Patient safety: some progress and many challenges.

Progress in patient safety has been exceedingly slow, hampered by lack of both clarity regarding the definition and standard methodology to assess iatrogenic patient harm in obstetrics and gynecology. Understanding the causes of medical error and strategies to reduce harm is simple compared with the complexity of clinical practice. On the other hand, patient safety interventions will not be successful without a receptive culture of safety. This culture can only occur with engaged organizational and individual leaders who understand the importance of patient safety. Transforming groups of individual experts into expert teams is central to this cultural transformation. Strategic pathways to accelerate future improvement in patient safety include fundamental changes in health care education, patient engagement, transparency, care coordination, and improving health care providers' morale.

Physician leadership: essential in creating a culture of safety.

Advances in patient safety require a receptive culture that values transparency, communication, and mutual respect. The Safety Attitude Questionnaire is an effective tool that can be used to assess the safety culture in a variety of clinical settings. Transformational leadership is essential in promoting a culture of safety. There are several strategies available to these leaders that will improve patient safety including Patient Safety Leadership Walkrounds, briefings, huddles, debriefings, and conflict resolution. Finally, leaders must maintain a "just culture" that recognizes most errors involve system deficiencies not human error and that disruptive behavior cannot be tolerated.

Blueprint for action: steps toward a high-quality, high-value maternity care system.

Childbirth Connection hosted a 90th Anniversary national policy symposium, Transforming Maternity Care: A High Value Proposition, 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?" Five stakeholder workgroups collaborated to propose actionable strategies in 11 critical focus areas for moving expeditiously toward the realization of the long term "2020 Vision for a High Quality, High Value Maternity Care System", also published in this issue. Following the symposium these workgroup reports and recommendations were synthesized into the current blueprint. For each critical focus area, the "Blueprint for Action" presents a brief problem statement, a set of system goals for improvement in that area, and major recommendations with proposed action steps to achieve them. 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.

The efficacy of visual cues to improve hand hygiene compliance.

BACKGROUND: Guidelines governing healthcare workers' (HCW) hand hygiene (HH) behavior are well established. Despite known hazards of healthcare-associated infection to both HCW and patients, hand hygiene compliance (HHC) rates remain dismally low. To evaluate a potential solution to this ongoing challenge, we used a simulated patient encounter in an actual hospital room to test the efficacy of individual HH triggers. METHODS: One hundred fifty HCW (75 physicians and 75 nurses) participated in this study and were randomly assigned to one of five equal-size groups. Each participant performed a focused physical examination on a standardized patient and was expected to maintain HH before and after the examination. Using two rooms on a medical-surgical unit in a tertiary care teaching hospital, various cues were employed, and the impact on pre- and postexamination HHC was recorded. In the control group, the hand sanitizer dispenser was in its usual location (Baseline). In one group, the dispenser was relocated to direct line of sight (Line-of-Sight) on entering the room; in another, flashing lights were affixed to the dispenser in its usual location (Baseline & Flicker); and in a third group, the dispenser was relocated to the line of sight, and flashing lights were attached (Line-of-Sight & Flicker). In the last group, a large warning sign (Warning Sign) was affixed to the door, informing the healthcare provider that the room was under electronic surveillance, and failure to perform HHC would trigger an alarm. Data were analyzed using a generalized linear model to perform a repeated measures logistic regression; P<0.05 was considered statistically significant. RESULTS: In the control group (Baseline), pre- and postexamination HHC rates were 36.7% and 33.3%, respectively. All interventions improved HHC preintervention compared with baseline (Line-of-Sight=53.3%, Baseline & Flicker=60%, Line-of-Sight & Flicker=66%, Warning Sign=93.3%), but only the Line-of-Sight & Flicker and the Warning Sign produced statistically significant increased pre-examination HHC (P=0.022 and P<0.001, respectively). Only the Warning Sign produced statistically significant increased HHC postexamination (P<0.001). CONCLUSIONS: Visual cues can improve HHC, but their efficacy varies. A warning sign informing of a surveillance system with subsequent reporting of noncompliance resulted in the most significant improvement in HHC. Using a standardized patient in an actual hospital room was a helpful tool in assessing the impact of various interventions designed to improve HHC and patient safety.

