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Quality, Safety & Ethics

Quality, Safety and Ethics in the use of computers to advise on patient care

Some definitions
"Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."
[Lohr KN (ed.). Medicare: a strategy for quality assurance. Washington: National Academy Press, 1990, p. 21]

The 2001 US Institute of Medicine report, Crossing the Quality Chasm: A New Health System for the 21st Century, specifies six quality dimensions for healthcare: "care should be safe, effective, patient-centered, timely, efficient and equitable".

Patient safety: "freedom from accidental injury due to medical care or medical errors".
[Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academies Press; 1999.]

"Safe care involves making evidence-based clinical decisions to maximize the health outcomes of an individual and to minimize the potential for harm."
[Aspden P, Corrigan JM, Wolcott J, Erickson SM (Eds). Patient Safety: Achieving a New Standard for Care. Board on Health Care Services, Institute of Medicine, November 2003, P334.]

An Error: "The failure of a planned action to be completed as intended (i.e. error of execution), and the use of a wrong plan to achieve an aim (i.e. error of planning)... It also includes failure of of an unplanned action that should have been completed (omission)."
[Aspden P, Corrigan JM, Wolcott J, Erickson SM (Eds). Patient Safety: Achieving a New Standard for Care. Board on Health Care Services, Institute of Medicine, November 2003, P330.]

Implications of using DSS in healthcare
Decision support systems, interactive guidelines and other "intelligent" point of care technologies have recently become prominent themes at major international conferences like Medinfo and AMIA. There is a growing number of technologies to choose from, and evidence of their potential benefits is becoming available. There is also much discussion regarding alternative design methods, delivery platforms, outcome evaluation, etc.

This is the positive side. The other side of this coin is that if clinical knowledge management is to be a responsible engineering discipline it also needs to address the reality that all technologies can have negative as well as positive effects. Questions that need to be addressed include: what are these effects likely to be? and how can we limit them?

Clinical information systems, like decision support systems, are in many ways analogous to any other kind of clinical intervention. As with any medical treatment, such as the use of drugs, it is generally accepted that medical technologists must demonstrate efficacy, and the standard method is to use rigorous and objective clinical trials of applications. But much more needs to be done. Decision aids, interactive guidelines and workflow management systems will depend for their efficacy on the quality of their design and implementation - covering both the quality of the knowledge content and the integrity of the software that delivers it.

Medicine is also a safety-critical field, like the pharmaceutical industry, but also like the aerospace and nuclear industries. It is standard practice in the pharmaceutical industry to carry out clinical trials to address safety empirically, but other industries have also shown that safety needs to be addressed separately, as an engineering problem.

What must we do to offer patients and healthcare professionals adequate guarantees of the quality and safety of the systems we are building?

This was the topic of a panel session organised by OpenClinical at the Medinfo conference that took place in London in September 2001. The goal of the panel was to begin a consensus-building process that addresses the quality and safety, and ethical, issues that are raised by these new technologies. The panel included some of the most experienced and influential figures in the field. They provided a set of distinctive personal views of the issues, and began a discussion that we believe is both important and timely.

Regulatory and legal implications of using HIT
It is generally acknowledged that a comprehensive regulatory and legal framework for using many types of new eHealth technologies is not in place in any country, even where they are gradually being introduced. The EU reports that "There is little current information available about the legal implications of eHealth". Here we aim to provide information on initiatives which aim to rectify this situation.


 EU  Legally eHealth A study being undertaken by the EU initiative (2006).
references: quality and safety

Black AD, Car J, Pagliari C et al. The impact of eHealth on the quality and safety of health care: a systematic overview. PLoS Med. 2011 Jan 18;8(1):e1000387.

[PubMed]   []

" BACKGROUND: There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care. METHODS AND FINDINGS: We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking. CONCLUSIONS: There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and "techno-enthusiasts" as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption. "

Huckvale C, Car J, Akiyama M, Jaafar S, Khoja T, Bin Khalid A, Sheikh A, Majeed A. Information technology for patient safety. Qual Saf Health Care. 2010 Aug;19 Suppl 2:i25-33.

[PubMed]   []

" BACKGROUND: Research on patient care has identified substantial variations in the quality and safety of healthcare and the considerable risks of iatrogenic harm as significant issues. These failings contribute to the high rates of potentially avoidable morbidity and mortality and to the rising levels of healthcare expenditure seen in many health systems. There have been substantial developments in information technology in recent decades and there is now real potential to apply these technological developments to improve the provision of healthcare universally. Of particular international interest is the use of eHealth applications. There is, however, a large gap between the theoretical and empirically demonstrated benefits of eHealth applications. While these applications typically have the technical capability to help professionals in the delivery of healthcare, inadequate attention to the socio-technical dimensions of their use can result in new avoidable risks to patients. RESULTS AND DISCUSSION: Given the current lack of evidence on quality and safety improvements and on the cost-benefits associated with the introduction of eHealth applications, there should be a focus on implementing more mature technologies; it is also important that eHealth applications should be evaluated against a comprehensive and rigorous set of measures, ideally at all stages of their application life cycle. "

Leape LL, Berwick DM. Five years after To Err Is Human: what have we learned? JAMA. 2005 May 18;293(19):2384-90.

