PeriGen Research

Abstract: As put forth by this Amnesty International review, “In 2009, the new US Administration and Congress focused on the need to reform the health care system, in particular on improving access to care and reducing the growth in health care spending. Although the proposals under debate would reduce the number of uninsured individuals, no legislation currently under consideration would realize the human rights standards of making health care available, accessible, acceptable, and of good quality to all, without discrimination. It is estimated that the proposed reforms would still leave between 18 and 24 million people without insurance, and for many health care costs would remain unaffordable. In addition, as reform is primarily focused around health care coverage, it would leave largely unaddressed the issues identified in the report regarding discrimination, systemic failures and accountability. As efforts to reform the US health care system are developed and implemented, it is imperative that human rights standards are applied, so that all have equal access to affordable, quality health care, including maternal health care. Maternal deaths and injuries are stark reminders of what is at stake when the government fails to put in place a health care system that respects, protects and fulfills the human right to health without discrimination. The consequences are evident every step of the way. Women have inadequate access to family planning, enter pregnancy in less than optimal health, receive late or inadequate prenatal care, are given inadequate or inappropriate care during delivery and have limited access to post-natal care. It is essential that the debate about health care in the USA goes beyond health care coverage and addresses access to quality health care for all on the basis of equality and non-discrimination. Maternal health care services must be improved for all women, and particularly for those most affected by current disparities in health care and outcomes. For over 20 years the US authorities have failed to improve the outcomes and disparities in maternal health care. This report shows the human cost of this failure and highlights the urgent steps needed to reduce maternal mortality and morbidity rates in the USA.”

 

 

 

Title: The legal effects of fetal monitoring guidelines

Publication: International Journal of Gynecology & Obstetrics

Date: 2/1/2010

Authors: Dickens BM, Cook RJ

 

 

Abstract: The new American College of Obstetricians and Gynecologists' (ACOG) monitoring guidelines introduce a new category of interpretation of fetal heart rate tracings between reassuring and nonreassuring, namely intermediate. The purpose is to reduce unnecessary cesarean deliveries. The legal role of medical guidelines is ambivalent. Providers are expected to be familiar with such guidelines, but also to exercise clinical judgment in their patients' interests. Practice departing from guidelines requires justification, but simple compliance without regard to patients' circumstances may constitute negligence. Some courts defer to medical professional guidelines, but others hold that professional standards are set as a matter of law, not by the profession itself. Unlike conclusions in medical science, which are open to continuing review, courts determine facts in a case only once, at trial. Litigation to compel patients' compliance with medical advice based on guidelines may fail, as may prosecutions, more common in the US, of patients who defy such advice.

 

 

 

Title: Quality and Safety in Women’s Health Care (Second Edition)

Date: 2010

Authors: American College of Obstetricians and Gynecologists, Women’s Health Care Physicians

 

Abstract: As stated in the introduction, “Quality and Safety in Women’s Health Care, Second Edition, is intended to serve as a primer for obstetricians and gynecologists starting or managing quality improvement programs within their hospital departments or ambulatory practices by focusing on the following practices:

• Quality and safety in the inpatient setting
• Clinical competence
• Quality and safety in the outpatient setting
• Data analysis tools

The manual is presented in five parts. Part 1 provides background information on the evolution of health care quality improvement efforts. Part 2 provides an overview of quality and safety in the inpatient setting, including quality measurement, disclosure of adverse events, hospital leadership roles in community hospitals and residency programs, and patient safety initiatives. Some information may be adapted for use in the ambulatory setting. Part 3 addresses the issues of assessing clinical competence, one of the key elements of any quality improvement program and certainly a major responsibility for chairpersons of obstetrics and gynecology departments. Part 4 addresses quality and patient safety issues in the outpatient setting. Part 5 covers tools that can be used to analyze data or study management issues.  Provided in the appendices are resources that include the 2009 Report of the Presidential Task Force on Patient Safety in the Office Setting and the World Health Organization’s Surgical Safety Checklist.” 

