Promoting patients’ rights through hospital accreditation

The Israeli accreditation project began as a voluntary process, initiated by Clalit Health Services in 2005. As the largest healthcare organization in the country, Clalit implemented the process in its hospitals, with the aim of improving the quality of care provided to its insured patients. Seven years after first introducing accreditation, with all eight of Clalitt’s hospitals successfully receiving the JCI certificate and with reported improvement in their quality of care [29], the Ministry of Health issued an administrative guideline requiring all general hospitals in Israel to receive JCI accreditation certification – as a prerequisite for their receiving their renewed hospital license [34].

By doing so, the Ministry of Health granted the JCI official regulatory authority over the national healthcare system. As stated in the Ministry’s guidelines, this mandatory accreditation was announced “due to the advantages of working in line with valid international standards for improving the quality and safety of the care” [34]. This guideline constituted a major shift in the nature and purpose of the accreditation process in Israel from a voluntary venture initiated by one healthcare organization to an official mandatory requirement for licensing [32]. Since then, accreditation of hospitals has thus become a model of integrated regulations within the healthcare sector [35, 36]. Integrated regulation is of “A form of extrinsic motivation where identified strategies are congruent with the person own values and needs.” [37]. Since healthcare organizations aim to provide safe and high quality care, a regulation requiring that hospitals meet the standards of an external accreditor is a model of integrated regulation within health care.

While state licensing generally aims at ensuring minimal service standards are met by each organization, as defined by the legislator, the JCI accreditation process aims at ensuring optimal standards of service. This shift in the regulatory model reflects the Ministry of Health’s recognition of JCI’s optimal standards rather than sufficing with minimal standards as in the past [35]. Despite this significant shift from minimal standards to optimal standards, healthcare officials, policy makers and legislators have not addressed its potential meaning and implication so far.

Importantly, as of 2018, JCI certification has been granted to 29 general hospitals in Israel, including five Palestinian hospitals in East Jerusalem [38].

The concept of patients’ rights first gained formal recognition in Israeli law in the mid-1990s, following the legislation of two main laws: The National Health Insurance Act (NHIA) in 1995, and the Patient’s Rights Act (PRA) in 1996. The NHIA specifies the fundamental principles that guide the operations and funding of the Israeli healthcare system: Justice, equality, and mutual assistance (i.e., solidarity). The law also affirmed the fundamental right to receive medical care with public funding of services that are included in the medical basket, and the consequent obligations of the state to fulfill this right [39]. The PRA then introduced a relatively elaborate bill of patients’ rights, reflecting principles previously determined in case law. These included: The right to receive medical care; the right to receive treatment without discrimination; the right to receive professional and humane treatment; the right to receive information regarding the identity of the caregivers and their role; the right to seek an additional opinion; the right to have an escort in every medical examination; the right to continuity of care; the right to medical confidentiality; the right to receive information and to review the medical records; and the right to give informed consent. The PRA also required establishment of an ethics committee in each medical institution and granted them legal authority for implementing the law and resolving possible rights-based conflicts [40, 41]. The endeavor to create a legislative patients’ rights scheme was continued in 1998 with the enactment of Equal Rights for Persons with Disabilities (ERPDL). This later developed into the right to equality in healthcare.

Over the following decade, additional rights were given formal recognition. For example, the Dying Patient Act (DPA) of 2005 and the Organ Transplant Act (OTA) of 2008 both addressed end-of-life related treatment. DPA focuses on patients’ rights during the final 6 months of their lives, acknowledging patients’ right to refuse life-prolonging treatment. While it refers to patients’ families as their proxy, this act does not view the family members as having related legal standing [42]. The OTA granted specific rights to both organ donors and their family members with regards to giving consent to the donation and establishing incentives for this purpose. While family members may still refuse to donate despite the explicit wishes of the deceased, PRA emphasizes and prioritizes the patients’ autonomy and privacy, and does not view the family members as having legal standing regarding the patients’ health and care [43‐45].

