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Based on observation, interview, and record review, the hospital failed to protect and promote each patient's rights when the nursing service failed to:

1. Ensure care was provided in a safe setting when direct care staff failed to demontrate safe operation of electric beds (Stryker I-beds), and ensure staff were educated hospital-wide regarding safety concerns with the Stryker I-beds (used on most units of the hospital) following an incident when a patient fell and a bed-exit alarm failed to function (see A-0144).

2. Ensure each patient's right to be free of restraints when a waist belt restraint was used before less restrictive measures were proved to be ineffective for one sampled patient (see A-0164).

3. Ensure staff were knowledgeable about the hospital's restraint policy and procedure when staff were not given updated training regarding restraint use after an incident when a patient fell and died while restrained (see A-0201).

The cumulative effects of these systemic problems resulted in the hospital's failure to deliver quality health care in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure care was provided in a safe setting when direct care staff failed to demontrate safe operation of Stryker I-beds (multifunction electric beds) for 3 sampled patients (1, 4 and 5). Findings:

1. Patient 1 was admitted to the hospital for medical care. On 02/10/13 Patient 1 fell out of a bed with a bed exit alarm ordered by the physician. During the investigation of the fall, it was determined the bed exit alarm failed to sound.

The bed exit alarm was a component of multi-function, computerized beds used in medical surgical, intensive care, coronary care, and the progressive care units.

During an interview on 5/8/13 at 8:10 a.m., the general clinical nurse educator (GCNE) stated after the fall incident nursing staff were educated by electronic mail and posted flyer as to how to set features and check settings of the multi-function beds.

The GCNE stated nursing staff who worked on the unit where Patient 1 fell were also provided an inservice class on the set up and operation of the multi-function beds. The nurses on other units where the beds were in use were not given the same training.



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2. During an observation and interview on 5/6/13 at 9 a.m., with charge nurse A (CN A), Patient 5 was sitting up in bed consuming a meal. On the footboard section of the bed a prominent LED light was flashing an orange color. CN A checked the status of the bed by checking the control panel on the footboard and stated the bed exit alarm was not on and the orange light indicated this. CN A stated the patient was at risk for falls and should have the bed exit alarm on (armed to make a sound if the patient should get up unattended). She stated she did not know why the alarm was not on.

During an interview on 5/6/13 at 9:05 a.m., certified nurse assistant B (CNA B) stated she was assigned to care for Patient 5. CNA B stated when she brought the meal to Patient 5, the bed alarm was on. She raised the head of the bed and turned off the bed alarm, because whenever the head of the bed was elevated the bed alarm would constantly go off, making multiple false alarms. She stated this was her experience with all the beds of that type. She was aware Patient 5 was at risk for falling, and stated while the bed alarm was turned off she would check on Patient 5 every fifteen minutes to ensure safety.

During an interview on 5/6/13 at 9:10 a.m., the unit manager (UM A) stated the bed may give an occasional alarm as a patient's head was raised because of a shift of weight, but for the most part the bed exit alarm functioned as designed. UM A stated hospital policy was to keep the bed alarm on even if the head of the bed was raised.

On 5/8/13 review of CNA B's training record indicated she was last trained on the use of the bed exit alarm on 9/16/09.

3. During an observation and interview on 5/6/13 at 9:15 a.m., Patient 4 was lying in bed. At the foot of the bed a prominent LED type light was flashing orange. CNA C entered the room and stated the orange light indicated the bed settings had been changed. He stated he lowered one of the bed's side-rails when he was in the room shortly before. He stated whenever any part of the bed set up was changed, such as lowering a side rail, the LED light changed from continuous green to flashing orange. He stated he should have used the bed controls to ensure the green light was on before he left the room, but did not. He stated the bed-exit alarm was still armed although the light was orange.

During an interview on 5/6/13 at 9:15 a.m., UM A stated the hospital policy was to keep the bed indicator light on the "green is good" condition.

On 5/7/13 a review of CNA B's training record indicated he had received a refresher training on the use of the bed on 2/14/13.

On 5/7/13 a review of the 4/5/2010 hospital policy and procedure for the Stryker I-Bed indicated parameters for the bed, including the bed alarm status, should be set by staff to ensure the bed indicator light would be green indicating a safe condition.

Based on observation, interview, and record review, the hospital failed to ensure less restrictive interventions had been determined to be ineffective to protect the patient from harm, before using a waist restraint, for one sampled patient (1). Patient 1 was admitted on 2/5/13 with a history of mental confusion. On 2/9/13 Patient 1 developed symptoms of increased restlessness and attempting to climb out of bed and was placed in a waist belt restraint to keep her from climbing out of bed. On 2/10/13 Patient 1 fell from the bed and expired while in the restraint. Less restrictive interventions including assigning a staff person to stay with the patient, moving the patient to an area where she would be visible to staff, and administration of medications to control her symptom of restlessness were not tried and determined to be ineffective before the restraint was used. Findings:

On 4/4/13 a review of the 2/2012 hospital policy titled "Patient Safety Attendants" (PSAs, trained staff members who stay in the room with the patient) indicated a PSA would be provided when the safety of the patient was in jeopardy. Assessment findings to consider when determining the need to request a PSA included the patient's level of orientation, memory and cognition, and impaired judgment that places the patient at high risk for injury. The policy indicated to also investigate alternative interventions including moving the patient closer to the nurse's station to maximize visibility by staff, and medications to alleviate symptoms.