[PubMed]   []

" Five years ago, the Institute of Medicine (IOM) called for a national effort to make health care safe. Although progress since then has been slow, the IOM report truly "changed the conversation" to a focus on changing systems, stimulated a broad array of stakeholders to engage in patient safety, and motivated hospitals to adopt new safe practices. The pace of change is likely to accelerate, particularly in implementation of electronic health records, diffusion of safe practices, team training, and full disclosure to patients following injury. If directed toward hospitals that actually achieve high levels of safety, pay for performance could provide additional incentives. But improvement of the magnitude envisioned by the IOM requires a national commitment to strict, ambitious, quantitative, and well-tracked national goals. The Agency for Healthcare Research and Quality should bring together all stakeholders, including payers, to agree on a set of explicit and ambitious goals for patient safety to be reached by 2010. "

Stelfox HT, Palmisani S, Scurlock C, Orav EJ, Bates DW. The "To Err is Human" report and the patient safety literature. Qual Saf Health Care. 2006 Jun;15(3):174-8.

[PubMed]   []

" BACKGROUND: The "To Err is Human" report published by the Institute of Medicine (IOM) in 1999 called for a national effort to make health care safer. Although the report has been widely credited with spawning efforts to study and improve safety in health care, there has been limited objective assessment of its impact. We evaluated the effects of the IOM report on patient safety publications and research awards. METHODS: We searched MEDLINE to identify English language articles on patient safety and medical errors published between 1 November 1994 and 1 November 2004. Using interrupted time series analyses, changes in the number, type, and subject matter of patient safety publications were measured. We also examined federal (US only) funding of patient safety research awards for the fiscal years 1995-2004. RESULTS: A total of 5514 articles on patient safety and medical errors were published during the 10 year study period. The rate of patient safety publications increased from 59 to 164 articles per 100 000 MEDLINE publications (p < 0.001) following the release of the IOM report. Increased rates of publication were observed for all types of patient safety articles. Publications of original research increased from an average of 24 to 41 articles per 100 000 MEDLINE publications after the release of the report (p< 0.001), while patient safety research awards increased from 5 to 141 awards per 100 000 federally funded biomedical research awards (p< 0.001). The most frequent subject of patient safety publications before the IOM report was malpractice (6% v 2%, p< 0.001) while organizational culture was the most frequent subject (1% v 5%, p< 0.001) after publication of the report. CONCLUSIONS: Publication of the report "To Err is Human" was associated with an increased number of patient safety publications and research awards. The report appears to have stimulated research and discussion about patient safety issues, but whether this will translate into safer patient care remains unknown. "

McFadden KL, Stock GN, Gowen CR 3rd. Exploring strategies for reducing hospital errors. J Healthc Manag. 2006 Mar-Apr;51(2):123-35;

[PubMed]   []

" The purpose of this study is to explore current strategies for reducing errors at U.S. hospitals. Reports by the Institute of Medicine highlight concerns about the staggering number of medical errors that occur in the U.S. healthcare system. These reports have exerted considerable pressure on hospitals to establish programs that reduce errors and improve patient safety. A previous research study identifies seven critical strategies for reducing hospital errors based on a case study of four Chicago-area hospitals. These strategies include (1) partnership with stakeholders, (2) reporting errors free of blame, (3) open discussion of errors, (4) cultural shift, (5) education and training, (6) statistical analysis of data, and (7) system redesign. This article reports the results of our nationwide survey of 525 hospitals. We examined the perceptions of healthcare quality directors about the importance of these seven patient safety strategies, the factors that act as barriers, the level of adoption of these strategies, and the benefits resulting from implementation of these strategies. Our results indicate that a considerable gap exists between current hospital practices and the perceived importance of various approaches to improving patient safety. Results of our regression analysis reveal that internal organizational barriers are associated with a larger gap between perceived importance and actual implementation. Moreover, the regression analysis also reveals that smaller gaps are associated with better error outcomes such as reduction in the frequency and severity of errors. The findings provide specific directions for enhancing patient safety programs at hospitals in the future. "

Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med. 2003 Jun 19;348(25):2526-34.

[nb: paper has no abstract]

"Health care is growing increasingly complex, and most clinical research focuses on new approaches to diagnosis and treatment. In contrast, relatively little effort has been targeted at the perfection of operational systems, which are partly responsible for the well-documented problems with medical safety.1 If medicine is to achieve major gains in quality, it must be transformed, and information technology will play a key part,2 especially with respect to safety. In other industries, information technology has made possible what has been called "mass customization" — the efficient and reliable production of goods and services according to the highly personalized . . . "
Berwick DM. Errors today and errors tomorrow. N Engl J Med. 2003 Jun 19;348(25):2570-2.
Editorial related to above paper by Bates and Gawande


"If the Institute of Medicine is right, then at the very least, 100 patients will die in hospitals in the United States today because of injuries from their care, not from their diseases. How many will die tomorrow? Tom Nolan, one of the leading quality-improvement scholars of our time, identifies three essential preconditions for improvement: will, ideas, and execution.1 Improvement requires will, because durable improvement is not an accident; it takes effort. Left alone, systems tend to deteriorate. Roads decay until someone decides to repair them. Patients will suffer injuries from care until someone decides otherwise. Improvement requires ideas, . . ."

