has evolved at our institution is as follows. The surgeon is responsible for ordering the prophylactic antibiotic while the anesthesiologist is responsible for administration. The acceptance by the anesthesiologist for the administration component was one of the changes that gave us our most dramatic improvement. Other institutions have reported similar improvements with the anesthesiologists administering the antibiotics.11 The pharmacy sends these premixed medications to the preoperative holding area where they are stored in a refrigerator. The preoperative nurse prepares the antibiotic for administration (attaches tubing and primes the line) and hangs it on the patient’s I.V. pole.

The anesthesiologist administers the antibiotic in the operating room within one hour prior to incision. During the intraoperative “time-out,” the circulating nurse asks the name of the antibiotic and the time it was administered. If none was ordered, the surgeon has a chance of ordering at that point. If the anesthesiologist has not administered it before the time-out, the antibiotic can then be administered before incision. The time out is an example of a redundant step to prevent a miss or “mitigate a failure.” In addition a visual prompt on the anesthesia record was added, which acts as an additional reminder to administer antibiotics (as well as simplifying the process of checking compliance). An electronic medical record can be leveraged using built-in prompts to remind practitioners to give antibiotics.6 By following the above process, we are currently at 99.5-percent adherence and have sustained rates of greater than 98 percent for the last 12 months for this measure. This is considerably higher than our baseline measure of 28 percent in 2003.

Making the Grade
One of the more difficult challenges is sustaining the improvement after the initial “honeymoon” period is over. This erosion occurs in most process changes as attention turns away to new problems. Erosion will not occur if the changes become part of the culture of the institution. Other ways to sustain compliance is through auditing and feedback. There are numerous methods for auditing and providing feedback of results. We do real-time chart reviews in order to capture errors in a timely manner (usually within 24 hours of procedure). A letter is sent to the anesthesiologist when an omission has occurred. The letter includes the patient’s name and date of surgery and describes the administration error (similar letters are sent to the surgeon if an incorrect antibiotic is prescribed or if the duration of prophylaxis is greater then 24 hours). An electronic medical record can link the lack of an antibiotic administered (i.e., over-riding the antibiotic prompt) to an automatic e-mail.6

Because of the competitive nature of physicians, a physician report card can be a powerful tool to influence behavior.12 We display physician report cards in the operating room suite and present individual physician results at departmental grand rounds. We do this in a blinded fashion, assigning each physician a number so that he/she sees how he or she compares with his or her colleagues. We also show how we compare as a group to national benchmarks. In contrast, unblinded data are sent to individual anesthesiologists with his/her compliance rate versus some benchmark (the group mean, the top 10 percent, national numbers, etc.). Finally, unblinded data can be used by the chairperson to help “outliers” come into compliance.

We have described a “how to" guide of process improvement using a national measure from SCIP, which anesthesiologists increasingly are being pressured to perform.3 The hallmarks of process improvement involve education, process development, implementation, monitoring results and feedback. As pay-for-performance and quality measures become increasingly popular in all aspects of medicine, it behooves us as a specialty to be proactive in determining which ones make the most sense for us to adopt while never forgetting that we are attempting to improve care for our patients.

See the “Practice Management” column on page 34 of this issue for more information on performance measures and the Physician Quality Reporting Initiative.

 

References:
1. McGlynn EA, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003; 348:2635-2645.
2. www.ASAhq.org. Accessed on January 18, 2006.
3. Warters, et al. The role of anesthesiologists in the selection and administration of perioperative antibiotic: A survey of the American Association of Clinical Directors. Anesth Analg. 2006; 102:1177-1182.
4. Kanter G, et al. A system and process redesign to improve perioperative antibiotic administration. Anesth Analg. 2006; 103:1517-1521.
5. Parker BM, et al. Six Sigma Methodology can be used to improve adherence for antibiotic prophylaxis in patients undergoing noncardiac surgery. Anesth Analg. 2007; 104:140-146.
6. O’Reilly M, et al. An anesthesia information system designed to provide physician-specific feedback improves timely administration of prophylactic antibiotics. Anesth Analg. 2006; 103:908-912.
7. www.medQIC.org. Accessed on January 18, 2006.
8. Bratzler DW, et al. Use of antimicrobial prophylaxis for major surgery: Baseline results from the National Surgical Infection Prevention Project. Arch Surg. 2005; 140:174-182.
9. Classen DC, et al. The timing of prophylactic administration of antibiotics and the risk of surgical-wound infection. N Engl J Med. 1992; 326:281-286.
10. Greene WH, et al. You get what you pay for. Anesth Analg. 2006; 103:1349-1350.
11. Hawn MT, et al. Timely administration of prophylactic antibiotics for major surgical procedures. JACS. 2006; 203:803-811.
12. Ransom SB, et al. The Healthcare Quality Book: Vision Strategy and Tools. Chicago, IL: Health Administration Press; 2004.



    Gary J. Kanter, M.D., is Director, Preadmission Evaluation Clinic and Associate Medical Director of Health Care Quality, Baystate Medical Center, Springfield, Massachusetts.

    Neil R. Connelly, M.D., is Director of Anesthesiology Research, Baystate Medical Center, Springfield Massachusetts, and Professor of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts.

    Jan Fitzgerald, M.S., R.N., C.P.H.Q., is Director, Quality and Medical Management Division of Healthcare Quality, Baystate Medical Center, Springfield, Massachusetts.


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