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Risk Management in Obstetrics and Gynecology

KLEIN, VICTOR R. MD, MBA, CPHRM, FACOG, FACMG, FASHRM

Clinical Obstetrics and Gynecology: September 2019 - Volume 62 - Issue 3 - p 550–559
doi: 10.1097/GRF.0000000000000473
Quality and Safety Programs in Obstetrics and Gynecology
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This article will review the basic principles of risk management, the role of the risk manager, and the importance of risk management in the patient safety movement as it pertains to obstetrics and gynecology. Several tools that are used by risk managers including risk assessments and root cause analyses will be used to illustrate positive patient safety measures that can be initiated to decrease adverse outcomes and reduced risk to an organization. The dramatic reduction in adverse outcomes and claims after the introduction of patient safety initiatives in a major obstetrical service will be reviewed.

Quality and Patient Safety, Obstetrics and Gynecology Service Line, Northwell Health, Great Neck, New York

The authors declare that they have nothing to disclose.

Correspondence: Victor R. Klein, MD, MBA, CPHRM, FACOG, FACMG, FASHRM, 600 Northern Blvd, Great Neck, NY. E-mail: vklein@northwell.edu

The importance of the integration of risk management into safety programs in obstetrics and gynecology cannot be underestimated. In this chapter, the fundamental principles of risk management and how they are applied to obstetrics and gynecology service lines will be outlined. The fundamental differences and similarities between patient safety and risk management will be identified. Patient safety initiatives introduced into maternity care have decreased maternal morbidity and mortality, and improved neonatal outcomes during the past decade. One of the problems with measuring the effectiveness of the introduction of patient safety bundles in relationship to claims is that claims data frequently trails reduction in claims years later. For example, in New York, the statute of limitations for an obstetrical malpractice suit is 10 years. It is well known that significant time may pass to see a reduction in claims after patient safety initiatives are begun. This chapter will define the role of the risk manager and explore the relationship between risk management and patient safety initiatives that the obstetrics and gynecology service lines implement. It will demonstrate that collaboration and teamwork improves patient safety and decreases risk to institutions. There are many connections between risk management, patient safety, and quality (Fig. 1).

FIGURE 1

FIGURE 1

In some organizations, Quality performs investigations of adverse outcomes; in others, it is Risk Management. In most organizations it is a collaboration of the service line and the Risk Management and Quality departments. Collectively, situations that result in adverse outcomes are investigated. Root causes are identified and process improvement recommendations are developed, implemented and measured for compliance. Quality often is delegated to support the regulatory responsibilities of an organization. In some organizations, the titles Patient Safety Specialist and Risk Manager have become combined as there is tremendous overlap in these disciplines.

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What is Risk Management?

Risk management is defined as the process of identifying and mitigating, and controlling threats to an organization. Initially, risk managers were involved in risk financing and claims management similar to non–health care industries. Risk financing involves the management of risk to an organization by the purchasing of insurance, retaining risk, and protecting the organization’s financial interests when claims are filed. Claims management deals with the management of lawsuits brought to the institution—how to successfully resolve either through settlement or trial. Risk management has evolved from these 2 functions of a traditional model and to what is known as Enterprise Risk Management (ERM).1

In the traditional model, risk management was viewed as having 7 domains or risk categories: financial, operational/clinical, human capital, strategic, legal/regulatory technological, and natural disaster/hazard. Health care ERM is a comprehensive new approach whereby the entire risks to an organization are considered interrelated. ERM broadly examines multiple categories of risk and estimates how the repercussions arising in a given risk may affect the organization as a whole.1 An example is a malpractice suit because of maternal death. Such an incident would affect the reputation of the institution, perhaps with adverse media coverage with financial exposure and potential regulatory intervention.

The organization that represents risk managers in the United States is the American Society for Healthcare Risk Management (ASHRM). With over 6200 members, the organization mission statement and strategic goals include patient safety as a core value. The purpose of ASHRM is to advance safe and trusted health care. It identifies the role of the risk manager as a professional who will lead the organization in improving patient safety, mitigating risk, and maximizing value (www.ashrm.org).

One of the 3 strategic goals of ASHRM is as follows: “the delivery of highly reliable and safe patient care will be the core to all risk management programs” (www.ashrm.org). By collaborating and working closely with risk management, patient safety will be increased and institutional risk will be mitigated (www.ashrm.org).

The role of the risk manager in health care has evolved in the past thirty-five years. Risk managers are nurses, practitioners, attorneys, physicians, and administrators whose responsibility is not only to manage the risk to an institution but also to identify and prevent potential risk.

