CoP: Patient's Rights

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482.13 Patient's Rights

A-0115 482.13 A hospital must protect and promote each patient's rights.

Interpretive Guidelines §482.13
These requirements apply to all Medicare or Medicaid participating hospitals including short-term, acute care, surgical, specialty, psychiatric, rehabilitation, long-term, children's and cancer, whether or not they are accredited. This rule does not apply to critical access hospitals. (See Social Security Act (the Act) §1861(e).)
These requirements, as well as the other Conditions of Participation in 42 CFR 482, apply to all parts and locations (outpatient services, provider-based entities, inpatient services) of the Medicare participating hospital.

482.13(a) Standard: Notice of Rights

A-0117 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible.

Interpretive Guidelines §482.13(a)(1)
The hospital must inform each patient, or when appropriate, the patient’s representative as allowed by State law, of the patient’s rights. Whenever possible, this notice must be provided before providing or stopping care. All patients, inpatient or outpatient, must be informed of their rights as hospital patients. The patient’s rights include all of those discussed in this condition, as well as any other rights for which notice is required under State or Federal law or regulations for hospital patients. (See 42 CFR 482.11.) The patient’s rights should be provided and explained in a language or manner that the patient (or the patient’s representative) can understand. This is consistent with the guidance related to Title VI of the Civil Rights Act of 1964 issued by the Department of Health and Human Services - “Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons” (August 8, 2003, 68 FR 47311). In accordance with §482.11, hospitals are expected to comply with Title VI and may use this guidance to assist it in ensuring patient’s rights information is provided in a language and manner that the patient understands. Surveyors do not assess compliance with these requirements on limited English proficiency, but may refer concerns about possible noncompliance to the Office for Civil Rights in the applicable Department of Health and Human Services Regional Office.
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must provide the designated individual with the required notice of patients’ rights in addition to the patient. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, then the hospital must, when presented with the document, provide the required notice of its policies to the designated representative. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide the required notice to the individual, unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record, along with the specific basis for the refusal.
In addition, according to the regulation at 42 CFR 489.27(a), (which cross references the regulation at 42 CFR 405.1205), each Medicare beneficiary who is an inpatient (or his/her representative) must be provided the standardized notice, “An Important Message from Medicare” (IM), within 2 days of admission. Medicare beneficiaries who have not been admitted (e.g., patients in observation status or receiving other care on an outpatient basis) are not required to receive the IM. The IM is a standardized, OMB-approved form and cannot be altered from its original format. The IM is to be signed and dated by the patient to acknowledge receipt. See Exhibit 16 for a copy of the IM. Furthermore, 42 CFR 405.1205(c) requires that hospitals present a copy of the signed IM in advance of the patient’s discharge, but not more than two calendar days before the patient’s discharge. In the case of short inpatient stays, however, where initial delivery of the IM is within 2 calendar days of the discharge, the second delivery of the IM is not required.
The hospital must establish and implement policies and procedures that effectively ensure that patients and/or their representatives have the information necessary to exercise their rights.

A-0118 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.

Interpretive guidelines §482.13(a)(2)
The patient should have reasonable expectations of care and services and the facility should address those expectations in a timely, reasonable, and consistent manner. Although 482.13(a)(2)(ii) and (iii) address documentation of facility time frames for a response to a grievance, the expectation is that the facility will have a process to comply with a relatively minor request in a more timely manner than a written response. For example, a change in bedding, housekeeping of a room, and serving preferred food and beverage may be made relatively quickly and would not usually be considered a "grievance" and therefore would not require a written response.
The hospital must inform the patient and/or the patient's representative of the internal grievance process, including whom to contact to file a grievance (complaint). As part of its notification of patient rights, the hospital must provide the patient or the patient's representative a phone number and address for lodging a grievance with the State agency. The hospital must inform the patient that he/she may lodge a grievance with the State agency (the State agency that has licensure survey responsibility for the hospital) directly, regardless of whether he/she has first used the hospital's grievance process.
A “patient grievance” is a formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative, regarding the patient's care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with the CMS Hospital Conditions of Participation (CoPs), or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489.
• "Staff present" includes any hospital staff present at the time of the complaint or who can quickly be at the patient's location (i.e., nursing, administration, nursing supervisors, patient advocates, etc.) to resolve the patient's complaint.
• If a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purposes of these requirements. A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf.
• Billing issues are not usually considered grievances for the purposes of these requirements. However, a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489 is considered a grievance.
• A written complaint is always considered a grievance. This includes written complaints from an inpatient, an outpatient, a released/discharged patient, or a patient’s representative regarding the patient care provided, abuse or neglect, or the hospital's compliance with CoPs. For the purposes of this requirement, an email or fax is considered "written."
• Information obtained from patient satisfaction surveys usually does not meet the definition of a grievance. If an identified patient writes or attaches a written complaint on the survey and requests resolution, then the complaint meets the definition of a grievance. If an identified patient writes or attaches a complaint to the survey but has not requested resolution, the hospital must treat this as a grievance if the hospital would usually treat such a complaint as a grievance.
• Patient complaints that are considered grievances also include situations where a patient or a patient's representative telephones the hospital with a complaint regarding the patient’s care or with an allegation of abuse or neglect, or failure of the hospital to comply with one or more CoPs, or other CMS requirements. Those post-hospital verbal communications regarding patient care that would routinely have been handled by staff present if the communication had occurred during the stay/visit are not required to be defined as a grievance.
• All verbal or written complaints regarding abuse, neglect, patient harm, or hospital compliance with CMS requirements are considered grievances for the purposes of these requirements.
• Whenever the patient or the patient's representative requests that his or her complaint be handled as a formal complaint or grievance or when the patient requests a response from the hospital, the complaint is considered a grievance and all the requirements apply.
• Data collected regarding patient grievances, as well as other complaints that are not defined as grievances (as determined by the hospital), must be incorporated in the hospital's Quality Assessment and Performance Improvement (QAPI) Program.

A-0119 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee.

Interpretive guidelines §482.13(a)(2)
The hospital's grievance process must be approved by the governing body. The hospital's governing body is responsible for the effective operation of the grievance process. This includes the hospital's compliance with all of the CMS grievance process requirements. The hospital's governing body must review and resolve grievances, unless it delegates this responsibility in writing to a grievance committee. A committee is more than one person. The committee membership should have adequate numbers of qualified members to review and resolve the grievances the hospital receives (this includes providing written responses) in a manner that complies with the CMS grievance process requirements.

A-0120 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization. At a minimum:

Interpretive Guidelines §482.13(a)(2)
Quality Improvement Organizations (QIOs) are CMS contractors charged with reviewing the appropriateness and quality of care rendered to Medicare beneficiaries in the hospital setting. The QIOs are also tasked with reviewing utilization decisions. Part of this duty includes reviewing discontinuation of stay determinations based upon a beneficiary’s request. The regulations state the functions of the QIOs in order to make Medicare beneficiaries aware of the fact that if they have a complaint regarding quality of care, disagree with a coverage decision, or they wish to appeal a premature discharge, they may contact the QIO to lodge a complaint. The hospital is required to have procedures for referring Medicare beneficiary concerns to the QIOs; additionally, CMS expects coordination between the grievance process and existing grievance referral procedures so that beneficiary complaints are handled timely and referred to the QIO at the beneficiary’s request.
This regulation requires coordination between the hospital’s existing mechanisms for utilization review notice and referral to QIOs for Medicare beneficiary concerns (See 42 CFR Part 489.27). This requirement does not mandate that the hospital automatically refer each Medicare beneficiary’s grievance to the QIO; however, the hospital must inform all beneficiaries of this right, and comply with his or her request if the beneficiary asks for QIO review.
Medicare patients have the right to appeal a premature discharge (see Interpretive Guidelines for 42 CFR 482.13(a)). Pursuant to 42 CFR 412.42(c)(3), a hospital must provide a hospital-issued notice of non-coverage (HINN) to any fee-for-service beneficiary that expresses dissatisfaction with an impending hospital discharge. Medicare Advantage (MA) organizations are required to provide enrollees with a notice of non-coverage, known as the Notice of Discharge and Medicare Appeal Rights (NODMAR), only when a beneficiary disagrees with the discharge decision or when the MA organization (or hospital, if the MA organization has delegated to it the authority to make the discharge decision) is not discharging the enrollee, but no longer intends to cover the inpatient stay.

A-0121 482.13(a)(2)(i) The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital.

Interpretive Guidelines §482.13(a)(2)(i)
The hospital’s procedure for a patient or the patient’s representative to submit written or verbal grievances must be clearly explained. The patient or patient’s representative should be able to clearly understand the procedure.

A-0122 482.13(a)(2)(ii) The grievance process must specify time frames for review of the grievance and the provision of a response.

Interpretive Guidelines §482.13(a)(2)(ii)
The hospital must review, investigate, and resolve each patient’s grievance within a reasonable time frame. For example, grievances about situations that endanger the patient, such as neglect or abuse, should be reviewed immediately, given the seriousness of the allegations and the potential for harm to the patient(s). However, regardless of the nature of the grievance, the hospital should make sure that it is responding to the substance of each grievance while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance.
Document when a grievance is so complicated that it may require an extensive investigation. We recognize that staff scheduling as well as fluctuations in the numbers and complexity of grievances can affect the timeframes for the resolution of a grievance and the provision of a written response. On average, a time frame of 7 days for the provision of the response would be considered appropriate. We do not require that every grievance be resolved during the specified timeframe although most should be resolved. 42 CFR 482.13(a)(2)(iii) specifies information the hospital must include in their response.
If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the hospital should inform the patient or the patient's representative that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within a stated number of days in accordance with the hospital's grievance policy. The hospital must attempt to resolve all grievances as soon as possible.

A-0123 482.13(a)(2)(iii) In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Interpretive Guidelines §482.13(a)(2)(iii)
The written notice of the hospital’s determination regarding the grievance must be communicated to the patient or the patient’s representative in a language and manner the patient or the patient’s legal representative understands.
The hospital may use additional tools to resolve a grievance, such as meeting with the patient and his family. The regulatory requirements for the grievance process are minimum standards, and do not inhibit the use of additional effective approaches in handling patient grievances. However, in all cases the hospital must provide a written notice (response) to each patient’s grievance(s). The written response must contain the elements listed in this requirement.
When a patient communicates a grievance to the hospital via email the hospital may provide its response via email pursuant to hospital policy. (Some hospitals have policies against communicating to patients over email.) If the patient requests a response via email, the hospital may respond via email. When the email response contains the information stated in this requirement, the email meets the requirement for a written response. The hospital must maintain evidence of its compliance with these requirements.
A grievance is considered resolved when the patient is satisfied with the actions taken on their behalf.
There may be situations where the hospital has taken appropriate and reasonable actions on the patient's behalf in order to resolve the patient's grievance and the patient or the patient's representative remains unsatisfied with the hospital's actions. In these situations, the hospital may consider the grievance closed for the purposes of these requirements. The hospital must maintain documentation of its efforts and demonstrate compliance with CMS requirements.
In its written response, the hospital is not required to include statements that could be used in a legal action against the hospital, but the hospital must provide adequate information to address each item stated in this requirement. The hospital is not required to provide an exhaustive explanation of every action the hospital has taken to investigate the grievance, resolve the grievance, or other actions taken by the hospital.

482.13(b) Standard: Exercise of Rights

A-0130 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care.

Interpretive Guidelines §482.13(b)(1)
This regulation requires the hospital to actively include the patient in the development, implementation and revision of his/her plan of care. It requires the hospital to plan the patient’s care, with patient participation, to meet the patient’s psychological and medical needs.
The patient’s (or patient’s representatives, as allowed by State law) right to participate in the development and implementation of his or her plan of care includes at a minimum, the right to: participate in the development and implementation of his/her inpatient treatment/care plan, outpatient treatment/care plan, participate in the development and implementation of his/her discharge plan, and participate in the development and implementation of his/her pain management plan.
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative to exercise the patient’s right to participate in the development and implementation of the patient’s plan of care. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must involve the designated representative in the development and implementation of the patient’s plan of care. The explicit designation of a representative by the patient takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, the hospital, when presented with the document, must involve the designated representative in the development and implementation of the patient’s plan of care. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child) or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and must involve the individual as the patient’s representative in the development and implementation of the patient’s plan of care, unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record, along with the specific basis for the refusal.

A-0131 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate.

Interpretive Guidelines §482.13(b)(2)
The right to make informed decisions means that the patient or patient’s representative is given the information needed in order to make "informed" decisions regarding his/her care.

Patient’s Representative:
A patient may wish to delegate his/her right to make informed decisions to another person (as allowed under State law).
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must provide the designated individual with the information required to make an informed decision about the patient’s care. The hospital must also seek the written consent of the patient’s representative when informed consent is required for a care decision. The explicit designation of a representative by the patient takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, the hospital must, when presented with the document, provide the designated individual the information required to make informed decisions about the patient’s care. The hospital must also seek the consent of the designated individual when informed consent is required for a care decision. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether
or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide the individual the information required to make informed decisions about the patient’s care. The hospital must also seek the consent of the individual when informed consent is required for a care decision. Hospitals are expected to treat the individual as the patient’s representative unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record must, along with the specific basis for the refusal.

Informed Decisions
The right to make informed decisions regarding care presumes that the patient or the patient’s representative has been provided information about his/her health status, diagnosis, and prognosis. Furthermore, it includes the patient's or the patient’s representative’s participation in the development of his/her plan of care, including providing consent to, or refusal of, medical or surgical interventions, and in planning for care after discharge from the hospital. The patient or the patient's representative should receive adequate information, provided in a manner that the patient or the patient's representative can understand, to assure that the patient or the patient’s representative can effectively exercise the right to make informed decisions.
Hospitals must establish processes to assure that each patient or the patient's representative is given information on the patient's health status, diagnosis, and prognosis.
Giving informed consent to a treatment or a surgical procedure is one type of informed decision that a patient or patient's representative may need to make regarding the patient's plan of care. Hospitals must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent. See the guidelines for 42 CFR 482.51(b)(2) pertaining to surgical services informed consent and the guidelines for 42 CFR 482.24(c)(2)(v) pertaining to medical records for further detail.
Informed decisions related to care planning also extend to discharge planning for the patient's post-acute care. See the guidelines at 42 CFR 482.43(c) pertaining to discharge planning for discussion of pertinent requirements.
Hospitals must also establish policies and procedures that assure a patient's right to request or refuse treatment. Such policies should indicate how the patient's request will be addressed. However, hospitals are under no obligation to fulfill a patient's request for a treatment or service that the responsible practitioner has deemed medically unnecessary or even inappropriate.

