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n the gap between excellence and perfection, there is suffering, harm, tragedy, and death."
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Journal of Patient Safety

Kevin T. Kavanagh MD, MS
Associate Editor
Journal of Patient Safety

Health Watch USA 
Health Watch USAsm Is a Non-Profit Patient Advocacy Organization Which Promotes Healthcare Value, Transparency & Quality

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a designated "Community Leader" for Value-Driven Healthcare  by the U.S. Dept. of Health and Human Services.

Thomas R. Frieden, Director of the CDC, has stated “Evidence indicates that, with focused efforts, these once formidable infections can be greatly reduced in number, leading to a new normal for healthcare-associated infections as rare, unacceptable events. -- October 2011  View Article  

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  • Slide 1  An Analysis of the FDA MAUDE Database and the Search for Cobalt Toxicity in Class 3 JohnsonWe were not able find in the FDA MAUDE database meaningful warning signs to support the contention that chromium-cobalt–containing Class 3 J&J and DePuy hip implants caused systemic neurological or thyroid symptoms in patients. The incidence of reported cardiomyopathy was rare but frequent enough to be cause of concern. The redaction of most patient data along with the nonstructured nature of data entry would be expected to hinder the identification of warning signs. Even identification of the type of device could not be consistently carried out. In addition, the FDA needs to implement a methodology to identify and group all reports from a single device implanted into a patient, so duplication of event counting would not occur. Of 83,550 J&J/DePuy KWA Reporter File records, we found only two physician reports sent directly to the FDA. Almost all reports are submitted by manufacturers and are most commonly authored by attorneys. A standard of care needs to be set for physicians to report medical device adverse events to the FDA.
  • Slide 2 View point: gaps in the current guidelines for the prevention of Methicillin-resistant Staphylococcus aureus surgical site infectionsThe authors advocate the two additional strategies to the current United State’s guidelines for the prevention of surgical site infections. It is known that Staphylococcus aureus, including MRSA, carriers are at a higher risk for the development of infections and they can easily transmit the organism. The carriage rate of Staph. aureus in the general population approximates 33%. The CDC estimates the carriage rate of MRSA in the U.S. is approximately 2%. The first strategy is preoperative screening of surgical patients for Staph. aureus, including MRSA. This recommendation is based upon the literature which shows a benefit in both prevention of infections and guidance in preoperative antibiotic selection. The 2nd is performing MRSA active surveillance screening on healthcare workers. The carriage rate of MRSA in healthcare workers approximates 5% and there are concerns of transmission of this pathogen to patients. MRSA decolonization of healthcare workers has been reported to approach a success rate of 90%. Healthcare workers colonized with dangerous pathogens, including MRSA, should be assigned to non-patient contact work areas. In addition, there needs to be a safety net for both the worker’s economic security and healthcare. Finally, a reporting system for the healthcare worker acquisition and infections with dangerous pathogens needs to be implemented. Staph. aureus including MRSA is endemic in the U.S. Policies regarding endemic pathogens which are to be implemented only upon the occurrence of a facility defined “outbreak” have to be questioned, since absence of infections does not mean absence of transmission. Optimizing these policies will require further research but until then we should error on the side of patient safety.
  • Slide 3 The incidence of MRSA infections in the United States:A review of epidemiological studies on the incidence of MRSA infections overtime was performed along with an analysis of data available for download from Hospital Compare ( We found the estimations of the incidence of MRSA infections varied widely depending upon the type of population studied, the types of infections captured and in the definitions and terminology used to describe the results. We could not find definitive evidence that the incidence of MRSA infections in U.S. community or facilities is decreasing significantly. Of concern are recent data reported to the National Healthcare Safety Network (NHSN) on MRSA bloodstream infections which indicate that by the end of 2015 there had been little change in the average facility Standardized Infection Ratio (0.988), compared to a 2010–2011 baseline and is significantly increased compared to the previous year. This is in contradistinction to the recent Veterans Administration study which reported over an 80% reduction in MRSA infections. However, this discrepancy may be due to the inability to reconcile the baselines of the two data sets; and the observed increase may be artifactual due to aberrations in the NHSN tracking system. Our review supports the need for implementation of a comprehensive tracking and monitoring system involving all types of healthcare facilities for multi-drug resistant organisms, along with concomitant funding for both staff and infrastructure. Without such a system, determining the effectiveness of interventions such as antibiotic stewardship and chlorhexidine bathing will be hindered.
