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Based on observation, information received from the complainant, review of facility policies/procedures, review of professional standards, review of facility grievance files, review of information provided the patient upon admission, review of variance reports, record review, and staff interview, during the complaint investigation completed on 09/01/10 and the full recertification survey completed 10/21/10, the hospital failed to establish and implement a process for prompt resolution of patient grievances (Refer to A118, A119, A122, and A123); failed to inform the patient's representative of injuries sustained and restraints used (Refer to A131); failed to provide a safe setting on the inpatient mental health unit (Refer to A144); failed to implement existing policies/procedures and failed to investigate potential abuse circumstances (Refer to A145); failed to ensure the use of restraints and/or seclusion occurred only when staff determined less restrictive interventions were ineffective (Refer to A164); failed to ensure the use of restraints and/or seclusion occurred only in accordance with the order of a physician or other licensed independent practitioner (LIP) responsible for the care of the patient (Refer to A168); failed to ensure a physician or LIP renewed orders for restraints and seclusion (Refer to A171); and failed to provide continuous monitoring of patients simultaneously secluded and physically restrained (Refer to A183).

Failure to ensure a system for grievance resolution and appropriate use of restraints and/or seclusion did not protect or promote patients' rights.

13246

Based on information received from the complainant, review of facility policies/procedures, review of facility grievance files, record review, and staff interview, the facility failed to establish and implement a process for prompt resolution of patient grievances for 3 of 3 patient grievances (Patient #11, #14, and #15) reviewed during the complaint investigation completed 09/01/10 and 6 of 7 patient grievances (Patient #63, #64, #65, #67, #68, and #103) reviewed during the full recertification survey completed 10/21/10. Failure to promptly investigate and resolve grievances and failure to provide written notification to the complainant regarding the results of the investigation has the potential for issues affecting the quality of patient care to remain undetected and placed all patients at risk for harm, injury, and/or avoidable care related complications.

Findings include:

Reviewed on 08/30/10, the handbook "Patients Rights and Related Information," provided to patients at the time of admission, included: "Patient Rights & Responsibilities . . . Resolution of Complaints/Grievances. [the right ] To be informed of who to contact if you have complaints, . . . [the right] To information regarding [name of facility] mechanism for initiation, review and, when possible, the resolution of patient complaints within a reasonable time frame. The complaint/grievance is documented, investigated and acted on by the manager or designee in order to resolve the problem. Some complaints can be handled quickly at the time, . . . For those that require additional or extensive research and follow-up, initial contact regarding the resolution of the complaint/grievance should take place in seven business days. If the complaint is not resolved at this time, assurance is given that steps are being taken to resolve the complaint and a time for future contact is established. The hospital will attempt to resolve all complaints/grievances as soon as possible."

Review of the facility's policy "Grievance/Complaints/Complaints of Discrimination of Patients/Families" occurred on 08/30/10. This policy, approved by the governing board 04/02 and revised 07/08, stated, "Policy: 1. The Patient Rights and Related Information handbook reflects our patient's rights and responsibilities. It addresses the patient's right to express concerns to caregivers, management, or administration and the right to receive a prompt resolution, if possible. . . . 4. This policy recognizes that some 'routine' complaints are readily addressed and do not require extensive documentation, i.e., it is not necessary to complete a Variance Report. . . . Any employee hearing a complaint should: a. Identify whether he/she can address the complaint. b. Forward the complaint promptly to the department that can address it or notify a supervisor. c. Communicate to the patient what steps are being taken to resolve the complaint. The responding department should address the complaint immediately, if possible. It is the department's responsibility to keep the patient informed of progress being made to resolve the complaint. . . . 5. When the complaint/grievance is more complex or serious in nature, intensive fact-finding may be required to determine a response. Follow-up begins at the time and place the complaint/grievance is received. Contact will be made with the complainant within seven (7) business days for follow-up or further research. This contact will provide the name of the contact person and if the complaint is not resolved at this time, provide assurance that steps are being taken to resolve the complaint and a time frame for future contact. Once the grievance is resolved, written contact will be made with the complainant. This will include the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion. 6. The manager or designee use the Variance Report to record the grievance and the follow-up sheet for response steps taken. . . ."

- Information received from the complainant indicated the complainant's spouse (Patient #11) sustained significant bruising while a patient in the facility's mental health unit between admission on 04/20/10 and 04/22/10. On 04/22/10, the complainant saw his wife in the emergency room (ER) and observed Patient #11 with significant bruising to her left shoulder/breast/chest and breast area, both knees, her right hand and arm, back and left hip. The complainant indicated staff from the mental health unit called him the morning of 04/22/10 and informed him Patient #11 had "some bruising and suggested it might have happened elsewhere, and that the ambulance was taking her to ER and I need to come down ASAP [as soon as possible]. . . . and I was in shock when I seen her and the bruising that was on her body. . . ." In addition to the bruising, x-rays determined Patient #11 sustained a fracture to her left clavicle.

