Specifically, the amendments:

- Update the “background and intent” provisions of 14 NYCRR Part 526 to reflect new “person-first” language, and to set forth the intent of OMH with respect to the use of restraint and seclusion as emergency interventions in facilities under its jurisdiction;

- Amend the “legal base” provisions to more comprehensively reflect the agency’s statutory authority with respect to quality of care, and to include applicable references to federal regulations governing restraint and seclusion;

- Update provisions governing the definitions and use of restraint and seclusion, reflecting current State statutory authority and incorporating, as appropriate, applicable federal Centers for Medicare and Medicaid regulations;

- Implement the requirements of Mental Hygiene Law Section 33.04 that orders for restraint and seclusion must be written by a physician, after examination, or if the physician is unavailable, by the most senior, qualified staff member present, by permitting acceptance of a verbal order of the physician, followed by confirmation of the order by the physician in writing within 30 minutes (and in no event beyond an hour);

- Require monitoring/documentation of the patient’s condition during the use of restraint or seclusion;

- Prohibit the simultaneous use of mechanical restraint and seclusion;

- Require order renewals to be signed after evaluation by physician and at least every 4 hours for adults; 1 hour for children 9-17 years and ½ hour for children under 9 years;

- Incorporate the federal requirement of notice to parents or guardians when restraint or seclusion is used at residential treatment facilities for children;

- Require facilities to conduct post-event analysis and debriefing activities by staff and patients to identify preventive measures that may be implemented in the future;

- Clarify that certain actions, when performed as defined in the regulation, do not constitute “restraint” or “seclusion,” i.e. “time out”, “mechanical support”, and “physical escort;” and

- Clarify that outpatient programs licensed by the Office of Mental Health shall not use restraint as a treatment intervention or in response to a crisis situation.

OMH has made several non-substantive changes to the final adopted rule. They are as follows:

- Replaced the terms, “behavioral management” with “management of violent or self-destructive behavior” and “seclusion and restraint” with “restraint and seclusion” to clarify intent and improve readability in Section 526.1 “Background and intent” and Section 526.4 “Restraint and seclusion.”

- Added references to federal regulations in Section 526.2 “Legal base” and Section 526.4 “Restraint and seclusion” as suggested by one commenter to restate the need for providers to be in compliance with applicable federal requirements. The regulation had already included references to federal regulations in the proposal; this addition is a restatement only.

- Restored language found in existing 14 NYCRR Section 27.7(b) with respect to seclusion use for persons with developmental disabilities. This language, with limited amendments to update it, has been included in Section 526.4. Specifically, the language clarifies that seclusion shall not be used with persons with a sole diagnosis of a developmental disability, and seclusion may be used for persons with a dual diagnosis of mental illness and a developmental disability, provided such persons are under one-to-one constant visual observation while in seclusion, and all other provisions of Section 526.4 are met.

- Eliminated scattered references to OMH guidelines in Section 526.4 and consolidated them in a new subdivision (e) of Section 526.4. This provision clarifies that OMH will issue guidelines, post them on its public website and assist providers with compliance and in achieving their restraint and seclusion goals.

- Amended provisions in Section 526.4 in response to a commenter’s concern regarding the potential burden placed on facilities by notification requirements if it is expected that restraint or seclusion will be required beyond a specific amount of time. The final rule requires notification and consultation with the facility medical director or director of psychiatry, who can appoint a designee to fulfill this function. Certain requirements regarding specific points to be addressed in the consultation have been eliminated to address this concern as well.

- Added language in Section 526.4 to clarify the requirements regarding assessment frequency, and to clarify the professional disciplines of the individuals conducting the assessment.

- Added language in Section 526.4 clarifying that the use of restraint and seclusion in comprehensive psychiatric emergency programs must be utilized in accordance with 14 NYCRR Part 590, as well as State law and federal regulations. This is not a new requirement; it merely codifies what is already in statute.

- Clarifying language has been added to Section 526.4 with respect to the use of physical force when necessary to protect the life and limb of any person. OMH has clarified that the purpose of the use of force in a situation such as this is limited to restoring safety.

A revised regulatory impact statement (RIS) is not included with this notice as the changes made to the final adopted rule do not necessitate a change to the RIS. The changes are non-substantive and serve to improve readability and provide clarification with respect to the expectations of the Office of Mental Health regarding the use of restraint and seclusion.

A revised Regulatory Flexibility Analysis for Small Businesses and Local Governments is not included with this notice as the changes made to the final adopted rule do not necessitate a change to this document. The changes are non-substantive and serve to improve readability and provide clarification with respect to the expectations of the Office of Mental Health regarding the use of restraint and seclusion. The amendments to 14 NYCRR Parts 27, 526 and 587 will not have an adverse economic impact upon small businesses or local governments.

A revised rural area flexibility analysis (RAFA) is not included with this notice as the changes made to the final adopted rule do not necessitate a change to the RAFA. The changes are non-substantive and serve to improve readability and provide clarification with respect to the expectations of the Office of Mental Health regarding the use of restraint and seclusion. The amendments to 14 NYCRR Parts 27, 526 and 587 will not impose any adverse economic impact on rural areas.