Bates DW, Gawande AA. Error in medicine: what have we learned? Ann Intern Med. 2000 May 2;132(9):763-7.

[PubMed]   [Annals]

" Over the past decade, it has become increasingly apparent that error in medicine is neither rare nor intractable. Traditionally, medicine has downplayed error as a negligible factor in complications from medical intervention. But, as data on the magnitude of error accumulate—and as the public learns more about them—medical leaders are taking the issue seriously. In particular, the recent publication of the Institute of Medicine report has resulted in an enormous increase in attention from the public, the government, and medical leadership. "
Bates DW, Cohen M, Leape LL, Overhage JM, Shabot MM, Sheridan T. White Paper: Reducing the frequency of errors in medicine using information technology. J Am Med Inform Assoc. 2001 Jul-Aug;8(4):299-308.

[PubMed]   [JAMIA]

" BACKGROUND: Increasing data suggest that error in medicine is frequent and results in substantial harm. The recent Institute of Medicine report (LT Kohn, JM Corrigan, MS Donaldson, eds: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999) described the magnitude of the problem, and the public interest in this issue, which was already large, has grown. GOAL: The goal of this white paper is to describe how the frequency and consequences of errors in medical care can be reduced (although in some instances they are potentiated) by the use of information technology in the provision of care, and to make general and specific recommendations regarding error reduction through the use of information technology. RESULTS: General recommendations are to implement clinical decision support judiciously; to consider consequent actions when designing systems; to test existing systems to ensure they actually catch errors that injure patients; to promote adoption of standards for data and systems; to develop systems that communicate with each other; to use systems in new ways; to measure and prevent adverse consequences; to make existing quality structures meaningful; and to improve regulation and remove disincentives for vendors to provide clinical decision support. Specific recommendations are to implement provider order entry systems, especially computerized prescribing; to implement bar-coding for medications, blood, devices, and patients; and to utilize modern electronic systems to communicate key pieces of asynchronous data such as markedly abnormal laboratory values. CONCLUSIONS: Appropriate increases in the use of information technology in health care- especially the introduction of clinical decision support and better linkages in and among systems, resulting in process simplification-could result in substantial improvement in patient safety. "

Harrington L, Kennerly D, Johnson C. Safety issues related to the electronic medical record (EMR): synthesis of the literature from the last decade, 2000-2009. J Healthc Manag. 2011 Jan-Feb;56(1):31-43; discussion 43-4.

[PubMed]   []

" Healthcare is a complex industry burdened by numerous and complicated clinical and administrative transactions that require many behavioral changes by patients, clinicians, and provider organizations. While healthcare information technology (HIT) is intended to relieve some of the burden by reducing errors, several aspects of systems such as the electronic medical record (EMR) may actually increase the incidence of certain types of errors or produce new safety risks that result in harm. Healthcare leaders must appreciate the complexity surrounding EMRs and understand the safety issues in order to mandate sound EMR design, development, implementation, and use. This article seeks to inform executives, clinicians, and technology professionals what has been learned through published research on the safety of HIT systems during the last decade, focusing on computerized physician order entry (CPOE), clinical decision support systems (CDSS), and bar-coded medication administration (BCMA). "

Jamal A, McKenzie K, Clark M. The impact of health information technology on the quality of medical and health care: a systematic review. HIM J. 2009;38(3):26-37.

[PubMed]   []

" The aim of this study was to systematically review the published evidence of the impact of health information technology (HIT) or health information systems (HIS) on the quality of healthcare, focusing on clinicians's; adherence to evidence-based guidelines and the corresponding impact this had on patient clinical outcomes. The review covered the use of health information technologies and systems in both medical care (i.e. clinical and surgical) and other areas such as allied health and preventive services. Studies were included in the review if they examined the impact of Electronic Health Record (EHR), Computerised Provider Order-Entry (CPOE), or Decision Support System (DS); and if the primary outcomes of the studies were focused on the level of compliance with evidence-based guidelines among clinicians. Measurements considered relevant to the review were either of changes in clinical processes resulting from a change of the providers' behaviour, or of specific patient outcomes that demonstrated the effectiveness of a particular treatment given by providers. Of 23 studies included in the current review, 17 assessed the impact of HIT/HIS on health care practitioners' performance. A positive improvement, in relation to their compliance with evidence-based guidelines, was seen in 14 studies. Studies that included an assessment of patient outcomes, however, showed insufficient evidence of either clinically or statistically important improvements. Although the number of studies reviewed was relatively small, the findings demonstrated consistency with similar previous reviews of this nature in that wide scale use of HIT has been shown to increase clinician's adherence to guidelines. "

Kathleen Covert Kimmel, Joyce Sensmeier. A Technological Approach to Enhancing Patient Safety. White paper published by The Healthcare Information and Management Systems Society (HIMSS) and sponsored by Eclipsys Corporation, 2002.



