HospitalInspections.org

Based on observation, review of facility policy, and staff interview, the Critical Access Hospital failed to ensure proper maintenance of 1 of 1 ice machine located in the kitchenette on the nursing unit. Failure to ensure the ice machine functioned properly, ensure cleaning occurred on a regular schedule, and prevent the development of corrosion has the potential to affect the health of patients consuming ice from the machine.

Findings include:

Review of the facility policy titled "Cleaning Ice Machines" occurred on the morning of 08/03/11. The policy, dated 11/08/04, stated, "Purpose: To maintain the ice machines in proper working order. Procedure:
A. Vend all the ice from the machine. . . .
C. Remove panels.
1. Remove the front panel from the unit in the kitchenette. . . .
F. Vacuum and clean scale buildup from the machines.
G. Mix ice machine cleaner per recommendations on the cleaner container, and pour it into the reservoir. . . .
H. Start the machine and pour the balance of the cleaning solution into the reservoir. Let it circulate for 20 minutes.
I. Drain the unit and vacuum the solution out. . . .
N. Replace all panels and make sure the unit is working properly.
You may need to flush several gallons of water through the unit to clean it properly. . . ."

- On the morning of 08/03/11, observation of the Scotsman ice machine located in the kitchenette on the nursing unit occurred with a supervisory maintenance staff member (#4). The ice machine showed evidence of thick, heavy corrosion, and some rust, where the removable top panels (one front and two sides) join the lower half of the ice machine. Observation showed evidence of water streaks along the lower outside exposed left wall and a brownish discoloration inside the plastic ice hopper (used to dispense ice from the ice machine).

During interview the morning of 08/03/11, a staff member (#4) stated the ice machine was over 20 years old and the local water created the above problem. The staff member stated the rust occurred due to water leaking over the top of the ice machine when the machine clogs up. The staff member reported changing a filter for the ice machine and cleaning the ice machine on an every six week basis and checking the ice machine daily. The staff member stated the facility had not ever de-scaled the plastic ice hopper device, but could do that.

During interview on the afternoon of 08/13/11, a staff member (#4) identified the facility did not keep a record of the cleaning of the Scotsman ice machine.

1. Based on observation, professional literature review, policy and procedure review, record review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the safe use of side rails, assess each patient individually prior to utilizing side rails, and provide education to the patient and the responsible party regarding the hazards of side rail use for 4 of 4 active swing bed patients (Patient #1, #2, #3, and #4) observed with elevated side rails; and failed to recognize the risks associated with falls and implement appropriate interventions to manage or prevent falls for 1 of 4 active swing bed patient (Patient #2) who experienced five falls in two months. Failure to evaluate and assess 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, and #4 at risk of entrapment or injury. Failure to recognize the risks associated with falls and take action to manage or prevent falls caused an unsafe environment for Patient #2 and had the potential to cause the patient harm should the patient fall and experience an 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. FDA received approximately 691 entrapment reports over a period of 21 years . . . These entrapment events have occurred in openings within the bed rails . . . under bed rails, between split rails . . . The most vulnerable to entrapment are elderly patients and residents, especially those who are frail, confused, restless, or who have uncontrolled body movement. 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 current IEC [International Electrotechnical Commission] standard recognizes that the . . . rails are the major elements involved in entrapment . . . 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. . . . This guidance describes seven zones in the hospital bed system where there is a potential for patient entrapment. Entrapment may occur in flat or articulated bed positions, with the rails fully raised or in intermediate positions. . . . FDA is recommending dimensional limits for zones 1 through 4 at this time because . . . the majority of the entrapments . . . have occurred in these zones. . . . Zone 1 is any open space within the perimeter of the rail. Openings in the rail should be small enough to prevent the head from entering. . . . The HBSW and IEC recommend that the space be less than . . . 4 3/4 inches . . . FDA is recommending a measure of less than . . . 4 3/4 inches as the dimensional limit for any open space within the perimeter of a rail. Zone 2 . . . This space is the gap under the rail between a mattress . . . Preventing the head from entering under the rail would most likely prevent neck entrapment in this space. FDA recommends that this space be small enough to prevent head entrapment, less than . . . 4 3/4 inches. IEC recommends the same dimensions . . . Zone 3 . . . This area is the space between the inside surface of the rail and the mattress compressed by the weight of a patient's head. The space should be small enough to prevent head entrapment . . . HBSW and IEC recommend a dimension of less than . . . 4 3/4 inches because the head is presumed to enter the space before the neck. FDA is recommending a dimensional limit of less than . . . 4 3/4 inches for the area between the inside surface of the rail and the compressed mattress. Zone 4 . . . This space is the gap that forms between the mattress compressed by the patient, and the lowermost portion of the rail, at the end of a rail. . . . The space poses a risk for entrapment of a patient's neck. . . . the IEC . . . recommends a dimensional limit of less than . . . 2 3/8 inches measured between the mattress support platform and the lowest portion of the rail at the rail end to prevent neck entrapment. . . . FDA recommends that the dimensional limit for this space also be less than . . . 2 3/8 inches. . . ."