Patient 1's record was reviewed on 3/14/13. The patient was admitted via the emergency department with diagnoses including upper respiratory infection and dementia (a brain disease which causes confusion). The 2/5/13 admission assessment indicated Patient 1 was elderly, weak, disoriented and had fallen at home on 12/31/12. The assessment indicated she wore glasses for a vision problem and was hard of hearing. The assessment indicated she was dependant on others for dressing, toileting, meals, medication, personal hygiene, and her ability to walk was severely limited. The assessment indicated Patient 1 was drowsy and confused while in the emergency department, but not agitated.

Physician's orders dated 2/5/13 indicated Patient was prescribed intravenous (IV) fluids (administered by a tube into a vein), breathing treatments, supplemental oxygen by nasal cannula (a plastic tube placed under the nose) oral trazodone (a sedative) at bedtime as needed for insomnia, oral risperidone (an antipsychotic medication) every 12 hours as needed for mild agitation, and haloperidol (an antipsychotic medication) by injection into the muscle every four hours as needed for non-psychotic symptoms associated with dementia in adults. On 2/8/13 the physician ordered diphenhydramine (an antihistamine) every 6 hours via IV.

A 2/5/13 falls risk assessment indicated Patient 1 was at high risk to fall due to history of falling previously, mental confusion, poor safety awareness, and infection with delirium (increased confusion due to an underlying cause such as a medication or an infection).

Patient 1's 2/5/13 care plan for risk for falls indicated the goal was the patient would not fall. Interventions included: apply fall risk arm band on patient. Instruct patient not to get up without calling for assistance. Have call light and personal items close. Monitor patient frequently. Ensure room is free of clutter and arrange furniture. Assess toileting needs frequently. Anticipate patient needs. Utilize appropriate lift aids and sufficient help when getting patient up. Utilize bed alarm. As appropriate, provide adequate nutrition to ensure energy.

Nurses notes of 2/6/13 at 7/53 a.m., 2/7/13 at 1:48 p.m., and 2/8/13 at 3:52 p.m. indicated the care plan interventions were effective at preventing Patient 1 from falling and the care plan was continued without revision.

A physician's note documented by the physician (MD) on 2/8/13 at 6:58 p.m. indicated Patient 1 was restless at times and trying get out of bed but mostly calm.

A nurses note of 2/9/13 at 12:32 p.m. written by licensed nurse C (LN C) indicated a change in Patient 1's behavior. Patient 1 became more restless and had increased pulling at tubes. She was reassessed as being at increased risk for injury from climbing out of bed.

A physician order dated 2/9/13 at 12:30 p.m. indicated Patient 1's physician prescribed a waist belt restraint to prevent the patient from pulling on tubes and to protect the patient from harm.

During an observation and interview on 3/20/13 at 2:50 p.m. the Director of Regulatory Compliance (DRC) provided a restraint of the type used for Patient 1. It was an approximately 8 foot long belt, wider in the middle and tapered at the ends. The belt was wrapped snugly around the patient's mid-torso and the straps were hooked to the sides of the bed. The belt allows the patient to roll from side to side, but is designed to keep the patient in the middle of the bed surface and away from the edges. The patient cannot self-release the belt restraint. The belt restraint did not prevent movement of the patient's arms or legs. An empty Stryker I-Bed like the one used by Patient 1 was shown. It had two side rails on each side of the bed which could be fully lowered, positioned half way up, or all the way up. The distance from the top of the mattress to the top of the rails when in their highest position was about 12 inches. The distance from the top of the mattress to the floor, with the bed in lowest position, was about 2 and 1/2 feet.

A restraint care plan was entered into the patient's electronic record by LN C on 2/9/13 at 12:32 p.m. The care plan indicated the waist belt restraint was used because the patient did not comprehend patient safety directions, was pulling at lines, tubes, dressings, and was restless. The goal was the patient would be free from injury and no pulling at lines or tubes. Interventions included provide reality reorientation as needed, attempt to treat distress, and evaluate effectiveness of continued use of the restraint. The use of the PSA was an intervention which could be added to the care plan by clicking on the corresponding checkbox, but the option was not selected.

