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Near-miss reporting and the OB Right program.

Hospital safety issues have been widely reported and have received significant attention recently. However, solutions have been slow in coming. Thus, the ongoing challenge of creating the safest labor and delivery environments possible has been left with obstetricians. Although the problem is daunting, there are many steps that obstetric and gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology.  practices can take on their own that will reduce adverse events in labor and delivery as well as optimize maternal-fetal outcomes.

Separate reports published almost a decade ago by the Institute of Medicine and the American Hospital Association estimated that 44,000-98,000 patients die each year from errors made during hospital stays.

That higher death rate accounts for almost double the number of people who die in motor vehicle accidents each year in this country, and double the number of women who die annually from breast cancer, according to according to
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

 the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. .

The problem is so severe that Dr. Mark R. Chassin, president of the Joint Commission (an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ), noted recently that the chance of any of us being injured from simply being in a hospital and not as the result of an illness is 40% greater than the likelihood of an airline mishandling our luggage.

The problem of inconsistent and dysfunctional clinical patterns of care in both the inpatient and outpatient settings is even more alarming. One large study involving the review of 18,000 patients received care in keeping with current best practices ("Epidemic of Care: A call for Safer, Better, and More Accountable Health Care." San Francisco: Jossey-Bass, 2003).

Approximately 5 years ago, the Joint Commission examined all perinatal "sentinel" events across the country in all types of institutions, and found that 72% of such events were linked to break downs in communication.

Other identified root causes included staff competency (47%), staff orientation and training (40%), inadequate fetal monitoring (34%), unavailable equipment or drugs (30%), and physician-credentialing issues (30%).

Major issues of concern in the labor and delivery setting involve the fetal heart rate fetal heart rate Obstetrics A rate which, in the non-stressed fetus, reflects cardioaccelerator and cardiodecelerator reflexes; analysis of the FHR requires evaluation of a baseline FHR between uterine contractions or periodic changes in the FHR and non-periodic,  tracing. iatrogenic iatrogenic /iat·ro·gen·ic/ (i-a´tro-jen´ik) resulting from the activity of physicians; said of any adverse condition in a patient resulting from treatment by a physician or surgeon.  prematurity, shoulder dystocia shoulder dystocia Obstetrics An obstetrical emergency that occurs when the anterior shoulder of the fetus becomes lodged behind the superior symphysis pubis, preventing further delivery; SD is not always preventable, and is usually not recognized until after the , and operative delivery, as well as all the verbal and written communications that are involved with each of these areas.

An American College of Obstetricians and Gynecologists survey noted that the fetal heart tracing accounts for the majority of liability claims pertaining to labor and delivery.

Labor and delivery safety programs should therefore focus primarily on these issues, and on the following;

* Simplifying and standardizing protocols for care.

* Adopting evidence-based practices.

* Relying more on simulation and training.

* Working together as a team to accomplish defined goals.

Near-Miss Reporting

The real crux of any patient safety initiative-and the element that goes hand in-hand with each of these aspects of a program-is a "near-miss" reporting system. This is a concept that medicine borrowed from the airline industry; it involves reporting any occurrence that could have resulted in an adverse event.

A near-miss reporting program is nonpunitive, and empowers everyone involved in the care of a patient to report events and happenings that they believe have the potential to cause problems for patients. Reports are made before injury happens and are reviewed in a blame-free environment. Systems can then be analyzed and modified to minimize recurrence of these events.

In fall 2005, a collaborative effort among the academic faculty at Eastern Virginia Medical School Coordinates:  Eastern Virginia Medical School, in Norfolk, Virginia is a public medical school.  (EVMS EVMS Enterprise Volume Management System
EVMS Eastern Virginia Medical School
EVMS Earned Value Management System
EVMS Earned Value Management Standard
EVMS Embedded Voice Mail System
EVMS Enterprise Vulnerability Management System
) in Norfolk, the obstetric community faculty in that city, and Sentara Healthcare established the OB Right program, with the mission of minimizing iatrogenic injury to the mother and infant and reducing adverse patient safety events at labor and delivery. The "near-miss report form" used by the patient safety program at EVMS and Sentara Healthcare asks for descriptions of events that were "out of the ordinary" or "made you uncomfortable." It also asks for suggested solutions.

