Foundation For Risk Management Research Articles

Malpractice carrier underwrites Fundamentals of Laparoscopic Surgery training and testing: a benchmark for patient safety

Fundamentals of Laparoscopic Surgery (FLS) is a validated program developed by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to educate and assess competency in minimally invasive surgery (MIS). This study reports the first malpractice carrier-sponsored FLS course for surgeons in practice underwritten by the Controlled Risk Insurance Company of Harvard's Risk Management Foundation (CRICO/RMF). The study investigated the participating surgeons' pattern of MIS skills acquisition, subjective laparoscopic comfort level, operative activity, and perception of the FLS role in surgical education, credentialing, and patient safety. A 1-day postgraduate continuous medical education (CME) course consisted of didactic presentations of the leading MIS faculty, proctored FLS hands-on training, psychomotor testing, and cognitive computer-based examination. Voluntary anonymous pre- and postcourse surveys were distributed to the participants at registration and at completion of both the didactic teaching and the skills modules of the program. The course was attended by 37 practicing surgeons in the Harvard system, and 86% of the survey forms were returned. The major driving forces for attending the course were directive from the chief/chairman (50%), improvement in MIS didactic knowledge (56%), and the belief that FLS would become a standard such as advanced trauma life support (ATLS), advanced cardiac life support (ACLS), or the like (53%). Surgeons reported that the FLS exam content was appropriate (Likert 4.41 +/- 0.91) and that mastery of the course material would improve safety (Likert 4.13 +/- 0.79) and technical knowledge of MIS (Likert 4.03 +/- 1.00). This unique cooperative effort between a liability carrier, a professional surgical society, and proactive surgeons should be considered a model for advancing competency and patient safety. The survey results indicate a positive view of FLS in surgical training, safety, and MIS education.

An ethical appraisal of hormesis: toward a rational discourse on the acceptability of risks and benefits

Hormesis has been defined as a dose-response relationship in which there is a stimulatory response at low doses but an inhibiting response at high doses, resulting in a U- or inverted U-shaped dose response. Until now, regulatory agencies have been reluctant to address this new insight or adjusted their routines for regulating such substances. Should regulators change their principles of decision making and standard setting in the light of the new insights from hormesis research? To answer this question, it is essential to review the ethical implications of hormesis in risk assessment and management. What kind of values should govern the regulation of substances and radiation that may cause positive and negative impacts at the same time (depending on dose and individual variability)? This article tries to address this problem. It deals with the basic ethical principles and foundations of risk management and introduces the essentials of ethics and the application of ethical principles to judging the acceptability of risks to humans and the environment. It will also discuss the merits of an analytic deliberative approach to evaluating complex risks and address the application of this discursive methods to risk management taking into account the hormesis challenge.

Enterprise Risk Management In a Pharmaceutical Company

Risks are everywhere and in any activity. Many pharmaceutical companies are currently looking to better understand, anticipate, and be able to mitigate business risk in order to deliver the rewards of risk taking, and to minimize the frequency and impact of risk on the downside. Some of them use Enterprise Risk Management concept (ERM, developed by COSO) to establish an effective corporate management system. In the present paper, we analyze the integrated approach that is used by the company as the foundation of risk management within a company. The reader is offered a case of constructing ERM system in practice.

Obstetric Simulation as a Risk Control Strategy

Patient safety initiatives aimed at reducing medical errors and adverse events are being implemented in Obstetrics. The Controlled Risk Insurance Company (CRICO), Risk Management Foundation (RMF) of the Harvard Medical Institutions pursued simulation as an anesthesia risk control strategy. Encouraged by their success, CRICO/RMF promoted simulation-based team training as a risk control strategy for obstetrical providers. We describe the development, implementation, and evaluation of an obstetric simulation-based team training course grounded in crisis resource management (CRM) principles. We pursued systematic design of course development, implementation, and evaluation in 3 phases, including a 1-year or more posttraining follow-up with self-assessment questionnaires. The course was highly rated overall by participants immediately after the course and 1-year or more after the course. Most survey responders reported having experienced a critical clinical event since the course and that various aspects of their teamwork had significantly or somewhat improved as a result of the course. Most (86%) reported CRM principles as useful for obstetric faculty and most (59%) recommended repeating the simulation course every 2 years. A simulation-based team-training course for obstetric clinicians was developed and is a central component of CRICO/RMF's obstetric risk management incentive program that provides a 10% reduction in annual obstetrical malpractice premiums. The course was highly regarded immediately and 1 year or more after completing the course. Most survey responders reported improved teamwork and communication in managing a critical obstetric event in the interval since taking the course. Simulation-based CRM training can serve as a strategy for mitigating adverse perinatal events.

