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Discussion

JAMES C. BENNEYAN
Northeastern University, Boston, MA 02115

surveillance is an important endeavor S in many health-care sectors, including public health, epidemiology, patient physiology, and hospiTATISTICAL

tal care-delivery processes. Broadly speaking, each of these areas is interested in the detection and analysis of trends, clusters, or unusual events, which in essence is a monitoring concern similar in some respects and unique in others to industrial quality control. Professor Woodall provides an excellent review of current uses of control charts and issues in healthcare monitoring, primarily focused on public-health surveillance and cumulative sum and related methods (e.g., resetting SPRT, set methods, CRAM charts), including the important topic of risk adjustment for diering patient acuity in mortality surveillance. Several applications and research opportunities also exist in other health-care areas, such as infection control, hospital quality, and patient safety. Use of industrial quality methods in hospitals was advocated by clinicians starting in the late 1980s (Berwick (1989), Lael and Blumenthal (1989), Blumenthal (1993), Batalden and Stoltz (1993)); and as early as 1942, Deming (1942) suggested the potential of SPC for infectious disease surveillance. Because I am largely in agreement with Woodalls review paper, after some general comments the remainder of my discussion focuses on other important applications, associated issues, and opportunities for greater interaction with the industrial quality-control community.

their relative use in other industries. Important applications include disease surveillance, infection control, mortality, and cluster detection. In terms of the interplay between methods development and performance, the properties of some methods have not been completely studied, as discussed by Professor Woodall, especially from the perspective of time until detection and somewhat in contrast with the quality control literature. Multiple control charts also sometimes are used simultaneously without much attention to the Bonferroni type of problem of increased overall false-alarm rates. In some settings, the interest is on both temporal and spatial surveillance, with the extension of cluster analysis to longitudinal monitoring being one of several opportunities for quality control research contributions. For example, Jacquez et al. (1996) provide an overview of cluster-detection methods used in epidemiology and public health, many of which are based on chi-squared statistics that could be incorporated into an SPC framework. Clustering of a similar nature occurs in some industrial applications, such as semiconductor fabrication, where overdispersed cluster distributions such as the Neyman, Thomas, and negative binomial have been found to be appropriate (Friedman (1993), Albin and Friedman (1989)). The control charts developed based on these models also might lend themselves to health-care cluster surveillance. Underdispersion also occurs in several important applications, especially in cases involving mixed populations or where data are aggregated across heterogeneous populations. Examples include acuityadjustment applications, such as monitoring mortality among patients with dierent a priori risks, the current trend toward monitoring health-care composite core measures, and data aggregation across dierent geographic regions, hospitals, or departments. These topics are discussed further below. Antibiotic drug resistance, such as methicillinresistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and vancomycin-

General Comments
As discussed by Professor Woodall, cumulative sum methods are fairly well established in public health, in general, more so than standard Shewhart and EWMA methods and perhaps in contrast to

Dr. Benneyan is an Associate Professor in the Department of Mechanical and Industrial Engineering. He is a senior member of ASQ. His email address is benneyan@coe.neu.edu.

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FIGURE 1. Quarterly Rates of Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteraemia (Blood Infections) per 1000 Acute Occupied Bed Days (AODB), Lanarkshire Division, January 2001September 2004. (Data sources: HPS Health Protection Scotland; EARSSEuropean Commissions European Antimicrobial Resistance Surveillance System.) From SSHAIP (2005), reproduced by permission of the Scottish Centre for Infection and Environmental Health and the Health Protection Scotland.

