Prevention of Restraint and Seclusion and Requirements When Used

(1) Restraint and seclusion may only be used in facilities operated by the Department, or licensed as Class III through VII; provided however, that no such seclusion or restraint of a minor may occur except in a facility that has been inspected and specially certified by the Department. (2) Prevention/Minimal Use of Restraint and Seclusion. A facility subject to 104 CMR 27.12 that uses restraint or seclusion shall develop and implement a strategic plan to reduce and, wherever possible, eliminate the use of restraint and seclusion. The strategic plan should be updated at least annually to reflect progress in implementation and to ensure efforts to reduce or eliminate restraint are ongoing. The facility's strategic plan shall include, at a minimum, the following: (a) a posted statement of the facility’s commitment to the prevention and minimal use of restraint and seclusion; (b) policies and procedures that support the prevention and minimal use of restraint and seclusion; (c) staff training that focuses on crisis prevention, de-escalation and alternatives to restraint and seclusion; (d) programming and milieu that are consistent with the prevention and minimal use of restraint and seclusion; (e) the development and integration of peer and family support within the program. This should include peer involvement in interventions to reduce the use of restraint and seclusion; (f) the development and use of sensory interventions and therapies designed to calm and comfort patients that utilize sight, touch, sound, taste, smell, pressure, weight or physical activity; (g) designation of a comfort or sensory space on the unit for patients to utilize to practice sensory modulation, coping skills, and/ or self-soothing techniques. This space should be a dedicated room including, but not limited to, a temporary location where staff may bring appropriate supplies and equipment for patient use; (h) the development and use of an individual crisis prevention plan for each patient; (i) assessment of the impact of trauma experience and the potential for re-traumatization for both patients and staff; (j) the regular use of debriefing activities for both patients and staff; (k) the process for addressing patient concerns and complaints about the use of restraint or seclusion; and (l) the use of data to monitor and improve quality and prevent and minimize the use of restraint and seclusion, such as identifying times or shifts with a high incidence of restraint or seclusion. (3) Staff Training. (a) A facility shall ensure that all unit staff and other staff who may be involved in restraint and seclusion receive training, and demonstrate competencies, in the prevention and minimal use of restraint and seclusion prior to participating in any episode of restraint or seclusion. Such training shall be completed no later than one month after hire, and shall be included in annual training thereafter. Training shall include, at a minimum, the following: 1. the harmful emotional and physical effects of restraint and seclusion on patients and staff; 2. the impact of trauma, including sexual and physical abuse and witnessing of violence, on both patients and staff; 3. the impact of restraint or seclusion on patients with a history of trauma, including the potential for re-traumatization; 4. calming and soothing, crisis prevention and de-escalation approaches and strategies; and 5. the use of individualized crisis prevention plans. (b) In addition to the training in 104 CMR 27.12(3)(a), staff who may be directly involved in authorizing, ordering, administering or applying, monitoring, or assessing for release from restraint or seclusion shall receive additional training, and annual retraining thereafter. No staff shall be permitted to participate in any restraint or seclusion prior to receiving such additional training. Such training shall include, at a minimum, the following: 1. applicable legal and clinical requirements for restraint and seclusion; 2. the safe and appropriate initiation of physical contact and application and monitoring of restraint and seclusion; and 3. approaches to facilitate the earliest possible release from restraint or seclusion. (c) Following initial training and each annual retraining, a facility shall require each staff member to demonstrate competencies in all areas of training. Staff shall not participate in an episode of restraint or seclusion prior to completing required training and demonstrating necessary competencies. A facility shall maintain documentation of staff training and competencies. (4) Individualized Crisis Prevention Planning. A facility shall develop an Individualized Crisis Prevention Plan with each patient. (a) Definition. An Individualized Crisis Prevention Plan is an age and developmentally appropriate, patient-specific plan or safety tool that identifies triggers that may signal or lead to agitation or distress in the patient and strategies to help the patient and staff intervene with de-escalation techniques to reduce such agitation and distress and avoid