A revised Job Impact Statement is not included with this notice as the changes made to the final adopted rule are not substantive. These changes serve to improve readability and provide clarification with respect to the Office of Mental Health regarding the use of restraint and seclusion. As is evident from the subject matter, the amendments to 14 NYCRR Parts 27, 526, and 587 will not have any impact on jobs and employment opportunities.

As a rule that does not require a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2019, which is no later than the 5th year after the year in which this rule is being adopted

The agency received six letters of comment in response to the proposed rule regarding restraint and seclusion. The comments are addressed below:

Comment: An international training organization submitted comments requesting that the regulations be amended to define, (and contain provisions regarding the use of), "transitional holds." This intervention is described as a brief physical restraint of an individual face-down for the purpose of quickly and effectively gaining physical control of that individual or prior to transport to enable the individual to be transported safely. The organization recommended that these holds only be applied by staff who have current training, including information regarding how to recognize and respond to signs of distress.

Response: OMH does not support the inclusion of "transitional holds" as a permitted intervention in the regulations. To do so would essentially create an exception to the prohibition against prone restraint, albeit for a "limited minimal amount of time." The training organization did not identify what a “limited minimal amount of time” might be, and, in any event, it is unclear how OMH could definitively identify the appropriate or maximum length of time that a transitional hold could be used. As written, these regulations unequivocally prohibit the use of prone (face down) restraint due to its direct relationship to positional asphyxia, which can lead to death. To avoid this result, there must be no weight placed on the restrained person's back while he or she is in a face down position. Although the organization indicates this intervention would only be used by trained staff, there is no assurance that such trained staff are proficient. OMH is not accepting this recommendation.

Comment: The above-referenced organization also notes that the regulations require providers to utilize training and education programs that have been approved by OMH, but points out that many states require the use of approved training organizations that are nationally-recognized and offer evidence-based programs.

Response: This comment does not require an amendment to the regulations. If such an organization offers training that is consistent with OMH standards (as determined by OMH), it could be utilized.

Comment: One commenter recommended cross referencing, or incorporating, specific Center for Medicare and Medicaid Services’ (CMS) requirements into the text of the regulation.

Response: The regulation already includes cross references to CMS requirements in the Legal Base provisions; however, OMH is in agreement with this comment and has clarified the regulations to restate the need for providers to be in compliance with applicable Federal requirements.

Comment: A commenter requested that OMH extend Federal provisions applicable to non-hospital psychiatric treatment programs for persons under age 21 to hospitals.

Response: OMH has not extended Federal provisions applicable to non-hospital psychiatric treatment programs for persons under age 21 to hospitals as the impact of doing so has not been evaluated.

Comment: A commenter expressed opposition to the repeal of 14 NYCRR § 27.7(b) pertaining to individuals with dual diagnosis served in OMH facilities. Specifically, it was requested that language currently found in in this section, which reads “seclusion, as defined in section 27.2(e) of this Part, shall not be used with used with the persons(sic) with a sole diagnosis of mental retardation or a sole diagnosis of any other developmental disability.”

Response: OMH has accepted this recommendation and has restored language found in 14 NYCRR § 27.7(b) to the proposed rule, with limited amendment to update language.

Comment: One commenter expressed concern that language in the proposed regulation that states “in situations in which alternative procedures and methods not involving the use of physical force cannot reasonably be employed, nothing in this Section shall be construed to prohibit the use of reasonable physical force when necessary to protect the life and limb of any person.” It was explained that the proposed language might be misconstrued as an implicit authorization for the use of physical force in the case of an emergency.

Response: OMH is not accepting this recommendation. This provision is essential to ensure that staff do not avoid taking necessary action in circumstances when a person’s life is in danger, and there is no other alternative, out of concern that they have no doctor’s order to do so. This should be an unusual and rare occurrence. OMH has sought to clarify this provision by indicating that the purpose of the use of force in a situation such as this is limited to “restoring safety.”

Comment: One commenter strongly recommended the prohibition of restraint and seclusion in residential treatment facilities for children and youth (RTF), noting the regulations prohibit its use in residential treatment facilities for adults. Assuming this recommendation is not accepted, however, the commenter asked that RTFs be required to notify parents or guardians that restraint or seclusion had been initiated “within one hour” of such initiation, as opposed to “as soon as possible,” as currently provided in the regulation.

Response: OMH is not accepting these recommendations. While elimination of restraint and seclusion in RTFs, which are a subclass of hospitals (see Mental Hygiene Law Section 1.03) is the inspiration behind these regulatory revisions, at the current time, it is an authorized intervention that is utilized in the RTF system. It is also subject to federal regulations as a term and condition of Medicaid reimbursement.

Comment: Several commenters objected to references to guidelines of the Office throughout the regulation, and suggested that by incorporating them by reference into the regulations, they are enforceable against providers. The comments recommended that the proposed regulations be withdrawn and revised such that federal requirements are to be incorporated by reference into State regulations.

