Begun in 2003, the Yale-New Haven Hospital comprehensive obstetric safety program consisted of measures to standardize care, improve teamwork and communication, and optimize oversight and quality review. Prior publications have demonstrated improvements in adverse outcomes and safety culture associated with this program. In this analysis, we aimed to assess the impact of this program on liability claims and payments at a single institution. We reviewed liability claims at a single, tertiary-care, teaching hospital for two 5-year periods (1998-2002 and 2003-2007), before and after implementing the safety program. Connecticut statute of limitations for professional malpractice is 36 months from injury. Claims/events were classified by event-year and payments were adjusted for inflation. We analyzed data for trends as well as differences between periods before and after implementation. Forty-four claims were filed during the 10-year study period. Annual cases per 1000 deliveries decreased significantly over the study period ( P < .01). Claims (30 vs 14) and payments ($50.7 million vs $2.9 million) decreased in the 5-years after program inception. Compared with before program inception, median annual claims dropped from 1.31 to 0.64 ( P = .02), and median annual payments per 1000 deliveries decreased from $1,141,638 to $63,470 ( P < .01). Even estimating the monetary awards for the 2 remaining open cases using the median payments for the surrounding 5 years, a reduction in the median monetary amount per case resulting in payment to the claimant was also statistically significant ($632,262 vs $216,815, P = .046). In contrast, the Connecticut insurance market experienced a stable number of claims and markedly increased cost per claim during the same period. We conclude that an obstetric safety initiative can improve liability claims exposure and reduce liability payments.
The health care safety and quality movement has multiple goals, including (1) improvement of quality of care for individual patients, (2) reduction in the incidence of and exposure to adverse events, and (3) control of health care spending through accountable and value-based care. Preventable medical errors and mishaps diminish the ability to achieve all 3 goals, and thus efforts to control their occurrence are taking center-stage in health care improvement discussions.
Patient safety interventions have demonstrated remarkable improvements in quality indicators and reductions in adverse outcomes. However, less is known about how such interventions impact health care costs. Reducing waste and the spending required to respond to adverse outcomes is one way to reduce costs. It is also presumed that improvements in safety culture and the resultant enhanced collaboration and teamwork results in staffing efficiencies, such as less staff turnover and fewer staff vacancies. Finally, quality improvement efforts may alleviate some medicolegally-motivated defensive medicine practices complicating health care.
The contribution of medicolegal concerns to direct and indirect health care costs is a subject of debate. However, with obstetrics in a chronic professional liability insurance crisis, and with liability insurance and defense consuming a considerable amount of financial resources in obstetrics, demonstrating an impact on medicolegal outcomes, in addition to adverse outcomes, is an important goal in this field. Fewer lawsuits may be a surrogate marker of improved outcomes, but are probably a valuable indicator on their own. Decreasing claims also would reduce the overhead costs associated with legal defense and should also reduce overall payments for awards and settlements.
In 2002, Yale-New Haven Hospital (YNHH) partnered with its liability insurance carrier (MCIC Vermont, Inc., New York, NY) to introduce a comprehensive obstetrics safety initiative aimed at improving quality of care and reducing liability costs. We have previously demonstrated reductions in adverse outcomes and improvements in safety culture/climate associated with this program. More than 3 years after the maturity of this program, we now aim to describe the changes in our liability profile, namely the number of and payments for obstetric legal cases.
Materials and methods
We incrementally introduced multiple patient safety interventions from Dec. 2002 to Nov. 2006 at a university-based obstetrics service at YNHH. The details of this program have been previously described. Briefly, the core elements of this project included:
- (1)
Outside Expert Review: we began in 2002 with a review of our obstetric services by 2 independent consultants. This site visit culminated in recommendations that focused on principles of patient safety, evidence based practice, and consistency with standards of professional and regulatory bodies.
- (2)
Protocols and Guidelines: protocol and guideline development began in 2004 with the aim to codify and standardize existing practices. Over 40 documents were produced during the study period.
- (3)
Obstetric Safety Nurse: an obstetric safety nurse was hired in 2004 to facilitate planned interventions and assist in data collection. This nurse was in charge of educational efforts—including team training and electronic fetal heart rate (FHR) monitoring certification—and operations relating to patient safety activities.