Required Hospital Disclosures to Patients:

Physician Ownership
In addition, there are certain provisions of the Medicare provider agreement rules concerning disclosures that certain hospitals are required to make which are enforced under 42 CFR 482.13(b)(2):
• 42 CFR 489.3 defines a “physician-owned hospital” as any participating hospital in which a physician or immediate family member of a physician (as defined in §411.351) has an ownership or investment interest in the hospital, except for those satisfying an exception found at §411.356(a) or (b). Surveyors are not required to make an independent determination regarding whether a hospital meets the Medicare definition of “physician-owned,” but they must ask whether the hospital is physician-owned.
• 42 CFR 489.20(u)(1) requires that all physician-owned hospitals provide written notice to their patients at the beginning of each patient’s hospital inpatient stay or outpatient visit stating that the hospital is physician-owned, in order to assist the patient in making an informed decision about his or her care, in accordance with the requirements of §482.13(b)(2).
• A planned inpatient stay or outpatient visit which is subject to the notice requirement begins with the provision of a package of information regarding scheduled preadmission testing and registration for a planned hospital admission for inpatient care or for an outpatient service subject to notice. An unplanned inpatient stay or outpatient visit subject to the notice requirement begins at the earliest point at which the patient presents to the hospital.
• The notice must disclose, in a manner reasonably designed to be understood by all patients, that the hospital is physician-owned and that a list of owners or investors who are physicians or immediate family members of physicians is available upon request. If the patient (or someone on behalf of the patient) requests this list, the hospital must provide it at the time of the request.
• However, the notice requirement does not apply to any physician-owned hospital that does not have at least one referring physician (as defined at §411.351) who has an ownership or investment interest in the hospital or who has an immediate family member who has an ownership or investment interest in the hospital. In such cases, the hospital must sign an attestation statement that it has no referring physician with an ownership or investment interest or whose immediate family member has an ownership or investment interest in the hospital. The hospital must maintain this attestation in its records.
• 42 CFR 489.20(u)(2) provides that physician-owned hospitals must require each physician owner who is a member of the hospital’s medical staff to agree, as a condition of obtaining/retaining medical staff membership or admitting privileges, to disclose in writing to all patients they refer to the hospital their ownership or investment interest in that hospital or that of any immediate family member. The hospital must require that this disclosure be made at the time of the referral and the requirement should be reflected in the hospital’s policies and procedures governing privileges for physician owners.
• The hospital may exempt from this disclosure requirement any physician owner who does not refer any patients to the hospital.
• 42 CFR 489.12 permits CMS to refuse to enter into a provider agreement with a physician-owned hospital applicant that does not have procedures in place to notify patients of physician ownership in the hospital as required under §489.20(u).
• 42 CFR 489.53(c) permits CMS to terminate a provider agreement with a physician-owned hospital if the hospital fails to comply with the requirements at §489.20(u).

MD/DO 24/7 On-Site Presence
42 CFR 489.20(w) mandates that if there is no doctor of medicine or osteopathy present in the hospital 24 hours per day, seven days per week, the hospital must provide written notice of this to all inpatients at the beginning of a planned or unplanned inpatient stay, and to outpatients for certain types of planned or unplanned outpatient visits. The purpose of this requirement is to assist the patient in making an informed decision about his/her care, in accordance with 42 CFR 482.13(b)(2). Hospitals that have an MD/DO on-site 24/7 (including residents who are MDs or DOs) do not need to issue any disclosure notice about emergency services capability.
• The notice must be provided to all inpatients and to those outpatients who are under observation or who are having surgery or any other procedure using anesthesia.
• The notice must be provided at the beginning of the planned or unplanned inpatient stay, or outpatient visit subject to notice.
• A planned inpatient stay or outpatient visit which is subject to the notice requirement begins with the provision of a package of information regarding scheduled preadmission testing and registration for a planned hospital admission for inpatient care or for an outpatient service subject to notice. An unplanned inpatient stay or outpatient visit which is subject to the notice requirement begins at the earliest point at which the patient presents to the hospital.
• Individual notices are not required in the hospital’s dedicated emergency department (DED) (as that term is defined in 42 CFR 489.24(b)), but the DED must post a notice conspicuously, in a place or places likely to be noticed by all individuals entering the DED. The posted notice must state that the hospital does not have a doctor of medicine or a doctor of osteopathy present in the hospital 24 hours per day, 7 days per week, and must indicate how the hospital will meet the medical needs of any patient with an emergency medical condition, as defined in 42 CFR 489.24(b) [the EMTALA definition], at a time when there is no doctor of medicine or doctor of osteopathy present in the hospital. If an emergency department patient is determined to require admission, then the individual notice requirements of 42 CFR 489.20(w) would apply to that patient.
• Before admitting an inpatient or providing outpatient services requiring notice, the hospital must obtain a signed acknowledgement from the patient stating that he/she understands that a doctor of medicine or doctor of osteopathy may not be present at all times services are furnished to him/her.
• In the event of an unplanned surgery or inpatient admission to treat an emergency medical condition, it may in some cases be necessary in the interest of the patient’s safety to proceed with treatment before the required notice can be given and acknowledgement can be obtained. In such circumstances, the hospital must provide notice and obtain acknowledgement as soon as possible after the patient’s stay or visit begins.
• For a hospital that participates in Medicare with multiple campuses providing inpatient services (e.g., a main provider campus and separate satellite, remote, and/or provider-based locations) under one CMS Certification Number, a separate determination is made for each campus or satellite location with inpatient services as to whether the disclosure notice is required. For example, if a hospital has a main campus and a satellite location and a physician is present 24/7 on the main campus but not at the satellite location, the hospital is required to provide the disclosure notice only at the satellite location. No notice is required for patients presenting to the main provider campus in this case. In this same example, if the hospital also has a provider-based, off-campus ambulatory (i.e., same-day) surgery department, no notice is required at that off-campus surgery site, since the hospital’s main campus does have an MD/DO present 24/7.
• 42 CFR 489.53(c) permits CMS to terminate a provider agreement with a hospital if the hospital fails to comply with the requirements at §489.20(w) when it does not have an MD or DO on-site 24/ 7.

A-0132 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), 489.102 of this part (Requirements for providers), and 489.104 of this part (Effective dates).

Interpretive Guidelines §482.13(b)(3)
An advance directive is defined at §489.100 as “a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated.” The patient (inpatient or outpatient) has the right to formulate advance directives, and to have hospital staff implement and comply with their advance directive. The regulation at 42 CFR 489.102 specifies the rights of a patient (as permitted by State law) to make medical care decisions, including the right to accept or refuse medical or surgical treatment and the right to formulate, at the individual’s option, advance directives.
In the advance directive, the patient may provide guidance as to his/her wishes concerning provision of care in certain situations; alternatively the patient may delegate decision-making authority to another individual, as permitted by State law. (In addition, the patient may use the advance directive to designate a “support person,” as that term is used in §482.13(h), for purposes of exercising the patient’s visitation rights.) When a patient who is incapacitated has executed an advance directive designating a particular individual to make medical decisions for him/her when incapacitated, the hospital must, when presented with the document, provide the designated individual the information required to make informed decisions about the patient’s care. (See also the requirements at §482.13(b)(2).) The hospital must also seek the consent of the patient’s representative when informed consent is required for a care decision. The explicit designation of a representative in the patient’s advance directive takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or, as applicable, outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.

§489.102 also requires the hospital to:
• Provide written notice of its policies regarding the implementation of patients’ rights to make decisions concerning medical care, such as the right to formulate advance directives. If an individual is incapacitated or otherwise unable to communicate, the hospital may provide the advance directive information required under §489.102 to the individual’s “family or surrogate in the same manner that it issues other materials about policies and procedures to the family of the incapacitated individual or to a surrogate or other concerned persons in accordance with State law.”(§489.102(e)) The guidance concerning the regulation at §482.13(a)(1) governing notice to the patient or the patient’s representative of the patient’s rights applies to the required provision of notice concerning the hospital’s advance directive policies. Although both inpatients and outpatients have the same rights under §482.13(a)(1), §489.102(b)(1) requires that notice of the hospital’s advance directive policy be provided at the time an individual is admitted as an inpatient. However, in view of the broader notice requirements at §482.13(a)(1), the hospital should also provide the advance directive notice to outpatients (or their representatives) who are in the emergency department, who are in an observation status, or who are undergoing same-day surgery. The notice should be presented at the time of registration. Notice is not required for other outpatients, given that they are unlikely to become incapacitated.
• The notice must include a clear and precise statement of limitation if the hospital cannot implement an advance directive on the basis of conscience. At a minimum, a statement of limitation should:
• Clarify any differences between institution-wide conscience objections and those
that may be raised by individual physicians or other practitioners;
• Identify the State legal authority permitting such an objection; and
• Describe the range of medical conditions or procedures affected by the conscience objection.
It should be noted that this provision allowing for certain conscience objections to implementing an advance directive is narrowly focused on the directive’s content related to medical conditions or procedures. This provision would not allow a hospital or individual physician or practitioner to refuse to honor those portions of an advance directive that designate an individual as the patient’s representative and/or support person, given that such designation does not concern a medical condition or procedure.
Issuance of the written notice of the hospital’s advance directive policies to the patient or the patient’s representative must be documented in the patient’s medical record.
• Document in a prominent part of the patient’s medical record whether or not the patient has executed an advance directive;
• Not condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive;
• Ensure compliance with requirements of State law concerning advance directives and inform individuals that complaints concerning the advance directive requirements may be filed with the State survey and certification agency;
• Provide for the education of staff concerning its policies and procedures on advance directives. The right to formulate advance directives includes the right to formulate a psychiatric advance directive (as allowed by State law); and
• Provide community education regarding advance directives and the hospital must document its efforts.
A psychiatric advance directive is akin to a traditional advance directive for health care. This type of advance directive might be prepared by an individual who is concerned that at some time he or she may be subject to involuntary psychiatric commitment or treatment. The psychiatric advance directive may cover a range of subjects, and may name another person who is authorized to make decisions for the individual if he or she is determined to be legally incompetent to make his/her own choices. It may also provide the patient’s instructions about hospitalization, alternatives to hospitalization, the use of medications, types of therapies, and the patient’s wishes concerning restraint or seclusion. The patient may designate who should be notified upon his/her admission to the hospital, as well as who should not be permitted to visit him or her. State laws regarding the use of psychiatric advance directives vary.
In accordance with State law, a psychiatric advance directive should be accorded the same respect and consideration that a traditional advance directive for health care is given. Hospitals should carefully coordinate how the choices of a patient balance with the rights of other patients, staff, and individuals in the event that a dangerous situation arises.
However, even if State law has not explicitly spoken to the use of psychiatric advance directives, consideration should be given to them inasmuch as this regulation also supports the patient’s right to participate in the development and implementation of his or her plan of care. When the patient is, for whatever reason, unable to communicate his/her wishes, the preferences expressed in the psychiatric advance directive can give critical insight to the MD/DOs, nurses, and other staff as they develop a plan of care and treatment for the patient.

A-0133 482.13(b)(4) The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital.

Interpretive Guidelines §482.13(b)(4)

Identifying Who Is to Be Notified
For every inpatient admission, the hospital must ask the patient whether the hospital should notify a family member or representative about the admission. If the patient requests such notice and identifies the family member or representative to be notified, the hospital must provide such notice promptly to the designated individual. The explicit designation of a family member or representative by the patient takes precedence over any non-designated relationship.
The hospital must also ask the patient whether the hospital should notify his/her own physician. In the case of scheduled admissions, the patient’s own physician likely is already aware of the admission. However, if the patient requests notice to and identifies the physician, the hospital must provide such notice promptly to the designated physician, regardless of whether the admission was scheduled in advance or emergent.
When a patient is incapacitated or otherwise unable to communicate and to identify a family member or representative to be notified, the hospital must make reasonable efforts to identify and promptly notify a family member or patient’s representative. If an individual who has accompanied the patient to the hospital, or who comes to or contacts the hospital after the patient has been admitted, asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide this individual information about the patient’s admission, unless:
• More than one individual claims to be the patient’s family member or representative. In such cases it would not be inappropriate for the hospital to ask
each individual for documentation supporting his/her claim to be the patient’s family member or representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment ;
• Treating the individual as the patient’s family member or representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s family member or representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual should be notified as the patient’s family member or representative, given the critical role of the representative in exercising the patient’s rights. Hospitals may also choose to provide notice to more than one family member.
When a patient is incapacitated and the hospital is able through reasonable efforts to identify the patient’s own physician – e.g., through information obtained from a family member, or from review of prior admissions or outpatient encounters, or through access to the patient’s records in a regional system of electronic patient medical records in which the hospital participates – the hospital must promptly notify the patient’s physician of the admission.

Prompt Notice
The hospital must provide the required notice promptly. “Promptly” means as soon as possible after the physician’s or other qualified practitioner’s order to admit the patient has been given. Notice may be given orally in person, by telephone, by e-mail or other electronic means, or by other methods that achieve prompt notification. It is not acceptable for the hospital to send a letter by regular mail.

Medical Record Documentation
The hospital must document that the patient, unless incapacitated, was asked no later than the time of admission whether he or she wanted a family member/representative notified, the date, time and method of notification when the patient requested such, or whether the patient declined to have notice provided. If the patient was incapacitated at the time of admission, the medical record must indicate what steps were taken to identify and provide notice to a family member/representative and to the patient’s physician.

482.13(c) Standard: Privacy and Safety

A-0143 482.13(c)(1) The patient has the right to personal privacy.

Interpretive Guidelines §482.13(c)(1)
The underlying principle of this requirement is the patient’s basic right to respect, dignity, and comfort while in the hospital.

Physical Privacy
“The right to personal privacy” includes at a minimum, that patients have physical privacy to the extent consistent with their care needs during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate.
People not involved in the care of the patient should not be present without his/her consent while he/she is being examined or treated. If an individual requires assistance during toileting, bathing, and other personal hygiene activities, staff should assist, giving utmost attention to the individual’s need for privacy. Privacy should be afforded when the MD/DO or other staff visits the patient to discuss clinical care issues or conduct any examination or treatment.
However, audio/video monitoring (does not include recording) of patients in medical-surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring and the monitors or speakers are located so that the monitor screens are not readily visible or where speakers are not readily audible to visitors or the public. Video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.
A patient’s right to privacy may also be limited in situations where a person must be continuously observed to ensure his or her safety, such as when a patient is simultaneously restrained and in seclusion to manage violent or self-destructive behavior or when the patient is under suicide precautions.

Protecting Patient Personal Information
The right to personal privacy also includes limiting the release or disclosure of patient information. Patient information includes, but is not limited to, the patient’s presence or location in the hospital; demographic information the hospital has collected on the patient, such as name, age, address, income; or information on the patient’s medical condition. Such patient information may not be disclosed without informing the patient or the patient’s representative in advance of the disclosure and providing the patient or the patient’s representative an opportunity to agree, prohibit, or restrict the disclosure. Below is a summary of privacy issues that surveyors might encounter in hospital settings, and the related privacy requirements.