The medication administration record (MAR) indicated LN C gave Patient 1 haloperidol 0.5 milligrams (mg) by injection on 2/9/13 at 12:47 p.m. and a 1.0 mg additional dose on 2/9/13 at 7:22 p.m. The effect on Patient 1 of the haloperidol was not documented. The MAR indicated the oral risperidone ordered for mild agitation and the oral trazodone for insomnia ordered on 2/5/13 were not given to Patient 1 during her entire hospitalization from 2/5/13 to 2/10/13.

Nurse notes on 2/9/13 at 5:36 p.m. and 2/10/13 at 10:36 a.m. indicated Patient 1 continued to be restless and confused. Licensed nurse A (LN A) documented in the nurse's notes on 2/10/13 at 10:22 p.m. "Patient had multiple attempts to get out of bed with belt restraint on and four side rails up. Patient kept swinging legs over the side rails and kept asking to help her get out of the room." The restraint care plan was continued without revisions.

LN A documented in the nurses notes on 2/11/13 at 12:07 a.m. (late entry) she was called to the room on 2/10/13 at 11:15 p.m. by certified nurses assistant A (CNA A) who stated the patient fell. LN A saw the patient on the floor by the bed with the restraint belt still on and the patient's face looked blue. Three staff members placed Patient 1 back in bed and checked her pulse, and there was none. LN A documented the patient had expired.

The "Expiration Processing and Release of Remains" form indicated Patient 1 was pronounced dead on 2/10/13 at 11:19 p.m.

The 2/19/13 Discharge Summary listed cause of death as influenza pneumonia complicated by acute community acquired pneumonia, and dementia with significant delirium as a contributing factor to her passing away. The summary documented "on the day of her death, [Patient 1] was found in a position where she had been trying to get out of bed and was found by the nurses unresponsive and pulseless."

During an observation on 3/14/13 at 4:10 p.m., the room where Patient 1 was housed was about 30 feet down a hallway to the left side of unit 2C's nursing station. From the nurses station the room was not visible.

During an interview on 4/2/13 at 3 p.m., LN C stated on 2/9/13 she was assigned to care for Patient 1. Her shift began at 7 a.m. on 2/9/13. She noted Patient 1 was trying to get out of bed, including trying to get over or around the side rails, and was mentally confused. LN C was making rounds (visiting rooms) every hour. She was concerned Patient 1 would fall so she called Patient 1's physician at 12:30 p.m. and requested an order for a waist belt restraint. The reason for the restraint was to prevent the patient from exiting the bed and falling. She obtained the waist restraint and applied it to Patient 1. The physician also ordered 0.5 mg of haloperidol by injection, which LN C gave. The medication helped Patient 1 calm down. LN C stated a less restrictive measure tried by nursing staff before using the restraint was visiting each hour and re-orienting (talking to the patient and reminding them of person, time, and place). The use of a patient safety attendant (PSA, a staff person assigned to stay in the room with the patient at all times for safety) was considered but not tried because the patient's family member was in the room visiting at that time.

During an interview on 3/20/13 at 2 p.m. CNA A stated he was assigned to provide care for Patient 1 on 2/10/13 from 3 p.m. to 11 p.m. Patient 1's family member had visited earlier and gone home, so Patient 1 was alone. Patient 1 was wearing a belt restraint and was frequently swinging her legs out of the bed. He was worried for her safety, checked on her about every 15 minutes, and put on the bed exit alarm. He began his last round at 11 p.m., checking on the patients assigned to him and going from room to room. When he reached the room adjacent to Patient 1's room, he looked into Patient 1's room and noticed she was not in her bed. He heard no bed exit alarm. He stated in the past, sometimes the bed alarm would function, and sometimes it would not. He entered the room and found Patient 1 out of the bed on the left side of the bed. Patient 1 was touching the floor with her feet but the remainder of Patient 1's body was suspended about six inches off the floor by the waist belt restraint, which was positioned over her abdomen and fastened to the bed on both sides. The bed rails were in the highest position. The patient was on her left side in a lying position and was not breathing. CNA A went to the nurses station to get help. LN A and LN B responded and came to the room. Staff placed Patient 1 back in the bed.

During an interview on 3/20/13 at 2:30 p.m., LN A stated she was assigned to care for Patient 1 on 2/10/13 for a twelve hour shift from 7 p.m. to 7:30 a.m. She received the patient in bed at 8 p.m. wearing the waist belt restraint, with the side rails of the bed raised. She observed the patient was restless, putting her legs out of bed and saying she wanted to leave the room. LN A made additional visits at 9 p.m. and 10 p.m. and noted the patient was calm while staff was in the room and more anxious and restless when alone in the room. At 11:15 p.m. CNA A called her to come to the room, along with another nurse (LN B). Upon entering the room she saw Patient 1 laying on the floor on her left side next to the bed, wearing the waist belt restraint. The restraint was positioned around the patient's waist and the ends of the straps were clipped to quick-release mechanism on each side of the bed. Patient 1 had a blue coloration to her skin and was not breathing and had no pulse. The patient was lifted back onto the bed. LN A stated she did not hear a bed alarm sound for Patient 1 prior to, or after, the fall. LN A stated she did not request a PSA because the patient was on isolation precautions (Kept apart from other patients due to having suspected influenza. Staff wear disposable gowns, mask, and gloves when in the room). She did not give the medications prescribed for Patient 1's anxiety and restless behavior as Patient 1 was calm when staff were in the room.

