Center for Medicaid and State Operations/Survey and Certification Group

Transcription

1 DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S Baltimore, Maryland Center for Medicaid and State Operations/Survey and Certification Group Dear Colleague: I am pleased to send you a draft for comment of revised Guidance to Surveyors of Long Term Care Facilities for the following current tags: F323 Accidents; and F324 Supervision to Prevent Accidents This draft product was developed as part of our contract with the American Institutes for Research to update the Guidance to Surveyors (also known as the interpretive guidelines) and to provide specific information to assist surveyors in making appropriate determinations of severity for deficiencies cited under these Tags. It includes interpretive guidelines, an investigative protocol, and severity guidance for deficiencies cited. This draft was developed with the assistance of a panel of expert clinicians and surveyors. Attachment A provides biographical information about the members of the Accidents and Supervision panel. Attachment B is intended to replace all current text contained in the Guidance to Surveyors for current Tags F323 and F324. We are providing a two-month comment period for review of the draft materials contained in Attachment B. We have included a reference sheet entitled Tips for Reviewers which contains tips for your review, as well as a copy of the current scope and severity grid that includes the letters for each grid box and the definitions of each severity level. This enclosure directly follows this letter. Be sure to review this information prior to reviewing the draft guidance. Please provide comment on these materials to the contractor by August 12, You may reply via regular mail addressed to: Nancy Matheson, Ph.D. Project Director American Institutes for Research 1000 Thomas Jefferson Street, NW Washington, DC You may also reply via to CMSPublicComment@air.org. Please organize your comments by attachment and page number in order to compare your comment to the text to which you are referring. If you have any questions about this mailout, please contact Dr. Matheson at

2 Page 2 We look forward to your comments on this mailout as well as future mailouts of revisions to other Tags, as we proceed with this project to improve our guidance to surveyors. Sincerely, /s/ Thomas E. Hamilton Director Attachments

3 TIPS FOR REVIEWERS This mail-out package includes the following materials for your review: Accidents and Supervision (Attachment B) o Guidance to Surveyors o Investigative Protocol o Task 6: Determination of Compliance o V. Deficiency Categorization (i.e., Severity Guidance). Note: V. Deficiency Categorization is considered part of Appendix P., Part V of the same title, but it will be stored in Appendix PP of the State Operations Manual (SOM) along with its tag. We have included the Scope and Severity Grid for your reference when reviewing the severity guidance for the Accidents and Supervision tags. This is included to assist your review and is not for comment. Tips for Commenting When providing comments to the materials included in this mailout package, please follow the referencing guidelines below. This will aid in our ability to sort comments by section, paragraph, and sentence. For each comment, please reference the following information, whenever possible: o Section within Document (i.e., Guidance to Surveyors; Investigative Protocol; Task 6; Deficiency Categorization) o Page Number When relevant, please also reference sub-heading within section, paragraph, and/or sentence to which the comment applies.

4 Severity Grid for Rating Nursing Home Deficiencies Immediate Jeopardy to Resident Health or Safety J K L Severity Actual Harm That Is Not Immediate Jeopardy No Actual Harm with Potential for More than Minimal Harm That Is Not Immediate Jeopardy No Actual Harm with Potential for Minimal Harm G H I D E F A B C Isolated Pattern Widespread Level 4: Immediate Jeopardy to resident health or safety. (J, K, L) Noncompliance that results in immediate jeopardy, a situation in which immediate corrective action is necessary because the facility s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident receiving care in a facility. Level 3: Actual Harm that is not Immediate Jeopardy. (G, H, I) Noncompliance that results in a negative outcome that has compromised the resident s ability to maintain and/or reach his/her highest practicable physical, mental, and psychosocial well-being. Level 2: No Actual Harm with potential for more than minimal harm that is not Immediate Jeopardy. (D, E, F) Noncompliance that results in no more than minimal physical, mental and/or psychosocial discomfort to the resident and/or has the potential, (not yet realized) to compromise the resident s ability to maintain and/or reach his/her highest practicable physical, mental and/or psychosocial well-being. Level 1: No Actual Harm with the potential for minimal harm. (A, B, C) A deficiency that has the potential for causing no more than a minor negative impact on the resident(s). NOTE: The Severity and Scope Grid is included to assist your review and is not for comment.