Permitted Disclosures:
A hospital is permitted to use and disclose patient information, without the patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for
the provision of health care to an individual.
• Hospital operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
Hospitals must develop and implement policies and procedures that restrict access to and use of patient information based on the specific roles of the members of their workforce. These policies and procedures must identify the persons, or classes of persons, in the workforce who need access to protected health information to carry out their duties and the categories of protected health information to which access is needed.
One example of a permitted disclosure is a Facility Directory. It is common practice in many hospitals to maintain a directory of patient contact information. The hospital must inform the patient, or the patient’s representative, of the individual information that may be included in a directory and the persons to whom such information may be disclosed. The patient, or the patient’s representative, must be given the opportunity to restrict or prohibit any or all uses and disclosures. The hospital may rely on a patient’s/representative’s individual’s informal permission to list in its facility directory the patient’s name, general condition, religious affiliation, and location in the provider’s facility. The provider may then disclose the patient’s condition and location in the facility to anyone asking for the patient by name, and also may disclose religious affiliation to clergy. If the opportunity to prohibit or restrict uses and disclosures cannot be provided due to the patient’s incapacity or emergency treatment circumstance, and there is no patient representative available, the hospital may disclose patient information for the facility’s directory if such disclosure is in the patient’s best interest. The hospital must provide the patient or the patient’s representative an opportunity to prohibit or restrict disclosure as soon as it becomes practicable to do so. The hospital may use patient information to notify, or assist in the notification of, a family member, a personal representative of the patient, or another person responsible for the care of the patient of their location, general condition, or death. The hospital must have procedures in place, in accordance with State law, to provide appropriate information to patient families or others in those situations where the patient is unable to make their wishes known.

Incidental Uses and Disclosures May be Acceptable:
An incidental use or disclosure is a secondary use or disclosure of patient information that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another use or disclosure that is permitted. Many customary health care communications and practices play an important role in ensuring the prompt delivery of effective care. Due to the nature of these communications and practices, as well as of the hospital environment, the potential exists for a patient’s information to be disclosed incidentally. For example, a hospital visitor may overhear a health care professional’s confidential conversation with another health care professional or the patient, or may glimpse a patient’s information on a sign-in sheet or nursing station whiteboard. The regulation protecting patient privacy does not impede these customary and essential communications and practices and, thus, a hospital is not required to eliminate all risk of incidental use or disclosure secondary to a permitted use or disclosure, so long as the hospital takes reasonable safeguards and discloses only the minimum amount of personally identifiable information necessary. For example, hospitals may:
• Use patient care signs (e.g. “falls risk” or “diabetic diet” ) displayed at the bedside or outside a patient room;
• Display patient names on the outside of patient charts; or
• Use “whiteboards” that list the patients present on a unit, in an operating room suite, etc.
Hospitals are expected to review their practices and determine what steps are reasonable to safeguard patient information while not impeding the delivery of safe patient care or incurring undue administrative or financial burden as a result of implementing privacy safeguards.
Examples of reasonable safeguards could include, but are not limited to:
• Requesting that waiting customers stand a few feet back from a counter used for patient registration;
• Use of dividers or curtains in areas where patient and physician or other hospital staff communications routinely occur;
• Health care staff speaking quietly when discussing a patient’s condition or treatment in a semi-private room;
• Utilizing passwords and other security measures on computers maintaining personally identifiable health information; or
• Limiting access to areas where white boards or x-ray light boards are in use, or posting the board on a wall not readily visible to the public, or limiting the information placed on the board.

A-0144 482.13(c)(2) The patient has the right to receive care in a safe setting.

Interpretive Guidelines §482.13(c)(2)
The intention of this requirement is to specify that each patient receives care in an environment that a reasonable person would consider to be safe. For example, hospital staff should follow current standards of practice for patient environmental safety, infection control, and security. The hospital must protect vulnerable patients, including newborns and children. Additionally, this standard is intended to provide protection for the patient’s emotional health and safety as well as his/her physical safety. Respect, dignity and comfort would also be components of an emotionally safe environment. In order to provide care in a safe setting, hospitals must identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers.
Patients at risk of suicide (or other forms of self-harm) or exhibit violent behaviors toward others receive healthcare services in both inpatient and outpatient locations of hospitals. The focus for a ligature “resistant” or ligature “free” environment is that of psychiatric units of acute care hospitals and psychiatric hospitals and does not apply to non-psychiatric units of acute care hospitals that provide care to those at risk of harm to self or others, e.g. emergency departments, intensive care units, medical-surgical units, and other inpatient and outpatient locations. It is important to note that not all patients with psychiatric conditions or a history of a psychiatric condition are cared for in psychiatric hospitals or psychiatric units of acute care hospitals. Therefore, non-
psychiatric settings of all hospitals where patients with psychiatric conditions may be cared for must also identify patients at risk for intentional harm to self or others and mitigate environmental safety risks. Psychiatric patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation or harm to others. The protection would be that of utilizing safety measures such as 1:1 monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.
Although all risks cannot be eliminated, hospitals are expected to demonstrate how they identify patients at risk of self-harm or harm to others and steps they are taking to minimize those risks in accordance with nationally recognized standards and guidelines. The potential risks include but are not limited to those from ligatures, sharps, harmful substances, access to medications, breakable windows, accessible light fixtures, plastic bags (for suffocation), oxygen tubing, bell cords, etc.
Identifying Patients at Risk
There are numerous models and versions of patient risk assessment tools available to identify patients at risk for harm to self or others. No one size fits all tool is available. Therefore, the type of patient risk assessment tool used should be appropriate to the patient population, care setting and staff competency. All hospitals are expected to implement a patient risk assessment strategy, but it is up to the hospital to implement the appropriate strategies. For example, a patient risk assessment strategy in a post-partum unit would most likely not be the same risk assessment strategy utilized in the emergency department.
Environmental Safety Risks
Just as all hospitals must implement a patient risk assessment strategy, all hospitals must implement an environmental risk assessment strategy. Environmental risk assessment strategies may not be the same in all hospitals or hospital units. The hospital must implement environmental risk assessment strategies appropriate to the specific care environment and patient population. That does not mean that a unit which does not typically care for patients with psychiatric conditions is not expected to conduct environmental risk assessments. It means that the risk assessment must be appropriate to the unit and should consider the possibility that the unit may sometimes care for patients at risk for harm to self or others. While CMS does not require the use of an Environmental Risk Assessment Tool (e.g. the Veteran’s Administration Environmental Risk Assessment Tool), the use of such tools may be used as a way for the hospital to assess for safety risks in all patient care environments in order to minimize environmental risks and to document the assessment findings. Examples of Environmental Risk Assessment Tool content may include prompts for staff to assess items such as, but not limited to:
• Ligature risks include but are not limited to, hand rails, door knobs, door hinges, shower curtains, exposed plumbing/pipes, soap and paper towel
dispensers on walls, power cords on medical equipment or call bell cords, and light fixtures or projections from ceilings, etc.
• Unattended items such as utility or housekeeping carts that contain hazardous items (mops, brooms, cleaning agents, hand sanitizer, etc.)
• Unsafe items brought to patients by visitors in locked psychiatric units of hospitals and psychiatric hospitals.
• Windows that can be opened or broken
• Unprotected lighting fixtures
• Inadequate staffing levels to provide appropriate patient observation and monitoring
A ligature risk (point) is defined as anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation. Ligature points include shower rails, coat hooks, pipes, and radiators, bedsteads, window and door frames, ceiling fittings, handles, hinges and closures. (CQC Brief Guide: Ligature points – Review date: June 2017). The most common ligature points and ligatures are doors, hooks/handles, windows, and belts or sheets/towels. The use of shoelaces, doors, and windows increased over time. (Hunt et al 2012; Ligature points used by psych inpatients.)The presence of ligature risks in the physical environment of a psychiatric patient compromises the patient’s safety. This is particularly an issue for a patient with suicidal ideation. The hospital Patient’s Rights Condition of Participation (CoP) at § 482.13(c)(2) provides all patients with the right to care in a safe setting. Psychiatric patients receiving care and treatment in a hospital setting are particularly vulnerable. The presence of ligature risks in the psychiatric patient’s physical environment compromise their right to receive care in a safe setting. Safety risks in a psychiatric setting include but are not limited to furniture that can be easily moved or be thrown; sharp objects accessible by patients; areas out of the view of staff; access to plastic bags (for suffocation); oxygen tubing; equipment used for vital signs or IV Fluid administration; breakable windows; access to medications; access to harmful medications; accessible light fixtures; non-tamper proof screws; etc. The focus of this memo and the forthcoming guidance is care delivered in psychiatric units/hospitals and does not apply to other healthcare settings such as acute care hospitals. Psychiatric patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation. The protection would be that of utilizing safety measures such as 1:1 monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.
Hospital staff must be trained to identify environmental safety risks regardless of whether or not the hospital has chosen to implement the use of an environmental risk assessment tool to identify potential or actual risks in the patient care environment.
Education and Training
Hospitals must provide the appropriate level of education and training to staff regarding the identification of patients at risk of harm to self or others, the identification of environmental patient safety risk factors and mitigation strategies. Staff includes direct employees, volunteers, contractors, per diem staff and any other individuals providing clinical care under arrangement. Hospitals have the flexibility to tailor the training to the particular services staff provide and the patient populations they serve. Hospitals are expected to provide education and training to all new staff initially upon orientation and whenever policies and procedures change. However, CMS recommends initial training and then ongoing training at least every two years thereafter.
Correction of Environmental Risks
Regulations at §488.28 require that the deficiencies addressed in a PoC be corrected within 60 days from receipt of the deficiency report. Follow up surveys to verify correction of condition level deficiencies or the ability of the hospital to correct the ligature risk deficiencies, will be done according to the standards established by the surveying agency. The ability of facilities to comply with the limited number of days allotted for the correction of ligature risks has proven to be burdensome based on a number of variables, such as the severity and scope of the deficiencies, the need to obtain governing body approval, capital budget funding requirements, engage in competitive bidding, availability of the required materials, time for completion of repairs, and access to the unit/hospital areas. Ligature risks are not eligible for life safety code (LSC) waivers as they are not LSC deficiencies.
Cited ligature risks, that do not pose an immediate jeopardy situation or no longer pose an immediate jeopardy situation because the immediate threat to patient health and safety has been removed by the hospital, or has been mitigated through the implementation of appropriate interim patient safety measures, are expected to be corrected within the allotted number of days accorded by the CMS RO, SA or AO. Interim patient safety measures are expected to be implemented as part of an acceptable plan of correction to mitigate patient safety risks, as appropriate, until the ligature risks can be eliminated. Per § 488.28, the correction period begins the date the facility is notified of the deficiencies by the SA or AO. In cases where the SA or AO determine that it is not reasonable to expect compliance within the specified number of days, SA or AO may recommend additional time be granted by CMS in accordance with the regulations at § 488.28. The SAs and AOs do not have independent authority to grant additional time for the correction of deficiencies.
Interim patient safety measures to mitigate identified ligature or safety risks may include continuous visual observation or 1:1 observation in which a staff member is assigned to observe only one patient at all times, including while the patient sleeps, toilets or bathes, to prevent harm directed toward self or others as well as other alternative nursing protocols recommended by the National Psychiatric Nursing Association (NPNA) at http://www.apna.org/files/public/Councils/PsychiatricNursingAvailabilityTool_021216.p
df . The level of constant visual observation may be determined based on the type of identified risk. For example, a suicidal patient that is placed in a room with windows that may be opened or with breakable glass, would require constant 1:1 visual observation that would allow the staff member to immediately intervene should the patient attempt to jump or break through the window. Another interim safety measure may include locking rooms in which ligature risks have been identified to prevent patient access.
Hospital requests for the extension of timeframes for the correction of ligature risk deficiencies must include the hospital’s accepted PoC, mitigation plan, an evaluation of the effectiveness of the mitigation plan, and an update on the status of the PoC. The hospital request must also include a rationale for why it is not reasonable to meet the correction timeframe. Non-deemed hospitals submit the request electronically to the SA; deemed hospitals submit the request electronically to their AO. If the SA or AO rejects the request for an extended timeframe for correction, the submission is returned to the hospital with a rationale for denial. If the SA or AO supports the request, the submission is forwarded electronically to the appropriate RO or CO, as appropriate, with a recommendation of approval. For deemed facilities, the AO will also copy the appropriate RO. All request packages will be submitted electronically via designated RO and CO e-mailboxes.
For non-deemed hospitals, the RO will provide an electronic response to the hospital and copy the SA; for deemed hospitals, CO will provide a response and copy the AO and RO within ten working days. The facility is required to provide electronic progress reports to the SA or AO on a monthly basis that include, but are not limited to, copies of invoices, receipts, communications with vendors, etc. detailing ongoing progress correcting the ligature risks and other safety deficiencies. The facility is also required to provide ongoing electronic routine status updates on the effectiveness of mitigation strategies utilizing outcome and process measures to demonstrate the effectiveness of the plan. The SA and AO are required to monitor PoCs, progress reports and mitigation measures, on a monthly basis, and provide an updated report to CMS (RO or CO, as appropriate) on a monthly basis. The SAs and ROs may use the current process in place using the CMS form-539. AOs will provide reports in a format specified by CMS.

A-0145 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment.

Interpretive Guidelines §482.13(c)(3)
The intent of this requirement is to prohibit all forms of abuse, neglect (as a form of abuse) and harassment whether from staff, other patients or visitors. The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment. The hospital must have mechanisms/methods in place that ensure patients are free of all forms of abuse, neglect, or harassment.
Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.
The following components are suggested as necessary for effective abuse protection:
• Prevent. A critical part of this system is that there are adequate staff on duty, especially during the evening, nighttime, weekends and holiday shifts, to take care of the individual needs of all patients. (See information regarding meaning of adequate at those requirements that require the hospital to have adequate staff. Adequate staff would include that the hospital ensures that there are the number and types of qualified, trained, and experienced staff at the hospital and available to meet the care needs of every patient.)
• Screen. Persons with a record of abuse or neglect should not be hired or retained as employees.
• Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
• Train. The hospital, during its orientation program, and through an ongoing training program, provides all employees with information regarding abuse and neglect, and related reporting requirements, including prevention, intervention, and detection.
• Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
• Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
• Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.
As a result of the implementation of this system, changes to the hospital’s policies and procedures should be made accordingly.

482.13(d) Standard: Confidentiality of Patient Records

A-0147 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records.

