RESTRAINTS, SECLUSION AND PATIENT RIGHTS STANDARDS FOR HOSPITAL UNDER THE MEDICARE/MEDICAID PROGRAM

| Examination |

   Learning Objectives

Upon successful completion of this course, you will be able to:

• Define the terms “restraints” and “seclusion” in the healthcare setting
• Identify the key elements of HCFA’s Patients' Rights Condition of Participation
• Explain the minimal requirements that must be reflected in any patient-hospital grievance process
• List and discuss the “standards on use of restraints and seclusion” set forth by HCFA

   Introduction

On July 2, 1999, the Health Care Financing Administration ("HCFA") issued a new Condition of Participation for hospitals participating in the Medicare and Medicaid programs. Published as an interim final rule with commentary, the Condition of Participation codifies certain rights and protections for hospital patients. Not to be confused with the Consumer Bill of Rights, the Patients' Rights Condition of Participation sets forth six (6) standards on the following patient rights: notice of rights; the exercise of patient rights; the right to privacy and safety; the right to confidentiality of patient records; the right to freedom from restraints used in the provision of acute medical and surgical care, unless clinically necessary; and, the right to freedom from restraints and seclusion used for behavior management, unless clinically necessary.

As a Condition of Participation, hospitals must meet the requirements imposed by this regulation in order to be approved for, or to continue participation in, the Medicare and Medicaid programs. Failure to comply also can result in monetary penalties and other sanctions. To enforce the regulatory provisions, HCFA will expect the State Survey Agency to determine if hospitals are in compliance. These agencies are guided in their task by a set of interpretive guidelines. The guidelines have become a part of the HCFA State Operations Manual. These guidelines are intended to be of assistance to hospitals in complying with the Patients' Rights Condition of Participation.

This course presents an overview of the six standards created by the Condition of Participation, with a special emphasis on the restraint and seclusion requirements. Part II discusses the standards concerning Notice of Patient Rights, Exercise of Rights, Privacy and Safety, and Confidentiality of Patient Records. Part III addresses the impact of the Restraint and Seclusion standards.

   II. Patients' Right Condition of Participation

A. Notice of Rights

Under this standard, a hospital is required to inform each patient (or his/her representative) of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. The regulation does not prescribe exactly where, how, when, and by whom this notice must be made. HCFA recognizes that hospitals are of varying sizes, and serve diverse populations in a wide range of locations. Instead of imposing a single requirement for all hospitals, HCFA thus allows hospitals flexibility and creativity in implementing this standard.

The interpretive guidelines, to be issued by HCFA in the near future, likely will contain additional guidance. While committed to maintaining flexibility, HCFA has commented that one method for handling some aspects of this requirement is to bundle such notices with existing information that must be provided to patients under other Federal laws and regulations. These include regulations promulgated under Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975.

The Notice of Rights standard also requires that a hospital establish a process for the prompt resolution of patient grievances as well as inform each patient whom to contact to file a grievance. The hospital's governing body must approve and be responsible for operation of the
grievance process, although it may delegate the responsibility to a grievance committee. The regulation has set forth certain minimal requirements that must be reflected in the grievance process:

• A clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital.
• Specific time frames for review of the grievance and the provision of a response.
• Written notice to the patient of the resolution decision, including the name of a contact person, the steps taken to investigate the grievance, the results of the process, and the date of completion.
• A mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Peer Review Organization.

By use of the term "Utilization and Quality Control Peer Review Organization," HCFA is referring to the State Peer Review Organizations (PROs). PROs are HCFA contractors charged with reviewing the appropriateness and quality of care rendered to Medicare beneficiaries in the hospital setting. The PRO for Virginia is the Virginia Health Quality Center. Procedures for referring Medicare beneficiary complaints to PROs already exist within hospitals. However, HCFA will expect coordination between the hospital grievance process and these existing procedures to ensure timely referral of complaints to the State PRO, when requested by the beneficiary or his/her representative.

• Although not stated in the regulation, HCFA will require that hospitals notify patients of their right to contact the State Survey Agency with a grievance, regardless as to whether the patient has first used the hospital's grievance process. HCFA also will expect that a hospital provide the patient with the address and phone number for the State Survey Agency. The Survey Agency for Virginia is the Center for Quality Health Care Services & Consumer Protection, which is an agency of the Virginia Department of Health.

