Legal Liability for HAIs: Understanding Infection Prevention's Role in Risk Management

Enhancing quality, promoting patient safety and ensuring value is the healthcare industry's current trifecta, but there are many more imperatives from a regulatory perspective, including shifting from volume-based to value-based reimbursement, enhancing transitions and reducing hospital readmissions, and improving patient satisfaction and engagement. In concert with these efforts comes the prevention of adverse events and infections. In today's environment of transparency and reform, understanding legal liability for healthcare-acquired infections (HAIs) is more critical than ever for infection preventionists as they assist their risk managers and patient safety officers with quality improvement initiatives.

By Kelly M. Pyrek

Enhancing quality, promoting patient safety and ensuring value is the healthcare industry's current trifecta, but there are many more imperatives from a regulatory perspective, including shifting from volume-based to value-based reimbursement, enhancing transitions and reducing hospital readmissions, and improving patient satisfaction and engagement. In concert with these efforts comes the prevention of adverse events and infections. In today's environment of transparency and reform, understanding legal liability for healthcare-acquired infections (HAIs) is more critical than ever for infection preventionists as they assist their risk managers and patient safety officers with quality improvement initiatives.

Goguen (2015) reminds us that failure to follow evidence-based practices can amount to medical negligence, and outlines three risk factors for acquiring an infection:
1. Patient Risk Factors: These include the duration of the patient's stay in a clinical setting, the severity of the illness or injury for which the patient was admitted, and the function and capacity of their immune system during their visit.
2. Organizational Risk Factors: These include the cleanliness of the hospital and treatment setting in general, including the filtration of the HVAC system, concentration of patient beds, cleanliness of water systems, cleanliness of building surfaces, and sterility of medical devices.
3. Iatrogenic Risk Factors: These include the care with which the doctors, hospital staff, nurses and other care providers perform. This includes the frequency with which hands are washed, use of antibiotics, and especially care used during invasive procedures such as intravenous administration of medication, intubation, and urine catheterization.

As Goguen (2015) notes, "Because it's so difficult to show exactly how the infection was transmitted -- only that it occurred while in treatment -- the hospital itself is the most likely to be held responsible … Determining liability for injuries or death resulting from HAI and sepsis can be very challenging from a legal perspective, and requires an investigation into the specific circumstances of how the infection was acquired, why it was not promptly treated, and whether it could or should have been prevented. Where hospitals are involved, it isn't always clear who is liable for the patient's infection, and if a doctor seems to be the one responsible, the hospital may not be on the legal hook if the doctor was actually an independent contractor as opposed to an employee. In order to bring a successful lawsuit for damages resulting from HAI and sepsis, the defendant's liability will need to be established, usually by a qualified expert medical witness (a neutral third party medical doctor) who examines the treatment situation and determines if there was compliance with the appropriate medical standard of care at every turn. If it is found that the infection was preventable, and that it occurred due to the negligence of a medical professional, then a lawsuit has a good chance of success. The patient can bring a medical malpractice lawsuit within a short time frame, or, in the worst case scenario, family members can sue the hospital for wrongful death."

Brigid Sheridan, RN, JD, associate general counsel and director of legal accounts for University Health System in San Antonio, Texas, explains that in general, for a person to bring a cause of action against another, the plaintiff must have an interest that is protected by law; must show the defendant had a legal duty to act; must prove the defendant breached the duty to act; must show injury or damage to the protected interest; and must prove that the defendant’s breach of duty caused the injury.

As author of the Legal Issues chapter of the APIC Text, Sheridan says that initially, the burden of proof rests with the plaintiff: "The plaintiff’s case must establish a burden of proof by a preponderance of the evidence. If the plaintiff succeeds in establishing proof, the burden of proof shifts to the defendant. If the plaintiff establishes liability, the plaintiff must then prove damages. In some cases, the court may decide there are no material fact issues and that the required elements of the cause of action do not exist or that a legal defense exists. In these cases, the court grants summary judgment in favor of the prevailing party without a trial."

Franchesca Charney, RN, MS, CPHRM, CPHQ, CPPS, CPSO, FASHRM, director of risk management for the American Association of Healthcare Risk Management (ASHRM), notes that "Infections occur for many, many reasons, but if someone sues a hospital or clinician as a result of acquiring an infection, then they are suing because they believe there was malpractice."

