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DEPARTMENT OF HEALTH AND medical and surgical care) and (f) assess compliance with the CoPs. The HUMAN SERVICES (Standard: Seclusion and restraint for SAs conduct these surveys using the behavior management) will be State Operations Manual (SOM) (HCFA Health Care Financing Administration considered if we receive them at the Publication No. 7). The SOM contains appropriate address as provided in the the regulatory language of the CoPs as 42 CFR Part 482 ADDRESSES section, no later than 5 p.m. well as interpretive guidelines and [HCFA±3018±IFC] on August 31, 1999. We will not survey probes that elaborate on consider comments on provisions of the regulatory intent and give in-depth RIN 0938±AJ56 regulation that remain unchanged from detail about how to maintain compliance. The SOM also outlines the Medicare and Medicaid Programs; the December 19, 1997 proposed rule or survey process and provides guidance Hospital Conditions of Participation: on provisions that were changed based for State administration of the survey Patients' Rights on our consideration of public comments. program. Under § 489.10(d), the SAs AGENCY: Health Care Financing ADDRESSES: Mail comments (an original determine whether hospitals meet the Administration (HCFA), HHS. and three copies) to the following CoPs and make corresponding recommendations to us about the ACTION: Interim final rule with address: Health Care Financing comment. Administration, Department of Health hospital’s certification, (that is, whether and Human Services, Attention: HCFA– the hospital has met the standards SUMMARY: This rule introduces a new 3018–IFC, P.O. Box 7517, Baltimore, required to provide Medicare and Patients’ Rights Condition of MD 21207–0517. Medicaid services and receive Federal Participation (CoP) that hospitals must If you prefer, you may deliver your and State reimbursement). Under section 1865 of the Act and meet to be approved for, or to continue comments (an original and three copies) § 488.5 (Effect of JCAHO or AOA participation in, the Medicare and to one of the following addresses: Medicaid programs. This interim final accreditation of hospitals), hospitals Room 443–G, Hubert Humphrey accredited by the Joint Commission on rule with comment sets forth six Building, 200 Independence Avenue, standards that ensure minimum Accreditation of Healthcare SW., Washington, DC 20201, or Organizations (JCAHO) or the American protections of each patient’s physical Room C5–16–03, 7500 Security and emotional health and safety. These Osteopathic Association (AOA) are not Boulevard, Baltimore, MD 21244– routinely surveyed for compliance by standards address each patient’s right to 1850 notification of his or her rights; the the SAs but are deemed to meet the exercise of his or her rights in regard to Because of staffing and resource requirements in the CoPs based on their his or her care; privacy and safety; limitations, we cannot accept comments accreditation. by facsimile (FAX) transmission. In confidentiality of his or her records; B. Why a Patients’ Rights CoP Is Needed freedom from restraints used in the commenting, please refer to file code HCFA–3018–IFC. Comments received In recent years, State surveyors, provision of acute medical and surgical patient advocacy groups, the media, and care unless clinically necessary; and timely will be available for public inspection as they are received generally the general public have brought freedom from seclusion and restraints complaints about hospitals violating used in behavior management unless beginning approximately 3 weeks after publication of a document, in Room patients’ rights to our attention. These clinically necessary. violations have consisted of denying or The issue of patients’ rights has been 443–G of the Department’s offices at 200 Independence Avenue, SW., frustrating a patient’s access to care, a longstanding concern for the Health denying a patient’s full involvement in Care Financing Administration. In Washington, DC, on Monday through Friday of each week from 8:30 a.m. to his or her treatment, disregarding a December 1997, we published a patient’s advance directives, denying a proposed rule that introduced the 5 p.m. (phone: (202) 690–7890). FOR FURTHER INFORMATION CONTACT: patient’s access to his or her medical proposed revision of all hospital CoPs, records, or inappropriately using including a new Patients’ Rights CoP. Monique Howard, OTR (410–786–3869); Julie Moyers (410–786–6772); Anita seclusion or restraints. Particularly Work to finalize the complete revision within the past year, the public, media, of the hospital CoPs continues; Panicker, RN, LCSW (410–786–5646); or Rachael Weinstein, RN (410–786–6775). and the Congress have grown however, the Patients’ Rights CoP is increasingly concerned about the need being finalized separately in an I. Background to ensure basic protections for patient accelerated time frame as recent reports A. General health and safety in hospitals, especially have evidenced a pressing need for the with regard to the use of restraints and codification and enforcement of these On December 19, 1997, we published seclusion. The Hartford Courant, a fundamental rights. Of particular a proposed rule entitled ‘‘Medicare and Connecticut newspaper, heightened concern is the danger posed to patient Medicaid Programs; Hospital Conditions public awareness of this issue with a health and safety by violations of basic of Participation; Provider Agreements series of articles in October 1998 citing patients’ rights, such as freedom from and Supplier Approval’’ at 62 FR 66726 the results of a study that identified 142 restraints and seclusion. to revise the entire set of conditions of deaths from seclusion or restraints use The Patients’ Rights CoP, including participation (CoPs) for hospitals that in behavioral health treatment facilities the standard regarding seclusion and are found at 42 CFR part 482. The CoPs over the past 10 years. The majority restraints, applies to all Medicare- and are the requirements that hospitals must were adolescent deaths. Medicaid-participating hospitals, that is, meet to participate in the Medicare and short-term, psychiatric, rehabilitation, Medicaid programs. These CoPs are C. Intent To Examine Restraint and long-term, children’s, and alcohol-drug. intended to protect patient health and Seclusion in Other Settings DATES: Effective Date: These regulations safety and to ensure that high quality Federal regulations for nursing homes are effective on August 2, 1999. care is provided to all patients. The already stress the right to be free of Comment date: Comments on 42 CFR State survey agencies (SAs), under restraints, and over the past 10 years, 482.13(e) (Standard: Restraint for acute contract with us, survey hospitals to significant strides have been made in

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36071 reducing inappropriate restraints used We have endeavored to incorporate In addition, although not specifically in this care setting. The Patients’ Rights the protections of the Bill of Rights into mentioned in the CBRR, patient safety CoP will further extend these the structures and operations of the necessitates that all hospitals should protections to another major provider of providers and plans that provide care to publicly disclose whether and when health care. However, this rule will not our beneficiaries. Some of the rights they provide emergency services. cover all care settings. As we finalized included in the proposed section • Protection of Whistleblowers: this rule, various stakeholders lobbied § 482.10 (now § 482.13) have direct Hospitals should be prohibited from for a much broader application of the correlates in the Consumer Bill of penalizing or seeking retribution against seclusion and restraint provisions. We Rights, but other significant protections health care professionals or other health are looking into the advisability of provided by the CBRR were not workers for advocating on behalf of their adopting a cross-cutting restraints and mentioned in the December 1997 patients. Individuals would be assured seclusion standard that would affect proposed rule. Even though some of of this right in the Patients’ Rights other kinds of health care entities with these protections currently exist due to section. • whom we have provider agreements and requirements on hospitals that are not Respect and Nondiscrimination: the inpatient psychiatric services for affected by the revisions to the CoPs, we While the preamble discusses the individuals under age 21 benefit. We are have decided not to add new regulatory applicable Federal and State laws that requesting comment on whether we requirements to the Patients’ Rights prohibit discrimination, an explicit should set forth the same requirements standard without subjecting them to a patient right to nondiscrimination is not as promulgated in this rule or whether more public vetting than is provided by currently included and would be added more stringent standards would be an interim final rule. We therefore ask to the Patients’ Rights section. appropriate. For example, is the current for comment on the following additional E. Other Patients’ Rights standard for continual monitoring of consumer rights, which we believe The remainder of the hospital CoPs patients in restraint adequate for would need to be incorporated in the and other Federal requirements provide children or should all restraints for CoPs in order to achieve compliance patients with additional rights that do children be monitored only by direct with the Bill of Rights: not appear in the new Patients’ Rights • Information Disclosure: According staff observation? In addition, we CoP. The fact that we have not explicitly to the Bill of Rights, consumers should acknowledge that more stringent stated or cross-referenced these rights in receive the following information from standards exist in the Medicaid the final rule does not mean that they health care facilities: requirements for restraint use in are not available to the patient, or that + Corporate form of the facility (that intermediate care facilities for the they are in any way less important than is, public or private; nonprofit or profit; mentally retarded. We are requesting the rights that this rule establishes. comments on whether we should ownership and management; affiliation Some of these rights are stated consider the same requirements for the with other corporate entities). elsewhere in law or regulation. For + Accreditation status. hospital setting. We plan to make a example, various the civil rights laws decision on our approach to restraints + Whether specialty programs meet guidelines established by specialty uphold the patient’s right to be free of and seclusion across these other settings discrimination. When the hospital and services by the end of the winter. societies or other appropriate bodies (for example, whether a cancer treatment enters into a provider agreement with Some patient advocates have asked us, a condition of that agreement is that that we go well beyond these entities center has been approved by the American College of Surgeons, the the hospital will abide by the principles and regulate care furnished by providers and requirements of title VI of the Civil with whom we have no provider Association of Community Cancer Centers or the National Cancer Rights Act, as implemented in agreements or care provided in settings regulation at 42 CFR part 80; section 504 where we may lack statutory authority Institute). + Volume of certain procedures of the Rehabilitation Act of 1973, as under the Social Security Act (the Act). performed at each facility. implemented by 45 CFR part 84; the Age Barring a legislative change, we cannot + Consumer satisfaction measures. Discrimination Act of 1975, as mandate a restraint and seclusion + Clinical quality performance implemented by 45 CFR part 90; and standard for those care settings or measures. other requirements of the Office for providers. + Procedures for registering a Civil Rights of DHHS (see 42 CFR D. Conformance of Patients’ Rights in complaint and for achieving resolution 489.10, Basic requirements). These Hospitals with the Consumer Bill of of that complaint. requirements span all of the provider Rights and Responsibilities (CBRR) + The availability of translation or types with whom we hold an agreement interpretation services for non-English and provide individuals with important In February 1998, President Clinton speakers and people with protections against discrimination. A directed the Department of Health and communication disabilities. second relevant example is the patient’s Human Services (DHHS), among other + Numbers and credentials of right that springs from the anti-dumping departments, to bring our health care providers of direct patient care (for regulations at § 489.24 (Special programs into compliance with the example, registered nurses, other responsibilities of Medicare hospitals in CBRR, as recommended by the licensed providers, and other emergency cases). The anti-dumping Presidential Advisory Commission on caregivers). regulations prohibit Medicare- Consumer Protection and Quality in the + Whether the facility’s affiliation participating hospitals with emergency Health Care Industry. We are strongly with a provider network would make it medical departments from refusing to committed to achieving this goal and are more likely that a consumer would be examine or to treat medically unstable continuing to work to ensure that the referred to health professionals or other patients. important consumer protections organizations in that network. While these two examples are clear articulated in the rights are available to + Whether the facility has been cut instances where patients’ rights are our beneficiaries, whether Medicare or excluded from any Federal health already codified, less visible rights also Medicaid, whether in managed care or programs (that is, Medicare or exist. For example, since the hospital is fee-for-service settings. Medicaid). required to have adequate nurse staffing