- (4)
Anonymous Event Reporting: we initiated in July 2004 a computerized and anonymous event reporting tool (Peminic Inc, Princeton, NJ) that allows any member of the hospital to report an event or condition leading to harm (or potential harm) to a patient or visitor. Reports were reviewed and investigated.
- (5)
Obstetric Hospitalists: resident supervision and leadership of the inpatient activities was assumed by our Maternal-Fetal Medicine team to provide 24-hour, 7-day a week in-house coverage, beginning in 2003.
- (6)
Obstetric Patient Safety Committee: established in 2004 this multidisciplinary committee of physicians, midwives, nurses, and administrators provides quality assurance and improvement oversight. In particular, this group met monthly to review adverse events and address the needs for protocols and policies.
- (7)
Safety Attitude Questionnaire: to assess employee perception of teamwork and safety, we annually surveyed our teams with this tool, adapted from the aviation field.
- (8)
Team Training: we implemented crew resource management seminars, based on those of airline and defense industries. These 4-hour classes included videos, lectures, and role-playing with the goal of integrating obstetric staffing silos (physicians, midwives, nurses, administrators, assistants) and teaching effective communication. Completion of the seminar was a condition for employment and/or clinical privileges.
- (9)
Electronic FHR Certification: teaching for this included dissemination and review of NICHD guidelines, review of tracings, allocation of study guides, and voluntary review sessions, culminating in a standardized, certified examination. All medical staff and employees responsible for FHR monitoring interpretation were obligated to pass this exam at program inception or within 1 year of employment.
Events, claims, and suits related to obstetric cases at YNHH were collected prospectively by the liability carrier (MCIC Vermont, Inc.) for the hospital and all of its employees and providers, and classified according to event year. MCIC Vermont, Inc. covers all care at YNHH, including professional liability insurance for all obstetricians and midwives. For the purposes of this study, only formal claims and suits filed against the hospital or a hospital provider were designated as ‘cases.’ A case consisted of a claim or suit requesting financial compensation of the patient for alleged harm and resulting in legal involvement and/or response by the liability carrier. This includes cases dropped by the plaintiff or settled with or without payment before the filing of a formal lawsuit. Events noted by the legal or medical liability teams to be at risk for legal action were not included.
Cases were categorized according to high, moderate, or low severity, as described in Table 1 , by the liability carrier using the industry standard National Association of Insurance Commissioners Index. Cases were also categorized according to the nature of the case/issue (eg, prenatal diagnosis, fetal monitoring, improper obstetric management, nonobstetric, and other).
| Severity | Injury description | Example of injury |
|---|---|---|
| High | Death, permanent major | Maternal or neonatal death, cerebral palsy |
| Moderate | Permanent minor, temporary major, temporary minor | Erb’s palsy, bowel perforation, preventable infection |
| Low | Temporary insignificant, emotional | Retained vaginal sponge, scalp laceration, improper management without physical harm |
Closed cases were defined as those resolved by withdrawal, court judgment, or settlement. Open cases were claims or suits filed in court but still unresolved at the time of performing the analysis. Connecticut state law (CGS § 52-584) requires that a medical malpractice lawsuit must be initiated within 2 years from the date the injury is first sustained or discovered (statute of limitations), or 3 years from the date of the act or omission causing the injury (statute of repose). Thus, a malpractice claim must be initiated within 3 years of the act/omission even if the injury is not discovered until after 3 years have passed. There is no law extending the statute of limitations for injured minors. Thus, obstetric cases up to Dec. 2007 must have been filed before Jan. 2011, ensuring complete accounting for all possible cases in this study. Study completion date of Dec. 2007 was chosen to allow for the statute of repose as well as a subsequent 18-month period to allow any open cases to resolve.
Indemnity payments were identified by our liability carrier and include all compensation to claimants of plaintiffs. Payments do not include costs of investigating or defending the case or other allocated loss adjustment expenses. As events that did not lead to claims or suits were not included, dollars held in reserve for possible future actions were not included. All monetary values are expressed in dollars and adjusted for inflation to reflect 2007 values, according to the Consumer Price Index.
There were no concurrent changes in malpractice law on caps or noneconomic damages in Connecticut during this study period. A statute requiring a ‘certificate of merit’ from a qualified health care provider for medical liability cases was passed in 2005 (CGS § 52-184c and 52-190a). There were no institutional changes in mediation or adverse event disclosure policies during the study period.