Reviewed on August 30 - September 1, 2010 and October 18 - 21, 2010, the facility's grievance files included the following:
* A variance report regarding Patient #11, dated 04/23/10 at 12:15 p.m., and issued by ICU (Intensive Care Unit) staff stated, "Pt's [patient's] husband [name] was concerned about the bruising that was on his wife while at Mental Health Unit. He explained that she was admitted to the Mental Health Unit on 4/20/10 and did not have a bruise on her and was readmitted to hospital on 4/22/10. When he came to the hospital he noticed she was full of bruises. He never received a call from staff at Mental Health Unit indicating there was any problems or that the patient had possibly fallen or gotten hurt. Husband upset that this happened. Also upset that glasses were broken and he was not notified."
The variance report included no further evidence of action taken in response to this identified allegation/concern.
* A variance report, dated 04/23/10 at 2 p.m., and issued by staff in the Mental Health Unit (3C) stated, "Received phone call from [name of ICU nurse]. Patient's husband verbalized dissatisfaction and concern re: [regarding] care his wife received on 3C. Patient had been discharged to ETC [Emergency Treatment Center], then admitted to ICU 4/22/10. Patient had severe bruising to left shoulder/chest area, was taken to x-ray, then had extremely dangerous behaviors on 4/22/10. I did personally speak pt's [sic] husband on 4/22/2010 prior to taking to x-ray. At the time, it was unknown to me how pt had sustained such bruising. After patient discharged, patient's chart reviewed by this writer. It had been noted on 4/21/2010 by [name of nurse] that patient had been exhibiting dangerous behaviors. (see attached note). Patient's family was not notified of incident. This writer, after speaking with [name of ICU nurse] did meet with Nursing staff re: incident and importance of notifying family of such incidents."
The attached nurse's notes included a note, dated 04/21/10 at 10:36 p.m., and described Patient #11 as "very anxious, delusional, confused, frantic, . . . and yelling that it was the end of the world and she needed to use the phone. . . . pt grabbed the phone . . . began to try ripping the phone from the wall. Two staff needed to pull phone away from pt. . . . Staff attempted to redirect pt. She the flopped to the ground and began rolling around. Pt resisted staff when they attempted to help her up. Pt was eventually taken to the quiet room by three staff and placed on bed. . . . Pt rolled around on the bed and then onto the floor. . . . Pt. continued to yell out through much of shift, rolling on the floor, banging on the door, refused all medications. Despite getting off the bed and rolling around and then kicking and hitting door, pt. refused to get up off floor. 2 staff had to assist pt. up to the bed. Pt. eventually did calm down and remained in bed and fell asleep at about 9 pm. Pts right hand middle finger appeared to be bruised." Patient #11's medical record, reviewed August 30-September 01, 2010, identified no bruising present at the time of admission and no evidence of bruising until this notation.
An attached nurse's note, dated 04/22/10 at 1:30 p.m., stated, "Pt spent the morning sitting in the gerichair in the quiet room. . . . She expressed excitement as staff entered her room throughout the morning, and requested that they stay longer and talk. She even thanked one staff member for getting so close to her and asked, 'Aren't you scared of me?' . . . Pt did complain of feeling stiff, and felt like maybe something might be broken, but was unable to describe details of her discomfort. Pt does have a large bruise to her left shoulder and bruising to her right hand. Pt was able to transfer herself from the gerichair to the bedside commode. . . ."
The variance report lacked evidence of an investigation of the cause/contributing factors resulting in the bruises Patient #11 experienced and addressed by the complainant, including: (1.) Review/investigation of the implementation of the facility's existing systems/processes for management/controlling extreme behavior and prevention of injury to the patient. (2.) Review/investigation of the manner in which staff intervened and physically moved Patient #11 in the above referenced notes. (3.) Investigation of the adequacy of monitoring of Patient #11 during the above described behavior and the adequacy, appropriateness, and timeliness of interventions implemented/used by staff. (4.) Investigation of contact with and adequate intervention by Patient #11's attending practitioner during the escalation and long duration of Patient #11's behavior. (5.) Investigation of the environment staff placed Patient #11 in (quiet room/seclusion room) and risk factors within the environment which may have contributed to the injuries sustained by the patient and/or placed the patient at increased risk for self-harm.
The variance report showed no evidence of communication of investigation results to the complainant.
* A variance report, dated 04/24/10 at 11 a.m., and completed by a supervisory nursing staff member (#8) stated, "[Patient #11's spouse] contacted me with a complaint he had about the care his wife received while on 3C . . . He stated he brought his wife to the ER [emergency room] on Tuesday April 20, 2010 because she had an increase in confusion at home and was becoming 'harder to handle.' He said the doctors referred her to 3C . . . He stated on Wednesday April 21, 2010 he got a call from the staff at 3C saying they had to move his wife to another room because she had a 'bad night.' He then stated he got a call on Thursday April 22, 2010 saying his wife is in the ER because they thought she was having possible seizures. The patient's husband then stated he noticed once his wife was transferred to the ICU [Intensive Care Unit] that she had multiple bruises throughout her body that were not there pre-admission to 3C. He was very upset and concerned with this finding. He stated to me the following: 'This is what I believed happened. I believe [Patient #11] was having one of her anxiety attacks at the psych unit and staff there didn't know how to handle it, so they put her in a room and she kicked and screamed and fell because she wasn't being watched. That's how she got all those bruises. . . .' He asked if I would look at her bruises and so he accompanied me to the room and waited behind the curtain while [name of another licensed nurse] and I checked her skin. She had bruises on her: bilateral knees (bluish green tint), left hip (purple in the center, fading around the outside), left clavicle from the front of her left shoulder to the back of her shoulder (a very large purple area, it was in an immobilizer), right upper arm towards the outside bicep area, right hand (purple), and scattered bruises on her right forearm that appeared to be faded bruises. She also had a faint bruise on, I believe her left forehead. . . ."
The variance report showed the facility had Patient #11's glasses repaired and returned to the patient. The variance report showed the licensed supervisory nursing staff member (#8) contacted various facility administrative and medical staff members and made them aware of the above referenced "situation." The variance report lacked evidence of an investigation into the cause/circumstances for the injuries Patient #11 sustained and no evidence of an investigation of the complainants alleged reason/cause for his wife's injuries.
The variance report showed the facility provided no communication with the complainant regarding the investigation of Patient #11's injuries and the conclusions/outcome.
* The grievance file showed Patient #11's spouse submitted his complaint/allegations to the State Board of Medical Examiners on 05/03/10, and the Board of Medical Examiners forwarded the information to the Division of Health Facilities on 05/05/10. The Division of Health Facilities, under their licensure authority, requested the medical record of Patient #11 from the facility on 05/11/10.
On 05/24/10, Patient #11's representative submitted his complaint/allegations to the facility's accrediting agency, who forwarded the letter received from the complainant to the facility on 05/24/10. The facility submitted a response to the accrediting agency and received a response on 07/08/10 indicating the accrediting agency would take no further action.
* The grievance file lacked evidence of any communication from the facility to the complainant in response to the grievance the complainant first identified to the facility on 04/23/10 and no evidence to support the facility's attempt or process used to resolve the complainant's issues with the care received by Patient #11 or the cause/reason for the injuries sustained.

During an interview on the morning of 08/31/10, administrative/management staff members (#1, #2, #3, #4, #5, and #6) indicated they had not provided Patient #11's representative with any written communication regarding an investigation of the complainant's concerns/allegations and, other than review of nursing notes in Patient #11's medical record, did not provide any additional information regarding investigation of the cause/reason/contributing factors resulting in Patient #11 fractured clavicle and significant bruising.

- A variance report, dated 05/05/10, stated the following, "Pt [Patient #14] came to . . . appt [appointment] 4/7. He stated his shins were 'scrubbed raw down to the bone' by the tech prepping him for stress test 4/5. 'I told him it hurt and he still kept on scrubbing' pt stated. Bilateral shins abraded (approximately 6 inches). Pt states surgery may have to be postponed 4/12 if area not healed. Wife very upset. 'This needs to be reported so it doesn't happen to someone else' she stated."

The variance report lacked evidence of any investigation of the complaint expressed by Patient #14. The variance report lacked evidence of any follow-up with Patient #14 in response to the complaint on 04/07/10, including acknowledgement of the patient's grievance, the name of the hospital contact person, steps taken to investigate the grievance, the results of the investigation, and the date of completion.

- A variance report, dated 04/30/10, included the following complaint/grievance from Patient #15: "Patient had a complaint about two night CNAs' [certified nurse assistants]. The patient felt the 2 were 'rough' with her. She said she feels she has been spoiled by all the good care she has been receiving from all the nurses, but felt these 2 'had an attitude' with her. She said every time she turned on her light it was like she was 'bothering them'. She gave 2 examples, one was 'the CNAs came in and told me I had to lie on my left side, I told them I couldn't lay on my left side because I have a bad left hip and they told me well you can't lay on your back forever so you have to lie on your left side.' The patient laid on her left side and said 'those two' never came back to turn her again after that. Another example she had was; she put her call light on to use the commode and they came in to help her, but when they got her out of bed they didn't put the side rail down. The patient said 'it's really no biggie, but it makes for getting back into bed easier because then when they got me back into bed I was all the way down to the foot of the bed. I was so low in bed that my feet were almost hanging off the end of the bed. They then left my head flat and didn't boost me up in bed so my head was on the pillow.' The patient said she would have turned on her call light, but she was too low in bed to reach it. So the patient tried to boost herself higher in bed. The patient had surgery on her left arm and has an external fixator on so it was difficult for her to boost herself in bed. When she reached her call light she asked them to help her up higher in bed. The patient then told me 'I asked those 2 girls when they were done with their shift and they said an hour and I told them good, I don't want to ever see you again.' She has requested they not come in to help her as they were 'rough and rude.' . . . "

The variance report showed no further investigation occurred to determine if a pattern existed in the manner the 2 CNAs provided care to patients and included no evidence of communication back to Patient #15. The variance report indicated two licensed nurses spoke to the 2 CNAs, however, no further investigation or action occurred to ensure these staff members did not jeopardize patient safety in the future.

During an interview the afternoon of 08/30/10, an administrative staff member (#1) provided no additional information regarding the investigation of Patient #14 and Patient #15's complaints and no evidence the facility had communicated the investigation results to the patients and resolved their complaints.

- A grievance report, dated 09/27/10, regarding care Patient #63 received in the emergency department stated, "Patient's wife states that they visited the Emergency Department twice during the prior week. Each time the patient was complaining of severe abdominal pain and draining from wounds. Wife states that she overheard people talking outside of patient's room, and picked up on the fact that the surgeon refused the admission of the patient. When this happened after the second ED [emergency department] visit, patient's wife drove him to [name of city with acute care facilities] where patient was admitted and taken immediately to surgery for abdominal abscesses. Wife has serious concerns about: 1. Feeling the ED physician was too passive; 2. Sent her home to perform dressing changes and care for wounds she is not qualified to care for; 3. Surgeon's refusal to admit her husband; 4. The urgency they saw when they went to [name of city where they sought medical treatment]; she feels her husband would have died had she not taken the initiative to take him to another facility."

The grievance report lacked evidence of investigation of all allegations identified by the complainant, investigation findings, written notification to the complainant informing her of the findings, and the name of a facility contact person in regard to further questions/concerns.

