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 Table of Contents  
Year : 2014  |  Volume : 1  |  Issue : 1  |  Page : 14-19

Improved compliance with prophylactic antibiotic guidelines in urologic prosthetic surgery using a simple protocol: Should antimicrobial prophylaxis be administered exclusively in the operating room?

1 Division of Urology, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT 84132, USA
2 Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City, UT 84132, USA
3 Division of Urology, Department of Surgery, University of Utah School of Medicine; The Center for Reconstructive Surgery and Mens Health, Salt Lake City, UT 84132, USA

Date of Web Publication25-Jul-2014

Correspondence Address:
William O Brant
50 N Medical Dr, 3A100, Salt Lake City, UT 84132
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2225-1243.137545

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Context: Established guidelines advocate for the administration of antimicrobial prophylaxis (AMP) within 60 min of the surgical incision. An internal audit of genitourinary prosthetics at our institution revealed, we were compliant in only 25% of cases and led to the development of a standardized protocol emphasizing administration of AMP in the OR by the anesthesia provider and specific duties for each member of the surgical team (anesthesia, surgery, and nursing). Aims: The aim was to describe the system factors that we recognized as responsible and determine our protocols effect on compliance. Settings and Design: A retrospective review of urologic prosthetics cases performed by a single surgeon at our institution from October 2009 to January 2011 was conducted. Sixty consecutive cases occurring: Prior to the protocol, immediately after, and 18 months after it went into effect were reviewed. Statistical Analysis: Categorical data were compared using the Fisher's exact test and continuous variables using the Student's t-test at the P > 0.05 significance level. Results: System factors associated with noncompliance included: Location of antibiotic administration (OR vs. preoperative area) and timing of the case (first case vs. not). Ninety-six percent of noncompliance was the result of AMP being administered too early. Compliance increased from 25% to >91% and the proportion of AMP administered in the OR increased from 20% to >88%. No drop-off in compliance occurred 18 months after initiation of the protocol. Conclusion: A defined protocol in conjunction with shifting administration of AMP to the OR and into the hands of the anesthesia provider can achieve a durable increase in compliance with established guidelines.

Keywords: Evidence-based practice, prophylactic antibiotic timing, quality improvement, surgical wound infection/prevention and control

How to cite this article:
Redshaw JD, Mobley EM, Hopf HW, Lowrance WT, Myers JB, Brant WO. Improved compliance with prophylactic antibiotic guidelines in urologic prosthetic surgery using a simple protocol: Should antimicrobial prophylaxis be administered exclusively in the operating room?. J Integr Nephrol Androl 2014;1:14-9

How to cite this URL:
Redshaw JD, Mobley EM, Hopf HW, Lowrance WT, Myers JB, Brant WO. Improved compliance with prophylactic antibiotic guidelines in urologic prosthetic surgery using a simple protocol: Should antimicrobial prophylaxis be administered exclusively in the operating room?. J Integr Nephrol Androl [serial online] 2014 [cited 2023 Dec 2];1:14-9. Available from: http://www.journal-ina.com/text.asp?2014/1/1/14/137545

  Introduction Top

Surgical site infections (SSI) are second only to urinary tract infections as the most commonly acquired nosocomial infection in the United States. [1],[2] The morbidity related to these infections is well-established; patients who develop SSIs spend more time in the Intensive Care Unit, are more likely to be readmitted, and have higher postoperative mortality. [3] Infections of surgical implants are particularly morbid, as they require longer periods of antibiotic treatment and additional surgical procedures resulting in enormous costs. For example, the overall cost of treating an infected penile prosthesis can surpass the cost of the original implant six-fold. [4] Numerous studies have demonstrated the efficacy of antimicrobial prophylaxis (AMP) for reducing the incidence of SSI. [5],[6],[7] Despite this, there is substantial evidence that AMP continues to be used inconsistently and outside of the appropriate time window. [8],[9],[10]

In August 2005, the Surgical Care Improvement Project (SCIP) was started with the goal of reducing preventable surgical morbidity and mortality nationwide. [11] Included in its core measures is the provision that, when appropriate, patients receive prophylactic antibiotics within 60 min prior to the surgical incision (SCIP-INF1). SCIP guidelines, however, do not specifically address the changes in the delivery of surgical care required to accomplish this goal and no consensus exists as to the optimal method of ensuring compliance. As performance based remuneration efforts expand, including the Hospital Value-Based Purchasing Program [12] established by the Affordable Care Act, there is increasing pressure to comply with established guidelines. [13],[14]

In 2009, as part of an internal quality control initiative, we evaluated our compliance with SCIP-INF1 in patients undergoing urological prosthetic surgery and found that we were compliant in a minority of cases. Following this discovery, we created and implemented a protocol for the administration of AMP in urological prosthetic surgery. The purpose of this paper is to describe the system factors that we recognized as responsible for our poor compliance with established SCIP guidelines and to summarize the changes we made to our surgical system that resulted in improved compliance.