resistant Staphylococcus aureus (VRSA), is another growing problem amenable to SPC. Resistance results from overprescription and overexposure of these last-defense antibiotics to infection organisms and subsequent mutation to a more resistant strain. Curran et al. (2001) described a hospital-wide resistance SPC surveillance program in the Glasgow Royal Inrmary hospitals, and the Scottish Surveillance of Healthcare Associated Infection Programme (SSHAIP (2005)) uses control charts to monitor MRSA episodes per 1000 acute occupied bed days in each of the 15 acute divisions and 12 boards in the national health-care system (see Lanarkshire division bacteremia blood-infection example in Figure 1). Beyond public health, other important applications and opportunities exist in hospital operations, clinical processes, infection control, patient safety, and clinical laboratories. Some of these are appropriate for standard SPC methods, whereas others have required research on new methods or remain somewhat unexplored. Conventional applications, opportunities for greater interaction, and the relationship between epidemiology and industrial quality control are discussed by Reinke (1991), Brewer and Gasser

(1993), Benneyan and Kaminsky (1995), and Benneyan (1998a, 1998b).

Hospital Quality, Reliability, and Safety Context


Concern has grown signicantly over the last two decades about quality and safety in hospitals, resulting in what is now a large, national patient-safety movement on an unprecedented scale, led by prominent organizations, such as the Institute for Healthcare Improvement (IHI), the Joint Commission for Accreditation of Healthcare Systems (JCAHO), the National Patient Safety Foundation (NPSF), and the Institute of Medicine (IOM). In the late 1980s, the National Demonstration Project demonstrated how standard qualityimprovement methods can contribute to health-care process improvement (Berwick et al. 1990). This work evolved a few years later into the Institute for Healthcare Improvement, largely based on the ideas of Deming and Shewhart (for example, Berwick (1991)). Physician established and led, IHI is now one of the leading worldwide voices in health-care quality, working with roughly half the hospitals in the

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United States and in over 50 countries internationally on such process problems as appointment access, waits and delays, clinical outcomes, care-system reliability, preventable mortality, infection control, medication errors, and adverse events. Although the U.S. health-care system is among the safest in the world, estimates of the national costs of adverse events and medical errors are staggering, including 770,000 to 2 million injured patients, 44,000180,000 care-induced deaths, and $8.829 billion annually (Bates et al. (1997), Bedell et al. (1991), Bogner (1994), Brennan et al. (1991), Cullen et al. (1997), Leape (1994)), prompting three recent publications by the National Academy of Engineering and the Institute of Medicine (1999, 2000, 2005) to advocate greater use of systems engineering and improvement methodologies. Hospital-acquired (nosocomial) infections include surgical site, pneumonia, bacteremia, urinary tract, gastrointestinal, bloodstream, and device-associated infections, aicting 25 million patients in the United States and causing approximately 8.7 million additional hospital days and 88,000 deaths per year (Thomas et al. (2000), Brown et al. (2002)). An estimated 610% of hospitalized patients suer a serious adverse event, with over $4.2 billion spent on adverse drug events (ADEs); a single ADE averages $40005000, and a single nosocomial infection averages $20003000 per episode (Berwick and Leape (1999), Thomas et al. (1999), Johnson et al. (1992), Gawande et al. (1999), Phillips et al. (1998), Goldmann and Huskins (1997)). Even using conservative estimates, medical errors are the eighth leading cause of death in this country, with more patients dying each year in U.S. hospitals from mistakes and adverse events than from trac accidents, breast cancer, or AIDS. The enormity of these gures and the groundswell of improvement activity recently culminated in two large-scale national initiatives having broad impact across the U.S. health-care system. In December 2004, IHI launched the Hundred Thousand Lives Campaign with the ambitious aim of preventing at least 100,000 needless deaths by June 2006 through the use of process-improvement methodologies to identify, implement, and improve best practices. The campaign has received major nancial and logistic support from almost all private and public healthcare sectors, with over 3000 U.S. hospitals (representing over 80% of all U.S. hospital beds) currently participating in this project.