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 36072 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations to provide nursing care to all patients as in Medicare- and Medicaid-participating and in each patient’s room, and in needed (see § 482.23, Condition of hospitals. The provisions of this CoP set verbal or written form with initial and participation: Nursing services), one forth minimum protections and promote additional information included in the could argue that the patient is thereby patients’ rights, including an admission packet. afforded the right to receive adequate individual’s right to—(1) notification of Response: We appreciate the nursing services and care. Or, since the his or her rights; (2) the exercise of his suggestions of how and where patients’ hospital is required to have dietary or her rights in regard to his or her care; rights should be displayed or conveyed. menus that meet the needs of the (3) privacy and safety; (4) However, hospitals will need flexibility patients (see § 482.28, Condition of confidentiality; and (5) freedom from to establish policies and procedures that participation: Food and dietetic the use of seclusion or restraint of any effectively ensure that patients and their services), the patient has the right to a form unless clinically necessary. In the representatives have the information diet that meets his needs. preamble, we solicited comments on a necessary to exercise their rights. These We considered an approach that more prescriptive approach to the use of policies and procedures will need to would have grouped all conceivable restraints and seclusion and provided address how, where, and when to notify patients’ rights within this CoP; relevant examples. patients of the full gamut of rights to however, the practical value of this Although we proposed codifying the which they are entitled under the Act. approach is questionable as these new Patients’ Rights CoP as § 482.10, in As hospitals assess the effectiveness of elements are codified elsewhere, and an the final rule it is designated as § 482.13 their proactive notification techniques, approach that attempts to be all- to coordinate with the numbering they need flexibility to continuously inclusive often inadvertently omits key system used in the current regulations. improve their performance in promoting elements. We believe that it suffices to When the remaining hospital CoPs are patients’ rights. say that we expect the hospital to honor finalized, we will renumber the This CoP covers hospitals of varying and promote all of the rights and standards in part 482. sizes operating in a wide range of protections that Federal law and the Our commitment to the revision of the locations, serving diverse populations, hospital CoPs offer. The rights codified remaining hospital CoPs to focus on with a variety of required notices; thus, by this rule either do not appear patient-centered, outcome-oriented care flexibility and creativity to allow for the elsewhere, or, as evidenced by reports, remains unchanged. We continue to effective implementation of this require a special emphasis. work on analysis of the over 60,000 requirement without undue burden is comments received on the proposed critical. Therefore, we are not including II. Legislation rule and will finalize the remaining further prescriptive language detailing Sections 1861(e) (1) through (8) of the hospital CoPs in the future. exactly where, how, when, and by Act define the term ‘‘hospital’’ and list whom this requirement must be carried the requirements that a hospital must IV. Comments and Responses out. meet to be eligible for Medicare Of the 60,000 comments received on While we are committed to preserving participation. Section 1861(e)(9) of the the December 1997 proposed rule, flexibility on this point, we note that Act specifies that a hospital must also approximately 300 focused on the one method for efficiently handling meet such other requirements as the Patients’ Rights CoP. Comments were aspects of this requirement may be to Secretary finds necessary in the interest received from hospitals, mental health bundle notices with the existing of the health and safety of the hospital’s treatment facilities, professional information that must be provided to patients. Under this authority, the associations, accrediting bodies, SAs, patients to fulfill Civil Rights Secretary has established in regulations patient advocacy groups, and members requirements. The regulations at 42 CFR part 482 the requirements that of the general public. Half of the implementing title VI of the Civil Rights a hospital must meet to participate in comments, and the strongest opposition, Act of 1964, section 80.6(d), section 504 Medicare. came in response to the proposed fifth of the Rehabilitation Act of 1973 (45 Section 1905(a) of the Act provides standard under Patients’ Rights— CFR 84.8), and the Age Discrimination that Medicaid payments may be applied seclusion and restraints. While many of Act of 1975, section 91.32, require to hospital services. Regulations at the respondents did not favor recipients of financial assistance from § 440.10(a)(3)(iii) require hospitals to prescriptive regulations that extended the DHHS to provide notice of their meet the Medicare CoPs to qualify for beyond the proposed regulations text, responsibility to comply with the participation in Medicaid. some welcomed more prescriptive appropriate nondiscrimination language under the standard for provisions and other pertinent III. Provisions of the Proposed requirements of the Office for Civil Regulations seclusion and restraints. A summary of the comments received Rights. For a hospital that falls under In our December 19, 1997 proposed on the five standards, major issues, and this requirement, some patients’ rights rule, we proposed revision of the our responses follows. notices could be effectively posted next Medicare hospital CoPs in concert with to these nondiscrimination notices. For Vice President Gore’s Reinventing A. Notice of Rights some of the educational notices the Government (REGO) initiative. The We proposed that a hospital must patient will receive as part of the new REGO initiative emphasized lessening inform each patient of his or her rights Patients’ Rights CoP, this public posting Federal regulation to eliminate in advance of furnishing care and that may be appropriate. unnecessary structural and process the hospital must have a grievance Comment: One commenter believed requirements, focus on outcomes of process and indicate who the patient that the standards in the Patients’ Rights care, allow greater flexibility to can contact to express a grievance. CoP are generally reflected in common hospitals and practitioners to meet Comment: Commenters indicated that hospital practice; however, she objected quality standards, and place a strong what constitutes sufficient notification to the general language that appeared at emphasis on quality assessment and needs to be clarified. One commenter the beginning of the condition; performance improvement. stated this requirement should be specifically, the phrase, ‘‘A hospital In the proposed rule, we proposed satisfied by providing written displays must protect and promote each patient’s setting forth a new Patients’ Rights CoP of patients’ rights in the hospital lobby rights.’’ This commenter was concerned

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36073 that the wording would be presented in further specify that the patient be given and qualified readers, taped texts, audio isolation to juries during medical a phone number and address for lodging recordings, Brailled materials, large malpractice cases, and that it would be a complaint with the SA. print materials, or other effective used to cover all legal and ethical rights. Comment: Some commenters stated methods of making visually delivered The commenter noted that a hospital the proposed rule should account for materials available to individuals with staff person could not know or be the fact that in certain situations, the visual impairments. Title VI of the Civil responsible for providing this degree of patient’s age, condition, health problem, Rights Act of 1964 also requires information. The commenter suggested and emergency situation will inhibit the recipients of certain public funds to that the language be amended to read, hospital’s ability to notify the patient of serve persons who are ‘‘Limited English ‘‘A hospital is responsible to have his or her rights before the provision or Proficient’’ (LEP). Translation of LEP policies and procedures in place which discontinuation of care. Commenters documents, use of bilingual staff, and protect and promote the patient’s rights believed that the rule should free provision of interpreters are usually as reflected in the following standards.’’ hospital personnel from the used to convey necessary information to Response: As stated earlier, we do responsibility of informing the patient LEP persons. expect the hospital to honor and of his or her rights if he or she is While we recognize the value of promote each patient’s rights, regardless experiencing an emergency medical appropriate communication techniques, of whether they appear in the Patients’ condition, is unconscious, or is at the we do not offer further regulation in this Rights CoP. With respect to the hospital for a brief outpatient encounter. area since existing laws ensure that commenter’s concern that this statement Response: A hospital should make appropriate attention will be given to will be taken in isolation and used in every effort to inform the patient of his providing information to those who medical malpractice cases, we do not or her rights before care provision or require special accommodation based want to provide a foothold for frivolous cessation of care. However, in some on their special needs. cases. With that said, however, it could instances a patient’s age, condition, Comment: Some commenters believed very well be that a patient who brings health problem, or emergency situation that the proposed rule needed to further suit against a provider has a legitimate does not allow the opportunity to define the patient’s role and cause for concern or complaint because communicate with the patient regarding responsibility when being informed of that provider failed to acknowledge his his or her rights. For this reason, we are his or her medical condition and that or her rights as established under these adding language to allow the hospital to the standard should place more regulations. Such a case would communicate these rights to the emphasis on discussion of prevention of generally require some substantiation patient’s representative (as allowed complications and rehospitalization. and elaboration on specifically which under State law). In the absence of State Response: The Patients’ Rights CoP right the provider failed to uphold. We law to cover particular health care upholds the patient’s right to full, are not persuaded that this language decisions, the hospital may also informed involvement in his or her care. opens up an otherwise closed avenue communicate these rights to a legal Under circumstances defined by State for pursuing legal action. Accordingly, representative whom the patient has law, this right may also be exercised by we are retaining this language. appointed as an ‘‘ad hoc’’ decision the patient’s legal representative on his Comment: One commenter noted that maker in the event of temporary or her behalf. We recognize that enumeration of the patient’s rights is of inability to make health care decisions. involvement in the plan of care and the little use if his or her only recourse is We still expect that as soon as the choice of treatment option may be open a grievance process that is controlled by patient can be informed of his or her to interpretation. We would like to the hospital. This commenter suggested rights, the hospital will provide that clarify that this right to involvement in adding a requirement that the patient information to the patient. health care decisions cannot be equated also be notified that he or she could Comment: Some commenters stated with the ability to demand medically lodge a complaint with the State survey that this discussion should be tailored unnecessary treatments or care. The agency either after or during the course to the patient’s level of understanding or patient has the right to be informed of of the hospital stay, regardless of communication needs by using alternate his or her status, to be involved in care whether the patient decided to file a means of communication (for example, planning and treatment, and to request grievance with the hospital’s system. audiotape, radio, sign language, and and refuse treatment. The patient Response: The patient’s right to file a Braille, or other culturally competent should be consulted about changes in complaint with or contact the vehicles), as necessary. care and treatment. Issues arising out of accreditation body or the State to report Response: Existing civil rights patient dissatisfaction with the an infraction on these rights is implicit; legislation (section 504 of the hospital’s response may be dealt with therefore, we do not believe it is Rehabilitation Act of 1973 and the under the hospital’s grievance process necessary to add this to the regulations Americans with Disabilities Act (ADA)) required under § 482.13(a); however, the text. To address the commenter’s emphasize the provision of effective patient may choose to lodge a complaint concern, however, we will specify in the aids, benefits, or services to individuals with the SA or accrediting body in interpretive guidelines that patient with disabilities. The ADA defines addition to or instead of using the notification of the grievance process auxiliary aids and services as including hospital’s grievance system. must include the fact that the patient qualified interpreters, notetakers, We agree that the patient’s health and also may address his or her concerns to transcription services, written materials, well-being are most likely affected by the State survey agency, regardless of telephone handset amplifiers, assistive the degree of collaboration between the whether he has first used the hospital’s listening devices, assistive listening patient and physician. The patient grievance process. Patients or residents systems, telephones compatible with should make every effort to bring of all Medicare-certified facilities have hearing aids, closed captioning, medical problems to the attention of the always had the ability to lodge telecommunications devices for deaf physician in a timely fashion, provide complaints about the quality of care persons, videotext displays, or other information about his or her medical they receive with the State survey effective methods of making aurally condition to the best of his or her agency or HCFA, and nothing in this delivered materials available to knowledge, and work in a mutually rule alters this opportunity. We will individuals with hearing impairments; respectful manner with the physician.

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However, the patient’s physical, mental, qualifications and competence of the As noted earlier, the interpretive psychological, and emotional status may nursing staff available (§ 482.23(b)(5)). guidelines will reiterate that the directly affect his or her ability to offer We believe that the patient has a right notification of a grievance process must this degree of cooperation. to nursing care in hospitals; however, include the fact that the patient has the Comment: A commenter stated that a we disagree with the commenter’s right to file a complaint with the SA member of the interdisciplinary assertion of the patient’s inherent right regardless of whether he or she chooses treatment team should document (in the to request and receive the direct services to use the hospital’s process, and that he medical record) that the patient’s rights of an RN. In rural areas where access to must be provided with the SA’s phone have been reviewed with the patient health care practitioners can be number and address. and whether the patient or his or her problematic, to mandate this We considered the commenters’ legal representative comprehends the requirement is impractical and concerns about burden; however, to information covered. A few commenters burdensome. The current nursing remain silent on general expectations stated that social workers should notify services requirement provides for RN for the grievance process could result in patients of their rights at the time of the services for each patient through the absence of key ingredients that intake or screening interview. supervision of the nursing care promote a meaningful, substantial Response: All of these suggestions provided. Existing regulations address have potential merit. However, as stated process that addresses patients’ and provide for the appropriate level of concerns and promotes their rights. To above, we believe it is necessary to care in situations where a patient’s provide the hospital with flexibility in promote the creation of an effective condition warrants an RN’s direct grievance process, in § 482.13(a)(2), we developing policies and procedures that service. are establishing general elements that fulfill the requirement’s intent, that is, Comment: One commenter agreed should be common to grievance to ensure that each patient’s rights are with our proposal that hospitals should protected. have a formal grievance process for processes across all hospitals. Comment: A few commenters complaints and recommendations. Development of more detailed strategies believed that no further details should However, we received more comments and policies to comply with the be included in the regulation as more in opposition to this requirement. Those requirement will be left to the discretion detail would add an unnecessary who opposed the provision believed it of each hospital. paperwork burden during the admission to be unnecessary, burdensome to Exercise of Rights process while not guaranteeing establish, and limited in scope since it improved quality of patient care. pertains only to patients’ rights. A B. We proposed That the Patient Has the Response: We have mandated neither commenter noted that we did not Right To Be Informed of His or Her the process that a hospital must use nor specify how the hospital should plan to Rights and To Participate in the the extent to which these rights must be investigate complaints or the time frame Development and Implementation of discussed as part of the admission within which hospitals would be His or Her Plan of Care process. In some cases, notification of required to respond to grievances. Comment: Commenters stated that the these rights must occur later in the Response: As we stated in the patient should be informed if the hospital stay to ensure that the patient’s December 1997 proposed rule, treatment is experimental in nature and rights are protected. Hospitals will have whenever possible, we have attempted informed of the types of outcomes the to adopt an outcome-oriented focus the flexibility and accountability to hospital has encountered from the care. rather than establish process determine how they can best ensure the Commenters also suggested that the requirements. However, we believe that protection of patients’ rights. patient and his or her representative Comment: A few commenters stated the establishment of a grievance process should be informed of the nature, that the patient should be informed of promotes patient empowerment in expected outcome, and potential the credentials, licensure, and health care. We recognize that in and of complications of treatment options that professional qualifications, including itself this process may not be sufficient are going to be undertaken, as well as certifications, of all personnel involved to resolve all potential sources of the potential outcomes if the treatment in his or her care through clear conflict. For example, in a situation is refused. disclosure of this information on the where a patient disagrees with a course hospital badge. of treatment, the disagreement might be Response: The hospital should foster Response: We believe that this is an between the patient and an independent an atmosphere that supports two-way issue that hospitals should consider in physician or health plan rather than communication with the patient developing their policies and with the hospital itself. Some issues regarding his or her care. We expect that procedures on notification of rights. We may more logically be pursued under the hospital will hold the responsible agree that it is important for patients to Medicare or Medicaid complaint physician accountable for discussing all be aware of the identities of individuals processes or through a State mechanism. information regarding treatment, who provide care in the hospital. For example, hospitals already have experimental approaches (hospitals are Comment: A few commenters procedures for referring Medicare required to comply with 45 CFR part 46, suggested a patient should have the beneficiaries’ complaints about quality protection of subjects of human right to request care by a registered and concerns about premature discharge research), and possible outcomes of care nurse (RN). to peer review organizations for to promote quality care delivery. We Response: Under the current hospital investigation and review. Whatever the believe it is unnecessary to codify the CoPs, hospitals are required to have 24- type of concern, we expect that the elements that must be discussed with a hour nursing services and an RN who hospital’s grievance process will patient regarding development of his or supervises or evaluates the nursing care facilitate prompt, fair resolution. The her plan of care, or with whom among for each patient (§ 482.23(b)(3)). In grievance process should route each the hospital’s staff or practitioners the addition, an RN must assign the nursing concern timely to the appropriate patient must speak to develop that plan care of each patient to other nursing decision-making body. This expectation of care. Flexibility is necessary because personnel in accordance with the for coordination has been added to the discussions of treatment information patient’s needs and the specialized text of the final rule. will differ for each patient.