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: National surveys of patient deaths occurring in the bed environment demonstrate the risk of entrapment . . . when the patient becomes entrapped in the bed rail . . . 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. . . . Bed Rail Safety Guidelines: If it is determined that bed rails are required and that other environmental or treatment considerations may not meet the individual patient's assessed needs, or have been tried and were unsuccessful in meeting the patient's assessed needs, then close attention must be given to the design of the rails . . . 1. The bars within the bed rails should be closely spaced to prevent a patient's head from passing through the openings and becoming entrapped. . . . 9. Maintenance and monitoring of the bed . . . should be ongoing."

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 "Safety Policies for Residents" occurred on 08/03/11. This policy, undated, stated, "I. PURPOSE: The following precautions are recommended to provide for the safety of residents in our facility. . . . B. SIDE RAILS: 1. Half side rails may be in the 'up' position, thus enhancing resident independence and mobility. . . ."

Review of the policy "Identifying Patients At Risk For Falls" occurred on 08/03/11. This policy, undated, stated, "POLICY: All patients will be assessed for risk for falls on admission and prn [as needed] as circumstances indicate. PURPOSE: To provide a safe environment for hospitalized patients (Acute and Swing Bed) . . . PROCEDURE: 1. Patients will be assessed on admission . . . 3. If determined to be 'At Risk' Initiate Falls Precautions . . . Instruct patient/family in precautions Provide appropriate intervention Note 'At Risk for Falls' on Kardex . . ."

Review of the policy "Falls Precaution Program" occurred on 08/03/11. This policy, undated, stated, "PURPOSE: To recognize potential risk factors for falls upon admission and throughout the hospital stay in order to minimize the potential for injury or to prevent injury to the patient that may occur should he/she fall. . . . PROCEDURE: A. Upon admission, assess patient's candidacy for the Fall Prevention Program . . . C. If patient is 'At Risk', 1. Begin the Falls protocol . . . 2. Nurse may use judgement as to whether to implement usual safety precautions or to secure an order for a Physical Therapy assessment. If patient is placed on usual precautions but does experience a fall, a Physical Therapy assessment should be requested (Must secure an order) . . . 4. Educate family on the Falls Prevention Program if patient/resident unable to comprehend falls protocol. D. Documentation 1. Document which precautions are taken on the Falls Precaution and/or Restraint Flow sheet. . . . 3. Also document in the same manner on the care plans. . . . 4. The flow sheet and care plan must be reviewed each shift. . . ."

Observation of the beds utilized on the nursing unit occurred on August 1-2, 2011. The beds utilized by the current swing bed patients all had four half rails, two half rails on each side, attached to the beds. Measurements of one type of bed, located specifically in Patient #1's room identified 5 1/2 to 7 1/2 inch open spaces within the rails of the top half rail and 7 1/2 to 9 inch open spaces within the rails of the bottom half rail. Measurements of another bed, located specifically in Patient #2's room identified the same open spaces within the rails. A nursing staff member (#2) stated all of the beds in the CAH are the same.

- Review of Patient #1's active medical record occurred on August 2-3, 2011, and identified the CAH admitted the patient on 01/29/10 with diagnosis of vascular dementia. Patient #1 sustained a right sided stroke, resulting in left sided weakness, while in a long term care facility prior to admission to the CAH. Review of Patient #1's admission History and Physical (H&P), dated 01/29/10, identified medications including Ativan (an anxiolytic, used to manage or treat anxiety) 0.5 milligrams (mg) daily at 5:00 p.m. and Ativan 1 mg every four hours as needed for anxiety. The H&P revealed Patient #1's physician performed a limited review of systems due to the patient's intermittent confusion and inability to respond to questions appropriately at times.