B. Exercise of Rights

The Exercise of Rights standard contains four separate patient rights.
A patient has the right to participate in the development and implementation of his plan of care, the right to make informed decisions, the right to formulate advance directives, and the right to have a family member or his/her own physician notified of the admission to the hospital. With regard to these rights, HCFA expects that a hospital will promote an atmosphere of two-way communication between the patient and hospital staff and treating practitioners.

The commentary to the rule indicates that a hospital must hold the responsible physician accountable for discussing all information regarding treatment, experimental approaches, and possible outcomes of care. The right to make informed decisions specifically includes the right to be informed of health status, the right to be involved in care planning and treatment, and the right to request and refuse treatment. HCFA declined to introduce more specific requirements for advance directives, commenting that regulations on the acknowledgment and handling of advance directives are found elsewhere in the Code of Federal Regulations.

C. Privacy and Safety

Under the Privacy and Safety standard, a patient has a right to privacy, the right to receive care in a safe setting, and the right to be free from abuse and harassment. These standards are intended to protect a patient’s physical and emotional health and safety. Freedom from abuse encompasses not only physical and verbal abuse but also psychological, sexual, and emotional abuse.

HCFA further elaborates on its expectations for patient privacy and safety through the interpretive guidelines. Of special note is whether the right to privacy would include a right to a private hospital room. HCFA has commented that the term "privacy" does not mean a right to a private room. However, HCFA would expect that a hospital provide some level of privacy even in semi-private rooms, i.e. pulling curtains closed for exams or requesting visitors to leave room when treatment issues are discussed.

D. Confidentiality of Patient Records

The Confidentiality standard has two specific provisions. One, a patient has the right to the confidentiality of his or her clinical records. Two, a patient has the right to access his or her records within a reasonable time frame. Under the Condition of Participation, "reasonable" access means that a hospital:
(1) does not frustrate the legitimate efforts of individuals to gain access
      to their own medical records, and
(2) actively seeks to meet these requests as quickly as possible.

Rather than set precise time limits for disclosure, HCFA decided on this approach in order to account for the impact of various factors such as location of data, urgency, and staff workload. Finally, in the comment to the rule, HCFA notes that there may be certain extreme cases in which information can be withheld from the patient. The comment lists six circumstances that might allow the withholding of information. These circumstances include concerns that disclosure is reasonably likely to endanger the life or physical safety of the patient or another individual. In such extreme circumstances, HCFA indicates that a hospital should redact the portions to be denied, and give the patient the rest of the information.

   III. Standards on Use of Restraints and Seclusion

The most controversial aspect of the Condition of Participation involves the two standards on restraint and seclusion use. The standards are a response to a public concern over injuries, accidents, and deaths resulting from restraints and seclusion. There are separate standards for the acute medical and surgical care setting and the behavior management setting. This approach is similar to the one taken by the Joint Commission on the Accreditation of Health Care Organizations.

The requirements of the two standards account for the differences between interventions used for acute medical and surgical care and interventions used for behavior management. However, both are founded upon the principle that a patient has the right to be free from seclusion and restraints, of any form, that are not medically necessary or that are used as a means of coercion, discipline, convenience, or retaliation.

Unfortunately, the regulation does not define the terms "acute medical and surgical care" or "behavior management." HCFA also has commented that the standards are not specific to the treatment setting but rather to the situation that the restraint is being used to address. For example, an acute care hospital with a psychiatric unit would need to meet the behavior management standard for those patients. While the applicable standard for a psychiatric patient may be clearly defined, a more difficult issue for acute care hospitals will be how to characterize an application of restraints for a surgical patient who needs to be immobilized to prevent injury. In such circumstances, which standard applies?

This determination is important because the behavior management standard has more stringent requirements, particularly on the timeliness of actions that must be taken by the ordering physician, than those requirements imposed by the acute medical and surgical care standard. Uncertainty as to the applicable standard will cause problems for hospitals when attempting an intervention.

HCFA's Questions and Answers on the Patients Rights Condition of Participation provides some additional insight for acute care hospitals in particular provide guidance in determining which standard applies to a given situation. For the acute medical and surgical care setting, the comments and answers appear to focus upon whether an emergency situation is present. In the absence of an emergency situation, the restraint use would need to meet the criteria under the acute medical and surgical care standard.