During an interview on 3/22/13 at 2 p.m., LN B stated she was working the shift from 3 p.m. to 11 p.m. on 2/10/13 but was not assigned to care directly for Patient 1. At around 11 p.m., CNA A came to the nurses station and stated a patient was on the floor. LN B went to the room to help. Upon entering the room Patient 1 was on the floor with the belt restraint around her waist. Patient 1's head was positioned toward the foot of the bed, and she was on her side so she appeared to be looking under the bed. LN A stated her face was blue and she had expired. Staff put her back on the bed.

LN B discussed hospital interventions for a patient who was restless and trying to get out of bed. She stated staff would consider getting a sitter (PSA). For a patient on droplet precautions isolation a PSA could be utilized and the PSA would need to wear a mask and gown while in the room. LN B stated if a patient was anxious and restless, she would give medication as ordered to treat those symptoms.

During an interview on 4/4/13 at 9 a.m., the physician (MD) stated she saw Patient 1 initially on 2/6/13. She stated the patient was very confused and became more so as the hospitalization progressed. She stated the patient's restlessness got worse due to multiple factors including the hospitalization itself, the pneumonia, and the use of antibiotics. The MD stated on 2/9/13 at 12:30 p.m. LN C called her and asked for an order for a waist belt restraint due to Patient 1's restless behavior and taking off the oxygen. The MD asked LN C if the bed alarm was on and if the side rails were up and LN C said yes. The MD stated a PSA was not considered because "from what I understood she was not strong enough to get out of the bed, although she eventually did." She stated she did not discuss moving the patient to a room where she could be observed from the nurse's station. MD stated she trusted the nurses to make decisions regarding use of restraints.

On 4/4/13 a review of the 3/12 restraint policy and procedure indicated less restrictive measures were those interventions appropriate to the needs of the patient which were applied to avoid the use of restraint. Staff will be trained to minimize the use of restraints, and in their safe use. Appendix A of the policy "09.02 RESTRAINTS POLICY" indicated for a patient pulling at lines, tubes, drains, etc and crawling over siderails, staff will try general less restrictive measures first such as assessing cardiopulmonary and neurological status, providing diversional activities, and consulting the pharmacist to review the drug profile. If those measure failed, staff will "consider leaving siderails down. Investigate possibility of sitter, family, security officer at bedside. Confer with Clinical Mgr./Administrative Supervisor for sitter authorization. Notify manager as soon as possible. Consult MD with condition change and need for a sitter order." The policy indicated if all measures have failed and physical restraint is indicated, staff will obtain a physician's order for the restraint and apply appropriately. Appendix C of the policy indicated patient monitoring and evaluation for restraint would include performing and documenting attempts at less restrictive measures, patient response, and continued need for the restraint every two hours.

On 4/4/13 a review of the 6/12 hospital policy and procedure titled "Falls, Management of the Inpatient at Risk For" indicated the purpose of the policy was to establish a process for identifying a patient at risk for falls, and to establish a fall prevention plan of care. For a patient at high risk for falls, interventions included the following: Place the patient near the nurses' station, if possible. Consider using the bed and chair alarms, consider use of a patient safety attendant (PSA) as appropriate, and consider use of restraints as per the restraint procedure, when appropriate.

According to the American Geriatrics Society, British Geriatric Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention, Guideline for the prevention of falls in older persons, Journal of American Geriatrics Society, 49(5): 664-72, 2001 May, the use of restraints for the prevention of falls should not be considered a routine part of a falls prevention program. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence the use of physical restraint (including but not limited to, raised side rails) will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries.

Based on interview and record review, the hospital failed to ensure nursing staff were educated regarding changes in restraint use following an incident where a patient fell and expired while in a waist belt restraint. Findings:

During an interview on 5/8/13 at 7:30 a.m., the Director of Regulatory Compliance stated Patient 1 was admitted on 2/5/13 to the hospital for medical care. On 02/10/13 Patient 1 fell out of bed while in a waist belt restraint and expired. During the investigation of the fall, it was determined the waist belt restraint was not safe or effective, and nursing staff needed reinforcement of the hospital policy to use less restrictive interventions before restraining a patient. The incident resulted in changes to the hospital medical restraint use, and also the nurses restraint competency training curriculum. The waist belt restraint was not to be used any longer. Staff would use alternatives for patient safety.