Patient #1's nursing assessment, dated 01/29/10, indicated the patient as alert, appropriate, pleasant, and "semi-confused." The assessment identified Patient #1 as paralyzed on the left side, requiring extensive assistance with bed mobility and transferring, and total dependence for toileting and locomotion. In the Safety/Falls section of the assessment, documentation showed staff indicated "unknown" as to whether Patient #1 used the call light appropriately or had a recent fall history. The assessment identified Patient #1 at risk for falls.

Patient #1's Nurses Notes stated the following:
*03/08/10 at 8:50 p.m.: "Pt [patient] turned call light on, laying in bed, uncovered, trying to move legs to side of bed, states 'I want to get up and walk in my room.' . . ."
*03/16/10 at 8:30 p.m.: "Pt aggitated [sic], wanted to 'walk in room' . . ."
*05/15/10 at 2:45 p.m.: "Pt very agitated. . . . Tried to climb out of bed. . . ."
*05/25/10 at 3:00 p.m.: Pt very agitated. Trying to get out of w/c [wheelchair]. . . . Put to bed . . . Pt tried to climb out of bed. . . ."
*09/24/10 at 2:00 a.m.: "Pt restless [and] anxious cannot sleep. Pt wants to get up for the day. . . ."
*10/07/10 at 10:55 p.m.: "Pt using light . . . sometimes does not know why she put the light on . . ."
*10/08/10 at 8:40 p.m.: "Pt using call light . . . wanting to get up for the day . . ."
10/11/10 at 8:05 p.m.: "Versertex [sic - a type of bed/chair alarm] alarming, CNA [Certified Nurses Aide] told by pt she 'wanted to see how long it would take someone to answer'."
At 8:20 p.m.: "Call light on, pt attempting to get out of bed . . ."
*10/14/10 at 11:25 p.m.: ". . . pt states 'I can't sleep' requesting to get out of bed . . . unable to re-orientate to time."
*10/21/10 at 8:35 p.m.: "Pt using call light every 5-10 minutes, trying to get out of bed, confused about time of day. . . ."
*10/23/10 at 7:30-11:30 p.m.: "Restless pm [evening]. Pt used call light every 5-10 min. . . . wanting to 'get up . . ."
*12/18/10, late entry at 7:00 a.m.: "yelling and confusion continued throughout night."
*01/11/11 at 7:49 p.m.: "Pt calling out [and] using call light freq [frequently]. Attempting to get out of bed. . . ."
*01/25/11 at 7:33 p.m.: "Repeatedly calling for help, trying to get OOB [out of bed] . . ."
*05/10/11 at 9:06 a.m.: " . . . decision making is impaired . . ."
*05/15/11 at 3:41 p.m.: ". . . Not oriented to time and place. . . . "
*06/07/11 at 10:10 p.m.: "Calling out, bed alarm sounding . . ."
*07/31/11 at 6:31 p.m.: "1000 [10:00] a.m. patient is very agitated. hollering out . . . Tried to re-orient patient to no avail . . ."

Patient #1's MAR (Medication Administration Record) identified the patient received prn (as needed) doses of lorazepam (Ativan) daily for agitation/restlessness multiple times from 01/31/10 through May 2011 in addition to the daily scheduled doses of lorazepam. The MAR also revealed Patient #1 received prn Haldol (an antipsychotic, used to manage psychotic disorders/behaviors) several times from 06/07/11 to 07/31/11.

Patient #1's Physician Progress Notes stated the following:
*04/07/10: ". . . She has been noted to be a fall risk and appropriate fall precautions have been instituted. . . ."
*11/10/10: ". . . She is mostly confused . . . She has had some episodes of agitation . . ."
*02/02/11: ". . . She is presently confused . . ."
*04/06/11: ". . . She has been having some episodes of agitation . . ."
*05/04/11: ". . . is mostly inappropriate . . . She had been having some behavioral problems . . . Mental status is at baseline. . . ."
*07/06/11: "Patient does have vascular dementia, advanced . . ."