Many practitioners view the risk manager as the person who is called when there is an adverse outcome or a lawsuit. However, one of the fundamental roles of the risk manager is patient safety and preventive medicine by decreasing claims and preventing harm.

As an obstetrician/gynecologist practicing for over thirty-five years, I was introduced to risk management as a junior resident when I helped deliver a baby that resulted in shoulder dystocia and Erbs palsy. After the adverse outcome occurred, the incident was reported to risk management. Two years later a lawsuit was filed and eventually resolved in a settlement. Today, the process is different. When an adverse outcome occurs, the risk managers are involved in the patient safety process. Was the adverse event preventable? Was there a medical error? Are there processes in place to prevent similar events? Was it a system error or a human error? How was the event documented?

Risk managers are involved in preventive medicine averting the adverse outcome and decreasing claims. In Principles of Risk Management and Patient Safety, the following table compares/contrasts risk management and patient safety. Let us look at this and see how today’s risk manager is also a patient safety advocate (Table 1).2

TABLE 1

TABLE 1

There is much overlap between risk management and patient safety. In some organizations risk managers also serve as patient safety officers, whereas in others there still exists a separation. To summarize the differences, we see that risk management focuses on individual cases, utilizing post‐event investigation. Patient safety addresses system failures and how adverse events occur. The Swiss cheese model described by James Reason looks at the failure to have systems to prevent errors and reduce harm, rather than individual errors. Whether it is called a near miss, good catch, or safety opportunity, risk managers are interested in improving the safe delivery of care while decreasing financial risk to an institution. Adverse outcomes also can compromise the reputation and referral patterns to a hospital. Consider a hospital that had 2 maternal mortalities—the social media, investigations by local and state department of health, all affect the reputation of a hospital even if the event was preventable.

Let us look at some examples of how the integration of risk management and patient safety has improved patient care.

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ROOT CAUSE ANALYSIS (RCA)

When an adverse outcome occurs, there should be a review of the events that were the basis or root cause of the event. An RCA is a comprehensive, system-based review process used to identify the basic factors—or root causes—that underlie variation in performance. Such variation in health care includes the occurrence or risk of occurrence of a medical error, adverse event, or a near miss which is defined as an event that could have resulted in harm but was identified before reaching the patient.3

An RCA is a process either conducted by risk management or quality in some organizations to investigate an adverse outcome. These events could be triggered by regulatory mandates such as The New York Patient Occurrence Reporting and Tracking System (NYPORTS) in New York State or on the basis of criteria where a significant harm or potential harm occurred.

The RCA is a multidisciplinary meeting conducted to determine the root cause of the event and examine the cause and effect of the adverse event. Often, a fishbone diagram is used to demonstrate the many possible causes of an adverse outcome. These include: people, communication, policies, technology, patient, and location (Fig. 2).

FIGURE 2

FIGURE 2

These case analyses serve to both improve patient safety and decrease risk to the organization. As processes improve to decrease patient harm, so will claims. However, there is a lag time from the implementation of patient safety initiatives to claims data.

Let us look at a typical RCA of a case of maternal hemorrhage and see how risk management and patient safety are involved.

A 25-year-old woman G1001 was admitted for induction of labor at 41 weeks gestation.

After a long 2-day induction and labor, she had a successful delivery of a vigorous infant. Immediately afterwards she had a postpartum hemorrhage. Medical management was initiated without success. A massive transfusion protocol was called. Simultaneously, a decision was made to proceed to hysterectomy as medical management with uterotonics failed. A blood transfusion was started, additional attendings were eventually called. The patient received massive blood transfusions. However, the patient suffered a cardiac arrest on the OR table and was unable to be resuscitated despite efforts by anesthesiology and the entire team.

The head of the performance improvement committee of the Ob/GYN department reviewed the case and scheduled an RCA. Members of the obstetrics, anesthesia, nursing, administration, blood bank, and quality and risk management attended, with risk leading the initiative.

What was learned from the RCA? Was the maternal death preventable? Were the actions timely and correct? It was determined that the maternal death was potentially preventable. The issues that were discussed as part of the root cause included; failure of adequate training to respond to hemorrhage; failure to transfuse in a timely manner, lack of a plan to have additional attendings present in cases of emergencies such as a hemorrhage team. There was a lack of policies and procedures.

The committee determined that the following corrective actions were needed: initiation of team training; establishment of a transfusion protocol; policies to establish triggers to timely transfuse patients; and to begin simulation training to replicate maternal hemorrhage in a safe environment to promote communication, assess systems of care and ensure appropriate patient management.

