Information Bulletin 98-3
Incidents Of Jeopardy/Harm To Patient/Resident Health And Safety
We encourage you to copy and distribute this information.
The Minnesota Department of Health is alerting nursing homes, hospitals, home health care agencies, group homes for the mentally retarded and hospice providers of recently identified incidents of resident deaths and injuries involving the use of medical equipment and devices. The Department is bringing this to your attention so that you are aware of these recent occurrences. We strongly encourage you to examine your own setting for similar situations and take prompt action to prevent similar occurrences. As reminder, interventions should be appropriate to each resident/patient/client's care and services so that individual needs are considered and incorporated into plans of care, treatment and daily living arrangements.
This bulletin contains substantiated findings from recent Minnesota Department of Health nursing home surveys and complaint investigations in which a determination of immediate jeopardy had been made.
Investigations and surveys by the Department found incidents related to one or more or the following standards:
- lack of medical symptoms for use of physical restraints;
- lack of individualized assessment or reassessment after a harmful or potentially harmful incident;
- environmental hazards; and
- inadequate supervision with use of assistance devices.
Because many of these incidents involved side rails and restraint devices, the Department is enclosing two safety alerts issued by the Federal Food and Drug Administration:
FDA: Potential Hazards With Restraint Devices, July 15,1992
FDA: Entrapment Hazards with Hospital Bed Side Rails - August 23,1995
Since the incidents discovered by the Department at the time of this publication have been identified in nursing homes, the examples are categorized by the citation to the federal nursing home regulation. However, because similar incidents may occur in other health and residential housing settings, this information is also being distributed to all hospitals, home health agencies, hospices and intermediate care facilities for the mentally retarded in Minnesota.
Recent "Immediate Jeopardy" Findings made by the Department of Health in Nursing Homes
Since April, 1998, the Department has identified a number of immediate jeopardy findings in nursing homes relating to incidents involving side rails.
Immediate jeopardy means a situation in which the provider's noncompliance has caused or is likely to cause serious injury, harm, impairment, or death to a resident.
Individual Resident Situations
The Department's awareness of the significant risk posed to residents through the use of side rails was increased during our review of resident deaths caused by side rail entanglement. It is the Department's position that appropriate assessment of the resident or an evaluation of the beds, mattresses and side rails to determine whether a safety hazard existed and could have prevented the death of these residents. During recent nursing home surveys, the Department found similar situations in which residents became entangled in side rails and where there was not appropriate evaluation or intervention. Since an entanglement in a side rail is likely to cause serious injury or death, an enforcement finding of immediate jeopardy was made.
Several of the deficiency excerpts relate to situations when no appropriate action was taken by the facility after a resident fell over or through a side rail or became entangled in a side rail. While it may not be possible to prevent an initial occurrence, the Department expects that once these situations occur that they be reviewed by the facility. It is also the Department's expectation that action be taken to prevent similar occurrences in order to protect the resident from serious injury or death. The failure to initiate such actions would result in a finding of immediate jeopardy.
Since each resident needs to be individually assessed, it is not possible to describe all possible facility responses to an entanglement situation. It is important that the response be focused on the individual needs and characteristics of the resident. The Department would expect that the facility's response include an assessment of why the resident was attempting to get out of bed and interventions be taken to prevent this from occurring. The Department would also expect that the continued use of a side rail, a restraint, or other medical device be evaluated in light of any changes in the resident's actions or behaviors. Even if the use of a device may have been appropriate in the past, an entanglement situation needs to result in another assessment to determine if the use of the device continues to be appropriate and does not place the resident at risk of serious harm or death. Federal nursing home regulations require that a resident "receive adequate supervision and assistance devices to prevent accidents." 42 CFR 483.25 (h)(2)
Physical Characteristics of Side Rails
There have also been concerns about the physical characteristics of side rails which could pose safety hazards to residents. Additional information regarding these concerns from the Federal Food and Drug Administration can be viewed at the following web site: http://www.fda.gov/cdrh/bedrails.html [expired link]. Health care and residential settings need to evaluate the physical characteristics of beds, mattresses, side rails and other devices to determine if an individual is at risk. Nursing home regulations specifically require that "the resident environment remains as free of accident hazards as is possible..." 42 CFR 483.25 (h)(1).