5 ATTACHMENT A REGULATORY TAG 323 ACCIDENTS AND SUPERVISION EXPERT PANEL BIOGRAPHIES Elizabeth Capezuti, PhD, RN, APRN-BC, FAAN, is Associate Professor of Nursing and Co-Director of the John A. Hartford Foundation Institute for Geriatric Nursing within New York University's School of Education. Dr. Capezuti has over 20 years of experience in the field of geriatrics, with her primary research interests in falls and injuries among older adults, side rail and restraint reduction, and elder mistreatment. Sherry Brunner, BS, currently serves as the Vice President of Risk and Insurance at Bons Secours Health Systems. In addition, Ms. Brunner has over 20 years of management experience in the healthcare field, as well as extensive experience in the development and implementation of strategic planning designed to improve quality, enhance customer satisfaction, and maximize fiscal performance. She is also a Certified Professional Healthcare Risk Manager (CPHRM) as well as a licensed Nursing Home Administrator (LNHA). Tom Lohuis, RN, NHA currently serves as Director of Operations/Nursing Home Administrator at Good Shepherd Services, Ltd. He has had over twenty years of supervisory experience in the long term care field. Mr. Lohuis has authored a book on survey compliance, is active in professional organizations and has achieved nine consecutive deficiency free surveys while at Good Shepherd. Captain Lee Shands (RET), MPH, CIH, RS, conducts training courses on a variety of health and safety topics with Shands Training and Consulting. She is a retired U.S. Public Health Service Commissioned Officer with over 20 years of service in the Indian Health Service. During this time, Captain Shands worked in the Institutional Environmental Health field and conducted research on various topics including the Hantavirus outbreak in the four-corners area and nitrous oxide exposure during cryosurgical procedures. Harry Strothers, III, MD, MMM currently serves as the Geriatric Team Leader with the National Center for Primary Care. Dr. Strothers also serves as Associate Professor at the Department of Family Medicine, Morehouse School of Medicine in Atlanta, Georgia. He has a Certificate of Added Qualifications in Geriatrics from the American Board of Family Practice. Joan Ferlo Todd, BSN, RN, currently serves as a Senior Nurse Consultant and Analyst with the U.S. Food and Drug Administration and evaluates and analyzes medical device adverse event reports related to general hospital and physical medicine medical devices. She is on the FDA's steering committee for hospital

6 bed safety to reduce patient entrapment in hospital beds. She has sixteen years of clinical experience, as well as eight years of experience with the medical device bed industry. Mary Fleming, BSN, RN, MHR, currently works in the Long Term Care Division of the Oklahoma State Department of Health. She served as the coordinator of nursing and specialized facilities in the Oklahoma State Department of Health for three years prior to her current position. Ms. Fleming is certified in adult training and development, and also brings over 15 years of experience in the field. Leslie A. Grant, MS Health and Medical Sciences, Ph.D., is Director of the Center for Aging Services Management at the University of Minnesota and Associate Professor of Healthcare Management in the Carlson School of Management. Dr. Grant is President of Alternative Living Solutions, Inc. He has over 25 years of experience in the fields of environmental design, aging, and long-term care. Peggy Williams, BA, is a licensed social worker, SMQT qualified health facility surveyor, and the Resident Assessment Coordinator for the South Dakota State Survey Agency. In addition, Ms. Williams has been a Public Health Advisor for the South Dakota Department of Health for over 10 years.

7 ATTACHMENT B F323 ACCIDENTS AND SUPERVISION GUIDANCE

8 NOTE TO REVIEWERS: The guidance for 42 CFR (h) (1) and (2) has been combined under one tag, F323. INTENT: (F323) (h) (1) and (2) Accidents and Supervision The intent of this requirement is to ensure the facility provides an environment that is free from hazards over which the facility has control and provides appropriate supervision to each resident to prevent avoidable accidents. This includes systems and processes designed to: Identify hazard(s) and risk(s); Evaluate and analyze hazard(s) and risk(s); Implement interventions to reduce hazard(s) and risk(s); and Monitor for effectiveness and modify approaches as indicated. NOTE: References to non-cms sources or sites on the Internet are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. DEFINITIONS Definitions are provided to clarify terms related to providing supervision and other interventions to prevent accidents. Accident refers to any unexpected or unintentional incident or chain of events, which may or may not result in injury or illness to a resident. This does not include adverse outcomes that are a direct consequence of treatment or care that is provided in accord with recognized standards of practice (e.g., drug side effects or reaction), which would be cited elsewhere. o Avoidable Accident means that a resident had an accident and the facility failed to: - Identify environmental hazards and individual resident risk of an accident, including the need for supervision; and/or - Evaluate/analyze the hazards and risk; and/or - Implement interventions, including adequate supervision, consistent with resident s needs, goals, plan of care, and CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 1

9 recognized standards of practice to order to reduce the risk of an accident; and/or - Monitor the effectiveness of the interventions and modify the approaches as necessary, in accordance with relevant care standards (e.g., industry practice standards). o Unavoidable Accident means that a resident had an accident despite proactive and thorough facility efforts to: - Identify hazards and individual resident risk of an accident based on the facility s assessment of the resident, including the need for supervision, and hazards in the resident environment; and - Evaluate/analyze the hazards and risk; and - Implement interventions, including adequate supervision, to reduce the risk of an accident that were consistent with resident s needs, resident s goals, resident s plan of care, and recognized standards of practice; and - Monitor the effectiveness of the interventions and modify the approaches as necessary, in accordance with relevant care standards. Assistance Device or Assistive Device refers to any item (e.g., fixtures such as handrails, grab bars, and devices/equipment such as transfer lifts, canes, and wheelchairs, etc.) that is used in the care of a resident. NOTE: The nomenclature widely accepted presently refers to assistive devices. Although the term assistance devices is used in the regulation, the Guidance provided in this document will refer to assistive devices. Environment is synonymous with resident environment. Fall refers to unintentionally coming to rest on the ground, floor, or other lower level but not as a result of an overwhelming external force (e.g., resident pushes another resident). An episode where a resident lost his/her balance and would have fallen, if not for staff intervention, is considered a fall. A fall without injury is still a fall. Unless there is evidence suggesting otherwise, when a resident is found on the floor, a fall is considered to have occurred. Hazards refer to elements of the resident environment that have the potential to cause injury or illness. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 2