Israeli courts also contributed to the establishing of patients’ rights, prior to and following the introduction of Patients’ Rights Laws. Courts developed the content of the right to healthcare [46‐48], the rights of patients’ autonomy [49‐51], and informed consent [49, 52, 53].

Even though the law officially protected patients’ rights since the 1990s, and successfully introduced mechanisms and tools that promote rights within the healthcare system [41, 54], there were several barriers to full implementation and enforcement of the legislation. First, doctors and other medical practitioners, were insufficiently informed [55] and were reluctant and hesitant. They perceived the law as vague [56], intervening in their clinical work [57, 58], and difficult to implement [57, 59]. Similar concerns were raised by the State Comptroller in his 2015 annual report [60]. The report reviewed the actions taken by the Ministry of Health to promote and protect patients’ rights and found them inadequate in safeguarding patients’ dignity and privacy. The report marked a disparity between hospitals as one of the main setbacks in implementing the PRA in Israel. It identified inconsistencies between healthcare providers and underlined the significance of standardizing procedures and protocols that protect patients’ rights, such as informed consent forms [60].

In summary, patients’ rights are essential for excellent healthcare performance. This is reflected in various accreditation models and reports [61]. However, to date, research has hardly focused on the implications of accreditation on patients’ rights in the healthcare system [62]. Accordingly, we have designed this research specifically to examine this important issue.

Patients’ rights in Israeli legislation are protected mostly by the PRA, with a significant focus on aspects of consent. Issues related to end of life and organ donations are covered by specific legislation. The PFR chapter includes rights established under the PRA, as well as those found in separate legislation concerning organ donation and end-of-life treatment.

It appears that the PFR chapter provides broader coverage of patients’ rights. However, the language used in the PFR chapter vs. Israeli laws covering patients’ rights differs. The JCI standards are characterized by a language of obligations and mostly refrain from making declarations or rights-related statements; whereas, all rights-related Israeli laws use a declarative language of patients’ rights – discrete from the procedures that must be employed to maintain such rights. For instance, PFR standard 5.1 entitled, “Informed Consent,” reads:“Patient informed consent is obtained through a process defined by the hospital and carried out by trained staff in a manner and language the patient can understand.” In contrast, article 13 of the PRA titled “Informed consent” reads: “No medical treatment will be provided to the patient without his informed consent, according to the provisions of this chapter.”

In summary, the PFR chapter aims at ensuring hospitals perform certain activities in line existing standards, whereas the national legislation sets the general foundations for the rights that are at stake. .

In addition, more than once do the JCI standards refer to patients’ cultural and religious beliefs, while related Israeli legislation does not. This may be because while in Israel consideration of different cultural and religious is applicable, the country is legally defined as a Jewish state with an Orthodox Jewish character in all areas of public administration. This definition leads to legislation prioritizing the protection of Jewish values and traditions, with less emphasis on pluralism or other religions and cultural minorities, whereas JCI standards originate from the USA and are applied worldwide, thereby necessarily addressing a large range of cultural and religious groups and needs. The influence of cultural and social factors on health accreditation systems has already been acknowledged in the literature [63].

The term “Family” is almost completely absent from the text of the PRA. The reason for this may be that the legislators deliberately avoided granting any rights or legal status to the patients’ families, aiming instead at the individual patient as having legal standing in the healthcare system. In any case, the law is influenced by a liberal philosophy emphasizing the isolated individual and her liberties vis-à-vis care providers. The law does not allow the disclosure of any patients’ information to anyone, families included, unless the patients themselves grant explicit permission to do so. While the DPA does refer to the patients’ family as their end-of-life proxy, it does not view the family as having legal standing regarding the patients’ health and care [42]. The ODA acknowledges the significance of the family in the donation process, but especially renders a right to receive relevant information.