Factors impacting hand hygiene compliance among new interns: findings from a mandatory patient safety course.

BACKGROUND: Residency is a critical transition during which individuals acquire lifelong behaviors important for professionalism and optimal patient care. One behavior is proper hand hygiene (HH), yet poor compliance with accepted HH practices remains a critical issue in many settings. This study explored the factors affecting hand hygiene compliance (HHC) in a diverse group of interns at the beginning of graduate training. METHODS: During a required patient safety course, we observed HH behaviors using a standardized patient encounter. Interns were instructed to perform a focused exam in a simulated inpatient environment with HH products available and clearly visible. Participants were blinded to the HH component of the study. An auditory alert was triggered if participants failed to perform prepatient encounter HH. Compliance rates and the number of alerts were recorded. All encounters were videotaped. RESULTS: The HHC among the 169 participants was 37.9% pre-encounter and was higher among female interns than males, although this difference was not statistically significant (41.6% versus 31.5%, P  =  .176). International medical graduates had significantly lower HHC compared with US graduates (23.2% versus 45.1%, P  =  .006). Most initially noncompliant participants performed HH after 1 alert (87.6%). DISCUSSION: The initial low rate of HHC in our sample is comparable to other studies. Using direct video surveillance and auditory alarms, we improved our success rates for prepatient encounter HHC. Our study identified medical school origin as an important factor for HHC, and the significantly lower compliance for international medical graduates compared with US graduates has not been previously reported. These findings should be considered in designing interventions such as intern orientation and clinical education programs to improve HH behaviors.

Interview with a quality leader: Paul Gluck, immediate past chair, National Patient Safety Foundation. Interview by Pamela K Scarrow.

Dr. Paul Gluck, MD, FACOG, has held many leadership positions. He served as the president/chair of the William A. Little OB/GYN Society, the Miami OB/GYN Society, the Florida OB/GYN Society, the Baptist Health Foundation, the Health Council of south Florida, the Florida Section of the American College of OB/ GYN (ACOG), National Patient Safety Foundation, as well as the Dade County Medical Association. He is currently ACOG assistant secretary and serves on their Executive Committee. Dr. Gluck has an interest in access to healthcare. For his work in establishing a prenatal clinic in an area of critical need he received ACOG president's Service Award and Humanitarian of the Year Award from the South Florida Perinatal Network. He led the Florida initiative to promote depression screening and treatment in women recognized by the Wyeth National Section Award. He co-chaired the Governance Committee of the Mayor's Task Force charged with solving the problem of providing care for the over 450,000 uninsured residents of Miami-Dade County.

Medical error theory.

Some errors in health care are inevitable because of human fallibility and system complexity. To improve patient safety we must develop three strategies. First, prevent errors with forcing functions, reducing complexity and providing reminders at the point of care. Second, everyone working in health care should be alert to identify and eliminate latent (potential) errors before patients are harmed. Finally, we must establish defensive barriers that will intercept those errors that still occur and prevent them from causing patient injury. Only in this way can health care fulfill its potential and significantly reduce iatrogenic harm.

Patient safety in women's health care: a framework for progress.

Patient safety research is hampered by lack of a clear taxonomy and difficulty in detecting errors. Preventable adverse events occur in medicine because of human fallibility, complexity, system deficiencies and vulnerabilities in defensive barriers. To make medicine safer there needs to be a culture change, beginning with the leadership. Latent systems deficiencies must be identified and corrected before they cause harm. Defensive barriers can be improved to intercept errors before patients are harmed. Strategies include: (1) providing leadership at all levels; (2) respecting human limits in equipment and process design; (3) functioning collaboratively in a team model with mutual respect; (4) creating a learning environment where errors can be analyzed without fear of retribution; and (5) anticipating the unexpected with analysis of high-risk processes and well-designed contingency plans. The ideal of a 100% safe health-care system is unattainable, but there must be continual improvement.

Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery. METHODS: A cluster-randomized controlled trial was conducted at seven intervention and eight control hospitals. The intervention was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at 20 weeks or more of gestation in which one or more adverse maternal or neonatal outcomes or both occurred (Adverse Outcome Index). Additional outcomes included 11 clinical process measures. RESULTS: A total of 1,307 personnel were trained and 28,536 deliveries analyzed. At baseline, there were no differences in demographic or delivery characteristics between the groups. The mean Adverse Outcome Index prevalence was similar in the control and intervention groups, both at baseline and after implementation of teamwork training (9.4% versus 9.0% and 7.2% versus 8.3%, respectively). The intracluster correlation coefficient was 0.015, with a resultant wide confidence interval for the difference in mean Adverse Outcome Index between groups (-5.6% to 3.2%). One process measure, the time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes versus 21.2 minutes, P=.03). CONCLUSION: Training, as was conducted and implemented, did not transfer to a detectable impact in this study. The Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00381056 LEVEL OF EVIDENCE: I.

The effect of pregnancy on the course of asthma.

The course of asthma is changed by pregnancy in variable ways for unknown reasons. Although the prospective studies used different criteria to stratify the severity of the patients' asthma, their conclusions were remarkably similar. Over-all, an equal number of women have asthma symptoms that improve, worsen, or are unchanged through pregnancy. Asthma symptoms can worsen during pregnancy because of identifiable factors, such as infection, gastroesophageal re-flux disease, reduction of appropriate medications by physician or patient, and smoking. Undertreatment, which remains a problem during pregnancy, can lead to continued difficulty with asthma. Severe asthmatics tend to have increased symptoms compared with mild asthmatics. If symptoms worsen, it usually occurs in the second and third trimesters, with the peak in the sixth month. Generally, there is improvement in asthma in the last 4 weeks of pregnancy. During labor and delivery, only 10% to 20% of asthmatics have symptoms;severe asthmatics are more likely to have exacerbations. Asthma tends to return to the prepregnancy state within 3 months post partum. Successive pregnancies tend to have a similar course in each individual. Every asthmatic woman should be maintained on appropriate medications and followed carefully throughout pregnancy, especially in the second and third trimesters. Asthma specialists should be available for collaborative care when asthma is uncontrolled, or if there is an exacerbation. A timely adjustment in treatment for any changes in asthma course that might occur ensures the best control of the disease in the face of complex multiple influences.

Assessing quality obstetrical care: development of standardized measures.

BACKGROUND: No nationally accepted set of quality indicators exists in obstetrics. A set of 10 outcome measures and three quality improvement tools was developed as part of a study evaluating the effects of teamwork on obstetric care in 15 institutions and > 28,000 patients. Each outcome was assigned a severity weighting score. MEASURES: Three new obstetrical quality improvement outcome tools were developed. The Adverse Outcome Index (AOI) is the percent of deliveries with one or more adverse events. The average AOI during the pre-implementation data collection period of the teamwork study was 9.2% (range, 5.9%-16.6%). The Weighted Adverse Outcome Score (WAOS) describes the adverse event score per delivery. It is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries. The average WAOS for the preimplementation period was 3 points (range, 1.0-6.0). The Severity Index (SI) describes the severity of the outcomes. It is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. The average SI for the pre-implementation period was 31 points (range, 16-49). DISCUSSION: The outcome measures and the AOI, WAOS, and SI can be used to benchmark ongoing care within and among organizations. These tools may be useful nationally for determining quality obstetric care.

A review of pregnancy outcomes after exposure to orally inhaled or intranasal budesonide.