Patient #1's Patient Information Sheet/Physician Visits (used by nursing staff for providers to review when rounding on patients) revealed the following:
*04/07/10: ". . . Pt is a fall risk. . . ."
*01/05/11: ". . . behavior/hallucination problem"
*04/06/11: ". . . had 48 hr. [hour] period of time this weekend when she did [not] sleep [at] all, so she had some behavior issues. . . .4/5/11 again having behavior issues, climbing out of bed . . . very restless . . ."
*05/04/11: ". . . had behavior problems . . ."
*07/06/11: ". . . behavior/anxiety problem on 6-7-11 during the NOC [night]."

Patient #1's Weekly Charting forms, from 02/05/10 to 02/22/11, identified the patient's cognitive skills for daily decision making as moderately impaired ("decisions poor, cues/supervision needed"), and indicated problems with memory. Observation of Patient #1 on all days of survey, while the patient rested in bed, identified two elevated upper half rails on the bed. Observation on the morning of 08/02/11, while Patient #1 rested in bed, showed the bed in the low position. Location of the nurse station from Patient #1's room, showed the station down the hall about 50 feet to the north, not visible from the room.

Patient #1's record 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. Given Patient #1's history of confusion, impaired cognitive skills and memory, agitation/restlessness, scheduled and prn anxiolytic and antipsychotic medications, left sided weakness, and attempts to get up out of bed by herself, the CAH staff failed to consider the elevated side rails a safety and entrapment hazard for Patient #1.

- Review of Patient #2's active medical record occurred on August 2-3, 2011, and identified the CAH admitted the patient for rehabilitation on 07/10/09 with diagnoses of confusion, altered mental status, and weakness/deconditioning. The record review showed Patient #2 fell multiple times in her living environment prior to admission to the CAH. Upon admission, the record identified Patient #2's activity level as "up as tolerated with walker" and showed no risk for falls.

Patient #2's Nurses Notes and Progress Notes stated the following:
*12/02/10 at 4:50 a.m.: "Nurse alerted by CNA that pt had fallen. Pt. found in BR [bathroom] on floor, states 'I was by my bed and I fell' then 'I crawled to the BR because I couldn't get the light out there.' . . . Approx [approximately] 2 cm [centimeter] cut to [right] forehead. Area of purple forming to [right] eye lid. Various eccy [ecchymotic] areas to [right] arm and shoulder. C/O [Complains Of] stiffness to [right] shoulder/arm . . ."
*12/03/10 at 7:00 a.m.: "eccymotic [sic] area around Rt. [right] eye. . . . Rt shoulder [arrow up] arm tender [with] movement . . ."
*05/26/11 at 12:25 a.m.: "Pt. uses call light to notify staff that she had fallen at approximately 2230 [10:30 p.m.] on 05/25/2011. Pt. states that she was coming out of bathroom . . . felt that her knee was going to 'give out' . . . so she sat on the floor. . . . she then crawled to her chair and took a pillow and fell asleep on the floor for . . . 2 hours. At this time pt. awoke and crawled to the side of bed and used call light. . . ."
*07/15/11 at 6:21 p.m.: "0830 [8:30 a.m.], Patient reports feeling 'funny' and somewhat 'Dizzy', advised to call for assistance when getting out of bed 1220 [12:20 p.m.] - patient found sitting on floor by CNA, states she 'sat down because I felt dizzy' . . . reminded to call for assistance when needing to get out of bed"
*07/16/11 at 12:45 p.m.: "Patient was found by CNA lying on her back on the floor between recliner and bed. Patient states ' I was walking to my bed, everything was whirling and I fell back and hit my head. My legs have been giving out on me. I could not reach my call light' . . . Patient encouraged to use call light for assistance. Call light within reach. . . ."
*07/16/11 at 2:10 p.m.: "Vicodin [used to treat or manage pain] 1 tab [tablet] . . . given per patient request for shoulder and arm 'stiffness from fall.' . . ."
*07/18/11 at 6:12 p.m.: ". . . low BP [blood pressure]. . . . States feels dizzy when up. States did get up to BR per self. . . ."
*07/21/11 at 9:45 a.m.: ". . . Patient reports 'dizziness' with repositioning. Patient encouraged to use call light for assistance. . . ."
*07/23/11 at 7:40 a.m.: "Patient states 'I am so dizzy'. . . . Patient encouraged to use call light for assistance. Call light in reach."
*07/24/11 at 7:45 a.m.: "Pt. confused states 'This looks like my room but i don't think it is, Did u [you] come downstairs to see me.' reoriented patient"
*07/25/11 at 6:00 p.m.: ". . . pt. needs reminders to ask for assist when up in bathroom to ambulate back to chair. . . ."
07/26/11 at 10:46 a.m.: "Patient is very confused today . . ."
07/29/11 at 6:28 p.m.: "has been sleepy today, has ambulated to bathroom per self . . . encouraged pt. to ask for assist. [assistance] if she feels weak when she stands. . . ."