  • Slide 4  Estimating hospital-related deaths due to medical error:  A perspective from patient advocatesThe authors present a viewpoint regarding the quality of data used in estimating the number of preventable hospital deaths in the United States. Data derived from countries with a nationalized healthcare system with well-defined and near uniform implementation of standards may not be applicable to the fragmented non-centralized delivery system found in the United States. Although U.S. studies evaluating preventable mortality have based their projections on a small sample size, it is unlikely that this observation is due to chance, since other studies evaluating adverse events, a precursor to preventable mortality, have a much larger sample size and also report an unacceptably high number of events. In addition, these estimates involved adult and Medicare eligible patients which may have a higher incidence of events and create a bias, but they also did not capture all events, take into account mortality which occurs post-hospitalization or from miss-diagnoses. It is also important not to mitigate adverse events in patients whose death is imminent. Medicine does not have the moral authority to place differing values on days, weeks or years of life. The contention that there are approximately 200,000 preventable hospital-related deaths in the United States is not unreasonable. Not all hospital systems in the United States make the same investment in patient safety. Recently, the Agency for Healthcare Research & Quality has demonstrated a decline in adverse events in hospitals, but until uniform implementation of safety standards takes place, our healthcare system as a whole may well lag behind other industrialized nations. -- Kavanagh KT, Saman DM, Rosie R, Westerman K. Journal of Patient Safety. Published Online Feb. 9, 2017.
  • Slide 5  A Perspective on the Principles of Integrity in Infections Disease ResearchThe medical literature is prone to overstating results; a condition not thoroughly recognized among policymakers. This article sets forth examples of potential problems with research integrity in the infectious disease literature. We describe articles that may be spun, categories lumped together in hopes of creating a significant effect (and sometimes an insignificant one), changes in metrics, and how trials may fail because of suboptimal interventions. When examined together, the examples show that the problems are widespread and illustrate the difficulty associated with interpreting medical research. The state of the current medical literature makes it of utmost importance that all sections of the manuscript are read, including associated letters to the editors and information on before authors’ recommendations are accepted. -- Kavanagh KT, Tower SS, Saman DM. J Patient Saf. 2016 Jun;12(2):57-62.
  • Slide 6  Commentary: Missing opportunities on the Presidential Advisory Council on Combating Antibiotic Resistance (PACCARB)   Antimicrobial resistance is a critically important impending public health crisis that not only threatens the treatment of infectious disease but also the very foundations of modern health care from transplantation to cancer chemotherapy. Many types of surgeries and the health of immunocompromised patients, including diabetics, will be placed at risk as antibiotics are no longer to prevent or treat infections. Even minor illnesses or injuries such as a scrape or paper cut become life threatening in the absence of effective antibiotics. Similar to other industrialized countries with national healthcare, the United States needs to set prioritized standards which can be implemented with near uniformity across our healthcare system. This will not be an easy task, but how the leaders in public health and infectious disease address this epidemic at this juncture will be studied for millennia and their actions dissected for centuries to come. Their decisions will determine their legacy and the future of modern health care as a whole. -- Landers T, Kavanagh KT. Am J Infect Control. 2016 Dec 1;44(12):1761-1762.