10 o Hazards over which the facility has control refer to hazards where reasonable efforts by the facility would influence the risk for resulting injury or illness. Hazards include those found in the nursing home and on the facility s grounds. o Free of accident hazards as is possible refers to being free of accident hazards over which the facility has control. Resident environment includes the surroundings to which the resident has access (e.g., room, unit, common use areas, and facility grounds, etc.). Risk refers to any characteristic of the resident that influences the likelihood of an accident. Supervision refers to observation and timely intervention by the facility and its staff to prevent or reduce the likelihood of an accident. OVERVIEW There are numerous and varied hazards that exist in everyday life. Not all accidents are avoidable. Unintended but not necessarily unexpected, an avoidable accident may occur but have less severe consequences because of staff intervention (e.g., catching a resident during a fall). The frailty of some residents increases their vulnerability to hazards in the resident environment and can result in life threatening injuries. It is imperative that all facility staff are knowledgeable about the facility s responsibility as well as their individual responsibility to ensure a safe environment. The greatest way to avoid accidents is for the facility to create a culture of safety, which includes systems that address resident risk and environmental hazards to minimize the likelihood of an accident. 1,2 A facility with a culture of safety: Acknowledges the high risk and error-prone nature of its activities; Develops a blame-free reporting system; Establishes multi-disciplinary teams and involves all employees to identify solutions to keep a facility safe; Supports leadership in directing resources to address safety concerns; and Demonstrates a commitment to safety at all levels of the organization. A key element of a systems approach is the consistent application of a process to address hazards and/or risks, as they are identified. Hazards might include aspects of the physical plant, equipment, and devices that are defective or not used properly (per manufacturer s CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 3

11 specifications), purposely disabled/removed, not individually fitted to the resident or that do not provide the adaptation that the resident needs. A facility with an effective system must not only identify environmental hazards and the resident s risk for an avoidable accident, but also the resident s need for supervision. Supervision that is needed but not provided may contribute to an accident. The likelihood of an accident should be identified and evaluated, factoring in the environment, the resident s risk factors, and need for supervision, care, and assistive devices. This will allow the facility to develop a plan of care that meets the individualized needs of the resident. The facility s response needs to be balanced with resident s wishes and the potential impact on other residents. The Guidance included in this document includes key references that can assist the surveyor in obtaining more extensive information about each topic. A SYSTEMS APPROACH If the survey team has discovered problems that could be evidence of a faulty facility system, they should evaluate the adequacy and effectiveness of facility systems to provide an environment that is free from hazards over which the facility has control. The facility s systems process should include: Identification of hazards and individual resident risk of an avoidable accident in the resident environment, including the need for supervision; Evaluation and analysis of hazards and risk information; Implementation of interventions, including adequate supervision, to reduce individual risk to hazards in the environment; and Monitoring for effectiveness and modification of approaches when necessary. These steps should be followed consistently, but the speed of the facility s response depends on the urgency of the situation presented and the hazards identified. Risks identified by the facility can pertain to individual residents or groups of residents. The facility-centered approach addresses risks for groups of residents; whereas, the residentdirected approach addresses risks for the individual residents. Identification of Hazards and Risks Identification of hazards and risks is the process through which the facility becomes aware of potential hazards in the resident environment and the risk of the resident having an avoidable accident. All disciplines should be involved in observing and identifying potential hazards in the environment, with consideration of the unique characteristics and abilities of the residents. The facility should make a good-faith effort to identify the CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 4