the use of restraint and seclusion. (b) Development of the Individualized Crisis Prevention Plan. As soon as possible after admission, facility staff shall collaborate with each patient and his or her legally authorized representative, if any, and, where appropriate, with other sources, such as family members, caregivers, to complete and implement an Individualized Crisis Prevention Plan. If the patient refuses or is unable to participate in the initial development of the plan, staff shall develop a plan using available information and shall make continuing efforts to include the patient’s participation in review and revision of the plan. Relevant clinical data, including medical risk factors, physical, learning, or cognitive disability, and the patient’s history of trauma shall inform the development of the plan. The plan shall include, at a minimum, the following elements: 1. identification of triggers that signal or lead to agitation or distress in the patient and, if not addressed, may result in the use of restraint or seclusion; 2. identification of the particular approaches and strategies that are most helpful to the patient in reducing agitation or distress, such as environmental supports, physical activity, and sensory interventions; and 3. in order to minimize trauma or re-traumatization if restraint or seclusion is used, identification of the patient’s preferences, such as type of intervention and positioning, gender of staff who administer and monitor the restraint or seclusion, and supportive interventions that may have a calming effect on the patient. (c) Update and Revision of Plan. The plan shall be updated, as necessary, to reflect changes in such triggers and strategies as well as following any restraint or seclusion episode and shall be reviewed at each treatment plan review. (d) Access to Plan. A facility shall ensure that all staff on all shifts are aware of and have ready access to the individualized crisis prevention plans for the patients in their care. A copy of the Individualized Crisis Prevention Plan and any revisions thereto, shall be recorded in the patient record and a copy shall be given to the patient and his or her legally authorized representative, if applicable. (5) Debriefing Activities. Recognizing that an episode of restraint or seclusion is a traumatic event affecting patients, staff, and the milieu, debriefing after such an event is critical. Therefore, a facility shall develop procedures to ensure that debriefing activities occur after each episode of restraint or seclusion in order to determine what led to the incident, what might have prevented or curtailed it, how to prevent future incidents, and to address the emotional needs of patients and staff who were impacted. Debriefing activities shall be documented and used in treatment planning, revision of the individualized crisis prevention plan, and ongoing facility-wide restraint and seclusion prevention efforts. (a) Staff Debriefing. As soon as possible following each episode of restraint or seclusion, supervisory staff and staff involved in the episode shall convene a debriefing. The debriefing shall, at a minimum, include the following: 1. identification of what led to the episode; 2. determination of whether the individual crisis prevention plan was used; 3. assessment of alternative interventions that may have avoided the use of restraint or seclusion; 4. determination of whether the patient’s physical and psychological needs were appropriately addressed and that the patient’s right to privacy was maintained; 5. consideration of counseling or medical evaluation and treatment for the involved patient and/or staff for any emotional or physical trauma that may have resulted from the incident; 6. consideration of whether other patients and staff who may have witnessed or otherwise been affected by the incident should be involved in debriefing activities or offered counseling; 7. determination of whether the legally authorized representative, if any, family members, or others should be notified of and/or involved in debriefing activities; and 8. consideration of whether additional supervision or training should be provided to staff involved in the incident. (b) Patient Debriefing. 1. As soon as possible, but no later than 48 hours after a patient’s release from restraint or seclusion, taking into consideration the emotional needs of the patient, the patient shall be asked to debrief and provide comment either in writing or verbally on the episode. The debriefing should, at a minimum, include: a. a review of the circumstances leading to the episode; b. consideration of staff or patient actions that could have helped to prevent or that may have contributed to the episode, including the adequacy of the patient’s Individualized Crisis Prevention Plan; and c. a discussion of the type of restraint or seclusion used, and any physical or psychological effects the patient may be experiencing from the restraint or seclusion. 2. Whenever possible and appropriate, the staff participating in debriefing with the patient shall not have been involved in the episode of restraint or seclusion. 