  • Slide 7  Questionable Validity of the Catheter Associated Urinary Tract Infection Metric Used for Value-Based PurchasingCatheter-associated urinary tract infections (CAUTIs) occur in 290,000 U.S. hospital patients annually, with an estimated cost of $290 million. Two different measurement systems are being used to track the U.S. Healthcare system’s performance in lowering the rate of CAUTIs. Since 2010, the AHRQ metric has shown a 28.2% decrease, while the CDC metric has shown a 3% to 6% increase, since 2009. Differences in data acquisition and the definition of the denominator may explain this discrepancy. The AHRQ metric analyzed chart audited data and reflects both catheter utilization and care. The CDC metric analyzed self-reported data and primarily reflects catheter care. Because the ARHQ metric’s analysis showed a progressive change in performance over time, and the scientific literature supporting the importance of catheter-utilization in the prevention of CAUTIs, it is suggested that risk-adjusted catheter-utilization data be incorporated into metrics that are used for determining facility performance and for value-based purchasing Initiatives. -- Calderon LE, Kavanagh KT, Rice MK. American Journal of Infection Control. Published online Jul. 1, 2015.
  • Slide 8  A response to “Screening and isolation to control methicillin-resistant Staphylococcus aureus:  sense, nonsense, and evidence”Active surveillance and isolation (ADI) for the prevention of methicillin-resistant Staphylococcus aureus (MRSA) has become a controversial topic. There have been calls from numerous authors for a movement away from rigid mandates and toward an evidence-based medicine approach. However, much of the evidence used is distorted. Negative findings in two major studies have been used to prevent recommendations on ADI for MRSA. However the findings in these studies can be explained by flaws in study implementation rather than the ineffectiveness of ADI. The use of daily chlorhexidine bathing has also been proposed as an alternative to surveillance and isolation. There is conflicting evidence in the literature regarding the effectiveness of chlorhexidine. In addition, the major concern with universal daily chlorhexidine bathing is the production of resistance. The use of ADI to address epidemics and common dangerous pathogens should solely depend upon ADI’s ability to prevent further spread to and infection of other patients through indirect contact. At present, there is a preponderance of evidence in the literature to support continuing use of ADI to prevent the spread of dangerous pathogens. -- Kavanagh KT, Calderon LE, Saman DM. Antimicrob Resist Infect Control. 2015 Feb 5;4:4
  • Slide 9  Conflict of Interest, Dr Charles Denham and the Journal of Patient SafetyThe Journal's mission is to publish work that will make patients safer, and that should not be subverted by commercial interests. We regret the breach of trust to the readers of the Journal caused by Dr Denham. It is important for the Journal and for the field of quality and safety that readers have greater trust in the Journal going forward.We believe that the best way to deal with conflicts is for them to be declared and dealt with by greater transparency. Conflicts need to be managed appropriately, and organizations need to have a culture in which people are attentive to conflicts and willing to identify them. -- Wu AW, Kavanagh KT, Pronovost PJ, Bates DW. Conflict of Interest, Dr Charles Denham and the Journal of Patient Safety. J Patient Saf. 2014 Dec;10(4):181-185.