The same year, the U.S. Centers for Medicare and Medicaid Services (CMS) and the Premier healthcare alliance launched their Pay for Performance national demonstration pilot program (www.cms. hhs.gov/quality/hospital/PremierFactSheet.pdf).The intents of this initiative are to monitor hospital performance using a set of minimum-care process measures and to adjust their reimbursement based on results. To reduce surgical site infections, for example, adherence to guidelines for appropriate prophylaxis antibiotic timing, hair removal technique, antibiotic selection and discontinuance are known in the scientic literature to reduce infection rates. Compliance to these measures is combined into an overall composite statistic that forms the basis for a hospitals reimbursement bonuses or penalties. Other conditions included in this pilot include joint replacement, coronary artery bypass graft surgery, acute myocardial infarction, community-acquired pneumonia, and congestive heart failure. Both these initiatives aect the majority of hospitals in the country in one way or another and present some interesting statistical issues, including how to best monitor and measure mortality reduction, how to estimate the number of needless deaths prevented, how to measure statistically signicant changes in composite measures composed of several nonhomogeneous subcomponent measures, and others discussed below.

Hospital SPC Applications


Conventional control charts have been applied in hospitals to care-delivery and clinical processes for at least two decades. Typical applications include laboratory turn-around times, patient waits and delays, patient satisfaction, lengths of stay, patient falls and slips, Cesarean section rates, medication errors, needle sticks, surgical-site infections, hospital-spread infections, and other adverse events. Figure 2 illustrates the monthly rate of ventilator-associated pneumonia (VAP) cases per device-use day for intensive care unit (ICU) patients on mechanical ventilators. VAP and nosocomial pneumonia are serious complications in ICU patients and a leading cause of mortality, morbidity, prolonged hospital stays, and further complications, associated with attributable mortality of up to 3050% and an average additional length of stay of 13 days (ANRQ (2001)). Related device-associated infections include catheter, central-line, blood stream, and urinary-tract in-

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FIGURE 2. Monthly Rate of Ventilator-Associated Pneumonia (VAP) per 1000 Device Days in Intensive-Care Unit Patients.

fections, all with associated costs and comorbidities. Basic epidemiology surveillance methods to detect device-associated, surgical-site, and other nosocomial infection outbreaks also were discussed by Birnbaum (1984), McGuckin and Abrutyn (1979), and Smyth and Emmerson (2000), and in essence establish signal thresholds 23 standard deviations above some baseline in a manner very similar to what is done in SPC. More generally, the majority of SPC applications in front-line hospital process improvement activities most commonly use p, u, and XmR Shewhart charts, frequently as extensions of simple run charts as a way to evaluate improvement interventions and with much less use of EWMA and CUSUM charts. Most of these applications historically have used attribute and outcome (defect) data, such as Poisson occurrence counts or binomial dichotomous data, with much less use of continuous data than typically is seen in manufacturing. For further discussion and examples of conventional health-care SPC applications, see Plsek (1992), Sellick (1993), Burnett and Chesher (1995), Benneyan (1998c), Carey and Lloyd (2001), and Benneyan et al. (2003). In the past several years, however, there has been a gradual move from outcome measures to process measures, which tend to be either binary (such as adherence to a surgery prep protocol) or continuous

(such as the time to begin thrombolytic treatment for an emergency cardiac patient). All the measures in the CMS Pay-for-Performance program described above, for example, are process measures known to have high correlation to improved outcomes, some of which are timed measures (e.g., time to treatment, time to beta blockers, time to antibiotics, etc.). Other applications of continuous data include process times, waits and delays, lengths of stay, and patient physiologic data, such as blood-sugar levels in diabetic patients and lung capacity in asthma patients. As one example, Benneyan (1998a, 1998b) monitored the timing of antibiotics before the start of surgery, with an optimal target of 60 minutes prior to the rst incision to allow the antibiotic sucient time to perfuse through the skin to the incision site (Classen et al. 1992). This application also illustrates the importance of transitioning from binary to continuous data, with many timed measures currently measured simply as meeting or not meeting a target, but with larger deviations from target having larger medical consequences. Control charts also have been used in clinical laboratories for at least half a century, after being introduced by Levey and Jennings (1950) to monitor the quality of laboratory results, assays, and calibration processes. In fact, XmR individuals charts sometimes are referred to as Levey and Jennings charts

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FIGURE 3. Individuals XmR Chart of Mammography Imaging Calibration Data.

within the clinical-laboratory community. An example of such an application is shown in Figure 3 for the daily readings of phantom mass samples in an unreliable mammography imaging-calibration process.