Patient safety knowledge and its determinants in medical trainees.

Patient safety is a core educational topic for medical trainees. To determine the current level and determinants of patient safety knowledge in medical trainees. Multi-institutional cross-sectional assessment of patient safety knowledge. Residents and medical students from seven Harvard-affiliated residencies and two Harvard Medical School courses. Participants were administered a 14-item validated test instrument developed based on the patient safety curriculum of the Risk Management Foundation (Cambridge, MA). The primary outcome measure was the amount of patient safety knowledge demonstrated by trainees on the validated test instrument. The secondary outcome measure was their subjective perceptions as to their baseline knowledge level in this domain. Ninety-two percent (640/693) of residents and medical students completed the patient safety test. Participants correctly answered a mean 58.4% of test items (SD 15.5%). Univariate analyses show that patient safety knowledge levels varied significantly by year of training (p = 0.001), degree program (p < 0.001), specialty (p < 0.001), country of medical school (p = 0.006), age (p < 0.001), and gender (p = 0.050); all but the latter two determinants remained statistically significant in multivariate models. In addition, trainees were unable to assess their own knowledge deficiencies in this domain. Patient safety knowledge is limited among medical trainees across a broad range of training levels, degrees, and specialties. Effective educational interventions that target deficiencies in patient safety knowledge are greatly needed.

Developing a Risk Assessment and Management Approach to Laboratory Biosecurity

A growing awareness in the microbiological research and policy communities centers on the need to increase the protection of dangerous biological agents from theft. However, existing security literature and regulatory requirements do not present a comprehensive approach or clear model for biosecurity, nor do they wholly recognize the operational issues within laboratory environments. The modern laboratory operating environment needs to be defined by both biosafety and biosecurity considerations. In addition to being a component of the operating environment, biosafety can serve as a model for biosecurity. Both of these paradigms should be implemented in a graded manner, with increased protection based on the results of a risk assessment. This article proposes a preliminary framework for assessing biosecurity considerations and provides examples that address specific biological materials. The bio can be divided into several fundamental steps: (1) assessing the materials based on their weaponization potential and potential consequences, (2) assessing the potential adversaries, and (3) analyzing security scenarios. The results of the risk assessment form the foundation for risk management and the design of a biosecurity program. By prioritizing risks, the assessment provides a rational basis for allocating scarce security resources.

Improving patient safety

The analysis of closed malpractice claim files is a valid and useful technique for learning from past experience. Harvard and the Risk Management Foundation (RF-HMI) were among the pioneers in this approach and have proven the value of looking beyond medical records to the more comprehensive information available in malpractice claim files. Helpful risk prevention strategies in several clinical disciplines have been the result. In this issue of Neurology , Glick et al.1 add to an expanding literature that describes neurology malpractice claims.2–4 Glick et al. reviewed 42 closed claims under the purview of the RMF-HMI. Of these claims, 24 represented, in the authors’ opinion, “authentic, partially or wholly preventable adverse events.”1 The detail of the reports provides insights unavailable from larger administrative studies that lack such in-depth case analysis. Instances of medical malpractice commonly implicate faulty systems of care rather than individual physicians. Substantial gains in patient safety often result from making systems modifications.5 The Glick et al. analysis of legitimate claims reinforces that idea: medication errors …

A Randomized Double-Blind Controlled Trial of Microstream Capnography to Reduce Oxygen Desaturation During Gastrointestinal Procedures with Conscious Sedation