" Despite having unparalleled technology and resources, the US healthcare system has room for improvement. Impressive advancements in medical knowledge have accelerated at a mind-boggling rate, but knowledge and information distribution are ineffective and not readily available to the majority of providers. Innovative surgical procedures using advanced technology diagnostic equipment offer a sophisticated understanding of a patient's condition, but information distribution and communication is hampered by the manual, paper-based patient charts in most hospitals. The multiple people, departments, and processes that are an integral component of effective and efficient patient-centered care are typically lacking. Handwritten medication orders are error prone. Indeed, deciphering handwriting is frequently a challenge for those processing orders. Medications with similar names, but different action classes, effects, and dose ranges further complicate the medication management process.... "

Ball MJ, Garets DE, Handler TJ. Leveraging information technology towards enhancing patient care and a culture of safety in the US. Methods Inf Med. 2003;42(5):503-8.

[PubMed]   []

" OBJECTIVES: To heighten awareness about the critical issues currently affecting patient care and to propose solutions based on leveraging information technologies to enhance patient care and influence a culture of patient safety. METHODS: Presentation and discussion of the issues affecting health care today, such as medical and medication-related errors and analysis of their root causes; proliferation of medical knowledge and medical technologies; initiatives to improve patient safety; steps necessary to develop a culture of safety; introduction of relevant enabling technologies; and evidence of results. RESULTS AND CONCLUSION: Medical errors affect not only mortality and morbidity, but they also create secondary costs leading to dissatisfaction by both provider and patient. Health care has been slow to acknowledge the benefits of enabling technologies to affect the quality of care. Evaluation of recent applications, such as the computerized patient record, physician order entry, and computerized alerting systems show tremendous potential to enhance patient care and influence the development of a culture focused on safety. They will also bring about changes in other areas, such as workflow and the creation of new partnerships among providers, patients, and payers. "

Delaney BC, Fitzmaurice DA, Riaz A, Hobbs FD. Can computerised decision support systems deliver improved quality in primary care? BMJ 1999 Nov 13;319(7220):1281.

[PubMed]    [BMJ]

" Summary points

  • Computerised reminder and recall systems increase the frequency of monitoring and preventive tasks in the management of chronic disease
  • Computerised dosing systems for warfarin improve the control of anticoagulation
  • Computerised diagnostic decision support has not yet been developed to the stage where it can significantly aid diagnostic accuracy
  • There is a lack of research with patient oriented outcomes in this topic
  • Shared decision making between doctors and patients is an issue where computer systems may develop an important role. "

  • Miller RA, Gardner RM. Summary recommendations for responsible monitoring and regulation of clinical software systems. Ann Intern Med. 1997 Nov 1;127(9):842-5.

    [Ann Intern Med/a>]

    " Clinical software systems are becoming ubiquitous. A growing literature documents how these systems can improve health care delivery, but concerns about patient safety must now be formally addressed. In 1996, the U.S. Food and Drug Administration (FDA) called for discussions on regulation of software programs as medical devices. In response, a consortium of organizations dedicated to improving health care through information technology developed recommendations for the responsible regulation and monitoring of clinical software systems by users, vendors, and regulatory agencies. These recommendations were revised and approved by the American Medical informatics Association Public Policy Committee and Board. Other organizations reviewed, modified, and approved the recommendations, and the Boards of Directors of most of the organizations in the consortium endorsed the guidelines. The consortium proposes four categories of clinical system risk and four classes of monitoring and regulatory action that can be applied on the basis of the risk level. The consortium recommends that most clinical software systems be supervised locally and that developers of health care information systems adopt a code of good business practices. Budgetary and other constraints limit the type and number of systems that the FDA can regulate effectively; therefore, the FDA should exempt most clinical software systems and focus on systems that pose high clinical risk and provide limited opportunity for competent human intervention. "

    Bakken S, Cimino JJ, Hripcsak G. Promoting patient safety and enabling evidence-based practice through informatics. Med Care. 2004 Feb;42(2 Suppl):II49-56.

    [PubMed]   []

    " OBJECTIVES: The purposes of this article are to highlight the role of informatics in promoting patient safety and enabling evidence-based practice (EBP), 2 significant aspects for assuring healthcare quality; to delineate some challenges for the future; and to provide key recommendations for education, practice, policy, and research. METHODS: First, we describe the components of an informatics infrastructure for patient safety and evidence-based practice. Second, we address the role of informatics in 4 areas: 1) information access; 2) automated surveillance for real-time error detection and prevention; 3) communication among members of the healthcare team; and 4) standardization of practice patterns. Last, we delineate some future challenges for nursing and for informatics and provide key recommendations for education, practice, policy, and research. RESULTS: The components of an informatics infrastructure are available and applications that bring together these components to promote patient safety and enable EBP have demonstrated positive or promising results. CONCLUSIONS: Challenges must be addressed so that an informatics infrastructure and related applications that promote patient safety and enable EBP can be realized. "

    Ball MJ, Garets DE, Handler TJ. Leveraging information technology towards enhancing patient care and a culture of safety in the US. Methods Inf Med. 2003;42(5):503-8.