Interpretive Guidelines §482.13(d)(1)
The right to confidentiality of the patient’s medical record means the hospital must safeguard the contents of the medical record, whether it is in paper or electronic format, or a combination of the two, from unauthorized disclosure. Confidentiality applies wherever the record or portions thereof are stored, including but not limited to central records, patient care locations, radiology, laboratories, record storage areas, etc.
A hospital is permitted to disclose patient information, without a patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for the provision of health care to an individual.
• Hospital operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
The hospital must develop policies and procedures that reasonably limit disclosures of information contained in the patient’s medical record to the minimum necessary, even when the disclosure is for treatment or payment purposes, or as otherwise required by State or Federal law.
When the minimum necessary standard is applied, a hospital may not disclose the entire medical record for a particular purpose, unless it can specifically justify that the whole record is the amount reasonably needed for the purpose.
A hospital may make an authorized disclosure of information from the medical record electronically, and may also share an electronic medical record system with other health care facilities, physicians and practitioners, so long as the system is designed and operated with safeguards that ensure that only authorized disclosures are made.
The hospital must obtain the patient’s, or the patient’s representative’s, written authorization for any disclosure of information in the medical record when the disclosure is not for treatment, payment or health care operations.

A-0148 482.13(d)(2) The patient has the right to access information contained in his or her clinical records within a reasonable time frame. The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its record keeping system permits.

Interpretive Guidelines §482.13(d)(2)
The requirements of the Department of Health and Human Services with regard to the confidentiality rights of individuals are set forth in the Privacy Rule at 42 CFR 164.500 et seq., pursuant to §264 of the Health Insurance Portability and Accountability Act of 1996.” The regulation at 42 CFR 164.524 specifies that patients should be allowed to inspect and obtain a copy of health information about them that is held by providers; and that providers may not withhold information except under limited circumstances. These circumstances include:
• Psychotherapy notes;
• A correctional institution or a health care provider acting at the direction of a correctional institution may deny an inmate’s request for access, if providing such access would jeopardize the health or security of the individual, other inmates, or officers or employees of the correctional institution;
• The information is about another person (other than a health care provider) and the hospital determines that the patient inspection is reasonably likely to cause sufficient harm to that person to warrant withholding;
• A licensed health care professional has determined that the access requested is reasonably likely to endanger the life or physical safety of the individual or another person;
• The information contains data obtained under a promise of confidentiality (from someone other than a health care provider), and inspection could reasonably reveal the source;
• The information is collected in the course of research that includes treatment and the research is in progress, provided that the individual has agreed to the denial of access and the provider informs the individual that his or her right of access will be reinstated when the research is completed;
• The protected health information is subject to the Clinical Laboratory Improvements Amendments of 1988, 42 CFR 263a, to the extent that providing the requested access would be prohibited by law;
• The protected health information is exempt from the Clinical Laboratory Improvements Amendments of 1988, pursuant to 42 CFR 493.3(a)(2);
• The information is compiled in reasonable anticipation of, or for use in, a civil,
criminal or administrative action or proceeding; and
• The request is made by an individual’s personal representative (as allowed under state law) and a licensed health care professional has determined that access is reasonably likely to cause substantial harm to the individual or another person.
In general, each patient should be able to see and obtain a copy of his/her records. Record holders may not deny access except to a portion of the record that meets criteria specified above. In these cases, the record holder may decide to withhold portions of the record; however, to the extent possible, the patient should be given as much information as possible.
If the patient is incompetent, the patient record should be made available to his or her representative (as allowed under State law). Upon the patient’s request, other designated individuals may access the patient’s records.
The patient has the right to easily access his/her medical records. Reasonable cost-based fees may be imposed only to cover the cost of copying, postage, and/or preparing an explanation or summary of patient health information, as outlined in 42 CFR §164.524(c). The cost of duplicating a patient’s record must not create a barrier to the individual’s receiving his or her medical record.

482.13(e) Standard: Restraint or Seclusion

A-0154 482.13(e) All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time.

Interpretive Guidelines §482.13(e):
The intent of this standard is to identify patients’ basic rights, ensure patient safety, and eliminate the inappropriate use of restraint or seclusion. Each patient has the right to receive care in a safe setting. The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. Each patient has the right to be free from all forms of abuse and corporal punishment. Each patient has the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may not be used unless the use of restraint or seclusion is necessary to ensure the immediate physical safety of the patient, a staff member, or others. The use of restraint or seclusion must be discontinued as soon as possible based on an individualized patient assessment and re-evaluation. A violation of any of these patients’ rights constitutes an inappropriate use of restraint or seclusion and would be subject to a condition level deficiency.
The patient protections contained in this standard apply to all hospital patients when the use of restraint or seclusion becomes necessary, regardless of patient location. The requirements contained in this standard are not specific to any treatment setting within the hospital. They are not targeted only to patients on psychiatric units or those with behavioral/mental health care needs. Instead, the requirements are specific to the patient behavior that the restraint or seclusion intervention is being used to address.
In summary, these restraint and seclusion regulations apply to:
• All hospitals (acute care, long-term care, psychiatric, children's, and cancer);
• All locations within the hospital (including medical/surgical units, critical care units, forensic units, emergency department, psychiatric units, etc.); and
• All hospital patients, regardless of age, who are restrained or secluded (including both inpatients and outpatients).
The decision to use a restraint or seclusion is not driven by diagnosis, but by a comprehensive individual patient assessment. For a given patient at a particular point in time, this comprehensive individualized patient assessment is used to determine whether the use of less restrictive measures poses a greater risk than the risk of using a restraint or seclusion. The comprehensive assessment should include a physical assessment to identify medical problems that may be causing behavior changes in the patient. For example, temperature elevations, hypoxia, hypoglycemia, electrolyte imbalances, drug interactions, and drug side effects may cause confusion, agitation, and combative behaviors. Addressing these medical issues may eliminate or minimize the need for the use of restraints or seclusion.
Staff must assess and monitor a patient’s condition on an ongoing basis to ensure that the patient is released from restraint or seclusion at the earliest possible time. Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion should be discontinued. However, the decision to discontinue the intervention should be based on the determination that the need for restraint or seclusion is no longer present, or that the patient’s needs can be addressed using less restrictive methods.

Hospital leadership is responsible for creating a culture that supports a patient’s right to be free from restraint or seclusion. Leadership must ensure that systems and processes are developed, implemented, and evaluated that support the patients’ rights addressed in this standard, and that eliminate the inappropriate use of restraint or seclusion. Through their QAPI program, hospital leadership should:
• Assess and monitor the use of restraint or seclusion in their facility;
• Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and
• Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by State law and hospital policy when the use of restraint or seclusion is necessary.
Patients have a right to receive safe care in a safe environment. However, the use of restraint is inherently risky. When the use of restraint is necessary, the least restrictive method must be used to ensure a patient’s safety. The use of restraint for the management of patient behavior should not be considered a routine part of care.
The use of restraints for the prevention of falls should not be considered a routine part of a falls prevention program. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence that the use of physical restraint, (including, but not limited to, raised side rails) will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries.1

--FOOTNOTES: 1- American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. Guideline for the prevention of falls in older persons. Journal of the American Geriatrics Society. 49(5):664-72, 2001 May.
- Neufeld RR, Libow LS, Foley WJ, Dunbar JM, Cohen C, Breuer B. Restraint reduction reduces serious injuries among nursing home residents. J Am Geriatr Soc 1999; 47:1202-1207.--
In fact in some instances reducing the use of physical restraints may actually decrease the risk of falling.2
Consider, for example, a patient who is displaying symptoms of Sundowner’s Syndrome, a syndrome in which a patient's dementia becomes more apparent at the end of the day than at the beginning of the day. The patient is not acting out or behaving in a violent or self-destructive manner. However, the patient has an unsteady gait and continues to get out of bed even after staff has tried alternatives to keep the patient from getting out of bed. There is nothing inherently dangerous about a patient being able to walk or wander, even at night. Under the provisions of this regulation, the rationale that the patient should be restrained because he “might” fall does not constitute an adequate basis for using a restraint for the purposes of this regulation. When assessing a patient’s risk for falls and planning care for the patient, staff should consider whether the patient has a medical condition or symptom that indicates a current need for a protective intervention to prevent the patient from walking or getting out of bed. A history of falling without a current clinical basis for a restraint intervention is inadequate to demonstrate the need for restraint. It is important to note that the regulation specifically states that convenience is not an acceptable reason to restrain a patient. In addition, a restraint must not serve as a substitute for the adequate staffing needed to monitor patients.
An individualized patient assessment is critical. In this example, an assessment should minimally address the following questions:
• Are there safety interventions or precautions (other than restraint) that can be taken to reduce the risk of the patient slipping, tripping, or falling if the patient gets out of bed?
• Is there a way to enable the patient to safely ambulate?
• Is there some assistive device that will improve the patient’s ability to self ambulate?
• Is a medication or a reversible condition causing the unsteady gait?
• Would the patient be content to walk with a staff person?
• Could the patient be brought closer to the nurse’s station where he or she could be supervised?
--Footnotes:
- Si M, Neufeld RR, Dunbar J. Removal of bedrails on a short-term nursing home rehabilitation unit. Gerontologist 1999; 39:611-614.
- Hanger HC, Ball MC, Wood LA. An analysis of falls in the hospital: can we do without bedrails? J Am Geriatr Soc 1999; 47:529-531.
- Tinetti ME, Liu YB, Ginter S. Mechanical restraint use and fall related injuries among residents of skilled nursing facilities. Ann Intern Med 1992; 116:369-374.
- Capezuti E, Evans L, Strumpf N, Maislin G. Physical restraint use and falls in nursing home residents. J Am Geriatr Soc 1996; 44:627-633.
- Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal and falls and injuries among nursing home residents. J Gerontol A Biol Sci Med Sci 1998; 53:M47-M52.
2University of California at San Francisco (UCSF)-Stanford University Evidence-based Practice Center Subchapter 26.2. Interventions that Decrease the Use of Physical Restraints” of the Evidence Report/Technology Assessment, No. 43 entitled, “Making Health Care Safer: A Critical Analysis of Patient Safety Practices.” The full report can be accessed at: http://www.ahrq.gov/qual/errorsix.htm --

If an assessment reveals a medical condition or symptom that indicates the need for an intervention to protect the patient from harm, the regulation requires the hospital to use the least restrictive intervention that will effectively protect the patient from harm. Upon making this determination, the hospital may consider the use of a restraint; however, that consideration should weigh the risks of using a restraint (which are widely documented in research) against the risks presented by the patient’s behavior. If the hospital chooses to use the restraint, it must meet the requirements contained in this standard.
In addition, a request from a patient or family member for the application of a restraint, which they would consider to be beneficial, is not a sufficient basis for the use of a restraint intervention. A patient or family member request for a restraint intervention, such as a vest restraint or raising all four side rails, to keep the patient from getting out of bed or falling should prompt a patient and situational assessment to determine whether such a restraint intervention is needed. If a need for restraint is confirmed, the practitioner must then determine the type of restraint intervention that will meet the patient's needs with the least risk and most benefit to the patient. If restraint (as defined by the regulation) is used, then the requirements of the regulation must be met.
Patient care staff must demonstrate through their documentation in the patient’s medical record that the restraint intervention used is the least restrictive intervention that protects the patient’s safety, and that the use of restraint is based on individual assessments of the patient. The assessments and documentation of those assessments must be ongoing in order to demonstrate a continued need for restraint. Documentation by the physician or other staff once a day may not be adequate to support that the restraint intervention needs to continue and may not comply with the requirement to end the restraint as soon as possible. A patient’s clinical needs often change over time.
CMS does not consider the use of weapons in the application of restraint or seclusion as a safe, appropriate health care intervention. For the purposes of this regulation, the term “weapon” includes, but is not limited to, pepper spray, mace, nightsticks, tazers, cattle prods, stun guns, and pistols. Security staff may carry weapons as allowed by hospital policy, and State and Federal law. However, the use of weapons by security staff is considered a law enforcement action, not a health care intervention. CMS does not support the use of weapons by any hospital staff as a means of subduing a patient in order to place that patient in restraint or seclusion. If a weapon is used by security or law enforcement personnel on a person in a hospital (patient, staff, or visitor) to protect people or hospital property from harm, we would expect the situation to be handled as a criminal activity and the perpetrator be placed in the custody of local law enforcement.
The use of handcuffs, manacles, shackles, other chain-type restraint devices, or other restrictive devices applied by non-hospital employed or contracted law enforcement officials for custody, detention, and public safety reasons are not governed by this rule. The use of such devices are considered law enforcement restraint devices and would not be considered safe, appropriate health care restraint interventions for use by hospital staff to restrain patients. The law enforcement officers who maintain custody and direct supervision of their prisoner (the hospital’s patient) are responsible for the use, application, and monitoring of these restrictive devices in accordance with Federal and State law. However, the hospital is still responsible for an appropriate patient assessment and the provision of safe, appropriate care to its patient (the law enforcement officer’s prisoner).

A-0159 482.13(e) (1) Definitions. (i) A restraint is:
(A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or

Interpretive Guidelines §482.13(e)(1)(i)(A)
This restraint definition applies to all uses of restraint in all hospital care settings. Under this definition, commonly used hospital devices and other practices could meet the definition of a restraint, such as:
• Tucking a patient’s sheets in so tightly that the patient cannot move;
• Use of a “net bed” or an “enclosed bed” that prevents the patient from freely exiting the bed. EXCEPTION: Placement of a toddler in an "enclosed" or "domed" crib;
• Use of "Freedom" splints that immobilize a patient's limb;
• Using side rails to prevent a patient from voluntarily getting out of bed; or
• Geri chairs or recliners, only if the patient cannot easily remove the restraint appliance and get out of the chair on his or her own.
NOTE: Generally, if a patient can easily remove a device, the device would not be considered a restraint. In this context, “easily remove” means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient’s physical condition and ability to accomplish objective (e.g., transfer to a chair, get to the bathroom in time).