On 5/8/13 a review of the revised 2/2013 Medical Restraint Competency curriculum, which is in the format of a PowerPoint presentation, indicated restraint options were limited to soft limb restraints, soft mitten restraints, and vest restraints (a mesh material shirt with straps to hold a patient in bed). The vest restraint was restricted to one unit only. The curriculum indicated nurses would try less restrictive alternatives before using a restraint and to document the results of the trials.

During an interview on 5/8/13 at 8:10 a.m., the general clinical nurse educator (GCNE) stated nurses were trained when they were first hired and then annually. The nurses demonstrated competency and signed a document so that attendance could be tracked. The last annual training was held over several days in December 2012. The next annual restraint competency class for all nursing staff was planned for December 2013 and would include medical restraint competency training. She stated new hires would be given restraint training as part of their orientation. The GCNE stated after the incident nursing staff were advised by electronic mail and posted flyer regarding changes made to the restraint use in the hospital. She stated she did not monitor whether the electronic mail or flyers were effective for training staff or determining how many staff had read the emails or flyers. She stated the revised restraint competency training curriculum had not yet been presented as a classroom training to nurses but would be presented at the next annual restraint competency training session.

On 5/8/13 a review of a 2/11/13 memo to nursing staff provided by the GCNE indicated to "immediately discontinue use of waist restraints due to a potential patient safety issue identified." The memo indicated all waist restraints were removed from the nursing units and supply areas. The memo indicated to "use alternatives for patient safety: use bed alarms. If all 4 side-rails are used, make sure there is only a small gap between siderails. Consult with Supervisor if a Patient Safety Attendant is required." The memo also included ways to check if the bed alarm was connected to the call system.

A review of the "09.02 RESTRAINTS POLICY" indicated the hospital would use a performance improvement method. The hospital would collect data. The policy indicated "Data will to utilized to help determine if policy, practice, staff education or other changes and interventions may decrease the use of restraint." The policy indicated "The organization will educate and assess the competence of staff in minimizing the use of restraints before they participate in any use of restraint."

Based on observation, interview, and record review, the hospital's nursing service failed to provide the nursing staff with necessary supervision to ensure the hospital policies were followed on use of patient restraints and revision of care plans.

1. Registered nurses failed to follow hospital policy on the use of restraints when a waist belt restraint was used for one sampled patient before appropriate less restrictive measures were determined to be ineffective. The patient fell from the bed while in the waist belt restraint (see A-0395).

2. Nurses failed to follow hospital policy on updating care plans to include the use of a bed exit alarm for three sampled patients (see A-0396).

The cumulative effects of these systemic problems resulted in the hospital's failure to deliver quality health care in a safe environment.

Based on observation, interview, and record review, the nursing service failed to ensure nurses followed the hospital policy to ensure less restrictive interventions were determined to be ineffective prior to use of a waist belt restraint for one sampled patient (1) who was placed in a waist belt restraint. Patient 1 was admitted on 2/5/13 with a history of mental confusion. On 2/9/13 Patient 1 developed symptoms of increased restlessness and attempting to climb out of bed. Nursing staff placed Patient 1 in a waist belt restraint to keep her from climbing out of bed. On 2/10/13 Patient 1 fell from the bed and expired while in the restraint. The hospital policy indicated less restrictive interventions including assigning a staff person to stay with the patient, moving the patient to an area where she would be visible to staff, and administration of medications to control symptom should be considered first before using a restraint, but were not. Findings:

On 4/4/13 a review of the 2/2012 hospital policy titled "Patient Safety Attendants" (PSAs, trained staff members who stay in the room with the patient) indicated a PSA would be provided when the safety of the patient was in jeopardy. Assessment findings to consider when determining the need to request a PSA included the patient's level of orientation, memory and cognition, and impaired judgment that places the patient at high risk for injury. The policy indicated to also investigate alternative interventions including moving the patient closer to the nurse's station to maximize visibility by staff, and medications to alleviate symptoms.

Patient 1's record was reviewed on 3/14/13. The patient was admitted via the emergency department with diagnoses including upper respiratory infection and dementia (a brain disease which causes confusion). The 2/5/13 admission assessment indicated Patient 1 was elderly, weak, disoriented and had fallen at home on 12/31/12. The assessment indicated she wore glasses for a vision problem and was hard of hearing. The assessment indicated she was dependant on others for dressing, toileting, meals, medication, personal hygiene, and her ability to walk was severely limited. The assessment indicated Patient 1 was drowsy and confused while in the emergency department, but not agitated.

Physician's orders dated 2/5/13 indicated the patient was prescribed intravenous (IV) fluids (administered by a tube into a vein), breathing treatments, supplemental oxygen by nasal cannula (a plastic tube placed under the nose) oral trazodone (a sedative) at bedtime as needed for insomnia, oral risperidone (an antipsychotic medication) every 12 hours as needed for mild agitation, and haloperidol (an antipsychotic medication) by injection into the muscle every four hours as needed for non-psychotic symptoms associated with dementia in adults. On 2/8/13 the physician ordered diphenhydramine (an antihistamine) every 6 hours via IV.

