RESTRAINT & SECLUSION: Implementing the CMS Hospital Patients’ Rights Conditions of Participation Final Rule

1. RESTRAINT & SECLUSION: Implementing the CMS Hospital Patients’ RightsConditions of Participation Final Rule National Association of Psychiatric Health Systems Training: February 15, 2007

2. Faculty • Patricia A. Chmielewski, RN, MS Deputy Director, Division of Acute Care Services, Survey and Certification Group, Centers for Medicare and Medicaid Services • Janice A. Graham, RN, MS Division of Institutional Quality Standards, Clinical Standards Group/OCSQ, Centers for Medicare and Medicaid Services -continued- National Association of Psychiatric Health Systems -- February 2007

3. Faculty (continued) • Dorothy Hill, R.N., C. Chief Executive Officer, Acadia Hospital, Bangor, ME • Harold Schwartz, M.D. Psychiatrist-in-Chief & Vice President of Behavioral Health The Institute of Living/Hartford Hospital, Hartford, CT • Kathleen McCann, R.N., Ph.D. (moderator) Director of Clinical and Regulatory Affairs, National Association of Psychiatric Health Systems National Association of Psychiatric Health Systems -- February 2007

4. Overview of the Final Rule Hospital Conditions of Participation on Patients’ Rights

5. Final Rule • In December 8, 2006, Federal Register • Effective January 8, 2007 • Applies to all hospitals participating in Medicare and Medicaid (including both general hospitals and freestanding psychiatric hospitals) • Sets minimum standards for patient care The 50-page final rule is available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-9559.pdf. National Association of Psychiatric Health Systems -- February 2007

6. Final Rule (continued) • Reflects responsiveness to the more than 4,000 comments received by CMS • Provides strong patient protections • Provides significant insight into the thinking and decision-making process CMS used in its development of the final rule • CMS interpretive guidelines (used in the survey process) will be updated at a future date National Association of Psychiatric Health Systems -- February 2007

7. Five Standards in Final Rule • Four standards were finalized without change from the interim final rule. • Notice of Rights • Exercise of Rights • Privacy and Safety • Confidentiality • The fifth standard on “Restraint or Seclusion” was revised in the final rule in both content and application (summary on pages 71418-28 and throughout the final rule) National Association of Psychiatric Health Systems -- February 2007

8. Final Rule Applies to All Patients • Combines requirements for all patients in restraint or seclusion under standard (e) with the goal of reducing restraint and seclusion use in all settings of the hospital. National Association of Psychiatric Health Systems -- February 2007

9. Final Rule Applies to All Patients (continued) • Eliminates distinctions made in the interim final rule between requirements for restraint and seclusion for “acute medical and surgical care (e)” and “behavior management (f).” National Association of Psychiatric Health Systems -- February 2007

10. Final Rule Applies to All Patients (continued) • However, the final rule defines special requirements when restraint or seclusion is used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. National Association of Psychiatric Health Systems -- February 2007

11. Key Messages • “All patients have the right to be free from physical or mental abuse, and corporal punishment;” • “Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time;” -continued- National Association of Psychiatric Health Systems -- February 2007

12. Key Messages (continued) • “All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff;” • “The patient has the right to safe implementation of restraint or seclusion by trained staff.” National Association of Psychiatric Health Systems -- February 2007

13. What’s Different Definitions

14. Restraint Definition Modified • Final rule definition is: A restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; …… -continued- National Association of Psychiatric Health Systems -- February 2007

15. Restraint Definition Modified (continued) • …..or a drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. National Association of Psychiatric Health Systems -- February 2007

16. Restraint Definition (continued) • Clarifies restraint does notinclude: • devices such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, • or to protect the patient from falling out of bed, • or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). National Association of Psychiatric Health Systems -- February 2007

17. Seclusion Definition • Interim final rule has been retained with minor revisions: Seclusionis the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. National Association of Psychiatric Health Systems -- February 2007

18. Seclusion Definition (continued) • The revised standards clarify that seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. National Association of Psychiatric Health Systems -- February 2007

19. Revised Standard (e) • Retains all current requirements formerly found under “restraint for acute medical and surgical care” • Adds the more stringent requirements formerly found in standard (f) “behavior management.” • However, the time limits on the length of each order and the 1-hour face-to-face evaluation only apply when restraint or seclusion are used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. National Association of Psychiatric Health Systems -- February 2007

20. Standard (e) Retains These Requirements for All Patients: • Restraint or seclusion may only be used when: • less restrictive interventions have been determined to be ineffective to protect the patient or others from harm; • the type or techniques used are the least restrictive intervention that will be effective; and • it is in accordance with a written modification to the patient’s plan of care and implemented in accordance with safe and appropriate techniques as determined by hospital policy and state law. National Association of Psychiatric Health Systems -- February 2007

21. Standard (e) Retains These Requirements for All Patients: • Restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient and is authorized to order restraint or seclusion by hospital policy in accordance with state law. • The order may never be written as a standing order or on an as-needed basis (PRN). • The attending physician must be consulted as soon as possible if restraint or seclusion is not ordered by the patient’s attending physician. National Association of Psychiatric Health Systems -- February 2007

22. Standard (e) Retains These Requirements for All Patients: • Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy (see special requirements). National Association of Psychiatric Health Systems -- February 2007

23. Standard (e) Retains These Requirements for All Patients: • The use of restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. National Association of Psychiatric Health Systems -- February 2007

24. Standard (e) Retains These Requirements for All Patients: • The condition of the patient who is restrained or secluded must be monitored by a physician or other LIP or by trained staff at an interval determined by hospital policy (see training requirements). National Association of Psychiatric Health Systems -- February 2007