3. The patient’s comments, if any, shall be included on the debriefing and comment form. a. The patient may complete the debriefing and comment form during the debriefing or afterwards, or may chose not to do so. b. The staff person shall provide the patient with any necessary assistance in completing the patient debriefing and comment form. c. If the patient does not complete the form, but provides verbal or other response to the episode, the staff person shall document such response on the form. d. Staff efforts to encourage the patient to provide comments shall be documented on the debriefing and comment form. e. Efforts to engage a patient who has refused to participate in debriefing activities after the 48-hour period shall be documented and shall continue as clinically appropriate. 4. The patient debriefing and comment form or other documentation shall be attached to the restraint and seclusion form and included in the patient record. Copies of the form shall be forwarded to the treatment team and the human rights officer as soon as possible once completed; provided however, that the treatment team shall review the episode no later than at its next scheduled meeting. 5. The patient shall be notified of the complaint procedure outlined in 104 CMR 32.00: Investigation and Reporting Responsibilities. The human rights officer shall offer to meet with a patient who requests such a meeting, or whose comments about or description of an episode of restraint or seclusion suggests a possible rights violation or other harmful consequence. (c) Senior Administrative Review. Senior administrative and clinical staff shall conduct a review of each episode of restraint or seclusion by the next business day. Such review shall include consideration of whether: 1. A patient or staff member experienced significant emotional or physical injury as a result of the episode; 2. The episode of restraint or seclusion exceeded six hours or episodes of restraint and/or seclusion for a patient exceeded 12 hours in the aggregate in any 48-hour period; 3. An exception to the restrictions on mechanical restraint of minors has occurred pursuant to 104 CMR 27.12(8)(g)5.; 4. The episode appears to be part of a pattern warranting review; 5. The episode is marked by unusual circumstances; 6. The episode resulted in a complaint or reportable incident, including patient or staff injury, pursuant to 104 CMR 32.00: Investigation and Reporting Responsibilities; or 7. There were multiple patients restrained or secluded at one time. (6) Senior administrative and clinical staff shall conduct regular reviews of all incidents of restraint and seclusion. The purpose of such review is to determine the need for expert consultation, training, performance improvement activities, change in policy, or other appropriate measures to further reduce and prevent the occurrence of restraint and seclusion. (7) Senior administrative reviews shall not become part of the patient’s record, but shall be documented and shall inform the implementation of the facility’s strategic plan developed pursuant to 104 CMR 27.12(2). (8) Requirements for the Use of Restraint and Seclusion. (a) Definitions. For purposes of 104 CMR 27.12, the following definitions shall apply: 1. Authorized Clinician. An authorized clinician is any physician or Psychiatric APRN who has been authorized by the facility director to order medication restraint, mechanical restraint, physical restraint or seclusion, to examine patients in such restraint or seclusion, and to assess for readiness for release and order release from restraint or seclusion. 2. Authorized Staff Person. An authorized staff person is any member of the licensed clinical staff at a facility who has been authorized by the facility director to initiate or renew mechanical restraint, physical restraint or seclusion pursuant to 104 CMR 27.12(8)(e)2. or (f)1., and to assess for readiness for release and order release from restraint or seclusion. 3. Restraint. Restraint, for purposes of 104 CMR 27.00, means behavioral restraint, including medication restraint, mechanical restraint and physical restraint. Restraint means bodily physical restriction, mechanical devices, or medication that unreasonably limits freedom of movement. Restraint does not include the use of restraint in association with acute medical or surgical care, adaptive support in response to the patient’s assessed physical needs, or standard practices, including limitation of mobility related to medical, dental, diagnostic, or surgical procedures and related post-procedure care. a. Medication Restraint. Medication restraint occurs when a patient is given a medication or combination of medications to control the patient’s behavior or restrict the patient’s freedom of movement and which is not the standard treatment or dosage prescribed for the patient’s condition. Medication restraint shall not include: i. involuntary administrations of medication when administered in an emergency to prevent immediate, substantial and irreversible deterioration of serious mental illness, provided