The program has been enormously successful. Over the past 3 years, almost 230 near-misses have been reported by our physicians, residents, and nurses. Echoing the 2004 Joint Commission report, our near-miss reports have shown us that communication issues account for at as many as 60% of these potentially dangerous situations. These reports also have helped solidify a patient safety approach that gives special attention to fetal heart rate monitoring, shoulder dystocia, iatrogenic prematurity, and operative deliveries.

Setting Up a Program

At the time the OB Right program was established, it encompassed two hospitals in the Sentara Healthcare System: Sentara Norfolk General Hospital Coordinates:

For the similarly named hospital in Simcoe, Ontario, see Norfolk General Hospital.
 (the academic tertiary hospital of EVMS) and Sentara Leigh Hospital, (a community hospital in Norfolk that has no 24-hour in-house obstetric coverage). The purpose of including both hospitals was to ensure that the program is successful in both settings.

A steering committee was established immediately to oversee the program, and a clinical nurse specialist clinical nurse specialist
A nurse who has advanced knowledge and competence in a particular area of nursing practice, such as in cardiology, oncology, or psychiatry.
 was recruited to coordinate program activities and serve as the link between the program and the staff. One of the nurse specialist's first tasks was identifying ways of communicating with physicians and staff, and later, letting them know early on of program successes.

The steering committee included physician leaders from the academic and community obstetric faculty, neonatology neonatology /neo·na·tol·o·gy/ (ne?o-na-tol´ah-je) the diagnosis and treatment of disorders of the newborn.

 and anesthesiology anesthesiology (ăn'ĭsthē'zēŏl`əjē), branch of medicine concerned primarily with procedures for rendering patients insensitive to pain, and for supporting life systems under the strains of anesthesia and surgery.  physicians, nurse leaders, hospital administrators, risk managers, and representatives from liability insurance companies.

An education and practice committee was formed to review and recommend educational modules for physicians and staff, to research and develop protocols on best practices, to review practice patterns and recommend changes, to establish a simulation lab, and to implement emergency drills.

A data committee was established to identify retrospective and prospective variables for data collection, as well as data collection methods. Its members were also assigned the jobs of conducting patient and physician satisfaction surveys and of developing a system to collect, report, and debrief de·brief  
tr.v. de·briefed, de·brief·ing, de·briefs
1. To question to obtain knowledge or intelligence gathered especially on a military mission.

 faculty and staff on reported near-misses.

Members of the technology committee led an effort to identify and develop technology that would improve patient safety at labor and delivery.

Building the Program

A Critical look at all available protocols is a key component of a safety initiative. Simplifying and standardizing the oxytocin oxytocin (ŏksĭtō`sĭn), hormone released from the posterior lobe of the pituitary gland that facilitates uterine contractions and the milk-ejection reflex.  order set, for instance, was something we did early on.

It's important to ensure that everyone is speaking the same language. We were particularly struck by the importance of common language and common understanding in fetal heart rate monitoring. For example, early on we surveyed EVMS residents and labor and delivery nurses about how they defined uterine uterine /uter·ine/ (u´ter-in) pertaining to the uterus.

Of, relating to, or in the region of the uterus.
 tachysystole. Responses were all over the board, with more than 20 different definitions.

Without, a common definition, we realized, we would have not only varying recognition of the problem at labor and delivery, but also poor communication among health team members and the potential for harming the patient.

To prevent errors of mistaking fetal heart rate of maternal heart rate during labor, we adopted the National Institute for Child Health and Human Development's definitions of uterine tachysystole and fetal heart rate patters. This was an important precursor to the development of protocols for addressing tachysystole and enhancing communication

We also established universal monitoring of maternal and fetal heart rates. The maternal heart rate is continuously displayed on the fetal heart rate monitor, which substantially reduces the chance for error.

In addition, we studied our cesarean section cesarean section (sĭzâr`ēən), delivery of an infant by surgical removal from the uterus through an abdominal incision. The operation is of ancient origin: indeed, the name derives from the legend that Julius Caesar was born in this  response time and developed new response time guidelines that enabled us to clearly and efficiently communicate with anesthesiology regarding the various levels of urgency involved. Ultimately, we created four cesarean section categories that provided clear communication among health care teams and allowed for data collection and review. (see box above.)

To significantly reduce unnecessary prematurity and its associated morbidity, we implemented elective induction and cesarean section bundles that require either a gestational age ges·ta·tion·al age
See estimated gestational age.