To explain the different applications, HCFA uses the examples of surgical patients who have Alzheimer's Diseases, Sundowner's Syndrome, or other mental impairments. One scenario uses patients that do not behave destructively or dangerously. However, the patients may have an unsteady gait or a history of wandering, and attempts to explain the situation to the patient are unsuccessful. Medical staff determine that less restrictive measures will not be effective to protect the patient. Use of a restraint in these circumstances would be governed by the acute medical and surgical care standard.

This standard applies because there is nothing inherently dangerous about a patient being able to walk or wander. In contrast, HCFA offers another example of a patient who becomes agitated and aggressive and threatens the health of other patients or staff members. This behavior presents an immediate and serious danger to the safety of the patient. Use of restraint or seclusion in this situation is applied under the behavior management standard.

While apparently straightforward in its application, the behavior management standard also will present difficulties. Particularly, there is inconsistency between the underlying limitations on seclusion and restraint and a patient’s right to be free from verbal abuse. The American Psychiatric Association presented the following question to HCFA.

A psychiatric patient has a manic hypersexual episode in which he is agitated and makes loud, repetitive, offensive, and lewd comments in the presence of other patients and staff. This patient poses no emergent threat to the physical safety of himself or others, so the patient cannot be restrained or secluded under the behavior management standard. However, the hospital also has the obligation to protect the right of the other patients to be free from all forms of abuse, which would include verbal abuse. This situation is yet another example of the problems that hospitals face in implementing the restraint and seclusion standards.

The standards provide some guidance on what may constitute a restraint or seclusion by defining those terms. The restraint definition parallels HCFA nursing home requirements and the definition for seclusion follows JCAHO standards. A physical restraint is any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient’s body that he or she cannot remove that restricts movement or normal access to one's body.

Whether a device is considered a restraint depends upon whether the patient can remove the restraint. For example, a sheet may be considered a restraint if the sheet is tucked in so tightly that the patient cannot move. Side rails that inhibit the patient’s ability to get out of bed when he or she wants also constitutes a restraint. However, if the patient is able to independently remove the sheet or the side rail, then the sheet or railing does not constitute a restraint.

A drug or medication is considered a restraint if:
(1) it is used to control behavior or to restrict the patient’s freedom of       movement; and,
(2) it is not a standard treatment for the patient’s medical or psychiatric
      condition.

In addition, HCFA stresses the fundamental right of a patient to be free from restraints of any form that are imposed for coercion, discipline, convenience, or retaliation by the staff. This can be an important consideration in deciding whether to use a drug to restrain a patient.

For example, HCFA explains that it would be improper for hospital personnel to administer Valium to a wandering patient simply because the staff finds his behavior bothersome. In that circumstance, the Valium is not needed for the patient’s medical or psychiatric condition, and rather is administered for the convenience of the staff.

Seclusion is the involuntary confinement of a person in a room or an area where the person is physically prevented from leaving. A private room would be considered seclusion if the patient is physically prevented from leaving that room. In addition, seclusion is not just confining an individual to an area, but separating him or her from others.

Both standards also have a continuing education requirement for hospital staff. The acute medical and surgical care standard simply states that all staff with direct patient contact must have ongoing education and training in the proper and safe use of restraints. The behavior management standard has more stringent requirements. Here, all staff who have direct patient contact must receive ongoing education and training in the proper and safe use of seclusion and restraint application and techniques, and alternative methods for handling behavior, symptoms, and situations that traditionally have been treated through the use of restraints or seclusion.

Finally, a hospital must report to the Health Care Financing Administration any death that occurs while a patient is restrained or in seclusion, or where it is reasonable to assume that a patient’s death is a result of restraint or seclusion. While found in the behavior management standard, HCFA probably would expect a hospital to report as well any deaths that occur from restraint use under the acute medical and surgical care standard. This information will be used to:
(1) authorize onsite investigations of hospitals in accordance with the
      current complaint investigation process; and,
(2) inform the Protection and Advocacy entity in the respective state
      or territory for further action.

A. Restraint Standard for Acute Medical and Surgical Care

Under this standard, restraints are permitted only if:
(1) needed to improve the patient’s well-being, and
(2) less restrictive interventions have been determined to be ineffective.

Seclusion can never be used in the acute medical care setting. Before using a restraint, personnel must conduct a complete assessment and document the need for protective intervention with a written modification to the patient’s plan of care. When assessing the patient, the hospital must determine and document that a patient has a medical condition or symptom that indicates a need
for protective intervention.