12 hazards and primary risk factors for each resident. These observations regarding individual residents should be documented in the medical record and communicated across all disciplines. There are a variety of strategies to identify hazards and resident risks in the long term care facility. Methods for identifying hazards and residents at risk include quality assurance activities, environmental rounds, MDS/RAPS data, medical history and physical exam, etc. The survey team should evaluate if the facility identified the risk of an accident based on the facility s determination of the resident s risk and hazards in the resident environment. Evaluation and Analysis Evaluation and analysis is the process through which the facility uses data, gathered through identification of hazards and risks, to develop interventions to reduce the potential for avoidable accidents. The evaluation and analysis step should be conducted by an interdisciplinary team, and sources of data utilized to determine each hazard and resident risk should be documented. Both the facility-centered and resident-directed approaches include evaluating hazard and accident risk data, analyzing potential causes for each hazard and accident risk, and identifying and designing interventions (including care plan interventions) based on the severity of the hazards and immediacy of risk. Evaluations should also look at trends such as time of day, location, etc. The survey team should evaluate if the facility developed interventions to reduce the potential for avoidable accidents based on evaluation and analysis of hazards and resident risks. Implementation of Interventions Implementation is the process through which interventions are used by the facility to reduce the resident s risk from hazards in the environment. The process includes: communicating the interventions to all relevant staff, assigning responsibility to appropriately trained individual(s), implementing and documenting interventions (e.g., QA plan), and ensuring that they are implemented. The reduction of risks is a facilitywide responsibility and not just that of the direct care staff. The interventions that are implemented should be based on the results of evaluation and analysis of information about hazards and risks and consistent with relevant standards, including evidence-based practice when available. If the interventions cannot be fully implemented right away, the facility should develop interim safety measures. Interventions for the facility-centered approach might include educating staff, repairing the device/equipment, etc. A resident-directed approach might include implementing the CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 5

13 care plan interventions, supervising staff and residents, etc. The documentation should reflect that the interventions have been implemented. The survey team should evaluate if the facility implemented interventions to reduce hazards and risks that were consistent with resident s needs, resident s goals, and recognized standards of practice. Monitoring and Modification Monitoring is the process through which the effectiveness of the intervention, approach, or system is evaluated. Modification is the process through which approaches are changed to make them more effective. The facility should (1) ensure that interventions are implemented correctly and consistently, (2) evaluate the effectiveness of interventions, (3) modify approaches as needed, and (4) evaluate the effectiveness of new interventions. For the resident-directed approach, this would include revising the resident s care plan to reflect current condition and risk factors, as well as implementing new interventions to replace those that were not effective. The survey team should evaluate if the facility monitored the effectiveness of interventions and modified them, as necessary, in accordance with relevant care standards. SUPERVISION During observations, the survey team evaluates whether the type and amount of supervision provided to residents are sufficient to meet their needs and to prevent avoidable accidents. Failure to provide adequate supervision can be a hazard for a resident who needs staff supervision. The lack of adequate supervision is hazardous when the facility: Determined there should be supervision of the resident, AND the facility did not provide it; and/or Failed to assess a resident to determine whether supervision was necessary, and the resident had an avoidable accident or caused an injury to another resident or there was high potential for an avoidable accident or injury to occur when supervision may have prevented it; and/or Should have been aware of the hazards in an area and provided supervision to protect the resident but did not. For a resident who needs supervision to be safe, the use of items, such as personal alarms, does not eliminate the need for supervision. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 6

14 There may be temporary hazards in the facility (e.g., construction, painting, and housekeeping activities) that affect most residents. Supervision of all facility residents in affected areas of the building is then necessary to prevent accidents. During observation of the facility, the survey team may see individual residents who are smoking tobacco products. Whether or not these residents are part of the sample, the issue of facility fires is so important that the survey team should determine if the situation is hazardous, requiring further investigation. For a resident who smokes, determination by the facility regarding the resident s abilities and capabilities would determine whether or not supervision is required. This includes an evaluation of the resident s alertness, physical abilities, etc. If the resident is found to need supervision for smoking, this information is included in the resident s care plan, and this plan reviewed periodically and revised as needed. If supervision is warranted, it must be provided. In addition, controls should be in place to limit the accessibility of matches and lighters by the resident who needs supervision when smoking. Smoking by residents when using oxygen is prohibited. Refer to the guidance for 42 CFR (b)(3) [F242] for information about facilities that desire to be smoke-free. HAZARDS IN THE RESIDENT ENVIRONMENT The survey team should note and investigate potential hazards that may be encountered during the entire survey. However, identifying specific hazards often points to a more serious problem: a lack of an effective system that would enable the organization to identify and correct the problem themselves. The discussion of specific common hazards is included to direct the surveyors to look for items that indicate a failure or absence of an organizational culture of safety. This section provides information regarding the most common potential hazards found in long term care facilities, but does not address all potential hazards. Professional standards for practice are ideally based on scientific evidence; however, some clinical practices have never been the subject of scientific study, and facilities must rely on best practice models that are described in the literature. Resident Vulnerability to Hazards The physical plant hazards, devices, and equipment described in this section are not hazards in and of themselves. It is the interaction between these potential hazards and the vulnerable resident that may lead to an accident. Some temporary hazards in the facility affect most residents if they have access to them (e.g., construction, painting, and housekeeping activities). Other hazards will be hazardous only for certain individuals (e.g., accessible smoking materials). In order for a hazard in the resident environment to be hazardous to an individual resident, the resident must have access to the hazard and have characteristics that make him/her vulnerable to it. Resident vulnerability is due to risk factors related to the CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 7