Oxygen desaturation is a relatively late sign of ventilatory compromise. ASGE monitoring guidelines for all GI procedures call for continuous pulse oximetry and visual assessment during conscious sedation (CS), which may not detect apnea until O2 desaturation has occurred. Microstream capnography may provide an “early warning system” by generating real-time waveforms of respiration (capnograms) in non-intubated patients. Aim: To determine whether intervention based on capnography indications of apnea reduces O2 desaturation during CS. Methods: We performed an IRB-approved double-blind randomized controlled trial of ASA Class I/II children undergoing GI procedures with midazolam + fentanyl CS, 2L supplemental O2, standard patient monitoring, and routine care. Endoscopy staff was blinded to additional continuous capnography monitoring (Philips M4 with Microstream® CO2). Study arm was determined by opening a pre-numbered sequence of envelopes containing randomly permuted assignments. In the intervention arm, a trained independent monitor (IM) signaled to the endoscopy staff by raised hand if capnograms indicated apnea for >15 sec. In the control arm, an IM signaled if capnograms indicated apnea for >60 sec. Upon IM signals, endoscopy RNs instructed patients to breathe deeply and/or touched their backs. We hypothesized that patients randomized to the intervention arm would have fewer episodes of minor O2 desaturation (O2 sats <95% for 5 sec) than patients in the control arm. Results: 163 participants (89 male; mean age 13 yr, range 6mo-19 yr; 86% ASA I) underwent 174 procedures (80% EGD, 13% colonoscopy, 7% both). Intervention and control patients did not differ significantly in sex, age, ASA class, procedures undergone, baseline O2 sats, or doses of midazolam and fentanyl. Endoscopy RNs documented poor ventilation in 2.7% of study patients and no apnea. Capnography indicated disordered ventilation during 56% of all procedures and apnea in 24%. Patients in the intervention arm were significantly less likely to have an intraprocedural episode of O2 desaturation than those in the control arm (11% vs 24%, p < 0.03). Conclusions: The results of this controlled effectiveness trial support the routine use of microstream capnography to improve detection of apnea and reduce O2 desaturation during CS for GI procedures. Supported by AHRQ (K08 HS1-367502), a Risk Management Foundation Patient Safety Grant and Children's Hospital Boston GCRC (M01-RR02172). Oxygen desaturation is a relatively late sign of ventilatory compromise. ASGE monitoring guidelines for all GI procedures call for continuous pulse oximetry and visual assessment during conscious sedation (CS), which may not detect apnea until O2 desaturation has occurred. Microstream capnography may provide an “early warning system” by generating real-time waveforms of respiration (capnograms) in non-intubated patients. Aim: To determine whether intervention based on capnography indications of apnea reduces O2 desaturation during CS. Methods: We performed an IRB-approved double-blind randomized controlled trial of ASA Class I/II children undergoing GI procedures with midazolam + fentanyl CS, 2L supplemental O2, standard patient monitoring, and routine care. Endoscopy staff was blinded to additional continuous capnography monitoring (Philips M4 with Microstream® CO2). Study arm was determined by opening a pre-numbered sequence of envelopes containing randomly permuted assignments. In the intervention arm, a trained independent monitor (IM) signaled to the endoscopy staff by raised hand if capnograms indicated apnea for >15 sec. In the control arm, an IM signaled if capnograms indicated apnea for >60 sec. Upon IM signals, endoscopy RNs instructed patients to breathe deeply and/or touched their backs. We hypothesized that patients randomized to the intervention arm would have fewer episodes of minor O2 desaturation (O2 sats <95% for 5 sec) than patients in the control arm. Results: 163 participants (89 male; mean age 13 yr, range 6mo-19 yr; 86% ASA I) underwent 174 procedures (80% EGD, 13% colonoscopy, 7% both). Intervention and control patients did not differ significantly in sex, age, ASA class, procedures undergone, baseline O2 sats, or doses of midazolam and fentanyl. Endoscopy RNs documented poor ventilation in 2.7% of study patients and no apnea. Capnography indicated disordered ventilation during 56% of all procedures and apnea in 24%. Patients in the intervention arm were significantly less likely to have an intraprocedural episode of O2 desaturation than those in the control arm (11% vs 24%, p < 0.03). Conclusions: The results of this controlled effectiveness trial support the routine use of microstream capnography to improve detection of apnea and reduce O2 desaturation during CS for GI procedures. Supported by AHRQ (K08 HS1-367502), a Risk Management Foundation Patient Safety Grant and Children's Hospital Boston GCRC (M01-RR02172).