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C. We Proposed That the Patient Has the as a condition of receiving the care with the advance directives Right To Make Decisions Regarding His [Medicare] benefit. The CoP for the requirement. Further, as noted earlier, or Her Care acute setting should address validating the proposed rule did not contemplate Comment: Some commenters stated the beneficiary’s ‘pre-selected amending the existing advance that the final rule should emphasize the designations.’’ ’ directives requirements. We do believe, Response: Section 1866(f) of the Act patient participating fully in his or her however, that referencing the patient’s contains the provider requirements care. Commenters believed that this right to formulate and have hospital concerning the acknowledgment and could be achieved by allowing the staff comply with advance directives in handling of advance directives. The patient to receive second opinions the new Patients’ Rights CoP will lead implementing regulations appear at 42 before starting a procedure that to increased communication regarding CFR part 489, Provider Agreements and significantly differs from the pre- end-of-life decisions, pain management, Supplier Approval; specifically, at admission plan of treatment. These and other palliative care. §§ 489.100 through 489.104. When we Comment: One commenter believed commenters stated that the final rule developed the December 1997 proposed should require the patient to ‘‘sign-off that a hospital should be required to rule, we believed that it was appropriate check and adhere to advance directives, on treatment options’’ and should to reference advance directives in the acknowledge the patient’s ability to including those pertaining to Patients’ Rights CoP, consistent with psychiatric emergencies, by refuse treatment and to refuse to other Medicare provider CoPs (for participate in experimental research. incorporating the appropriate training to example, existing regulations for ensure patients are knowledgeably Response: We agree that the patient nursing homes and home health must be adequately informed of these consenting and by including quality agencies). The regulations governing improvement efforts to study the issue. options so that he or she can make advance directives and their educated decisions regarding his or her Response: We believe that existing implementation are not directly affected regulations at §§ 489.100, 489.102, and care. The requirement supports this or under debate in this rule. This rule emphasis and implicitly includes the 489.104 already address these concerns. is not the appropriate venue for The final rule cross-references these commenters’ concerns that a patient be addressing the more general issue of able to refuse a certain treatment or citations and supports the existing advance directives, which spans regulatory expectation. However, the participation in experimental research. provider types and is not specific to the However, in light of this comment, we commenter touched upon a point that hospital CoPs. merits additional response: specifically, decided to introduce a higher degree of Comment: A commenter stated that specificity in the final rule. First, we that advance directives are not limited the language regarding advance to end-of-life decisions. In the mental noted that the patient’s representative directives should encourage increased (as allowed under State law) can also health setting, a patient may form communication about and access to advance directives that relate to what exercise the right to make informed palliative care for the terminally ill. decisions on the patient’s behalf. should be done if he or she experiences Another commenter believed that a psychiatric crisis. In an advance Second, we introduced a more detailed detailed advance directives should description of what the patient’s right to directive, a person with a mental apply to inpatients, but not outpatients. disorder leaves instructions as to his or make informed decisions entails. The Response: Regarding the commenter’s her health care when he or she no patient has the right to be informed of concern that advance directives should longer has decision-making capacity. his or her health status, to be involved apply to inpatients not outpatients, These instructions may include, for in care planning and treatment (this section 1866(f) of the Act and example, the name of the health care includes pain management, as this implementing regulations at § 489.102 proxy, the name of the facility in which aspect of treatment planning is often not require that the hospital give each one wishes to receive services, the name discussed with patients), and to be able individual (1) written information of the provider from whom one wishes to request and refuse treatment. concerning an individual’s rights under Abridgement of these patients’ rights State law to make decisions concerning to receive treatment, names of would be subject to the grievance medical care, including the right to medications and dosages that work best, process required by § 482.13(a). It is accept or refuse medical or surgical and the methods to be used to de- critical to note, however, that the treatment and the right to formulate, at escalate a crisis to avoid the use of standard does not provide the patient the individual’s option, advance seclusion and restraint. In the with the right to demand treatment or directives, and (2) written policies of the interpretive guidelines, we will further services that are not clinically or provider or organization with respect to describe the aspect of advance medically indicated. the implementation of advance directives that relates to psychiatric directives. Section 1866(f)(2)(A) emergencies to place a greater emphasis D. We proposed that the patient has the specifically notes that this information on and encourage responsiveness to right To Formulate Advance Directives must be provided when an individual is these situations. and To Have Hospital Staff and admitted as an inpatient to a hospital; E. Privacy and Safety Practitioners Who Provide Care in the therefore, the hospital need not provide Hospital Comply With These Directives this information to those who are We Proposed That the Patient Has the Comment: One commenter wanted receiving outpatient services. Right to Privacy and To Receive Care in the issue of advance directives to be We appreciate the commenter’s a Safe Setting addressed at the time of the patient’s suggestion that the language about Comment: One commenter stated that Medicare enrollment rather than at the advance directives incorporate language of the preamble that referred to time of an acute care admission. This increased information about and access the patient’s respect, comfort, and commenter stated that, ‘‘Medicare to palliative care for the terminally ill. dignity was not included in the beneficiaries could be required to However, neither the statute nor the regulations text. designate their wishes with regard to ‘do existing regulations about advance Response: We believe that patient not resuscitate’ (DNR) status and their directives discuss linking increased respect, dignity, and comfort are the surrogate healthcare decision-maker[s] discussion of and access to palliative foundation of the expectations outlined

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A few commenters believed intended to provide protection for the the hospital is responsible for ensuring that the regulation should state that the patient’s physical and emotional health the patient’s health and safety and his patient has a right to a copy of his or and safety. Respect, dignity, and or her physical, emotional, and her records within 4 hours of an comfort would be components of an psychological well-being. We recognize inpatient stay and within 48–72 hours emotionally safe environment. This that there is always a chance a patient for a patient who has been discharged. point will be reinforced when we can misinterpret staff’s intentions. We A few commenters believed that the prepare corresponding interpretive expect that hospital staff would regulations text should clearly account guidelines to implement this final rule. intervene in a timely, appropriate for the impact of variations in location Comment: Commenters agreed with manner to correct any of data, record complexity, urgency, and the concept of the patient’s right to misinterpretations in a timely, staff workload. privacy but believed that the term appropriate manner, if this situation Response: Regarding the definition of ‘‘privacy’’ is broad and undefined. Some were present. ‘‘reasonable,’’ we believe that stated that ‘‘personal privacy’’ should be In the final rule, we have amended ‘‘reasonable’’ means that the hospital (1) defined and a statement should be the language to address all forms of will not frustrate the legitimate efforts of included to relieve hospitals of the abuse rather than just physical and individuals to gain access to their own responsibility of providing each patient verbal abuse. We recognize that any sort medical records, and (2) will actively with a private room, since ‘‘privacy’’ of abuse, including verbal, physical, seek to meet these requests as quickly as could be misinterpreted to mean that a psychological, sexual, and emotional, is its recordkeeping system permits. We patient has a right to a private room. unacceptable. have included these expectations in the Response: We understand the G. Confidentiality of Patient Records regulations text at § 482.13(d)(2). commenters’ concerns but are not We agree with the commenters who including a description of ‘‘privacy’’ in We Proposed That the Patient Has the asserted that we should account for the the final rule. We intend to address the Right to Confidentiality of His or Her impact of various factors such as accommodation of privacy rights Clinical Records location of data, urgency, and staff through the interpretive guidelines, as workload. Rather than attempting to that venue permits a more thorough Comment: A commenter stated that without specific language regarding stipulate time frames within the explanation of expectations. regulation that would cover all possible We agree that ‘‘privacy’’ does not privacy and confidentiality, research combinations of factors, we are simply mean that each patient has a right to a efforts may be stifled by the regulation. retaining the word ‘‘reasonable.’’ We private room. However, even if a patient Response: Presumably, the trust that if the patient believes that he is in a semiprivate room, the hospital commenter is concerned that without a is being subjected to unreasonable should provide a patient with privacy clear statement regarding the treatment as he tries to obtain a copy of by steps such as pulling curtains closed confidentiality of patient records, his medical records, he will use the for exams and requesting visitors to patients would be reluctant to hospital’s grievance process or will leave the room when treatment issues participate in medical research if asked. report difficulties to the SA or JCAHO. are being discussed. We have maintained the proposed Comment: Some commenters believe language regarding confidentiality; While setting a concrete time frame ‘‘personal privacy’’ and ‘‘receive care in however, we agree with the might provide a better measuring stick a safe setting’’ should not be combined commenter’s assertion that patients for performance, it would not since they are separate issues. need to have a clear understanding of adequately account for the kinds of Response: We agree and have how a hospital operationalizes this variation that are apt to occur in separated the two elements under the requirement. We will discuss this different hospital settings. standard ‘‘Privacy and Safety.’’ further in interpretive guidelines. Comment: Some commenters Comment: A commenter questioned suggested that the rule be expanded to F. We Proposed That the Patient Has the whether the stated language is state, ‘‘In accordance with local and Right To Be Free From Verbal or expressing a concern for each patient’s State laws, the patient has a right to Physical Abuse or Harassment ability to access his or her records or confidentiality of his or her clinical and Comment: Some commenters wanted whether the language views a hospital’s personal information and records and a the word ‘‘free’’ to be replaced by tendency to ‘‘systemically’’ frustrate right to a copy of his or her medical ‘‘protected’’ and the phrase ‘‘from individuals’ legitimate attempts to gain record or information in his or her hospital staff’’ included in the standard. access to medical records as a violation medical record within a reasonable time One commenter observed that patients of the requirement. frame.’’ can misinterpret hospital staff’s helpful Response: We believe it is each Response: This comment could have verbalizations as abusing and harassing. patient’s inherent right to have access to several meanings. The idea of deferring Commenters believed that this section his or her clinical record, as well as to to local and State law could apply to the should clarify that verbal warnings or have his or her clinical record kept confidentiality provision, the access physician contact with a patient, visitor, confidential. We are setting forth this requirement, the reasonable time frame, or employee, that are reasonably requirement in the final rule. or all three. Specifically, it could be necessary to protect others from Comment: A few commenters noted construed to mean that— intimidation or threat of violence will that there was no definition provided (1) ‘‘The patient’s right to the not be construed as verbal or physical for the term ‘‘reasonable’’ when it was confidentiality of his or her record is abuse. Other commenters wanted the used to describe the time frame within governed by State or local law (rather regulation to express sensitivity to the which the hospital must provide the than Federal law).’’ Currently, DHHS’s fact that hospital personnel will not patient with access to information in his position on this point is to defer to State

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For information obtained under a promise of confidentiality (from someone other would defer to either State or local example, in the December 1997 guidance on this point. proposed rule, we proposed under the than a health care provider), and revised Information Management CoP inspection could reasonably reveal the The criteria we have set out above, source. that would describe circumstances that that the patient’s medical information • must be available to all authorized The information is held by an might limit access by patients to their professional personnel providing oversight agency and access by the hospital medical records, are not being medical care to the patient. If the patient could be reasonably likely to incorporated into this final rule. Rather, patient’s care is to be well integrated impede an ongoing oversight or law we are raising them now as examples of and planned, those who are providing enforcement activity. the narrow areas in which providers • The information is collected in the the various professional services should exercise discretion. Once we course of a clinical trial, the trial is in involved in the patient’s treatment may have reviewed the comments, we will progress, an institutional review board need to review the patient’s medical consider whether further guidance is has approved the denial of access, and status and history. It is expected that necessary. the patient has agreed to the denial of there will be management choices and access when consenting to participate. Comment: One commenter stated the policies determining what uses and • The information is compiled regulation should require records to be disclosures of patient information are principally in anticipation of, or for use supplied at a fair market rate. authorized, and that there will be in, a legal proceeding. Response: Pricing must not create a administrative, management, and DHHS’s policy also provides that technical safeguards to ensure that only barrier to the individual receiving his or those holding these health care records her medical records. Records should be persons using records for authorized be permitted to deny inspection if the purposes may have access to them. For supplied at a cost not to exceed the information is used solely for internal community standard. If State law example, the release of the patient’s management purposes and is not used record may occur if the patient is establishes a rate for the provision of in treating the patient or making any records, State law should be followed. transferred to another facility, to comply administrative determination about the with the provisions of Federal law and However, in the absence of State law, patient, or if it duplicates information the rate charged by organizations such State law (where State law is not available for inspection by the patient. as the local library, post office, or a local inconsistent with Federal law), when The DHHS’s policy sets forth the allowed under third party payment expectation that in general, patients commercial copy center that would be contract, as approved by the patient, should be able to see and copy their selected by a prudent buyer can be used and when inspection by authorized records, and that recordholders should as a comparative standard. agents of the Secretary is required for only be able to deny access to the We are finalizing the requirement as the administration of the Medicare portion of the record that meets the proposed and believe that charging program. aforementioned criteria. The excessive fees for copies of a patient’s (2) ‘‘The patient’s right to access his recordholder should redact the portions medical record would constitute a or her record should be governed by allowed to be denied and should give violation of the Patients’ Rights CoP as State and local law.’’ A discussion of the patient the rest of the information. this practice could be used to frustrate DHHS’s position is in order. The general The accompanying discussion of the legitimate efforts of individuals to policy position of the DHHS on this DHHS’s policy recommendations gain access to their own medical topic is set out in ‘‘Confidentiality of supports patient access to his or her records. We expect that we would Individually-identifiable Health own records. At least 31 States receive and investigate complaints if Information, Recommendations of the explicitly provide this right by law. hospitals charged excessive fees for Secretary of Health and Human While we acknowledge the provider’s medical records. Services, pursuant to section 264 of the right to exercise judgment in the release Comment: Some commenters stated Health Insurance Portability and of a patient’s record in these narrow that consideration should be given to Accountability Act of 1996,’’ in which instances, we firmly believe that a risk management issues involved in the the Secretary recommended Federal patient cannot take an active, release of incomplete medical records. legislation to protect the rights of meaningful role in his or her health care patients with respect to their health decisions if he or she is not allowed to Response: We are unsure whether the information. know what is happening to his or her commenter is referring to a closed The policy recommended there is that own body or mind. If he or she cannot record that may be incomplete or to a the patient should be allowed to inspect comprehend that information, then it request for a copy of a current, open and copy health information about should be available to his or her record that, until the patient is himself or herself held by providers and representative (as allowed under State discharged, will be incomplete. In either payers, but that providers and payers law), who then acts on his or her behalf. situation, we believe it is a patient’s could, in their discretion, withhold The patient’s right to be informed of his inherent right to have access to his or information from the patient under very treatment, his health status, and his her clinical record. A hospital may narrowly defined circumstances: prognosis is just that—his inherent decide to provide a staff member to • The information is about another right, to be exercised by the individual review the record with the patient as person (other than a health care or at his or his representative’s (as necessary to minimize provider) and the holder determines allowed under State law) discretion. We misunderstandings and respond to that patient inspection would cause believe that this right is best supported concerns.