 

Title: Is Better Patient Safety Associated with Less Malpractice Activity?
Publication: RAND Institute for Civil Justice
Date: 2010
Authors: Michael D. Greenberg, Amelia M. Haviland, J. Scott Ashwood, Regan Main

Full Article

Abstract: Summarizing from the reports introduction, “The purpose of this report is to investigate the relationship between safety outcomes in hospitals and malpractice claiming against providers, using administrative data and measures. The results of our analysis are suggestive of a link between safety outcomes and malpractice liability, with important implications for public policy. This study is the first in a series of planned research projects seeking to address this relationship and its implications for policy. The current report will be of interest to anyone who is concerned with either patient safety or medical malpractice policy in the United States. The research described in this report was conducted under the auspices of the RAND Institute for Civil Justice (ICJ) and funded by pooled contributions from the ICJ and from several insurance companies, individuals, and nonprofit groups with interests in patient safety and medical malpractice policy.”

 

Title: Greenlight Issues for the CFO: Investing in Patient Safety
Publication: Journal of Patient Safety
Date: 3/1/2010
Authors: Charles R. Denham, MD

Full Article

Abstract: As opined by the author, “Fairly or unfairly reflecting reality, many in the quality and patient safety leadership positions bemoan that the role of the CFO has been to say ‘No’ to spending on performance improvement. Yet, changes in health care will mandate new coalitions and new partnerships between players who are often on opposing sides of budget debates. The next generation of great hospital leaders may come from the ranks of our finance leaders, who can help translate core values into bottom line performance by educating themselves in the financial impact of performance improvement. There are a number of issues with great potential for performance improvement, which include performance envelopes, chasing zero infections, impact scenarios, legal myths, quality teams and financial know-how, changing revenue assumptions, readmission red-ink revenue, coding issues, evidence-based point estimates, delegated purchasing risk, vendor risk, cost of technology adoption, cost of leadership failure, and purchaser gain sharing. It is our belief that the next generation of great leaders may come from the ranks of our CFOs and finance leaders who help translate core values into bottom-line performance.”

 

Title: Sentinel Event Alert #44 - Preventing Maternal Death
Publication: The Joint Commission Sentinel Event Alert
Date: 1/25/2010
Authors: The Joint Commission

Full Article

Abstract: The goal of all labor and delivery units is a safe birth for both the newborn and mother. As a previous Alert reviewed the causes of death and injury among newborns with normal birth weight and suggested risk reduction strategies, this Alert addresses the loss of mothers. Unfortunately, current trends and evidence suggest that maternal mortality rates may be increasing in the U.S., despite the rarity of the incidence of maternal death: deaths that occur within 42 days of birth or termination of pregnancy. Since 1996, a total of 84 cases of maternal death have been reported to The Joint Commission’s sentinel event database, with the largest numbers of events reported in2004, 2005 and 2006. According to the National Center for Health Statistics of the Centers for Disease Control and Prevention, in 2006, the national maternal mortality rate was 13.3 deaths per 100,000 live births.

 

Title: Human Factors and Error in Perinatal Care: The Interplay Between Nurses, Machines, and the Work Environment
Publication: Journal of Perinatal and Neonatal Nursing
Date: 1/1/2010
Authors: Laura R. Mahlmeister, PhD, RN

Full Article

Abstract: The author claims that, “The failure to keep pace with human factors innovations in the design of high-risk health care operations undoubtedly contributes to significant error and “never events”(serious errors that should never occur) in perinatal care. This article defines medical error and describes how the interplay between human factors, technology, and the work environment influences medical error rates. The efficacy of HFE [human factor engineering] in reducing and mitigating errors in obstetric settings is discussed. Recommendations are made for the application of HFE to perinatal systems.”