The Promise and Challenge of Integrated Risk Management

INTRODUCTION In the past, risk management was rarely undertaken in a systematic and integrated fashion across the firm. Integrated risk management has only recently become a practical possibility, because of the enormous improvements in computer and other communications technologies, and because of the wide-ranging set of financial instruments and markets that have evolved over the past decade. A sophisticated and globally tested legal and accounting infrastructure is now in place to support the use of such contractual agreements on a large scale and at low cost. Equal in importance to this evolution in capital markets is the cumulative experience and success in applying modern finance theory to the practice of risk management. Today, managers can analyze and control various risks as part of a unified, or integrated, risk management policy Integrated risk management is the identification and assessment of the collective risks that affect firm value, and the implementation of a firm-wide strategy to manage those risks. Integrated risk management, then, looks well beyond the set of traditionally insurable risks, seeking to address all of a firm's risks within an organized and coherent framework. At the foundation of risk management is the integration of the three ways that a firm can alter its risk profile. These fundamental ways that a firm can implement risk management objectives, by modifying the firm's operations, by adjusting its capital structure, and by employing targeted financial instruments, interact to form the firm's risk management strategy. Managers must weigh the advantages and disadvantages of any particular approach in order to find an optimal mix of the three. Traditional insurance, then, a type of targeted financial instrument, is but one tool available to the firm. This article presents a managerial overview of integrated risk management, investigating the range of management decisions that it can influence and the benefits for the firm from its implementation. To illustrate these concepts, the article places a special focus on one firm, Honeywell Inc., and its first steps toward integrating traditionally insured risks with other treasury-based risks. WHAT IS RISK MANAGEMENT? Traditionally, risk managers focused on insurable risks and loss control. To those outside the insurance industry, however, risk management tends to evoke thoughts of derivatives and strategies that magnify, not reduce, risk. While today's risk management may use derivatives, derivatives, as a risk management tool, are only a small part of the integrated risk management process. Moreover, a proper risk management strategy does not involve speculation, or betting on the future price of oil, corn, currencies, or interest rates, and indeed is antithetical to such speculation. Instead, the goal of integrated risk management is to maximize value by shaping the firm's risk profile, shedding some risks while retaining others. By applying integrated risk management, managers will benefit from new insights about the interplay among different types of risk and traditional financial decision areas, connections easily missed without a comprehensive framework. Because the three ways to manage risk are functionally equivalent in their effect on risk, their use connects seemingly unrelated managerial decisions. For instance, because capital structure is one component of a firm's risk management strategy, effective capital structure decisions cannot be made in isolation from the firm's other risk management decisions. Consequently, a firm's capital structure choice is inextricably linked to its capital expenditure plans, along with many other operational decisions. This article's discussion of the integrated risk management framework emphasizes the connection among the ternary mechanisms to alter the firm's risk profile and offers guidance on their practical application. BENEFITS OF INTEGRATED RISK MANAGEMENT A cascade of basic decisions about objectives faces the manager who seeks to implement a risk management program. …

Global surveillance needed to prevent foodborne disease

In the interest of improving their diet and health, consumers have increased their demand for fresh fruits and vegetables. Meeting this demand has stimulated worldwide trade in fresh produce. Several highly publicized outbreaks of foodborne disease highlight the risks of fresh produce being contaminated during growing, harvesting, processing or transportation. These outbreaks have included domestic as well as imported produce. However, two factors — the challenge of implementing and maintaining good agricultural practices in developing countries, and the potential for produce contamination with exotic microorganisms that can cause foodborne disease — raise special concerns about the safety of imported produce. Investigating outbreaks of foodborne disease can identify new foodborne disease hazards and lead to new strategies to prevent and control them. A strong system of public-health surveillance for foodborne disease provides a foundation for risk management of worldwide food distribution.

Guidelines for prescribing psychiatrists in consultative, collaborative, and supervisory relationships.