  Subjects and methods Top

Data collection

A retrospective review of urological prosthetics cases performed by a single surgeon (WOB) at our institution was conducted. Sixty consecutive cases were selected for review from each of 3 time periods. Period one was from September 2009 to January 2011 before implementation of the AMP protocol (detailed below). Period two began immediately following implementation of the protocol in February 2011 and ended in December 2011. Period three began 18 months after implementation of the protocol in July 2012 and continued to April 2013. This study was determined to be exempt from Institutional Review Board approval based on the fact that it was an internal quality improvement project.

For our prosthetic cases, we generally give dual coverage antibiotic prophylaxis, as recommended within our institution by a multidisciplinary team including infectious disease. Compliance was defined as administration of both antibiotics within 60 min prior to incision (2 h for vancomycin) in accordance with SCIP-INF1. Surgical data collected included: Length of case, surgical "lag time" (i.e., the time between when anesthesia alerts the surgeon that the patient is ready for prep/positioning and when the surgical incision occurs), type and dosage of antibiotics administered, location of antibiotic administration, surgical procedure performed, and whether it was the first case of the day or not. Cases with inadequate or missing documentation were excluded from the analysis. Antibiotic timing was calculated as the interval from when antibiotics were started to the surgical incision, as recorded in the electronic anesthesia record. The nursing record was also reviewed in order to obtain all possible information; if a discrepancy was encountered regarding the location and/or time of administration between the anesthesia and nursing records, the first recorded administration time was used, and the discrepancy was noted on the data collection form.

Protocol design

Data from period one was collected and analyzed in order to identify factors, which impede appropriate antimicrobial administration and would be amendable to process improvement. Location of antibiotic administration (i.e., OR vs. the preoperative area) and the ambiguity in roles and responsibilities inherent in antibiotics routinely being administered in several locations in the hospital and by different personnel were identified as modifiable system factors and became the focus of improvement. Based on this information a standardized protocol for ordering, documenting, and administering AMP was developed and agreed upon by representatives from anesthesia, infectious disease, pharmacy, nursing, and the urologic surgery team.

Protocol overview

The administration of prophylactic antibiotics was re-designed to occur in a stepwise fashion with clearly defined roles and responsibilities for each member of the team. According to the protocol, the urologic surgeon is responsible for ordering the antibiotics and ensuring that a preprinted order set is filled out and faxed to preoperative nursing prior to each case. The order set includes instructions for the antibiotics to be administered according to a weight-based dose, as well as specific instructions for redosing of antibiotics, and for the infusion to occur by the anesthesia provider just after arrival in the operating room. Following receipt of the order set the preoperative nurse provider is responsible for obtaining the antibiotics from the pharmacy and placing them in the patient's chart with the preprinted form, which accompanies the patient to the OR. Once in the OR, the anesthesiologist assumes responsibility for administration either before or just after induction. The protocol was designed to function independently without any case-by-case oversight from urology, anesthesia, nursing, or pharmacy. On February 1, 2011, it was put into effect for all urologic prosthetics cases.

Statistical analysis

Our primary outcome was compliance with SCIP-INF1 (administration of prophylactic antibiotics within 60 min prior to incision) following implementation of our urologic prosthetics AMP protocol. As a secondary outcome, we evaluated long-term compliance with SCIP after the "honeymoon" phase of the new protocol had worn off, as no method of feedback was built into the protocol. Cases from period one served as historical controls and were compared to the cases immediately following the new protocol (period two) and 18 months after it had been implemented (period three) in order to determine the effectiveness of the protocol for increasing compliance with SCIP guidelines.

Categorical data were summarized as counts and percentages, and continuous variables were summarized by mean and standard deviation or median and interquartile range across time periods. Categorical data were compared using the Fisher's exact test with two-tailed P values at the P > 0.05 significance level and continuous variables using the Student's t-test. SPSS Version 19 (IBM, Armonk, NY) was used for data analysis.