- A grievance, dated 09/08/10, regarding care received by Patient #64 stated, "Pt was brought to the ER yesterday. She was seen and tests done.
. . . they were told by the doctor she had not had a stroke . . . and were sent home. When they got home they called her primary caregiver . . . After listening to her symptoms and what had happened in the ER, [name of primary caregiver] told them to take her back to the ER . . . she [Patient #64] was admitted this time and a stroke was the diagnosis. Family is upset. . . . they want her case reviewed. 'We shouldn't have had to come back much less wait 5 hours to be admitted the second time.' They feel the first ER doctor didn't do an exam - 'He relied on the tests instead!' She also shares that when they came back to the ER the second time there was a very sick lady at the admitting desk. 'She didn't have any hair so she probably had cancer.' She was sitting in a wheelchair with her head on the counter asking, 'please let me lay down.' She was told there were no beds. Then she asked - 'let me lay on the floor' and was told no, she couldn't do that by the admit staff. I couldn't stand it, I found someone to help her. Here I am with my mother having a stroke having to help another patient. You need to look at your processes, it doesn't seem right.' She is also unhappy with the nurse [name]. . . . Family didn't feel we had enough staff or the right processes in place to help take care of those who came for help."

The grievance report showed facility staff met with the complainant on 09/09/10. The complainant addressed/reiterated her concerns regarding the care provided Patient #64 and made several requests of the facility for the continuum of care of Patient #64 and resolution of their complaint. The meeting concluded with the complainant's request of, "They [Patient #64's family] would like to hear back on the review and our decision about their requests before the end of the month."

The grievance file showed no further action/investigation and response to the complainant prior to a telephone call received from the complainant on 09/21/10 at 10:55 a.m. The complainant called the facility and indicated they had been trying to reach the facility's chief executive officer regarding Patient #64's pending discharge from rehabilitative services on 09/28/10 and wanted answers regarding the direction the facility intended for Patient #64's continued care, stating, she [the complainant] "feels we are forcing her to take her issues outside of our facility and she doesn't want to this . . . I'll pull out more guns if I have to, do you understand."

The grievance file showed facility administrative staff met with the complainant on 09/24/10 and reached agreement with the complainant on some of the requests made on 09/09/10, but not all.

The grievance file lacked evidence of investigation of the complainant's concerns including the allegation of inadequate staffing in the emergency room, insufficient available beds, and the complaint regarding the care received by medical and nursing staff members. The file showed letters written by the facility and sent to the physicians involved in the emergency room care of Patient #64, dated 10/21/10, after the surveyor requested information regarding the facility's investigative findings. The grievance file lacked evidence of a written response to the complainant regarding the findings of an investigation and the name of the person(s) the complainant could contact for further resolution if necessary/desired.

- A grievance, dated 09/09/10, identified the following family concerns regarding the care received by Patient #65: 1. The patient did not receive prescribed inhalers for four days. 2. The facility overhydrated Patient #65 resulting in complications. 3. Staff placed Patient #65 on NPO [nothing by mouth] for a procedure which was scheduled for a different patient. 4. Patient #65 developed skin breakdown due to a lack of adequate management of bowel incontinence. 5. Patient #65 experienced four falls on one day due to over medication. 6. Patient #65 did not receive adequate oral care. 7. Staff did not properly position Patient #65 with pillows between his knees.

The grievance file lacked evidence of investigation of the allegations identified by the complainant and lacked evidence of a written response to the complainant regarding the facility's investigation results and the name of the individual the complainant could contact regarding complaint investigation findings/resolution.

Review of facility variance reports occurred October 20-21, 2010. These reports lacked evidence of completed variance reports for falls the complainant alleged Patient #65 experienced. An interview with a facility quality improvement staff member (#7) occurred on the afternoon of 10/20/10 to request the facility's investigation or variance report regarding the alleged falls. The facility did not provide additional information or evidence of an investigation and determination regarding the validity of the allegation.

Failure to investigate and determine whether avoidable falls may have occurred without proper reporting and investigation placed Patient #65, as well as other patients, at risk for preventable falls and/or injury.

- A variance report, dated 07/24/10, included written complaints from Patient #67 regarding the "poor care received in the emergency room." The variance report included an attached letter dated August 25, 2010 (one month later) addressed to Patient #67 stating, "This letter is to let you know your letter and the comments you have shared with me verbally have been shared with Emergency Physician Management for review. I will let you know when the review is complete."

The grievance file lacked evidence of any further communication with Patient #67 including a written response regarding the investigation outcome.

- A grievance submitted by the mother of Patient #68, dated 10/09/10, expressed the mother's dissatisfaction of the services provided her daughter on 10/05/10. The complainant indicated she needed to bring her daughter to the emergency room for two visits, on 10/05/10 and 10/08/10. At the time of the 10/05/10 visit, the complainant stated the physician told her "it was a waste of your time to come." The complainant returned with her daughter two nights later with a peritonsillar abscess. The complainant indicated the abscess required draining and her daughter had a tonsillectomy performed.

The grievance file lacked evidence the facility conducted an investigation of the allegations and had not provided the complainant with a written response regarding the allegations until a request for additional information by the surveyor occurred on 10/20/10. Following the request for additional information, the facility provided a letter addressed to the complainant, dated 10/20/10, which stated, "This letter is in follow-up to our phone call. Your concerns related to [name's] [the name the facility printed in the letter was not the name of the daughter identified on the grievance report] care are currently being reviewed and I hope to have information for you early next week. Thank you for your patience during this process. . . ."

Failure to respond to grievances/complainants in a timely and accurate manner creates the potential for additional anger and/or frustration for the patient/complainant.

- A grievance report, dated 10/07/10, addressed dissatisfaction regarding the care/services Patient #103 received through the facility's urology department. The allegations included problems with equipment resulting in a procedure not completed, difficulty in obtaining services from one urologist, and being able to make appointments with only one urologist. The complainant indicated the delay in receiving necessary treatment resulted in Patient #103 experiencing a urinary tract infection, at which point the patient sought services from a facility approximately 110 miles away.

The grievance file lacked evidence of an investigation of the specific allegations and lacked evidence of written communication to the complainant regarding the investigation results. According to the grievance file no action into the investigation of the allegations had occurred as of 10/14/10 (the last dated entry by the facility). The file lacked evidence of an investigation and findings after 10/14/10.

Following a request for additional information on 10/20/10, the facility later provided a letter, dated 10/20/10, addressed to the complainant. The facility provided no additional information regarding the completion of the investigation.

13246

Based on information received from the complainant, review of facility policies/procedures, review of facility grievance files, record review, and staff interview, the governing body failed to establish and implement a process for prompt review and resolution of patient grievances for 3 of 3 patient grievances reviewed (Patient #11, #14, and #15) during the complaint investigation completed 09/01/10 and 6 of 7 patient grievances (Patient #63, #64, #65, #67, #68, and #103) reviewed during the full recertification survey completed 10/21/10. Failure by the facility to promptly investigate and resolve grievances and failure to provide written notification to the complainant regarding the results of their investigation has the potential for issues affecting the quality of patient care to remain undetected and placed all patients at risk for harm, injury, and/or avoidable care related complications.

Findings include:

Refer to A118. The lack of implementation of facility grievance/complaint policies/procedures, lack of prompt/timely review and resolution of grievances, and lack of written notification of the facility's investigation findings to the complainant(s) indicated the governing body failed to ensure the facility maintained an effective process for patients to exercise their individual rights to submit and receive resolution to their grievances/complaints.

13246

Based on information received from the complainant, review of facility policies/procedures, review of facility grievance files, record review, and staff interview, the facility failed to establish and implement a process for prompt review and resolution of grievances and written notification of investigation results for 3 of 3 patient grievances reviewed (Patient #11, #14, and #15) during the complaint investigation completed 09/01/10 and 6 of 7 patient grievances (Patient #63, #64, #65, #67, #68, and #103) reviewed during the full recertification survey completed 10/21/10. Failure by the facility to promptly investigate and resolve grievances and to provide written notification to the complainant regarding the results of the investigation has the potential for issues affecting the quality of patient care to remain undetected and placed all patients at risk for harm, injury, and/or avoidable care related complications.

Findings include:

Refer to A118. The lack of prompt/timely review and resolution of grievances and lack of written notification of the facility's investigation findings to the complainant(s) within seven days of receipt of the complaint/grievance indicated the facility failed to implement existing grievance/complaint policies/procedures and failed to ensure the patients' rights to submit and receive resolution to their grievances/complaints.