15 individual resident s functional status, medical condition, cognitive abilities, mood state, and health treatments (e.g., medications). The improper actions or omissions of the staff can create hazards such as: those found in the physical plant (e.g., building and grounds) and those related to devices and equipment. These hazards might include fire doors that have been propped open, disabled locks or latches, alarms that are non-functional, buckled carpets, cords on floors, irregular walking surfaces, improper storage and access to toxic chemicals, exposure to heating unit surfaces and unsafe water temperatures. Potential hazards may also include furniture that is not appropriate for the residents (e.g., chairs that are too low or unsteady and may present a fall hazard) and lighting that is inadequate or at intensity that creates glare. Devices for resident care, such as pumps, ventilators, and assistive devices, may be hazardous when they are defective, disabled, or improperly used. Certain sharp items, such as scissors, knitting needles, or other items, may be appropriate for many residents but may present a hazard for a resident with cognitive impairments. Hazards may change over time. Ongoing resident assessment will help identify when elements in the resident s environment become hazards to that particular resident. Hand rails, assistive devices, and any surface that comes in contact with the resident are capable of causing injury, if they are not in good repair and relatively free from sharp edges. Issues Contributing to Resident Vulnerability to Hazards Two issues highly prevalent in long term care facilities are falls and unsafe wandering/elopement. An overview of each of these syndromes is described along with the most frequently encountered potential hazards in this environment. Falls. According to the American Geriatrics Society s Guideline for the Prevention of Falls in Older Persons, the elderly have both a high incidence of falls and a high susceptibility to injury. 3 Falls can result in psychological and social consequences, including the loss of self-confidence to ambulate. Staff should evaluate the causal factors that led to a resident falling and provide consistent interventions to help ensure resident safety. A surveyor investigating a fall should evaluate if the facility took proper action following the fall to: Ascertain if there were injuries and treat if necessary; Determine what caused or contributed to the fall; Address the contributing factors; and Revise the resident s care plan, as appropriate, to prevent another fall. NOTE: A fall by a resident does not necessarily indicate a deficient practice. Not all falls can be avoided. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 8

16 A fall refers to unintentionally coming to rest on the ground, floor, or other lower level but not as a result of an overwhelming external force (e.g., resident pushes another resident). An episode where a resident lost his/her balance and would have fallen, if not for staff intervention, is considered a fall. A fall without injury is still a fall. Unless there is evidence suggesting otherwise, when a resident is found on the floor, a fall is considered to have occurred. Resident falls may be due to environmental hazards as well as to the resident s underlying disease processes, medication side effects, and other individual risk factors (e.g., lower extremity weakness, balance disorders, poor grip strength, functional and cognitive impairment, visual deficits). NOTE: Falls are often related to the side effects of medications. Unsafe Wandering or Elopement. 4 Wandering is locomotion with no apparent destination and is most often associated with dementia. This movement may be goaldirected in which the person appears to be searching for something or for an exit or may be non-goal-directed in which the person walks aimlessly. Moving about the facility with no apparent destination may indicate that the resident is frustrated, anxious, bored, or depressed. It may also indicate an unmet need, such as hunger, thirst, constipation, etc. When a resident who does not have a history of dementia begins to walk aimlessly, this behavior can mean a change in mental status, or it may be a symptom of an undetected medical problem, whose only symptom is acute confusion. The resident in this situation requires a facility to respond in a manner that addresses both safety issues and an assessment to rule out root causes. These types of movement are associated with falls and related injuries. Unsafe wandering occurs when the resident enters an area that is physically unsafe, especially stairwells, access areas for egress such as windows that open, poorly lit areas, construction areas, etc. There is an increased risk for falls with unsafe wandering. Entering an area that contains potential safety hazards, such as chemicals, tools, and equipment may result in an accident. Unknowingly trespassing in another resident s room may lead to an altercation or contact with hazardous items. Alarms can help to monitor the activities of a resident, but they require staff vigilance and should not be used in lieu of staff supervision. Adequate staffing is necessary to respond in a timely manner to the audible alarms. The most dangerous form of wandering is elopement, which occurs when a resident who needs supervision leaves a safe area without staff supervision. Elopement occurs when a resident goes outside unsupervised and may experience (or has the potential to experience) heat or cold exposure, dehydration and/or other medical complications, drowning, or be struck by a motor vehicle. Facility policies should clearly define the mechanisms and procedures a facility employs to prevent a resident from leaving the building/premises without staff knowledge. In addition, the resident at risk should have interventions in their comprehensive care plan to address the potential for elopement. A CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 9

