There are several different types of hospital regulation. All hospitals in the United States are subject to state licensure requirements (8). Hospitals seeking reimbursement from the Medicare and Medicaid programs must also meet standards established under federal and state laws (8,9). Important standards also are established by public health authorities, such as the Centers for Disease Control and Prevention (CDC) and the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) (6,10), and by private accrediting groups, such as the Joint Commission (formerly the Joint Commission on the Accreditation of Healthcare Organizations) (11,12).

Hospital licensure statutes are designed to protect patients. These statutes generally require that hospitals reduce the risks of infection to patients, staff, or others by maintaining appropriate equipment, employing persons with specialized training, and implementing mechanisms to reduce the risk of infection. The Florida statute provides, for example, that hospital regulators must adopt “reasonable and fair minimum standards for ensuring that hospitals implement “[i]nfection control, housekeeping, sanitary conditions, and medical record procedures that will adequately protect patient care and safety” (13).

The guidelines of public health entities such as the CDC and HICPAC are important even though they may not be incorporated into a specific statute or regulation, because they might be used, explicitly or implicitly, by licensing authorities or others (10). The Joint Commission’s hospital accreditation requirements are incorporated into many state licensure statutes (14) and the federal Medicare and Medicaid regulations (15). The end result is that hospitals are subject to specific performance-based standards designed to ensure that they monitor and reduce the risk of infection. The CDC’s National Healthcare Safety Network also creates the opportunity for studying the results of hospital infection control policies (16).

These general infection control standards are supplemented by more specific requirements for some diseases. The special rules governing HIV and hepatitis B virus (HBV) are particularly important. Several states have enacted statutes designed to protect hospital patients from HIV or HBV infection (17). Under federal law, states generally must implement the CDC’s recommendations to reduce the risk of HIV or HBV transmission from healthcare workers to patients (18). The CDC’s 1991 recommendations require healthcare workers who perform “exposureprone procedures” to know their HIV and HBV status and to refrain from engaging in those procedures without the consent of an expert review panel (19). Depending on state law, hospitals may have a role in implementing these recommendations by defining which procedures are exposure-prone or through establishing expert review panels that can advise HIV- or HBV-infected practitioners (19,20). It has been difficult for hospitals to implement these regulations in the absence of consensus about either the degree of actual risk posed by HIV-infected healthcare workers or the identification of exposure-prone procedures (18,21).

A hospital’s compliance with government regulations, public health guidelines, and private accreditation requirements can be very important in three respects. First, hospitals that fail to meet these requirements risk suspension of licensure, the imposition of civil fines, and the attendant bad publicity. Second, hospitals without effective infection control policies might lose eligibility for Medicare reimbursement, an important source of revenue. Third, a hospital’s failure to comply with these public or private regulatory schemes increases the risk of tort liability. Injured patients will be able to claim that a hospital’s violation of a particular statutory or regulatory requirement is evidence that the hospital was negligent in providing for the welfare of its patients.

The Deficit Reduction Act of 2005 resulted in significant changes to Medicare reimbursement policies with respect to HAI. The Act required the U.S. Secretary of Health and Human Services to identify certain HAIs that create higher Medicare costs and “could reasonably have been prevented by evidence-based guidelines” (22). Hospitals are denied Medicare reimbursement for care associated with these infections in many circumstances as of October 2008. The effort to use the financial incentive of nonpayment to encourage hospitals to act to reduce infections has its critics (23,24 and 25). For example, critics argue that the rule places an undue burden on hospitals by refusing to pay for conditions that are not preventable (24,25).

Hospitals and healthcare professionals are increasingly concerned about tort liability. The charitable or governmental immunity doctrines that long protected hospitals from lawsuits have crumbled over the past 50 years (26,27). The tort system requires a defendant to compensate a plaintiff when the plaintiff can show that the defendant’s negligence caused the plaintiff’s injury (28). Negligence is a legal term meaning that a defendant failed to exercise the degree of care owed to the plaintiff (28). Generally, individuals or institutions have the duty to exercise reasonable care (28). In the healthcare context, hospitals are often required to observe the standard of care that would reasonably be exercised by other hospitals under similar circumstances (28). Statutes, regulations, or accreditation requirements can be used to define a hospital’s required standard of care (29). There are several different types of hospital liability (28,30). Hospitals are generally held liable for the negligent acts of hospital employees under the doctrine of respondeat superior (28). Hospitals also are directly liable for institutional negligence, such as for failing to have equipment necessary to prevent HAI or for failing to establish policies or procedures designed to reduce the risk of infection. Matters are complicated somewhat by the fact that hospital patients are often treated by private physicians who are not hospital employees. A hospital generally will not be held liable for the negligence of a private physician so long as it is clear to patients that the physician is not a hospital employee (28). However, the hospital can be held liable if its employees knew or should have known of the risk of infection and failed to take appropriate action, even if the patient is also under the care of a private physician.²

There are four elements to a patient’s tort claim against a healthcare professional or hospital. The plaintiff must show that the defendant owed her or him a duty to provide a particular standard of care, that the defendant failed to meet the required standard of care (negligence), that the breach of the standard of care caused the plaintiff’s injury, and that the plaintiff’s injury is of a type that deserves compensation (28). The plaintiff must prove these four elements by a preponderance of the evidence.