that the requirements of 104 CMR 27.10(1)(c) are complied with; or ii. for other treatment purposes when administered pursuant to a court approved substituted judgment treatment plan. b. Mechanical Restraint. Mechanical restraint occurs when a physical device or devices are used to restrain a patient by restricting the movement of a patient or the movement or normal function of a portion of his or her body. c. Physical Restraint. Physical restraint occurs when a manual method is used to restrain a patient by restricting a patient’s freedom of movement or normal access to his or her body. The application of force to physically hold a patient in order to administer a medication against the patient’s wishes, including court ordered medication, is considered a physical restraint. Physical restraint shall not include: i. non-forcible guiding or escorting of a patient to another area of the facility where the patient can easily remove or escape the grasp; or ii. taking reasonable steps to prevent a patient at imminent risk of entering a dangerous situation from doing so with a limited response to avert injury, such as blocking a blow, breaking up a fight, or preventing a fall, a jump, or a run into danger. 4. Seclusion. a. Seclusion occurs when a patient is involuntarily confined in a room and is physically prevented from leaving, or reasonably believes that he or she will be prevented from leaving, by means that include, but are not limited to, the following: i. manually, mechanically, or electrically locked doors, or “one-way doors”, that when closed and unlocked, cannot be opened from the inside; ii. physical intervention of staff; and iii. coercive measures, such as the threat of restraint, sanctions, or the loss of privileges that the patient would otherwise have, used for the purpose of keeping the patient from leaving the room. b. Seclusion shall not include voluntary, collaborative separation from a group or activity for the purpose of calming a patient. (b) Emergency Basis for Medication Restraint, Mechanical Restraint, Physical Restraint or Seclusion. Medication restraint, mechanical restraint, physical restraint or seclusion may be used only in an emergency, such as the occurrence of, or serious threat of, extreme violence, personal injury, or attempted suicide. Such emergencies shall only include situations where there is a substantial risk of, or the occurrence of, serious self-destructive behavior, or a substantial risk of, or the occurrence of, serious physical assault. As used in the previous sentence, a substantial risk includes only the serious, imminent threat of bodily harm, where there is the present ability to effect such harm, where there is the present ability to effect such harm; provided however, that physical restraint may be used in accordance with 104 CMR 27.12, if it is determined to be necessary to safely administer court authorized treatment. 1. Restriction on Medication Restraint, Mechanical Restraint, Physical Restraint or Seclusion; Use of Individualized Crisis Prevention Plan. Medication restraint, mechanical restraint, physical restraint or seclusion may be used only after the failure of less restrictive alternatives, including strategies identified in the Individualized Crisis Prevention Plan, or after a determination that such alternatives would be inappropriate or ineffective under the circumstances, and may be used only for the purpose of preventing the continuation or renewal of such emergency condition. The preferences in the patient’s Individualized Crisis Prevention Plan, such as type of restraint or seclusion and gender of staff, shall be considered in ordering or initiating restraint or seclusion. 2. Duration of Medication Restraint, Mechanical Restraint, Physical Restraint, or Seclusion. Medication restraint, mechanical restraint, physical restraint or seclusion may only be used for the period of time necessary to accomplish its purpose; but in no event beyond the periods established in 104 CMR 27.12(8)(e) through (g). 3. PRN Orders Prohibited. No “PRN” or “as required” authorization of medication restraint, mechanical restraint, physical restraint or seclusion may be written. 4. Seclusion Used with Mechanical Restraint Prohibited. No patient shall be placed in seclusion while in mechanical restraints. 5. Other Requirements. When an emergency condition exists justifying the use of medication restraint, mechanical restraint, physical restraint or seclusion, such use must conform to all applicable requirements of 104 CMR 27.12. (c) Physical and Mechanical Restraint or Seclusion – Physical Conditions. 1. Position in Physical or Mechanical Restraint. A patient shall be placed in a position that allows airway access and does not compromise respiration. A face-down position shall not be used, unless: a. there is a specified patient preference and no psychological or medical contra-indication to its use; or b. there is an overriding psychological or medical justification for its use, which shall be documented. 