Response to Deficiencies
The response of some facilities to a deficiency or to a finding of immediate jeopardy has also caused concern. We have seen examples of "knee-jerk reactions by the facility where immediate removal of devices without appropriate individual assessment or consideration of the facility's ability to safely monitor residents has placed those residents at risk of injury. In immediate jeopardy situations, there is a need for a prompt response to protect the resident from serious injury, Harm, impairment or death. For example, if the Department makes a finding that a side rail entanglement resulted in immediate jeopardy, we would expect that the facility's assessment take into consideration the needs of the resident and that the response be based on those considerations. In some cases, the abrupt removal of a side rail, without any alternatives or other interventions might continue to place the resident at risk. There is not an automatic answer that can be provided to all situations.
For nursing homes, the correction of an immediate jeopardy finding can be made without being in substantial compliance with the regulations. It is common in most immediate jeopardy situations that the initial action taken by the facility would abate the jeopardy; however, additional time might be required to have the facility fully in compliance with the regulations. In situations where deficiencies have been issued relating to restraints, the facility's response must allow for individual assessments and can allow for a gradual reduction of the restraining devices. For example, if a deficiency identifies that a number of residents are restrained without a medical symptom, the immediate removal may place residents at risk. A plan of correction which includes time for the assessment and possibly the need for the resident to be monitored in a restraint reduction plan may be acceptable. We encourage you to discuss these issues with the supervisory staff of the Minnesota Department of Health Licensing and Certification Program unit, or with the Office of Health Facility Complaints.
Excerpts From Deficiencies
CFR 483.13(a) Tag, 221 The resident has the right to be free from any physical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.
Intent: This standard is to promote highest well-being for each person by prohibiting the use of restraints for discipline or convenience and limits use to an individual who has a medical symptom that warrants the use of restraints.
- The closed record indicated the facility used side rails to keep the resident from falling out of bed. The nurses notes indicated the resident was found against the side rail twice and had received bruises on the right side of the forehead. Nurses notes continue to document the "resident has been restless and pulling self into side rails X 6 during the night". The following day a posey belt was added, while the resident was in bed. No other alternatives were tried at that time. A nurses note included the statement, "Is not safe with full side rails as s/he tries to climb over them or over the foot of the bed." The side rails continue to be used. The resident was "found with the right shoulder wedged behind the one-half side rail, body hanging with the soft posey belt intact from off of the bed. Red area under the breast and on the back from the posey belt". No medical symptom warranting the use of the restraint was noted.
- Resident had two incidents of physical harm resulting from the use of one and one-half side rails on the bed. The resident was found by nursing staff laying on his/her left side with his/her face down between the mattress and the side rail, resulting in puffiness of both eyes and a red mark on the right cheekbone. The head of the bed was in the low position. The staff stated "The resident had been positioned on his/her left side and s/he had slipped into the side railing. The resident was unable to move his/herself in the bed because s/he had contracture of the knees, hips and arms." There was no assessment of the side rails, nor was there an assessment which identified safety issues regarding the side rails for the resident, before the next incident. The resident was next found with his/her lower extremities hanging over the side of the bed. The staff member described the incident: "The forehead and right cheek were pressed into the side rail. The buttocks were on the bed and the abdomen was over the edge of the bed". Record of the incident stated there was a red mark on the right elbow and a bruise below the right knee. During an interview, the licensed nursing staff indicated there had been no assessments or changes in use of the side rails prior to surveyor intervention during the survey. Review of the resident record did not establish that there were medical symptoms for the use of the side rails and side rails were not used for assistance in mobility.