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H. Seclusion and Restraint hospital. J Am Geriatr Soc (1987) those instances where restraints are 35:290; Frengley, JD and Mion, LC: contemplated or in use * * * Further, more (1) We Received Approximately 150 Incidence of physical restraints on acute attention to staff education regarding Comments Regarding the Proposal That general medical wards. J Am Geriatr Soc selection of appropriate restraints by type Patients Have the Right To Be Free From (1986) 34:565; Strumpf, NE and Evans, and size and their proper application and the Use of Seclusion or Restraint, of Any monitoring seems to be warranted if restraint- LK: Physical restraint of the Form, as a Means of Coercion, related accidental injuries and deaths are to hospitalized elderly: Perceptions of Convenience, or Retaliation by Staff be avoided.’’ (J Am Geriatr Soc (1989) 37:70). patients and nurses. Nursing Research Comment: None of the commenters (1998) 37:132.) The FDA estimates that In its Safety Alert of July 15, 1992, the voiced an objection to the addition of at least 100 deaths from the improper FDA echoed the need for training to this standard under Patients’ Rights. use of restraints may occur annually. decrease the incidence of deaths and Response: Since we proposed the rule Mion et al. further noted that, ‘‘Some injuries involving restraining devices. in 1997, interest in the use of seclusion evidence exists that the use of physical The FDA suggested that institutions and restraint and its consequences has restraints is not a benign practice and is provide in-service training for staff as increased markedly. Part of this associated with adverse effects, such as regularly as possible, including a heightened awareness is due to media longer length of hospitalization, higher demonstration of proper application of attention devoted to this topic. One of mortality rates, higher rates of restraint. Given the stated need for the most controversial series of complications, and negative patient training if accidental injuries and deaths newspaper reports appeared in October reactions. Physical restraints have a are to be avoided and the use of 1998 in Connecticut’s Hartford Courant. detrimental effect on the psychosocial alternative measures promoted, we have The articles cited the results of a study well-being of the patient’’ (see Mion et added language to the final rule that that identified 142 deaths from al.: A further exploration of the use of will require a training program on seclusion and restraint use in behavioral physical restraints in hospitalized restraint for staff. We have also noted health treatment facilities, including patients. Jour Am Geriatr Soc (1989) that these training programs should psychiatric hospitals and psychiatric 37:955; Schafer, A: Restraints and the review alternatives to restraint and treatment units in general hospitals, elderly: When safety and autonomy seclusion, to teach skills so that staff over the past 10 years. Restraint use has conflict. Can Med Assoc J (1985) who have direct patient contact are well also been covered in the broadcast 132:1257–1260). equipped to handle behaviors and media and has been investigated by the Research findings on the impact of symptoms as much as possible without General Accounting Office. All of this restraints use have lead to research on the use of restraints or seclusion. attention has generated a great deal of and development of alternative methods In the final rule, we have added the concern for patient safety and well- for handling the behaviors and word ‘‘discipline’’ to the standard being within the public, private, and symptoms that historically prompted statement to read, ‘‘The patient has the regulatory sectors. the application of restraint. However, right to be free from the use of seclusion While we find the reports of deaths various studies provide evidence that or restraint, of any form, as a means of associated with restraint use disturbing, restraint is still being used when coercion, discipline, convenience, or we are equally concerned with the alternate solutions are available (see retaliation by staff.’’ Discipline is not an impact that restraint use has on acute Donat, DC: Impact of a mandatory acceptable reason for secluding or and long-term care patients. The behavior consultation on seclusion/ restraining a patient. In the treatment prevalence of injuries and accidents restraint utilization in psychiatric environment, it is impossible to involving restraint is difficult to gauge. hospitals. J Behav Ther Exp Psychiatry distinguish between ‘‘discipline’’ and If manufacturers learn of a death or (1998 March) 29:1, 13–9; Dunbar, J: ‘‘punishment.’’ serious injury caused by a medical Making restraint-free care work. Another addition to the final rule are device, they must report it to the Food Provider (1997 May) 75–76, 79; and definitions of ‘‘physical restraint,’’ and Drug Administration (FDA). Device Moss, RJ: Ethics of mechanical ‘‘drug that is used as a restraint,’’ and user facilities (hospitals, nursing homes, restraints. Hasting Center Report (1991 ‘‘seclusion.’’ We believe that codifying outpatient treatment facilities, Jan-Feb) 21(1):22–25.) the definitions of these terms will outpatient diagnostic facilities) must While we acknowledge that in some provide a clear legal basis for the report a death of one of their patients emergency situations the use of restraint enforcement of these standards. caused by the medical device to FDA may be the least potentially harmful We have decided upon a division of and the manufacturer, and a serious way to protect the individual’s safety or the restraint and seclusion standard in injury to the manufacturer only. No that of others, the patient’s right to be the final rule. As we began work on the other entities are required to report to free from restraint is paramount. final rule, we discovered a pattern of FDA or the manufacturer. Restraint use should be the exception to differences between an intervention Research indicates that the potential the rule, not a standard practice. The used in the provision of acute medical for injury or harm with the use of question that arises is how we and the and surgical care and one used to restraint is a reality. In a 1989 article medical community, with the common manage behavioral symptoms. This published in the Journal of the goal of the well-being of each patient, difference was situation-specific rather American Geriatrics Society, Evans and can eliminate the inappropriate use of than necessarily linked to provider type. Strumpf pointed to an association restraint and can ensure the safety and While the definition of ‘‘restraint’’ spans between the use of physical restraint health of the patient in emergency care settings, the circumstances and and death during hospitalization (Evans, situations where a restraint is applied. expected outcomes for restraints use LK and Strumpf, NE: Tying down the In considering how to achieve these vary. elderly: A review of the literature on goals, we refer to the article by Evans In the final rule, we have attempted physical restraint. J Am Geriatr Soc and Strumpf: to differentiate between situations (1989) 37:65–74; also see Robbins, LJ, ‘‘ * * * the consideration of the anticipated where a restraint is being used to Boyko E, Lane, J, et al.: Binding the length of time in restraint, goals of care, and provide acute-level medical and surgical elderly: A prospective study of the use the likely outcome for the patient become care and those where restraint or of mechanical restraint in an acute care extremely important questions to answer in seclusion is used to manage behavior.

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This approach is similar to that adopted Accordingly, we are accepting be renewed in the previously mentioned in existing standards that JCAHO has commenters’ suggestions to regulate the increments (4 hours for adults; 2 hours created for restraint and seclusion. time frames within which certain for patients ages 9 to 17; 1 hour for When a restraint is applied in the course actions must occur in the behavior patients under 9) for up to a total of 24 of acute medical and surgical care, the management scenario. We are adopting hours—to that point, the practitioner intervention is generally not undertaken the concept of time-limited orders that must reevaluate his or her patient face- because of an unanticipated outburst of appears in JCAHO’s 1999 Hospital to-face before writing a new order. We severely aggressive or destructive Accreditation Standards. Specifically, believe that it is appropriate to behavior that poses an imminent danger the intent statement for standard recognize JCAHO’s work in this area to the patient and others. In medical and TX.7.1.3.1.8 provides that written orders and maintain consistency between surgical care, a restraint may be for restraint or seclusion for behavioral Federal and accreditation standards necessary to ensure that an intravenous health patients are limited to 4 hours for when possible. (IV) or feeding tube will not be removed, adults, 2 hours for children and In situations where a restraint must be or that a patient who is temporarily or adolescents ages 9 to 17, or 1 hour for used for behavior management, permanently mentally incapacitated patients under age 9. These time frames increased vigilance is required because will not reinjure him or herself by were created for JCAHO’s use by a of the heightened potential for harm or moving after surgery has been committee of experts in the field. We injury as the patient struggles or resists. completed. Using a device such as an IV stress, however, that these time frames Furthermore, there is an immediate arm board to provide medication that, if represent the maximum time intervals need for assessment of what has skipped, would cause the patient for which each order can be written. triggered this behavior and for considerable injury or harm may be the Physicians or licensed independent continuous monitoring of the patient’s least restrictive intervention that practitioners may write orders for condition. To address the need for quick accomplishes the necessary shorter increments of time. A licensed assessment of the condition, we are administration of the medication. The independent practitioner is any specifying that the physician or licensed use of a restraint in this circumstance is individual permitted by law and by the independent practitioner see the patient necessary for the patient’s well-being (to hospital to provide care and services, face-to-face within 1 hour of the receive effective treatment) when less without direction or supervision, within application of the restraint or the use of restrictive interventions, such as the scope of the individual’s license and seclusion. keeping the patient’s arm free and consistent with individually granted The standard for restraint use in the mobile have been determined to be clinical privileges. Additionally, under provision of acute medical and surgical ineffective. regulation, while the patient is being services and the standard for restraints Depending on the patient’s diagnosis restrained or secluded, his or her status and seclusion use for behavior and health status, whether the acute must be continually monitored, management are built on the same medical and surgical care patient assessed, and reevaluated, with an eye foundation; however, the behavior requires constant monitoring while toward releasing him or her from the management standard contains more restrained or can be monitored and restraint or seclusion at the earliest rigorous requirements for the timeliness reassessed at regular intervals is a possible time. We believe that these of actions that must be taken by a matter of clinical judgment. factors will ensure that the patient is physician or other licensed independent Additionally, seclusion is not an restrained or secluded for as brief a time practitioner who is granted authority intervention selected to help with the as possible. In addition, we are under State law and by the hospital to provision of medical or surgical requiring that if the restraint or order restraints use or seclusion. The services; therefore, references to seclusion order is written by a physician creation of two restraints standards does seclusion have been removed from the or licensed independent practitioner not represent any lessening in our final standard that appears as subsection other than the ‘‘treating’’ physician, the commitment to restraint reduction and, (e). treating physician must be consulted as as much as possible, elimination in both A critical point to remember is that soon as possible The ‘‘treating’’ the provision of acute care and behavior these standards are not specific to the physician is the physician who is management situations. The distinction treatment setting, but to the situation responsible for the management and does acknowledge, however, that it may the restraint is being used to address. care of the patient. We believe that this not be reasonable to have identical For example, if a hospital has a wing for is important because the ‘‘treating’’ standards for two very different psychiatric patients where it uses physician may have information situations. The absence of time frames restraint or seclusion to manage regarding the patient’s history which for the acute care standard should not behavior, it must meet the restraint and may have a significant impact on the be construed as permission to restrain seclusion behavior management selection of restraint or seclusion as an patients without timely interaction with standard for those patients. intervention. For example, the patient the physician or other licensed The use of restraints or seclusion to may have a history of sexual abuse and independent practitioner who is manage behavior is an emergency restraints or seclusion may actually permitted by the State and the hospital measure that should be reserved for cause psychological harm. to order restraint. When restraint is used those occasions when an unanticipated, JCAHO also states in its explanation to provide acute medical or surgical severely aggressive or destructive of intent for standard TX.7.1.3.1.7 that care, we still expect the patient to be behavior places the patient or others in each licensed independent practitioner continually assessed, monitored, and imminent danger. While different best carries out his or her responsibility reevaluated by hospital staff. The factors may precipitate this type of when he or she participates in daily patient’s care needs will dictate how psychiatric, behavioral, and physical reviews of restraints and seclusion use frequently reassessment by a physician outburst for an individual patient, the related to his or her patients. We are or other licensed independent need for rapid assessment and adopting a parallel philosophy by practitioner is necessary. In any case, continuous monitoring is applicable in specifying in the regulation that an we expect the discontinuation of the each case. order for restraint or seclusion may only restraint at the earliest possible time.