2. Personal Needs and Comfort. Provision shall be made for appropriate attention to the personal needs of the patient, including access to food and drink and toileting facilities, by staff assistance or otherwise, and for the patient’s physical and mental comfort. 3. Personal Dignity. Patients in restraints or seclusion shall be fully clothed, limited only by patient safety considerations related to the type of intervention used, and the restraint devices used shall afford patients maximum personal dignity. 4. Physical Environment. The physical environment shall be as conducive as possible to facilitating early release, with attention to calming the patient with sensory interventions where possible and appropriate. 5. Seclusion – Observation. Any room used to confine a patient in seclusion must provide for complete visual observation of the patient so confined. 6. Mechanical Restraint – Locks Prohibited. No locked mechanical restraint devices requiring the use of a key for their release may be used. (d) Medication Restraint – Order. A patient may be given medication restraint only on the order of an authorized clinician who has determined, either while present at the time of (i.e., at any time during the course of) the emergency justifying the use of the restraint or after telephone consultation with a physician, registered nurse or certified physician assistant who is present at the time and site of the emergency and who has personally examined the patient, and using all relevant information available regarding the patient, that such medication restraint is the least restrictive, most appropriate alternative available. 1. Such order, along with the reasons for its issuance, shall be recorded in writing at the time of its issuance. 2. Such order shall be signed at the time of its issuance by such authorized clinician if present at the time of the emergency. 3. Such order, if authorized by telephone, shall be transcribed and signed at the time of its issuance by the physician, registered nurse or physician assistant who is present at the time of the emergency. 4. An authorized clinician shall conduct an in-person examination of the patient as soon as possible, but no later than within one hour of the initiation of the restraint if the restraint was authorized by telephone. Such examination must include documentation of both a physical and behavioral assessment conducted of the patient. 5. The requirement for examination pursuant to104 CMR 27.12(8)(d)4. may be satisfied through utilization of telemedicine or other technology pursuant to protocols approved by the Department that assure verbal and visual observation and communication between the patient and an off-premises authorized clinician and adequate on-premises clinical staff only in cases where a physician, registered nurse or certified physician assistant has assessed the patient and determined that: a. the medication restraint has taken effect and the patient is not in need of further restraint; b. the patient has not experienced side effects of the medication restraint; and c. there are no apparent medical or physical conditions, including injury, related to the medication restraint that require an in-person examination. (e) Initiation of Mechanical Restraint, Physical Restraint or Seclusion. 1. The order that a patient be placed in mechanical restraint, physical restraint, or seclusion shall be made by an authorized clinician who is present when an emergency as defined in 104 CMR 27.12(8)(b) occurs, except as provided in 104 CMR 27.12(8)(e)2. a. Such order along with the reasons for its issuance and criteria for release shall be recorded in writing and signed at the time of its issuance by such clinician. b. Such order shall authorize use of mechanical restraint, physical restraint or seclusion for no more than two hours, subject to the additional restrictions in 104 CMR 27.12(8)(g). c. Such order shall terminate whenever a release decision is made pursuant to 104 CMR 27.12(8)(h)8., and shall be subject to the monitoring, examination and release provisions of 104 CMR 27.12(8)(h). 2. If an authorized clinician is not present when an emergency justifying the use of mechanical restraint, physical restraint or seclusion occurs, a patient may be placed in mechanical restraint, physical restraint or seclusion at the initiation of an authorized staff person, subject to the following conditions and limitations; a. Such initiation shall be subject to the additional restrictions in 104 CMR 27.12(8)(g). b. Such initiation along with the reasons for its issuance shall be recorded in writing and signed at the time of the incident by such authorized staff person. c. Such initiation shall authorize use of mechanical restraint, physical restraint or seclusion for no more than one hour, shall terminate whenever a release decision is made pursuant to 104 CMR 27.12(8)(h)8., and shall be subject to the monitoring, examination and release provisions of 104 CMR 27.12(8)(h). d. An authorized clinician shall conduct an in-person examination of the patient as soon as possible, but no later than one hour of such initiation of mechanical restraint, physical restraint, or seclusion. Such examination