  • Slide 10  The effectiveness of Medicare’s non-paymentof hospital-acquired conditions policyThe policy of not paying for certain hospital-acquired conditions (HACs) was mandated by the U.S.Congress for Medicare in the 2006 Deficit Reduction Act and for Medicaid by the Affordable Care Act and essentially enacted line item penalties in a largely bundled payment system; a plan some would argue was doomed to fail at its onset. -- Kavanagh KT. Letter to the Editor regarding: The effectiveness of Medicare's non-payment of hospital-acquired conditions policy. Health Policy. 2014 Aug 27. pii: S0168-8510(14)00221-8. doi: 10.1016/j.healthpol.2014.08.006. [Epub ahead of print]
  • Slide 11  The use of surveillance and preventative measures for methicillin-resistant staphylococcus aureus infections in surgical patientsTwo recommendations are emerging for the control of MRSA. The first is to screen for and treat carriers, them second is universally treat everyone and run the theoretical risk of worsening bacterial resistance and changing the microbiome of both the patient and the facility. The decade long policy followed in some, and hopefully few, facilities of not doing either of these interventions appears to no longer be an option. -- Kavanagh KT, Calderon LE, Saman DM, Abusalem SK. The use of surveillance and preventative measures for methicillin-resistant staphylococcus aureus infections in surgical patients. Antimicrob Resist Infect Control. 2014 May 14;3:18. eCollection 2014
  • Slide 12  A perspective on how the United States Fell behind Northern Europe in the battle against methicillin-resistant Staphylococcus aureusGiven the evidence, it is unclear why the U.S. health care industry has not embraced ADI (active detection and isolation) as an integral part of infection control. Some patient advocates believe that one of the reasons is to prevent the passage of legislative mandates. If this is the case, the best way to prevent legislative mandates is by having a quality health care system that adopts and implements standards of care based upon the best evidence available. In view of the severity of the MDRO epidemic in the United States, a reevaluation of the setting of standards of care for the expanded and uniform use of active MRSA surveillance testing should be undertaken. -- Kavanagh KT, Saman DM, Yu Y. A perspective on how the united states fell behind Northern Europe in the battle against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2013 Dec;57(12):5789-91. doi: 10.1128/AAC.01839-13. Epub 2013 Oct 7
  • Slide 13  Moving Heatlhcare Quality Forward With Nursing Sensitive Value-Based PurchasingValue-based purchasing is in its infancy. Devising an effective system that recognizes and incorporates nursing measures will facilitate the success of this initiative. NSVBP needs to be designed and incentivized to decrease adverse events, hospital stays, and readmission rates, thereby decreasing societal healthcare costs. At the heart of NSVBP is the concept that one cannot have a quality institution without providing highly trained and skilled nursing care. Yet nursing is at risk for inadequate support, both in staffing numbers and skill mix, particularly in today’s cost-driven and financially stressed healthcare delivery systems. -- Kavanagh KT, Cimiotti JP, Abusalem S, Coty MB. Moving healthcare quality forward with nursing-sensitive value-based purchasing. J Nurs Scholarsh. 2012 Dec;44(4):385-95.
  • Slide 14  The Relationship Between Tort Reform and Medical UtilizationThe comparison of the Dartmouth Atlas Medicare Reimbursement Data with Malpractice Reform State Rankings, which are used by the PRI, did not support the hypothesis that defensive medicine is a driver of rising health-care costs. Additionally, comparing Medicare reimbursements, premedical and postmedical tort reform, we found no consistent effect on health-care expenditures. Together, these data indicate that medical tort reform seems to have little to no effect on overall Medicare cost savings. -- Kavanagh KT, Calderon LE, Saman DM. J Patient Saf. 2014 Dec;10(4):222-30
  • Slide 15  Can Inpatient Hospital Experiences Predict Central Line-Assoicated Bloodstream InfectionsUsing national datasets, we found that inpatients' hospital experiences were significantly associated with an increased risk of ICU reported CLABSIs. This study suggests that hospitals with lower staff responsiveness, perhaps because of an understaffing of nurse and supportive personnel, are at an increased risk for CLABSIs. This study bolsters the evidence that patient surveys may be a useful surrogate to predicting the incidence of hospital acquired conditions, including CLABSIs. Moreover, our study found that poor staff responsiveness may be indicative of greater hospital problems and generally poorly performing hospitals; and that this finding may be a symptom of hospitals with a multitude of problems, including patient safety problems, and not a direct cause. -- Saman DM, Kavanagh KT, Johnson B, Lutfiyya MN. Can inpatient hospital experiences predict central line-associated bloodstream infections? PLoS One. 2013;8(4):e61097.