17 facility s disaster and emergency preparedness plan should include a plan to locate the missing resident. 5 Physical Plant Hazards Chemicals and Toxics. There are a variety of materials in the facility that can pose a potential hazard to residents. Hazardous materials can be found in the form of solids, liquids, gases, mists, dusts, fumes, and vapors. The routes of exposure for toxic materials may be through inhalation, absorption, or ingestion. For a material to pose a safety hazard to a resident, it must be toxic, accessible, and available in a sufficient dose to cause harm. Although toxic materials may be present in the facility, they do not pose a hazard if the resident does not have access to them. Some materials that would be considered harmless when used as designed could pose a hazard to a resident with cognitive impairment who may accidentally ingest or make contact with the material. Materials that may pose a hazard to a resident include: Chemicals used by the facility staff in the course of their duties (e.g., housekeeping chemicals) and chemicals or other materials brought into the facility by staff, other residents, or visitors; Drugs and other therapeutic agents; Plants and other natural materials that may be found in the facility or in the outdoor environment (e.g., poison ivy). One source of information concerning the toxicity of a material is its Material Safety Data Sheet (MSDS). The facility should have an MSDS available for all hazardous materials utilized by staff during the course of their duties. MSDS are available on-line for numerous chemicals and should be reviewed carefully to determine if the material is indeed toxic and pose a hazard because MSDS are also available for non-toxic materials, such as sterile water. Poison control centers are also a source of information for potential hazards, including non-chemical hazards such as plants. NOTE: The Oklahoma State University web site, provides links to a variety of MSDS and toxicological information web sites. Toxicological profiles for a limited number of hazardous materials are accessible on the ATSDR web site at The Cornell web site has over 325,000 MSDS available on-line at The American Association of Poison Control Centers web site, lists contact information for local poison control centers. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 10

18 Water Temperature. Water may reach temperatures in hand sinks, showers, and tubs that can scald a resident. Burns related to hot water/liquids may be due to spills and/or immersion. Many residents in long term care facilities have conditions that may put them at increased risk for burns caused by scalding. These conditions include: decreased skin thickness, decreased skin sensitivity, peripheral neuropathy, decreased agility (reduced reaction time), decreased cognition or dementia, decreased mobility, and decreased ability to communicate. 6 The combination of the water temperature, the amount of skin exposed, and the duration of exposure will determine the level of injury. Some States have regulations regarding the specific maximum water temperature that is allowed. Table 1 illustrates damage to skin in relation to the temperature of the water and the length of time of exposure. 7 NOTE: A vulnerable resident may be at risk of harm when exposed to water at a temperature *even below those identified in the table, depending on his/her individual condition and the length of exposure. Table 1. Time and Temperature Relationship to Serious Burns Water Temperature Time Required for a 3 rd Degree Burn to Occur 155 F 148 F 140 F 133 F 127 F 124 F 120 F 100 F 68 C 64 C 60 C 56 C 52 C 51 C 48 C 37 C 1 sec 2 sec 5 sec 15 sec 1 min 3 min 5 min *Safe Temperatures for Bathing Based upon the time of the exposure and the temperature of the water, the severity of the harm to the skin is identified by the degree of burn, as follows. 8 First-degree burns involve the top layer of skin. Sunburn is a first-degree burn. These may present as red and painful to touch, and the skin will show mild swelling. Second-degree burns involve the first two layers of skin. These may present as deep reddening of the skin, pain, blisters, glossy appearance from leaking fluid, and possible loss of some skin. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 11

19 Third-degree burns penetrate the entire thickness of the skin and permanently destroy tissue. These present as loss of skin layers, often painless (pain may be caused by patches of first- and second-degree burns which often surround thirddegree burns), and dry and leathery skin, and skin may appear charred or have patches which appear white, brown or black. Electrical Safety. Electrical equipment and appliances are very common in long term care facilities. Any electrical device than can be plugged into an electric outlet can become hazardous to the residents through improper use or improper maintenance. Equipment electrical cords can become tripping hazards. Halogen lamps or heat lamps can cause fires if not properly installed away from combustibles in the resident environment. The Life Safety Code prohibits the use of portable electrical space heaters in resident areas. Extension cords are prohibited from being used in resident care areas. Power strips should not take the place of adequate electrical outlets in a facility but may be used for multiple equipment usage, such as for a computer, monitor, and printer. Power strips should not be located in areas where the cords could become tripping hazards to residents. Power strips should be compatible with the device being used. If an electrical device draws more current than a power strip can carry, it may cause the power strip and device to overheat and create a fire. The wires on electric blankets should not be tucked in or squeezed. Constriction can cause the internal wires to break. A person should not go to sleep with an electric blanket or heating pad turned on. There have been reports of death and injuries related to the use of heating pads. Most deaths are attributable to heating pad that generated fires, but most injuries are burns from prolonged use or inappropriate temperature setting. Prolonged use on one area of the body can cause a severe burn, even when the heating pad is at a low temperature setting. 9 The use of ground fault circuit interruption (GFCIs) may be required in locations near water sources to prevent electrocution of staff or residents. 10 Lighting. The risk of an accident increases when there is insufficient light or too much light, which often results in glare. There is a great deal of variability in vision among older persons; therefore, no single level of illumination can be recommended to ensure safety for all residents. The proper amount of light depends on the resident s visual needs and the task he/she is performing. An older person typically needs more light than a younger one to see equally well. However, a resident with cataracts or glaucoma may be sensitive to bright light, and an increase in lighting could make it more difficult to see clearly and may increase his/her fall risk. 11 Creating transitional zones between light and dark spaces helps to improve sight recovery. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 12