A-0160 482.13(e)(1) (I) A restraint is:
(B) A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

Interpretive Guidelines §482.13(e)(1)(i)(B)
Drugs or medications that are used as part of a patient's standard medical or psychiatric treatment, and are administered within the standard dosage for the patient’s condition, would not be subject to the requirements of standard (e). These regulations are not intended to interfere with the clinical treatment of patients who are suffering from serious mental illness and who need therapeutic doses of medication to improve their level of functioning so that they can more actively participate in their treatment. Similarly, these regulations are not intended to interfere with appropriate doses of sleeping medication prescribed for patients with insomnia, anti-anxiety medication prescribed to calm a patient who is anxious, or analgesics prescribed for pain management. The regulatory language is intended to provide flexibility and recognize the variations in patient conditions.
Whether or not an order for a drug or medication is PRN (Latin abbreviation for pro re nata - as needed; as circumstances require) or a standing-order does not determine whether or not the use of that drug or medication is considered a restraint. The use of PRN or standing-order drugs or medications is only prohibited if the drug or medication meets the definition of a drug or medication used as a restraint.
Criteria used to determine whether the use of a drug or medication, or combination of drugs or medications is a standard treatment or dosage for the patient's condition includes all of the following:
• The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters;
• The use of the drug or medication follows national practice standards established or recognized by the medical community, or professional medical associations or organizations; and,
• The use of the drug or medication to treat a specific patient’s clinical condition is based on that patient's symptoms, overall clinical situation, and on the physician's or other licensed independent practitioner’s (LIP) knowledge of that patient's expected and actual response to the medication.
Another component of “standard treatment or dosage” for a drug or medication is the expectation that the standard use of a drug or medication to treat the patient's condition enables the patient to more effectively or appropriately function in the world around them than would be possible without the use of the drug or medication. If the overall effect of a drug or medication, or combination of drugs or medications, is to reduce the patient's
ability to effectively or appropriately interact with the world around the patient, then the drug or medication is not being used as a standard treatment or dosage for the patient's condition.
As with any use of restraint or seclusion, staff must conduct a comprehensive patient assessment to determine the need for other types of interventions before using a drug or medication as a restraint. For example, a patient may be agitated due to pain, an adverse reaction to an existing drug or medication, or other unmet care need or concern.
There are situations where the use of a drug or medication is clearly outside the standard for a patient or a situation, or a medication is not medically necessary but is used for patient discipline or staff convenience (neither of which is permitted by the regulation).
• EXAMPLE 1: A patient has Sundowner's Syndrome, a syndrome in which a patient's dementia becomes more apparent at the end of the day rather than at the beginning of the day. The patient may become agitated, angry, or anxious at sundown. This may lead to wandering, pacing the floors, or other nervous behaviors. The staff finds the patient’s behavior bothersome, and asks the physician to order a high dose of a sedative to “knock out” the patient and keep him in bed. The patient has no medical symptoms or condition that indicates the need for a sedative. In this case, for this patient, the sedative is being used inappropriately as a restraint for staff convenience. Such use is not permitted by the regulation.
A drug or medication that is not being used as a standard treatment for the patient’s medical or psychiatric condition, and that results in restricting the patient’s freedom of movement would be a drug used as a restraint.
In addition, the regulation does not permit a drug or medication to be used to restrain the patient for staff convenience, to coerce or discipline the patient, or as a method of retaliation. While drugs or medications can be a beneficial part of a carefully constructed, individualized treatment plan for the patient, drug and medication use should be based on the assessed needs of the individual patient, and the effects of drugs and medications on the patient should be carefully monitored.
• EXAMPLE 2: A patient is in a detoxification program. The patient becomes violent and aggressive. Staff administers a PRN medication ordered by the patient’s physician or other LIP to address these types of outbursts. The use of the medication enables the patient to better interact with others or function more effectively. In this case, the medication used for this patient is not considered a “drug used as a restraint.” The availability of a PRN medication to manage outbursts of specific behaviors, such as aggressive, violent behavior is standard for this patient’s medical condition (i.e., drug or alcohol withdrawal). Therefore, this patient’s medication does not meet the definition of “drug used as a restraint” since it is a standard treatment or dosage for the patient’s medical or psychiatric condition. The use of this medication for this patient is not affected by standard (e).
If a drug or medication is used as a standard treatment (as previously defined) to address the assessed symptoms and needs of a patient with a particular medical or psychiatric condition, its use is not subject to the requirements of this regulation. However, the patient would still need to receive assessments, monitoring, interventions, and care that are appropriate for that patient’s needs.
The regulation supports existing State laws that provide more vigorous promotion of the patient’s choice and rights. Therefore, when a State’s law prohibits the administration of drugs against the wishes of the patient without a court order, the State law applies.

A-0161 482.13(e)(1)(i)(C) A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort).

Interpretive Guidelines §482.13(e)(1)(i)(C)
The devices and methods listed here would not be considered restraints, and, therefore, not subject to these requirements. These devices and methods are typically used in medical-surgical care.
Use of an IV arm board to stabilize an IV line is generally not considered a restraint. However, if the arm board is tied down (or otherwise attached to the bed), or the entire limb is immobilized such that the patient cannot access his or her body, the use of the arm board would be considered a restraint.
A mechanical support used to achieve proper body position, balance, or alignment so as to allow greater freedom of mobility than would be possible without the use of such a mechanical support is not considered a restraint. For example, some patients lack the ability to walk without the use of leg braces, or to sit upright without neck, head, or back braces.
A medically necessary positioning or securing device used to maintain the position, limit mobility, or temporarily immobilize the patient during medical, dental, diagnostic, or surgical procedures is not considered a restraint.
Recovery from anesthesia that occurs when the patient is in a critical care or postanesthesia care unit is considered part of the surgical procedure; therefore, medically necessary restraint use in this setting would not need to meet the requirements of the regulation. However, if the intervention is maintained when the patient is transferred to another unit, or recovers from the effects of the anesthesia (whichever occurs first), a restraint order would be necessary and the requirements of standard (e) would apply.
Many types of hand mitts would not be considered restraint. However, pinning or otherwise attaching those same mitts to bedding or using a wrist restraint in conjunction with the hand mitts would meet the definition of restraint and the requirements would apply. In addition, if the mitts are applied so tightly that the patient's hand or fingers are immobilized, this would be considered restraint and the requirements would apply. Likewise, if the mitts are so bulky that the patient's ability to use their hands is significantly reduced, this would be considered restraint and the requirements would apply.
NOTE: Because this definition of physical restraint does not name each device and situation that can be used to immobilize or reduce the ability of the patient to move his or her arms, legs, body or head freely, it promotes looking at each patient situation on a case-by-case basis.
In addition, if a patient can easily remove a device, the device would not be considered a restraint. In this context, “easily remove” means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient’s physical condition and ability to accomplish the objective (e.g., transfer to a chair, get to the bathroom in time).
Age or developmentally appropriate protective safety interventions (such as stroller safety belts, swing safety belts, high chair lap belts, raised crib rails, and crib covers) that a safety-conscious child care provider outside a health care setting would utilize to protect an infant, toddler, or preschool-aged child would not be considered restraint or seclusion for the purposes of this regulation. The use of these safety interventions needs to be
addressed in the hospital’s policies or procedures.

Physical Escort
A physical escort would include a “light” grasp to escort the patient to a desired location. If the patient can easily remove or escape the grasp, this would not be considered physical restraint. However, if the patient cannot easily remove or escape the grasp, this would be considered physical restraint and all the requirements would apply.

Physical holding
The regulation permits the physical holding of a patient for the purpose of conducting routine physical examinations or tests. However, patients do have the right to refuse treatment. See §482.13(b)(2). This includes the right to refuse physical examinations or tests. Holding a patient in a manner that restricts the patient's movement against the patient’s will is considered restraint. This includes holds that some member of the medical community may term “therapeutic holds.” Many deaths have occurred while employing these practices. Physically holding a patient can be just as restrictive, and just as dangerous, as restraining methods that involve devices. Physically holding a patient during a forced psychotropic medication procedure is considered a restraint and is not included in this exception.
For the purposes of this regulation, a staff member picking up, redirecting, or holding an infant, toddler, or preschool-aged child to comfort the patient is not considered restraint.

Physical Holding for Forced Medications
The application of force to physically hold a patient, in order to administer a medication against the patient’s wishes, is considered restraint. The patient has a right to be free of restraint and, in accordance with §482.13(b)(2), also has a right to refuse medications, unless a court has ordered medication treatment. A court order for medication treatment only removes the patient’s right to refuse the medication. Additionally, in accordance with State law, some patients may be medicated against their will in certain emergency circumstances. However, in both of these circumstances, health care staff is expected to use the least restrictive method of administering the medication to avoid or reduce the use of force, when possible. The use of force in order to medicate a patient, as with other restraint, must have a physician’s order prior to the application of the restraint (use of force). If physical holding for forced medication is necessary with a violent patient, the 1-hour face-to-face evaluation requirement would also apply.
In certain circumstances, a patient may consent to an injection or procedure, but may not be able to hold still for an injection, or cooperate with a procedure. In such circumstances, and at the patient’s request, staff may “hold” the patient in order to safely administer an injection (or obtain a blood sample, or insert an intravenous line, if applicable) or to conduct a procedure. This is not considered restraint.

Side rails
A restraint does not include methods that protect the patient from falling out of bed. Examples include raising the side rails when a patient is: on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from falling out of the bed. The use of side rails in these situations protects the patient from falling out of bed and, therefore, would not be subject to the requirements of standard (e).
However, side rails are frequently not used as a method to prevent the patient from falling out of bed, but instead, used to restrict the patient’s freedom to exit the bed. The use of side rails to prevent the patient from exiting the bed would be considered a restraint and would be subject to the requirements of standard (e). The use of side rails is inherently risky, particularly if the patient is elderly or disoriented. Frail elderly patients may be at risk for entrapment between the mattress or bed frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get around a raised side rail and exit the bed. When attempting to leave the bed by any of these routes, the patient is at risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail, with a possibility for sustaining greater injury or death than if the patient had fallen from the height of a lowered bed without raised side rails. In short, the patient may have an increased risk for a fall or other injury by attempting to exit the bed with the side rails raised. The risk presented by side rail use should be weighed against the risk presented by the patient's behavior as ascertained through individualized assessment.
When the clinician raises all four side rails in order to restrain a patient, defined in this regulation as immobilizing or reducing the ability of a patient to move his or her arms, legs, body, or head freely to ensure the immediate physical safety of the patient, then the requirements of this rule apply. Raising fewer than four side rails when the bed has segmented side rails would not necessarily immobilize or reduce the ability of a patient to move freely as defined in the regulation. For example, if the side rails are segmented and all but one segment are raised to allow the patient to freely exit the bed, the side rail is not acting as a restraint and the requirements of this rule would not apply. Conversely, if a patient is not physically able to get out of bed regardless of whether the side rails are raised or not, raising all four side rails for this patient would not be considered restraint because the side rails have no impact on the patient’s freedom of movement. In this example, the use of all four side rails would not be considered restraint. Therefore, the requirements of this rule would not apply.
When a patient is on a bed that constantly moves to improve circulation or prevents skin breakdown, raised side rails are a safety intervention to prevent the patient from falling out of bed and are not viewed as restraint.
When a patient is placed on seizure precautions and all side rails are raised, the use of side rails would not be considered restraint. The use of padded side rails in this situation should protect the patient from harm; including falling out of bed should the patient have a seizure.
Placement in a crib with raised rails is an age-appropriate standard safety practice for every infant or toddler. Therefore, placement of an infant or toddler in the crib with raised rails would not be considered restraint.
If the patient is on a stretcher (a narrow, elevated, and highly mobile cart used to transport patients and to evaluate or treat patients), there is an increased risk of falling from a stretcher without raised side rails due to its narrow width, and mobility. In addition, because stretchers are elevated platforms, the risk of patient injury due to a fall is significant. Therefore, the use of raised side rails on stretchers is not considered restraint but a prudent safety intervention. Likewise, the use of a seat belt when transporting a patient in a wheelchair is not considered restraint.

A-0162 482.13(e)(1)(ii) Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior.

Interpretive Guidelines §482.13(e)(1)(ii)
Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
Seclusion is not just confining a patient to an area, but involuntarily confining the patient alone in a room or area where the patient is physically prevented from leaving. If a patient is restricted to a room alone and staff are physically intervening to prevent the patient from leaving the room or giving the perception that threatens the patient with physical intervention if the patient attempts to leave the room, the room is considered locked, whether the door is actually locked or not. In this situation, the patient is being secluded.
A patient physically restrained alone in an unlocked room does not constitute seclusion.
Confinement on a locked unit or ward where the patient is with others does not constitute seclusion.
Timeout is not considered seclusion. Timeout is an intervention in which the patient consents to being alone in a designated area for an agreed upon timeframe from which the patient is not physically prevented from leaving. Therefore, the patient can leave the designated area when the patient chooses.

A-0164 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm.

Interpretive Guidelines §482.13(e)(2)
A comprehensive assessment of the patient must determine that the risks associated with the use of the restraint or seclusion is outweighed by the risk of not using the restraint or seclusion. Less restrictive interventions do not always need to be tried, but less restrictive interventions must be determined by staff to be ineffective to protect the patient or others from harm prior to the introduction of more restrictive measures. Alternatives attempted or the rationale for not using alternatives must be documented.
The underpinning of this regulation is the concept that safe patient care hinges on looking at the patient as an individual and assessing the patient’s condition, needs, strengths, weaknesses, and preferences. Such an approach relies on caregivers who are skilled in individualized assessment and in tailoring interventions to the individual patient’s needs after weighing factors such as the patient’s condition, behaviors, history, and environmental factors.
Resources are available to assist clinicians in identifying less restrictive interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with clinicians in the field and included extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org.

A-0165 482.13(e)(3) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm.

Interpretive Guidelines §482.13(e)(3)
Resources are available to assist clinicians in identifying less restrictive restraint or seclusion interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with the field and extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org

A-0166 482.13(e)(4) The use of restraint or seclusion must be:
(i) in accordance with a written modification to the patient's plan of care.

Interpretive Guidelines §482.13(e)(4)(i)
The use of restraint or seclusion (including drugs or medications used as restraint as well as physical restraint) must be documented in the patient’s plan of care or treatment plan. The use of restraint or seclusion constitutes a change in a patient’s plan of care.
The regulation does not require that a modification to the patient’s plan of care be made before initiating or obtaining an order for the use of restraint or seclusion. The use of a restraint or seclusion intervention should be reflected in the patient’s plan of care or treatment plan based on an assessment and evaluation of the patient. The plan of care or treatment plan should be reviewed and updated in writing within a timeframe specified by hospital policy.

A-0167 482.13(e)(4) The use of restraint or seclusion must be:
(ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.

Interpretive Guidelines §482.13(e)(4)(ii)
Restraint or seclusion must be implemented appropriately and safely, and reflect hospital policy in accordance with State law.
The use of restraint or seclusion must never act as a barrier to the provision of other interventions to meet the patient’s needs.

A-0168 482.13(e)(5) The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §481.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law.

Interpretive Guidelines §482.13(e)(5)
Hospitals must have policies and procedures for the initiation of restraint or seclusion that identify the categories of LIPs that are permitted to order restraint or seclusion in that hospital, consistent with State law.
The regulation requires that a physician or other LIP responsible for the care of the patient to order restraint or seclusion prior to the application of restraint or seclusion. In some situations, however, the need for a restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to the application of restraint or seclusion. In these emergency application situations, the order must be obtained either during the emergency application of the restraint or seclusion, or immediately (within a few minutes) after the restraint or seclusion has been applied. The failure to immediately obtain an order is viewed as the application of restraint or seclusion without an order. The hospital should address this process in its restraint and seclusion policies and procedures. The policies and procedures should specify who can initiate the emergency application of restraint or seclusion prior to obtaining an order from a physician or other LIP.

Licensed Independent Practitioner (LIP)
For the purpose of ordering restraint or seclusion, an LIP is any practitioner permitted by State law and hospital policy as having the authority to independently order restraints or seclusion for patients.
A resident who is authorized by State law and the hospital’s residency program to practice as a physician can carry out functions reserved for a physician or LIP by the regulation. A medical school student holds no license, and his/her work is reviewed and must be countersigned by the attending physician; therefore, he or she is not licensed or independent. A medical school student is not an LIP.