Sheridan says that HAI-related litigation is separate from medical malpractice "because it is geared more toward the healthcare institution than the actual physician, and so it is more of a civil, wrongful tort action that would be primarily aimed against the hospital," she says.

According to the APIC Text, "Medical malpractice is legally defined as professional negligence by act or omission by a healthcare provider in which the treatment provided falls below the accepted standard of practice in the medical community and causes harm to the patient. Physicians generally obtain professional liability insurances to offset the risk and costs of lawsuits based on medical malpractice. Other healthcare providers can also procure their own professional liability insurance but most do not because of the high cost of the insurance coverage and rely solely upon the general liability coverage provided by their employer. The medical malpractice cases filed in the in the legal system generally seek large amounts of monetary compensation, and no matter how small or large the claim, the cost of defending the claim impacts health care professionals and the healthcare organization involved. Large monetary awards in medical malpractice cases that proceed to a jury trial receive notoriety that in turn encourage the filing of medical malpractice claims by others, thus perpetuating the cycle of litigation that impacts the cost of delivery of healthcare and threatens the overall accessibility, affordability, and quality of healthcare in this country."
Sheridan says that an individual acts negligently if he or she departs from the conduct expected of a reasonably prudent person acting under similar circumstances. Departure from reasonable conduct may take the form of an omission or commission of an act. Omission of an act includes failing to administer medications; failing to order diagnostic tests; or failing to follow up on abnormal test results. Commission may include administering the wrong medication to a patient; administering medication to the wrong patient; or performing a surgical procedure without patient or family consent.

According to Sheridan, for a plaintiff to recover damages resulting from a negligent act, the plaintiff must address the following four elements.
1. Duty: an obligation to conform to a recognized standard of care.
2. Breach of duty: a deviation from the recognized standard of care.
3. Causation: an act or conduct departing from the recognized standard of care that caused injury.
4. Injury: the result of the deviation from the recognized standard of care

As Sheridan writes, "To illustrate negligence, consider an example of a patient who acquires an infection during his or her hospital stay. The patient must establish: He or she contracted an infection in the hospital; the hospital, through an act of negligence, breached its duty to the patient and did not follow a policy or procedure to prevent the infection; the hospital’s negligence caused the infection; the patient’s condition worsened because of the infection. The test for negligence in this example rests on whether the hospital care or lack of care caused the infection and whether the hospital and the personnel working with the patient acted in a reasonable and prudent manner to recognize, report and try to control the infection."
Going to the heart of the matter is if and how healthcare institutions have followed practice parameters, Sheridan explains. These practice parameters are medical guidelines that encompass a broad range of strategies designed to assist practitioners in the clinical decision-making process. Sheridan says they are standardized specifications for care developed through a formal process that incorporates the best scientific evidence of effectiveness with expert opinion. Medical professionals in specific areas set these guidelines in order to advise colleagues of the recommended standard of care to use in a given situation. Practice parameters also help healthcare facilities to meet national quality indicators, as they often include strategies to meet these indicators.

Sheridan warns that practice parameters are not absolute rules of conduct. "Because compliance is voluntary, most practice parameters include incentives for physicians, healthcare institutions, and healthcare workers. Incentives may include full reimbursement for care, reduced length of stay in a hospital, national recognition from accreditation associations, higher patient satisfaction, lower risk management premiums, and fewer survey enforcement activities from state and federal regulators," she writes in the APIC Text. "Such incentives help shape the conduct of physicians, institutions, and other healthcare workers, thereby improving patient care, patient outcomes, and quality of life."

Sheridan emphasizes that although healthcare institutions have a duty to protect patients from injury due to infections, courts never maintain that organizations guarantee that patients will not acquire an infection while in the institution. However, organizations must realize that the potential of liability exists if a patient’s infection results from negligence of its physicians or employees.