Gestational age
The estimated age of a fetus expressed in weeks, calculated from the first day of the last normal menstrual period.
 of at least 39 weeks or documented fetal lung maturity fetal lung maturity Obstetrics A parameter that determines the likelihood a neonate will develop RDS; infants delivered at 40 ± 2 wks have 0% incidence of RDS; at 36 wks 0-2%, at 34 wks 8-34%–depending on birthweight .

These criteria are currently part of the national voluntary consensus standards for perinatal care in 2008 that were developed by a committee of the National Quality Forum.

Following much debate, we also implemented, at both hospitals, the universal collection of arterial and venous cord pH with every delivery. We have found this practice to be cost effective and to provide objective documentation of fetal intrapartum oxygenation oxygenation /ox·y·gen·a·tion/ (ok?si-je-na´shun)
1. the act or process of adding oxygen.

2. the result of having oxygen added.
. It also identifies neonates for targeted resuscitation resuscitation /re·sus·ci·ta·tion/ (-sus?i-ta´shun) restoration to life of one apparently dead.

cardiopulmonary resuscitation
 and is a mechanism for continuous quality improvement. Given its potential controversy, however, this practice should not be at the top of the list for safety initiatives at labor and delivery.

Plans in the immediate future include a focus on shoulder dystocia, operative delivery, and triage of patients at labor and delivery.

Given the early success of OB Right, we decided to expand this program to the five other Sentara Healthcare hospitals that provide obstetric services in southeastern Virginia.

In order to achieve this goal, we have created a Clinical Effectiveness Council with physician /nurse team representation from each of the hospitals. The council meets monthly and is currently in the process of implementing key components of the OB Right program.

Keys to Success

We have learned that "buy-in" is key to an effective patient safety initiative. Hospital administration must devote the resources necessary for the success of the program, and both physicians and nurses must be at the table together and be involved as a team with a common safety goal.

A clinical safety coordinator is also essential to the success of a program. This person provides the consistency required and plays a critical role in communicating with the staff in the trenches.

Additionally, it is important to establish methods of communication early on, and to deliver and communicate tangible successes as soon as possible.

The OB Right program communicates with the health care team through posters on labor and delivery, and a newsletter that reports every 3 months on the issues and successes of the program. It also has a Web site with educational modules, near-miss reporting, meeting scheduled and minutes, and other interactive tools.

Since OB Right began, we've almost eliminated elective deliveries at less than 39 weeks' gestation, and have achieved an almost-universal compliance with simultaneous maternal and fetal heart rate tracing and measurement of arterial and venous cord pH at both hospitals.

One of the major liability insurances companies sends a representative to the OB Right steering committee meetings and provides premium discounts for physician participation in the OB Right program.

As reported in the Institute of Medicine report "Crossing the Quality Chasm: A New Health System for the 21st Century," the biggest challenge to moving toward a safer health system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures but as opportunities to improve the system and prevent harm.
Categories Developed Under the OB Right Patient Safety Program

Category                  Timing                  Examples

Category 1 (Stat)      Delivery to be         Cord prolapse Uterine
                       accomplished           rupture Ominous fetal
                       immediately because    heart rate pattern
                       of risk of
                       to mother and/or

Category 2 (Urgent)    Delivery to be         Failed vacuum or forceps
                       accomplished in a      Nonreassuring fetal heart
                       timely fashion in      rate pattern
                       first available room;
                       should be expedited
                       to avoid increasing
                       risk to the fetus.

Category 3             Early delivery         Prolonged second stage
                       needed; time to be     Arrest of descent
                       determined by
                       consultation between
                       obstetrician and

Category 4 (Elective)  Generally scheduled    Elective repeat cesarean
                       in advances and        section
                       categorized as
                       without immediate
                       risk of maternal or
                       fetal harm insofar as
                       timing is concerned.

Source: Dr. Abuhamad

RELATED ARTICLE: Key Points About Patient Safety

* An estimated 44,000-98,000 patients die each year from errors made during hospital stays.

* Two-thirds of perinatal sentinel events are primarily linked to communication issues.

* Experience with the OB Right patient safety initiative at Eastern Virginia Medical School and Sentara Healthcare has demonstrated the importance of common language and common understanding when it comes to fetal heart rate monitoring.

* To significantly diminish unnecessary prematurity and its associated morbidity, patient safety initiatives should include elective induction and C-section bundles that require either a gestational age of at least 39 weeks or documented fetal lung maturity.

Alfred Z. Abuhamad, M.D.
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Title Annotation:MASTER CLASS
Author:Abuhamad, Alfred Z.
Publication:OB GYN News
Date:Jan 1, 2009
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