Restraints and Bed Rail PowerPoint: Frith Law Firm

1	RESTRAINTS/BED RAILS AND ASPHYXIATION T. DANIEL FRITH, III dfrith@frithlawfirm.com LAUREN M. ELLERMAN lellerman@frithlawfirm.com FRITH LAW FIRM, P.C. 303 WASHINGTON AVENUE ROANOKE, VIRGINIA 24016 540.985.0098 www.frithlawfirm.com
2	DEFINITION OF RESTRAINT Any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. 42 CFR 483
3	TYPES OF RESTRAINTS PHYSICAL CHEMICAL
4	EXAMPLES OF PHYSICAL RESTRAINTS Seat Belts
5	Geri-Chairs
6	Wrist Restraints
7	Vest or “Posey” restraints
8	Hand mittens
9	Side rails
10	Wheelchair safety bars/belts or lap buddies
11	EXAMPLES OF CHEMICAL RESTRAINTS Psychotropic Medications Drugs that affect brain activities associated with mental processes and behavior (also called “psychoactive” or “psychotherapeutic”). Psychotropic medications are divided into four broad categories: anti-psychotic; anti- depressant; anti-anxiety; and hypnotic medications.
12	EXAMPLES OF CHEMICAL RESTRAINTS Anti-psychotic Drugs Used to treat various psychoses and neurologic conditions. including: schizophrenia, delusional disorder, psychotic mood disorder, acute psychotic episode, Tourette’s syndrome, and Huntington’s disease. Other indications for long-term anti-psychotic use in the elderly are organic mental syndromes (including dementia with associated psychotic and/or agitated features defined by “certain behaviors” that are harmful to self or others) and mood disorders with psychotic features. Trade names Thorazine, Mellaril, Trilafon, Prolixin, Stelazine, Navane, Haldol, Clozaril
13	EXAMPLES OF CHEMICAL RESTRAINTS Anti-depressant Drugs Used in the treatment of depression and agitation, and in low dosages for insomnia. Side effects include excessive sedation, anti-cholinergic effects (dry mouth, constipation, urinary retention, blurred near vision, rapid heart rate, confusion and disorientation), orthostatic hypotension (which can predispose a resident to falls), and electro cardiographic changes. Most anti-depressants have a long enough half-life that the elderly, who have lower tolerance levels for most drugs, require smaller and less frequent doses. Trade names Elavil, Wellbutrin, Norpramin, Adapin, Sinequan, Prozac, Tofranil, Marplan, Ludiomil, Pamelor, Paxil, Nardil, Zoloft, Parnate, Desyrel
14	EXAMPLES OF CHEMICAL RESTRAINTS Anti-anxiety and Hypnotic Drugs Anti-anxiety drugs are used for the short-term management of anxiety and insomnia. Hypnotics are medications used for short-term sleep aids. However, even lower dosages of these two categories of drugs in the elderly population are associated with impairment of daytime functioning and may increase confusion and disorientation, and in turn exacerbate problem behaviors. Trade names Dalmane, Librium, Tranxene, Valium, Klonopin, Doral, Paxipam, Ativan, Serax, Xanax Restoril, Ambien, Dalmane, ProSom, Noctec, Doriden, Noludar, Halcion
15	Applicable Federal Regulations/Statutes 42 CFR 482.13 – Physician’s Order All restraints must be ordered by a physician and the physician’s order must be specific about they type of restraint as well as the reasons for and the specific circumstances of its use. The order may not provide that the restraint may be used “prn” or “as needed.” The physician’s order alone may not be sufficient as the resident’s chart must reflect an assessment identifying a specific medical symptom or problem requiring the use of the restraint.
16	Applicable Federal Regulations/Statutes 42 CFR 483.25(1) - each resident’s drug regimen must be free from unnecessary drugs and defines “unnecessary drugs” as any drug used: - In excessive dose; - For excessive duration; - Without adequate monitoring or without adequate indications for its use; - In the presence of adverse consequences which indicate the dosage should be reduced or discontinued; or - Without specific target symptoms.