must include documentation of both a physical and behavioral assessment conducted of the patient. e. The requirement for examination pursuant to 104 CMR 27.12(8)(e)2.d. may be satisfied through utilization of telemedicine or other technology pursuant to protocols approved by the Department that assure verbal and visual observation and communication between the patient and an off-premises authorized clinician and adequate on-premises clinical staff only in cases where restraint or seclusion episode has ended, the patient has been permanently released from restraint or seclusion in accordance with 104 CMR 27.12(8)(h)8., and there are no apparent medical or physical conditions, including injury, related to the mechanical restraint or seclusion restraint that require an in-person examination. 3. At the time of initiation of restraint, an authorized staff person, or authorized clinician shall observe and make written note of the patient’s physical status, including respiratory functioning, skin color and condition, and the presence of undue pressure to any part of the body. (f) Mechanical Restraint, Physical Restraint or Seclusion – Renewals to Continue Use. 1. Continuation for a Second Hour of Mechanical Restraint, Physical Restraint or Seclusion Initiated by an Authorized Staff Person – Exceptional Circumstances. In exceptional circumstances, where an authorized clinician has not examined the patient within the first hour of initiation of restraint or seclusion as required by 104 CMR 27.12(8)(e)2.d, an authorized staff person may issue a single renewal for a second one hour period, subject to the following conditions and limitations: a. Such renewal shall be subject to the additional restrictions in 104 CMR 27.12(8)(g). b. Such renewal may only be issued if such authorized staff person determines that such restraint or seclusion is necessary to prevent the continuation or renewal of an emergency condition or conditions as defined in 104 CMR 27.12(8)(b). c. Such renewal shall authorize use of mechanical restraint, physical restraint or seclusion for no more than one hour, shall terminate whenever a release decision is made pursuant to 104 CMR 27.12(8)(h)8., and shall be subject to the monitoring, examination and release provisions of 104 CMR 27.12(8)(h). d. An authorized clinician shall conduct an in-person examination of the patient as soon as possible, but no later than within one hour of such renewal of mechanical restraint, physical restraint or seclusion, and may order the restraint to continue for no more than two hours from the initiation of the restraint or seclusion by the authorized staff person, subject to the additional restrictions in 104 CMR 27.12(8)(g). 2. Continuation of Mechanical Restraint or Seclusion for Additional Two-hour Periods. Subsequent orders for renewals of mechanical restraint or seclusion may be made for up to two-hour periods only if an authorized clinician has examined the patient and ordered such renewal prior to the expiration of the preceding order, subject to the following conditions and limitations. a. Such a renewal order shall be subject to the additional restrictions in 104 CMR 27.12(8)(g). b. Such a renewal order may only be issued if such clinician determines that such restraint or seclusion is necessary to prevent the continuation or renewal of an emergency condition or conditions as defined in 104 CMR 27.12(8)(b). c. Each such order shall be recorded in writing and signed by such clinician, but only after examination of the patient in restraint or seclusion by such clinician. d. Each such order shall authorize continued use of mechanical restraint or seclusion for no more than two hours from the time of expiration of the preceding order, shall terminate whenever a release decision is made pursuant to 104 CMR 27.12(8)(h)8., and shall be subject to the monitoring, examination and release provisions of 104 CMR 27.12(8)(h). Continuation of a restraint or seclusion requires documentation that the patient’s symptoms necessitate the continuation of the restraint or seclusion. (g) Additional Restrictions and Limitations on the Use of Restraint or Seclusion. 1. No episode of physical restraint shall exceed two hours. 2. No order for the restraint or seclusion of a minor younger than nine years old may exceed one hour. 3. No minor younger than nine years old shall be in seclusion or restraint for more than one hour in any 24-hour period. 4. No minor nine through 17 years of age shall be in seclusion for more than two hours in any 24-hour period. 