How does this RCA and process relate to risk management and patient safety?

Part of the mission of ASHRM is to promote safe health care. The coordination of a search for the root causes as in this case serves to both improve patient safety and decrease risk to the hospital. When an adverse event occurs, there is a potential of a malpractice suit. In addition, the reputation of an organization may suffer. Maternal death can be publicized on social or other media and compromise the good reputation of the hospital. A lawsuit can result in either a settlement or verdict in favor of the patient in the sum of tens of millions of dollars. Insurance premiums can increase and self-insured or retained risk can result in a significant financial loss to an institution that was directed to capital improvements or salaries. By remediating the problems that surfaced by conducting the RCA, patient safety is improved and risk management decreases potential malpractice claims. Were there processes in place to prevent maternal death? What needs to be done to prevent a similar adverse event from occurring?

In The Doctors Company (TDC), Obstetrics and Gynecology: A Clinical Guide To Improving Patient Safety And Managing Risk, it was noted that 3.3% of obstetrics-related claims are due to postpartum hemorrhage.4 Their review of the cases and a deep analysis of each case identified the top factors that contributed to the patient injury in postpartum hemorrhage cases. By addressing the contributing factors, identified by the insurance carriers and risk management department, the service line can make changes to decrease adverse outcomes. If technical performance was found to be a top factor, then the department can have trainings, and have surgeons available such as a hemorrhage team to be available to assist quickly when hemorrhage occurs (Fig. 3).

FIGURE 3

FIGURE 3

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RISK ASSESSMENTS

Risk assessments are a process whereby a hospital, outpatient facility, or service line can be investigated and studied to identify the risks to an entity. A comprehensive assessment is performed to assess safety risks and exposure to an institution with respect to adverse outcomes and claims. These risks include patient safety issues that affect the care delivered, regulatory issues that may not be in accordance with state or federal laws, and potential malpractice suits that may result from processes or lack of a process when an adverse outcome occurs. Several insurance companies and their risk managers work closely with hospitals to decrease adverse outcomes to patients. Some hospitals request a risk assessment when several adverse events occur to determine how to improve the quality of care rendered. Some insurance companies include these assessments at intervals as a preventive measure to assess processes at different intervals.

How does an obstetrical risk assessment improve patient safety and decrease risk?

A typical risk assessment has 3 parts: previsit, onsite visit, and postvisit recommendations. The previsit includes a risk checklist including review of policies, procedures, and asking specific questions concerning how the staff interacts, education, and response to obstetrical emergencies. In addition, questions are asked regarding culture, adverse outcomes and procedures, coverage, etc. The site visit may be a 1 to 2 day visit with a team of surveyors—a risk manager, nurses, and a physician to interview various staff members, including attendings, anesthesiology, pediatrics, emergency department, and senior administrators. The purpose is to identify risk points and safety issues. The post‐visit conference call reviews the written report, which identifies the issues that were identified and provides recommendations to improve and eliminate the risks identified. With this independent review, the institution can make changes to improve patient safety and decrease potential claims.

The American College of Obstetricians and Gynecologist has instituted the Voluntary Review of Quality of Care (VRQC), which is a program instituted over 30 years ago to conduct risk assessments with meaningful analysis and recommendations (www.acog.org/AboutACOG/ACOG-Departments/VRQC-and-Scope/VRQC-Program-Overview).

These reviews address issues that are both clinical management and systems, amd leadership and communication issues. Issues such as poor documentation, poor physician performance, nursing staffing issues, and lack of policies and procedures are identified, and comprehensive recommendations reviewed.

The relationship between obstetrical care and risk management is in the desire for patient safety and identifying risk points that may compromise patient safety and increase malpractice suits.

The Michigan Professional Insurance Exchange (MPIE) a large medical liability insurance company in Michigan has long provided risk assessments for hospitals to identify risk to an organization and provide comprehensive reports to improve safety (www.mpie.org).

If several adverse outcomes occur in a specific hospital, the insurance company may request a risk assessment to identify risks that increase claims. A risk assessment can identify opportunities for improvement.