As Sheridan explains in the APIC Text, "To determine a standard of care, organizations must monitor patient outcomes. At a minimum, monitoring includes conducting quality assurance activities such as performing infection surveillance; reviewing and revising infection prevention policies and procedures; providing in-service training sessions for staff about appropriate infection prevention practices; and adhering to the National Patient Safety Goals (NPSGs). Two NPSGs that relate to infection prevention include compliance with the hand hygiene guidelines and managing identified cases of unexpected death or major permanent loss of function associated with HAIs as a sentinel event. If a patient establishes that he or she acquired an infection at a hospital, the hospital may have to prove infection prevention policies and practices were in place and that the physician and staff took immediate and appropriate interventions to treat and minimize the patient’s infection. To ensure that the hospital meets its standard of care, the hospital should continuously evaluate how staff use aseptic technique and follow infection prevention procedures. Organizations should monitor with consistency through direct observation of staff performance to validate proper compliance. The organization should make sure that all members of the healthcare team follow state and federal infection prevention regulations, accreditation standards, and practices and procedures. In addition to staff compliance with infection prevention practices, organizations should establish clear, useful internal practice manuals that are readily available to all staff members."

A study that sampled populations in the UK, Germany, France, the Netherlands and the U.S., found that most likely to sue following a serious Hai were French patients, followed by those in Germany and the UK. In the U.S., the report said, the propensity to sue was lower than in the UK and Europe, possibly because state support for plaintiffs is less, and only one-quarter of cases end up in the plaintiff's favor, according to the U.S. Bureau of Justice.

A Google search yields instances of plaintiffs successfully suing hospitals and healthcare systems due to failure to diagnose and/or treat hospital-acquired infections. For example, a Dallas jury in 2009 awarded an amputee $17.5 million in a high-profile MRSA case (later reduced to $7.5 million under Texas damages cap ruling).

As Kennerly (2012) confirms, "Whenever you find someone winning a nosocomial infection case, it turns out to be a case involving the failure to properly diagnose and treat the infection, rather than causing the infection in the first place. In the end you find some unique factual situations - like a treating surgeon testifying quite clearly that MRSA had to originate from within the spine (and thus a contaminated instrument rather than from the skin) - and generally conclude that 'The key to increasing the likelihood of success in such cases is obtaining concrete evidence on the possible sources of infection coupled with an expert witness with sufficient skill to examine that evidence.' [Robert Steinbuch, Dirty Business: Legal Prophylaxis for Nosocomial Infections, 97 Ky. L.J. 505, 512 (2009)]."

Kennerly (2012) points out that, "Hospital-acquired infections are a serious and shockingly commonplace matter, causing somewhere around $30 billion in direct medical costs annually - ten times the entire cost of our malpractice liability system - and so every medical malpractice law firm has its fair share of potential clients calling us up to ask what can be done after a severe MRSA or C. difficile infection … we look both for negligence in causing the infection and in diagnosing and treating it, but the former often stalls out at the lack of ironclad evidence that courts these days demand of medical malpractice plaintiffs."
HAI-related litigation notwithstanding, Sheridan says that the bigger challenge is patients and other whistleblowers reporting healthcare institutions to the accreditation bodies such as the Joint Commission or to the Centers for Medicare and Medicaid Services (CMS) directly, "because it is the sanctions from CMS that are pretty significant now," she emphasizes. "What we are seeing is an increase in people making complaints because they have figured out that it really doesn't cost them any money to make that complaint to CMS or to the Joint Commission, or to a state's health services department." She adds, "I think people are also afraid of the CMS rules and Joint Commission regulations. If they are going to get cited by Joint Commission, the institution could lose its accreditation or its licensure with the state, or in the worst-case scenario, CMS could ban you from the Medicare program, and that can be financially devastating for any institution. It's not just the litigation fear but it's also the regulatory issues at stake."

This leaves hospitals and other healthcare facilities vulnerable, and they must balance life-saving responsibilities to patients, with risk management strategies to save their profits and their reputations.

"I think hospitals are bending over backwards, trying to cooperate and trying to be transparent, to show that they are cooperating and they are sharing their infection and adverse event data," Sheridan says. "The double-edged sword that comes from that is you put all that data out there and the consumer, through malevolence or through wanting revenge -- thinks, 'How can I use and manipulate this data to support my position and what happened to me. One of the things that comes with transparency is you are putting it out there but you better be able to defend it as well."

In an era of public reporting, transparency may lend itself to either staving off or encouraging HAI-related litigation, depending on the intent of the individual using the data.