Protocols
A protocol cannot serve as a substitute for obtaining a physician's or other LIP’s order prior to initiating each episode of restraint or seclusion use. If a hospital uses protocols that include the use of restraint or seclusion, a specific physician or LIP order is still required for each episode of restraint or seclusion use. The philosophy that serves as a foundation for the regulation is that restraint or seclusion use is an exceptional event, not a routine response to a certain patient condition or behavior. Each patient must be assessed, and interventions should be tailored to meet the individual patient’s needs. The
creation of a protocol can run counter to this philosophy if it sets up the expectation that restraint or seclusion will be used as a routine part of care. The use of restraint or seclusion is a last resort when less restrictive measures have been determined ineffective to ensure the safety of the patient, staff or others, should not be a standard response to a behavior or patient need.

A-0169 482.13(e)(6) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

Interpretive Guidelines §482.13(e)(6)
This regulation prohibits the use of standing or PRN (Latin abbreviation for pro re nata - as needed; as circumstances require) orders for the use of restraint or seclusion. The ongoing authorization of restraint or seclusion is not permitted. Each episode of restraint or seclusion must be initiated in accordance with the order of a physician or other LIP. If a patient was recently released from restraint or seclusion, and exhibits behavior that can only be handled through the reapplication of restraint or seclusion, a new order would be required. Staff cannot discontinue a restraint or seclusion intervention, and then re-start it under the same order. This would constitute a PRN order. A “trial release” constitutes a PRN use of restraint or seclusion, and, therefore, is not permitted by this regulation.
When a staff member ends an ordered restraint or seclusion intervention, the staff member has no authority to reinstitute the intervention without a new order. For example, a patient is released from restraint or seclusion based on the staff’s assessment of the patient’s condition. If this patient later exhibits behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others that can only be handled through the use of restraint or seclusion, a new order would be required.
NOTE: A temporary, directly-supervised release, however, that occurs for the purpose of caring for a patient's needs (e.g., toileting, feeding, or range of motion exercises) is not considered a discontinuation of the restraint or seclusion intervention. As long as the patient remains under direct staff supervision, the restraint is not considered to be discontinued because the staff member is present and is serving the same purpose as the restraint or seclusion.
The use of PRN orders for drugs or medications is only prohibited when a drug or medication is being used as a restraint. A drug or medication is deemed to be a restraint only if it is not a standard treatment or dosage for the patient’s condition, and the drug or medication is a restriction to manage the patient’s behavior or restricts the patient’s freedom of movement Using a drug to restrain the patient for staff convenience is expressly prohibited.
EXCEPTIONS
• Geri chair. If a patient requires the use of a Geri chair with the tray locked in place in order for the patient to safely be out of bed, a standing or PRN order is permitted. Given that a patient may be out of bed in a Geri chair several times a day, it is not necessary to obtain a new order each time.
• Raised side rails. If a patient's status requires that all bedrails be raised (restraint) while the patient is in bed, a standing or PRN order is permitted. It is not necessary to obtain a new order each time the patient is returned to bed after being out of bed.
• Repetitive self-mutilating behavior. If a patient is diagnosed with a chronic medical or psychiatric condition, such as Lesch-Nyham Syndrome, and the patient engages in repetitive self-mutilating behavior, a standing or PRN order for restraint to be applied in accordance with specific parameters established in the treatment plan would be permitted. Since the use of restraints to prevent self-injury is needed for these types of rare, severe, medical and psychiatric conditions, the specific requirements (1-hour face-to-face evaluation, time-limited orders, and evaluation every 24 hours before renewal of the order) for the management of violent or self- destructive behavior do not apply.

A-0170 482.13(e)(7) The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion.

Interpretive Guidelines §482.13(e)(7)
The attending physician is the MD/DO who is responsible for the management and care of the patient. Hospital medical staff policies determine who is considered the attending physician. The intent of this requirement is to ensure that the physician who has overall responsibility and authority for the management and care of the patient is aware of the patient’s condition and is aware of the restraint or seclusion intervention. It is important to consult with the attending physician to promote continuity of care, to ensure patient safety, and to elicit information that might be relevant in choosing the most appropriate intervention for the patient. The attending physician may have information regarding the patient’s history that may have a significant impact on the selection of a restraint or seclusion intervention or an alternative intervention, and the subsequent course of treatment. Therefore, consultation should occur as soon as possible. Hospital policies and procedures should address the definition of “as soon as possible” based on the needs of their particular patient population(s). However, any established time frames must be consistent with “as soon as possible.”
The hospital CoPs do permit the patient to be under the care of a treating LIP other than a physician. Section 482.12(c)(1) requires every Medicare patient to be under the care of a doctor of medicine or osteopathy; or, within the scope of their respective licenses, a doctor of dental surgery or dental medicine, a doctor of podiatry, chiropractor, or clinical psychologist. The individual overseeing the patient’s care may be the attending physician or a health professional practicing with the delegated authority or supervision of a doctor of medicine or osteopathy as permitted by State law and hospital policy.
When the attending physician of record is unavailable, responsibility for the patient must be delegated to another physician, who would then be considered the attending physician.
This provision does not specify that consultation with the attending physician be face-to-face. The consultation can occur via telephone.

A-0171 482.13(e)(8) Unless superseded by State law that is more restrictive:
(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and

Interpretive Guidelines §482.13(e)(8)(i)
Patients of all ages are vulnerable and at risk when restrained or secluded to manage violent or self-destructive behavior. Therefore, time limits have been established for each order for restraint or seclusion used to manage violent or self-destructive behavior. State law may require more restrictive time limits. These time limits do not apply to orders for restraint used to manage non-violent or non-self-destructive behavior. However, the requirement that restraint use be ended at the earliest possible time applies to all uses of restraint.
In the final rule on the use of restraint or seclusion, CMS did not include specific criteria for differentiating between emergency situations where the patient’s behavior is violent or self-destructive and jeopardizes the immediate physical safety of the patient, a staff member, or others, and non-emergency use of restraint. Clinicians are adept at identifying various behaviors and symptoms, and can readily recognize violent and self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Asking clinicians to act based on an evaluation of the patient’s behavior is no different than relying on the clinical judgment that they use daily in assessing the needs of each patient and taking actions to meet those individual needs.
The regulation identifies maximum time limits on the length of each order for restraint or seclusion based on age. The physician or other LIP has the discretion to write the order for a shorter length of time. The length-of-order requirement identifies critical points at which there is mandatory contact with a physician or other LIP responsible for the care of the patient. In addition, the time limits do not dictate how long a patient should remain in restraint or seclusion. Staff is expected to continually assess and monitor the patient to ensure that the patient is released from restraint or seclusion at the earliest possible time. Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion should be discontinued. The regulation explicitly states that the intervention must be discontinued at the earliest possible time, regardless of the length of time identified in the order. For example, if a patient’s behavior is no longer violent or self-destructive 20 minutes after the intervention is initiated, then the restraint or seclusion should be discontinued, even if the order was given for up to 4 hours. If restraint or seclusion is discontinued prior to the expiration of the original order, a new order must be obtained prior to reinitiating the use of restraint or seclusion.
At the end of the time frame, if the continued use of restraint or seclusion to manage violent or self-destructive behavior is deemed necessary based on an individualized patient assessment, another order is required. When the original order is about to expire, an RN must contact the physician or other LIP, report the results of his or her most recent assessment and request that the original order be renewed (not to exceed the time limits established in the regulation). Whether or not an onsite assessment is necessary prior to renewing the order is left to the discretion of the physician or other LIP in conjunction with a discussion with the RN who is over-seeing the care of the patient. Another 1-hour face-to-face patient evaluation (see §482.13(e)(12) and the related interpretive guidance) is not required when the original order is renewed.
The original restraint or seclusion order may only be renewed within the required time limits for up to a total of 24 hours. After the original order expires, a physician or other LIP must see and assess the patient before issuing a new order.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0172 482.13(e)(8) Unless superseded by State law that is more restrictive:
(ii) After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c) of this part and authorized to order restraint or seclusion by hospital policy in accordance with State law must see and assess the patient.

Interpretive Guidelines §482.13(e)(8)(ii)
At a minimum, if a patient remains in restraint or seclusion for the management of violent or self-destructive behavior 24 hours after the original order, the physician or other LIP must see the patient and conduct a face-to-face re-evaluation before writing a new order for the continued use of restraint or seclusion. Twenty-four hours of restraint or seclusion for the management of violent or self-destructive behavior is an extreme measure with the potential for serious harm to the patient.
State laws may be more restrictive and require the physician or other LIP to conduct a face-to-face re-evaluation within a shorter timeframe.
When the physician or other LIP renews an order or writes a new order authorizing the continued use of restraint or seclusion, there must be documentation in the patient’s medical record that describes the findings of the physician's or other LIP's re-evaluation supporting the continued use of restraint or seclusion.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0173 482.13(e)(8) Unless superseded by State law that is more restrictive:
(iii) Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy.

Interpretive Guidelines §482.13(e)(8)(iii)
Hospitals have the flexibility to determine time frames for the renewal of orders for restraint of the non-violent, non-self-destructive patient. These time frames should be addressed in hospital policies and procedures.

A-0174 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order.

Interpretive Guidelines §482.13(e)(9)
Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion must be discontinued.
Staff members are expected to assess and monitor the patient’s condition on an ongoing basis to determine whether restraint or seclusion can safely be discontinued. The regulation requires that these interventions be ended as quickly as possible. However, the decision to discontinue the intervention should be based on the determination that the patient’s behavior is no longer a threat to self, staff members, or others. When the physician or LIP renews an order or writes a new order authorizing the continued use of restraint or seclusion, there must be documentation in the medical record that describes the patient’s clinical needs and supports the continued use of restraint or seclusion.
The hospital policies and procedures should address, at a minimum:
• Categories of staff that the hospital authorizes to discontinue restraint or seclusion in accordance with State law; and
• The circumstances under which restraint or seclusion is to be discontinued.

A-0175 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy.

Interpretive Guidelines §482.13(e)(10)
Ongoing assessment and monitoring of the patient's condition by a physician, other LIP or trained staff is crucial for prevention of patient injury or death, as well as ensuring that the use of restraint or seclusion is discontinued at the earliest possible time. Hospital policies are expected to guide staff in determining appropriate intervals for assessment and monitoring based on the individual needs of the patient, the patient's condition, and the type of restraint or seclusion used. The selection of an intervention and determination of the necessary frequency of assessment and monitoring should be individualized, taking into consideration variables such as the patient’s condition, cognitive status, risks associated with the use of the chosen intervention, and other relevant factors. In some cases, checks every 15 minutes or vital signs taken every 2 hours may not be sufficient to ensure the patient’s safety. In others, it may be excessive or disruptive to patient care (e.g., it may be unnecessary to mandate that a patient with wrist restraints, and who is asleep, be checked every 15 minutes and awakened every 2 hours to take the patient’s vital signs). Similarly, depending on the patient’s needs and situational factors, the use of restraint or seclusion may require either periodic (e.g., every 15 minutes, every 30 minutes, etc.) or continual (i.e., moment to moment) monitoring and assessment.
Hospital policies should address: frequencies of monitoring and assessment; assessment content (e.g., vital signs, circulation, hydration needs, elimination needs, level of distress and agitation, mental status, cognitive functioning, skin integrity, etc.); providing for nutritional needs, range of motion exercises, and elimination needs; and mental status and neurological evaluations.
With the exception of the simultaneous use of restraint and seclusion, one-to-one observation with a staff member in constant attendance is not required by this regulation unless deemed necessary based on a practitioner’s clinical judgment. For example, placing staff at the bedside of a patient with wrist restraints may be unnecessary. However, for a more restrictive or risky intervention and/or a patient who is suicidal, self injurious, or combative, staff may determine that continual face-to-face monitoring is needed. The hospital is responsible for providing the level of monitoring and frequency of reassessment that will protect the patient's safety.
Hospitals have flexibility in determining which staff performs the patient assessment and monitoring. This determination must be in accordance with the practitioner’s scope of clinical practice and State law. For example, assessment and monitoring are activities within a registered nurse’s scope of practice. However, some trained, unlicensed staff may perform components of monitoring (e.g., checking the patient's vital signs, hydration and circulation; the patient’s level of distress and agitation; or skin integrity), and may also provide for general care needs (e.g., eating, hydration, toileting, and range of motion exercises). Section 482.13(f) requires that before applying restraints, implementing seclusion, or performing associated monitoring and care tasks, staff must be trained and able to demonstrate competency in the performance of these actions.

A-0176 482.13(e)(11) Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed independent practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion.

Interpretive Guidelines §482.13(e)(11)
At a minimum, physicians and other LIPs authorized to order restraint and seclusion must have a working knowledge of hospital policy regarding the use of restraint and seclusion.
Hospitals have the flexibility to identify training requirements above this minimum requirement based on the competency level of their physicians and other LIPs, and the needs of the patient population(s) that they serve. Physicians receive training in the assessment, monitoring, and evaluation of a patient’s condition as part of their medical school education. However, physicians generally do not receive training regarding application of restraint or implementation of seclusion as part of their basic education. Depending on the level and frequency of involvement that a physician or other LIP has in the performance of these activities, additional training may or may not be necessary to ensure the competency of these individuals in this area. The hospital is in the best position to determine if additional physician or other LIP training is necessary based on the model of care, level of physician competency, and the needs of the patient population(s) that the hospital serves.

A-0178 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention:
(i) By a:
(A) Physician or other licensed independent practitioner; or
(B) Registered nurse or physician assistant who has been trained in accordance with the requirements specified in paragraph (f) of this section.

Interpretive Guidelines §482.13(e)(12)(i)
When restraint or seclusion is used to manage violent or self-destructive behavior, a physician or other LIP, or a registered nurse (RN) or physician assistant (PA) trained in accordance with the requirements specified under §482.13(f), must see the patient face-to-face within 1-hour after the initiation of the intervention. This requirement also applies when a drug or medication is used as a restraint to manage violent or self-destructive behavior.
The 1-hour face-to-face patient evaluation must be conducted in person by a physician or other LIP, or trained RN or PA. A telephone call or telemedicine methodology is not permitted.
If a patient’s violent or self-destructive behavior resolves and the restraint or seclusion intervention is discontinued before the practitioner arrives to perform the 1-hour face-to-face evaluation, the practitioner is still required to see the patient face-to-face and conduct the evaluation within 1 hour after the initiation of this intervention. The fact that the patient’s behavior warranted the use of a restraint or seclusion indicates a serious medical or psychological need for prompt evaluation of the patient behavior that led to the intervention. The evaluation would also determine whether there is a continued need for the intervention, factors that may have contributed to the violent or self-destructive behavior, and whether the intervention was appropriate to address the violent or self-destructive behavior.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0179 482.13(e)(12) The patient must be seen face-to-face within 1 hour after the initiation of the intervention:
(ii)To evaluate:
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.