Beyond Shewhart
Beyond the use of simple Shewhart charts, more advanced monitoring approaches or new methods sometimes are appropriate, with some important applications including rare events, heterogeneous processes, auto-correlated processes, and patient physiologic data, including feedback control applications. For example, Brown et al. (2002) describe an automated infectious-disease surveillance system that uses binary cumulative sum and moving average control charts to detect increases in the rate of VRE, a somewhat rare but important problem, as mentioned above (see Figure 4). Monitoring rare events also becomes important in other surveillance and patient-safety applications, with time-between or number-between types of control charts often used in such cases. Figure 5 illustrates an EWMA g control chart based on a geometric distribution of the number of surgeries between postoperative surgical-site infections (Benneyan (2001)). Other g chart applications discussed elsewhere include open heart surgery complications, Clostridium dicile colitis positive assays, accidental needle sticks, and insulin reactions (Nugent et al. (1994), Plourde et al. (1998), and Finison et al. (1993)).

Prescription medication abuse is another emergent public health problem, increasing nearly 16-fold in the United States during the 1990s and gaining widespread attention following the OxyContin epidemic in 2000, prompting the U.S. Department of Health and Human Services and the Department of Justice to call for greater use of surveillance methods. Figure 6 illustrates a standardized EWMA chart to detect increases in regional opioid-abuse rates, with the fraction of sampled subjects using opiates nonmedically normalized so the plotted statistic is a weighted average of random variables with the same mean and variance (Benneyan et al. 2006). Monitoring is particularly important when new drugs are introduced to identify products at high risk for abuse, leading to the interesting problem of how to monitor the rate of abuse increase, rather than the abuse rate itself. Heterogeneous dichotomous data occur in several settings in which the likelihood of an event is not the same for all trials in the sample. Examples include risk-adjusted mortality, surgical-site infections for patients with dierent likelihoods, and adverse events aggregated across departments or procedures. For example, the risk of a mechanically ventilated ICU patient acquiring ventilator-associated pneumonia ranges from 6% to 52%, dependent on patient acuity and various risk factors, and surgical-site infection rates can vary from 3% to 46%, with patients typically stratied into dierent risk strata or with their individual risks estimated via logistic regression or related methods.

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FIGURE 4. Binary CUSUM Control Chart for Vancomycin-Resistant Enterococcus. Reproduced with permission from Brown et al. (2002).

Benneyan and Borgman (2004) developed a mixed-risk probability distribution and corresponding control charts for such applications, where trials either all have dierent failure probabilities or can be partitioned into j intrahomogeneous subpopulations. Figure 7 illustrates a standardized EWMA version of these charts for surgical site infections, with patients stratied into the four National Nosocomial Infection Surveillance (NNIS) risk categories. As shown, results can signicantly dier from those based on the binomial independent and identically distributed assumption, with associated eects on run-length detection properties. These charts also can be used to monitor regional data aggregated across dierent geographic areas and the CMS composite statistics mentioned above that combine compliance data across multiple measures.