The PFR chapter, however, choses a very different approach with regards to the rights of the patients’ family members. The acronym PFR pertains to the rights of both the patients (P) and their family (F). The family is mentioned in six different standards and thirteen measurable elements. First, in a more general and declaratory standard, it is stated that the hospital is responsible for providing processes that support the rights of the patients’ families’. In addition, the standards maintain that the hospital will support the rights of both the patients and their families to partake in the patients’ healthcare process (especially with regards to decision making). They also stipulate that the hospital should inform patients and families about their rights and responsibilities to refuse or discontinue treatment, withhold resuscitative services, and forgo or withdraw life-sustaining treatment. Next, the hospital is required to inform patients and their families about its processes for receiving and acting on complaints, conflicts, and differences of opinion regarding the patients’ care and their right to partake in these processes. Above all, patients and their families should receive adequate information about the illness, procedures, treatment, and healthcare practitioners – so that they can make education healthcare-related decisions. For the list of these standards see Table 2 in Appendix B.

It follows that these standards in the PFR provide a special and significant place for the rights of the patients’ family members in areas of informed consent, medical decision-making, and conflict resolution. This contradicts the comprehensive responsibility granted to competent individual patients about being informed and making medical decisions pertaining to their own medical condition that are mostly specified in the PRA. The PFR standards refer to the family members of a patient – not only as a proxy of the patients’ interests or as a substitute decision-maker, but also, and more meaningfully, as having legal standing: The PFR asserts that the family has the right to receive information and take part in the patients’ healthcare, as well as to be informed of possible conflicts and be involved in their resolution. In the authors’ view, this well-deserved place of the patients’ family is distinguished from that of the patient.

Despite its importance in achieving positive outcomes for patients and their families, implementing patients’ rights in Israel has encountered certain reservations and even a lack of awareness among healthcare professionals. As recent studies show, accreditation improves safety and additional indicators of healthcare quality [17, 22‐25]. In addition to increasing awareness regarding patients’ rights in healthcare institutions – framed in a language of obligations – the PFR chapter of the accreditation process reaffirms the meaning of patients’ rights and consequently, the obligations of institutions and healthcare providers. Accordingly, we feel that there needs to be a government-led effort to increase the awareness and compliance with this chapter. Such an effort is likely to have a positive effect on implementing patients’ rights. It is probable that medical staff with a better understanding and attentiveness of patients’ rights will be more compliant with related standards and will be less reluctant to implement the rights of patients and their families in their practice.

The operative features of accreditation are also important. The recurrent evaluations require hospitals to prepare, train, and educate personnel on JCI standards, including the PFR chapter. The JCI instructs hospitals as to which specific actions must be taken in order to meet the standards and measurable elements and explicates how rights should be protected and promoted – thereby raising the awareness of the medical staff regarding patients’ rights.

Moreover, the integrated regulatory model of accreditation (external accreditation as a condition of state licensing) requires evaluation and training that is carried out independently, without state involvement, and is accompanied by significant enforcement measures and sanctions, specifically, revocation of a hospital’s license by the Ministry of Health. The integrated model of regulation, if enforced, is likely to enhance staff compliance with regards to promoting patients’ rights in hospitals, thereby raising efficiency rates in regulation.

Accreditation may lead to increasing both consistency and inconsistency in the protection of patients’ rights. On the one hand, the implementation of the PFR chapter as part of the accreditation process will increase consistency in the way rights are understood, protected, and promoted in healthcare institutions. In order to pass the JCI evaluation and receive accreditation, hospitals are required to generate their own procedures and forms. As rights are usually vague and declarative by nature, applying them as general principles may lead to divergence than implementing detailed standards and measurable elements. Therefore, it is reasonable to assume that accredited hospitals establish specific protocols in order to meet the necessary measurable elements. As such,.

On the other hand, while accreditation may lead to increased consistency between hospitals and regulated bodies, it may accentuate the differences between these and other healthcare organizations, such as community clinics, healthcare organizations, and independent and private physicians that are not subject to the JCI evaluation. For example, while medical personnel in hospitals should promote patients’ rights in the same standardized manner, their colleagues outside the hospital will not necessarily develop and implement a uniform standard of patients’ rights. As such, this regulatory difference can create differences and gaps in awareness of patients’ rights and overall healthcare.