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(2) We Proposed That if Seclusion and As mentioned above, we have modified hospital does have the ability to use Restraints Are Used (Including Drugs the final rule to introduce separate these devices. Used as Restraints), They Must be Used standards to address restraint or We expect hospital policies and in Accordance With the Patient’s Plan of seclusion used for behavior procedures regarding all use of Care, Used Only as a Last Resort, in the management and restraint used in the restraints or seclusion to comply with Least Restrictive Manner Possible, and provision of acute medical and surgical the same fundamental standard: At the Removed or Ended at the Earliest care. This change reflects the differing very least and before all else, the Possible Time emphases contained within JCAHO’s intervention should do no harm. Any intervention must be made in the Comment: One commenter suggested current requirements. As we further develop the guidelines, we will context of an ongoing loop of that there needs to be better continue to work closely with JCAHO. assessment, intervention, evaluation, understanding of why seclusion and Comment: A number of commenters and reintervention. A corollary restraints are used, and development of suggested that the terms ‘‘as a last principle is that the greater the risks efforts to reduce their use. However, this resort’’ should be replaced with, ‘‘when associated with an intervention, the commenter did not believe further medically indicated,’’ or, ‘‘when more careful and thorough the prescriptive Federal regulation is medically necessary,’’ or ‘‘when other assessment must be. necessary. appropriate measures have been found Comment: Seclusion and restraint Response: There is a need to to be ineffective.’’ should never be used simultaneously understand why seclusions and Response: We have replaced the term, and should not cause physical pain to restraints are used; however, the reasons ‘‘as a last resort’’ with ‘‘when other less the patient. behind the use of restraints have been restrictive measures have been found to Response: We are strengthening the studied and to some extent documented be ineffective.’’ We reaffirm that final rule by specifying that physical (see Strumpf NE and Evans, LK: restraints use should not be a standard restraints may not be used in Physical restraint of the hospitalized practice, and restraints should be used combination with seclusion unless the elderly: Perceptions of patients and only when other less restrictive patient is either (1) continually nurses. Nursing Research (1988) 37:132– alternatives are ineffective to protect the monitored face-to-face by an assigned 137; Evans LK and Strumpf NE: Tying safety of the patient or others. staff member; or (2) is continually down the elderly: A review of the Comment: A few comments suggested monitored by staff using both video and literature on physical restraint. Jour including ‘‘and hospital policy’’ after audio equipment. This monitoring must Amer Geriatr Soc (1989) 37:65–74; ‘‘patient’s plan of care’’ to link patient be in close proximity to the patient. Janelli, LM: Physical restraint use in care to the hospital requirements. We agree that the use of a restraint acute care settings. J Nurs Care Qual Response: To meet the restraint and should not harm or cause pain to the (1995 Apr) 9(3) 86–92.) Various studies seclusion requirements, hospitals may patient. We will address this topic in substantiate that restraints are being develop their own policies focusing on the interpretive guidelines. We believe used when alternate solutions are alternatives to seclusion and restraint, that these concepts should be covered as available (see Donat, DC: Impact of a the underlying patient condition, and part of the staff training in the proper mandatory behavior consultation on the discontinuation of seclusion or use of seclusion and restraint. seclusion/restraint utilization in restraint as soon as possible. However, A slightly different issue is the use of psychiatric hospitals. J Behav Ther Exp it seems redundant to require hospitals a drug as a restraint in combination with Psychiatry (1998 March) 29:1, 13–9; to then follow their own policies. Our a physical restraint or seclusion. As Dunbar, J: Making restraint-free care primary concern is that the acknowledged elsewhere in this work. Provider (1997 May) 75–76, 79; requirements of the regulation be met. preamble, drugs may be used for a and Moss, RJ: Ethics of mechanical Ensuring the connection between the variety of purposes and may have restraints. Hasting Center Report (1991 regulations and standards of practice positive value as part of a well-planned Jan–Feb) 21(1):22–25.) and smooth implementation is part of therapeutic strategy. Some are While restraints reduction and the hospital’s responsibility to meet the appropriate given the individual’s plan education programs are underway and CoPs. Accordingly, we are not adopting of care and specific situation. The should be encouraged, we believe that it the commenter’s suggestion. regulation supports the patient’s right to is critical to reinforce appropriate Comment: One commenter suggested be free from drugs that are used to restraints reduction by acknowledging that less restrictive and more restrictive restrain the resident in the absence of the patient’s right to be free from devices should be held to different medical symptoms or for the purpose of restraints except when the use of a standards. discipline, convenience, retaliation, or restraint is the least restrictive option Response: We do not want to apply coercion; however, we do not wish to that will provide the greatest benefit to unnecessary multiple standards when introduce regulations that might block the patient (that is, the risks associated the overarching principle is that the the strides made to appropriately with the use of the restraint are patient has the right to be free from medicate patients who are, for example, outweighed by the risk of not using it). restraints, whether artificially or in pain or clinically depressed. When used to manage behavior, the use scientifically classed, that restrict Comment: A few commenters of restraint or seclusion is only an normal movement or access to his or her suggested that the requirement for emergency measure and requires careful body. We recognize the difference patient records include alternative assessment and monitoring to ensure between an arm restraint applied to approaches attempted before the use of patient safety. enable the provision of needed seclusion and restraints. Comment: Some commenters medication versus a posey vest or four Response: Documentation included in suggested that this regulation display point restraint; however, when their use the patient’s medical record was consistency between HCFA and JCAHO is avoidable, we expect that the hospital discussed in the proposed rule of requirements. will refrain from using any of these December 1997 at proposed Response: We understand and devices. When this intervention is § 482.120(a), the Information appreciate concerns about consistency absolutely necessary to the safety and Management CoP. The proposed between HCFA and JCAHO standards. well-being of the patient or others, the Information Management CoP requires

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36081 recording the diagnosis, comprehensive Furthermore, we are soliciting comment these working definitions, giving assessment and plan of care, on the pros and the cons of requiring the consideration to differences in patient evaluations, consent forms, notes on reporting of serious injury or abuse care issues that are age and population treatments, nursing, medications, related to the use of restraints or specific in acute care hospitals, reactions, a summary report with seclusion, as well as the type of injury behavioral health treatment facilities, provisions for follow-up care, and any or abuse that would be reported, and the and nursing homes. These commenters relevant reports. The CoP also requires process whereby these incidents would requested inclusion and clarification of that revisions to the plan of care be be reported. when the use of side rails constitutes a documented in the patient’s record. Comment: Some commenters restraint and a discussion of leather Accordingly, as the general suggested the need for hospitals to versus soft restraints. requirements are addressed in another develop and implement hospital-based Response: We have provided section that will be addressed in the performance and outcome measures for definitions of ‘‘physical restraint,’’ hospital CoP rule when it is published restraints and seclusion. ‘‘drug that is used as a restraint,’’ and as final, we are not adopting the Response: We are not mandating the ‘‘seclusion’’ in the final rule and plan to commenter’s suggestion. However, we development of these standards at this provide further guidance in the expect that the medical record will time. However, we expect that a interpretive guidelines in the SOM. To contain information on less restrictive hospital, as part of its internal quality adequately respond to commenters’ measures that may have been assessment and performance questions, we will respond in three considered before the selection of improvement program, will evaluate parts. itself in patient care activities that have seclusion or restraint use. In the 1. Physical Restraint interpretive guidelines, however, we potential safety issues, including the use will go into further detail about the of restraints and seclusion. The functional definition of ‘‘physical expectation surrounding the Comment: Commenters stated the restraint’’ parallels existing guidance requirement that restraint or seclusion need to provide periodic educational regarding restraints found in HCFA’s only be used after less restrictive sessions for hospital staff on the proper SOM Appendix P (nursing home interventions are shown to be use of seclusion and restraint in requirements). A restraint is a restraint ineffective. The interpretive guidance compliance with HCFA guidelines. regardless of setting. A posey vest is no will describe what surveyors should Response: We agree. We are adding a less restrictive when applied in a look for in examining compliance with requirement that as part of ongoing hospital than when used in a nursing this standard. training, staff who have direct patient home. Comment: Data showing the use of contact are trained in the proper and Similarly, we are not categorizing seclusion and restraints and any patient safe use of seclusion and restraints, as varieties of physical restraints, such as injuries incurred as a result should be well as trained in techniques and soft versus leather. An object is a reported. alternatives to handle the symptoms, restraint by functional definition; that Response: It is possible that States behaviors, and situations that have is, when it restricts the patient’s and localities may have requirements historically prompted restraint or movement and access to his or her body. for reporting these incidents. seclusion. For example, topics of Under this definition, all sorts of Additionally, Federal law requires that training could include cardiopulmonary devices and practices could constitute a deaths involving restraining devices be resuscitation techniques, methods for restraint. For example, tucking a reported to the FDA, and that both appropriately positioning a restrained patient’s sheets in so tightly that he or deaths and serious injuries associated patient’s head and body to ensure she cannot move is restraining him or with restraint use be reported to the proper respiration and circulation, or her. In that instance, a sheet is a device’s manufacturer. However, this methods for monitoring cardiovascular restraint. One has to examine how the reporting does not cover the situations status. We will provide a more detailed device or object is being used. Putting where patients are suffocated or description of safe, appropriate up side rails that inhibit the patient’s critically injured during physical holds. restraining techniques in the ability to get out of bed when he or she To be more inclusive, we are adding a interpretive guidelines. wants to constitutes a restraint. In § 482.13(f)(7) (under the behavior Research on restraints supports summary, we have adopted a functional management standard) that requires education as the key component in definition that does not name each each hospital to report to us any death decreasing or eliminating the use of device and situation that can be used to that occurs while a patient is restrained seclusion or restraints (see Stilwell, EM: inhibit an individual’s movement or in seclusion, or where it is reasonable Nurses’ education related to use of simply because we believe that this to assume that a patient’s death is as restraints. (1991 Feb) 17(2) 23–6; Cruz, approach is counterproductive. One result of restraint or seclusion. HCFA V: Research-based practice: Reducing could not possibly capture all scenarios will track the reports of deaths from restraints in acute care setting. (1997 or devices in regulation, and a restraints or seclusion occurring in Feb) 23(2)31–40; and Janelli, LM: Acute/ functional approach promotes looking at hospitals. HCFA will use this critical care nurses’ knowledge of individual situations. From our information to (1) authorize onsite physical restraints-implications for staff experience with nursing homes, we investigations (complaint surveys) of development. (1994 Jan–Feb) 10(1)6– know that many people look for a clear- these hospitals in accordance with the 11). As noted earlier, education may cut list of restraints. We believe that current complaint investigation process; also be crucial in efforts to reducing and clinicians will agree, however, that each and (2) inform the Federally-mandated eliminating restraints-related injuries. case is different. A device that acts as a Protection and Advocacy (P&A) entity Comment: A commenter requested restraint for one individual may not in the respective State or territory. further clarification of the definition of inhibit the movement of another. Protection and Advocacy programs are ‘‘restraint,’’ the types of restraints, and Accordingly, we have incorporated a Congressionally authorized (in the types of situations where these definition that focuses on function for accordance with 42 U.S.C. 10101 et.seq.) measures should be used. Commenters the individual. to access facilities and to investigate wanted HCFA and the medical Concerning leather and soft restraints, abuse and neglect complaints. community to collaborate in developing patient safety and comfort are primary