Auto-correlated data arise in several health-care and patient-monitoring applications that lend themselves to the various SPC methods developed for cyclic processes. Figure 8 illustrates the moving centerline MCEWMA control chart proposed by Montgomery and Mastrangelo (1991), to monitor a patients systolic blood pressure. Somewhat similar forecast-based methods are used in some diseasesurveillance monitoring systems to establish expectations and statistical thresholds, such as for community inuenza-related mortality surveillance and microbiology laboratory monitoring described by Garnerin et al. (1992) and Dessau and Steenberg (1993), respectively. Other examples of autocorrelated health-care processes include appointment delays, patient waits, asthmatic lung volumes, bloodsugar levels, and other physiologic data. Respiratory

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FIGURE 5. EWMA g Chart of Number of Surgeries Between Postoperative Surgical-Site Infections.

illness, inuenza, and other communicable disease rates also tend to exhibit seasonal behavior, suggesting extension of SPC methods beyond autoregressive and moving-average approaches to include seasonality, day-of-week, and time-of-day factors. As in other industries, it sometimes may be desirable to control a process about a target via engi-

neering control, possibly combined with SPC to detect changes in a patients underlying physiology. In patient management, however, periodic rather than continuous adjustments typically are preferable due to the cost, practicality, and clinical impact of frequent modications. Figure 9 illustrates bounded feedback adjustment (Box (1991), Box and Luceno (1993)) to control warfarin anticoagulant levels and

FIGURE 6. Standardized EWMA p Chart of Prescription Opioid-Abuse Rates (Fraction Using Opioids in Last 30 Days).

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FIGURE 7. Risk-Adjusted j-Binomial Standardized EWMA Chart for Surgical-Site Infections, Using the j = 4 National Nosocomial Infection Surveillance (NNIS) Risk Categories.

the resultant center-truncated draw-bridge distribution (unlike for continuous feedback) of the periodic adjustments under stability and drift, with implications on the best way to apply SPC in this context. Other potential applications include diabetic glucose levels, ICU patient blood counts, oxygen-saturation levels, and pituitary hormone adjustment, all being cyclic and desirable to periodically control, but where competing costs of adjustments, deviations from desired levels, and delayed change detection need to be balanced.

Discussion and Opportunities


Many fertile opportunities exist for greater interaction between health-care and quality control communities, by both applying existent monitoring methods and researching new methods where appropriate. Methods more traditionally used in health care also may prove useful to industrial quality-engineering work. As one example, a common problem in health care, as elsewhere, is establishing control charts for

FIGURE 8. Moving Centerline EWMA Control Chart of Systolic Blood-Pressure Data.

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FIGURE 9. Bounded Feedback Control of Anticoagulant Process and Distribution of Adjustment Amounts.

new processes or when little data exist, suggesting the use of start-up or job-shop control charts. Multivariate methods also may have potential applications for monitoring patient symptoms, but remain largely unexplored. The use of loss functions, change-point detection, optimal chart design, and designed experiments also have been barely explored in health-care delivery processes. In particular, evolutionary operation (EVOP) may have the potential to systematically improve existing processes while maintaining satisfactory outcomes, especially given that oline designed experiments are not feasible in many health-care scenarios. It also might be interesting to investigate optimal sampling and overall chart design, such as via the models developed by Duncan (1956), Montgomery et al. (1975), and others, given that the magnitude and relative costs of false alarms, delayed detection, and sampling costs can be fundamentally dierent than in other industries. For example, sampling by chart review is very labor intensive and expensive, signal investigation costs can exceed $1000, and the cost of a surgical site infection can exceed $14,000. More broadly, there appear as many similarities as dierences between health-care and industrial monitoring methods, each of which might benet from closer collaboration. For example, industrial applications of acuity-adjusted control charts might include monitoring defective items produced on dierent lines or in job shops, accidents combined across dierent facilities, and incoming quality from dierent venders. Regression-adjusted charts (e.g., Hawkins (1991),

Jackson (1959), and Mandel (1969)) also might be applied to continuous data, such as severity-adjusted lengths of hospital stays, and the funnel plots proposed by Spiegelhalter (2002) and the related charts recommended by Adab et al. (2002) appear similar to analysis of means and regression control charts because there is no real-time dimension. Monitoring rates of change, such as reduction in risk-adjusted mortality and of increases in drug abuse, also seem to be important needs. In contrast, epidemiology makes greater use of interrupted time-series analysis methods to determine if an intervention aected subsequent outcomes, an approach that might also be useful in quality-control applications.