 

Title: Fetal monitoring bundle
Publication: ACOG Green Journal
Date: 12/1/2009
Authors: Minkoff H, Berkowitz R; Greater New York Hospital Association's Perinatal Safety Committee

Full Article

Abstract: In 2008, the Eunice Kennedy Shriver National Institute of Child Health and Human Development published guidelines for categorizing fetal heart rate patterns. However, even if universally adopted, they will fail to improve outcomes unless they are integrated into a "bundle" of activities. Bundles reduce risks by assuring that key steps in a process are always taken. A fetal monitoring bundle would have four components: credentialed staff, an escalation policy, a known responsible party, and the capability for rapid response. The first requirement would be that all providers are qualified to appropriately interpret and respond to fetal heart rate tracings. Education should be uniform across disciplines, and there should be a credentialing process. Second is an escalation policy: an algorithm for nurses to use when getting help. It would avoid delays that occur when a nurse requesting a check on a tracing is required to call a hierarchical series of residents who must all concur before the attending who can move the patient to the operating room is called. Third, there must be an identified responsible provider at all times, ie, an obstetrician who can be readily contacted in emergent circumstances. Finally, there must be the capability of a rapid response; whenever a patient is monitored, the institution must have the obstetric, anesthesia, and pediatric resources necessary to respond to deteriorating fetal status. This bundle is a key, but not sole, piece of the perinatal safety pie; perinatal safety is advanced through a multifaceted approach anchored in a culture that values and invests in safety.

 

Title: New perinatal quality measures from the National Quality Forum, the Joint Commission and the Leapfrog Group
Publication: Current Opinion in Obstetrics and Gynecology
Date: 12/1/2009
Authors: Elliott K. Main

Full Article

Abstract: Characteristics of perinatal quality measures are examined, including how they are developed and judged; nine obstetric care measures are discussed in detail, including literature support and specifications; the challenges of designing and testing new measures are explored. The importance of this quality measure set is stressed, as both the Joint Commission and the Leapfrog Group have selected their next set of perinatal measures from this group, and state and regional public reporting organizations intend to do the same. Hospital quality improvement activities will be increasingly focused on improving performance on these perinatal quality measures.

 

Title: BLUEPRINT FOR ACTION: Steps Toward a High-Quality, High-Value Maternity Care System
Publication: Childbirth Connection
Date: Received 17 September 2009; revised 11 November 2009; accepted 11 November 2009
Authors: THE TRANSFORMING MATERNITY CARE SYMPOSIUM STEERING COMMITTEE: Peter B. Angood, MD, Elizabeth Mitchell Armstrong, PhD, MPA, Diane Ashton, MD, MPH, Helen Burstin, MD, MPH, Maureen P. Corry, MPH, Suzanne F. Delbanco, PhD, Barbara Fildes, MS, CNM, FACNM, Daniel M. Fox, PhD, Paul A. Gluck, MD, Sue Leavitt Gullo, RN, MS, Joanne Howes, R. Rima Jolivet, CNM, MSN, MPH*, Douglas W. Laube, MD, Donna Lynne, DrPH, Elliott Main, MD, Anne Rossier Markus, JD, PhD, MHS, Linda Mayberry, PhD, RN, FAAN, Lynn V. Mitchell, MD, MPH, Debra L. Ness, Rachel Nuzum, MPH, Jeffrey D. Quinlan, MD, Carol Sakala, PhD, MSPH, and Alina Salganicoff, PhD

Full Article

Abstract: The introduction to the article states, “On April 3, 2009, in Washington, DC, over 100 leaders from across the range of stakeholder perspectives were actively engaged in the symposium work to improve the quality and value of U.S. maternity care through broad system improvement. A multi-disciplinary symposium steering committee guided the strategy from its inception and contributed to every phase of the project. The ‘‘Blueprint for Action: Steps Toward a High Quality, High Value Maternity Care System,’’ issued by the Transforming Maternity Care Symposium Steering Committee, answers the fundamental question, ‘‘Who needs to do what, to, for, and with whom to improve the quality of maternity care over the next five years?” As a result, “This process created a clear sightline to action that if enacted could improve the structure, process, experiences of care, and outcomes of the maternity care system in ways that when anchored in the culture can indeed transform maternity care.”