    [PubMed]   []

    " OBJECTIVES: To heighten awareness about the critical issues currently affecting patient care and to propose solutions based on leveraging information technologies to enhance patient care and influence a culture of patient safety. METHODS: Presentation and discussion of the issues affecting health care today, such as medical and medication-related errors and analysis of their root causes; proliferation of medical knowledge and medical technologies; initiatives to improve patient safety; steps necessary to develop a culture of safety; introduction of relevant enabling technologies; and evidence of results. RESULTS AND CONCLUSION: Medical errors affect not only mortality and morbidity, but they also create secondary costs leading to dissatisfaction by both provider and patient. Health care has been slow to acknowledge the benefits of enabling technologies to affect the quality of care. Evaluation of recent applications, such as the computerized patient record, physician order entry, and computerized alerting systems show tremendous potential to enhance patient care and influence the development of a culture focused on safety. They will also bring about changes in other areas, such as workflow and the creation of new partnerships among providers, patients, and payers. "

    (US) 2005 National Healthcare Quality Report (NHQR)

    []   [AHRQ]

    " The 2005 National Healthcare Quality Report (NHQR) is a comprehensive national overview of quality of health care in the United States. The 2005 NHQR includes 179 performance measures that can be used to monitor the Nation's progress toward improved health care quality for all Americans. This year's report focuses on a group of 46 "core" measures representing the most important and scientifically sound measures of quality. The report presents, in chart format, the latest available findings on the quality of health care in the general U.S. population, focusing on four components of quality: effectiveness, patient safety, timeliness, and patient centeredness... "

    Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Prepared for the Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment, No. 43. Prepared by the University of California at San Francisco (UCSF) and Stanford University Evidence-based Practice Center.


    Report commissioned by AHRQ in January 2001 as a review of the scientific literature regarding safety improvement.

    Longo DR, Hewett JE, Ge B, Schubert S. The long road to patient safety: a status report on patient safety systems. JAMA. 2005 Dec 14;294(22):2858-65.

    [PubMed]   []

    " CONTEXT: Since the Institute of Medicine (IOM) reports on medical errors and quality, national attention has focused on improving patient safety through changes in "systems" of care. These reports resulted in a new paradigm that, rather than centering on individual errors, focuses on the "systems" necessary to facilitate and enhance quality and protect patients. OBJECTIVES: To assess the status of hospital patient safety systems since the release of the IOM reports and to identify changes over time in 2 states that collaborated on a patient safety project funded by the Agency for Healthcare Research and Quality. DESIGN, SETTING, AND PARTICIPANTS: Survey of all acute care hospitals in Missouri and Utah at 2 points in time, in 2002 and 2004, using a 91-item comprehensive questionnaire (n = 126 for survey 1 and n = 128 for survey 2). To assess changes over time, we also studied the cohort of 107 hospitals that responded to both surveys. MAIN OUTCOME MEASURES: Responses to the 91-question survey as well as changes in responses to the survey questions over an 18-month period. Seven latent variables were constructed to represent the most important patient safety constructs studied: computerized physician order entry systems, computerized test results, and assessments of adverse events; specific patient safety policies; use of data in patient safety programs; drug storage, administration, and safety procedures; manner of handling adverse event/error reporting; prevention policies; and root cause analysis. For each hospital, the 7 latent variables were summed to give an overall measure of the patient safety status of the hospital. RESULTS: Development and implementation of patient safety systems is at best modest. Self-reported regression in patient safety systems was also found. While 74% of hospitals reported full implementation of a written patient safety plan, nearly 9% reported no plan. The area of surgery appears to have the greatest level of patient safety systems. Other areas, such as medications, with a long history of efforts in patient safety and error prevention, showed improvements, but the percentage of hospitals with various safety systems was already high at baseline for many systems. Some findings are surprising, given the overall trends; for example, while a substantial percentage of hospitals have medication safety systems, only 34.1% [corrected] reported full implementation at survey 2 of computerized physician order entry systems for medications, despite the growth of computer technology in general and in hospital billing systems in particular. CONCLUSIONS: The current status of hospital patient safety systems is not close to meeting IOM recommendations. Data are consistent with recent reports that patient safety system progress is slow and is a cause for great concern. Efforts for improvement must be accelerated. "

    References: implementing patient safety measures

    Bukunt S, Hunter C, Perkins S, Russell D, Domanico L. El Camino Hospital: using health information technology to promote patient safety. Jt Comm J Qual Patient Saf. 2005 Oct;31(10):561-5.