Response: OMH cannot incorporate federal regulations into State regulations, because in some instances, State law is more restrictive than federal regulations governing restraint and seclusion. Instead, OMH has based its own guidelines heavily on federal implementation guidance that has been already issued. These guidelines have been supplemented with additional “best practice” information to assist regulated parties in complying with these regulations, and to serve as technical assistance as providers move toward achieving the goal of reducing the use of seclusion and restraint. This additional information is not enforceable against regulated parties, but is intended to help explain and identify compliance strategies. However, OMH removed reference to the guidelines in various provisions throughout the regulations and consolidated them into a single provision that indicates OMH will issue guidelines, and post them on its public website, to assist providers with compliance and in achieving their restraint and seclusion reduction goals.

Comment: One commenter objected to the timeframes established in the proposed regulations that differ from the standards of CMS and the Joint Commission, which will cause confusion in general hospital settings. The commenter requests restraint/seclusion durations up to the following limits: 4 hours for adults (consistent with proposed regulations); 2 hours for children/adolescents age 9-17 (proposed regulations provide 1 hour); and 1 hour for children under age 9 (proposed regulations provide 30 minutes).

Response: OMH is not accepting this recommendation. Based upon its statutory authority to establish standards of care in facilities under its jurisdiction, OMH believes limiting restraint and seclusion duration for minors is in the best interest of persons served in the public mental health system. Should an exceptional circumstance present wherein a child needed to be restrained or secluded beyond a 30 minute (to 1 hour) or 1 hour (to 2 hour) limit, there are permitted procedures to do so.

Comment: One commenter objected to the requirement that the Facility Director and Medical Director be notified if it is expected that restraint or seclusion will be required beyond 2 hours for adults, 1 hour for children and adolescents ages 9 to 17, or 30 minutes for children under age 9. The commenter objected to the potential burden this could place upon facilities.

Response: Although this provision is being retained in the proposed regulations, OMH has modified it to minimize the perceived burden on facilities. The provision is being retained because it is the goal of OMH to create a violence and coercion-free environment in the NY public mental health system and to significantly reduce the use and duration of restraint and seclusion by employing alternative strategies. The 4 hour maximum time limit for orders of restraint or seclusion, although currently permitted under New York law and federal regulations, is nonetheless clearly inconsistent with this goal. Involving senior management in decisions to continue restraint or seclusion for longer than 2 hours for adults, 1 hour for children or adolescents ages 9 to 17, and 30 minutes for children under the age of 9, (i.e, “witnessing”) is more in concert with this initiative, and thus is required by these regulations. “Witnessing” by leadership sends a very clear message that restraint and seclusion beyond these time frames is a very serious matter, and should be extremely rare occurrences. However, to address the concern about burden, the proposed regulations have been amended to require notification and consultation with the facility medical director or director of psychiatry, who can appoint a designee to fulfill this function. OMH has also eliminated requirements detailing specific points that must be addressed in the consultation.

Comment: One commenter objected to the inclusion of “drug used as a restraint” as a form of restraint.

Response: OMH is not accepting this recommendation. Federal CMS regulations require that if medications are used in such a way that they “disable,” rather than “enable” a patient from actively participating in treatment, they must be considered a restraint and must follow the procedures governing the use of restraint. OMH does not consider the use of medication as a restraint to be a standard practice. However, there may be emergency situations where the degree of harm posed by a patient’s behavior is such that the primary intent of a physician in ordering a medication is to restrict the ability of the patient to engage in the dangerous behavior, thereby minimizing harm to the patient and others. When medication is used in this manner, there must be a STAT (immediate one-time) physician‘s order for the medication, and the use of the medication must also be identified as a restraint.

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 can be considered. For example, a patient may be agitated due to pain or adverse reaction to an existing drug or medication or other unmet need or concern. It is important to note that the use of a drug or medication as a restraint does not supersede a patient’s right to object to medication as otherwise set forth in Section 527.8 of Title 14 NYCRR.

Comment: A comment was received regarding the use of restraint and seclusion in comprehensive psychiatric emergency programs.

Response: OMH agrees with the commenter that language should be included in the regulation. Language has been added to clarify that the use of restraint and seclusion in comprehensive psychiatric emergency programs must be utilized in accordance with 14 NYCRR Part 590, as well as State law and federal regulations. This non-substantive change is not a new requirement; it simply codifies what already exists in statute.

Comment: One commenter noted that the proposed regulations do not apply to secure treatment facilities for the care and treatment of dangerous sex offenders, (Article 10 facilities) and indicated that residents of those facilities should not be subjected to restraint and seclusion without regulatory oversight and defined standards of care.

Response: OMH has issued defined standards of care for the employment of restraint and seclusion in State operated psychiatric facilities, including Article 10 facilities. These standards are codified in OMH Official Policy directive PC-701, available on OMH’s public website: http://www.omh.ny.gov/omhweb/policymanual/pc701.pdf