  • Slide 16  A tale of two cows: Why we have a cow map and not a healthcare acquired infection mapIf there is a USA Beef Cow Density Map by county, why can't we have a MRSA map or a map for all Health Care Acquired Infections ?? -- Posted by the Center for Disease Dynamics, Economics and Policy. Mar. 13, 2012. Authors: Dr Daniel Saman, DrPH, MPH, CPH and Dr Kevin Kavanagh, MD, MS, FACS
  • Slide 17  Redefining the Standarized Infection Ratio to Aid in Consumer Value PurchasingRedefining the Standarized Infection Ratio to Aid in Consumer Value PurchasingTo be most understandable to the consumer, the Standarized Infection Ratio National Benchmark of 1.0 should reflect what is obtainable. The SIR is a tool intended to be used by consumers in value purchasing to compare differences between facilities and thus should not adjust for these differences. Ideally, factors used in risk adjustment should solely be based upon patient characteristics. Thus, facility-specific adjustments (i.e., medical school affiliation, major teaching institution and unit bed size) should be used with caution in calculating the SIR and their use made clearly transparent to health-care consumers. -- Saman DM, Kavanagh KT, Abusalem SK. Redefining the standardized infection ratio to aid in consumer value purchasing. J Patient Saf. 2013 Jun;9(2):55-8.
  • Slide 18  Assessing the Necessity of the Standarized Infection Ratio for Reporting Central Line-Associated Bloodstream InfectionsEvidence is mounting that all hospitals should be able to achieve a near zero incidence of CLABSIs and that these infections may in fact be near 'never events', which begs whether risk adjustment with the SIR is needed and whether it adds more information than does rate adjustment using CLABSI rates. … nearly 70% of 1721 reporting hospitals with at least 1000 central line days had five or fewer infections during 2011. These hospitals had 39.3% of the total central line days and a significantly lower SIR than poorer performing hospitals with six or more CLABSIs (p=0.0001). In addition, 19 hospitals are presented which had central line days between 9000 to over 22,000 that also had zero to three CLABSIs. -- Saman DM, Kavanagh KT. Assessing the necessity of the standardized infection ratio for reporting central line-associated bloodstream infections. PLoS One. 2013 Nov 4;8(11):e79554.
  • Slide 19  A Perspective on the Evidence Regarding Methicillin-resistant Staphylococcus aureus SurveillanceTwo prominent studies have been used by policy makers to prevent the enactment of standards of care regarding active surveillance of patients with methicillin-resistant Staphylococcus aureus in hospital settings. In this brief review and perspective of those studies, we contend that both studies have serious limitations (i.e., the intervention group was not given optimal intervention) that may not have been scrutinized by many policy makers, health officials, and other researchers. These studies seem to have had a disproportionate impact on health-care policy despite their limitations. Furthermore, health-care policy and treatment standards need to reflect the preponderance of evidence with appropriate weight given to research studies based on their strengths and limitations. -- Kavanagh K, Abusalem S, Saman DM. A perspective on the evidence regarding methicillin-resistant Staphylococcus aureus surveillance. J Patient Saf. 2012 Sep;8(3):140-3.
  • Slide 20  Financial Incentives to Promote Health Care Quality:  The Hosptial Acquired Condition Nonpayment PolicyThe Hosptial Acquired Condition Nonpayment PolicyAs a further initiative to promote quality, financial incentives have been implemented by the Centers for Medicare and Medicaid Services. Surgeons have lived under stringent financial incentives since the mid-1980s when they were placed under global surgical fees. Medicare currently must make expenditure reductions because it is at risk of becoming insolvent within the decade. Implementation of financial incentives should depend upon a balance between the nonpayment of providers for nonpreventable HAC verses the promotion of health care quality and patient safety, the reduction in patient morbidity and mortality, the spurring of mechanisms to further reduce HAC, and the recouping of taxpayer dollars for HAC that could have been prevented. -- Kavanagh KT. Financial incentives to promote health care quality: the hospital acquired conditions nonpayment policy. Soc Work Public Health. 2011;26(5):524-41.
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