Interpretive Guidelines §482.13(e)(12)(ii)
The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient’s history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient’s condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient’s violent or self-destructive behavior.
Training for an RN or PA to conduct the 1-hour face-to-face evaluation would include all of the training requirements at §482.13(f) as well as content to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition (documented training in conducting physical and behavioral assessment); and the need to continue or terminate the restraint or seclusion.

A-0180 482.13(e)(13) States are free to have requirements by statute or regulation that are more restrictive than those contained in paragraph (e)(12)(i) of this section.

Interpretive Guidelines §482.13(e)(13)
States are free to have requirements that are more restrictive regarding the types of practitioners who may conduct the 1-hour face-to-face evaluation. Generally, States may have more restrictive requirements as long as they do not conflict with Federal requirements.

A-0182 482.13(e)(14) If the face-to-face evaluation specified in paragraph (e)(12) of this section is conducted by a trained registered nurse or physician assistant, the trained registered nurse or physician assistant must consult the attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under 482.12(c) as soon as possible after the completion of the 1 hour face-to-face evaluation.

Interpretive Guidelines §482.13(e)(14)
When a trained RN or PA conducts the required face-to-face evaluation, he or she must consult the attending physician or other LIP responsible for the patient’s care as soon as possible after the completion of the evaluation. Hospital policy should address the expected time frame for and the components of the consultation with the attending physician or other LIP consistent with “as soon as possible.” This consultation should include, at a minimum, a discussion of the findings of the 1-hour face-to-face evaluation, the need for other interventions or treatments, and the need to continue or discontinue the use of restraint or seclusion. A consultation that is not conducted prior to a renewal of the order would not be consistent with the requirement, “as soon as possible.”

A-0183 482.13(e)(15) All requirements specified under this paragraph are applicable to the simultaneous use of restraint and seclusion. Simultaneous restraint and seclusion use is only permitted if the patient is continually monitored:
(i) Face-to-face by an assigned, trained staff member; or
(ii) By trained staff using both video and audio equipment. This monitoring must be in close proximity to the patient.

Interpretive Guidelines §482.13(e)(15)
When the simultaneous use of restraint and seclusion is employed, there must be adequate documentation that justifies the decision for simultaneous use as well as vigilance in continuously monitoring the patient so that the patient’s care needs are met.
All requirements specified under standard (e) apply to the simultaneous use of restraint and seclusion. The simultaneous use of restraint and seclusion is not permitted unless the patient is continually monitored by trained staff, either through face-to-face observation or through the use of both video and audio equipment. Monitoring with video and audio equipment further requires that staff perform the monitoring in close proximity to the patient. For the purposes of this requirement, “continually” means ongoing without interruption. The use of video and audio equipment does not eliminate the need for frequent monitoring and assessment of the patient.
An individual who is physically restrained alone in his or her room is not necessarily being simultaneously secluded. The individual’s privacy and dignity should be protected to the extent possible during any intervention. In fact, the purpose of restraining a patient alone in his or her room may be to promote privacy and dignity versus simultaneously using seclusion and restraint. While this distinction may be difficult to make, it is helpful to consider whether the patient would, in the absence of the physical restraint, be able to voluntarily leave the room. If so, then the patient is not also being secluded. However, if the physical restraint was removed and the patient was still unable to leave the room because the door was locked or staff were otherwise physically preventing the patient from doing so, then the patient is also being secluded.
Staff must take extra care to protect the safety of the patient when interventions that are more restrictive are used. Monitoring must be appropriate to the intervention chosen, so that the patient is protected from possible abuse, assault, or self injury during the intervention.

482.13(e)(16) - When restraint or seclusion is used, there must be documentation in the patient's medical record of the following:

A-0184 482.13(e)(16)(i) The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior.

Interpretive Guidelines §482.13(e)(16)(i)
When restraint or seclusion is used to manage violent or self-destructive behavior, the 1 hour face-to-face medical and behavioral evaluation must be documented in the patient’s medical record.

A-0185 482.13(e)(16)(ii) A description of the patient's behavior and the intervention used.

Interpretive Guidelines §482.13(e)(16)(ii)
Documentation that must be included in the patient’s medical record when the patient is restrained or secluded includes a description of the patient’s behavior and the intervention used. The patient’s behavior should be documented in descriptive terms to evaluate the appropriateness of the interventions used. The documentation should include a detailed description of the patient’s physical and mental status assessments, and of any environmental factors (e.g., physical, milieu, activities, etc.) that may have contributed to the situation at the time of the intervention.

A-0186 482.13(e)(16)(iii) Alternatives or other less restrictive interventions attempted (as applicable).

Interpretive Guidelines §482.13(e)(16)(iii)
The use of restraint or seclusion must be selected only when less restrictive measures have been judged to be ineffective to protect the patient or others from harm. It is not always appropriate for less restrictive alternatives to be attempted prior to the use of restraint or seclusion. When a patient’s behavior presents an immediate and serious danger to his- or herself, or others, immediate action is needed. For example, when a patient physically attacks someone, immediate action is needed. While staff should be mindful of using the least intrusive intervention, it is critical that the intervention selected be effective in protecting the patient or others from harm.

A-0187 482.13(e)(16)(iv) The patient's condition or symptom(s) that warranted the use of the restraint or seclusion.

Interpretive Guidelines §482.13(e)(16)(iv)
A comprehensive, individualized patient assessment is necessary to identify the most appropriate intervention to effectively manage a patient’s condition or symptom(s). When using a restraint or seclusion intervention, the patient’s condition or symptom(s) must be identified and documented in the patient’s medical record.

A-0188 482.13(e)(16)(v) The patient's response to the intervention(s) used, including the rationale for continued use of the intervention.

No information available.

482.13(f) Standard: Restraint or Seclusion : Staff Training Requirements

A-0194 482.13(f) The patient has the right to safe implementation of restraint or seclusion by trained staff.

Interpretive Guidelines §482.13(f)
Without adequate staff training and competency, the direct care staff, patients, and others are placed at risk. Patients have a right to the safe application of restraint or seclusion by trained and competent staff. Staff training and education play a critical role in the reduction of restraint and seclusion use in a hospital.

A-0196 482.13(f)(1) Training Intervals Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion:
(i) Before performing any of the actions specified in this paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital policy.

Interpretive Guidelines §482.13(f)(1)(i) - (iii)
All staff designated by the hospital as having direct patient care responsibilities, including contract or agency personnel, must demonstrate the competencies specified in standard (f) prior to participating in the application of restraints, implementation of seclusion, monitoring, assessment, or care of a patient in restraint or seclusion. These competencies must be demonstrated initially as part of orientation and subsequently on a periodic basis consistent with hospital policy. Hospitals have the flexibility to identify a time frame for ongoing training based on the level of staff competency, and the needs of the patient population(s) served.
Training for an RN or PA to conduct the 1-hour face-to-face evaluation would include all of the training requirements at §482.13(f) as well as content to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion. An evaluation of the patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient’s history, medications, most recent lab results, etc. The purpose of the 1-hour face-to-face evaluation is to complete a comprehensive review of the patient’s condition and determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient’s violent or self-destructive behavior.
Once initial training takes place, training must be provided frequently enough to ensure that staff possesses the requisite knowledge and skills to safely care for restrained or secluded patients in accordance with the regulations. The results of skills and knowledge assessments, new equipment, or QAPI data may indicate a need for targeted training or more frequent or revised training.
Hospitals are required to have appropriately trained staff for the proper and safe use of seclusion and restraint interventions. It would not be appropriate for a hospital to routinely call upon a law enforcement agency or agencies as a means of applying restraint or initiating seclusion. If hospital security guards, or other non-healthcare staff, as part of hospital policy, may assist direct care staff, when requested, in the application of restraint or seclusion, the security guards, or other non-healthcare staff, are also expected to be trained and able to demonstrate competency in the safe application of restraint and seclusion (in accordance with §482.13(f)).

482.13(f)(2) Training Content: The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:

A-0199 482.13(f)(2)(i) Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.

Interpretive Guidelines §482.13(f)(2)(i)
The term “appropriate staff” includes all staff that apply restraint or seclusion, monitor, assess, or otherwise provide care for patients in restraint or seclusion.
All staff, including contract or agency personnel, designated by the hospital as having direct patient care responsibilities are required to receive training in the areas of clinical techniques used to identify patient and staff behaviors, events and environmental factors that may trigger circumstances that require the use of restraint or seclusion. This training should be targeted to the specific needs of the patient populations being served, and to the competency level of staff.
Staff needs to be able to employ a broad range of clinical interventions to maintain the safety of the patient and others. The hospital is expected to provide education and training at the appropriate level to the appropriate staff based upon the specific needs of the patient population being served. For example, staff routinely providing care for patients who exhibit violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others (such as in an emergency department or on a psychiatric unit) generally require more in-depth training in the areas included in the regulation than staff routinely providing medical/surgical care. Hospitals may develop and implement their own training programs or use an outside training program. However, standard (f) specifies that individuals providing staff training must be qualified as evidenced by education, training, and experience.
Hospitals have the flexibility to develop their own training program to meet the staff training requirements at §482.13(f) or purchase a training program from the outside. CMS does not specify that any particular outside vendor must be used to provide the required training. Each hospital must assess the learning needs and competency of their staff to determine how extensive periodic training and staff competency demonstration must be subsequent to initial training. The training program must be provided to all appropriate staff. Any person monitoring or providing care to a restrained patient must demonstrate the knowledge and abilities required by the regulations.
At a minimum, physicians and other LIPs authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint and seclusion. Hospitals have the flexibility to identify training requirements above this minimum based on the competency level of their physicians and other LIPs and the needs of the patient population that they serve.

A-0200 482.13(f)(2)(ii) The use of nonphysical intervention skills.

Interpretive Guidelines §482.13(f)(2)(ii)
Although we recognize that there may be circumstances in which the use of restraint or seclusion may be necessary to prevent a patient situation from escalating, staff often skillfully intervene with alternative techniques to redirect a patient, engage the patient in constructive discussion or activity, or otherwise help the patient maintain self-control and avert escalation.
The use of nonphysical intervention skills does not mean attempting a complex series of interventions or a lengthy checklist of steps to initiate before restraining or secluding a patient. Rather, a whole toolbox of possible interventions can be implemented during the course of a patient’s treatment based upon the assessment of an individual patient’s responses.

A-0201 482.13(f)(2)(iii) Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition.

Interpretive Guidelines §482.13(f)(2)(iii)
The underpinning of this regulation is the concept that safe patient care hinges on looking at the patient as an individual and assessing the patient’s condition, needs, strengths, weaknesses, and preferences. Such an approach relies on caregivers who are skilled in individualized assessment and in tailoring interventions to individual patient’s needs after weighing factors such as the patient’s condition, behaviors, history, and environmental factors.
Resources are available to assist clinicians in identifying less restrictive interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with the field and extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion, and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org

A-0202 482.13(f)(2)(iv) The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia).

Interpretive Guidelines §482.13(f)(2)(iv)
Patients have a right to the safe application of restraint or seclusion by trained and competent staff.

A-0204 482.13(f)(2)(v) Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.

Interpretive Guidelines §482.13(f)(2)(v)
The use of restraint or seclusion must be ended at the earliest possible time regardless of the length of time identified in the order. Staff must be trained and demonstrate competency in their ability to identify specific patient behavioral changes that may indicate that restraint or seclusion is no longer necessary and can be safely discontinued.

A-0205 482.13(f)(2)(vi) Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

Interpretive Guidelines §482.13(f)(2)(vi)
Staff must be trained and demonstrate competency in monitoring the physical and psychological well-being of a patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and as well as any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

A-0206 482.13(f)(2)(vii) The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

Interpretive Guidelines §482.13(f)(2)(vii)
Hospitals are required to provide a safe environment for the patients in their care. When restraint or seclusion techniques are used, patients are placed at a higher risk for injuries or even death. Hospitals must require appropriate staff (all staff who apply restraint or seclusion, monitor, access or provide care for a patient in restraint or seclusion) to receive education and training in the use of first aid techniques as well as training and certification in the use of cardiopulmonary resuscitation.
Hospitals are not required to use any particular recognized first aid course. Additionally, such courses may not adequately address the immediate interventions, the “first aid”, that needs to be rendered to a restrained or secluded patient who is in distress or injured. The goal is for staff to be able to render the appropriate “first aid” required if a restrained or secluded patient is in distress or injured. For example, a patient is found hanging in a vest restraint, a restrained patient is choking on food, a secluded suicidal patient is found hanging, a secluded suicidal patient has cut himself, etc. Hospital staff need to assess their patient population and identify likely scenarios, develop a first aid training that addresses those scenarios, and provide that “first aid” training to all staff that care for restrained or secluded patients.

A-0207 482.13(f)(3) Trainer Requirements: Individuals providing staff training must be qualified as evidenced by education, training, and experience in techniques used to address patients' behaviors.

Interpretive Guidelines §482.13(f)(3)
There is no requirement that training be obtained from Federally-specified programs. Hospitals may develop and implement their own training programs or use an outside training program. However, individuals providing the training must be qualified as evidenced by education, training and experience in techniques used to address patients’ behaviors for the patient populations being served. Trainers should demonstrate a high level of knowledge regarding all the requirements of these regulations as well as the hospital’s policies and procedures that address these requirements.

A-0208 482.13(f)(4) Training Documentation: The hospital must document in the staff personnel records that the training and demonstration of competency were successfully completed.

Interpretive Guidelines §482.13(f)(4)
Staff personnel records must contain documentation that the training and demonstration of competency were successfully completed initially during orientation and on a periodic basis consistent with hospital policy.

482.13(g) Standard: Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.

A-0213 482.13(g)(1) With the exception of deaths described under paragraph (g)(2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient’s death:
(i) Each death that occurs while a patient is in restraint or seclusion.
(ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time. “Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.
(2) The staff must document in the patient’s medical record the date and time the death was:
(i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or….