    [PubMed]   []

    " BACKGROUND: El Camino Hospital is a leader in the use of health information technology to promote patient safety, including bar coding, computerized order entry, electronic medical records, and wireless communications. OVERALL APPROACH TO QUALITY AND SAFETY: Each year, El Camino Hospital's board of directors sets performance expectations for the chief executive officer, which are tied to achievement of local, regional, and national safety and quality standards, including the six Institute of Medicine quality dimensions. He then determines a set of explicit quality goals and measurable actions, which serve as guidelines for the overall hospital. The goals and progress reports are widely shared with employees, medical staff, patients and families, and the public. ADDRESSING THE SIX IOM QUALITY AIMS: For safety, for example, the medication error reduction team tracks and reviews medication error rates. The hospital has virtually eliminated transcription errors through its 100% use of computerized physician order entry. Clinical pathways and standard order sets have reduced practice variation, providing a safer environment. CHALLENGES: Many projects focused on timeliness, such as emergency department wait time, lab turnaround time, and pneumonia time to initial antibiotic. Results have been mixed, with projects most successful when a link was established with patient outcomes, such as in reducing time to percutaneous transluminal coronary angioplasty for patients with acute myocardial infarction. "

    References: ethics, computerized clinical decision support systems and other health information technologies

    Alan J Green. Ethical considerations for the development of Decision Support Systems. OpenClinical briefing paper.

    []   [OC]

    "Decision Support Systems can have both positive and negative effects on ethical medical practice. The increase in the doctor’s and the patient’s knowledge have a positive effect on autonomy; in contrast where knowledge is withheld, either by not being presented by the DSS, or by the doctor not passing on all the knowledge imparted by the DSS autonomy may be reduced; where this is thought to be in the patient’s best interest there will be an increase in paternalism.

    "The incorporation of such systems into the healthcare process brings ethical considerations that extend the features of the doctor-patient relationship to non-medical professionals. I have introduced the concept of chains of duty and shown how trustworthiness and duty of care propagate along the chain of people involved in the development and maintenance of the systems. I have indicated that knowledge of eventual use provides a good end point for these chains.

    "The eventual incorporation of DSSs into normal practice will depend on many factors. Education of doctors in the use (and abuse) of the systems will play a part in this process (the Royal College of General Practitioners run many continuing professional development and other courses and publish a number of information guides for GPs; these could offer a conduit for knowledge of the use of DSSs to be given to GPs). Availability of funding and the recommendations of National Institute for Clinical Excellence will play a part as will the attitude of the courts if, for example, the use of DSSs forms part of any case of negligence. However the attitude of the public will also have a strong influence on the acceptance of such systems; in order that the public see the systems as offering a benefit the systems must be seen as trustworthy; the use of open methods of control of the systems will play a crucial role in this. "

    Marckmann G. Recommendations for the ethical development and use of medical decision support systems. MedGenMed. 2001 Jun 20;3(3):5.

    [PubMed]   [Medscape]

    " Medical decision support systems (MDSS) play an increasingly important role in medical practice. By assisting physicians with making clinical decisions, MDSS are expected to improve the quality of medical care. However, there are also concerns that malfunctioning or inappropriate use of MDSS could jeopardize the well-being of the patient. While several authors have already discussed ethical issues arising with the use of computer-assisted medical decision making, there is still no consensus about the ethically appropriate use of MDSS. Based on a review and synthesis of previous relevant work, this paper proposes a comprehensive set of recommendations for the ethical development and application of MDSS. "

    Alexander GL. Issues of trust and ethics in computerized clinical decision support systems. Nurs Adm Q. 2006 Jan-Mar;30(1):21-9.

    [PubMed]   []

    " Clinical decision support systems are computer technologies that model and provide support for human decision-making processes. Decision support mechanisms facilitate and enhance a clinician's ability to make decisions at the point of care. Decisions are facilitated through technology by using automated mechanisms that provide alerts or messages to clinicians about a potential patient problem. A clinician's level of trust in these technologies to support decision making is affected by how knowledge is represented in these tools, their ability to make reasonable decisions, and how they are designed. Furthermore, ethical tensions occur if these systems do not promote standards, if clinicians do not understand how to use these systems, and when professional relationships are affected. Issues of trust and ethical concerns will be examined in this article, using a research study of midwestern nursing homes that implemented a clinical decision support system. "

    Laurinda Harman. Ethical Challenges in the Management of Health Information, Second Edition, Jones & Bartlett, 2006. pp 655.

    []   []

    " Published in conjunction with the American Health Information Management Association (AHIMA), Ethical Challenges in the Management of Health Information, Second Edition addresses HIPAA and contains new chapters on management, e-HIM, clinical decisions at the end of life and issues related to working with vendors. The protection of privacy and confidential information is the primary ethical obligation of the health information management (HIM) professional and this obligation is central to the decisions that are made on behalf of patients. This extensive revision is an ideal resource for students and practitioners in many disciplines—HIM, healthcare professions (physicians, nurses, therapists), ethics, information technology, healthcare administration and public health. HIM professionals who work on behalf of patients to protect privacy, healthcare providers who treat patients and patient care advocacy groups will find this book to be a unique and invaluable resource. This book aids all of these readers in exploring professional values and obligations, with guidance from the AHIMA Code of Ethics. "

    Berner ES, Moss J. Informatics challenges for the impending patient information explosion. J Am Med Inform Assoc. 2005 Nov-Dec;12(6):614-7.

