Testimony Before the Subcommittee on Oversight and Investigations, Committee on Veterans Affairs, House of Representatives
“VA Research: Actions Insufficient to Further Strengthen Human Subjects Protections”
Statement of Cynthia A. Bascetta, Director, Health Care–Veterans Health and Benefits Issues U.S. General Accounting Office, www.gao.gov/cgi-bin/getrpt?GAO-03-917T, Released June 18, 2003
Audience: professionals involved in human subjects research
Key words: human subjects protection, research participants, veterans affairs

Results of a previous investigation identified numerous problems in the Veterans Affairs system with regard to protecting the thousands of veterans who volunteer to participate in research every year. These problems were reported to the subcommittee in September 2000 and recommendations for correction were presented. These recommendations included improved guidance, training, monitoring and oversight, handling of adverse event reports, and funding of human subjects protection activities. The purpose of the present GAO investigation was to examine whether sufficient progress had been made to correct human subject protection deficiencies in the VA system identified in 2000.

In her testimony, Bascetta noted that “…VA has not taken sufficient action to strengthen protections for human subjects, although it has made some progress” (p. 2). Continued concerns include lack of sufficient policy to ensure that personnel understand all regulations for protecting human subjects and methods to keep personnel current as regulations change. Bascetta also reports that information provided to those who review risks associated with research projects is inadequate and resource allocation for ensuring protection of those participating in research is insufficient. However, she noted that the VA system has made progress with respect to guidance and training offered to personnel and internal oversight of human subjects protection programs.

During her testimony, Bascetta detailed the problematic areas with specific suggestions for improvements. As such, this report should interest professionals responsible for human subject protection within their organizations.

Reviewed by Jean A. Grube, PhD MBA MSN

National Voluntary Consensus Standards for Hospital Care: An Initial Performance Measure Set
The National Quality Forum, www.qualityforum.org, 2003, $33, 92 pages, Document Number NQFCR-05-03
Audience: Healthcare quality and informatics professionals, health plans, healthcare regulators, researchers, and other healthcare professionals interested in quality measurement and reporting
Key Words:  quality measures, NQF, public reporting, standardization

The report was published by the National Quality Forum (NQF), a private, not-for-profit membership organization whose mission is to improve healthcare through consensus-based national standards for data measurement and public reporting. NQF performed this work at the direction of the Centers for Medicare & Medicaid Services (CMS) and the Agency for Healthcare Research and Quality.

The report describes the NQF process for developing a set of 39 quality measures for acute coronary syndrome, heart failure, patient safety, pediatric conditions, pneumonia, pregnancy/childbirth/neonatal conditions, smoking cessation, and surgical complications. The purpose is to facilitate public reporting of hospital data to promote public accountability in assisting patients and families in making healthcare decisions and promoting quality improvement, benchmarking, and sharing of best practices among hospitals.

NQF’s work and the systematic process used to develop the measure set are to be commended. The process involved soliciting candidate measures from the field, considering current measure sets, and using expert panels and a consensus process with final vote on measures by NQF board members. NQF used criteria such as reasonableness, publicly available data, high-volume populations, and ease of data collection to select the quality measures.

Development of standardized measure sets for hospital public reporting is a challenge. Although NQF’s work began in 2001 with publication in 2003, the measure set has not been widely adopted. There are many barriers to adoption of the quality measure set. For example, some of these measures are inconsistent with measures already used by many hospitals for regulatory and accreditation compliance. In addition, there is no coordinating body to assist hospitals in data collection, analysis, and reporting of these measures.

Furthermore, hospitals are faced with pressure to report standardized measure sets other than the quality measures set forth by NQF. In particular, the ten measures included in the National Quality Initiative, including reimbursement incentives effective in 2005 included in the recently signed Medicare prescription bill are important to many hospitals. Hospitals must prioritize data collection and reporting efforts to ensure limited resources are used efficiently and effectively. Although the NQF measures may be useful as other national initiatives and individual hospital projects are developed, with such pressure and limited resources it is questionable what value NQF’s consensus set of measures will have on future hospital public reporting activities.

The value of this report is in gaining a better understanding of issues in and the process of defining measures for hospital public reporting. The publication will be useful to individuals seeking to understand measure sets for hospital public reporting and issues involved in identifying and reaching consensus on such measure sets.

Reviewed by Rebecca Miller

Patient Safety Handbook
Barbara Youngberg, Martin J. Hatlie, Eds., Jones and Bartlett Publishers, www.jbpub.com, 2004, $99.95, 779 pages, ISBN 0-7637-3147-1
Audience: All healthcare professionals, governing board/body, legal counsels
Key Words: Public policy, public relations, quality of care, rights of patients/residents, risk management, safety and security, process improvement, professional liability, medication errors, legal/statutory issues, governing board/body, government regulations, environmental safety, ethics, disclosure, consumer/advocacy, Baldrige

The reader will be amazed with the vast and timely information on patient safety in this book. While patient safety has been a buzzword in recent years in the healthcare industry, credentialing institutions, and the government system, it is a valid global concern and presents challenges for managers who must decide how and where to start in tackling the problems.