The first element has two parts: The hospital must have a duty to the plaintiff to provide a particular standard of care. In general, a hospital has a duty to protect persons who are foreseeably at risk for harm from the hospital’s conduct. This is a relatively easy element for plaintiffs to prove. Patients are under the care and control of the hospital, and it is foreseeable that the hospital’s failure to take care in the provision of its services could cause its patients harm. A hospital’s duty to protect its patients from infection also arises from the statutes, regulations, and standards discussed previously. Hospitals clearly have a duty to protect patients from the risk of infection (29, 30 and 31). Hospitals have an additional duty to protect nonpatients who are the foreseeable victims of hospital negligence. A hospital may in some circumstances be held liable, for example, for injuries sustained by the family members or visitors of infected patients who are foreseeably exposed to infection (30,31 and 32,33).

However, the issue of a hospital’s duty is not always clear, particularly when family members and friends of a patient are involved. Courts sometimes hold, for example, that hospitals do not owe a duty of care to nonpatient family and friends who visit the patient or who provide care for the patient (34,35,36 and 37).

The second part of the first element requires plaintiffs to establish the hospital’s required standard of care. For hospitals, the standard of care is measured by what other hospitals would do under like or similar circumstances. Sometimes the standard of care can be determined by examining the relevant statutes or regulations. In Ford v Saint Francis Hospital, Inc. (38), for example, a patient who contracted staphylococcal infection of his aortic valve while hospitalized for heart surgery alleged that the defendant hospital was negligent per se, because it was violating federal regulations governing infection control. The hospital was able to defend the action by showing that it had passed a state agency’s surprise inspection shortly before the surgery took place.

Plaintiffs and defendants might also rely on the guidelines issued by public health authorities, such as the CDC and the HICPAC, to establish the standard of care. Both sides may also present testimony about the customary practices of other hospitals as a method of establishing the required standard of care (29). The testimony of medical experts generally is used to establish the standard of care against which the hospital’s conduct will be measured (28,29). Newly emerging threats, such as the threat of bioterrorism, may complicate the situation because healthcare institutions and physicians must rapidly identify and implement a newly emerging standard of care (39).

The second element of the plaintiff’s cause of action requires proof that the defendant breached the standard of care. This is often a difficult task for the plaintiff who may not be able to present evidence showing, for example, that a particular hospital employee failed to use the sterile technique required by the standard of care. Courts sometimes use the legal doctrine of res ipsa loquitur (the thing speaks for itself) to assist plaintiffs who cannot identify the specific act of negligence committed by the defendant (28). Under res ipsa loquitur, the jury might be permitted to presume the existence of a breach of the standard of care under some circumstances, such as where the patient’s infection is rare and difficult to acquire in the absence of negligence (28). Courts have rejected the application of res ipsa loquitur and have required plaintiffs to prove a breach of the standard of care in cases alleging injury from some common types of infections because the inference that hospital negligence caused the infection is no longer justified (40,41,42 and 43).

The first two elements of a negligence claim, therefore, require the plaintiff to prove that the defendant hospital breached a duty it owed to the plaintiff to provide a particular standard of care. There have been a number of cases analyzing a hospital’s duty to protect its patients or visitors from infection; several examples can be used to illustrate how the first two legal elements apply in the typical hospital setting.

The first example involves the scope of a hospital’s duty to exercise care in selecting and assigning staff. In Taaje v St. Olaf Hospital (44), the court held a hospital liable for an infant’s death from TB based on a nursing supervisor’s failure to “exercise due care to see that her nurses were free from communicable disease.” Despite this decision, hospitals do not have an absolute continuing duty to screen all employees for all communicable diseases. The hospital’s duty to screen—the standard of care governing screening—is established by medical knowledge and community practice at the time the patient received care. In one 1962 case, for example, the court refused to find a hospital liable for the transmission of Staphylococcus aureus, in part, because the standard of care did not require employee screening during the relevant time period (41).