17	Applicable Federal Regulations/Statutes 42 CFR 483.13 (a) (1987) - The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms. Medicare State Operations Manual, Appendix PP: Guidance for Surveyors – Long Term Care Facilities, p. 44, Guidelines 483.13(a) – “Convenience” is defined as “any action taken by the facility to control the resident’s behavior or manage a resident’s behavior with a lesser amount of effort by the facility and not in the resident’s best interest.” Residents Rights, 42 CFR 483.13(b)(2) - Physical restraints are considered to be part of the care plan and federal regulations make it clear the resident has a right to refuse treatment.
18	Patient Assessment Minimum Data Set (MDS) – required of all Medicare/Medicaid facilities. The MDS must be completed by the facility (MDS coordinator/RN) upon admission (within 14 days). Quarterly Annually And upon a significant change in the status of the resident.
19	Patient Assessment Resident Assessment Protocol (RAP) - RAP sheets identify social, medical, and psychological problems and form the basis for an individualized and appropriate care plan. There are 18 problem oriented RAP’s, each of which includes a MDS-based “trigger” which signal the need for further assessment and review.
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38	Bed rails/Asphyxia History Bed rails have been in existence for years and are manufactured by several different companies with numerous configurations and designs. In hospitals, their use is typically a nursing decision rather than based upon a physician’s order. In nursing homes, Federal regulations require a physician’s order if bed rails are to be used, as the regulations recognize side rails as a form of restraint. Notwithstanding the requirement for nursing homes, physician’s orders are often not obtained because of the belief that bed rails are simply a safety device.
39	Examples of Bed Rails
40	Entrapment Hazards
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48	FACTS From 1985 to January 1, 2006, the U.S. Food and Drug Administration received 691 reports in which vulnerable patients (undergoing care and treatment in American health care facilities) became entrapped in bed rails. In these reports, 413 people died and 120 were injured. Over 50% of these cases were in nursing homes. Out of those reported deaths, 84% involved strangulation, suffocation, or asphyxiation. A study in California revealed that approximately 200 Americans die each year in restraints, and federal officials say they believe these are just a fraction of the actual numbers of injuries and deaths.
49	State of Knowledge – Known Risk since 1985 FDA issued a Safety Alert in August of 1995 regarding the entrapment hazards and safety concerns. The Safety Alert was communicated to hospital administrators, hospital associations, nursing homes, risk managers, bio-medical/clinical engineers, and directors of nursing. The Alert was not specific to any one manufacturer or particular design of bed rails but warned health care providers that the FDA had received 102 reports of head and body entrapment incidents involving bed rails between 1990 and 1995.
50	"FDA Safety Alert Recommendations:" FDA Safety Alert Recommendations: Inspect all hospital bed frames, bed rails, and mattresses. Bed rail and mattress should leave no gap wide enough to entrap a patient’s head or body. Gaps can be created by movement or compression of the mattress which may be caused by patient weight, patient movement, or bed position. Be alert to replacement mattresses and bed rails with dimensions different than the original equipment supplied or specified by the bed frame manufacturer. Not all bed rails, mattresses, and bed frames are interchangeable.
51	WHO TO SUE – Nursing Home Failing to employ a reasonable amount of attention and skill in monitoring the resident; Failing to properly attend to the resident especially given her/his physical limitations; Failing to properly insure the resident’s safety; Failing to properly set up, maintain, and operate the air mattress and bed side rails used by the resident; Failing to properly train its staff on the maintenance and operation of the air mattress and bed side rails used by the resident; Failing to regularly inspect the safe operation of the air mattress and bed side rails used by the resident; and 7. Failing to properly select the type and style of bed side rails and air mattress used by the resident.
52	WHO TO SUE - Manufacturer Failing to design safe and effective products for use, alone or in combination with other products, by long term care facilities; Failing to manufacture safe and effective products for use, alone or in combination with other products, by long term care facilities; Failing to warn long term care facilities, and consumers, of the dangerous nature of its products; Failing to provide adequate instructions and warnings regarding the proper use of it products; Failing to properly train nursing home staff on the maintenance and operation of the air mattress and bed rails used by the resident; 6. Failing to properly instruct the purchaser/leasor with regard to the type and style of bed, bed rails and air mattress to use for the resident.
53	Thank you for your attention Restraints/Bed Rails and Asphyxiation T. Daniel Frith, III dfrith@frithlawfirm.com Lauren M. Ellerman lellerman@frithlawfirm.com Frith Law Firm, P.C. 303 Washington Avenue Roanoke, Virginia 24016 540.985.0098 www.frithlawfirm.com