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Based on observation, professional literature review, policy and procedure review, review of the facility's Plan of Correction (POC), record review, and staff interview, the Critical Access Hospital (CAH) failed to assess each patient individually prior to utilizing side rails, and failed to provide education to the patient and the responsible party regarding the hazards of side rail use for 5 of 5 active swing bed patients (Patient #1, #2, #3, #35, and #36) observed with elevated side rails. Failure to assess and evaluate the use of side rails, and failure to educate patients and responsible parties regarding the hazards of using side rails placed Patients #1, #2, #3, #35, and #36 at risk of entrapment or injury.

Findings include:

FDA (Food and Drug Administration) Safety Alert: Entrapment Hazards with Hospital Bed Side Rails, August 23, 1995, and Joint Commission on Accreditation of Healthcare Organization: Sentinel Event Alert, Issue 27, September 6, 2002, identified bed rail-related entrapment deaths and injuries can occur in the elderly population, who are often at risk due to limited mobility, psychoactive or sedative medications, confusion, sedation, restlessness, lack of muscle control, size and physical deformities. Death by asphyxiation or injuries to the resident's extremities can occur when the resident becomes caught between the mattress and the bed rail; the headboard and the bed rail; or getting his or her head/extremity stuck in the bed rail. Both split and full rails have the potential to cause fall-related injuries as well as entrapment. Additionally fall-related injuries or injuries to extremities can occur when confused/disoriented residents climb over the top of side rails or get an arm or leg entrapped.

The United States Department of Health and Human Services, Food and Drug Administration (FDA), and Center for Devices and Radiological Health (CDRH) publication titled, "Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment", issued on 03/12/06, stated, ". . . This guidance provides recommendations relating to hospital beds . . . The guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems. . . . We suggest that facilities . . . determine the level of risk for entrapment and take steps to mitigate the risk. . . . For 20 years, FDA has received reports in which . . . patients have become entrapped in hospital beds while undergoing care and treatment in health care facilities. . . . Patient entrapments may result in death and serious injuries. . . . The population most vulnerable to entrapment are elderly patients . . . especially those who are frail, confused, restless . . . Entrapments have occurred in a variety of patient care settings, including hospitals . . . In response to continued reports of patient entrapment, the FDA . . . formed a working group in 1999 known as the Hospital Bed Safety Workgroup (HBSW) . . . to improve patient safety associated with the use of hospital beds. The HBSW identified 7 potential zones . . . in hospital beds. . . . The issue of patient entrapment in hospital beds is complex and affects . . . healthcare practitioners and facilities . . . patients, and caregivers. . . . Reducing the risk of entrapment involves a multi-faceted approach that includes . . . clinical assessment and monitoring . . . FDA recommends that healthcare facilities conduct a risk-benefit analysis to ensure that steps taken to mitigate the risk of entrapment do not create different, unintended risks or reduce clinical benefits available to patients . . . Three key body parts at risk for life-threatening entrapment in the seven zones of a hospital bed system in this guidance are the head, neck, and chest. . . . "