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 36082 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations considerations in selecting a restraining of every 24 hours), to have face-to-face of specificity for the standard for technique or device. We do not feel contact, and to have primary authority restraint and seclusion in behavior qualified to comment on one being to initiate written orders for seclusion management.) Regardless of the preferable to the other, but would offer and restraints. A commenter pointed out situation that is presented to the that restraints in general should be that the proposed rule will exceed the hospital, the nurse’s observation and avoided as much as possible. current law in his State. In that State, intervention in patient care remains seclusion and restraint orders may be critical. Concerning the falsification of 2. Drug Used as a Restraint issued by either a physician, Ph.D., records, we see no connection between We have noted in the regulations text licensed clinical psychologist, or the requirements we are establishing in at § 482.13(e)(1) and § 482.13(f)(1) that a master’s prepared registered nurse. One this rule and an increase in the drug used as a restraint is a medication commenter believed that frequency of behavior. used to control behavior or to restrict assessment should be based on the Comment: A commenter wanted to the patient’s freedom of movement and patient’s presenting factors. Many prohibit PRN orders and mandate 15- is not a standard treatment for the commenters believed the proposed rule minute checks on restrained patients. patient’s medical or psychiatric would be restrictive and impractical, Some responders believed that there condition. Before discussing the thereby encouraging false should not be a defined time limit for concepts behind this definition, we documentation and limiting the ability restraint use, while a few believed that would point out that the language that of the registered nurse in ‘‘sound this limit should be instituted. One precedes this definition clearly sets clinical decision making.’’ commenter believed that patients under forth that the patient has the right to be Response: We acknowledge the age 18 should be in seclusion or free from seclusion or restraint, of any perceived burden of a more prescriptive restraint for shorter periods than adults. form, imposed as a means of coercion, set of standards. As we explained above, One responder suggested a maximum of discipline, convenience, or retaliation in this rule we have attempted to 16 hours. by staff. This right is provided under differentiate between situations where a Response: We agree that PRN orders both the acute medical and surgical care restraint is being used to provide acute- should never be used with or as a part provisions and the behavior level medical and surgical care and of seclusion and restraints, and this management provisions. those when restraint or seclusion is concept has been added to the final rule. Even when there are medical used to manage behavior. The use of PRN orders for seclusion and indications for the use of a drug as a To address the concerns about the restraints would allow a facility to restraint, we believe that the burden of requiring all of these indiscriminately seclude or restrain precautions outlined in the regulation functions to be performed by the patients. As noted earlier, in the acute are necessary to protect the patient. The physician, as well as the comment that medical and surgical care standard, the definition contains a phrase that merits some States permit other licensed need for monitoring continually versus some discussion—‘‘and is not a independent practitioners to order periodic checks is a determination that standard treatment for the patient’s restraint and seclusion, we have will largely be correlated with the medical or psychiatric condition.’’ As changed the final regulation to indicate individual patient’s diagnosis, stated elsewhere, we do not want to the possible involvement of these other treatment, and health status. Basically, unintentionally interfere with the types of professionals as permitted by the determination of frequency of administration of drugs that are part of State law and hospital policy. However, monitoring must be made on an a patient’s therapeutic plan of care—for we are interested in receiving comments individual basis. However, we are example, for a patient with a psychiatric on whether we should adopt more mandating that restraints or seclusion be diagnosis, a mood or behavior-affecting restrictive requirements that would ended at the earliest possible time based drug may be part of the patient’s overall allow only physicians to order restraints on continuous assessment and care plan. To address this consideration, or seclusion for behavior management. reevaluation of the patient’s condition. we added language to address what we We considered the other commenters’ We expect that this assessment would see as the primary point the standard concerns about the restrictiveness and include items such as vital signs, hopes to address—not the drug that is impracticality of the requirements, the circulation, hydration needs, level of being used as an integrated part of the adverse effect that the requirements distress, and agitation. In interpretive care plan, but the drug that is not part might have on the RN’s ability to make guidance, we will specify what is meant of a standard treatment for the patient’s sound clinical judgments, and the by ‘‘continuous assessment and medical or psychiatric condition. potential for falsification of records. We reevaluation of the patient.’’ disagree with these comments on In response to the commenter who 3. Seclusion several counts. First, the RN’s decision- believed in differentiating between the The definition adopted, ‘‘the making skills and judgment are a length of restraint for adults and involuntary confinement of a person in cornerstone of good patient care. This patients under the age of 18, we have a room or an area where the person is rule is not curtailing the RN’s role in adopted JCAHO’s approach to time- physically prevented from leaving,’’ is patient care. Second, the standard for limited orders for restraints or an adaptation of JCAHO’s definition. restraint use for acute medical and seclusion. Concerning the comment that Comment: We proposed a more surgical care maintains flexibility. We restraint should be limited to 16 hours, prescriptive set of requirements for have avoided being overly prescriptive we understand the desire to put some restraints and seclusion in the preamble in this standard because of the need for sort of a cap on the amount of time that to the proposed rule. Many commenters sound clinical judgment in meeting the an individual can be restrained. cited a potential burden, inefficiency of patient’s individual care needs. In the However, we found no precedent for a care, expense, and safety issues that provision of acute medical and surgical 16-hour or any other time-specific cap, may arise as a direct result of mandating care, we agree with the commenter who and we believe that it is clinically ill- physician consultation to evaluate for observed that patient assessment should advised to set an absolute maximum on restraint utilization, to write orders be based on his or her presenting how long an individual can be every 2 hours for pediatric patients or condition. (Earlier, we described the restrained. As discussed earlier, we every 6 hours for adult patients (instead rationale for codifying a greater degree have indicated that orders for physical

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36083 restraint and seclusion may be renewed approved by the medical staff to be used outcomes, we agree that a detailed in the previously mentioned increments in emergency situations in a manner process does not necessarily in and of for up to a total of 24 hours. At that consistent with these regulations. itself guarantee quality of care. point, the physician or licensed Comment: Commenters stated that we However, we believe that we have independent practitioner who ordered are singling out the use of established a framework in regulations the use of restraints or seclusion must psychopharmacological drugs in the that promotes the patient’s right to be see his or her patient in person to overall proposed rule. One commenter free of restraints and seclusion and determine whether the issuance of a asked that references to protects him or her when their use is new order is appropriate. The psychopharmacological drugs be instituted. requirement that patients who are removed from the CoP. Comment: One commenter asserted restrained for behavioral purposes are Response: We agree that there is no that particularly in psychiatric continually assessed, monitored, and need to specify institutions, restraints and seclusion can reevaluated, combined with the ‘‘psychopharmacological’’ drugs and be used to prevent patients from filing regulatory expectation that restraints have removed the term. Any drug that complaints or taking steps to initiate use will be discontinued at the earliest alters mood, mental status, or behavior discharge. The commenter further noted possible time, should ensure that can be used as a restraint depending on that even those patients who are not in restrained patients are released as soon the situation. seclusion may effectively be prevented as they can commit to safety and no Comment: Many comments centered from using the phone to notify family or longer pose a threat to themselves or around linking the valid use of a primary physician of their others. restraints (including drugs used as hospitalization by an unscrupulous While the regulation stresses the restraints) to the patient’s plan of care provider. To address this situation, the minimal use of restraint or seclusion, and the hospital’s policy. commenter recommended that we when these steps are necessary, the Response: The use of restraints must include the patient’s right to request staff’s training should provide a good be linked to the patient’s modified plan that a family member of his or her groundwork for ensuring that staff know of care, and we have put this language choice and his or her physician be how to meet each patient’s basic needs. in the regulation. We refer to the notified promptly of his or her As a result of their training, staff should ‘‘modified’’ plan of care to reinforce our admission to the hospital. be equipped to assess, monitor, and expectation that restraint or seclusion Response: In the final rule, we have reevaluate each restrained patient as should not be a standard response to a added a requirement that addresses this well as provide care to meet basic particular behavior or situation. The use right. needs. of these interventions is an emergency Comment: Suggestions were made measure that temporarily protects the General Comments that nurses should be allowed (1) to safety of the patient and others; Comment: Recommendations were receive verbal or telephone orders from however, it is not a long-term solution made for us to provide more guidance physicians who are prescribing restraint for handling problematic behavior. on the specific documentation hospitals or seclusion orders and (2) to use If restraints are used, their use must are required to provide to surveyors to ongoing assessment and a standardized be in accordance with a physician’s indicate compliance and, ultimately, for restraint protocol. order (or other licensed independent us to be aware of how these regulations Response: Current requirements at practitioner’s order, as noted earlier) may impact patient safety. § 482.23(c)(2)(i) allow nurses to receive and the patient’s modified plan of care; Response: We intend to issue verbal or telephone orders. In addition, used in the least restrictive manner interpretive guidance that will elaborate many States have laws regarding possible; used in accordance with on the hospital’s responsibilities, what telephone orders. We agree that appropriate restraining techniques; use the surveyors should evaluate to professional staff should be able to use only when other appropriate measures determine compliance with this standard seclusion or restraint have been found to be ineffective to requirement, and the extent to which protocols, in accordance with medical protect the patient or others from harm; the use of seclusion or restraints in each standards of practice and hospital and ended at the earliest possible time. individual instance provides policies and procedures that are The patient’s treating physician must be demonstrable evidence that the consistent with these regulations. If a consulted as soon as possible, if the intervention is clearly tied to the hospital and medical staff develop and treating physician did not order the individual patient’s plan of care. authorize the use of this protocol for restraint. In addition, the condition of Through our on-site survey presence in emergency situations, it would meet the the restrained patient must be initial certification surveys, requirement that restraints be used in continually assessed, monitored, and recertification surveys and the accordance with the order of a reevaluated. investigation of complaints, HCFA will physician or other licensed independent Comment: A commenter believed that monitor how well hospitals are meeting practitioner who is approved by the no further details need to be included in these new standards. State and the hospital to issue this the regulation as it only increases the Comment: A commenter suggested the order. We will explain this further in paperwork burden for the hospital while use of measurement and assessment interpretive guidelines. We expect that not guaranteeing improved quality of processes that would identify the nurse or other professional who patient care. opportunities to reduce the risk initiates the protocol will contact the Response: We have adopted more associated with restraint use through appropriate physician at the earliest prescriptive requirements based on introducing preventive strategies, possible time to obtain a verbal order for recent public health concerns, as noted innovative alternatives, and process the restraint or seclusion intervention. above. The paperwork aspect of both the improvement. Comment: Provisions need to be made acute medical and surgical restraint use Response: We think this is an for the emergency application of and the behavior management restraints excellent suggestion; however, we are restraints. and seclusion are minimal. As other not mandating specific measures or Response: We agree. Hospitals may factors, such as the professionalism and assessment protocols. We expect a develop an emergency protocol training of staff, will affect patient hospital, through its quality assessment

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 36084 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations and performance improvement have been made to strengthen the The fifth standard, Restraint for Acute activities, to assess itself in this regard. proposed regulation and are set forth as Medical and Surgical Care, codifies the Comment: A commenter suggested follows. patient’s right to be free from both including the right to nondiscriminatory The first standard, Notice of Rights, physical restraints and drugs that are treatment—which should include a states, ‘‘A hospital must inform each used as a restraint that are not medically prohibition against discrimination on patient, or when appropriate, the necessary or are used as a means of the basis of mental or physical disability patient’s representative (as allowed coercion, discipline, convenience, or and socioeconomic status. under State law) of the patient’s rights retaliation by staff. The rule defines Response: As a result of their receipt in advance of furnishing or ‘‘restraint,’’ ‘‘physical restraint,’’ and of Federal funds, Medicaid-and discontinuing patient care whenever ‘‘drug used as a restraint.’’ In Medicare-participating hospitals are possible.’’ This standard also requires accordance with commenters’ already prohibited from discriminating that the hospital have a grievance suggestions, we removed the term on the basis of race, color, or national process and indicate who the patient ‘‘psychopharmacological’’ from the origin (under title VI of the Civil Rights can contact to express a grievance. The standard to acknowledge that a wide Act of 1964), age (under the Age minimum elements that must be range of drugs may be used as a Discrimination Act of 1975), and common to all hospital grievance restraint. disability (under section 504 of the processes are specified. The regulation states that a restraint Rehabilitation Act of 1973). In addition, The second standard, Exercise of can only be used when less restrictive the Americans with Disabilities Act Rights, provides the patient the right to interventions have been determined to protects persons with disabilities from participate in the development and be ineffective. It also acknowledges the discrimination. implementation of his or her plan of ability of licensed independent The regulations governing the care, and to request or refuse treatment. practitioners authorized by the State Medicare provider agreement recognize The Exercise of Rights standard sets and the hospital to write orders for these protections and discuss them at forth the patient’s right to make restraints. The regulation states that the § 489.10(b). Specifically, this section, patient’s treating physician must be entitled ‘‘Basic requirements,’’ requires decisions regarding his or her care and the right to formulate advance directives contacted, as soon as possible, if the the provider to meet the applicable civil restraint is not ordered by the patient’s rights requirements of title VI of the and to have hospital staff and practitioners who provide care in the treating physician. We have added Civil Rights Act of 1964, as language that mandates that restraints hospital comply with those directives, implemented by 45 CFR part 80, which must never be written as a standing in accordance with § 489.100 provides that no person in the United order, or on an as needed basis (that is, (Definition), § 489.102 (Requirements States shall, on the ground of race, PRN). The final rule states that restraint for providers), and § 489.104 (Effective color, or national origin, be excluded use must be in accordance with a dates). We have added a requirement from participation in, be denied the written modification to the patient’s that the patient has the right to have a benefits of, or be subject to plan of care; in the least restrictive family member or representative of his discrimination under any program or manner possible; in accordance with or her choice and his or her physician activity receiving Federal financial safe and appropriate restraining notified promptly of his or her assistance. Section 489.10(b) also techniques; and selected only when requires compliance with section 504 of admission to the hospital. other less restrictive measures have the Rehabilitation Act of 1973 (which The third standard, Privacy and been found to be ineffective to protect provides protection against Safety, has been changed so that the patient or others from harm. The discrimination to qualified persons with ‘‘personal privacy’’ and ‘‘receive care in standard regarding restraint use related disabilities), the Age Discrimination Act a safe setting’’ could be made into two to acute medical and surgical care also of 1975 (which provides protection separate elements under this standard as requires that the condition of the patient against discrimination based on age), requested by commenters. The final in restraints must be continually and other pertinent requirements of the regulation states that ‘‘The patient has assessed, monitored, and reevaluated; Office for Civil Rights of the Department the right to personal privacy,’’ and, the restriction of patient movement or of Health and Human Services. ‘‘The patient has the right to receive activity by restraints be ended at the Moreover, if a facility is funded under care in a safe setting.’’ We have altered earliest possible time; and all direct care title VI or title XVI of the Public Health the requirement that the patient has the staff must have ongoing education and Service Act, it is prohibited from right to be free from verbal or physical training in the proper and safe use of denying services to persons unable to abuse and harassment to state that the restraints. pay for needed services if the persons patient has the right to be free from all The last standard, Seclusion and are seeking emergency services and forms of abuse or harassment. Restraint for Behavior Management, reside in the hospital service area or if The fourth standard, Confidentiality contains many of the same elements those persons are eligible under the and Patient Records, contains the stated in the fifth standard (related to uncompensated services provision of provisions of the proposed rule; restraints used in acute medical and the Act. The facility is also prohibited specifically, the right to the surgical care) but goes further by from discriminating based on method of confidentiality of his or her record and discussing the use of seclusion and payment. the right to access information provides specific requirements for the contained in his or her clinical records monitoring and evaluation of a secluded V. Provisions of the Final Rule within a reasonable time frame. To this or restrained patient for behavior For reasons specified in the preamble, standard, we have added a requirement management. we are codifying the Patients’ Rights stating that the hospital must not This standard provides that seclusion CoP within the current hospital CoPs frustrate the legitimate efforts of or restraint for behavior management under Subpart B—Administration at individuals to gain access to their own can only be used in emergency § 482.13. The six standards to the CoP medical records and must actively seek situations if it is needed to ensure the will set forth minimum protections and to meet these requests as quickly as its patient’s physical safety, and less will promote patients’ rights. Changes recordkeeping system permits. restrictive interventions have been