    [PubMed]   []

    " As we move toward an era when health information is more readily accessible and transferable, there are several issues that will arise. This article addresses the challenges of information filtering, context-sensitive decision support, legal and ethical guidelines regarding obligations to obtain and use the information, aligning patient and health professionals' expectations in regard to the use and usefulness of the information, and enhancing data reliability. The authors discuss the issues and offer suggestions for addressing them. "

    Miller RA, Schaffner KF, Meisel A. Ethical and legal issues related to the use of computer programs in clinical medicine. Ann Intern Med. 1985;102:529-536.

    [PubMed]   []

    " As computer programs are used with increasing frequency in the clinical setting, ethicists, lawyers, computer scientists, clinicians, and patients must confront a group of problems: In what situations is it appropriate to use a medical computer program? Who should use these programs and how should they be used? What is the legal status of a computer program that provides medical advice? Can a proper balance be achieved between confidentiality of patient information and shared access to records by health care personnel? How can regulatory agencies, physicians, and patients determine if a program is safe for human use? Will programs be able to communicate with users well enough to prevent clinically harmful misunderstandings? Because few if any definitive answers are yet available, these questions remain the subject of much discussion. "

    Miller RA. Legal issues related to medical decision support systems. J Clin Monit Comput. 1989 Apr;6(2):75-80.


    " The use of computer-based decision support programs in medicine will result in litigation when adverse health care outcomes affect patients. This paper reviews how the United States legal system is likely to handle such cases. To date, there is minimal direct experience with such cases in the American legal system. Medical decision support systems are more likely to be viewed as tools used by physicians in providing a service to patients than as products owned by patients. Therefore, it is fairly certain that the negligence principles applied in medical malpractice cases will also be applied in cases involving computer-based medical decision support systems. Only under special circumstances will principles of strict product liability apply. As there are no existing standards, and medical decision support programs are hybrids having characteristics of both services and products, future litigation will be handled on a case by case basis. "

    Kirsti A Dyer. Ethical Challenges of Medicine and Health on the Internet: A Review. J Med Internet Res 2001;3(2):e23.

    []   [JMIR]

    " Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role that medicine and health play in the growing area of Internet communication and commerce and many of the ethical challenges raised by the Internet for the medical community are explored and some possible ways to address these ethical challenges are postulated. "

    McSherry B. Ethical issues in HealthConnect's shared electronic health record system. J Law Med. 2004 Aug;12(1):60-8.

    [PubMed]   []

    " Many countries are in the process of implementing systems of shared electronic health records. This article explores some of the ethical concerns raised by Australia's proposed HealthConnect system which aims to create electronic event summaries of health information. Three areas of ethical concern relating to confidentiality, consent and the involvement of the private sector are examined. It is argued that unless the HealthConnect system is firmly grounded in policy based on ethical considerations, patients may not want to "opt in" to it. "

    References: legal issues and health information technologies

    Terry NP. Electronic health records: international, structural and legal perspectives. J Law Med. 2004 Aug;12(1):26-39.

    [PubMed]   []

    " The EHR is a database record that incorporates a patient's health care details from conception to death and which can be distributed over a number of sites or aggregated at a particular source. This article describes the function and concept of the EHR by relating it to other medical information technologies, parallel changes in health care delivery, and a holistic health information model. The article compares the progress that Europe, Australia and the United States have made in the journey towards EHR implementation and concludes by highlighting some of the costs, barriers and consequences associated with the transition to a comprehensive EHR system. "

    Stefaan Callens. E-Health & The Law. Dordrecht: Kluwer Law International/International Bar Assocation, 2003.

    [PubMed]   []

    " The term e-health has come into use to characterize the burgeoning electronic communications system by which medical professionals, institutions, and enterprises share information, data, and access to medicinal products. This phenomenon has given rise to numerous legal complexities related to medical ethics, consent, remuneration, distribution of pharmaceuticals, quality assurance, protection of medical records, scientific research, and many other emerging issues of serious concern to the medical profession, the health care community, and the pharmaceutical industry. This book is among the first to focus on this important new area of legal practice. It is based on a seminar sponsored by the Medicine and Law Committee of the International Bar Association and held at Cancun in October 2001. The book presents the reports of nine outstanding health law practitioners from Belgium, The Netherlands, Germany, the United States, and Canada that examine such diverse and significant matters as the following: - doctor-patient relationships on the Internet - relevance of the European e-commerce directive to health law - liability issues in the practice of telemedicine - medical malpractice on the Internet - filtering and rating tools for assessment of medical information Web sites - commercial practicality of the draft International Convention on Telemedicine and Telehealth - protection of medical records under European data protection legislation - health care provider competition on the Internet - cross-border processing of personal health data Although many more issues continue to arise in this new and complex field, this book provides a clear path to a reasoned analysis of the subject, and is sure to be useful as an opener of the way for future research and analysis. It will be of great value not only to health care lawyers and legal researchers but also to government regulators and providers whether medical professionals, hospitals and other health care institutions, or manufacturers and distributors of health care products. "

    References: Information systems-related errors

    Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc. 2004 Mar-Apr;11(2):121-4.