  Results Top

Sixty cases from period one were reviewed and included in the preprotocol analysis. Overall, only 36.7% (22 of 60) of AMP was administered in compliance with SCIP-INF1 based on the anesthesia record. In 21 cases (35%), a discrepancy existed between when anesthesia and the nursing staff documented the time of antibiotic administration. Adjusting for this discrepancy (such that the earlier of the 2 times recorded was used as the time stamp) resulted in a compliance rate of 25% (15 of 60) [Table 1].
Table 1: Preprotocol analysis of factors in relation to timely administration of AMP

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Being the first case of the day was associated with timely administration of antibiotics. For the first case starts, we achieved a compliance rate of 40% (10 of 25), compared with 14.3% (8 of 35) compliance when the case was not a first start relative risk (RR: 2.8 95% confidence interval [CI]; 1.1-7.2). There were considerable differences in timely administration depending upon the location of AMP administration. When both antibiotics were administered in the OR, compliance was 66.7% (8 of 12) compared with only 14.5% (7 of 48) when one or both antibiotics was administered in the preoperative holding area. Comparing administration of both antibiotics in the OR with the other two administration schemes yielded a RR for appropriate administration of 4.6 (95% CI; 2.1-10.1). Noncompliance was the result of antibiotics being administered too early in 96% of cases, such that the mean time from administration to incision was 39 min for compliant cases and 87 min when noncompliant. The type of case, type of antibiotic, length of surgery, and lag time were not associated with compliance [Table 1].

A review of the 60 cases from the immediate postprotocol period (period two) resulted in 59 cases with sufficient documentation for inclusion in the analysis [Table 2].
Table 2: Comparison of AMP administration before and after implementation of protocol

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Sixty of 60 cases reviewed in the sustained compliance time period (period three) were included in the analysis. There was no difference in the number of cases classified as the first case of the day or surgical lag time across time periods [Table 2].

Adjusted compliance increased following institution of the protocol from 25% in period one to 92% in period two (RR: 8.9 95% CI; 3.8, 20.8). This was accompanied by a decrease in charting discrepancies from 35% to 3.4% of cases (P < 0.001). Prior to the protocol going into effect, both antibiotics were administered in the OR in only 20% of cases compared with 81.4% of cases in period 2 and 96.7% of cases in period three. No decrease in compliance occurred between period two and period three [Table 2].

When noncompliant in period one, antibiotics were administered, on average, 27 min outside of the 60-min preoperative window (mean of 87 min). In period two, when still noncompliant, this gap decreased to 6 min. In period three, no antibiotics were administered too early, and the four cases of noncompliance were the result of antibiotics being administered following the incision (mean of 2 min). Another noteworthy finding was that even among compliant cases, the interval from administration of AMP to incision decreased following the protocol to a mean of 27 min compared to a mean of 39 min before the protocol (P = 0.024).

  Discussion Top

Data from our institution demonstrate that prior to 2011; we were compliant with SCIP guidelines for the administration of timely AMP in an alarming minority of patients. With an established baseline compliance of 25% at the worst and 37% at the best depending on the interpretation of documentation discrepancies, we set out to improve our compliance. This was accomplished through a root cause analysis of the causative factors, followed by the creation and implementation of a standardized protocol with specific education of the entire surgical team. In our case, the root cause for noncompliance was early administration of AMP in the preoperative holding area as opposed to in the OR. Likewise, we had significant troubles coordinating the appropriate administration of AMP in those cases that were not scheduled as a first case start, indicative of a multi-factorial problem.

Studies have identified both individual and system based factors as having an impact on compliance with established guidelines. [8],[9],[15],[16],[17] In a study by Tan et al., [15] the variability induced by having antibiotics administered on the wards, in the preoperative area, and in the OR was identified as key to the breakdown on a systems level. Similarly, in our preprotocol analysis, this common practice of preoperative antibiotic administration was a significant contributor to our untimely AMP administration.

Restricting administration of AMP to the OR is not novel. A considerable amount of data supporting its effectiveness for reducing untimely administration exists; [17],[18] the mechanism by which this is effective is by reducing the gap between antibiotic administration and induction of anesthesia and thus the surgical incision. The University of Michigan recently shifted responsibility for antibiotic administration to the anesthesiologist in the OR and witnessed an increase from their baseline compliance of 69% to 92% over a 1-year period. [17] The presumption in this study and others is that prolonged surgical prep and position has a negative effect on timely administration. While we did not observe an association between longer surgical "lag times" and compliance per se, "lag time" likely still contributes to noncompliance. At our institution, the median time required for prep and positioning for all cases reviewed was 29 min. Put another way, the maximum time allowable for transporting a patient to the OR and completing safe induction of anesthesia is only 31 min if antibiotics were given in the preoperative area. It would be near impossible to be 100% compliant with this guideline if we were only given 30 min to prep, position, scrub and make an incision once the patient arrives in the OR. We believe that the shift from administering AMP in the preoperative holding area to the operating room (20% preprotocol to 96.7% 18 months postprotocol) was the primary driving force for our improvement in compliance.