Professional liability companies have often engaged with insureds, both hospitals and practitioners, to identify risk areas. CRICO, the Harvard-based medical liability insurance company recently introduced Risk Appraisal and Plan (RAP), a patient safety risk assessment tool that identifies the vulnerabilities that exist in a specific service, system, or an entire organization. It is designed to provide institutions and/or their insurance company an understanding of both their strengths and vulnerabilities in the context of risk management and patient safety.5

The Alliance for the Innovation of Maternal Health (AIM) is a national alliance of several organizations to promote consistent and safe maternity care to reduce maternal morbidity and mortality. It is funded through the federal Maternal and Child Health Bureau. The process of improving patient safety is through the implementation of safety bundles including obstetrical hemorrhage, severe hypertension/preeclampsia, prevention of venous thromboembolism, and reduction of primary cesarean section. ASHRM is one of the partners with AIM with the goals of promoting patient safety, decreasing adverse outcomes, and a concomitant decrease in malpractice claims.

In 2012, ASHRM published a white paper entitled: Serious Safety Events: Getting to Zero. The paper stated that “a core value of healthcare delivery is to heal without causing harm.” A core competency for risk management and patient safety professionals consists of knowing how to prevent serious safety events, how to investigate them when they occur, and how to use the lessons learned for correction and future prevention.6

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Patient Safety Decreases Claims

The elimination of all avoidable harm is a mandate to all of us who care for pregnant women and their families. However, the initiation of safety processes, team training, improved staffing, fetal tracing courses, simulation trainings, and the initiation of safety bundles such as in hemorrhage, venous thromboembolism, and hemorrhage, cost money. I find it difficult to discuss the return of investment when the safe delivery of a baby and safe delivery of obstetrical care is compromised on the basis of lack of finances. However, administrators may need justification for increasing staffing or investing in expensive process improvement.

A sentinel paper correlating improvements in patient safety and decreasing liability payments to patients was published by Grunebaum et al7: “The Effect of a comprehensive obstetrical patient safety program on compensation payments and sentinel events” studied the effect of the implementation of the comprehensive patient safety program. The study reviewed the period of 2003 to 2009 when the patient safety program was first initiated. The insurance carrier MCIC Vermont collaborated with physicians at New York Weil Cornell Medical Center obstetrics/GYN department and a risk assessment by independent consultants was performed. Initiatives included labor and delivery team training, documentation, chain of command, protocols for induction of labor, safety drills, and attending coverage regulations. The average yearly compensation payments to plaintiffs decreased from $27,591,610 between 2003 and 2006 to $2,550,136 between 2007 and 2009, sentinel events decreased from 5 in 2000 to none in 2008 to 2009. The conclusion was that the initiation of several safety protocols into a comprehensive program resulted in improved patient safety and decreased claims and compensation to plaintiffs. Ultimately, this will result in a decrease in liability insurance costs and reinsurance rates from carriers as claims and litigation cost plummet. Although you cannot put a price on a life, there is clearly a decrease in claims, a decrease in cost, and marked decrease in sentinel events (Figs. 4, 5).

FIGURE 4

FIGURE 4

FIGURE 5

FIGURE 5

Northwell Health, formally North Shore LIJ Health system has 10 hospitals with obstetrical services. Hospital delivery volumes range from 350 to 9700 per year, for a total of 34,000 deliveries per year. An adverse outcome task force was initiated to improve patient safety and reduce adverse outcomes to maternity patients. The 2 service lines that began the initiative were obstetrics and the emergency department. The members of the task include senior leadership from quality, risk management, and obstetric service line. The purpose is similar to a risk assessment and is to identify opportunities to decrease harm. It is important to evaluate the effectiveness of safety initiatives by looking at adverse events and claims. The insurance carrier actuary is evaluating a decrease in claims as to adjust premiums similar to the Weil-Cornell initiatives.

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MALPRACTICE CLAIMS IN OBSTETRICS

A study by TDC, the nation’s largest physician-owned medical malpractice insurance company, reviewed 882 closed obstetrical claims from 2007 to 2014.8 Their data-driven approach enables TDC to anticipate emerging trends and deliver innovative patient safety tools to help our members reduce risk. TDC identified the 3 most common patient allegations in obstetrical claims: (1) delay in treatment of fetal distress (22%); (2) improper performance of vaginal delivery (20%); (3) improper management of pregnancy (17%).

By understanding the basis of the claims, it was further determined what the top factors contributing to patient injury are:

  • Selection and management of therapy
  • Patient assessment issues
  • Technical performance
  • Communication among providers
  • Patient factors
  • Insufficient or lack of documentation
  • Communication between patient/family and provider

Overall, the review of claims data gives insight into obstetrical practice potential and can lead to process development, improvement, and improved safety.