Patient #2's Physician Progress Notes stated the following:
*01/05/11: ". . . She did have bruising due to a fall . . ."
*07/01/11: ". . . She did have a fall and has had persistent right knee pain and some swelling since. . . ."
*07/19/11: ". . . She has been having blood pressure readings as low as 88/47. Heart rates have also been in the 40s. Patient has had dizziness since I put her on the oxybutynin [used to treat overactive bladder]. . . . She fell twice over the weekend and got a bruise at the back of her head. . . . She had been on Neurontin [used to treat pain] which was discontinued due to some altered mental status and gait instability. . . ."
*07/27/11: . . . Her heart rate has improved. Nursing staff have noticed some confusion . . . She has been complaining of some orthostatic lightheadedness, no vertigo. . . ."

A facility incident report, dated 05/26/11 (fall occurred 05/25/11 at 10:30 p.m.), identified Patient #2 notified staff she fell in the bathroom while getting ready for bed. The patient stated her knee gave out and she sat on the floor as not to fall, but continued to sit on the floor for two hours before alerting staff about the incident. The report showed, prior to the fall, staff identified Patient #2 as a mild fall risk with a mobility status of up with assistance, implemented frequent checks, elevated one side rail, and placed the call light within reach. As indicated in the report for action and follow-up measures, reinforcement provided to CNA and nursing staff on checking patient's frequently.

A second facility incident report, dated 06/12/11 (fall occurred 06/12/11 at 11:20 p.m.), identified staff found Patient #2 on the floor during rounds. The patient stated she slipped out of the chair. The report showed, prior to the fall staff identified Patient #2 as a high fall risk with a mobility status of up with assistance of rolling walker, implemented frequent checks, elevated two side rails, and placed the call light within reach. The report lacked action and follow-up measures.

A third facility incident report, dated 07/15/11 (fall occurred 07/15/11 at 12:20 p.m.), identified staff found Patient #2 on the floor. The patient stated she sat on the floor because she felt funny and became dizzy. The report showed prior to the fall, staff identified Patient #2 as a moderate fall risk with an unlimited mobility status and muscle strength deficiency, implemented frequent checks and use of assistive devices, elevated two side rails, and placed the call light within reach. As indicated in the report for action and follow-up measures, staff were notified to implement bed and chair alarms and to encourage use of the call light.

A fourth facility incident report, dated 07/16/11 (fall occurred 07/16/11 at 12:45 p.m.), identified staff found Patient #2 on the floor between a recliner and the bed. The patient stated everything whirled as she walked to her bed, stating her legs gave out on her. The report showed prior to the fall, staff identified Patient #2 as a high fall risk with a mobility status of muscle strength deficiency, implemented frequent checks, used assistive devices, elevated two side rails, and placed the call light within reach. As indicated in the report for action and follow-up measures, staff were encouraged to use alarms. Review of an Initial Post Fall Assessment, dated 07/16/11 at 3:05 p.m., lacked the interventions of a versetex, chair alarm, or bed alarm prior to and after the fall.