"We encourage patients to use publicly reported information to talk to their physicians, nurses and other caregivers about the course of their treatment and any concerns they may have, including what steps they can take to reduce the chance they will get an infection," Charney says.

Hospitals are seemingly on the defense at all times. "It starts from the very get-go in the emergency room," says Sheridan. "It's sort of damned-if-you-do and damned-if-you-don’t scenario. For example, in the case of an automobile accident, if you test patients that have been involved in that wreck -- are you going to be the doctor sitting on the witness stand later in court and asked, 'Why didn’t you do this test?' versus the auto insurance company saying 'You did too many tests and we are not going to pay you.' So it's which seat do you want to be in? Even from an infection control perspective, you can find yourself in a situation where you could be asked, 'Why didn't you test the products that your housekeepers were using?' Or 'Are you part of the decision-making and purchasing and what kind of guidelines do you have out there about what your housekeeping staff should be buying?' Or 'If you're not part of the decision-making process, why aren't you?' Hospitals must constantly consider all aspects of potential liability."

Some infection preventionists (IPs) are finding themselves to be part of their institution's risk management strategy, with key roles in enforcement of the aforementioned practice parameters and quality measures. 

"Infection preventionists are being used by hospitals as safeguards for compliance and being recognized as doing the right thing by patients," Sheridan says. "Organizations are also hiring them to come in as consultants to review processes that are in place, to review practices and provide recommendations for improvement. By doing so, healthcare institutions are being much more proactive in trying to prevent potential litigation. Examining your policies is also very important -- do they reflect best practices in the institution, and what are your processes for educating personnel about your standards? And how are you determining competency in implementing those processes? Those are big issues, and the attorneys are looking at them from a litigation standpoint -- that's why more and more organizations are adopting risk management strategies to prevent the litigation in the first place. HAIs have forced hospitals to hold themselves accountable."

Sheridan writes that infection preventionists must ensure that "the organization and its employees follow established standards of care to protect employees, patients, and patients’ family members from exposure to infection and to maintain an environment of safety and protection from injury. In order to do so, infection preventionists must ensure: accurate and complete documentation reflects the care provided; organizations implement and monitor compliance with National Patient Safety Goals; organizations maintain patient and employee confidentiality; institutions develop clear policies and systems to control and prevent the spread of infection from healthcare personnel to patient and vice versa, and to the community; and that the infection prevention department works in concert with the risk management and quality assurance departments.

Sheridan says, "The take-home message for infection preventionists -- sometimes they are the bad guys and sometimes departments and administrators don't want to hear what they have to say but they have to move forward and know they are doing the right thing in serving the public and the institution and they did speak up and there wouldn't be that accountability -- so even on their worst days they need to remember that they are trying to do the right thing so don't take it personally when an administrator says you want me to spend how much on what?"

Tort reforms and patient safety initiatives are working to curb some potential litigation. 

"Patient safety initiatives focused on reducing the incidence of health care-associated infections certainly have had an impact," says Charney. "We have seen laudable reductions in some dangerous types of infection, but the truth is that we can never let up on our efforts to prevent infections. Hospitals are also focused on patient engagement, ensuring patients feel they are at the center of their care and are receiving information they need to make choices about their care."

Interestingly, analysis of value-based purchasing, healthcare-acquired conditions, and readmission quality measures seems to indicate that quality metrics do not play a significant role as determinants of a healthcare institution's professional liability loss costs or claim frequency. As the Aon/ASHRM Hospital and Physician Professional Liability Benchmark Analysis report (2015) observes, "A review of Google data suggests that public interest in medical malpractice seems to be on a significant downward trend since 2005. This trend is similar to claim frequency and cost of risk trends over the same time period. The seemingly parallel nature of these trends indicates that societal trends and tendencies are the dominant force in driving professional liability claim levels."

Additionally, a review of patient satisfaction scores using survey results from HCAHPS, presents a statistical relationship to claim frequency. According to the Aon/ASHRM report (2015), "Healthcare organizations having lower patient satisfaction results tend to have a higher frequency of professional liability claims. This finding supports the theory that patient relationships and perceptions are important drivers of professional liability claim activity, perhaps more than the clinical quality of care."         

There are steps hospitals can take to mitigate their legal risks without compromising patient and healthcare worker interests and wellbeing. 