13246

Based on information received from the complainant, review of facility policies/procedures, review of facility grievance files, record review, and staff interview, the facility failed to establish and implement a process for prompt review and resolution of grievances and provision of written notification of its decision, including the name of the hospital contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date of completion for 3 of 3 patient grievances reviewed (Patient #11, #14, and #15) during the complaint investigation completed 09/01/10 and 6 of 7 patient grievances (Patient #63, #64, #65, #67, #68, and #103) reviewed during the full recertification survey completed 10/21/10. Failure by the facility to promptly investigate, resolve grievances, and provide written notification to the complainant regarding the results of the investigation has the potential for issues affecting the quality of patient care to remain undetected and placed all patients at risk for harm, injury, and/or avoidable care related complications.

Findings include:

Refer to A118. The lack of prompt/timely review and resolution of grievances and lack of written notification of the facility's investigation findings to the complainant(s) within seven days of receipt of the complaint/grievance indicated the facility failed to implement existing grievance/complaint policies/procedures and failed to ensure the patients' rights to submit and receive resolution to their grievances/complaints.

Based on information obtained from the complainant, record review, review of information provided the patient upon admission, and staff interview, during the complaint investigation completed 09/01/10, the facility failed to inform the patients' representatives of injuries sustained and restraints used by 2 of 2 sampled patients (Patient #11 and #25) who experienced significant bruising/injury when placed in restraints and a fall experienced by Patient #25. The failure to inform the representatives of Patients #11 and #25 of the bruising incurred, the restraints used by the patients, and a fall experienced by Patient #25, did not allow the patients' representatives the opportunity to make informed health care decisions on behalf of the patients and maintain involvement in the care planning process.

Findings include:

Reviewed on 08/31/10, the information provided to patients and representatives upon admission stated, "Patient Rights and Related Information, page 7, [the right] to participate actively in determining your course of treatment. . . . To have your family involved in care decisions . . . To receive, or have your representative receive information related to the risks, benefits of, and alternatives to the proposed procedure or treatment so you can make an informed decision regarding your care. . . ."

- Information received from the complainant indicated the complainant's spouse (Patient #11) sustained significant bruising while a patient in the facility's mental health unit between admission on 04/20/10 and 04/22/10, at which time the complainant saw his wife in the emergency room (ER) and observed Patient #11 with significant bruising to her left shoulder/breast/chest and breast area, both knees, her right hand and arm, back and left hip. The complainant indicated staff from the mental health unit called him the morning of 04/22/10 and informed him Patient #11 had "some bruising and suggested it might have happened elsewhere, and that the ambulance was taking her to ER and I need to come down ASAP [as soon as possible]. . . . and I was in shock when I seen her and the bruising that was on her body. . . ." In addition to the bruising, x-rays determined Patient #11 sustained a fracture to the left clavicle.

Reviewed on 08/30/10, Patient #11's medical record showed the patient became agitated during the evening of 04/21/10, during which time three staff physically took the patient from her room to the "quiet room" (seclusion room). At 5:58 a.m. on 04/22/10, nurse's notes stated, "Patient complained of pain whenever she was touched by staff. She said her leg, shoulder, and hip were broken. She would not stay in bed throughout the night. She does have a purple and red bruise to her left shoulder."

The record provided no further description of Patient #11's injuries and complaints of pain until 04/22/10 at 1:10 p.m. when nurse's notes stated, "Pt [patient] spent the morning sitting in the gerichair in the quiet room. . . . Pt did complain of feeling stiff, and felt like maybe something might be broken . . . Pt does have a large bruise to her left shoulder and her right hand. . . ."

Nurse's notes on 04/22/10 at 1:42 p.m. (eight hours after Patient #11 first complained of pain and feeling as if bones were broken and noted to have bruising to her left shoulder) stated, "Spoke with patient's husband regarding the large bruise to patient's left shoulder/chest area. . . . Did receive approval to administer Haldol 2 mg [milligrams] and Cogentin 0.5 mg for patient to be taken to radiology for xray of chest and possibly shoulder as well. . . ."

The record lacked evidence the facility notified Patient #11's spouse/representative of the patient's extreme agitation on the evening/night of 04/21/10 and the placement of the patient in seclusion and a gerichair. The record indicated the facility failed to notify the spouse/representative of the bruising and pain experienced by the patient until eight hours after it first became apparent/recognized.

- The medical record of Patient #25, reviewed on 09/01/10, showed the patient presented to the emergency room on 04/23/10, and the facility admitted the patient to an observation bed while awaiting admission to the mental health unit. The record included the following "Final Report" - nursing note upon discharge from observation to the mental health unit: "0025 [12:25 a.m. on 04/24/10] Patient found on floor in hallway by patient's room by staff. Patient lying with no distress curled on side. Patient confused and disoriented . . . No injury noted except hematoma where IV [intravenous] was pulled out to left forearm. . . . House supervisor and [name of physician] paged at 0045 [12:45 a.m.]. Doctor did not page back at this time. . . ." The record lacked evidence the facility notified the patient's representative of the fall experienced by Patient #25.

The record showed the facility admitted Patient #25 to the mental health unit at 10:11 p.m. on 04/24/10. Admission nursing notes identified, "pt was changed into scrubs and placed in a gerichair. . . . pt has bruising to both lower arms which appear to be from IV or blood draws. . . ."

Additional nurse's notes included:
* 04/25/10, 1 p.m. "As staff attempted to change the patients attends, she did make a few inappropriate comments to staff . . . She also attempted to squeeze staffs fingers tightly and was grabbing at staff."
* 04/25/10, 2:30 p.m. "Pt did wake for the day and was attempting to get out of her gerichair."
* 04/25/10, 10:22 p.m. "Pt was out to the lounge in the gerichair for the evening. . . . While assisting pt. with cares staff noted a bruise to the inner curve of her right buttock, approximately 5 inches in length, purple in color. . . ."
* 04/26/10 11:26 p.m. ". . . staff got pt up and she was incontinent of urine, pt has bruising to the inner folds of her buttocks and vagina, pt also has bruising to the lower arms, pt did not strike out as this time, pt placed in the gerichair. . . ."
* 04/28/10, 1:47 a.m. ". . . She was pleasant and not aggressive. . . . This staff person assisted her to change her brief around 8 p.m. At that time a large dark purple bruise was noted on her buttocks through her perineal area to her pubic area. . . . Other bruises were noted on her arms bilaterally, to her lower legs bilaterally, and to her left hip, 5x6 inches, purple and greenish in color. These bruises had been noted previously. . . . While this staff person was going to administer medications around 9:30 p.m., she was found laying on the floor next to the bed . . . Both half rails were in place, and the bed alarm was turned on but had not sounded. It did sound when the numerous blankets on her bed were moved. . . ."
* 04/28/10, 6:27 a.m. "Pt. was awake for part of the night in the gerichair in quiet room 2 [the unit is equipped with 2 seclusion rooms, #1 and #2], resting on and off. . . ."
* 04/28/10, 8:04 a.m. "This writer notified patient's POA [Power of Attorney] that patient being transferred to radiology for xray of pelvis and lumbar spine. Pt had previous fall, documented from 4/24/10 prior to arrival to 3C. Patient also had fall 4/27/10 at 2247 [10:47 p.m.] Patient has bruising to periarea, buttocks and pelvic area, documented prior to fall on 4/27/10. Patient's POA states that she was not aware of fall on 04/24/10 . . ."

The record lacked evidence of notification of Patient #25's POA of the fall experienced by the patient on 04/24/10, the significant bruising experienced beginning 04/25/10 through 04/27/10, and the placement of the patient in seclusion and a gerichair. The record lacked evidence of notification of the need for seclusion and the gerichair, the risks associated with the use of these restraints, and options available other than the use of the restraints. The failure to provide the POA with notification of the referenced health/care related needs of Patient #25 prevented the POA from providing consent for treatment used, did not allow the POA the opportunity for involvement in the patient's ongoing plan of care, and failed to allow the POA the right to make informed decisions on behalf of Patient #25.

An interview occurred on the morning of 09/01/10 with an administrative staff member (#1) requesting additional information regarding the facility's notification of Patient #11 and #25's representatives in regard to the above referenced findings. The facility did not provide any additional information.