A 2/5/13 falls risk assessment indicated Patient 1 was at high risk to fall due to history of falling previously, mental confusion, poor safety awareness, and infection with delirium (increased confusion due to an underlying cause such as a medication or an infection).

Patient 1's 2/5/13 care plan for risk for falls indicated the goal was the patient would not fall. Interventions included: apply fall risk arm band on patient. Instruct patient not to get up without calling for assistance. Have call light and personal items close. Monitor patient frequently. Ensure room is free of clutter and arrange furniture. Assess toileting needs frequently. Anticipate patient needs. Utilize appropriate lift aids and sufficient help when getting patient up. Utilize bed alarm. As appropriate, provide adequate nutrition to ensure energy.

Nurses notes of 2/6/13 at 7/53 a.m., 2/7/13 at 1:48 p.m., and 2/8/13 at 3:52 p.m. indicated the care plan interventions were effective at preventing Patient 1 from falling and the care plan was continued without revision.

A physician's note documented by the physician (MD) on 2/8/13 at 6:58 p.m. indicated Patient 1 was restless at times and trying get out of bed but mostly calm.

A nurses note of 2/9/13 at 12:32 p.m. written by licensed nurse C (LN C) indicated a change in Patient 1's behavior. Patient 1 became more restless and had increased pulling at tubes. She was reassessed as being at increased risk for injury from climbing out of bed.

A physician order dated 2/9/13 at 12:30 p.m. indicated Patient 1's physician prescribed a waist belt restraint to prevent the patient from pulling on tubes and to protect the patient from harm.

During an observation and interview on 3/20/13 at 2:50 p.m. the Director of Regulatory Compliance (DRC) provided a restraint of the type used for Patient 1. It was an approximately 8 foot long belt wider in the middle and tapered at the ends. The belt was wrapped snugly around the patient's mid-torso and the straps were hooked to the sides of the bed. The belt allowed the patient to roll from side to side, but is designed to keep the patient in the middle of the bed surface and away from the edges. The patient cannot self-release the belt restraint. The belt restraint did not prevent movement of the patient's arms or legs. An empty Stryker I-Bed like the one used by Patient 1 was shown. It had two side rails on each side of the bed which could be fully lowered, positioned half-way up, or all the way up. The distance from the top of the mattress to the top of the rails when in their highest position was about 12 inches. The distance from the top of the mattress to the floor, with the bed in lowest position, was about 2 and 1/2 feet.

A restraint care plan was entered into the patient's electronic record by LN C on 2/9/13 at 12:32 p.m. The care plan indicated the waist belt restraint was used because the patient did not comprehend patient safety directions, was pulling at lines, tubes, dressings, and was restless. The goal was the patient would be free from injury and no pulling at lines or tubes. Interventions included provide reality reorientation as needed, attempt to treat distress, and evaluate effectiveness of continued use of the restraint. The use of the PSA was an intervention which could be added to the care plan by clicking on the corresponding checkbox, but the option was not selected.

The medication administration record (MAR) indicated LN C gave Patient 1 haloperidol 0.5 milligrams (mg) by injection on 2/9/13 at 12:47 p.m. and a 1.0 mg additional dose on 2/9/13 at 7:22 p.m. The effect on Patient 1 of the haloperidol was not documented. The MAR indicated the oral risperidone ordered for mild agitation and the oral trazodone for insomnia ordered on 2/5/13 were not given to Patient 1 during her entire hospitalization from 2/5/13 to 2/10/13.

Nurse notes on 2/9/13 at 5:36 p.m. and 2/10/13 at 10:36 a.m. indicated Patient 1 continued to be restless and confused. Licensed nurse A (LN A) documented in the nurse's notes on 2/10/13 at 10:22 p.m. "Patient had multiple attempts to get out of bed with belt restraint on and four side rails up. Patient kept swinging legs over the side rails and kept asking to help her get out of the room." The restraint care plan was continued without revisions.

LN A documented in the nurses notes on 2/11/13 at 12:07 a.m. (late entry) she was called to the room on 2/10/13 at 11:15 p.m. by certified nurses assistant A (CNA A) who stated the patient fell. LN A saw the patient on the floor by the bed with the restraint belt still on and the patient's face looked blue. Three staff members placed Patient 1 back in bed and checked her pulse, and there was none. LN A documented the patient had expired.

The "Expiration Processing and Release of Remains" form indicated Patient 1 was pronounced dead on 2/10/13 at 11:19 p.m.

The 2/19/13 Discharge Summary listed cause of death as influenza pneumonia complicated by acute community acquired pneumonia, and dementia with significant delirium as a contributing factor to her passing away. The summary documented "on the day of her death, [Patient 1] was found in a position where she had been trying to get out of bed and was found by the nurses unresponsive and pulseless."