The Patient Safety Handbook starts with a strong Foreword from the mother of Betsy Lehman, who lost her life because of a medical mishap. The foreword challenges providers to improve patient safety—thus setting the tone for the entire book.

This book provides strong content on the substantive areas that have the greatest effect on patient safety. Youngberg and Hatlie have put together materials written by experts with diverse backgrounds. The reader is thus exposed to the wisdom of various professionals’ knowledge, expertise, experiences, research, analysis, and insights. The multidisciplinary view is the strength of this book.

The book addresses such topics as transformation change, ethics, technology, and the culture of safety. The book also discuss the importance of interpersonal relationships, taking a common sense approach that stresses respect and noting the trickle-down effect from management to line staff.

The handbook could have broadened its discussion by providing contributions from patients or healthcare professionals who had significant experiences, and how these were utilized to address the issue of patient safety. Chapter 47, “The Criminalization of Healthcare: When Is Medical Malpractice a Crime?” offers discussion that may be of greatest interest to risk managers.

The editors offer an insight into the complexity of patient safety—that the challenge for improving safety rests with all stakeholders, not just those working within the healthcare system.

Reviewed by Tess P. Panizales, MSN RN

Health Information Management: Concepts, Principles and Practice
Kathleen M. LaTour, Shirley Eichenwald, Eds., American Health Information Management Association, http:// www.ahima.org, 2002, $90, 771 pages, ISBN 1-58426-100-5
Audience: Health information management students, professors and professionals, quality professionals who are in the health information
management arena
Key Words: Computerization, data analysis, ethics, and health information management

The authors use a methodical approach in this text on health information management. The book is divided into six parts. Part I addresses the concepts of informatics and information management and provides a brief history of the American Health Information Management Association (AHIMA). Part II discusses the patient perspective of health information systems. It touches on such topics as hard copy medical records, electronic medical records, and the processes involved in the transition from hard copy to electronic. Of special interest to me were Chapters 10 and 11, which focus on legal and regulatory issues and their related work processes. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is briefly discussed, and an overview of ethical issues involving coding and reimbursement is provided.

Part III will be a fascinating read for data enthusiasts who are involved with statistical analysis and decision-making. Part IV deals with the use of comparative data, while Part V addresses knowledge-based data with an interesting discussion on the transition of information to knowledge within an organization. Part VI explores the strategies in the operational management of health information, including human resources and project management. I found the glossary very useful since abbreviations evolve over time. This book is comprehensive and a much needed reference for health information management professionals.

Reviewed by Teresa I. Gonzalvo, MPA RN CPHQ LNC

The Gold Standard—The Challenge of Evidence-Based Medicine and Standardization in Health Care
Stefan Timmermans and Marc Berg, Temple University Press, www.temple.edu/tempress/titles/1670_reg.html, 2002, $20 (paper), 280 pages, ISBN 1-59213-188-3
Audience: Physician leadership, case managers, UR, QI and research professionals
Key Words: Evidence-based medicine, health policy, ethics

From the first establishment of hospital standardization in the early 20th century to practice standards for virtually every aspect of healthcare delivery today, The Gold Standard delves into the politics and transformation of practicing, buying, and receiving medical care in terms of outcomes research and clinical trials. Timmermans and Berg capture the concept of standardization by describing how evidence-based guidelines shaped their own research. This insightful historical account of the transition to evidence-based medicine (EBM) provides the reader with a clear picture of its evolution. The authors are not timid about presenting the downside of EBM but do not become enmeshed in a philosophical discussion. Instead, The Gold Standard questions the benefits of EBM by examining the content, design, and overall implementation of these standards and how they affect outcomes. By posing questions relating to what, who, and how, Timmermans and Berg effectively examine the pros and cons of standardization and EBM. Readers will also appreciate the political insights of EBM and how they affect healthcare professionals and patients.

The Gold Standard is reader friendly and an intelligent explanation of EBM from the political and social perspectives. Persuasive arguments and case studies make it an interesting read for all healthcare professionals, students, and patients
Reviewed by Richard W. Hritz, MBA CPHQ

JHQ welcomes the opportunity to review various media that could potentially be of benefit to healthcare quality professionals and the people they serve. Reviews are published in every issue of JHQ. To have your product reviewed by a healthcare quality expert, please send a nonreturnable copy to:

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