5. No minor younger than 13 years old may be placed in mechanical restraint, except under the following conditions: a. The facility medical director is notified prior to the use of such restraint or immediately after the initiation of the restraint, if an emergency as defined in 104 CMR 27.12(8)(b) occurs. The facility medical director shall inquire about the circumstances warranting the use of such restraint, the efforts made to de-escalate the situation, the alternatives to such restraint considered and tried, any preferences indicated in the Individual Crisis Prevention Plan, and whether other measures or resources might be helpful in avoiding the use of mechanical restraint or in facilitating early release. b. The facility director shall also be immediately informed of the use of such restraint and shall report it in writing to the Department by the next business day. c. All other applicable provisions of 104 CMR 27.12 shall be complied with. 6. Mechanical Restraint or Seclusion Exceeding Six Hours or Multiple Episodes. If an episode of mechanical restraint or seclusion has exceeded five hours and it is expected that a new order will be issued to extend the episode beyond six hours or if there are two or more episodes of any restraint or seclusion for a patient in any 12-hour period, the facility director and facility medical director shall be notified. The facility medical director shall inquire about the circumstances of the episode(s) of restraint or seclusion, the efforts made to facilitate release, and the impediments to such release, and help to identify additional measures or resources that might be beneficial in facilitating release or preventing additional episodes. 7. Mechanical Restraint or Seclusion Exceeding 12 Hours or Total Episodes Exceeding 12 Hours in a 48-hour Period. If an episode of mechanical restraint or seclusion has exceeded 11 hours and it is expected that a new order will be issued to extend the episode beyond 12 hours, or if episodes of restraint and/or seclusion for a patient have exceeded 12 hours in the aggregate in any 48-hour period, the following shall occur: a. The patient shall receive a medical assessment. b. The facility director and facility medical director shall be notified. The facility medical director shall inquire about the outcome of the measures identified pursuant to 104 CMR 27.12(8)(g)6., in the case of a continuous episode, and about the circumstances that resulted in the continued or multiple use of restraint or seclusion. The facility medical director shall take steps, including consultation with appropriate parties, to identify and implement strategies to facilitate release as soon as possible and/or eliminate the use of multiple episodes, such as psychopharmacological reevaluation or other consultation, assistance with communication, including interpreter services, and consideration of involving family members or other trusted individuals. c. The episode(s) shall be reported to the Department by the next business day. 8. Release Prior to Expiration of Order. If a patient is released from a restraint or seclusion prior to the expiration of the original order and an emergency as defined in 104 CMR 27.12(8)(b) occurs prior to such order’s expiration, a new order must be obtained prior to reinitiating the use of restraint or seclusion. Such return to restraint or seclusion shall be documented in the record and the procedures for ordering or initiating restraint or seclusion pursuant to 104 CMR 27.12(8)(e) shall be followed. (h) Monitoring and Assessment of Patients in Mechanical Restraint, Physical Restraint or Seclusion; Release. 1. One-on-one Staff Monitoring. Whenever a patient is in physical or mechanical restraint or seclusion, a staff person shall be specifically assigned to monitor such patient one-on-one. 2. The staff person conducting such monitoring may be immediately outside a space in which a patient is being secluded without mechanical restraint provided that the following conditions are met: a. The staff person must be in full view of the patient (e.g., the patient may approach the seclusion door and see the staff person through a window in the door if he or she wishes to do so); and b. The staff person must be able at all times to observe the patient. 3. The staff person shall monitor a patient in mechanical or physical restraint by being situated so that the staff person is able to hear and be heard by the patient and visually observe the patient at all times. It is not necessary for a staff person monitoring a patient in mechanical or physical restraint to be in full view of the patient; although if such visibility has been expressed as a preference by the patient, consideration shall be given to honoring such preference. 4. Staff who monitor a patient in physical or mechanical restraint or seclusion shall continually assist and support the patient, including monitoring physical and psychological status and comfort, body alignment, and circulation, taking vital signs when indicated, and monitoring for readiness for release pursuant to 104 CMR 27.12(8)(h)6. Such monitoring activities shall be documented every 15 minutes. 5. Staff who monitors a patient in restraint or seclusion shall attempt appropriate interventions designed to calm the patient throughout the episode of restraint or seclusion and shall ensure that the patient has access to a means of marking the passage of time, either visually or verbally. 