The Hospital Bed Safety Workgroup publication titled, "Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities, and Home Care Settings, dated April 2003, stated, "Every patient . . . deserves a safe and comfortable sleeping and bed environment. . . . The purpose of this guidance is to provide a uniform set of recommendations for caregivers in hospitals . . . to use when assessing their patients' need for and possible use of bed rails. . . . In the spectrum of care including hospital . . . settings, bed rails serve a variety of purposes, some of which are in the best interest of the patient's health and safety. Bed rails: . . . can facilitate turning and repositioning within the bed or transferring in or out of a bed; may provide a feeling of comfort and security, or facilitate access to bed controls; and may be used as a physical barrier to remind the patient of the bed perimeters . . . Achieving the goal of a safe and comfortable bed and sleeping environment may necessitate the reduction or elimination of bed rail use in cases in which the bed rail is not in the best interests of the patient's health and safety. Although various types may be used depending on a patient's medical and functional needs, bed rails may pose increased risk to patient safety. Clinical research suggests that bed rails may not be benign safety devices. For example, evidence indicates that half-rails pose a risk of entrapment and full rails pose a risk of entrapment as well as falls that occur when patients climb over the rails or footboards when the rails are in use. . . . CMS [Centers for Medicare and Medicaid Services] has imposed performance expectations on hospitals . . . For example . . . CMS issued guidance in June 2000 . . . One section of the guidance states, 'It is important to note that side rails present an inherent safety risk, particularly when the patient is elderly or disoriented. Even when a side rails is not intentionally used as a restraint, patients may become trapped between the mattress or bed frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get around a raised side rail. When attempting to exit the bed by any of these routes, the patient is at risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail, with a possibility for sustaining greater injury or death than if he/she had fallen from the height of a lowered bed without raised siderails. . . . Guiding Principles: The population at risk for entrapment are patients who are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain . . . that cause them to move about the bed or try to exit from the bed. . . . The principles that follow are intended to guide the development of the patients' care plans. 1. The automatic use of bed rails may pose unwarranted hazards to patient safety. . . . 2. Decisions to use or to discontinue the use of a bed rail should be made in the context of an individualized patient assessment . . . with input from the patient and family . . . Policy Considerations: 1. Regardless of the purpose for which bed rails are being used or considered, a decision to utilize or remove those in current use should occur within the framework of an individual patient assessment. . . . 3. Use of bed rails should be based on patients' assessed medical needs and should be documented clearly . . . Bed rail effectiveness should be reviewed on a regular basis. The patient's chart should include a risk-benefit assessment that identifies why other care interventions are not appropriate or not effective if they were previously attempted and determined not to be the treatment of choice for the patient. . . . 5. Bed rail use for patient's mobility and/or transferring . . . should be accompanied by a care plan. . . . The care plan should: include educating the patient about possible bed rail danger to enable the patient to make an informed decision; and address options for reducing the risks of the rail use. . . . 7. Creating a safe bed environment does not necessarily preclude the use of bed rails. However, a decision to use them should be based on a comprehensive assessment and identification of the patient's needs, which include comparing the potential for injury or death associated with use or non-use of bed rails to the benefits for an individual patient. In creating a safe bed environment, the following general principles should be applied: Avoid the automatic use of bed rails of any size or shape. . . . Re-assess the patient's needs and re-evaluate the equipment if an episode of entrapment or near-entrapment occurs, with or without serious injury. . . . Process/Procedure Considerations: . . . 1. Individualized Patient Assessment: Any decision regarding bed rail use or removal from use should be made within the framework of an individual patient assessment. If a bed rail has been determined to be necessary, steps should be taken to reduce the known risks associated with its use. . . . Risk Intervention: Assessment of risk should be part of the individual patient's assessment, and steps to address the risk should be incorporated into the patient's care plan. . . . Patient Choice: . . . if a patient, family member, or authorized representative requests the inappropriate use of side rails, then the interdisciplinary care team has a responsibility to discuss the risks involved, as well as the benefits of any clinical and/or environmental interventions that may be safer in meeting the patients's assessed needs, individual circumstances, and environment. . . . Education/Training: Hospitals . . . should provide education and training about bed rail use to assist in creating and implementing a safe and comfortable sleeping environment for their patients. . . ."

The Hospital Bed Safety Workgroup publication titled, "A Guide to Bed Safety - Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts", revised April 2010, stated, ". . . Between 1985 and January 1, 2009, 803 incidents of patients caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. Food and Drug Administration. Of these reports, 480 people died . . . Most patients were frail, elderly or confused. . . . Patients who have problems with memory . . . or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm, such as falling. Assessment by the patient's health care team will help to determine how best to keep the patient safe. . . . Potential benefits of bed rails include: Aiding in turning and repositioning within the bed. Providing a hand-hold for getting into or out of bed. Providing a feeling of comfort and security. . . . Providing easy access to bed controls and personal care items. Potential risks of bed rails may include: Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint. Feeling isolated or unnecessarily restricted. Preventing patients, who are able to get out of bed, from performing routine activities such as going to the bathroom . . . Most patients can be in bed safely without bed rails. Consider the following: Use beds that can be raised and lowered close to the floor . . . Keep the bed in the lowest position with wheels locked. When the patient is at risk of falling out of bed, place mats next to the bed . . . Monitor patients frequently. Anticipate the reasons patients get out of bed . . . meet these needs . . . When bed rails are used, perform an on-going assessment of the patient's physical and mental status; closely monitor high-risk patients. Consider the following: Lower one or more sections of the bed rail . . . Use a proper sized mattress or mattress with raised foam edges to prevent patients from being trapped between the mattress and rail. Reduce the gaps between the mattress and side rails. . . . A process that requires ongoing patient evaluation and monitoring will result in optimizing bed safety. . . . If patients or family ask about using bed rails, health care providers should: Encourage patients or family to talk to their health care planning team to determine whether or not bed rails are indicated. Reassure patients and their families that in many cases the patient can sleep safely without bed rails. Reassess the need for using bed rails on a frequent, regular basis."