 

Title: Impact of a Comprehensive Patient Safety Strategy on Obstetric Adverse Events
Publication: AJOG Grey Journal (American Journal of Obstetrics and Gynecology)
Date: 5/1/2009
Authors: Christian M. Pettker

Full Article

Abstract: Yale studied incrementally introduced multiple patient safety interventions from September 2004 through November 2006 at a university-based obstetrics service. This initiative included outside expert review, protocol standardization, the creation of a patient-safety nurse position and patient-safety committee, and training in team skills and fetal heart monitoring interpretation. The Adverse Outcome Index (AOI) was followed for trending over this time. Results demonstrated that interventions significantly reduced the Adverse Outcomes Index. Concurrent with these improvements, clinically significant improvements in safety climate was measured by validated safety attitude surveys.

 

Title: Oxytocin, Excessive Uterine Activity, and Patient Safety Time for a Collaborative Approach
Publication: Journal of Perinatal and Neonatal Nursing
Date: 3/1/2009
Authors: Lisa A. Miller JD, CNM 

Full article

Abstract: Extensive review of physiology of labor and use of oxytocin in the course of labor management as currently practiced.  Intrapartum oxytocin falls into 2 categories: use for induction of labor or use for augmentation of labor.  Both situations require knowledge related to uterine response to oxytocin, patient characteristics influencing such response, and the influence of uterine activity on the fetus.  In addition, successful induction of labor requires knowledge of cervical ripening, appropriate patient selection, and realistic expectations on the part of the healthcare team as well as the patient.  Successful and appropriate augmentation also requires appropriate and timely diagnosis and management of labor abnormalities.  This includes the differentiation of latent versus active-phase abnormalities in the first state of labor and identification of second-stage abnormalities should they arise.
 

 

Title: Elective Cesarean Section : Why Women Choose It and What Nurses Need to Know
Publication: AWHONN Nursing for Women's Health
Date: 12/1/2008
Authors: Tara D. Collard, Habi Diallo, Alona Habinsky, Colleen Hentschell and Toni M. Vezeau

Full article

Abstract: Factors and implications related to elective cesarean delivery.  Incidence, costs, and risks are discussed.  Most common reasons for selection of cesarean delivery include convenience, fear of complications of vaginal birth (eg. pelvic floor prolapse), previous adverse birth experience, fear of fetal death, fear of potential need for emergent cesarean delivery.
 

 

Title: Evidence-based labor and delivery management
Publication: AJOG Grey Journal (American Journal of Obstetrics and Gynecology)
Date: 11/1/2008
Authors: Vincenzo Berghella, MD; Jason K. Baxter, MD, MSCP; Suneet P. Chauhan, MD

Full Article

Abstract: Per the authors, “the aim of this article is to review the evidence for the management of labor and delivery, and offer recommendations that are based (where available) on randomized trials. Proper choice of interventions, proven to be associated with the highest safety and effectiveness, with avoidance of less safe and effective ones, will minimize the morbidity, and possibly the mortality, that can be associated with labor and delivery for both the mother and her fetus”. The authors “aspire to stimulate better clinical management, promote education, and foster research trials in areas of uncertainty, focusing on prevention of possible complications rather than treatment.” They also “intended to provide obstetricians with evidence-based guidance for management decisions made in labor and delivery.”