Based on policy and procedure review and staff interview, the hospital failed to ensure provision of community education regarding advance directives and its policies and procedures for 1 of 1 year (October 22, 2009 through October 21, 2010) reviewed during the full recertification survey completed 10/21/10. Failure to provide community education on advance directives and the hospital's policies and procedures limited the community's ability to make informed medical care decisions.

Findings include:

Review of the hospital policy and procedure, Advanced Medical Directives, occurred on October 12-13, 2010. This policy, revised 07/08, stated, "POLICY: Trinity Hospital will comply with Patient Self Determination Act consistent with reasonable medical practice. . . ." This document included sections titled "DEFINITIONS, PROCEDURES, AMD [Advanced Medical Directives], INFORMED HEALTH CARE CONSENT LAW, DETERMINATION OF INCAPACITY, DISPUTE MEDIATION."

During interview on 10/12/10 at 4:00 p.m., an administrative nursing staff member (#2) reported the hospital's pastoral care staff provides community education regarding the hospital's AMD.

During interview on 10/13/10 at 1:00 p.m., a pastoral care management staff member (#15) reported the facility provides community education regarding AMD when requested. The information provided relates to the purpose of an AMD and general function of the AMD. The education provided does not include information regarding the hospital's policy and procedure, including the patient's right to file a grievance and information regarding the hospital's dispute mediation process. This staff member (#15) reported he was not aware of community education provided in the past year or documentation of community education provided in the past.

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Based on observation, review of information submitted by the complainant, record review, review of professional standards, review of facility policies/procedures, and staff interview, the hospital failed to provide a safe setting on the inpatient mental health unit for 2 of 2 closed records (Patients #11 and #12) reviewed of patients who sustained injuries while in seclusion rooms during the complaint investigation completed 09/01/10; and failed to follow current standards of practice for patient environmental safety regarding side rails attached to hospital beds observed on 3 of 3 nursing units (inpatient mental health, fifth floor medical, and intensive care) during the complaint investigation completed 09/01/10 and for 8 of 10 nursing units (medical, intensive care, oncology, obstetrics, surgical, orthopedic, rehabilitation, and chemical dependency) during the full recertification survey completed 10/21/10. Failure to assess and evaluate the environment for patient safety has the potential to place patients at risk for injury.

Findings include:

Review of the Inpatient Mental Health Unit's policy "Behavior Management" occurred on 09/01/10. This policy, dated August 2008, stated, "PURPOSE: provide a safe nonviolent behavior management technique designed to prevent an escalating situation and to provide the best possible care and welfare of the assaultive disruptive, or out-of-control person(s). POLICY: 1. Implementation *Identify preventative techniques of nonviolent crisis intervention . . . *No procedure that physically hurts/harms, or is a psychological risk to the patient, is allowed. . . ."

- A tour of the Inpatient Mental Health Unit, with a supervisory nursing staff member (#6) occurred at approximately 11:15 a.m. on 08/30/10. The tour included two seclusion rooms, located directly across from the nurses' station. The staff member (#6) identified Room #1 as the "Restraint Room." The staff member explained staff use Room #1 if a patient is becoming dangerous to other patients or to themselves, and staff visually check on the patient every 15 minutes. She stated the unit will "try to keep a staff member in the room if the patient tries to hurt themselves." The staff member stated the only type of restraint staff use on the psychiatric unit is "locked, leather restraints," and if the patient is in seclusion in Room #1, staff close and lock the door. Observation showed a single, low, wood-framed bed secured to the floor in Room #1. The room had a hard tile surface floor and concrete block walls. The door to this room had four metal latching locks on the outside of the door. The staff member identified Room #2 as the "geriatric room" and said staff utilize this room to provide "quiet and comfort" for patients if they need less stimuli. Observation of this room showed a single bed with two 1/2 side rails attached to each side of the bed. The staff member (#6) stated staff use this room for older patients who are at risk for falls. Room #2 also had a hard-surface tile floor, concrete block walls, and large metal latching locks on the outside of the door. When asked about the policies and procedures for use of these two rooms, the staff member stated the policies are "in development" and there is no current policy in place for use of the seclusion rooms on the psychiatric unit. Observation on the psychiatric unit showed a geriatric chair in one of the rooms designated for geriatric patients. The geriatric chair was equipped with a tray table on the side of the chair. The staff member (#6) stated they use this chair for geriatric patients because they do not have a recliner on the psychiatric unit. The staff member stated staff do not consider the geriatric chair a restraint unless they utilize the tray table and the patient cannot get out of the chair.

Information submitted by the complainant (dated 05/03/10) to another State agency, and forwarded to the North Dakota Department of Health, Division of Health Facilities identified the following allegations/grievances: (1) The complainant admitted his wife to the facility's mental health unit on 04/20/10. At the time of admission, his wife had no bruises or injuries to her body. (2) On the afternoon of 04/21/10, the facility called and informed the complainant his wife "was acting up" and they were going to put her in the "quiet room." (3) The facility called the complainant on the morning of 04/22/10 and informed the complainant his wife "had some bruising and suggested it might have happened elsewhere," and the ambulance had taken his wife to the emergency room. (4) When the complainant arrived and saw his wife in the emergency room, "I was in shock when I seen the bruising that was on her body. She had bruising on her left shoulder, breast, back, arm, head, knees (both) left hip, and right hand." (5) X-rays taken by the facility showed the complainant's wife had a fractured clavicle.

- Review of Patient # 11's closed record occurred on August 30 - September 1, 2010. The record identified admission to the inpatient mental unit on 04/20/10 with a diagnosis of senile dementia. The Adult Psychiatric Admission Data Sheet identified nursing diagnoses of anxiety, sleep pattern disturbance, and acute confusion.

The "Nursing Rounds" documentation identified staff placed Patient #11 in the "quiet room" at 6:32 p.m. on 04/21/10. The notes indicated Patient #11 remained in this room for the majority of her hospital stay until discharge to the emergency room on 04/22/10. The documentation also identified the use of a geriatric chair while in the quiet room, but failed to indicate if staff used the tray table on the chair.

The "Nursing Progress Notes" identified the following:
04/21/10 at 10:36 p.m. - "Pt [patient] very anxious, delusional, confused, frantic, . . . Staff attempted to redirect pt. and she then flopped to the ground and began rolling around. Pt. resisted staff when they attempted to help her up. Pt. was eventually taken to the quiet room by three staff and placed on bed. She continued to act irrational . . . Pt. rolled around on the bed and then onto the floor. . . . Pt continued to yell out through much of shift, rolling on the floor, banging on the door . . . Despite getting off the bed and rolling around and then kicking and hitting door, pt. refused to get up off of floor. 2 staff had to assist pt. up to the bed. . . . Pts right hand middle finger appeared to be bruised."
04/22/10 at 5:58 a.m. - "Patient complained of pain whenever she was touched by staff. She said her leg, shoulder and hip were broken. She would not stay in bed throughout the night. She does have a purple and red bruise to her left shoulder."
04/22/10 at 1:10 p.m. - "Pt spent the morning sitting in the gerichair in the quiet room. She was hyperverbal while speaking to staff . . . Pt did complain of feeling stiff, and felt like maybe something might be broken, but was unable to describe details of her discomfort. . . ."
04/22/10 at 1:32 p.m. - "Spoke with patient's husband, [name], regarding large bruised area to Patient's left shoulder/chest area. . . . patient to be taken to radiology for xray of chest and possibly of shoulder as well. . . ."
(NOTE: A computed radiology exam on 04/23/10 confirmed Patient #11 had a "Displaced comminuted fracture of the distal clavicle.")
04/22/10 at 3:41 p.m. - "pt sent to ER at 1530 [3:30 p.m.] due to mental status change. . . . pt displays a blank stare and is unable to communicate with staff . . ."

The ambulance note, dated 04/22/10 at approximately 3:30 p.m., stated ". . . According to nursing staff, pt. has blacked out 3x [times] in the last hour, w/ [with] several falls. . . . We find above pt. sitting in a recliner, alert, confused and combative, pt. is pushing and trying to get out of the chair. . ."

The ER physician's note, dated 04/22/10, documented "severe ecchymosis . . . to left chest wall into shoulder and back."