- Resident had severe cognitive deficits. Resident had four one-half side rails when in bed and required total assistance with all care and transfers. Record review revealed the following incidents: On 2/11/98, the resident was found sitting on the floor at 2:45 a.m., hanging onto the side rails. The resident had slipped through the space between the one-half side rails. On 2/15/98, at 10:30 p.m., the resident was found with his/her knees bent and wedged between the side rails. There were red indented marks on the right upper outer leg, the lower leg, and across the toes. The record noted, on 2/19/98, the bruise marks from 2/15/98 were blue and purple.
- Resident was noted to have been restrained by a gait belt tied across the front of the wheelchair. The staff stated the resident was very wild and the gait belt was used to keep the resident from falling. Record review noted a fall: the resident was found lying on her/his right side with the wheelchair on top of the legs and hips. The gait belt was down to the resident's knees.
- Restraint not required to treat the resident's medical symptom.
Resident found lifting up a black clip seat belt over head while
sliding down onto the floor in her wheelchair. Resident's physician
wrote an order to discontinue the use of the belt. During the survey
resident observed to have a self-release belt restraint on when seated
in her wheelchair. The resident was cognitively impaired.
CFR 483.20 (b) Tag 272 Resident Assessment. The facility must make a comprehensive assessment of a resident's needs based on a uniform data set... describes the resident's capability to perform daily life functions and significant impairments in functional capacity.
Intent: This standard is for the provider to have information necessary to develop a care plan and to provide the appropriate care and services for each individual.
- Resident had a fall where s/he slid between the half side rails onto the floor. S/he was also found with the lower extremities entangled in the side rails. There was no assessment of the resident's safety with ongoing use of four one-half side rails.
- Resident had moderate cognitive deficit and required total assist
for transfers. S/he had left sided weakness. The resident had four
one-half side rails to define the parameters of the bed as a physicians
order. The resident got her/his feet tangled in the side rails which
caused "horrible pain". There had been no assessment of
least restrictive measures and documentation of alternatives for
the side rails which caused the pain.
CFR 483-20)(c) Tag 276 Resident Assessment . A facility must assess a resident using the quarterly review instrument specified by the State and approved by HCFA not less frequently than once every 3 months
Intent: This standard is to assure that the individual assessment is accurate and reflects the resident's current status.
- Facility failed to ensure that each resident was reassessed as necessary when there was a change in the resident's status. Resident experienced multiple falls continuing until her death at which time the resident was found wedged between the mattress and side rail. The cause of death was positional asphyxia. Resident had well-known history of sitting up on the edge of the bed and attempting to get out of bed without assistance, especially at night. Although resident wore a TABS alarm, resident had recent history of unplugging it. Resident had several recent incidents where SEA slid out of bed or was found out of bed on the floor. Resident also experienced three recent problems with side rail entanglement.
- Resident diagnosed with multi-farct dementia, Parkinson's and old CVA. At the time of the survey, the resident was restrained in bed with a roll belt and had a single elevated side rail because of repeated falls. The resident was observed to be restrained in bed with a roll belt. The left side rail elevated. The medical record indicated that the resident had fallen from the bed with the roll belt intact and was found lying on her right side on 9/22/97, 10/6/97 and 4/10/98.
- The assessment identified the resident's increasing falls and ongoing
risk of falls. However, an assessment of the problem, including the
nature of the condition, complications, risk factors and possible
alternative care planning interventions is lacking. The resident
has fallen at least 3 times since the MDS was completed with no new
interventions attempted. A fall on 2/26/98 was related to a rug placed
on the floor by the resident's bed. A rug on the floor by the resident's
bed was observed during the survey.
CFR 483.25(h)(l) Tag 323 The facility must ensure that the resident environment remains as free of accident hazards as is possible.
Intent: This standard is for the provider to prevent accidents by providing an environment as free from hazards over which the provider has control.