Acknowledgments
Portions of the described research were supported by National Science Foundation grants DMI-0085262 and DMI-0323856.

Additional References
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Burnett, L. and Chesher, D. (1995). Applications of CQI Tools to the Reduction in Risk of Needlestick Injury. Infection Control and Hospital Epidemiology 16, pp. 503505. Carey, R. G. and Lloyd, R. C. (2001). Measuring Quality Improvement in Healthcare: A Guide to Statistical Process Control Applications. American Society for Quality, Quality Press, Milwaukee, WI. Classen, D. C.; Evens, R. S.; Pestotnik, S. L.; Horn, S. D.; Menlove, R. L.; and Rurke, J. P. (1992). The Timing of Prophylactic Administration of Antibiotics and the Risk of Surgical-Wound Infection. New England Journal of Medicine 326, pp. 281286. Cullen, D. J.; Sweitzer, B. J.; Bates, D. W.; Burdick, E.; Edmonson, A.; and Leape, L. L. (1997). Preventable Adverse Drug Events in Hospitalized Patients: A Comparative Study of Intensive Care and General Care Units. Critical Care Medicine 25(8), pp. 12891297. Curran, E.; Benneyan, J. C.; and Hood, J. (2001). Controlling Methicillin-Resistant Staphylococcus aureus: A Feedback Approach Using Annotated Statistical Process Control Charts. Infection Control and Hospital Epidemiology 23(1), pp. 1318. Deming, W. E. (1942). On a Classication of the Problems of Statistical Inference. Journal of the American Statistical Association 37(218), pp. 173185. Dessau, D. B. and Steenberg, P. (1993). Computerized Surveillance in Clinical Microbiology with Time Series Analysis. Journal of Clinical Microbiology 31, pp. 857860. Duncan, A. J. (1956). The Economic Design of Charts Used to Maintain Current Control of a Process. Journal of the American Statistical Association 51, pp. 228242. Finison, L. J.; Spencer, M.; and Finison, K. S. (1993). Total Quality Measurement in Health Care: Using Individual Charts in Infection Control. ASQC Quality Congress Transactions, pp. 349359. Garnerin, P. H.; Saidi, Y.; and Valleron, A. J. (1992). The French Communicable Diseases Computer Network. Annals of the New York Academy of Sciences 670, pp. 2942. Gawande, A. A.; Thomas, E. J.; Zinner, M. J.; and Brennan, T. A. (1999). The Incidence and Nature of Surgical Adverse Events in Colorado and Utah in 1992. Surgery 126(1), pp. 6675. Goldmann, D. A. and Huskins, W. C. (1997). Control of Nosocomial Antimicrobial-Resistant Bacteria: A Strategic Priority for Hospitals Worldwide. Clinical Infectious Diseases 24, pp. S139S145. Institute of Medicine. (1999). To Err Is Human: Building a Safer Health System, Kohn, L. T.; Corrigan, J. M.; and Donaldson, M. S. (editors). National Academy Press, Washington, DC. Institute of Medicine. (2000). Crossing the Quality Chasm: A New Health System for the 21st Century. National Academy Press, Washington, DC. Institute of Medicine. (2005). Building a Better Delivery System: A New Engineering/Healthcare Partnership, Reid, P. P.; Compton, W. D.; Grossman, J. H.; and Fanjiang, G. (editors). National Academy Press, Washington, DC. Jacquez, G. M.; Waller, L. A.; Grimson, R.; and Wartenberg, D. (1996). On Disease Clustering. Part 1: State of the Art. Infection Control and Hospital Epidemiology 17, pp. 319327. Jackson, J. E. (1959). Quality Control Methods for Several Related Variables. Technometrics 1, pp. 359377.

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