Review of documentation from physical therapy, dated 06/01/11, stated, "Fall reported by nursing 5-25-11. Pt was found on the floor beside her bed. Cautioned her to use call light for assistance.", on 06/15/11 stated, "Fall reported by nursing 6-12-11. Cautioned pt. to use call light if she needs assistance.", and on 07/20/11 stated, "Falls reported by nursing 7-15-11 and 7-11-11. Pt states she was walking and just started feeling 'whirly.' Reminded pt to get assistance if needed for transfers and amb [ambulation]." Further documentation, dated 08/01/11, stated, "Fall reported by Nursing 7-29-11. Pt c/o leg pain and a giving out sensation in legs while ambulating. Started Pt on Funct [Functional] Maint [Maintenance] Program for balance and gait activities." The record lacked any further documentation re

Based on observation, record review, review of medical staff meeting minutes, review of Quality Improvement (QI) committee meeting minutes, facility policy, and staff interview, the Critical Access Hospital (CAH) failed to consider the Quality Improvement/Peer Review Plan and take corrective action as part of the Quality Improvement program for 1 of 1 year reviewed (August 2010 - July 2011). Failure to take corrective action for deficiencies found through the QI program puts the facility at risk of providing inappropriate care to patients, specifically patients at risk for elopement and at risk of scalding from hot coffee served on the nursing unit.

Findings include:

Review of the policy titled "QUALITY IMPROVEMENT/PEER REVIEW PLAN," occurred on August 02-03, 2011. This policy, revised 02/07, stated:
"ELEMENTS OF THE QUALITY IMPROVEMENT/PEER REVIEW PROCESS . . .
6. Whenever opportunities for improvement of patient care/departmental services are identified, the following will be required:
a. ACTION - Once an opportunity for improvement is identified the first step is to determine appropriate action.
b. MONITOR - After action is implemented, continue to monitor the opportunity for improvement to assure that the action is having the desired effect.
c. DOCUMENT - It is essential to maintain proper documentation of the QI /Peer Review process.
d. COMMUNICATE - Findings from any monitors as well as all other opportunities for improvement that are identified within the department must be reported, as designated, to the Central QI/Peer Review Committee.
7. The department plan must identify responsibilities for the QI/Peer Review process. . . ."

The plan defined the responsibility of the QI/Peer Review Committee as:
"1. Review departmental QI/Peer Review activities on a routine basis and provide follow-up and guidance as needed to assure compliance with facility requirements.
2. Make appropriate recommendations for corrective actions to be taken. . . .
5. Monitor Medical Staff compliance with quality improvement/peer review requirements and assist the Medical Staff in the development of monitor systems.
6. Review any submitted opportunities for improvement and assist in the identification of opportunities for improvement of facility services.
7. Assign opportunities for improvement when they involve two or more departments. . . ."

- Review of Medical Staff meeting minutes for the past twelve months (August 2010 through July 2011) occurred on the afternoon of 08/01/11. The meeting minutes identified the following occurrences:
* September 22, 2010: " . . . COMMUNICATIONS: . . . recent elopement and were in communication with family members. A change will be made to the nursing initial assessment form to include assessment of patient's risk of elopement/wandering. . . ."
* October 19, 2010: ". . . Business . . . Recent case of patient elopement and the risk to the patient was discussed. [Director of Nursing-DON] stated nursing does complete a falls risk assessment during their initial assessment and an elopement risk could be done at the same time. She will add this to the initial assessment form. . . . Occurrence Reports from the month of August 2010 . . . Category-Other . . . Elopement: patient left facility without the knowledge of the nursing staff, engaged the community cab and returned to own home. Family contacted hospital stating patient was at home. No injuries/harm occurred to patient. . . ."

Review of QI Committee meeting minutes occurred on the afternoon of 08/02/11. The meeting minutes identified the following:
* September 14, 2010: ". . . New Business . . . Patient elopement: [administrator] brought to discussion the occurrence involving the recent patient elopement and questioned why a wanderguard had not been placed when the patient was admitted. In the discussion which followed, [DON] stated nursing staff does a falls assessment at the time of their initial assessment and this could be adapted to include risk of elopement. . . . Occurrence Reports: . . . from the month of August 2010 . . . Elopement: patient left facility without the knowledge of the nursing staff, engaged the community cab and returned to own home. Family contacted hospital stating patient was at home. No injuries/harm occurred to patient."

On 08/02/11 at 2:20 p.m., an administrative staff nurse (#1) stated the facility did not add a "risk of elopement" assessment to the "falls assessment at the time of their initial assessment" as recommended at Medical Staff and QI Committee meetings in response to the elopement. The staff nurse stated the facility did not develop an elopement risk assessment or elopement policy since the above occurrence. The staff member provided a copy of the facility "Wanderguard Signaling Device" and bracelet system for wandering patients on the nursing unit.