Most psychiatrists enter into a variety of professional relationships with other clinicians in which they prescribe medications or make recommendations about pharmacotherapy. This paper describes a set of guidelines for prescribing psychiatrists involved in consultation, collaboration, and supervision with other clinicians. The guidelines were developed by psychiatrists for the Harvard Risk Management Foundation. The terms consultation, collaboration, and supervision are defined, and the psychiatrist's roles and responsibilities in each type of arrangement are described. The guidelines limit consultation and collaboration to relationships with professionals who are licensed or credentialed. Based on the definitions, the paper describes a structure for working with other clinicians, which begins with a thorough assessment of the context and circumstances of the clinical situation. The guidelines strongly encourage structured communication among clinicians and with the patient and significant others, as well as clarification by clinicians of their respective responsibilities for treatment and follow-up.

The Level of Anesthesia Resident Training Does Not Affect the Risk of Dental Injury

The Level of Anesthesia Resident Training Does Not Affect the Risk of Dental Injury

Profiles in Cognitive Aging

Trivial mental lapses often accompany advancing age, but differentiating these from the early stages of serious cognitive disorders can be a challenge even for experienced clinicians. Such questions have a greater urgency than ever, now that legislatures have largely disbanded mandatory retirement and more older persons remain active in professions that demand high mental acuity. Physicians are often asked to judge an individual's mental competence, yet few of us have the training or time to do detailed cognitive assessment. In addition, the simple screening tools we are familiar with, such as the Mini-Mental State Examination, are notoriously insensitive to early decline in highly functioning persons. Anticipating this problem nearly a decade ago, the Risk Management Foundation of the Harvard Medical Institutions underwrote a series of studies and field tests that led to the development and validation of MicroCog, a cognitive testing battery designed to be administered and scored by a

Grand rounds on medical malpractice

Grand rounds on medical malpractice. Campion, Francis X., The Risk Management Foundation of the Harvard Medical Institutions Incorporated, and American Medical Association(American Medical Association, Chicago, Illinois, 1990), 372 pages, AMA member price $40, nonmember price$55.

Using practice guidelines and standards in QA and RM programs.

Manager 1Loss Prevention/Risk Evaluation Risk Management Foundation of the Harvard Medical Institutions, Inc. Cambridge, MA Marva West Tan has seventeen years experience in risk, quality and utilization., control, including nine years in national consulting. Currently, Ms. Tan is Manager, Loss Prevention/Risk Evaluation at the Risk Management Foundation of the Harvard Medical Institutions, Cambridge, MA. Her former positions include senior associate at InterQual, Inc. and director of utilization review/quality assurance at George Washington University Medical Center in Washington, D. C. Ms. Tan has both published extensively and presented numerous educational programs to a wide variety of professional audiences. Ms. Tan is a member of the American Society of Healthcare Risk Management, where she currently serves on the Index Measures Task Force; NAQAP; the International Quality Assurance Society; and the American Medical Writers Association. Ms. Tan is also an RN.

Risk Management in Psychiatry

This article introduces some basic concepts of psychiatric risk management and demonstrates how risk management and quality assurance can work together. Risk exposure areas and loss prevention issues identified during a review of 98 psychiatric claims managed from 1976 to 1988 by the Risk Management Foundation of the Harvard Medical Institutions are detailed.

Liability insurance issues in anesthesiology.

From the Risk Management Foundation of the Harvard Medical Institutions, Cambridge, MA. Address correspondence to Mr Holzer, Vice President, Risk Management Foundation, 840 Memorial Dr. Cambridge, MA 02139.

Survey identifies hospital risk management statutes

Perspectives in Healthcare Risk ManagementVolume 6, Issue 2 p. 2-3 Article Survey identifies hospital risk management statutes Wyndell Wright, Wyndell Wright Legal intern Risk Management Foundation of the Harvard Medical Institutions, Cambridge, MA To prepare this article, Wright surveyed the statutes of all 50 states in order to find statutes applicable to risk management in hospitals and other health care organizations. In this article, Wright discusses the various provisions generally found in such statutes.Search for more papers by this author Wyndell Wright, Wyndell Wright Legal intern Risk Management Foundation of the Harvard Medical Institutions, Cambridge, MA To prepare this article, Wright surveyed the statutes of all 50 states in order to find statutes applicable to risk management in hospitals and other health care organizations. In this article, Wright discusses the various provisions generally found in such statutes.Search for more papers by this author First published: Spring 1986 https://doi.org/10.1002/jhrm.5600060202 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume6, Issue2Spring 1986Pages 2-3 RelatedInformation