Recently, several studies have suggested that the optimal time for antibiotic administration might actually be much closer to the surgical incision. [19],[20] In a series of over 4000 patients, Koch et al. [19] found that administering AMP within 30 min was associated with a statistically significant reduction in the risk of infection compared with administration between 30 min and 60 min prior to the incision. They were also able to calculate a theoretical optimal timing for antibiotic administration of <18 min prior to the incision in order to minimize infections. An unanticipated result of our protocol was a reduction in the antibiotic timing interval among compliant cases as well as noncompliant cases when compared to the preprotocol era. The mean reduction we observed (~13 min) brought our mean dosing interval to within 30 min of the incision. Because surgical infections occur at a very low rate, we were unable to see any difference in outcomes between the time period before the protocol and after the protocol; but, we can infer that there may be a benefit to reduction of infection due to the decreased mean time to AMP administration based upon the above study.

When considering the relatively small window in which to administer preoperative antibiotics, it is not surprising that compliance is higher for the first case of the day, as was observed in this study. The variability in scheduled and actual case start times naturally increases throughout the day, making it much more difficult to predict the actual 60 min window prior to incision. Antibiotics given "on call" to the OR are often given too early [8] as was the case in our study (prior to protocol implementation) where we were compliant in only 11.1-16.7% of cases when this approach was used. Even for the first case starts, where the difference between actual start time and scheduled start time is much closer, our compliance was still quite low (40%). This highlights the multitude of factors involved in the timely administration of antibiotics as well as a getting a case started on time.

Other studies on administration of AMP have suggested that in order to achieve high compliance, a method of feedback on a physician's individual performance must be implemented. [17] While feedback has been shown to result in sustained compliance, it can also be burdensome secondary to resources required to generate meaningful and recurring reports. For this reason, we designed our protocol to function autonomously, without individual oversight, but with redundancy built in so that specifics tasks and responsibility for correct administration were spread out over numerous members of the surgical team. The high level of compliance observed in period three in this study, 18 months after the protocol went into effect, supports the idea that a well-designed protocol is able to achieve a durable, high level of compliance without the need for constant vigilance and without being overly burdensome.

When interpreting these results it must be acknowledged that the design of this study is susceptible to the Hawthorne effect, whereby compliance improves because clinical staff is aware they are being monitored. The change in compliance noted between period one and period two may have been in part due to the increased scrutiny over our AMP delivery; however, the sustained improvement demonstrated in period three would argue against this as a driving force for our improved compliance. It must also be acknowledged that the small size of our study population and isolated application to urological prosthetic surgery may not be reproducible across all areas of surgery. We feel the results are compelling enough though, that this protocol is now being phased in throughout the surgical system at our hospital. In addition, our infection rate of urologic prosthetics is <1%, and so we could not identify whether our improvement in compliance changes our rate of clinical infection.

  Conclusion Top

Prior to establishing a standardized protocol for AMP, administration of antibiotics in the preoperative area and lack of clearly defined responsibilities among the surgical team resulted in a high rate of noncompliance at our institution. Implementation of a simple protocol, which emphasized administration of AMP by the anesthesia provider in the OR, in conjunction with specific wise approach with clearly defined roles for the entire surgical team was able to achieve a durable increase in compliance with recommended SCIP guidelines. Administration of prophylactic antibiotics in the OR also shifts the timing interval much closer to the surgical incision, which has implications for further reducing the risk of infection.

  Acknowledgment Top

Dr. Redshaw is supported by a generous fellowship grant in reconstructive urology from American Medical Systems, Inc., Minnetonka, Minnesota.

  References Top

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8.Hawn MT, Gray SH, Vick CC, Itani KM, Bishop MJ, Ordin DL, et al. Timely administration of prophylactic antibiotics for major surgical procedures. J Am Coll Surg 2006;203:803-11.  Back to cited text no. 8
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12.Department of Health and Human Services, Centers for Medicare and Medicaid Services: 42 CFR Parts 422 and 480 (CMS-3239-P), RIN 0938-AQ55. Medicare Program: Hospital Inpatient Value-Based Purchasing Program. Proposed January 2011 as Part of Section 3001(a) Patient Protection and Affordable Health Care Act (Pub L 111-148) enacted March 23; 2010.  Back to cited text no. 12
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14.Weston A, Caldera K, Doron S. Surgical care improvement project in the value-based purchasing era: More harm than good? Clin Infect Dis 2013;56:424-7.  Back to cited text no. 14
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16.Turnbull BR, Zoutman DE, Lam M. Evaluation of hospital and patient factors that influence the effective administration of surgical antimicrobial prophylaxis. Infect Control Hosp Epidemiol 2005;26:478-85.  Back to cited text no. 16
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20.Steinberg JP, Braun BI, Hellinger WC, Kusek L, Bozikis MR, Bush AJ, et al. Timing of antimicrobial prophylaxis and the risk of surgical site infections: Results from the trial to reduce antimicrobial prophylaxis errors. Ann Surg 2009;250:10-6.  Back to cited text no. 20


  [Table 1], [Table 2]


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