Analysis was performed tracking the number of liability cases per 1000 deliveries, per year. Cases were normalized per 1000 deliveries to control for any variation in volume across study years or periods. Comparisons were made for 2 5-year periods (before study inception [Jan. 1998-Dec. 2002] and after study inception [Jan. 2003-Dec. 2007]) using Student’s t test, the median test, Mann-Whitney U test and χ 2 or Fisher exact test where appropriate. Poisson regression was used to analyze annual trends in numbers of claims per 1000 deliveries. In addition, analysis of differences and trends in annual liability payments was performed on closed as well as open and closed (combined) cases. For combined case payment analysis, we used the overall median liability payment for the 5 surrounding years as the estimate for each open claim, assuming each open case resulted in payment. Cases that did not result in payment were not included in payment analyses. We performed the additional analysis of combined cases because a closed claim analysis may bias results in favor of the second epoch, given that it is likely to have more open claims. When claims remained open we performed worst-case and best-case scenario analyses when estimating the numbers of claims settled without payment. Worst-case scenarios designated open cases as being settled with payment, whereas best-case scenarios designated them as settled without payment. P values < .05 were considered statistically significant. Analysis was performed using commercially available software (SPSS version 18.0; SPSS, Inc., Chicago IL).
This project was reviewed by the Chair of the Yale University Human Investigations Committee and was deemed a quality assurance activity and thus not required to undergo review by the Committee.
Results
Our unit averaged approximately 4600 deliveries annually, with no statistically significant difference between both epochs ( Table 2 ). We identified 44 cases overall during the entire 10 year study period, with 30 of those associated with events before initiation of our safety initiative and 14 after. Twelve (12) cases resulted in no payment made, with 7 of these in the 5 years before our patient safety project and 5 cases after the initiation of our intervention ( Table 3 ). There were 2 open claims remaining at the time of this report, both being in the second 5-year epoch.
| Variable | 1998-2002 | 2003-2007 | P value |
|---|---|---|---|
| Deliveries; n | 23,499 | 23,372 | — |
| Annual deliveries; mean (±SD) | 4699 (± 159) | 4674 (± 58) | .70 a |
| Liability cases | |||
| Total cases; n | 30 | 14 | — |
| Total cases per 1000 deliveries; n | 1.28 | 0.60 | — |
| Annual cases; median (range) | 6 (4–7) | 3 (1–5) | .02 b |
| Annual cases per 1000 deliveries; median (range) | 1.31 (0.88-1.45) | 0.64 (0.22-1.06) | .02 b |
| Closed case analysis | |||
| Total payments | $50,721,033 | $2,239,173 | — |
| Annual payments; median (range) | $632,262 (2293–15,421,842) | $81,714 (13,505–1,579,496) | .03 c |
| Total payments per 1000 deliveries | $2,158,434 | $95,806 | — |
| Annual payments per 1000 deliveries; median (range) | $1,141,638 (264,352–4,536,653) | $63,470 (0–335,349) | < .01 b |
| Combined (open + closed) case analysis (estimated) | |||
| Total payments | $50,721,033 | $2,878,937 | — |
| Annual payments; median (range) | $632,262 (2293–15,421,842) | $216,815 (13,505–1,579,496) | .046 c |
| Total payments per 1000 deliveries | $2,158,434 | $123,179 | — |
| Annual payments per 1000 deliveries; median (range) | $1,141,638 (264,352–4,536,653) | $63,925 (13,353–403,264) | .08 b |
| Cases | 1998-2002 | 2003-2007 | P value |
|---|---|---|---|
| Total cases | 30 | 14 | — |
| Cases without payment | 7 (23%) | 5 (42%) a | .27 |
| Case severity | |||
| High | 16 (53%) | 8 (57%) | .97 |
| Moderate | 9 (30%) | 4 (28%) | |
| Low | 5 (17%) | 2 (14%) | |
| Case type | |||
| Improper management | 13 (43%) | 7 (50%) | .91 |
| Fetal heart rate monitoring | 5 (17%) | 2 (14%) | |
| Failure to diagnose | 3 (10%) | 2 (14%) | |
| Other | 9 (30%) | 3 (21%) | |
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