The hospital failed to provide a safe environment for Patient #11 while in the seclusion room on the psychiatric unit. Documentation in the medical record indicated Patient #11 would get out of the bed and roll around on the floor, and would also attempt to get out of the geriatric chair. The medical record provided no evidence staff evaluated the physical environment of the seclusion room and the effect it had on the patient's behavior. The medical record provided no evidence staff attempted to provide a softer surface, such as a mat, etc. for the patient, who continued to roll on the floor, nor did it provide evidence of how frequently staff monitored Patient #11 while she was in the quiet room.

- Review of Patient #20's medical record occurred 08/31/10, and showed the facility admitted the patient to the mental health unit on 05/01/10. Nurses notes indicated staff placed Patient #20 in seclusion room #1 during the evening of 05/06/10 where Patient #20 remained until 4:20 p.m. on 05/08/10.

A variance report from 05/08/10 at 3:15 a.m. stated, "Pt has been awake all night and has been yelling at staff while locked in quiet room #1. He started the evening in 4 point restraints, but appeared to chew through all 4 of them within 2 minutes time frame around 2:30 a.m. He initially used the broken restraints to swing them at the door, ceiling and mattress. He paced around the bed in his room and would rest for short periods before returning to yelling and pounding. Around 0315 [3:15 a.m.] patient broke the window in the quiet room, and proceeded to remove the broken glass pieces. He was eventually able to reach out the window and unlock two of the deadbolts on the door. . . . police called for assistance in again returning the patient to 4 point restraints. . . . At 0640 [6:40 a.m.] pt broke the leather restraint on his right leg. Pt continued to yell at staff for the rest of the shift."

The variance report and Patient #20's medical record lacked evidence of corrective action regarding placement of the window glass in seclusion room #1 and lacked evidence the facility replaced the window with a non-breakable/safe material. Failure to address the safety aspects of the window in the seclusion room placed Patient #20 and other patients placed in seclusion at continued risk for injury/harm.

- The Food and Drug Administration (FDA) Center for Devices and Radiological Health publication titled, "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," issued on 03/10/06, stated, ". . . FDA has received reports in which . . . patients have become entrapped in hospital beds while undergoing care and treatment in health care facilities. The term 'entrapment' describes an event in which a patient is caught, trapped or entangled in the space in or about the bed rail, mattress, or hospital bed frame. Patient entrapments may result in death and serious injuries . . . The current International Electrotechnical Commission (IEC) standard recognizes that the bed frame, deck, and rails are the major elements involved in entrapment . . ." The FDA's recommendation of the spacing between the inside surface of the rail and the mattress compressed by the weight of the patient's head be small enough to prevent head entrapment when taking into account the mattress compressibility, any lateral shift of the mattress or rail, and degree of play from loosened rails. The IEC and the FDA recommend a dimension limit of less than 120 millimeters (4 and 3/4 inches) for the following: 1) within the rail; 2) under the rail, between rail supports or next to a single rail support; and 3) between the rail and mattress.

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.

Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings, Hospital Bed Safety Workgroup, Food and Drug Administration, April 2003, stated,
"Guiding Principles . . .
2. Decisions to use or to discontinue the use of a bed rail should be made in the context of an individualized patient assessment using an interdisciplinary team with input from the patient and family or the patient's legal guardian. . . .

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 and approved by the interdisciplinary team.
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.
. . .
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. This should be done immediately because fatal 'repeat' events can occur within minutes of the first episode.

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. . . .

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. . . .

Bed Rails as Restraints
When bed rails have the effect of keeping a patient from voluntarily getting out of bed, they fall under the definition of a physical restraint. If they are not necessary to treat medical symptoms, and less restrictive interventions have not been attempted and determined to be ineffective, bed rails used as restraints should be avoided. . . .

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 and the relationship between rails and other parts of the bed.
1. The bars with the bed rails should be closely spaced to prevent a patient's head from passing through the openings and becoming entrapped.
2. The mattress to bed rail interface should prevent an individual from falling between the mattress and bed rails and possibly smothering.
. . ."

Review of the Hospital's nursing policy "Safety" occurred 10/19/10. This policy, reviewed September 2008, stated, "PURPOSE: To provide for the safety of all patients. POLICY STATEMENT: The safety of each patient shall be ensured at all times during his/her stay. POLICY: 1. Patient top bed rails and cart side rails will be in the up position unless a nurse is in attendance.
. . ."

Observation of the beds utilized on the inpatient mental health unit, fifth floor medical unit, and the intensive care unit occurred on August 30-31, 2010. The beds varied in make and style with all of the beds having either four half rails (two half rails on each side) or two half rails (one half rail on each side). On the intensive care unit, 17 of 19 beds had spacing between the side rails greater than 4 and 3/4 inches. Observation of the inpatient mental health unit showed one bed in the seclusion room with spacing between the side rails greater than 4 and 3/4 inches. Random observations of beds on the 5th floor medical unit showed a majority of the beds had spacing between the side rails greater than 4 and 3/4 inches.

During interview, the morning of 08/31/10, an administrative nurse (#6) on the mental health unit stated staff elevate the upper half rails on each side of the bed to allow patients to reposition themselves in bed.

Observations on the intensive care unit, at 10:30 a.m. on 08/31/10, showed the upper half rails on each side of the bed elevated on the beds of Patient #5, #6, and #7. The rails on these beds had spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

Random observations of patients on the fifth floor medical unit on August 31 - September 1, 2010 showed the upper half rails on each side of the bed elevated. Observation of Patient #9 showed all four half rails elevated on the bed. The rails on this bed had spaces greater then 4 and 3/4 inches, presenting a risk for entrapment.

Review of the medical records for Patient #5, #6, #7 and #9 occurred on August 31 - September 1, 2010. These medical records lacked documentation of an assessment of each of these patients for safety regarding use of side rails. The staff failed to consider the side rails as a potential entrapment and safety hazard.

Observation of the St. Joseph's inpatient Rehabilitation Unit on 10/19/10 at 1:15 p.m. identified beds in rooms 540, 544, and 546 equipped with side rails with spacing greater than 4 and 3/4 inches, presenting a risk for entrapment. The unit census report identified patients occupied rooms 544 and 546.

During interview the afternoon of 10/19/10, a supervisory nursing staff member (#14) reported she was uncertain if the staff used the side rails for these patients or if the staff completed patient assessments for use of the side rails. This staff member reported the facility frequently moved beds off and on the unit as the facility admitted and discharged patients and did not know how long these beds had been on the unit.

Observation of the inpatient chemical dependency unit at St Joseph's hospital occurred on 10/19/10 at 3:30 p.m. A tour of the rooms on this unit showed beds with various types of side rails. The bed in Patient #46's room had the upper half rails elevated on each side of the bed, and staff had placed vinyl padding over the top of the rails. Observation of the rails showed spaces greater than 4 and 3/4 inches, presenting a risk for entrapment. A supervisory nurse (#16) stated staff elevated the side rails because the patient has a history of seizures. The nurse stated the side rails are padded to protect the patient from the hard rail if he had a seizure.

Review of Patient #46's medical record occurred on October 19-21, 2010. Record review identified the lack of an individualized assessment of risk and safety for the utilization of the side rails for Patient #46. The hospital staff failed to consider the side rails as a potential entrapment and safety hazard.

Random observations of current inpatients on the Medical Unit on the afternoon of 10/18/10, identified Patients #35, #36, #37, and #38 resting in bed with the upper half rails elevated on each side of the bed. Observations of the rails on these beds showed spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

A random observation of Patient #43, in the Intensive Care Unit, occurred on 10/19/10 at 2:45 p.m., and identified this patient resting in bed with the upper half rails elevated on each side of the bed. Observations of the rails on these beds showed spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

Review of the medical records for Patient's #35, #36, #37, #38, #43 occurred on October 19-21, 2010. Record review identified the lack of an individualized assessment of risk and safety for the utilization of side rails on each of these patients. The Hospital staff failed to consider the side rails as a potential entrapment and safety hazard.

During an interview on 10/19/10 at 3:00 p.m., a supervisory nursing staff member (#17) stated staff does not perform an assessment of risk factors or safety for utilization of side rails and confirmed staff elevated the top two side rails for all patients.