Interpretive Guidelines §482.13(g)(1) & (3)(i)
The hospital must report to its CMS Regional Office each death that occurs:
• While a patient is in restraint or in seclusion, except when no seclusion has been used and the only restraint used was a soft, cloth-like two-point wrist restraints;
• Within 24 hours after the patient has been removed from restraint or seclusion, except when no seclusion has been used and the only restraint used was a soft, two-point wrist restraint; or,
• Within 1 week after use of restraint or seclusion where the death is known to the hospital and it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient’s death, regardless of the type(s) of restraint used on the patient during this time.
o “Reasonable to assume” applies only to those deaths that occur on days 2-7 after restraint or seclusion has been discontinued.
o This criterion applies regardless of the type of restraint that was used on the patient. In other words, it applies to all uses of restraint or seclusion where the patient has died on days 2-7 after the restraint or seclusion was discontinued, and it is reasonable to assume the use of the restraint or seclusion contributed to the patient’s death. In a case where only two-point soft wrist restraints were used and there was no seclusion, it may reasonably be presumed that the patient’s death was not caused by the use of restraints.
o In cases involving death within one week after use of restraint or seclusion where the intervention may have contributed to the patient’s death, it is possible that the patient’s death might occur outside the hospital and that the hospital might not learn of the patient’s death, or that there might be a delay in the hospital’s learning of the patient’s death.
See the guidance for §482.13(g)(2) for handling of deaths while a patient was in, or within 24 hours after removal of a soft, two-point wrist restraint, when no other restraint or seclusion was used.
The reports required under §482.13(g)(1) must be submitted to the CMS Regional Office by telephone, facsimile, or electronically, as determined by the Regional Office no later than close of the next business day following the day in which the hospital knows of the patient’s death. The report must include basic identifying information related to the hospital, the patient’s name, date of birth, date of death, name of attending physician/practitioner, primary diagnosis(es), cause of death (preliminary, in case a final, official cause of death is not yet available), and type(s) of restraint or seclusion used. CMS makes a standard form available for hospitals to use in submitting the required reports.
Hospitals must document in the patient’s medical record the date and time each reportable death associated with the use of restraint or seclusion was reported to the CMS Regional Office.
After reviewing the submitted information, the Regional Office will determine whether an on-site investigation of the circumstances surrounding the patient’s death is warranted and will direct the State Survey Agency to conduct a survey if applicable.

A-0214 482.13(g)(2) When no seclusion has been used and when the only restraints used on the patient are those applied exclusively to the patient’s wrist(s), and which are composed solely of soft, non-rigid, cloth-like materials, the hospital staff must record in an internal log or other system, the following information:
(i) Any death that occurs while a patient is in such restraints.
(ii) Any death that occurs within 24 hours after a patient has been removed from such restraints.
(3) The staff must document in the patient’s medical record the date and time the death was:
(ii) Recorded in the internal log or other system for deaths described in paragraph (g)(2) of this section.
(4) For deaths described in paragraph (g)(2) of this section, entries into the log or other system must be documented as follows:
(i) Each entry must be made not later than seven days after the date of death of the patient.
(ii) Each entry must document the patient’s name, date of birth, date of death, name of attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c), medical record number, and primary diagnosis(es).
(iii) The information must be made available in either written or electronic form to CMS immediately upon request.

Interpretive Guidelines §482.13(g)(2), (3)(ii), & (4)
Hospitals must maintain an internal log or other type of tracking system for recording information on each death that occurs:
• While a patient is in only 2-point soft, cloth-like non-rigid wrist restraints and there is no use of seclusion; and
• Within 24 hours of the patient being removed from 2-point soft, cloth-like non-rigid wrist restraints where there was no use of any other type of restraint or seclusion.
Use of the log or tracking system is limited only to patient deaths meeting one of these two criteria. Examples of patient deaths associated with restraints that must still be reported to CMS include:
• Deaths occurring during or within 24 hours of discontinuation of 2-point soft, cloth-like non-rigid wrist restraints used in combination with any other restraint device or with seclusion; or
• Deaths associated with the use of other types of wrist restraints, such as 2-point rigid or leather wrist restraints.
These cases would not be included in this internal log or tracking system and would require reporting the death to CMS using telephone, fax, or electronically.
The two-point soft wrist restraint death report must be entered into the internal log or tracking system within 7 days of the patient’s death.
The death report log or tracking system entry must include:
• The patient’s name;
• Patient’s date of birth;
• Patient’s date of death;
• Name of the attending physician or other licensed independent practitioner who is responsible for the care or the patient;
• Patient’s medical record number; and
• Primary diagnosis(es).
Depending on the size and nature of the patient population the hospital serves and the types of services it provides, there will likely be variations in the frequency of restraint use as well as in the incidence of patient deaths. Surveyors should adjust their expectations for the volume of log or tracking system entries accordingly. For example, hospitals with intensive care units might be more likely to use both soft, 2-point wrist restraints and to have seriously ill patients who die as a result of their disease while such restraints are being used or within 24 hours after their discontinuance. On the other hand, a rehabilitation hospital would be expected to use such restraints less frequently, and to have patients who die less frequently while hospitalized.
The log or tracking system must be available in written, i.e., hard copy, or electronic form immediately upon CMS’s request. CMS will specify the form in which the information is to be provided. Generally CMS would request access to the log or tracking system during an on-site survey by CMS staff or State surveyors acting on CMS’s behalf when assessing compliance with restraint/seclusion requirements. However, CMS may also request that a copy of portions or the entire log or tracking system be provided, even though no survey is in progress. Accreditation organizations conducting hospital inspections in accordance with a CMS-approved Medicare hospital accreditation program are also entitled to immediate access to the log or tracking system.
The hospital is not required to make the contents of the log or tracking system available to any other outside parties, unless required to do so under other Federal or State law.
The hospital must document in the patient’s medical record the date and time the death report entry was made into the log or tracking system.

482.13(h) Standard: Patient Visitation Rights

A-0215 482.13(h) A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation.

Interpretive Guidelines, §482.13(h)
Visitation plays an important role in the care of hospital patients. An article published in 2004 in the Journal of the American Medical Association (Berwick, D.M., and Kotagal, M.: “Restricted visiting hours in ICUs: time to change.” JAMA. 2004; Vol. 292, pp. 736-737) discusses the health and safety benefits of open visitation for patients, families, and intensive care unit (ICU) staff and debunks some of the myths surrounding the issue (physiologic stress for the patient; barriers to provision of care; exhaustion of family and friends). The article ultimately concluded that “available evidence indicates that hazards and problems regarding open visitation are generally overstated and manageable,” and that such visitation policies “do not harm patients but rather may help them by providing a support system and shaping a more familiar environment” as they “engender trust in families, creating a better working relationship between hospital staff and family members.” Hospitals that unnecessarily restrict patient visitation often miss an opportunity to gain valuable patient information from those who may know the patient best with respect to the patient’s medical history, conditions, medications, and allergies, particularly if the patient has difficulties with recall or articulation, or is totally unable to recall or articulate this vital personal information. Many times visitors who may know the patient best act as an intermediary for the patient, helping to communicate the patient’s needs to hospital staff.
Although visitation policies are generally considered to relate to visitors of inpatients, “visitors” also play a role for outpatients who wish to have a support person present during their outpatient visit. For example, a same-day surgery patient may wish to have a support person present during the pre-operative patient preparation or post-operative recovery. Or an outpatient clinic patient may wish to have a support person present during his or her examination by a physician. Accordingly, hospital visitation policies must address both the inpatient and outpatient settings.
Hospitals are required to develop and implement written policies and procedures that address the patient’s right to have visitors. If the hospital’s policy establishes restrictions or limitations on visitation, such restrictions/limitations must be clinically necessary or reasonable. Furthermore, the hospital’s policy must include the reasons for any restrictions/limitations. The right of a patient to have visitors may be limited or restricted when visitation would interfere with the care of the patient and/or the care of other patients. The regulation permits hospitals some flexibility, so that health care professionals may exercise their best clinical judgment when determining when visitation is, and is not, appropriate. Best clinical judgment takes into account all aspects of patient health and safety, including the benefits of visitation on a patient’s care as well as potential negative impacts that visitors may have on other patients in the hospital.
Broad examples of circumstances reasonably related to the care of the patient and/or the care of other patients that could provide a basis for a hospital to impose restrictions or limitations on visitors might include (but are not limited to) when:
• there may be infection control issues;
• visitation may interfere with the care of other patients;
• the hospital is aware that there is an existing court order restricting contact;
• visitors engage in disruptive, threatening, or violent behavior of any kind;
• the patient or patient’s roommate(s) need rest or privacy;
• in the case of an inpatient substance abuse treatment program, there are protocols limiting visitation; and
• the patient is undergoing care interventions. However, while there may be valid reasons for limiting visitation during a care intervention, we encourage hospitals to try to accommodate the needs of any patient who requests that at least one visitor be allowed to remain in the room to provide support and comfort at such times.
It may also be reasonable to limit the number of visitors for any one patient during a specific period of time, as well as to establish minimum age requirements for child visitors. However, when a hospital adopts policies that limit or restrict patients’ visitation rights, the burden of proof is upon the hospital to demonstrate that the visitation restriction is reasonably necessary to provide safe care.
Hospitals are expected to provide a clear explanation in their written policy of the clinical rationale for any visitation restrictions or limitations reflected in that policy. Hospitals are not required, however, to delineate each specific clinical reason for policies limiting or restricting visitation, given that it is not possible to anticipate every instance that may give rise to a clinically appropriate rationale for a restriction or limitation. If visitation policies differ by type of unit, e.g., separate policies for intensive care units, or for newborn nurseries, the hospital policy must address the clinical rationale for this differentiation explicitly.
The hospital’s policies and procedures are expected to address how hospital staff who play a role in facilitating or controlling visitor access to patients will be trained to assure appropriate implementation of the visitation policies and procedures and avoidance of unnecessary restrictions or limitations on patients’ visitation rights.

A-0216 482.13(h)(1) Inform each patient (or support person, where appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights, when he or she is informed of his or her other rights under this section.
(2) Inform each patient (or support person, where appropriate) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.

Interpretive Guidelines §482.13(h)(1)&(2)
Hospitals are required to inform each patient (or the patient’s support person, where appropriate) of his/her visitation rights. A patient’s “support person” does not necessarily have to be the same person as the patient’s representative who is legally responsible for making medical decisions on the patient’s behalf. A support person could be a family member, friend, or other individual who supports the patient during the course of the hospital stay. Not only may the support person visit the patient, but he or she may also exercise a patient’s visitation rights on behalf of the patient with respect to other visitors when the patient is unable to do so. Hospitals must accept a patient’s designation, orally or in writing, of an individual as the patient’s support person.
When a patient is incapacitated or otherwise unable to communicate his or her wishes and an individual provides an advance directive designating an individual as the patient’s support person (it is not necessary for the document to use this exact term), the hospital must accept this designation, provide the required notice of the patient’s visitation rights, and allow the individual to exercise the patient’s visitation rights on the patient’s behalf.
When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no advance directive designating a representative on file, and no one has presented an advance directive designating himself or herself as the patient’s representative, but an individual asserts that he or she, as the patient’s spouse, domestic partner (including a same-sex domestic partner), parent or other family member, friend, or otherwise, is the patient’s support person, the hospital is expected to accept this assertion, without demanding supporting documentation, provide the required notice of the patient’s visitation rights, and allow the individual to exercise the patient’s visitation rights on the patient’s behalf. However, if more than one individual claims to be the patient’s support person, it would not be inappropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s support person.
• Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s support person, given the critical role of the support person in exercising the patient’s visitation rights.
• A refusal by the hospital of an individual’s request to be treated as the patient’s support person with respect to visitation rights must be documented in the patient’s medical record, along with the specific basis for the refusal.
Consistent with the patients’ rights notice requirements under the regulation at §482.13(a)(1), the required notice of the patient’s visitation rights must be provided, whenever possible, before the hospital provides or stops care. The notice to the patient, or to the patient’s support person, where appropriate, must be in writing. If the patient also has a representative who is different from the support person, the representative must also be provided information on the patient’s visitation rights, in addition to the support person, if applicable. In the event that a patient has both a representative and a support person who are not the same individual, and they disagree on who should be allowed to visit the patient, the hospital must defer to the decisions of the patient’s representative.
As the individual responsible for making decisions on the patient’s behalf, the patient’s representative has the authority to exercise a patient’s right to designate and deny visitors just as the patient would if he or she were capable of doing so. The designation of, and exercise of authority by, the patient’s representative is governed by State law, including statutory and case law. Many State courts have addressed the concept of substituted judgment, whereby the patient’s representative is expected to make medical decisions based on the patient’s values and interests, rather than the representative’s own values and interests. State courts have also developed a body of closely related law around the matter of a representative acting in the patient’s best interest. Such case law regarding substituted judgment and best interest may be a resource for hospitals on how to address such conflict situations as they establish visitation policies and procedures. Hospitals may also choose to utilize their own social work and pastoral counseling resources to resolve such conflicts to assure the patient’s well-being.
The required visitation rights notice must address any clinically necessary or reasonable limitations or restrictions imposed by hospital policy on visitation rights, providing the clinical reasons for such limitations/restrictions, including how they are aimed at protecting the health and safety of all patients. The information must be sufficiently detailed to allow a patient (or the patient’s support person) to determine what the visitation hours are and what restrictions, if any, apply to that patient’s visitation rights.
The notice must also inform the patient (or the patient’s support person, where appropriate) of the patient’s right to:
• Consent to receive visitors he or she has designated, either orally or in writing, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend;
• Receive the visitors he or she has designated, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend; and
• Withdraw or deny his/her consent to receive specific visitors, either orally or in writing.
The medical record must contain documentation that the required notice was provided to the patient or, if appropriate, the patient’s support person.

A-0217 482.13(h)(3) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences.

Interpretive Guidelines §482.13(h)(3)&(4)
The hospital’s visitation policies and procedures may not use the race, color, national origin, religion, sex, gender identity, sexual orientation, or disability of either the patient (or the patient’s support person ore representative, where appropriate) or the patient’s visitors (including individuals seeking to visit the patient) as a basis for limiting, restricting, or otherwise denying visitation privileges.
The hospital’s policies and procedures must ensure that all visitors (including individuals seeking to visit the patient) enjoy full and equal visitation privileges, consistent with the preferences the patient (or, where appropriate, the patient’s support person) has expressed concerning visitors. In other words, it is permissible for the patient (or the patient’s support person, where appropriate) to limit the visiting privileges of his/her visitors, including providing for more limited visiting privileges for some visitors than those for others. But it is not permissible for the hospital, on its own, to differentiate among visitors without any clinically necessary or reasonable basis. This includes visitors designated by the patient who have characteristics not addressed specifically in §482.13(h)(3), when those characteristics do not reasonably relate to a clinically reasonable basis for limiting or denying visitation. For example, it would not be appropriate to prohibit a designated visitor based on that individual’s style of dress, unless there was a clinically reasonable basis for doing so.
The hospital is responsible for ensuring that hospital staff treat all individuals seeking to visit patients equally, consistent with the preferences of the patient (or, where appropriate, the patient’s support person) and do not use the race, color, national origin, religion, sex, gender identity, sexual orientation, or disability of either the patient(or the patient’s support person or representative, where appropriate) or the patient’s visitors (including individuals seeking to visit the patient) as a basis for limiting, restricting, or otherwise denying visitation privileges. Hospitals are expected to educate all staff who play a role in facilitating or controlling visitors on the hospital’s visitation policies and procedures, and are responsible for ensuring that staff implement the hospital’s policies correctly. Hospitals are urged to develop culturally competent training programs designed to address the range of patients served by the hospital.

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.