20 NOTE: Refer to guidance for 42 CFR (h)(5) [F256] for lighting issues related to Quality of Life. Devices/Equipment Hazards NOTE: The Safe Medical Devices Act of 1990 (SMDA) requires hospitals, nursing homes, and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices. The procedures established by the facility for such mandatory reporting should be followed. Assistive Devices for Mobility. Mobility devices include all types of assistive devices, such as, but not limited to, canes, standard and rolling walkers, manual or non-powered wheelchairs, and powered wheelchairs. These devices can pose a hazard if not fitted and/or maintained properly. 12 Personal fit, or how well the assistance device meets the individual needs of the resident, influences the likelihood of an avoidable accident. There are three primary reasons for potential harm related to the use of assistive devices for mobility: 1. Resident Characteristics. Lower extremity weakness, gait disturbances, loss of range of motion, and poor balance are physical limitations for some residents. When combined with cognitive impairment, these problems can make the use of mobility devices particularly hazardous. Unsafe behaviors, such as failure to lock wheelchair brakes and trying to stand or transfer from a wheelchair unsafely, can result in falls and related injuries; 2. Equipment Condition and Personal Fit. Poor maintenance and repair of equipment can be hazardous for residents. A mobility device that does not fit the resident can be a hazard; and 3. Staff Use. Mobility devices not placed within easy reach of the resident may create a hazardous situation. Unsafe transfer technique or improper use by staff may result in an accident. Inadequate supervision during the initial trial period of use or improper personal fit can lead to falls and/or injury. Assistive Devices for Transfer. Mechanical assistive devices for transfer include, but are not limited to, portable total body lifts, sit-to-stand devices, and transfer or gait belts. The facility s comprehensive assessment of the resident will determine his/her degree of mobility and physical impairment and the proper transfer method. For residents who suddenly lose their balance, the facility must decide whether two caregivers or a mechanical device is necessary for a safe transfer. The relative sizes of the caregiver and the resident must be considered, and this information must be clearly communicated to all staff that may care for the resident, including temporary staff. Lifts that frighten residents may lead to resistance movements that can result in avoidable accidents. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 13

21 Factors that influence safe resident handling include staff workload, resident abilities, and staff training. 13 Excessive workloads can be hazardous to residents, as well as to caregivers. The resident s ability to communicate and identify physical limitations or to aid in the transfer will help determine the need for a mechanical lift. New employees must receive proper training and orientation regarding resident assessment, safe transfer techniques, and the proper use of mechanical lifts including device weight limitations. Physical Restraints and Entrapment Risks. Physical restraints are defined as 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. Any device that meets this definition is considered a physical restraint unless otherwise noted in the information in the guidance for 42 CFR (a) [F221]. Whether a device is a physical restraint depends on the effect the device has on the particular resident for whom it is being used, not the intent or purpose of its use. In 1992, the Food and Drug Administration (FDA) issued a Safety Alert entitled Potential Hazards with Restraint Devices. 14 Serious injuries, as well as death, have been reported as a result of using physical restraints. Physical restraints carry a risk of severe injury, strangulation, and asphyxiation. Restrained residents are subject to injuries and fatalities due to self-attempts to remove restraints, to ambulate while restrained, or because the physical restraints are improperly fitted or used. When bed rails (also referred to as side rails, bed side rails, and safety rails ) cannot be removed easily by the resident and impede the resident s freedom of movement or normal access to one s body, the device meets the definition of a physical restraint. Bed rails can pose increased risk to resident safety. In 1995, the FDA issued a Safety Alert entitled Entrapment Hazards with Hospital Bed Side Rails. 15 Residents most at risk are those who are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain, uncontrolled body movement, hypoxia, fecal impaction, and acute urinary retention that may cause them to move about the bed or try to exit from the bed. The absence of timely toileting, positioning, and other nursing care related activities can contribute to the risk of entrapment. Entrapment may occur when a resident slips between the mattress and bed rail or becomes caught in the bed rail itself. Technical issues, such as the miss-sizing of mattresses, loose bed rails, or design elements (e.g., wide spaces between bars in the bed rails) also increase the risk of resident entrapment. The use of a specialty air-filled mattress or therapeutic air-filled bed presents an entrapment risk that is different from rail entrapment with a regular mattress. The high compressibility of an air-filled mattress compared to a regular conventional mattress presents the need for precautions for use with a resident at risk for entrapment. As a person moves to one side of an air-filled mattress, that side compresses. This raises the center of the mattress and lowers the side which makes it easier for a resident to slide off the mattress or against the rail. Mattress compression widens the space between the CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 14