BACKGROUND: Inadequately controlled rhinitis is associated with worsening asthma, one of the most common potentially serious causes of pregnancy complications. Recent evidence-based guidelines now stress the importance of inhaled corticosteroids as first-line therapy in controlling asthma during pregnancy, with preference given to budesonide. Both inhaled and intranasal budesonide formulations are rated Pregnancy Category B; all other inhaled and intranasal corticosteroids are rated Pregnancy Category C. OBJECTIVE: To review data from clinical and epidemiological studies investigating the effects of orally inhaled or intranasal budesonide on pregnancy outcomes. METHODS: Clinical and epidemiological studies on the effects of maternal exposure to orally inhaled or intranasal budesonide were identified through searches of the literature indexed on Medline or the Developmental and Reproductive Toxicology (DART) database through January 2005. The search terms used were: 'budesonide' and 'pregnancy'; 'pregnancy complications'; 'teratogens'; 'fetus'; 'embryo'; or 'toxicology'. The search was limited to English-language articles and those evaluating humans. Pertinent abstracts were identified from recent US asthma and allergy meetings. RESULTS: A total of five articles and three abstracts meeting the search criteria were identified. Retrospective epidemiological studies and a randomized, placebo-controlled, multicenter trial found no clinically or statistically significant effects on fetal outcomes among more than 6600 infants whose mothers were exposed to orally inhaled budesonide during pregnancy. Women who reported use of orally inhaled budesonide either during early pregnancy only or throughout pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths, multiple births, or congenital malformations. In a retrospective case-control analysis, no association was found between inhaled budesonide or intranasal budesonide and the overall rate of infant cardiovascular defects. However, a marginally increased risk of less severe cardiovascular defects (odds ratio = 1.58, 95% confidence interval 1.02 to 2.46) was observed with intranasal budesonide in one analysis, possibly the result of a random association due to multiple testing or an unidentified confounder. CONCLUSION: Maternal exposure to orally inhaled budesonide during pregnancy is not associated with an increased risk of congenital malformations or other adverse fetal outcomes in studies of more than 6600 infants. Data on pregnancy outcomes after maternal exposure to intranasal budesonide are limited, but the totality of evidence, including pharmacological studies showing a much lower systemic exposure after intranasal administration, indicates its safety profile is at least comparable with that of orally inhaled budesonide.

Asthma controller therapy during pregnancy.

OBJECTIVE: This study was undertaken to educate physicians on the safety of asthma controller use during pregnancy. STUDY DESIGN: A comprehensive literature search using MEDLINE, the Cochrane Controlled Trials Register and Database of Systematic Reviews, EMBASE, and selected bibliographies identified human gestational studies of asthma controller medications from which maternal and fetal outcomes were obtained. The US Food and Drug Administration (FDA) pregnancy category ratings were identified from product package inserts. RESULTS: Human gestational studies were identified for the inhaled corticosteroids (ICSs) beclomethasone, budesonide, and triamcinolone and for cromolyn sodium, theophylline, and salmeterol. Human pregnancy data support an FDA Pregnancy Category B rating for budesonide. Pregnancy Category B ratings for cromolyn, nedocromil, montelukast, and zafirlukast are based primarily on safety in animal reproduction studies. ICSs other than budesonide, theophylline, zileuton, and long-acting beta 2 -adrenergic agonists are Pregnancy Category C. CONCLUSION: Human pregnancy data for many asthma controllers are lacking; nonetheless, data support a range of choices among medications rated Pregnancy Category B.

Peer review in obstetrics and gynecology by a national medical specialty society.

BACKGROUND: Since 1986 the American College of Obstetricians and Gynecologists (ACOG) has offered a voluntary consultation service (Voluntary Review of Quality of Care [VRQC] program) to assist departments of obstetrics and gynecology in assessing their quality of care. HOW THE VQRC PROGRAM WORKS: The VRQC program review team selects three to five topics for on-site medical record review to further investigate the care processes that may contribute to the perceived problems. Each chart is evaluated by a single reviewer with the use of worksheets with explicit, objective criteria that represent practice guidelines. In addition, key departmental and hospital personnel are interviewed on site to provide insight into the issues that prompted the request. EVALUATION OF THE VRQC PROGRAM: The first 100 site visits took place in 29 states and represented a diverse geographic cohort of hospital departments of obstetrics and gynecology. Overall departmental and systemic deficiencies were significantly more common than clinical concerns. Obstetric issues were more prevalent than gynecologic issues. Induction and augmentation of labor was the most common deficiency, and the availability and quality of obstetric anesthesia was the second. CONCLUSION: The VRQC program, as a voluntary consultative peer review program, addresses hospital-specific quality problems and also identifies common deficiencies across a diverse group of hospitals, which may warrant continuing education.