25. Standard (e) Retains These Requirements for All Patients: • Physician and other LIP training requirements must be specified in hospital policy. • At a minimum, this must include a working knowledge of hospital policy regarding the use of restraint or seclusion. CMS does not require that physicians and LIPs participate in the full training required of other hospital staff. National Association of Psychiatric Health Systems -- February 2007

26. Standard (e) Retains These Requirements for All Patients: • When restraint or seclusion is used, there must be documentation in the medical record of: • the results of the 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others; • alternatives or other less restrictive interventions attempted (as applicable); continued National Association of Psychiatric Health Systems -- February 2007

27. Standard (e) Retains These Requirements for All Patients: • Documentation requirements (continued): • the patient’s condition or symptoms that warranted the use of the restraint or seclusion; • the patient’s response to the intervention used, including the rationale for continued use of the intervention. National Association of Psychiatric Health Systems -- February 2007

28. Requirements Violent or Self-Destructive Behavior

29. Requirements (Violent or Self-Destructive Behavior) • Applicable if restraint or seclusion is used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others National Association of Psychiatric Health Systems -- February 2007

30. Requirements (Violent or Self-Destructive Behavior) • Each order may only be renewed in accordance with the following limits for up to a total of 24 hours: • 4 hours for adults 18 years of age or older, • 2 hours for children and adolescents 9 to 17 years of age, and • 1 hour for children under 9 years of age. National Association of Psychiatric Health Systems -- February 2007

31. Requirements (Violent or Self-Destructive Behavior) • After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other LIP who is responsible for the care of the patient and authorized to order restraint or seclusion must see and assess the patient. National Association of Psychiatric Health Systems -- February 2007

32. Requirements (Violent or Self-Destructive Behavior) • Expansion of the type of practitioners permitted to conduct the 1-hour face-to-face evaluation represents a major change in the Condition of Participation. National Association of Psychiatric Health Systems -- February 2007

33. Requirements (Violent or Self-Destructive Behavior) • A physician or other LIP or a registered nurse (RN) or physician assistant (PA) trainedin accordance with the requirements specified in the CoP (see training section) must see the patient face-to-face within 1 hour after the initiation of the intervention. National Association of Psychiatric Health Systems -- February 2007

34. Requirements (Violent or Self-Destructive Behavior) • This practitioner must evaluate: • the patient’s immediate situation, • the patient’s reaction to the intervention, • the patient’s medical and behavioral condition, and • the need to continue or terminate the restraint or seclusion. National Association of Psychiatric Health Systems -- February 2007

35. Requirements (Violent or Self-Destructive Behavior) • If the 1-hour face-to-face evaluation is conducted by a trained RN or PA, • the attending physician or other LIP who is responsible for the care of the patient must be consultedas soon as possible after completion of the evaluation. - continued- National Association of Psychiatric Health Systems -- February 2007

36. Requirements (Violent or Self-Destructive Behavior) • Patients in both restraint and seclusion must be continually monitored face-to-face by an assigned, trained, staff member, or continually monitored by trained staff using both video and audio equipment. • This monitoring must be in close proximity to the patient. National Association of Psychiatric Health Systems -- February 2007

37. Training Requirements Standard (f)

38. Standard (f) • Is a new section that expands staff training requirements National Association of Psychiatric Health Systems -- February 2007

39. Training RequirementsStandard (f) • Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion before performing any of these actions, as part of orientation, and subsequently on a periodic basis consistent with hospital policy. National Association of Psychiatric Health Systems -- February 2007

40. Training RequirementsStandard (f) • In addition, the hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following: -continued- National Association of Psychiatric Health Systems -- February 2007

41. Training RequirementsStandard (f) • techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require restraint or seclusion; • the use of non-physical intervention skills; -continued- National Association of Psychiatric Health Systems -- February 2007

42. Training RequirementsStandard (f) • choosing the least restrictive intervention based on an individualized assessment of the patient’s medical or behavioral status or condition; • the safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (e.g., positional asphyxia); -continued- National Association of Psychiatric Health Systems -- February 2007

43. Training RequirementsStandard (f) • clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary; -continued- National Association of Psychiatric Health Systems -- February 2007

44. Training RequirementsStandard (f) • monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, • respiratory and circulatory status, • skin integrity, • vital signs, and • any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation; -continued- National Association of Psychiatric Health Systems -- February 2007

45. Training RequirementsStandard (f) • the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification. National Association of Psychiatric Health Systems -- February 2007

46. Training RequirementsStandard (f) • Individuals providing staff training must be qualified as evidenced by education, training, and experience in techniques used to address patients’ behaviors. • The hospital must document in the staff personnel records that the training and demonstration of competency were successfully completed. National Association of Psychiatric Health Systems -- February 2007

47. Death Reporting Requirements Standard (g)

48. Standard (g) Retains These Requirements for All Patients: • The hospital must report to CMS each death: • that occurs while a patient is in restraint or in seclusion at the hospital; • that occurs within 24 hours after the patient has been removed from restraint or seclusion; -continued- National Association of Psychiatric Health Systems -- February 2007

49. Standard (g) Retains These Requirements for All Patients: • The hospital must report to CMS each death: • known to the hospital that occurs within one week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient’s death. • For the purpose of the regulation, “reasonable to assume” includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation. National Association of Psychiatric Health Systems -- February 2007

50. Standard (g) Retains These Requirements for All Patients: • Each death referenced in this section: • must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient’s death. • Staff must document in the patient’s medical record the date and time the death was reported to CMS. This requirement modifies and clarifies the interim final rule. National Association of Psychiatric Health Systems -- February 2007