Observation on the 6th floor oncology unit on 10/19/10 8:30 a.m. identified Patient #47 resting in bed with the upper half rails elevated on each side of the bed. Observation showed the rails had spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

A tour of the obstetrics unit took place on 10/19/10 at 9 a.m. with three administrative nurses (#2, #10, and #11). One nurse (#11) stated the facility equips most beds on the obstetric unit with bilateral half rails with spaces greater than 4 and 3/4 inches.

Observation on the obstetrics unit on the morning of 10/19/10 identified Patient #53 at rest in bed with the upper half rails elevated on each side of the bed. Observation showed the rails had spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

Observations of current inpatients on the Surgical Unit on the morning of 10/19/10, identified Patients #27, #28, #29, #55, and #56 resting in bed with the upper half rails elevated on each side of the bed. Observations of the rails on these beds showed spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

Observations of current inpatients on the Orthopedic Unit on the morning of 10/19/10, identified Patients #30 and #31 resting in bed with the upper half rails elevated on each side of the bed. Observations of the rails on these beds showed spaces greater than 4 and 3/4 inches, presenting a risk for entrapment.

Review of the medical records for Patient's #27, #28, #29, #30, and #31 occurred on October 19-21, 2010. Record review identified the lack of an individualized assessment of risk and safety for the utilization of side rails on each of these patients. The Hospital staff failed to consider the side rails as a potential entrapment and safety hazard.

During an interview on 10/19/10 at 9:15 a.m., a supervisory nursing staff member (#12) stated, "Hospital policy is that the top two rails are up on every bed at all times no matter what." The staff member (#12) stated the patients needed the rails up to move in bed and identified staff did not complete individual patient assessments for the use of side rails.

During an interview on 10/19/10 at 10:30 a.m., a supervisory nursing staff member (#13) stated staff does not perform an assessment of risk factors or safety for utilization of side rails and confirmed staff elevated the top two, sometimes three, side rails for patient positioning. The staff member (#13) stated the Hospital failed to consider the side rails as a potential risk for safety and entrapment.


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Based on record review, review of facility policies/procedures, review of information submitted by the complainant, review of variance reports, and staff interview, the facility failed to implement existing policies/procedures and failed to investigate potential abuse circumstances for 2 of 2 sampled patients (Patients #11 and #25) who experienced injuries of unknown origin and 2 of 2 patients (Patients #14 and #15) who voiced complaints of alleged abuse/neglect at the time of the complaint investigation completed 09/01/10 and for 1 of 1 patient (Patient #65) who submitted a complaint of potential neglect at the time of the full recertification survey completed 10/21/10. Failure to recognize and investigate potential abuse indicators/circumstances placed all patients at risk for abuse/neglect.

Findings include:

Review of the facility's policy/procedure "Abuse, Neglect, and Assault/Molestation of Children and/or Adults" occurred on 09/01/10. This policy, last revised 08/2009, included policies/procedures for the recognition and reporting of potential/suspected abuse to appropriate agencies. The policies/procedures lacked provision for recognizing potential internal abuse/neglect, the reporting mechanism for staff to use, and the investigation process to determine whether actual abuse occurred.

- Information received from the complainant indicated the complainant's spouse (Patient #11) sustained significant bruising while a patient in the facility's mental health unit between admission on 04/20/10 and 04/22/10, at which time the complainant saw his wife in the emergency room (ER) and observed Patient #11 with significant bruising to her left shoulder/breast/chest and breast area, both knees, her right hand and arm, back and left hip. The complainant indicated staff from the mental health unit called him the morning of 04/22/10 and informed him Patient #11 had "some bruising and suggested it might have happened elsewhere, and that the ambulance was taking her to ER and I need to come down ASAP [as soon as possible]. . . . and I was in shock when I seen her and the bruising that was on her body. . . ." In addition to the bruising, x-rays determined Patient #11 sustained a fracture to her left clavicle.

Review of Patient #11's medical record occurred August 30-September 01, 2010, and included nurses notes as follows:
* 04/21/10 at 10:36 p.m. - "Pt [patient] very anxious, delusional, confused, frantic . . . and yelling that it was the end of the world and she needed to use the phone. . . . pt grabbed the phone . . . began to try ripping the phone from the wall. Two staff needed to pull phone away from pt. . . . Staff attempted to redirect pt. She then flopped to the ground and began rolling around. Pt resisted staff when they attempted to help her up. Pt was eventually taken to the quiet room by three staff and placed on bed. . . . Pt rolled around on the bed and then onto the floor. . . . Pt. continued to yell out through much of shift, rolling on the floor, banging on the door, refused all medications. Despite getting off the bed and rolling around and then kicking and hitting door, pt. refused to get up off floor. 2 staff had to assist pt. up to the bed. Pt. eventually did calm down and remained in bed and fell asleep at about 9 pm. Pts right hand middle finger appeared to be bruised." Patient #11's medical record identified no bruising present at the time of admission and no evidence of bruising until this notation.
* 04/22/10 at 1:30 p.m. - "Pt spent the morning sitting in the gerichair in the quiet room. . . . She expressed excitement as staff entered her room throughout the morning, and requested that they stay longer and talk. She even thanked one staff member for getting so close to her and asked, 'Aren't you scared of me?' . . . Pt did complain of feeling stiff, and felt like maybe something might be broken, but was unable to describe details of her discomfort. Pt does have a large bruise to her left shoulder and bruising to her right hand. . . ."

Review of facility Variance Reports on 08/30/10, lacked evidence staff submitted a variance report following identification of the above referenced bruises and pain experienced by Patient #11.

In addition, Patient #11's medical record lacked evidence of an investigation of potential abuse/neglect as a contributing factor in the bruises and fracture of the patient's clavicle including: (1) Review/investigation of the implementation of the facility's existing systems/processes for management/controlling extreme behavior and prevention of injury to the patient. (2) Review/investigation of the manner in which staff intervened and physically moved Patient #11 in the above referenced notes. (3) Investigation of the adequacy of monitoring of Patient #11 during the above described behavior, including the adequacy of staff, and the appropriateness and timeliness of interventions implemented/used by staff. (4) Investigation of contact with and adequate intervention by Patient #11's attending practitioner during the escalation and long duration of Patient #11's behavior. (5) Investigation of the environment staff placed Patient #11 in (quiet room/seclusion room) and risk factors within the environment which may have contributed to the injuries sustained by the patient and/or placed the patient at increased risk for self-harm.

- Review of Patient #25's medical record occurred 09/01/10 and included the following nurses notes:
* 04/25/10 at 1 p.m. - "As staff attempted to change the patients attends, she did make a few inappropriate comments to staff . . . She also attempted to squeeze staffs fingers tightly and was grabbing at staff."
* 04/25/10 at 2:30 p.m. - "Pt did wake for the day and was attempting to get out of her gerichair."
* 04/25/10 at 10:22 p.m. - "Pt was out to the lounge in the gerichair for the evening. . . . While assisting pt. with cares staff noted a bruise to the inner curve of her right buttock, approximately 5 inches in length, purple in color. . . ."
* 04/26/10 at 11:26 p.m. - ". . . staff got pt up and she was incontinent of urine, pt has bruising to the inner folds of her buttocks and vagina, pt also has bruising to the lower arms, pt did not strike out at this time, pt placed in the gerichair.
. . ."
* 04/28/10 at 1:47 a.m. - ". . . She was pleasant and not aggressive. . . . This staff person assisted her to change her brief around 8 p.m. At that time a large dark purple bruise was noted on her buttocks through her perineal area to her pubic area. . . . Other bruises were noted on her arms bilaterally, to her lower legs bilaterally, and to her left hip, 5 x 6 inches, purple and greenish in color. These bruises had been noted previously. . . ."

Reviewed on 09/01/10, facility Variance Reports lacked evidence staff submitted a variance report following identification of the above referenced bruises experienced by Patient #25.

In addition, the record lacked evidence of investigation of the above referenced injuries experienced by Patient #25 for possible abuse/neglect including: (1) Investigation of adequacy of staffing and training in the provision of personal perineal care of elderly female individuals and (2) Investigation of the potential/occurrence of sexual abuse.