A fear that a patient might fall is an inadequate basis for using a restraint unless that patient has a history of falls or wandering. HCFA also expects that the medical record will contain information on less restrictive measures that were considered before the selection of restraint use.

Restraints must be ordered by a physician or other licensed independent practitioner permitted by the state and hospital to order a restraint. Orders cannot be written as a standing order or on an as needed basis. If the treating physician does not order the restraint or seclusion, the treating physician must be consulted as soon as possible. There is no time limitation for a restraint order in the acute medical/surgical care setting. However, the regulation states that the intervention should be ended at the earliest possible time.

The condition of the patient also must be continually assessed, monitored, and reevaluated. In addition, HCFA will expect that a hospital establish a policy and procedure, or issue staff guidelines, on how to determine an appropriate interval for assessment, monitoring, and reevaluation based upon the patient’s needs and condition, and the type of restraint used.

B. Restraint and Seclusion Standard for Behavior Management

Restraints and seclusion can be used for behavior management only in emergency situations. An emergency is defined as:
(1) when needed to ensure the patient’s physical safety, and
(2) less restrictive interventions have been determined to be ineffective.

The medical record must document the necessity for the intervention, and that less restrictive interventions have been determined to be ineffective. As with the acute medical and surgical care setting, the intervention must be in accordance with a written modification to the patient’s plan of care, implemented in the least restrictive manner, and ended at the earliest possible time.

Physicians or a licensed independent practitioner also must order the restraint or seclusion use. Again, orders cannot be written as standing orders or on an as needed basis. Understanding that a physician sometimes may be unavailable during an emergency, HCFA has commented that a hospital may develop an emergency protocol, approved by medical staff, that can be used in a manner consistent with the regulations. This protocol may allow a registered nurse to initiate an intervention based upon an appropriate assessment of the patient. In such emergent circumstances, the treating physician must evaluate, in person, the patient within one hour. This evaluation must be performed even if the patient quickly recovers within the one-hour period.

According to HCFA, the fact that a patient’s behavior warrants the use of restraint or seclusion indicates a serious medical or psychological need for prompt assessment of the situation as well as the physiological and psychological condition of the patient.

The most controversial aspect of the behavior management standard is the introduction of mandated time limits for restraint and seclusion use. The American Psychiatric Association and the American Hospital Association, among others, have protested these requirements on the
grounds that they are an inappropriate attempt to practice medicine and may substitute a practitioner's best clinical judgment.

Despite such opposition, HCFA retained the following maximum time limits in the behavior management standard. A written order is limited to a maximum of 4 hours for adults, 2 hours for patients aged 9 to 17, and 1 hour for patients under 9. After this original order expires, HCFA will allow a registered nurse to examine the patient, contact the ordering physician by telephone, and report the findings from the most recent assessment. The use of the restraint or seclusion can then continue upon the physician's instructions. After the original order is continued up to a maximum of 24 hours, the physician or licensed independent practitioner must assess, in person, the patient before issuing a new order.

The behavior management standard also addresses the simultaneous use of both a restraint and seclusion . This is permitted only if the patient is continually monitored face-to-face by an assigned staff member, or continually monitored by staff using both video and audio equipment. In the latter circumstance, the monitoring must be in close proximity to the patient.

IV. Conclusion

The Patients' Rights Condition of Participation will require careful analysis on the part of hospitals to ensure that existing policies and procedures are in compliance with its directives. Hospitals also should review the interpretive guidelines, once issued, so that the hospital is in compliance with HCFA expectations. Finally, hospitals can expect further regulatory effort in these areas, especially with regard to restraint and seclusion use. HCFA has already begun considering whether to require the reporting of "serious injuries" related to restraints and seclusion, in addition to the reporting requirement for patient deaths. HCFA also is working with state and other federal agencies to determine the best system for maintaining comprehensive records of seclusion and restraints incidents.

Aside from HCFA’s guidelines, numerous organizations and hospitals (of course) have established their own guidelines that should be reviewed as you learn about these important patient rights. We offer some of those for your examination here:

   The American College of Emergency Physicians (ACEP)
     Use of Patient Restraints

Approved by the ACEP Board of Directors April 2001. This statement replaces one with the same title approved by the ACEP Board of Directors, June 2000. Replaced with policy statement with the same title and approved by the ACEP Board of Directors January 1996

The American College of Emergency Physicians (ACEP) supports the careful and appropriate use of patient restraints or seclusion. ACEP recognizes that patient restraint involves issues of civil rights and liberties, including the right to refuse care, freedom from imprisonment, and freedom of association. However, there are circumstances when the use of restraints is in the best interest of the patient, staff, or the public.