Review of the closed record of Patient #9 identified the facility admitted Patient #9 on August 18, 2010 and discharged him on 08/20/10. The discharge diagnoses included hematuria, urinary incontinence, status post bladder resection surgery, and Alzheimer's dementia. The discharge summary stated, "The patient is an 89-year-old . . . wife had difficulty looking after the patient due to his dementia and incontinence. Therefore, patient was admitted to swingbed . . . On 08-20-10 patient left the facility via Cap Cab. Family decided to keep the patient home since they were planning to take him home the next day." Review of Patient #9's swingbed nursing assessment, completed on 08/18/10, identified the patient as alert and oriented to person and place, and not always to time; with short term memory loss, pleasant mood/behavior, able to understand, and be understood, walks with a walker, gets up to the bathroom by himself, with no recent fall history and and not at risk for falls.

Patient #9's nurse's notes stated the following:
* 08/18/10 at 4:00 p.m.: ". . . admit . . . wife states increasingly difficult to care for pt. [Patient] @ [at] home . . . has been incontinent . . . has hx [history] dementia - ambulates per self [with] cane/and or walker gait steady no hx of falls @ home - needs frequent redirection - short term memory very poor."
* 08/19/10 at 6:30 a.m.: "Pt awake since 0515 [5:15 a.m.]. Pt confused - oriented to self. Pt. questions wife's whereabouts. Pt out in hall per self. Pt. redirected to room. Pt. on call light repeatedly to question about wife."
* 08/19/10 from 7:00 a.m. to 7:00 p.m. "Confused to time/place . . . Ambulates [with] walker/self @ steady pace."
* 08/20/10 at 1:00 - 1:15 p.m.: "Received phone call from [family member] that [Patient] had arrived home via Cap Cab. . . ."

- On the morning of 08/02/11, an interview occurred with a facility staff nurse (#2) who stated the facility currently had no wandering patients.

Observation of the nursing unit on the afternoon of 08/02/11 identified the wanderguard alarm system located next to the stairways in the north and central stairways, and next to the elevator, limiting exiting capability for those patients assessed for wandering and for whom facility staff utilized wanderguard bracelets. Observation identified the nursing unit with three other stairways: a west stairway (past cardiac rehab), an east stairway, and south stairway; each with a push button exit access leading down a steep staircase, with no wanderguard signaling device. On the afternoon of 08/02/11, an administrative staff member (#6) identified the facility had 13 long term swingbed patients, all residing on the east and south corridors (without the wanderguard signal device).

On the morning of 08/03/11, an administrative staff nurse (#1) provided a copy of the facility "POLICY REGARDING A RESIDENT MISSING FROM UNIT." The policy addressed steps for staff to take once facility staff identified a missing patient.

The facility failed to develop an elopement prevention policy and procedure, including an assessment process to identify patients at risk of elopement, and a comprehensive staff training program following Patient #9's elopement. Failure to take appropriate corrective action for patients with risk factors for elopement places these patients at risk for serious harm.

- Review of Medical Staff meeting minutes for the past twelve months (August 2010 through July 2011) occurred on the afternoon of 08/01/11. The meeting minutes identified the following occurrences:
* April 24, 2011: ". . . Occurrence Reports . . . Other/Safety: patient spilled hot coffee onto her lap. Severity of injury level as a 5 - event reached patient and caused minor/temporary harm. . . ."
* July 26, 2011: ". . . Occurrence Reports . . . Other: patient scaled [sic] by hot coffee. Patient had been given 1/2 cup of hot coffee, started laughing and spilled the coffee on herself. Severity of injury-5, minor temporary injury."