During an observation on 3/14/13 at 4:10 p.m., the room where Patient 1 was housed was about 30 feet down a hallway to the left side of unit 2C's nursing station. From the nurses station the room was not visible.

During an interview on 4/2/13 at 3 p.m., LN C stated on 2/9/13 she was assigned to care for Patient 1. Her shift began at 7 a.m. on 2/9/13. She noted Patient 1 was trying to get out of bed, including trying to get over or around the side rails, and was mentally confused. LN C was making rounds (visiting to the room) every hour. She was concerned Patient 1 would fall so she called Patient 1's physician at 12:30 p.m. and requested an order for a waist belt restraint. The reason for the restraint was to prevent the patient from exiting the bed and falling. She obtained the waist restraint and applied it to Patient 1. The physician also ordered 0.5 mg of haloperidol by injection, which LN C gave. The medication helped Patient 1 calm down. LN C stated a less restrictive measure tried by nursing staff before using the restraint was visiting each hour and re-orienting (talking to the patient and reminding them of person, time, and place). The use of a patient safety attendant (PSA, a staff person assigned to stay in the room with the patient at all times for safety) was considered but not tried because the patient's family member was in the room visiting at that time.

During an interview on 3/20/13 at 2 p.m. CNA A stated he was assigned to provide care for Patient 1 on 2/10/13 from 3 p.m. to 11 p.m. Patient 1's family member had visited earlier and gone home, so Patient 1 was alone. Patient 1 was wearing a belt restraint and was frequently swinging her legs out of the bed. He was worried for her safety, checked on her about every 15 minutes, and put on the bed exit alarm on. He began his last round at 11 p.m., checking on the patients assigned to him and going from room to room. When he reached the room adjacent to Patient 1's room, he looked into Patient 1's room and noticed she was not in her bed. He heard no bed exit alarm. He stated in the past, sometimes the bed alarm would function, and sometimes it would not. He entered the room and found Patient 1 out of the bed on the left side of the bed. Patient 1 was touching the floor with her feet but the remainder of Patient 1's body was suspended about six inches off the floor by the waist belt restraint, which was positioned over her abdomen and fastened to the bed on both sides. The bed rails were in the highest position. The patient was on her left side in the lying position and was not breathing. CNA A went to the nurses station to get help. LN A and LN B responded and came to the room. Staff placed Patient 1 back in the bed.

During an interview on 3/20/13 at 2:30 p.m., LN A stated she was assigned to care for Patient 1 on 2/10/13 for a twelve hour shift from 7 p.m. to 7:30 a.m. She received the patient in bed at 8 p.m. wearing the waist belt restraint, with the side rails of the bed raised. She observed the patient was restless, putting her legs out of bed and saying she wanted to leave the room. LN A made additional visits at 9 p.m. and 10 p.m. and noted the patient was calm while staff was in the room and more anxious and restless when alone in the room. At 11:15 p.m. CNA A called her to come to the room, along with another nurse (LN B). Upon entering the room she saw Patient 1 laying on the floor on her left side next to the bed, wearing the waist belt restraint. The restraint was positioned around the patient's waist and the ends of the straps were clipped to quick-release mechanism on each side of the bed. Patient 1 had a blue coloration to her skin and was not breathing and had no pulse. The patient was lifted back onto the bed. LN A stated she did not hear a bed alarm sound for Patient 1 prior to, or after, the fall. LN A stated she did not request a PSA because the patient was on isolation precautions. (Kept apart from other patients due to having suspected influenza. Staff wear disposable gowns, mask, and gloves when in the room.) She did not give the medications prescribed for Patient 1's anxiety and restless behavior as Patient 1 was calm when staff were in the room.

During an interview on 3/22/13 at 2 p.m., LN B stated she was working the shift from 3 p.m. to 11 p.m. 2/10/13 but was not assigned to care directly for Patient 1. At around 11 p.m., CNA A came to the nurses station and stated a patient was on the floor. LN B went to the room to help. Upon entering the room Patient 1 was on the floor with the belt restraint around her waist. Patient 1's head was positioned toward the foot of the bed, and she was on her side so she appeared to be looking under the bed. LN A stated her face was blue and she had expired. Staff put her back on the bed.

LN B discussed hospital interventions for a patient who was restless and trying to get out of bed. She stated staff would consider getting a sitter (PSA). For a patient on droplet precautions isolation a PSA could be utilized and the PSA would need to wear a mask and gown while in the room. LN B stated if a patient was anxious and restless, she would give medication as ordered to treat those symptoms.