Review of the policy "Patient Safety Policies" occurred on 07/07/11. This policy, revised June 2011, stated, ". . . 2. Side rails may be used for safety, transfers and per patient request if addressed in their care plan. The use of 4 side rails is prohibited due to risk of greater injury or entrapment. See Falls Prevention Program. . . ."

Review of the policy "Falls Prevention Program" occurred on 07/07/11. This policy, dated June 2011, stated, ". . . To provide guidelines for the management of those patients who are at risk to prevent falls. . . . 1. The Program is implemented to reduce/eliminate falls and associated injuries by ensuring patients receive appropriate . . . Fall Prevention Interventions. . . . 3. Environmental hazard and safety monitoring is expected of all PMC [Presentation Medical Center] employees. . . . 5. Patient/Family are educated in the appropriate interventions for the Fall Prevention Program. . . ."

Review of the facility's POC occurred on 07/07/11. Review of pages 14-16, stated, ". . . Nursing staff will be inserviced . . . The FDA Hospital Bed System statement March 10, 2006, the JCAH Sentinal Event Alert 2002 statement, FDA April 2003 Guiding Principles will be reviewed at Nursing Unit meetings on June 21, 2011, and June 23, 2011. Assessment and evaluations for the use of side rails will be reviewed at the unit meetings on June 21 and 23. The Falls Prevention Program will identify patients with a potential for inappropriate side rail use. The new Falls Prevention policy . . . and program has been developed and inserviced to staff and will be followed beginning June 20, 2011. A monitor . . . has been developed . . . Beginning June 20, 2011, the [administrative nurse] (Acute Care Charge Nurse in her absence) will monitor all patients daily for 14 days. . . . The use of side rails was reviewed. . . . Nursing staff was educated at unit meetings held on June 21 & 23, 2011. . . ." Page 14 and 15 of the facility's POC identified a compliance date of 06/23/11.

An inservice on the CAH's new Falls Awareness/Prevention Program occurred on June 15-17, 2011 and 06/23/11. Review of the inservice information identified nursing staff completed the education. Review of the June 21st and 23rd Nursing Unit Meeting Minutes occurred on 07/07/11. The meeting minutes stated, ". . . The use of side rails was discussed. . . . [administrative nurse] will be monitoring patients to track the use of side rails. . . ."

- Observation of Patient #1 on 07/07/11 at 12:20 p.m., while the patient rested in bed, identified three elevated half rails on the bed. Observation showed Patient #1's bed in the low position, and a padded mat placed on the floor next to the patient's bed. Location of the nurse station from Patient #1's room, showed the station down the hall about 30 feet to the east, not visible from the room.

Review of Patient #1's active record occurred on 07/07/11, and identified the CAH admitted the patient to swing bed on 08/23/09 for assistance with activities of daily living. Patient #1's medical history included osteoarthritis, chronic right hip pain, and general weakness. Record review showed the patient sustained a fall at a previous facility resulting in a fractured pelvis prior to admission to the CAH. Patient #1's record showed the patient attempted to get out of the bed or chair on numerous occasions by self throughout the patient's stay in swing bed, and acquired multiple falls in doing so.

Review of Patient #1's nursing documentation from 06/23/11 to 07/07/11, indicated confusion, forgetfulness, disorientation to place and time, general weakness, and decreased muscle tone. Review of Patient #1's Morse Fall Scale findings from 06/23/11 to 07/07/11, indicated a high fall risk. Record review showed three elevated side rails for patient safety. Patient #1's Kardex, undated, identified assist with two, pivot, and lift with EZ Stand in the activities section; and showed three of four side rails per family request for safety, and bed and chair alarm in the supportive/safety section. The nursing documentation showed Patient #1 frequently tried to get up out of the bed or chair by self.

Patient #1's Physician Orders and Progress Notes, dated 06/23/11 at 9:50 a.m., stated physician notified of worsening confusion past 18 hours, and on 06/28/11 a mid-level provider stated nursing staff report more confusion.

Patient #1's Progress Notes in the electronic medical record, used by nursing staff for documentation, stated the following:
*06/23/11 at 6:48 a.m.: ". . . was confused t/o [throughout] night . . ."
*06/23/11 at 2:05 p.m.: "patient confused and agitated . . ."
*06/27/11 at 12:23 p.m.: "Pt [patient] has had periods of increased confusion over the last 1-2 weeks. . . ."
*07/01/11 at 10:15 a.m.: "Pt trying to get out of her chair byself. . . ."
*07/01/11 at 5:25 p.m.: "Pt's tag alarm sounding writer huried [sic] into room and saw pt sliding out of chair onto the floor. . . . pt stated she slid onto her butt. . . . Pt was on BSC [bedside commode] at 5pm and had tag alarm and call light within reach, chair was in the lift position for pt to reach supper tray and the chair is working proporly [sic]."
*07/03/11 at 9:30 p.m.: "Pt found three times this shift with chair in elevated position. . . . Call light remains with in reach. Tag alarm is on. . . ."
*07/04/11 at 9:01 a.m.: "[patient] has a good week. She has exhibited minimal confusion. . . ."
*07/06/11 at 9:00 p.m.: "Pt has been found several times this shift with the lift chair elevated and pt has been found with the remote in her hand. Pt is able to find the remote even when placed out of her reach. . . ."
*07/07/11 at 4:30 a.m.: "Pt's tag alarm sounding. Pt found sitting up in bed. States she has to go to the BR [bathroom]. . . ."