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36085 determined to be ineffective. This ongoing training in both the proper and However, to the extent the rule may standard also provides that seclusion or safe use of seclusion and restraints and have significant effects on providers or restraint use must be in accordance with alternative techniques and methods for beneficiaries, or be viewed as the order of a physician or other handling the behaviors, symptoms, and controversial, we believe it is desirable licensed independent practitioner who situations that traditionally have been to inform the public of our projections is permitted by the State and hospital to treated through restraint and seclusion. of the likely effects of the proposals. order seclusion or restraint use. It also While we are not detailing the sorts of The Unfunded Mandates Reform Act requires that the patient’s treating behaviors, symptoms, and situations of 1995 requires (in section 202) that physician be consulted, as soon as here, we plan to further describe them agencies prepare an assessment of possible, if the restraint or seclusion is in the interpretive guidelines that will anticipated costs and benefits for any not ordered by the patient’s treating implement this regulation. rule that may result in an annual physician. The final rule also states Finally, the regulation requires the mandated expenditure by State, local, explicitly that the requirement for hospital to report to us any death that and tribal governments, in the aggregate restraint or seclusion use for behavior occurs while a patient is restrained or in or by both the private sector, of $100 management will be superseded by seclusion, or where it is reasonable to million. This rule has no mandated existing State laws that are more assume that a patient’s death is as a consequential effect on State, local, or restrictive. result of restraint or seclusion. tribal governments, or the private sector This standard provides that seclusion and will not create an unfunded or restraints may not be ordered on a VI. Regulatory Impact Statement mandate. standing or PRN basis. The regulation A. Overall Impact In December 1997, we proposed to requires a physician or other licensed revise all of the hospital CoPs in concert independent practitioner to see and We have examined the impact of this with Vice President Gore’s REGO evaluate the need for restraint or rule as required by Executive Order initiative. The REGO initiative seclusion within 1 hour after the (E.O.) 12866 and the Regulatory emphasized lessening Federal initiation of this intervention. Flexibility Act (RFA) (Public Law 96– regulation to eliminate unnecessary The final rule sets limits for each 354). E.O. 12866 directs agencies to structural and process requirements, written order for physical restraints or assess all costs and benefits of available focus on outcomes of care, allow greater seclusion based on a patient’s age. For regulatory alternatives and, when flexibility to hospitals and practitioners adults, the written order is limited to 4 regulation is necessary, to select to meet quality standards, and to place hours; for children and adolescents (age regulatory approaches that maximize a stronger emphasis on quality 9–17), the written order is limited to 2 net benefits, including potential assessment and performance hours; for patients under age 9, the economic, environmental, public health improvement. written order is limited to 1 hour. The and safety effects, distributive impacts, Within this newly revised CoP, we final rule states that the original order and equity. proposed the establishment of a may only be renewed for up to a total The RFA (5 U.S.C. 601 through 612) Patients’ Rights CoP for hospitals that of 24 hours. After the original order requires agencies to analyze options for contains rights not addressed in the expires, a physician or licensed regulatory relief for small entities. current provisions. We solicited independent practitioner (if permitted Consistent with the RFA, we prepare a comments on the Patients’ Rights CoP by State law) must see and assess the regulatory flexibility analysis unless we and received strong support for its patient before issuing a new order. certify that a rule will not have a establishment. There was consensus The final rule states that any restraint significant economic impact on a among the public, mental health or seclusion use must be in accordance substantial number of small entities. For advocacy groups, media, and the with a written modification to the purposes of the RFA, we treat most Congress that we should move toward patient’s plan of care, implemented in hospitals and most other providers, establishing such a CoP. This consensus the least restrictive manner possible, in physicians, health care suppliers, was prompted by serious concern about accordance with appropriate restraining carriers, and intermediaries as small improper care of patients in the hospital techniques, and selected only when less entities, either by nonprofit status or by setting, with regard to all aspects of restrictive measures have been found to having revenues of $5 million or less patient care, including the use of be ineffective to protect the patient or annually. Individuals and States are not seclusion and restraint. These factors others from harm. included in the definition of a small led us to set forth this final rule with The standard discusses restraints and entity. comment to ensure the protections of seclusion used in combination, and Also, section 1102(b) of the Act patients’ rights in the hospital setting, provides that they may not be used requires us to prepare a regulatory including the right to be free from the simultaneously unless the patient is impact analysis if a rule may have a use of seclusion and restraint. We continually visually monitored, in significant impact on the operations of believe that this regulation will broaden person, by an assigned staff member, or a substantial number of small rural the consumer’s role in safeguarding and is continually monitored by staff by hospitals. That analysis must conform to participating in his or her care. audio and video equipment. This audio the provisions of section 604 of the Consumer protections are of vital and video monitoring must occur in RFA. For purposes of section 1102(b) of importance in the hospital setting. The close proximity to the patient. It also the Act, we define a small rural hospital recent focus of efforts such as the states that the condition of the patient as a hospital that is located outside of formulation of the Consumer Bill of who is in restraints or seclusion must a Metropolitan Statistical Area and has Rights and Responsibilities points to the continually be assessed, monitored, and fewer than 50 beds. Although the public acknowledgment of the reevaluated and that the restriction of provisions of this interim final rule with important role that each individual is patient movement or activity by comment do not lend themselves to a called upon to play in his or her care. seclusion or restraint use must be ended quantitative impact estimate, we do not We believe that Medicare CoPs must at the earliest possible time. anticipate that they would have a foster each individual’s rights as an The rule also requires that all staff substantial economic impact on most informed consumer and decision maker. who have direct patient contact have Medicare-participating hospitals. Accordingly, we are promoting the

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 36086 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations concepts in the Consumer Bill of Rights associated with the implementation of interventions; however, we are not and Responsibilities, and we are asking some portions of this regulation, we dictating how a hospital meets this the public for comments on believe that by recognizing and requirement. Therefore, hospitals will incorporating additional consumer attending to patients’ rights, hospitals be afforded the flexibility of deciding rights into the hospital CoPs in order to may find improvements in patient how to meet this requirement (for promote compliance with the Consumer collaboration and satisfaction with care, example, provide the training directly Bill of Rights. a reduction of patient-initiated lawsuits through ‘‘in-house’’ training, obtain a regarding care, and through the contractor to provide the training either B. Anticipated Effects hospital’s own grievance process, find a at the hospital or off-site, etc.). We 1. Effect on Hospitals wealth of information to guide quality believe that the benefits associated with Since the Patients’ Rights CoP set improvement efforts. training staff far outweigh the costs We expect hospitals to develop forth below is a newly established CoP, involved since proper training will different approaches to compliance with protect the hospital from situations of we have no factual reports, studies, or the Patients’ Rights CoP based on their inappropriate restraint and seclusion data to aid in the development of cost varying resources and patient use and situations that may lead to or savings estimates. However, we populations, differences in laws in patient injuries and death. believe most hospitals are already various localities, and other factors. Finally, hospitals will have to report fulfilling many of the requirements of However, even in situations where the to HCFA, through the appropriate HCFA this regulation due to State regulation could result in some regional office, any deaths that result requirements, and hospital policies and immediate costs to an individual from restraint or seclusion use for procedures, especially existing policies hospital (that is, developing and behavior management. We believe that and procedures to meet the Life Safety implementing a process to notify the number of deaths related to restraint Code and Physical Environment patients of their rights and allow or seclusion use may be under reported requirements of the current hospital patients to exercise their rights), we in the United States; however, we have CoP, which cover safe environment believe that the changes that the no concrete estimate of the number of issues. Therefore, there may be no hospital would make would produce deaths that occur per year. The Hartford significant increase in burden to most real long-term economic benefits to the Courant, a Connecticut newspaper, hospitals. hospital (that is, a reduction in heightened public awareness of this Given the shift toward regulatory lawsuits). It is important to note that issue with a series of articles in October flexibility, for the most part, we are not because of the flexibility afforded 1998 citing the results of a study that prescribing the exact process hospitals hospitals to implement this regulation, identified 142 deaths from seclusion must follow to meet the regulatory the extent of the economic impact on and restraint use in behavioral health requirements regarding Patients’ Rights. individual hospitals will vary and is treatment facilities over the past 10 However, there are several provisions subject in large part to their decision- years. However, this number includes that will impact hospitals to a greater or making. The impact will also vary deaths from seclusion and restraint use lesser degree. Specifically, hospitals according to each hospital’s current in more than just the hospital setting. will have to establish policies and policies and procedures and level of There may be a small cost involved in procedures necessary for compliance compliance with existing State law and making a telephone call to the HCFA with this regulation: notification of regulations. regional offices; however, because we rights, exercise of rights, privacy and Overall, we believe that the benefits of expect this regulation to reduce the safety, confidentiality, and patient complying with the Patients’ Rights CoP number of deaths from restraint and access to records. Hospitals will have to will far outweigh the costs involved. We seclusion use, the number of reports develop a grievance process and ensure also note that with regard to the certainly will average less than one call that staff are provided with ongoing restraint and seclusion standards for per hospital per year. Therefore, we education and training in the proper both acute medical and surgical care think the cost will be negligible. and safe use of seclusion and restraint and behavior management, there should application and techniques and be no significant additional burden for, 2. Effect on Beneficiaries alternative methods for handling at least, the 80 percent of Medicare- The implementation of the Patients’ behavior, symptoms, and situations that participating hospitals accredited by Rights CoP will serve to protect not only traditionally were treated through the JCAHO since the requirements are Medicare and Medicaid beneficiaries use of restraints or seclusion. In modeled on JCAHO’s standards for both but all patients receiving care in any of addition, hospitals will have to report to their hospital accreditation program and the 6,163 (4,734 accredited and 1,429 the appropriate HCFA regional office their behavioral health care nonaccredited) Medicare-participating any deaths that result from restraint or accreditation program. For the other 20 hospitals (that is, short-term, seclusion use for behavior management. percent of hospitals that are psychiatric, rehabilitation, long-term, Regarding the grievance process, nonaccredited, there may be some one- children’s, and alcohol-drug), including hospitals may use different approaches time costs associated with developing small rural hospitals. Our goal is to to effectively meet this CoP. We are policies and procedures for restraint and safeguard against the mistreatment of all setting forth the general elements that seclusion use. However, we believe that patients in these facilities including, but should be common to grievance the benefits far outweigh the costs not limited to, deaths due to processes across all hospitals, but we because, from a risk management inappropriate seclusion and restraint are not explicitly delineating strategies viewpoint, clear policies will protect the use, violation of patients’ privacy and and policies to comply with the hospital from situations of inappropriate confidentiality in various aspects of the requirement. Also, we are setting forth restraint and seclusion use and health care delivery process, and more detailed, prescriptive situations that may lead to patient systematic frustration of the patient’s requirements than were contained in the injuries and death. There may be costs efforts to acquire his or her medical proposed rule for the use of seclusion associated with developing training record. We believe the patient will and restraint for behavior management programs for staff regarding restraint benefit from the hospital’s focus on situations. Despite the potential burden and seclusion use and alternative patients’ rights. Through these