 

Title: Improved outcomes, fewer cesarean deliveries, and reduced litigation: results of a new paradigm in patient safety.
Publication: AJOG Grey Journal (American Journal of Obstetrics and Gynecology)
Date: 8/1/2008
Authors: Steven L. Clark, MD; Michael A. Belfort, MD, PhD; Spencer L. Byrum, LCDR (ret.) USCG; Janet A. Meyers, RN; Jonathan B. Perlin, MD, PhD

Full Article

Abstract: The authors describe their intentions as follows – “In a health care delivery system with an annual delivery rate of approximately 220,000, a comprehensive redesign of patient safety process was undertaken based on the following principles: (1) uniform processes and procedure result in an improved quality; (2) every member of the obstetric team should be required to halt any process that is deemed to be dangerous; (3) cesarean delivery is best viewed as a process alternative, not an outcome or quality endpoint; (4) malpractice loss is best avoided by reduction in adverse outcomes and the development of unambiguous practice guidelines; and (5) effective peer review is essential to quality medical practice yet may be impossible to achieve at a local level in some departments. Since the inception of this program, we have seen improvements in patient outcomes, a dramatic decline in litigation claims, and a reduction in the primary cesarean delivery rate.” In conclusion, “[w]ith an integrated, comprehensive patient safety program, the goals of improved patient outcomes, reduced litigation, and a lower primary cesarean rate appear to be achievable. These results are encouraging and suggest that our use of a different patient safety paradigm, based on the aforementioned principles, maybe of value in addressing some of the most vexing problems in obstetrics and, more generally, in creating highly reliable health care.”

 

Title: Getting to Havarti: Moving towards patient safety in Obstetrics
Publication: ACOG Green Journal (Obstetrics and Gynecology)
Date: 11/5/2007
Authors: Larry Veltman

Full Article

Abstract: This article discusses major areas of "failure modes" in obstetric practice, and suggests remedies for improvements in patient safety and quality outcomes. Failure modes include: unavailability of clinician; poor sign-out practices; inadequate protocols for consultation, referral or transfer; acquiescing to patient requests that are fundamentally unsafe; off-site monitoring of high-risk situations; operation of hierarchy and the lack of teamwork regarding safety issues; inadequate back-up; and failure to recognize the effects of “human factors” on the ability to impair vigilance. Remedies are discussed, which include: improving communications; preparing for rare critical events through simulation training; developing protocols for administration of important medications used in labor and delivery (oxytocin, misoprostol, and magnesium sulfate); increasing the in-house presence of obstetricians; developing an effective departmental infrastructure that includes effective peer review; providing risk management education about high-risk clinical areas that have the potential to result in catastrophic injury; and staffing the unit for all contingencies during all hours, day and night.  Acceptance by the obstetric medical staff is critical to the implementation of these patient safety elements.
 

Title: Perinatal Clinical Decision Support System: A Documentation Tool for Patient Safety
Publication: Nursing for Women’s Health
Date: 7/30/2007
Authors: Carla Provost, RN, Molly Gray MS, RN

Full Article

Abstract: This article, based on the experience of nurses at PeriGen’s client hospital Baystate Medical Center, describes their experiences with the clinical decision support embedded in PeriGen’s PeriBirth™ system for OB. They asked the question, “How can DSS [decision support system] support nursing care?” They concluded, “Our interactive DSS presents information relevant to the patient for the nurse in real time at the point of care. The DSS database includes department policies and protocols that follow national standards and guidelines from the Association of Women’s Health, Obstetric and Neonatal Nurses and the American College of Obstetricians and Gynecologists. Regulatory requirements from the Joint Commission on Accreditation of Hospital Organizations are included. The DSS protocols and standards are based on research and reflect evidenced-based practice. During documentation, the DSS does not present an index of all the available guidelines but customizes the guidelines based on specific clinical situations. As the nurse enters patient data, the system presents prompts for essential documentation entries, recognizes the clinical situation and supports the safe management of the patient. The DSS presentation promotes compliance with our hospital’s best practice guidelines. The information collected with both the CIS and DSS creates an organized database that can be searched to answer clinical questions. Another goal of ours was to use this database for nursing research in the future.”