22 mattress and rail. When a resident is between the mattress and rail, the mattress can reexpand and press the chest, neck or head against the rail. The use of air therapy is beneficial in the prevention and treatment of pressure ulcers and healthcare providers should not abandon its use but take precautions to mitigate the risk of entrapment. Precautions may include following manufacturer equipment alerts and increasing supervision. 16 NOTE: The lack of a medical symptom for the use of a restraint, should be cited at 42 CFR (a) [F221]. Use this tag to cite assistive devices/equipment (e.g., mobility devices, lifts and transfer aids, bed rails, call lights, physical restraints, pumps, belts) that are defective, not used properly or according to manufacturer s specifications; disabled or removed; not provided or do not meet the resident s needs (poor fit or not adapted); and/or used without adequate supervision when required. ENDNOTES 1 Pizzi, L.T., Goldfarb, N.I., Nash, D.B. (2002). Promoting a culture of safety. In: K.G. Shojania, B.W. Duncan, K.M. McDonald, & R.M. Wachter (Eds.), Evidence Report/Technology Assessment, No. 43. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Rockville, MD: Agency for Healthcare Research and Quality. Retrieved February 9, 2004 from < 2 Singer, S.J., Gaba, D.M., Geppert, J.J., et al. (2003). The culture of safety: Results of an organization-wide survey in 15 California hospitals. Qual Saf Health Care, 12, American Geriatrics Society, British Geriatrics Society American Academy of Orthopaedic Surgeons Panel on Falls Prevention. (2001). Guideline for the prevention of falls in older persons. J Am Geriatr Soc, 49, Boltz, M. (2003). Litigation Issues Related To Wandering and Elopement. The John A. Hartford Foundation Institute for Geriatric Nursing, New York University, The Steinhardt School of Education, Division of Nursing. < 5 Futrell, M., Melillo, K.D. (2002). Evidence-Based Protocol. Wandering. Iowa City (IA): University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core. 6 Katcher, L.K. (1981). Scald Burns from Hot Tap Water. Journal of Am Med Assoc., 246(11), CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 15

23 7 Moritz, A.R., Henriques F.C. Jr. (1947). Studies of Thermal Injury: II. The Relative Importance of Time and Surface Temperatures in the Causation of Cutaneous Burns. Am J Pathology, 23, < 9 US Dept. of Health and Human Services. Food and Drug Administration. (December 12, 1995). Public Health Advisory: Hazards Associated with the Use of Electric Heating Pads. 10 Electrical Safety Foundation International. Plug into Electrical Safety. Retrieved February 9, 2004 from < 11 Tideiksaar, R. (1998). Falls in Older Persons: Prevention and Management (2 nd Edition). Baltimore, MD: Health Profession Press. 12 Taylor, J.A., Brown, A.K., Meredith, S., Ray, W.A. (2002). The fall reduction program: a comprehensive program for reduction of falls and injuries in long-term care residents. Nashville, TN: Department of Preventive Medicine, Vanderbilt University School of Medicine. 13 US Dept. of Veterans Affairs, Office of Occupational Safety and Health. (January. 2003). Safe Patient Movement and Handling Guide. 14 US Dept. of Health and Human Services. Food and Drug Administration. (July 15, 1992). FDA Safety Alert: Potential Hazards with Restraint Devices. 15 US Dept. of Health and Human Services. Food and Drug Administration. (August 23, 1995). FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails. 16 Miles,S. (June 2002). Death between bedrails and air pressured mattresses. J Am Geriatr Soc, 50(6), CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 16

24 INVESTIGATIVE PROTOCOL ACCIDENTS AND SUPERVISION ACCIDENTS AND SUPERVISION Objectives Use To determine if the facility has identified hazard(s) present in the resident environment and the individual resident s risk for an avoidable accident posed by the hazard; To determine if a resident accident was avoidable or unavoidable; To evaluate the adequacy and effectiveness of facility systems to provide an environment that is as free as possible of hazards over which the facility has control, and minimizes the potential for harm; and To determine if the facility provided adequate supervision and assistive devices to prevent avoidable accidents. Use this protocol: For a sampled resident who is at risk for or who has a history of accidents, falls, or unsafe wandering/elopement to determine if the facility provided appropriate care and services including assistive devices as necessary, to prevent and correct hazards/risks for avoidable accidents; For a sampled resident who is at risk for, or who creates a risk for avoidable accidents to themselves or others, in order to determine if the facility has provided appropriate supervision; and For identified hazards/risks to determine if the facility has a system in place to identify, assess, correct and monitor for the elimination, to the extent possible, of the hazards/risks. Procedures Conduct observations of the general environment and sampled resident environment. For a sampled resident, briefly review the assessment and care plan to identify facility interventions and to guide observations to be made. For a resident newly admitted either at risk for avoidable accidents and/or falls, the staff is expected to assess and provide appropriate care from the day of admission. Corroborate observations by interview and record review. CENTERS FOR MEDICARE AND MEDICAID SERVICES B- 17