Review of Quality Improvement Committee meeting minutes occurred on the afternoon of 08/02/11. The meeting minutes identified the following:
* March 29, 2011: ". . . Occurrence Reports: . . . from the month of February 2011 . . . Other/Safety: Patient dropped coffee cup onto her lap. Patient's clothing was immediately removed and ice was applied to burn areas. Severity of injury level was reported as 5 - reached patient and caused temporary/minor harm." Review of the occurrence report identified the incident occurred at 11:25 a.m. on 02/04/11 in the dining/activity room and "ice pack applied for 15 mins [minutes] to both inner thighs."
* June 23, 2011: ". . . Occurrence Reports: . . . reported in the month of May 2011 . . . Other: patient scaled [sic] by hot coffee. Patient had been given 1/2 cup of hot coffee, started laughing and spilled the coffee on herself. Severity of injury-5, minor temporary injury." Review of the occurrence report identified the incident occurred at 9:30 a.m. on 05/19/11 in the patient's room and "Inner thigh red. Had ice pack changed and applied all shift. No redness noted at end of shift." The Supervisory follow-up noted that a ". . . blister like area on back of thigh was noted 2 days later. Instructed staff to monitor area daily. Notify provider as needed. [name of provider] notified."

A review of the severity codes utilized for the QI program occurred on the afternoon of 08/03/11. The codes defined a Category 5 occurrence as "An event that may have contributed to or resulted in temporary harm and required intervention." The code defined examples as "Falls with abrasion, bumps, scratches, bruises . . . Injury of any kind. . . ."

Review of Fire, Safety and Disaster (committee as a whole) Committee meeting minutes from September 2010 through July 2011 occurred on the afternoon of 08/02/11. The meeting minutes lacked evidence of any discussion regarding the patient burns which occurred in February and May 2011.

Review of the CAH's census information on 08/01/11 at 1:00 p.m., identified the CAH admitted Patient #24, in August 2008 with diagnoses including malaise/fatigue and general muscle weakness. Patient #24 sustained the hot coffee burn in February 2011. The CAH admitted Patient #25, in March 2010 with diagnoses including peripheral vascular disease. Patient #25 sustained the hot coffee burn in May 2011.

During an interview on 08/02/11 at 8:30 a.m., a staff nurse (#2) stated dietary staff deliver meal trays at the following times: breakfast between 7:30 to 8:00 a.m.; lunch at 12:00 p.m.; and dinner at 5:30 p.m. The staff nurse (#2) stated nursing staff obtain coffee from the coffee maker in the kitchenette for patients on the nursing floor between meals.

Observation on 08/02/11 at 8:35 a.m., showed a nursing staff member (#7) entered the kitchenette, retrieved a half cup of coffee directly from an automated coffee machine, and delivered the cup of coffee to Patient #25 in her room, leaving the patient alone in her room to drink the coffee.

During an interview on 08/02/11 at 11:45 a.m., a dietary staff member (#8) stated dietary staff filled a coffee carafe with coffee from an automated coffee machine in the staff/visitor cafeteria, placed the carafe on the food cart with patient trays at meal time, and sent the cart up to the nursing floor. The staff member (#8) stated once the food cart arrived on the nursing floor, nursing staff poured the coffee and delivered the coffee to the patients in the dining room or personal room with their meal tray, and confirmed dietary staff do not check the temperature of the coffee prior to sending the coffee up to the nursing floor. The dietary staff member (#8) stated CAH administration did not inform her of any patient incidents involving hot coffee.

During a tour of the kitchenette on the nursing floor with a dietary staff member (#8) on 08/02/11 at 11:50 a.m., observation showed an automated coffee machine, from which the staff member (#8) obtained a cup of coffee. The temperature reading of the coffee ranged from 165 to 167 degrees Farenheit (F).

Observation on 08/02/11 at 12:05 p.m., showed the food cart delivered to the nursing floor with two coffee carafes setting on top of the cart. A nursing staff member (#2) poured coffee into a cup from the carafe. The temperature reading of the coffee ranged from 150 to 155 degrees F.

During an interview on 08/02/11 at 12:05 p.m., a staff nurse (#2) confirmed staff do not check coffee temperatures prior to passing the coffee to the patients at meals or in between meals

During an interview on the morning of 08/03/11, an administrative staff member (#4) of the safety committee stated he was unaware of the patient burns that occurred in February and May and stated he chaired the safety committee.

During an interview on the afternoon of 08/03/11, an administrative staff member of the QI committee (#5) stated she would expect corrective action for the hot coffee spills to come from the department where it originated from for the action plan and stated recommendations can come from the committee.

Failure to take corrective action to prevent burns to patients served hot coffee on the nursing unit places all patients at risk for additional harm.