6. Monitoring for Readiness for Release. a. Staff conducting monitoring shall continually consider whether a patient in mechanical restraint, physical restraint or seclusion appears ready to be released. Whenever the staff person believes that the patient may be ready to be released from such restraint or seclusion either because the criteria for release have been met or an emergency condition or conditions as defined in 104 CMR 27.12(8)(b) no longer exists, he or she shall immediately notify an authorized clinician or authorized staff person, who shall promptly assess the patient for readiness to be released. b. If a patient falls asleep while in mechanical restraint, staff conducting monitoring shall notify an authorized clinician or authorized staff person, who shall release the patient from the restraint or seclusion, unless such efforts are reasonably expected to re-agitate the patient. c. If, at any time during mechanical restraint, physical restraint, or seclusion, a patient is briefly released from such restraint or seclusion to attend to personal needs pursuant to 104 CMR 27.12(8)(c)2., or for other purpose, staff conducting monitoring shall notify an authorized staff person as soon as possible, who shall promptly assess the patient for readiness to be released. 7. Assessment. An authorized staff person or authorized clinician shall assess a patient in mechanical or physical restraint or seclusion for physical and psychological comfort, including vital signs, and readiness to be released at least every 30 minutes and at any other time that it appears that the patient is ready to be released. Such assessments shall be documented in the record. 8. Permanent Release. A patient shall be released from mechanical restraint, physical restraint or seclusion as soon as an authorized clinician or authorized staff person determines after examination of the patient or consultation with staff that such mechanical restraint, physical restraint, or seclusion is no longer needed to prevent the continuation or renewal of an emergency condition or conditions as defined in 104 CMR 27.12(8)(b) and, in no event, no later than the expiration of an initial or renewed order for such mechanical restraint or seclusion, unless such order is renewed in accordance with the requirements or 104 CMR 27.12(8)(f). The circumstances considered in making such a determination shall be documented and signed by the authorized clinician or authorized staff person making the determination. (i) Documentation Requirements. 1. The Restraint and Seclusion Form. Each facility shall ensure that a restraint and seclusion form is completed on each occasion when a patient is placed in restraint or seclusion. The restraint and seclusion form shall conform to the following requirements: a. The restraint and seclusion form, including the patient debriefing and comment form, must be in a form approved by the Department. b. The completed restraint and seclusion form shall be placed in the patient’s record. One copy shall be used for the patient’s comments pursuant to 104 CMR 27.12(4)(b), and one copy shall be used for the review by the Commissioner or designee pursuant to 104 CMR 27.12(8)(i)3. c. Any attachments, including the patient debriefing and comment form required by 104 CMR 27.12 shall be included with each copy of the restraint and seclusion form. 2. Examinations. Examinations of patients conducted pursuant to 104 CMR 27.12 shall be documented in the patient’s record. 3. Submission to the Commissioner; Review. At the end of each month, a facility shall submit to the Department copies of all restraint and seclusion forms with attachments, if any, required by 104 CMR 27.12 and an aggregate report for each facility unit, on a form approved by the Department, containing statistical data on the episodes of restraint and seclusion for the month. The Commissioner or designee shall review such aggregate reports and review a sample of restraint and seclusion forms, and shall maintain statistical records of all uses of restraint or seclusion, organized by facility and unit. 4. Human Rights Committee/Human Rights Officer Review. At the end of each month, copies of all restraint and seclusion forms and attachments and aggregate reports, if any, sent to the Department pursuant to 104 CMR 27.12(8)(i)3. shall be sent to the human rights committee of the facility, if operated by or under contract to the Department, and otherwise to the human rights officer, which shall review the use of all restraints by the facility or program. The committee or human rights officer shall have the authority to: a. review all pertinent data concerning the behavior that necessitated restraint or seclusion; b. obtain information about the patient’s needs from appropriate staff, relatives and other persons with direct contact or special knowledge of the patient; c. monitor the use of the individual crisis prevention plan and consider all less restrictive alternatives to restraint and seclusion in meeting the patient’s needs; d. review and refer to the person in charge for action in accordance with 104 CMR 32.00: Investigation and Reporting Responsibilities all complaints that the rights of a patient are being abridged by the use of restraint or seclusion; and e. generally monitor the use of restraint and seclusion in the facility.