"For hospitals and healthcare risk managers, keeping our patients and workers safe is the most effective way we know of mitigating risk," Charney says. "Our interests and those of our patients and workers are aligned. Not all infections are preventable – even with the standard of care being met there are circumstance where an infection will present. But infection rates have decreased in a number of areas. The risk manager should be working with the entire healthcare team including the infection preventionists, to eliminate infections whenever possible.  Working collaboratively on issues such as handwashing and antibiotic stewardship, as well as conducting root cause analysis and using risk management data together with infection control data can improve patient care.  Infection control is not the work of one person but it is work of the entire healthcare team."

Risk management functions encompass activities that are intended to conserve financial resources from loss. Sheridan says that an effective risk management program must involve a risk assessment of the buildings, grounds, equipment, occupants, and internal systems plus policies and procedures for the timely reporting and resolution of situations that pose an immediate threat to life, health or property. According to the APIC Text, a risk management program includes the following components of risk identification, risk analysis, risk control and risk financing:
• Reducing financial losses through effective investigation and management of claims.
• Developing a patient representative program.
• Reviewing and coordinating insurance programs.
• Inspecting the premises and discovering deficiencies in the physical plant.
• Reviewing policies and procedures to reflect acceptable quality of care.
• Investigating adverse incidents and reviewing incident reports.
• Reviewing patient grievances.
• Conducting educational programs to minimize future risks.
• Conducting root cause analysis to determine what contributes to an adverse event.

Sheridan says the healthcare institution's risk manager must work closely with the IP to identify, monitor and control HAIs. "A facility should adopt a team approach to control the spread of disease and prevent further outbreaks. Both risk management and the IP can handle matters such as noncompliance with infection prevention procedures, breaks in sterile technique, or equipment contamination," she says. The IP should inform the risk manager of incidents such as preventable infections, infections that could lead to a malpractice claim, and infections that attribute to the death of a patient.        

Hospital professional liability is a constantly moving target. In a recent report, CNA -- a commercial insurance writer as well as a property and casualty company -- examined professional liability claims that closed over the 10-year period from Jan. 1, 2005, through Dec. 31, 2014. According to actuarial projections, the frequency of claims has remained fairly constant, based upon all claims incurring indemnity and/or expense payments in CNA's primary hospital program. The report shows that indemnity and expense payments have fluctuated over time, with the ultimate severity of indemnity payments trending upward between 2005 and 2014, from an average of approximately $87,000 to $136,000.
The report's 591 closed professional liability claims incurred an average total paid amount of $250,970, and most of the claims occurred on an inpatient medical unit, in the emergency department, or in surgical or other invasive procedure areas. The most frequent allegations were related to treatment and care as opposed to assessment, monitoring or governance. The report noted the need for increased attention to issues of communication, credentialing and privileging, medication safety, patient falls and hospital-acquired pressure ulcers.

According to the CNA report (2014), for an infection, the average paid expense was $42,585 and the average paid indemnity was $139,338, for a total of $181,923. Permanent injury was the most common outcome, at 41.1 percent of all claims and an average total paid of $271,401, while death had the highest average total paid at $320,975. Infection and/or sepsis was responsible for 16.7 percent of deaths, according to the CNA report.

The CNA report (2014) provides information on 31 closed claims related to pressure ulcers, with an average total paid of $191,632.Most of these claims occurred on inpatient general medical and surgical units, and in more than 80 percent of pressure ulcer claims, the patient's outcome was permanent harm (38.7 percent) or death (41.9 percent). Temporary injury occurred in 19.4 percent of pressure ulcer claims.

"The healthcare industry is undergoing a dramatic transformation, as incentives shift and transparency increases," says Ron Stegeman, vice president of healthcare at CNA. "Paying attention to the details means that patient services are more likely to reflect processes that are foundational to high quality and safe patient care."

The Aon/ASHRM Hospital and Physician Professional Liability Benchmark Analysis report (2015) updates the outlook for hospital professional liability claims, which show a moderate decreasing trend of 1 percent annually. However, claim severity, including defense costs, if growing at a 2 percent annual rate. For the upcoming 2016 accident year, the Aon/ASHRM report (2015) projects that hospitals will experience an annual loss rate of $2,800 per occupied bed equivalent and $5,130 per Class 1 employed physician for professional liability events.