The debate about hospital duties to screen and select employees currently is focused on the risks presented by HIV- or HBV-infected healthcare workers. As noted previously, hospitals are required to follow the CDC’s 1991 HIV- and HBV-infected healthcare worker guidelines (18,19). These guidelines impose the duty on healthcare workers to know their own HIV and HBV status rather than requiring hospitals to screen healthcare workers (19). Could a hospital avoid liability altogether by implementing even stricter restrictions on the continued practice of HIV- or HBV-infected healthcare workers? The answer is no. Healthcare workers infected with contagious diseases are considered persons with disabilities who are protected by federal and state laws prohibiting discrimination based on disability. Hospitals may only discriminate against an infected healthcare worker when the worker presents a significant risk to the health or safety of others, such as that identified in the CDC guidelines (45). Workers who
present minute or insignificant risks are protected from discrimination (46).

The second example of litigation about the standard of care involves hospital decisions regarding the acquisition and maintenance of equipment and facilities. In Bush v Board of Managers of Binghamton City Hospital (47), the plaintiff claimed that his wife had died from diphtheria acquired in the course of her hospital stay. The court held that the hospital defendant could not be held liable for the woman’s death, in part because the evidence indicated that its facilities were “suitable, adequate, and safe for the purposes in the manner used; that the means of sterilization and disinfecting employed were safe and adequate; and that the rooms were surgically clean” (47).

The third type of standard of care litigation involves disputes over the adequacy of hospital policies designed to identify and respond to the presence of infection. In Helman v Sacred Heart Hospital (48), the plaintiff claimed that he had acquired a staphylococcal infection from his hospital roommate. The plaintiff presented evidence on the required standard of care, including the existence of “hospital … rules … requiring isolation of all patients known to be infected with staphylococci and requiring all medical personnel to report open sores, boils and pimples, which emitted purulent drainage, among both patients and hospital personnel” (48). The plaintiff also presented evidence that hospital employees had breached this standard of care by failing to “observe the sterile techniques prescribed by the hospital in cases where infection is suspected; they [also] did not wash their hands or leave the room between administering to the patients, even after the plaintiff’s roommate experienced a boil with purulent drainage” (48). The plaintiff, thus, presented evidence defining the required standard of care and demonstrated that the defendant had violated this standard of conduct.

In other cases, however, defendants have avoided liability by showing that hospital personnel followed standard practice in caring for a patient (49). In Roark v St. Paul Fire & Marine Ins. Co. (31), the plaintiff claimed that he had acquired a staphylococcal infection because of the negligence of the Glenwood Hospital. The defendant was able to avoid liability because:

Similar results have been achieved in transfusionrelated HIV transmission cases; most jurisdictions have shielded hospitals from liability so long as the hospital blood banking organization followed the standard of care in effect at the time the transfusion took place (50,51,52).

The degree of care required may vary with the type of patient. A hospital has a heightened duty to protect patients who it knows are particularly vulnerable to infection. In Kapuschinsky v United States (53), for example, the hospital was held to a greater duty to exercise care because premature infants were particularly susceptible to infection. Hospitals generally have a heightened duty to protect immunocompromised patients.

The discussion of tort liability thus far has focused on the first two elements of the plaintiff’s claim: establishing that the hospital has breached a required standard of care. The third element of a plaintiff’s case is causation. The plaintiff must show that the defendant’s negligence was the actual and legal cause of the plaintiff’s injury (28). The causation requirement is another source of protection for hospital defendants and another source of problems for plaintiffs. Common infections, such as those resulting from staphylococci, present particular difficulties of proof for plaintiffs because there are multiple possible sources of infection (54). Medical tests designed to determine the source of infection are extremely important. In the early 1990s, researchers relied on a genetic analysis of HIV in determining that dentist David Acer was the source of HIV infection for five of his patients (55). Other techniques, such as contact tracing, historically have been used to identify possible sources of other HAIs (56).

Causation can also be difficult to prove because of the lack of evidence linking the hospital’s conduct to the plaintiff’s injury (57). In Contreras v St. Luke’s Hospital (58), for example, Solomon Contreras brought suit against St. Luke’s Hospital and his surgeon after he sustained a surgical site infection caused by enterococci. The court held that the evidence was insufficient to impose liability, because “there is no evidence that th[e] delay [in removing a bedpan] or understaffing had any connection with the infection. Similarly, there is nothing to indicate that the failure of the nurses to trim the plaintiff’s ingrown toenail had anything to do with the infection” (58). Mere negligence and injury are not sufficient; the plaintiff must be able to show that the defendant’s wrongful acts actually caused the injury (59).

The fourth and final element of the plaintiff’s tort claim is the requirement of a legally recognized injury. Often the plaintiff will seek compensation for the extra expenses associated with a lengthened hospital stay or for the additional pain and suffering accompanying the negligently inflicted infection. Occasionally, the patient dies from the infection, and the patient’s estate and beneficiaries will bring survival and wrongful death claims. In Jistarri v Nappi (60), for example, the decedent’s estate sued the defendant doctors and hospital, claiming that a series of negligent acts during the decedent’s treatment for a broken wrist had allowed staphylococci to enter the decedent’s bloodstream, after which it weakened her heart and eventually caused her death.