Methods of patient restraint include physical restraints, chemical restraints, and seclusion. Patient restraint should be considered when a careful assessment establishes that the patient is a danger to self or others by virtue of a medical or psychiatric condition.

ACEP endorses the following principles regarding patient restraints:

• Restraints should be individualized and afford as much dignity to the patient as the situation allows.
• Any restraints should be humanely and professionally administered.
• Protocols to ensure patient safety should be developed to address observation and treatment during the period of restraint and periodic assessment as to the need and means of restraint.
• The use of restraints should be carefully documented. Such documentation should include the reasons for and means of restraint and the periodic assessment of the restrained patient.
• The method of restraint should be the least restrictive necessary for the protection of the patient and others.
• ACEP opposes any requirement by hospital representatives or medical staffs that emergency physicians provide inpatient restraint or seclusion orders. Patient restraint or seclusion requires comprehensive patient assessment, 1 and the emergency physician's principal legal and ethical responsibility is to patients who present to be seen and treated in the emergency department. 2
• The use of restraints should conform to applicable laws, rules, regulations, and accreditation standards.
  

References

1. 42 CFR 482.13(f).
2. American College of Emergency Physicians. Emergency physicians'     patient care responsibilities outside of the emergency department     [policy statement];Approved September 1999. Ann Emerg Med     2000;35:209.

   The American Academy of Physician Assistants position paper on      the HCFA guidelines:

Patients' Rights: Restraint and Seclusion

Recent patient deaths resulting from inappropriate restraint techniques have focused public attention on the use of restraints in institutional care. Some advocacy groups recommend that seclusion and restraint be completely eliminated. Health care providers, particularly those in emergency departments and mental health settings, argue that in some situations seclusion and restraint are necessary components of treatment for individuals who are threatening immediate harm to themselves or others.

The AAPA opposes inappropriate use of restraint or seclusion. Academy policy states, "The American Academy of Physician Assistants believes that patients have the right to be free of all forms of seclusion and physical and chemical restraint that are not medically necessary. Seclusion and restraint should not be used as a means of coercion, discipline, convenience, or retaliation. Seclusion and restraint should only be used according to accepted medical standards for the purpose of protecting the patient or others and to improve a patient's functional well being and only if less intrusive interventions have been determined to be ineffective."

Language chosen by both the Health Care Financing Administration(HCFA) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to limit the use of restraints and seclusion has been problematic for some PAs and physicians. Both HCFA regulations and JCAHO standards state that restraint or seclusion use must be ordered by a physician or other "licensed independent practitioner." Although this language appears to prohibit physicians from delegating these tasks to physician assistants, both organizations state that is not their intent. Indeed, both organizations state that physicians may delegate this to the extent allowed by state law and institutional policy.

In addition, the National Alliance for the Mentally Ill (NAMI), a nonprofit, grassroots, self-help, support and advocacy organization of consumers, families, and friends of people with severe mental illnesses, such as schizophrenia, major depression, bipolar disorder, obsessive-compulsive disorder, and anxiety disorders has issued its position paper:

   Seclusion and Restraint

NAMI’s Position (summarized from the NAMI Policy Platform)

   The Media: A Clear Pattern of Abuse Exposed

In October 1998, The Hartford Courant published a five-part investigative series that revealed an alarming number of deaths resulting from the inappropriate use of physical restraints in psychiatric treatment facilities across the United States. A 50-state survey conducted by the newspaper documented at least 142 deaths in the past decade connected to the use of physical restraints or to the practice of seclusion. The report also suggested that the actual number of deaths is many times higher because many incidents go unreported. According to a separate statistical estimate commissioned by The Courant and conducted by the Harvard Center for Risk Analysis, between 50 and 150 restraint- or seclusion-related deaths occur every year across the country.

As a result of The Hartford Courant series and NAMI’s communications with its members, NAMI members have shared their horror stories of abuse and death. These are compiled in NAMI’s report, Cries of Anguish. More than 60 personal stories of incidents from 24 states and the District of Columbia were reported as of August 2000.

Understanding the Issue

Restraints are human or mechanical actions that restrict freedom of movement or normal access to one’s body. Since the development of more effective psychotropic medications, emergency situations have become increasingly rare. In fact, some hospitals have moved to restraint-free policies.