CRICO strategies publishes a benchmarking report evaluating obstetrics claims.9 The value of such a review of obstetrical claims is that risk gives us insight into safety events. What type of cases are obstetricians/gynecologists being sued for? What is the frequency of claims? What is the severity of claims? Overall, review of claims data, unasserted claims (incidents with the potential claim) trails live reporting but does give trends and insight into the type of safety events that trigger claims. The CRICO Comparative Benchmarking System (CBS) “enables participants to capture compelling snapshots of high risk preventable adverse outcome, identify their most significant vulnerabilities. This allows organizations to prioritize the application of patient safety funding to support key interventions.”9

The relationship between data and claims and comparative data will shed insight into system problems and allow development and result in decrease claims, decreased preventable errors, and decreased risk to an organization.

The Obstetrical Risk Management Playbook published by ASHRM is a major treatise that emphasizes the concept that patient safety and risk reduction have a strong relationship. The playbook covers the role of risk management in obstetrical care. Compared with the past, the goal in today’s obstetrical care delivery is to be more proactive with anticipation of potential risk and ultimately to avoid harm.10

Risk management pearls for obstetrics states that obstetrical malpractice claims continue to have a major financial impact on hospitals with maternity services. Improvements in teamwork, communication, and checklist simulation have all increased patient safety and quality.11

Although the majority of safety and risk management in obstetrics and gynecology service line is related to childbirth, gynecology also has issues. The majority of cases are puncture/perforation at the time of surgery, or diagnostic errors such as failure to diagnose ectopic pregnancy or breast cancer.

Although obstetrics remains a leader in both frequency and severity of malpractice claims, gynecology is also an area of adverse events and claims exposure. The failure to administer adequate and proper antibiotics leading to surgical site infections, readmissions, reoperations are all potential areas of both patient safety and risk for claims.

One area of patient safety that risk managers are involved in is the introduction of new techniques and surgical procedures. The introduction of laparoscopic surgery and more recently robotic surgery must be implemented with the medical staff, the service line, risk management, and quality. The delineation of privileges, and the establishment and maintenance of competencies are within the domain of the risk manager when new techniques are introduced. The safety of the patient and protection of the organization from adverse outcomes that can lead to claims and a poor reputation are all issues when new surgical approaches are introduced.

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TEAMSTEPPS

Communication problems in health care are considered to be a leading cause of medical errors and the root cause of many sentinel events. The introduction of TeamSTEPPS with a breaking down of hierarchy, increased teamwork, and improved communication has been advocated by quality and risk management disciplines as a way of establishing a culture of safety while decreasing patient injuries and decreasing claims.12

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Summary

The disciplines of obstetrics and gynecology, and risk management have changed dramatically over the past few decades. The Institute of Medicine’s To Err is Human: Building a Safer Health System in 1999 made us reflect on how we practice medicine and what changes must be made to increase patient safety.

Patient safety and risk reduction strategies are intertwined and all have the same goal—the safe delivery of the newborn and safe obstetrical care for the mother. Our goal will not be completed until preventable errors, both severe maternal and neonatal morbidity and mortality, are reduced to zero.

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References

1. Carroll R, Nakamura PLB. Risk Management Handbook for Healthcare Organizations, 6th ed. San Francisco, CA: Jossey Bass; 2011:1–19.
2. Youngberg BJ. Principles of Risk Management and Patient Safety. Ontario: Jones & Bartlett Learning; 2011:1–11.
3. GNYHA. GNYHA—Conducting Root Cause Analysis—A Resource Guide for Health Care Providers; Monograph; 2009:1–61.
4. The Doctors Company: Obstetrics and Gynecology—A Clinical Guide to Improving Patient Safety and Managing Risk; California; 2017:1–32.
5. CRICO Strategies. Available at: http://www.rmf.harvard.edu. Accessed November 22, 2018.
6. ASHRM. Serious Safety Events: Getting to Zero. 2012 white paper.
7. Grunebaum A, Chervenak F, Skupski D. Effect of a comprehensive obstetric patient safety program on compensation payments and sentinel events. Am J Obstet Gynecol. 2011;204:97–105.
8. The Doctors Company. Obstetrics Closed Claims Study: 1–4.
9. Annual Benchmarking Report Malpractice Claims in Obstetrics. CRICO Strategies; 2010. Available at: www.rmf.harvard.edu. Accessed August 3, 2018.
10. ASHRM. Obstetrical Risk Management Playbook. Connelly NA, Klein VR, et al. p9, 2017.
11. ASHRM. Risk Management Pearls for Obstetrics Part I, II. 2013.
12. Sheppard F, Williams M, Klein VR. Team STEPPS and patient safety in healthcare. J Healthc Risk Manag. 2013;32:5–10.
Keywords:

risk management; obstetrics and gynecology; patient safety

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