The PFR chapter explicitly emphasizes the hospitals’ significant responsibility for providing processes that support the rights of patients’ families during healthcare, including providing all relevant and necessary information regarding these rights. While the Israeli legislators did not grant the patients’ families legal rights and status, the JCI standards introduce the concept of family rights and specify the measures hospitals are obliged to take in order to promote them.

Although one should inquire into to the extent with which such standards apply to and constitute an organizational culture different than the one required by the law, the incorporation of JCI standards as a mandatory licensing requirement for hospitals introduces family rights in a way that undoubtedly requires the attention of policy makers and legislators. Indeed, a direct application of the PFR chapter may contradict the main principles presented in the Israeli Bill of Patients’ Rights. Failure to provide a clear-cut policy that addresses the above-mentioned contradictions may lead to litigation that could have been prevented, as family members may seek recognition and protection of their rights in line with the hospitals’ accreditation and license requirements. One such scenario may be when a competent patient and his family are in disagreement about the best therapeutic plan for this patient. While under the PRA, the patient’s autonomy and rights prevail those of his family, implementing the PFR chapter may confer family members some legal status, thereby mandating the establishment of a balance between the parties involved or deterrence to a third party decision-making. The hospital omission or avoidance from taking such steps may, therefore raise legal action against it. A coherent policy on the status of the patients’ family in light of these different regulatory frameworks would also be beneficial, for preventing such litigation as well as for guiding medical and other hospital personnel in directing care and providing patients and families with information about their rights within the healthcare system. In light of this issue, we recommend a careful examination of each standard and measurable element is necessary to establish the desired balance between the independent evaluators’ requirements and the accepted interpretation of the current law – assuming such a balance can be achieved. Such an examination may be best achieved through a collaborative work of the Ministry of Health, the Labor, Welfare and Health Committee of the Knesset and patients’ rights organizations and advocates.

If addressed by policymakers, the Patients’ Rights Chapter in the accreditation process could be implemented throughout the healthcare system – not just in hospitals – with regards to informing, promoting, and applying these rights in a standardized and uniform manner. However, it should be noted that the PFR chapter may not necessarily lead to significant improvement. Thus, a study that compared between 89 hospitals in six European countries found that while accredited hospitals consistently score higher in measures of quality and safety compared to hospitals with ISO certifications or with no external assessment whatsoever, such a finding was not seen with regards to the specific dimension of Patients’ Rights [64]. Similar results were also found in a more recent study on 53 hospitals in Hungary [65].

These results are also echoed in patients’ dissatisfaction with accredited hospitals with regard to their respect of patients’ rights [66]. This may be related to the relatively limited efforts and actions required by the accreditation process on this issue, which merely focuses on posting lists of patients’ rights in corridors and rooms, or making mere declarations about the importance of such rights [67]. Such findings may reflect the challenges associated with, on the one hand, providing a comprehensive scheme by which hospitals comply with standards, and on the other hand, not putting too much burden on them in implementing these standards, especially as these standards are in some contradiction with local laws. They also reflect the fact that the accreditation process uses existing laws which are translated and conveyed to the medical team and looks for their fulfillment. Although, as shown in the ISQua definition of accreditation, the pre-determined accreditation requirements may address more than legal requirement, the process does not aim at replacing the law. These important insights therefore refer to areas which the accreditation process needs further review and re-evaluation.

Challenges regarding patients’ rights in the accreditation process should also be considered in light of the more general criticism of this process – specifically arguments warning policymakers and third-party payers not to encourage accreditation programs, as hospital accreditation might be a socially inefficient institution given the insufficient evidence of its positive outcome and due to hospital staff lack of belief in its possible quality-improvement effects [68].

Other challenges relate to the disagreement on what counts as patients’ rights, especially with regards to the healthcare institutions’ responsibilities for ensuring such rights [69] as well as the narrow focus on individual rights as opposed to healthcare justice, thereby ignoring societal issues that may affect treatment options, decision making, and quality [70].