In current practice, physical restraints are sometimes imposed on a patient involuntarily for control of the environment (curtailing individual behavior to avoid the necessity for adequate staffing or clinical interventions); coercion (forcing the patient to comply with the staff’s wishes); or punishment (staff punishing or penalizing patients). NAMI rejects these as legitimate reasons to impose restraints.

Federal Protections Enacted in 2000

In October 2000, President Clinton signed the Children’s Health Act of 2000, P.L. 106-310. This significant new law established national standards that restrict the use of restraint and seclusion in all psychiatric facilities that receive federal funds and in "non-medical community-based facilities for children and youth."

NAMI will be following the implementation of key provisions under the general requirements, which include:

For children's non-medical community programs:

These R/S standards apply only to psychiatric treatment facilities that receive federal funding. They do not affect use of restraint and seclusion in schools, wilderness camps, jails, or prisons. P.L. 106-310 also does not impede any federal or state laws or regulations that provide greater protections than written in the Children’s Health Act of 2000. Thus, rules issued by the Health Care Financing Administration in 1999 that included a requirement for face-to-face evaluations by mental health professionals within one hour of initiating restraint are affirmed.

NAMI’s Advocacy Goals and Strategies

NAMI strongly supports full implementation of the restraint and seclusion provisions included in P.L 310-106;

NAMI will monitor the progress of the Department of Health and Human Services in issuing national guidelines and regulations specifying adequate number of staff in facilities and appropriate training in the use of R/S and their alternatives;

NAMI will also advocate for a national standard in schools, wilderness camps, jails, and prisons

What Should You Do If You Experience Restraint And Seclusion Abuse?

If you or your family member has experienced abuse of R/S in a treatment facility, you should take the following action.

Contact your state’s Protection and Advocacy program. For the phone number of your state’s program, call the National Association of Protection and Advocacy Systems (NAPAS) at 202-408-9514. If a P & A does not assist you, let NAMI know by contacting Kim Encarnation at 703-312-7895 or by email at kim@nami.org.

File a complaint with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) hotline at 1-800-994-6610 and/or complaint@jcaho.org

File a complaint with your state’s health and hospital-licensing agency.

File a complaint with your U.S. Health Care Financing Administration (HCFA) regional office. There are 10 regional offices in the United States. To find yours, call the HCFA Medicare Hotline, 1-800-638-6833. You can also call the HCFA Office of Medicare Customer Assistance, 410-786-7413.

Share your story in writing and submit it to be included in NAMI’s Cries of Anguish report. Contact Kim Encarnation at 703-312-7895 or kim@nami.org

Consider sharing your story with your local media.

Consider retaining an attorney if you believe your legal rights have been violated

The Mental Health Legal Advisors Committee has also put out their perspective on how guidelines relating to restraints and seclusion should be structured:

RIGHTS IN HOSPITALS REGARDING RESTRAINT AND SECLUSION

Hospitals may use restraint and seclusion only in cases of emergency and in compliance with strict standards. Additional requirements, not included here, apply when restraining children.

I. WHAT IS RESTRAINT?

"Restraint" is physical force, mechanical devices, chemicals, seclusion, or any other means which unreasonably limit freedom of movement. Hospital staff may use four types of restraint to restrict patients who are acting, or threatening to act, in a violent way towards themselves or others.

• Physical restraint -- holding a patient in a way that restricts his or her movement.
  
  
• Mechanical restraint -- using a device, such as four-point or full-sheet restraint, to restrict a patient's movement (excludes devices prescribed for medical purposes).
  
  
• Chemical restraint -- medicating a patient against the patient's will for the purpose of restraint rather than treatment.
  
  
• Seclusion -- placing a patient alone in a room so that the patient cannot see or speak with patients or staff and so that the patient cannot leave or believes he or she cannot leave. In facilities licensed, operated, or contracted for by the state Department of Mental Health (DMH), a mechanically restrained patient cannot be secluded.

II. WHEN MAY RESTRAINT BE USED?

Restraint may only be used to prevent violence in an emergency. An emergency is the occurrence of or serious imminent threat of extreme violence or self-destructive behavior, "where there is the present ability to effect such harm." Restraint may not be used for treatment, punishment, behavior modification, staff convenience or on an "as needed" basis (PRN orders). Restraint must be the most appropriate alternative available. Restraint may only be used when less restrictive interventions have been determined to be ineffective.