- The facility failed to ensure that the resident environment remained
as free from accident hazards, as is possible for 13 residents in
the sample, and 39 additional residents who were utilizing partially
dropped side rails on their beds... Fifty-two residents utilized
full side rails which the facility had lowered at the foot of the
bed, leaving only the top portion of the rail, near the head elevated.
CFR 483.25 (h)(2) Tag 324 Qualitv of Care The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.
Intent: This standard is that the provider identifies each resident at risk for accidents and/or falls, and adequately plans care and implements procedures to prevent accidents.
- Observed during the survey to have 2 full side rails up and the foot of bed elevated whenever in bed. Staff indicated the side rails and elevating the foot of the resident's bed were used for safety and indicated that the only measure explored utilized bed alarms. There was no assessment. Weekly charting (of one week): "noted to climb out of bed 9 times this week". Weekly charting (of another week) indicated, "noted to climb out of bed 5 times this week". Incident revealed resident climbed over the rails and was found by the nurse on the floor holding onto the side rail...there was no evidence in the medical record that the facility had assessed the safety factors for the use of the side rails and the resident's continual attempts to climb over the rails to get out of bed.
- Resident had three falls from bed while wearing a roll belt. The resident continued to use the belt from between 9/22/97 and 4/10/98. Continual use of the roll belt created a situation where the resident could have been seriously injured or harmed. The resident was found on right hip with head and upper body off the floor and roll belt intact and still tied. The bed alarm did not sound. Red rope burn area from roll belt on left side of back half way down.
- Based on observation, interview, and record review, the facility
failed to ensure adequate supervision and assistance devices to prevent
recurring accidents. Two full side rails were observed on the resident's
bed. Staff indicated that two full side rails are elevated whenever
the resident is in bed. The full side rails had been applied on 11/28/97
due to resident's unsteadiness, weakness, and attempts to get out
of bed unassisted. The resident had continued to use the full side
rails since that date. The plan of care indicated, "two side
rails up when resident is in bed for positioning and agitation." From
3/l/98 to 5/23/98 this resident had 6 different incidents of being
discovered out of bed on the floor with her full side rails still
up when staff discovered her on the floor of her bedroom. Previous
to all of these falls the resident had been in her bed.
On 3/l/98, the resident was found on the floor in her bedroom. Her full side rails were still elevated when staff found her in her bedroom. The resident had a small superficial cut over her left eye and this area had to be steri stripped.
On 3/4/98, the resident was found sitting on the floor of her room. Her full side rails were still elevated when staff found her on the floor. The resident had a 1.5 cm abrasion noted on the right scapula with at 0.5. cm abrasion on the right clavicle.
On 3/31/98, the resident was found on the floor of her room. Just prior to finding the resident she had been in her bed. The resident hit her left forehead when she fell and received a 5 cm by 6 cm raised bump. She also received a 1.2 cm scratch on her left knee.
On 4/19/98, the resident has been assisted to bed after lunch. The resident had been found on the floor laying on her right side. Both of her full side rails were still elevated on her bed when staff found her on the floor.
On 5/13/98, the resident had been in bed. She was found kneeling on the floor of her room. Both her side rails were still elevated on her bed when staff found her on the floor.
On 5/23/98, the resident was found on her back, on the floor of her room. She was crying and complaining of burning in her hips. She had previously been in the bed. Both of her full side rails were still elevated when staff found her on the floor.
After 6 incidents of climbing out of bed with two full side rails up, the facility continued to use the full side rails on the bed. Although staff moved the resident closer to the nurses desk, staff failed to implement any other procedures to prevent any further accident from occurring.
Comments On MDH Informational Bulletin 98-3
The Minnesota Department of Health appreciates your effort to work with us on this public health concern. We invite your comments regarding Informational Bulletin 98-3. We encourage you to let us know suggestions of other information that would be beneficial and examples of your success in preventing similar situations from occurring. Thank you.
Comments on Information Bulletin 98-3
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Minnesota Department of Health
Health Regulation Division
85 East Seventh Place, Suite 300
P.O. Box 64900
St. Paul, Minnesota 55164-0900