During an interview on 4/4/13 at 9 a.m., the physician (MD) stated she saw Patient 1 initially on 2/6/13. She stated the patient was very confused and became more so as the hospitalization progressed. She stated the patient's restlessness got worse due to multiple factors including the hospitalization itself, the pneumonia, and the use of antibiotics. The MD stated on 2/9/13 at 12:30 p.m. LN C called her and asked for an order for a waist belt restraint due to Patient 1's restless behavior and taking off the oxygen. The MD asked LN C if the bed alarm was on and if the side rails were up and LN C said yes. The MD stated a PSA was not considered because "from what I understood she was not strong enough to get out of the bed, although she eventually did." She stated she did not discuss moving the patient to a room where she could be observed from the nurse's station. The MD stated she trusted the nurses to make decisions regarding use of restraints.

On 4/4/13 a review of the "09.02 RESTRAINTS POLICY" indicated less restrictive measures were those interventions appropriate to the needs of the patient which were applied to avoid the use of restraint. Staff will be trained to minimize the use of restraints, and in their safe use. Appendix A of the policy indicated for a patient pulling at lines, tubes, drains, etc and crawling over siderails, staff will try general less restrictive measures first such as assessing cardiopulmonary and neurological status, providing diversional activities, and consulting the pharmacist to review the drug profile. If those measure failed, staff will "consider leaving siderails down. Investigate possibility of sitter, family, security officer at bedside. Confer with Clinical Mgr./Administrative Supervisor for sitter authorization. Notify manager as soon as possible. Consult MD with condition change and need for a sitter order." The policy indicated if all measures have failed and physical restraint is indicated, staff will obtain a physician's order for the restraint and apply appropriately. Appendix C of the policy indicated patient monitoring and evaluation for restraint would include performing and documenting attempts at less restrictive measures, patient response, and continued need for the restraint every two hours.

On 4/4/13 a review of the 6/12 hospital policy and procedure titled "Falls, Management of the Inpatient at Risk For" indicated the purpose of the policy was to establish a process for identifying a patient at risk for falls, and to establish a fall prevention plan of care. For a patient at high risk for falls, interventions included the following: Place the patient near the nurses' station, if possible. Consider using the bed and chair alarms, consider use of a patient safety attendant (PSA) as appropriate, and consider use of restraints as per the restraint procedure, when appropriate.

According to the American Geriatrics Society, British Geriatric Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention, Guideline for the prevention of falls in older persons, Journal of American Geriatrics Society, 49(5): 664-72, 2001 May, the use of restraints for the prevention of falls should not be considered a routine part of a falls prevention program. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence the use of physical restraint (including but not limited to, raised side rails) will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries.

Based on observation, interview and record review, the nursing service failed to update the use of bed exit alarms as an additional intervention in the nursing care plans for three (5, 8, and 9) of 38 sampled patients. Findings:

1. During an observation and interview on 5/6/13 at 9 a.m. with the unit 2C charge nurse (CN A), Patient 5 was in bed with the head of the bed up. CN A stated Patient 5 was at high risk for falls and part of her care plan was the use of a bed exit alarm (an alarm will sound to alert staff if the patient attempts to exit the bed).

On 5/6/13 at 2 p.m., the clinical record for Patient 5 was reviewed in the company of the Medical-Surgical director (MSD). The clinical record indicated the nursing care plan for fall risk for Patient 5 did not include an intervention to utilize the bed exit alarm. The MSD reviewed the record and stated the care plan should have included the bed exit alarm.

2. During an observation and interview on 5/6/13 at 9:30 a.m., with the unit 4A charge nurse (CN B), Patient 8 was in bed with the side rails up. CN B stated Patient 8 was at risk for falling and had a broken hip from a previous fall. A sign on the wall by the door indicated "Bed Alarm in Use."

On 5/6/13 at 2:10 p.m., the clinical record for Patient 8 was reviewed in the company of the MSD. The clinical record indicated the nursing care plan for fall risk for Patient 8 did not include an intervention to utilize the bed exit alarm. The MSD reviewed the record and stated the care plan should have included the bed exit alarm.

3. During an observation and interview on 5/6/13 at 9:35 a.m. with CN B, Patient 9 was in bed. CN B stated the patient was in a room close to the nurse's station because she was at risk to fall. Patient 8's bed was displaying a green LED light. CN B stated the green light indicated the bed alarm was on.

On 5/6/13 at 2:15 p.m., the clinical record for Patient 9 was reviewed in the company of the MSD. The clinical record indicated the nursing care plan for fall risk for Patient 9 did not include an intervention to utilize the bed exit alarm. The MSD director reviewed the record and stated the care plan should have included the bed exit alarm. She stated hospital policy and procedure was to include all interventions on the care plan and to revise the care plan as the patient's condition and needs changed.

The 2/12 hospital policy and procedure titled "Plan of Care, Interdisciplinary" indicated "Each plan includes approaches or interventions which support the patient's goals...Each discipline caring for the patient is responsible for the development, review, and update of the Plan of Care."