III. WHO MAY ORDER RESTRAINT?

Mechanical restraint, physical restraint and seclusion require written orders by an authorized physician or other licensed independent practitioner permitted by the state and hospital to order a restraint. If the physician or other qualified practitioner is unavailable, a designated staff person may authorize restraint for no more than one hour. A physician or other licensed independent practitioner must see and evaluate the need for restraint or seclusion within one hour after the initiation of the intervention. These orders may be renewed only to prevent a continued or renewed emergency. Only an authorized physician may order chemical restraint, but he or she may issue the order over the telephone by speaking to a registered nurse or certified physician's assistant who has personally examined the patient. A physician may only order chemical restraint if the medication has been previously authorized in the patient's treatment plan. Furthermore, chemical restraint may only be administered if it is the least restrictive, most appropriate alternative available. The treating physician must be consulted as soon as possible, if he or she does not order the restraint.

IV. HOW LONG MAY RESTRAINT CONTINUE?

When an emergency no longer exists, the patient must be released. Thus, staff should release a patient who, upon examination, appears calm. The total time which a patient may be restrained is limited:

• An initial restraint or seclusion order is valid for three hours.
• After three hours, a superintendent, authorized physician, registered nurse, or certified physicians assistant may continue restraint or seclusion if the emergency still exists.
• After six hours, an authorized physician must examine the patient and renew the order.
• The maximum amount of restraint or seclusion allowed is eight hours in any 24-hour period unless the superintendent or his or her designee so authorizes.

V. WHAT FURTHER PROTECTIONS EXIST FOR RESTRAINED PATIENTS?

A patient in a facility operated by DMH, contracted for by DMH, or licensed by DMH has additional rights:

• The patient must be fully clothed consistent with patient safety and dignity;
  
  
• The patient must have access to the bathroom;
  
  
• The patient should be continually assessed by staff to determine if the restraint or seclusion is still needed. These checks must be made at least once every 30 minutes;
  
  
• Any space or device used must provide appropriate and safe ventilation, heating and lighting;
  
  
• Once restrained or secluded, staff should help the patient calm down by using appropriate interventions; and
  
  
• Staff must determine if the patient has a history of abuse by gathering information during intake from the patient, the patient's record, and, when necessary, from other treating clinicians. If the patient has an abuse history, staff will use strategies to help reduce the patient's agitation so as to avoid the need for restraint. If restraint or seclusion is necessary, staff must determine which type will be the least traumatic for the patient and which gender of staff would be most appropriate to administer or monitor it.

Furthermore, a patient in a DMH-operated facility has these additional rights:

• To avoid restraint, staff should attempt to calm the patient through talking and other non-violent means;
  
  
• The attendant accompanying the patient to the bathroom should be of the same sex as the patient;
  
  
• A patient may not be held in restraint or seclusion for more than one-half hour without a break unless he or she poses a violent threat to self or others (or is asleep);
  
  
• A patient who is quiet must be released for a trial period; and
  
  
• Staff should experience restraint as part of their training.

VI. WHAT ARE THE OBSERVATIONAL REQUIREMENTS FOR RESTRAINT?

When a patient is restrained or secluded, a specially trained person must be able to observe the patient. The condition of the patient in restraint must continually be assessed, monitored, and re-evaluated.

During seclusion, the observer may be immediately outside the patient's room--provided that the patient can fully see staff and staff can continuously observe the patient.

All staff who have direct patient contact must have ongoing education and training in the proper and safe use of restraint application and techniques and alternative methods for handling behavior, symptoms, and situations that traditionally have been treated through the use of restraints.

In facilities licensed, operated, or contracted for by DMH, staff must check a patient in mechanical restraint or seclusion every 15 minutes for comfort, body alignment and circulation.

VII. WHAT DOCUMENTATION IS NECESSARY FOR RESTRAINT?

• Each time restraint is ordered or renewed, the authorizer must record the reason for its use on a form.
  
  
• Within 24 hours of being restrained, the patient must receive a copy of the restraint form and be permitted to attach comments concerning the use of restraint.
  
  
• The form and the patient's comments must be placed in the patient's chart and a copy sent to the Commissioner of DMH, who must review and sign them within 30 days.
  