A facility incident report, dated 07/01/11 at 5:25 p.m., identified Patient #1's tag alarm sounded, nursing staff entered the patient's room, and found the patient sliding to the floor from the recliner, landing in the sitting position. The report indicated Patient #1's call light within reach, and noted the recliner chair lift control found on the floor. The report identified staff toileted Patient #1 at 5:00 p.m., and at that time, noted the recliner chair lift control in pocket out of the patient's reach. Review of the report indicated Patient #1 frequently attempted to get up out of the chair by self using the recliner chair lift control, even though staff placed the control out of the patient's reach as a means of preventing the patient from getting up alone.

Patient #1's care plan (located within the paper chart), dated 06/24/11, included the problem "Risk for Falls", and included "room placement close to nurse station" as a plan of approach. Patient #1's comprehensive care plan (located within the electronic medical record), last reviewed 07/04/11, included the problem "Increased susceptibility to falling that may cause physical harm", and included "Use side rails of appropriate length and height to prevent falls from bed, as needed, as an approach.

Review of the administrative nurse's (#1) daily quality assurance monitoring of side rail use on Patient #1 occurred on 07/07/11, and identified three elevated side rails from 06/20/11 to 07/06/11.

Patient #1's medical record lacked an individualized assessment of risk and safety for use of side rails. Given the patient's history of confusion, forgetfulness, disorientation, and attempts to get out of the bed or chair by self, the CAH staff failed to consider the side rails as a potential safety hazard for Patient #1. Patient #1's record identified the CAH staff initiated and continued to use three side rails for the patient at the family's request, but lacked evidence of education to the family regarding the possible hazards of side rail use. The record showed the CAH staff used other interventions including a bed and chair alarm, and padded mat as a means to prevent falls and injury, but lacked an assessment of the effectiveness of these interventions prior to utilizing the three side rails. The CAH staff documented moving Patient #1 close to the nurse station as another intervention to prevent falls, but the staff failed to implement this intervention as Patient #1 remained in the same room, which is not visible from the nurse station.

- Observation of Patient #2, #3, #35, and #36 on 07/07/11 at 12:20 p.m., while the patients rested in bed, identified two elevated half rails on the beds. Review of Patient #2, #3, #35, and #36's active medical records occurred on 07/07/11. Record review on each patient showed two elevated side rails for patient safety. Patient #2, #3, #35, and #36's records lacked an individualized assessment of risk and safety for use of side rails, and lacked evidence of patient or responsible party education regarding the hazards of side rail use. The CAH staff failed to consider the side rails as a potential safety hazard for the patients.

During an interview on 07/07/11 at 2:30 p.m. an administrative nurse (#1) stated nursing staff elevate the side rails for patient security, positioning/mobility, access to bed controls/call light, and per patient/family request. The nurse (#1) indicated confusion and safety as the reason for Patient #1's elevated side rails to prevent the patient from falling out of bed. The administrative nurse (#1) stated she provided education to nursing staff on side rail use, but mentioned the staff does not perform or document an assessment for risk factors or safety for utilization of side rails.

During an interview on 07/07/11 at 2:40 p.m., a nurse (#11) stated nursing staff does not perform an assessment of risk factors or safety for utilization of side rails. The nurse (#11) stated staff elevate the side rails for patient safety, positioning, and access to bed controls/call light. The nurse (#11) stated the CAH failed to consider the side rails a risk for safety and a potential hazard for entrapment for patients.

Completion of the onsite revisit lacked evidence the CAH corrected this issue. The CAH failed to decrease side rail use as nursing staff continued to utilize side rails as a means to prevent patients from falling out of bed without first performing an individualized risk assessment and providing education to the patient or responsible party on the hazards of side rail use. The CAH provided no further documentation or information to support staff recognized this noncompliance and implemented corrective action. Continued use of the side rails placed Patient #1 at risk of entrapment or injury.