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36087 protections, patient care can be health care accreditation than for clinically necessary. The Patients’ delivered in an atmosphere of respect hospital accreditation. Rights CoP is a new requirement for for an individual patient’s comfort, We considered recognizing only hospitals. Therefore, we have prepared dignity, and privacy. We also believe physicians as the individuals able to a voluntary analysis consistent with the that implementation of the Patients’ order restraints or seclusion. However, analysis set forth by the RFA. We solicit Rights CoP will lead to a reduction in in recognizing that licensure and scope public comments on the extent that any the numbers of restraint-related injuries of practice are within a State’s domain, of the entities would be significantly and deaths in hospitals. and considering that other types of economically affected by these licensed independent practitioners provisions. 3. Effect on Medicare and Medicaid provide a great deal of care in rural and Programs frontier areas, we did not adopt that VII. Collection of Information We do not expect the implementation approach. However, we are requesting Requirements of the new Patients’ Rights CoP to comment on whether we should adopt Under the Paperwork Reduction Act generate any significant cost to the more restrictive requirements that (PRA) of 1995, agencies are required to Medicare or Medicaid programs. Also, would allow only physicians to order provide 60-day notice in the Federal we do not believe there will be any restraints or seclusion for behavior Register and solicit public comment additional costs to the survey and management. before a collection of information certification program as compliance Regarding the time frames in which a requirement is submitted to the Office of with this new CoP will either be physician or licensed independent Management and Budget (OMB) for reviewed through a routine, practitioner must see and assess a review and approval. In order to fairly nonaccredited hospital survey, patient after initiation of restraints or evaluate whether an information validation survey or as part of the seclusion for behavior management, we collection should be approved, section existing complaint survey process for considered adopting the Pennsylvania 3506(c)(2)(A) of the PRA requires that hospitals. Office of Mental Health policy of a 1⁄2 we solicit comment on the following hour time frame. However, we C. Alternatives Considered issues: recognized that this requirement might • Whether the information collection We considered adding more not be realistic for rural or frontier areas is necessary and useful to carry out the prescriptive requirements regarding where it may be impossible to get a proper functions of the agency; exactly where, how, when, and by physician or licensed independent • The accuracy of the agency’s whom ‘‘notification of rights’’ must be practitioner to the hospital in 1⁄2 hour. estimate of the information collection carried out. However, in the interest of Therefore, we propose a 1 hour time burden; flexibility and the recognition that this frame and ask the public for comment. • Recommendations to minimize the requirement will apply to hospitals of We considered adopting more information collection burden on the varying size, operating in wide ranges of restrictive requirements for the affected public, including automated localities, serving diverse populations, maximum time frames for the length of collection techniques. we did not adopt this approach. We an order for restraint and seclusion. Therefore, we are soliciting public considered very general regulations text However, since there was no supporting comment on each of these issues for the language addressing the establishment literature or studies, we decided to information collection requirements of a hospital grievance process. adopt the approach and time frames summarized and discussed below. However, based on public comment, we developed and articulated by JCAHO for decided that to remain silent on general its hospital accreditation and behavioral Section 482.13 Condition of expectations for the grievance process health care accreditation programs. Participation: Patients’ Rights could result in the absence of key These standards were developed by A hospital must inform each patient, ingredients that promote a meaningful, experts from the health care field and or when appropriate, the patient’s substantial process that addresses represent consensus on the approach representative (as allowed under State patients’ concerns and promotes their and time frames for issues of seclusion law), of the patient’s rights in advance rights. We believe that the establishment and restraints. In addition, 80 percent of of furnishing patient care whenever of a grievance process promotes patient the Medicare- and Medicaid- possible. empowerment in health care. To participating hospitals are already We anticipate that a hospital will promote the creation of an effective subject to these requirements. Therefore, provide a single ‘‘Notice of Patients’’ grievance process, we are establishing we believe it is reasonable to adopt Rights’’ to each patient or his or her general elements that should be requirements similar to those of JCAHO. representative at the time of admission. common to grievance processes across As referenced in this regulation the all hospitals. Development of more D. Conclusion disclosure notice must inform each detailed strategies and policies to The new Patients’ Rights CoP for patient of his or her right to (1) File a comply with the requirement will be left hospitals sets forth six standards that grievance and whom the patient can to the discretion of each hospital. ensure minimum protections of each contact to file a grievance; (2) We originally considered developing patient’s physical and emotional health participate in the development and one set of very general requirements and safety. These standards address implementation of his or her plan of regulating restraint and seclusion use in each patient’s right to (1) Notification of care; (3) make decisions regarding his or all hospitals for all situations. However, his or her rights; (2) the exercise of his her care; (4) be informed of his or her based on public comments and recent or her rights in regard to his or her care; status, involved in care planning and concerns about restraint and seclusion (3) privacy and safety; (4) treatment, and the ability to refuse use for behavior management situations, confidentiality of his or her records; (5) treatment; (5) formulate advance we concluded that one set of freedom from restraints used in the directives and to have hospital staff and requirements did not afford patients provision of acute medical and surgical practitioners who provide care in the with adequate protections. In addition, care unless clinically necessary; and (6) hospital comply with these directives, we noted that JCAHO has more freedom from seclusion and restraints in accordance with § 489.100, § 489.102, prescriptive standards for behavioral used in behavior management unless and § 489.104; (6) personal privacy; (7)

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 36088 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations receive care in a safe setting, free from We have submitted a copy of this final writing to a grievance committee. The verbal or physical abuse or harassment; rule to OMB for its review of the grievance process must include a (8) confidentiality of his or her clinical information collection requirements in mechanism for timely referral of patient records and the ability to access § 482.13. These requirements are not concerns regarding quality of care or information contained in his or her effective until they have been approved premature discharge to the appropriate clinical records within a reasonable by OMB. Utilization and Quality Control Peer time frame; and (9) be free from If you have any comments on any of Review Organization. At a minimum: restraints and seclusion of any form these information collection and (i) The hospital must establish a used as a means of coercion, discipline, recordkeeping requirements, please mail clearly explained procedure for the convenience, or retaliation by staff. the original and three copies directly to submission of a patient’s written or The burden associated with this the following: verbal grievance to the hospital. requirement is the time and effort Health Care Financing Administration, (ii) The grievance process must necessary to disclose the notice Office of Information Services, specify time frames for review of the requirements referenced above to each Standards and Security Group, grievance and the provision of a patient. We estimate that on average it Division of HCFA Enterprise response. will take each of the 6,097 estimated Standards, Room N2–14–26, 7500 (iii) In its resolution of the grievance, hospitals 8 hours to develop the Security Boulevard, Baltimore, MD the hospital must provide the patient required notice and that it will take each 21244–1850, Attn: John Burke HCFA– with written notice of its decision that hospital 5 minutes to provide each 3018–IFC. contains the name of the hospital notice, with an average of 5,515 notices and contact person, the steps taken on behalf provided per hospital on an annual of the patient to investigate the Office of Information and Regulatory basis. Therefore, the total annual burden grievance, the results of the grievance Affairs, Office of Management and associated with this requirement is process, and the date of completion. 2,850,801 hours. Budget, Room 10235, New Executive (b) Standard: Exercise of rights. (1) In its resolution of the grievance, a Office Building, Washington, DC The patient has the right to participate hospital must provide the patient with 20503, Attn: Allison Eydt, HCFA Desk in the development and implementation written notice of its decision that Officer. of his or her plan of care. contains the name of the hospital List of Subjects in 42 CFR Part 482 (2) The patient or his or her contact person, the steps taken on behalf Grant programs—health, Health representative (as allowed under State of the patient to investigate the facilities, Medicaid, Medicare, law) has the right to make informed grievance, the results of the grievance Reporting and recordkeeping decisions regarding his or her care. The process, and the date of completion. patient’s rights include being informed The burden associated with this requirements. For the reasons set forth in the of his or her health status, being requirement is the time and effort involved in care planning and necessary to disclose the written notice preamble, 42 CFR chapter IV, part 482 is amended as follows: treatment, and being able to request or to each patient who filed a grievance. refuse treatment. This right must not be We estimate that on average it will take PART 482ÐCONDITIONS OF construed as a mechanism to demand each hospital 15 minutes to develop and PARTICIPATION FOR HOSPITALS the provision of treatment or services disseminate the required notice. We deemed medically unnecessary or further estimate that 6,097 hospitals will 1. The authority citation for part 482 inappropriate. provide 55 notices on an annual basis, continues to read as follows: (3) The patient has the right to a total annual burden of 83,834 hours. Authority: Secs. 1102 and 1871 of the formulate advance directives and to Hospitals will have to report to HCFA, Social Security Act (42 U.S.C. 1302 and have hospital staff and practitioners through the appropriate HCFA regional 1395hh), unless otherwise noted. who provide care in the hospital comply office, any deaths that result from with these directives, in accordance restraint or seclusion use for behavior Subpart BÐAdministration with § 489.100 of this part (Definition), management. The burden associated 2. Section 482.13 is added to subpart § 489.102 of this part (Requirements for with this requirement is for hospitals to B to read as follows: providers), and § 489.104 of this part notify HCFA, via telephone call, of any (Effective dates). deaths. Based upon current data, we § 482.13 Condition of participation: (4) The patient has the right to have estimate the number of reports to Patients' rights. a family member or representative of his average less than 10 calls on an annual A hospital must protect and promote or her choice and his or her own basis. Therefore, this requirement is not each patient’s rights. physician notified promptly of his or subject to the PRA, as defined under 5 (a) Standard: Notice of rights. (1) A her admission to the hospital. CFR 1320.3(c). hospital must inform each patient, or (c) Standard: Privacy and safety. (1) Hospitals must maintain when appropriate, the patient’s The patient has the right to personal documentation that each of the representative (as allowed under State privacy. standards and related requirements law), of the patient’s rights, in advance (2) The patient has the right to receive referenced in this regulation have been of furnishing or discontinuing patient care in a safe setting. met. While this requirement is subject to care whenever possible. (3) The patient has the right to be free the PRA, we believe that the burden (2) The hospital must establish a from all forms of abuse or harassment. associated with this requirement is process for prompt resolution of patient (d) Standard: Confidentiality of exempt from the PRA, as defined in 5 grievances and must inform each patient patient records. (1) The patient has the CFR 1320.3(b)(2) and 1320.3(b)(3) whom to contact to file a grievance. The right to the confidentiality of his or her because this requirement is considered hospital’s governing body must approve clinical records. a usual and customary business and be responsible for the effective (2) The patient has the right to access practice; is required under State or local operation of the grievance process and information contained in his or her law; and is used to satisfy accreditation must review and resolve grievances, clinical records within a reasonable requirements. unless it delegates the responsibility in time frame. The hospital must not

VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36089 frustrate the legitimate efforts of (5) All staff who have direct patient hours for adults; 2 hours for children individuals to gain access to their own contact must have ongoing education and adolescents ages 9 to 17; or 1 hour medical records and must actively seek and training in the proper and safe use for patients under 9. The original order to meet these requests as quickly as its of restraints. may only be renewed in accordance recordkeeping system permits. (f) Standard: Seclusion and restraint with these limits for up to a total of 24 (e) Standard: Restraint for acute for behavior management. (1) The hours. After the original order expires, medical and surgical care. (1) The patient has the right to be free from a physician or licensed independent patient has the right to be free from seclusion and restraints, of any form, practitioner (if allowed under State law) restraints of any form that are not imposed as a means of coercion, must see and assess the patient before medically necessary or are used as a discipline, convenience, or retaliation issuing a new order. means of coercion, discipline, by staff. The term ‘‘restraint’’ includes (iii) In accordance with a written convenience, or retaliation by staff. The either a physical restraint or a drug that modification to the patient’s plan of term ‘‘restraint’’ includes either a is being used as a restraint. A physical care; physical restraint or a drug that is being restraint is any manual method or (iv) Implemented in the least used as a restraint. A physical restraint physical or mechanical device, material, restrictive manner possible; is any manual method or physical or or equipment attached or adjacent to the (v) In accordance with safe mechanical device, material, or patient’s body that he or she cannot appropriate restraining techniques; and equipment attached or adjacent to the easily remove that restricts freedom of (vi) Ended at the earliest possible patient’s body that he or she cannot movement or normal access to one’s time. easily remove that restricts freedom of body. A drug used as a restraint is a (4) A restraint and seclusion may not movement or normal access to one’s medication used to control behavior or be used simultaneously unless the body. A drug used as a restraint is a to restrict the patient’s freedom of patient is— medication used to control behavior or movement and is not a standard (i) Continually monitored face-to-face to restrict the patient’s freedom of treatment for the patient’s medical or by an assigned staff member; or movement and is not a standard psychiatric condition. Seclusion is the (ii) Continually monitored by staff treatment for the patient’s medical or involuntary confinement of a person in using both video and audio equipment. psychiatric condition. a room or an area where the person is This monitoring must be in close (2) A restraint can only be used if physically prevented from leaving. proximity the patient. needed to improve the patient’s well- (2) Seclusion or a restraint can only be (5) The condition of the patient who being and less restrictive interventions used in emergency situations if needed is in a restraint or in seclusion must have been determined to be ineffective. to ensure the patient’s physical safety continually be assessed, monitored, and (3) The use of a restraint must be— and less restrictive interventions have reevaluated. been determined to be ineffective. (i) Selected only when other less (6) All staff who have direct patient (3) The use of a restraint or seclusion restrictive measures have been found to contact must have ongoing education must be— be ineffective to protect the patient or and training in the proper and safe use others from harm; (i) Selected only when less restrictive measures have been found to be of seclusion and restraint application (ii) In accordance with the order of a ineffective to protect the patient or and techniques and alternative methods physician or other licensed independent others from harm; for handling behavior, symptoms, and practitioner permitted by the State and (ii) In accordance with the order of a situations that traditionally have been hospital to order a restraint. This order physician or other licensed independent treated through the use of restraints or must— practitioner permitted by the State and seclusion. (A) Never be written as a standing or hospital to order seclusion or restraint. (7) The hospital must report to HCFA on an as needed basis (that is, PRN); and The following requirements will be any death that occurs while a patient is (B) Be followed by consultation with superseded by existing State laws that restrained or in seclusion, or where it is the patient’s treating physician, as soon are more restrictive: reasonable to assume that a patient’s as possible, if the restraint is not (A) Orders for the use of seclusion or death is a result of restraint or seclusion. ordered by the patient’s treating a restraint must never be written as a (Catalog of Federal Domestic Assistance physician; standing order or on an as needed basis Program No. 93.773, Medicare Hospital (iii) In accordance with a written (that is, PRN). Insurance; Program No. 93.778, Medical modification to the patient’s plan of (B) The treating physician must be Assistance Program) care; consulted as soon as possible, if the Dated: May 24, 1999. (iv) Implemented in the least restraint or seclusion is not ordered by Nancy-Ann Min DeParle, restrictive manner possible; the patient’s treating physician. Administrator, Health Care Financing (v) In accordance with safe and (C) A physician or other licensed Administration. appropriate restraining techniques; and independent practitioner must see and (vi) Ended at the earliest possible evaluate the need for restraint or Approved: June 9, 1999. time. seclusion within 1 hour after the Donna E. Shalala, (4) The condition of the restrained initiation of this intervention. Secretary. patient must be continually assessed, (D) Each written order for a physical [FR Doc. 99–16543 Filed 6–24–99; 4:29 pm] monitored, and reevaluated. restraint or seclusion is limited to 4 BILLING CODE 4120±01±P

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