  
• The hospital must report to the federal Health Care Finance Agency any death that occurs while a patient is restrained or in seclusion, or where it is reasonable to assume that a patient's death is a result of restraint and seclusion.

VIII. WHAT SHOULD YOU DO IF YOU BELIEVE YOU HAVE BEEN ILLEGALLY RESTRAINED?

If you believe that you were illegally restrained while at a program or facility operated by, contracted for, or licensed by DMH, ask to speak with the Human Rights Officer. You may also file a written complaint with the Person in Charge of the program or facility. You can give your complaint to any facility employee; he or she must forward it to the Person in Charge. If you are dissatisfied with the response of the Person in Charge and believe that additional fact-finding should occur, you have 10 days to request reconsideration. You also may file an appeal to a higher level up to 10 days after receiving a decision. The person to whom the appeal is made depends upon the type of complaint and the type of facility. In most cases, you have the right to a further appeal, which must be filed within 10 days of receiving the appeal decision. If you have questions about the complaint process, contact the Human Rights Officer or the Mental Health Legal Advisors Committee (1-800-342-9092).

Mental Health Legal Advisors Committee, 294 Washington Street, Suite 320,Boston, MA 02108--(617) 338-2345--(800) 342-9092

The last sample position paper on the use of restraints and seclusion we would like you to review is that of the American Nurses’ Association:

   Reduction of Patient Restraint and Seclusion in Health Care     Settings

Summary:

Dilemmas in patient care situations are an inevitable consequence of professional accountability. With regard to use of restraints, nurses struggle with conflicts stemming from patients' rights of freedom, nurses' feelings of obligation to "protect" patients, and family and peer pressure to use restraints. ANA believes only when no other viable option is available should restraint be employed. In those instances where restraint, seclusion or therapeutic holding is determined to be "clinically appropriate and adequately justified," registered nurses, who possess the necessary knowledge and skills to effectively manage the situation, must be actively involved in the assessment, implementation and evaluation of the selected intervention.

Background

Nursing has a history of being involved with attempts at reduction in the use of restraint going back well over one hundred years. Frequently, when restraint was employed it was in the belief that such action would promote patient safety. It was this belief, in part, which led to the increase in restraint use in the nursing home population. As concern about the quality of patient care in that setting rose the Nursing Home Reform Act (a part of the Omnibus Reconciliation Act of 1987) was adopted into law. The results of this law, which greatly affected the quality of care received through increased assessment of and care planning for the patient as well as through reduction of both physical and chemical restraint, have implications for individuals with mental illness as well. The patient populations affected are the elderly, psychiatric patients (adults and children) and disoriented or physically aggressive patients. The settings of restraint use include: psychiatric facilities and residential sites for those with mental illness, developmental or behavioral problems; general hospitals, emergency departments, nursing homes (Sullivan-Marx and Strumpf, 1996).

Definitions:

Restraint is... any involuntary method (chemical or physical) of restricting an individual's freedom of movement, physical activity, or normal access to the body.

Chemical restraint:
The use of a sedating psychotropic drug to manage or control behavior. Psychoactive medication used in this manner is an inappropriate use of medication.

Physical restraint:
The direct application of physical force to a patient, without the patient's permission, to restrict his or her freedom of movement (JCAHO, 2000).

The physical force may be human, mechanical devices, or a combination thereof. This definition does not apply to (1) interactions with patients that are brief and focus on redirection or assistance in activities of daily living, such as hygiene and (2) the use of any psychoactive medication that is a usual or customary part of a medical diagnostic or treatment procedure, and that is used to restrict a patient's freedom of movement (JCAHO, 2000).

Seclusion refers to... the involuntary confinement of a person in a locked room (JCAHO, 2000).

Therapeutic holding is... the physical restraint of a child by at least two people to assist the child who has lost control of behavior to regain control of strong emotions (American Academy of Pediatrics, 1997).

In the past, when restraint was employed it was in the belief that such action would promote patient safety and without effective restraint and seclusion practices, patients were considered to be in danger of injuring themselves or others, including nursing staff, or being injured by other assaultive patients. The danger of employing such restraint, however, has been demonstrated to be problematic. There is a need for additional research to explore patient safety factors related to restraint and seclusion and the role of the registered nurse in their elimination.

A 50-state survey by a Connecticut newspaper (Hartford Courant 1998), revealed at least 142 deaths related to the use of physical restraint or seclusion since 1988. The report also noted that the true number of deaths is much higher since data about many such deaths is not public