The CNA report (2014) notes that fundamental processes, such as establishing policies and procedures, training employees and reviewing staff competencies, were not always followed in the hospitals that experienced professional liability claims. As the CNA report indicates, "Many organizations continue to find it a challenge not only to develop and implement effective protocols, but also to create a culture of safety." The CNA report offers five principles that can help healthcare organizations provide safe, consistently high-quality care:
1. Sensitivity to operations: Leadership, management and staff at high-reliability organizations (HROs) are mindful of the systems in place, as well as the situation, environment and issues that can affect patient care.
2. Reluctance to simplify: HRO leaders and staff refuse to accept simplistic explanations for failures; rather, they acknowledge complexity and consider the full range of possible reasons for error.
3.  Preoccupation with anticipating and avoiding failure: HROs focus on identifying and eliminating potential failures, not simply reacting to them. For example, near-miss events are perceived as opportunities to identify system vulnerabilities and make improvements rather than taking refuge in the idea that the system worked.
4. Deference to expertise: HROs foster a culture where leadership and staff defer to the individual with the most knowledge, regardless of rank.
5. Resilience: HROs adopt and implement procedures and systems to facilitate continued functioning even under unexpected situations.

When it comes to healthcare professionals' liability, the 2014 Aon Risk Solutions/American Society of Healthcare Risk Management (ASHRM) Hospital and Physician Professional Liability Benchmark report, personnel continued to experience relatively flat medical malpractice costs.

“Although overall cost levels appear to be calm, these seemingly still waters hide a system of swirling undercurrents,” says Erik Johnson, leader of the healthcare practice group with Aon’s Actuarial & Analytics Practice. “Proactive organizations are using data, analytics and business intelligence to reduce costs and strengthen risk management in this stable environment."

The 2014 report findings include:
- Projected loss rate for hospital professional liability is $2,870 per occupied bed equivalent for events occurring in 2015. The frequency of claims is projected to be 1.69 percent per OBE and the severity of claims is expected to be $170,000 per claim.
- Projected loss rate for physician professional liability is $6,230 per class 1 (internal medicine) physician for events occurring in 2015. The frequency of claims is projected to be 3.37 percent per class 1 physician and severity of claims is expected to be $185,000 per claim.
- Projected loss rate for hospital general liability is $125 per OBE; the average general liability claim is expected to be $38,000 for claims occurring in 2015.

The Aon/ASHRM Hospital and Physician Professional Liability Benchmark database includes claims from all U.S. states and provides specific benchmarks for 27 states as well as the District of Columbia. Florida ($7,920) has the highest projected loss rates for 2015; Indiana, ($800) and Minnesota ($770) have the lowest projected loss rates for 2015. In California, Aon estimated that the passage of Proposition 46, an increase in the Medical Injury Compensation Reform Act’s non-economic damage caps, would result in an increase in medical malpractice costs of 15percent to 35 percent.

Nurses' malpractice claims have increased over the last five years, according to a new report from the Nurses Service Organization (NSO), a division of Aon Affinity, the affinity business of Aon plc and CNA.  The report, "Nurse Professional Liability Exposures: 2015 Claim Report Update," says that claim costs are on the rise, with an average paid indemnity (settlements and court judgments) increasing from $151,053 in 2007, to $161,501 in 2010, to $164,586 in 2015. Medical/surgical nurses are the most frequently sued specialty, with nurse specialists experiencing the most frequent malpractice claims work in adult medical/surgical (36.1 percent), aging services (16.4 percent) and home health/hospice (12.4 percent). The majority of nurses’ malpractice claims involve death of a patient.  Forty-four percent of medical malpractice lawsuits against nurses involve the death of a patient when death was not an expected outcome of the disease or injury process, resulting in an average claim payment of $144,618.  Of these claims, 25.5 percent were due to cardiopulmonary arrest, 13.6 percent were due to pressure ulcers and 11.9 percent were due to bleeding/hemorrhage. According to the report, the most frequent malpractice allegation against nurses: treatment/care. Allegations related to treatment and care continue to represent the highest percentage (45.9 percent) of all malpractice allegations that nurses experience. Improper assessment reflects the second most frequent, representing 15.7 percent of allegations.


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