    [PubMed]   [PubMed Central]

    " Medical error reduction is an international issue, as is the implementation of patient care information systems (PCISs) as a potential means to achieving it. As researchers conducting separate studies in the United States, The Netherlands, and Australia, using similar qualitative methods to investigate implementing PCISs, the authors have encountered many instances in which PCIS applications seem to foster errors rather than reduce their likelihood. The authors describe the kinds of silent errors they have witnessed and, from their different social science perspectives (information science, sociology, and cognitive science), they interpret the nature of these errors. The errors fall into two main categories: those in the process of entering and retrieving information, and those in the communication and coordination process that the PCIS is supposed to support. The authors believe that with a heightened awareness of these issues, informaticians can educate, design systems, implement, and conduct research in such a way that they might be able to avoid the unintended consequences of these subtle silent errors. "

    Han YY, Carcillo JA, Venkataraman ST et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics. 2005 Dec;116(6):1506-12.

    [PubMed]   []

    " OBJECTIVE: In response to the landmark 1999 report by the Institute of Medicine and safety initiatives promoted by the Leapfrog Group, our institution implemented a commercially sold computerized physician order entry (CPOE) system in an effort to reduce medical errors and mortality. We sought to test the hypothesis that CPOE implementation results in reduced mortality among children who are transported for specialized care. METHODS: Demographic, clinical, and mortality data were collected of all children who were admitted via interfacility transport to our regional, academic, tertiary-care level children's hospital during an 18-month period. A commercially sold CPOE program that operated within the framework of a general, medical-surgical clinical application platform was rapidly implemented hospital-wide over 6 days during this period. Retrospective analyses of pre-CPOE and post-CPOE implementation time periods (13 months before and 5 months after CPOE implementation) were subsequently performed. RESULTS: Among 1942 children who were referred and admitted for specialized care during the study period, 75 died, accounting for an overall mortality rate of 3.86%. Univariate analysis revealed that mortality rate significantly increased from 2.80% (39 of 1394) before CPOE implementation to 6.57% (36 of 548) after CPOE implementation. Multivariate analysis revealed that CPOE remained independently associated with increased odds of mortality (odds ratio: 3.28; 95% confidence interval: 1.94-5.55) after adjustment for other mortality covariables. CONCLUSIONS: We have observed an unexpected increase in mortality coincident with CPOE implementation. Although CPOE technology holds great promise as a tool to reduce human error during health care delivery, our unanticipated finding suggests that when implementing CPOE systems, institutions should continue to evaluate mortality effects, in addition to medication error rates, for children who are dependent on time-sensitive therapies. "

     bullet  Public reports on quality in healthcare [OC]  bullet  Public reports on safety in healthcare [OC]  bullet  Public reports on ethics in healthcare [OC]
    links: national and international bodies and organisations
     bullet  ISQua: the International Society for Quality in Health Care  bullet  Leapfrog Group - "an initiative driven by organizations that buy health care who are working to initiate breakthrough improvements in the safety, quality and affordability of healthcare for Americans."  bullet from Cerner Bridge Medical  bullet  ECRI - "a nonprofit health services research agency ...[whose] ... mission is to improve the safety, quality and cost-effectiveness of healthcare"  bullet  Institute for Healthcare Improvement - based in Cambridge, Massachusetts, campaigns to improve health care worldwide  bullet  Joint Council on Accreditation of Healthcare Organizations (JCAHO) (mission: "improve the safety and quality of care provided to the public through the provision of health care accreditation" ...)  bullet  NCQA: National Committee for Quality Assurance  bullet  URAC - organization offering accreditation and certification programs to ensure health care quality  bullet  World Alliance for Patient Safety (WHO)  bullet  Agency for Healthcare Research and Quality (AHRQ) (US Department of Health and Human Services)  bullet  Quality Indicators (AHRQ)  bullet  Patient safety (Agency for Healthcare Research and Quality)  bullet  Australian Commission on Safety & Quality in Health Care  bullet  National Patient Safety Agency (UK) - "Special Health Authority created to co-ordinate the efforts of all those involved in healthcare, and more importantly to learn from, patient safety incidents occurring in the NHS."  bullet  Sweden National Board of Health and Welfare Patient safety - Socialstyrelsen, Patientsäkerhet  bullet  Irish Society for Quality and Safety in Healthcare
    page history
    Entry on OpenClinical: 10 October 2001
    Last main update: 15 March 2006; 29 October 2006

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