- A variance report, dated 05/05/10, stated, "Pt [Patient #14] came to . . . appt [appointment] 4/7. He stated his shins were 'scrubbed raw down to the bone' by the tech prepping him for stress test 4/5. 'I told him it hurt and he still kept on scrubbing' pt stated. Bilateral shins abraded (approximately 6 inches). Pt states surgery may have to be postponed 4/12 if area not healed. Wife very upset. 'This needs to be reported so it doesn't happen to someone else' she stated."

The variance report lacked evidence of any investigation of the complaint expressed by Patient #14, including investigation of abuse/neglect. Failure to investigate the allegation of abuse/neglect communicated by Patient #14 placed other patients at risk for similar harm/injury.

- A variance report, dated 04/30/10, included the following complaint/grievance from Patient #15: "Patient had a complaint about two night CNAs' [certified nurse assistants]. The patient felt the 2 were 'rough' with her. She said she feels she has been spoiled by all the good care she has been receiving from all the nurses, but felt these 2 'had an attitude' with her. She said every time she turned on her light it was like she was 'bothering them'. She gave 2 examples, one was 'the CNAs came in and told me I had to lie on my left side, I told them I couldn't lay on my left side because I have a bad left hip and they told me well you can't lay on your back forever so you have to lie on your left side'. The patient laid on her left side and said 'those two' never came back to turn her again after that. Another example she had was; she put her call light on to use the commode and they came in to help her, but when they got her out of bed they didn't put the side rail down. The patient said 'it's really no biggie, but it makes for getting back into bed easier because then when they got me back into bed I was all the way down to the foot of the bed. I was so low in bed that my feet were almost hanging off the end of the bed. They then left my head flat and didn't boost me up in bed so my head was on the pillow.' The patient said she would have turned on her call light, but she was too low in bed to reach it. So the patient tried to boost herself higher in bed. The patient had surgery on her left arm and has an external fixator on so it was difficult for her to boost herself in bed. When she reached her call light she asked them to help her up higher in bed. The patient then told me 'I asked those 2 girls when they were done with their shift and they said an hour and I told them good, I don't want to ever see you again.' She has requested they not come in to help her as they were 'rough and rude.' . . ."

The variance report lacked evidence of investigation of the alleged neglect/abuse identified by Resident #15. The lack of a thorough investigation of the alleged neglect/abuse identified by Patient #15 placed the patient, as well as other patients, at risk for potential harm/injury.

An interview occurred on the morning of 09/01/10 with an administrative staff member (#1) for purposes of reviewing the above referenced findings and allowing the facility the opportunity to provide information regarding abuse/neglect investigations completed by the facility. The facility provided no additional information.

- A grievance, dated 09/09/10, identified the following family concerns regarding the care received by Patient #65: 1. The patient did not receive prescribed inhalers for four days. 2. Patient #65 developed skin breakdown due to a lack of adequate management of bowel incontinence including frequent changing of the patient's incontinent brief and adequate perineal cleansing/hygiene. 3. Patient #65 experienced four falls on one day due to over medication. 4. Patient #65 did not receive adequate oral care. 5. Staff did not properly position Patient #65 with pillows between his knees.

The grievance file lacked evidence of an investigation by the facility in response to allegations of potential patient neglect identified by the complainant.

Based on observation, review of information submitted by the complainant, record review, staff interview, and review of policy and procedure, the hospital failed to ensure the use of restraints and/or seclusion only when staff determined less restrictive interventions were ineffective in protecting the patient, staff member, or others from harm for 2 of 2 current patients (Patient #2 and #9) and 6 of 6 closed records (Patient #11, #16, #17, #19, #20 and #25) reviewed during the complaint investigation completed 09/01/10 and for 2 of 2 current patients (Patients #27 and #43) on the medical unit, transferred from the intensive care unit, reviewed during the recertification survey completed 10/21/10. Failure to ensure the use of restraints and/or seclusion occurs only when clinically necessary and after determining less restrictive interventions were ineffective has the potential to result in physical or psychological harm to patients.

Findings include:

Information submitted by the complainant (dated 05/03/10) to another State agency, and forwarded to the North Dakota Department of Health, Division of Health Facilities identified the following allegations/grievances: (1) The complainant admitted his wife to the facility's mental health unit on 04/20/10. At the time of admission, his wife had no bruises or injuries to her body. (2) On the afternoon of 04/21/10, the facility called and informed the complainant his wife "was acting up" and they were going to put her in the "quiet room." (3) The facility called the complainant on the morning of 04/22/10, and informed the complainant his wife "had some bruising and suggested it might have happened elsewhere," and the ambulance had taken his wife to the emergency room. (4) When the complainant arrived and saw his wife in the emergency room, "I was in shock when I seen the bruising that was on her body. She had bruising on her left shoulder, breast, back, arm, head, knees (both) left hip, and right hand." (5) X-rays taken by the facility showed the complainant's wife had a fractured clavicle.

- A tour of the Inpatient Mental Health Unit, with a supervisory nursing staff member (#6) occurred at approximately 11:15 a.m. on 08/30/10. The tour included two seclusion rooms located directly across from the nurses' station. The staff member (#6) identified Room #1 as the "Restraint Room." The staff member explained staff use Room #1 if a patient is becoming dangerous to other patients or to themselves, and staff visually check on the patient every 15 minutes. She stated the unit will "try to keep a staff member in the room if the patient tries to hurt themselves." The staff member stated the only type of restraint staff use on the psychiatric unit is "locked, leather restraints," and if the patient is in seclusion in Room #1, staff close and lock the door. Observation showed a single, low, wood-framed bed secured to the floor in Room #1. The room had a hard tile surface floor and concrete block walls. The door to this room had four metal latching locks on the outside of the door. The staff member identified Room #2 as the "geriatric room" and staff utilize this room to provide "quiet and comfort" for patients if they need less stimuli. Observation of this room showed a single bed with two 1/2 side rails attached to each side of the bed. The staff member (#6) stated staff use this room for older patients who are at risk for falls. Room #2 also had a hard-surface tile floor, concrete block walls, and large metal latching locks on the outside of the door. When asked about the policies and procedures for use of these two rooms, the staff member stated the policies are "in development" and there is no current policy in place for use of the seclusion rooms on the psychiatric unit. Observation on the psychiatric unit showed a geriatric chair in one of the rooms designated for geriatric patients. The geriatric chair was equipped with a tray table on the side of the chair. The staff member (#6) stated they use this chair for geriatric patients because they do not have a recliner on the psychiatric unit. The staff member stated staff do not consider the geriatric chair a restraint unless they utilize the tray table and the patient cannot get out of the chair.

Review of the hospital policy "Restraints/Seclusion" occurred on 09/01/10. This policy, dated May 2008, stated, "Purpose: To outline the components necessary for safe use of restraints when utilized to protect the patient or others from injury. Policy: . . . commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/her self or others. . . . strive to create a safe environment where restraint use can be prevented or where alternatives to restrain can be employed. All patient care processes are designed to preserve the patient's dignity, rights and well being. . . . Definitions: 1. Restraint - The direct application of human or mechanical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. . . . 3. Seclusion - The involuntary confinement of a person where the person is physically prevented from leaving. . . .5. LIP [licensed independent practitioner] - Any individual permitted by law and the organization to provide care, treatment and services without direction or supervision. PROCEDURE: A. Restraint use for Medical and Surgical Care (to support physical healing) 1. Assessment *The RN [registered nurse], in collaboration with the Charge Nurse or Supervisor, assesses the need for patient restraint. *After assessment, chooses least restrictive restraint method. 2. Restraint Order *RN initiates order only if LIP [licensed independent practitioner] is not available *Notify LIP within 12 hours (immediately if significant change in patient condition) to obtain verbal or written order 3. Patient Exam/Order Time Limit *LIP examines pt. [patient] and writes renewal order within 24 hours of initiation. Renewal order and re-exam required at least every 24 hours . . . 4. Monitoring of the patient in restraint *At least every 2 hours *Requires observation, direct interaction or examination by a nurse or LIP 5. Discontinuation of Restraint *Restraints are terminated as soon as possible . . . Restraint use for Behavioral Health Care. 1. Assessment *Patient Admission Assessment Data - Use to identify ways of mitigating patient's behavior, therefore minimizing the need to use restraint or seclusion. *The RN, in collaboration with the Charge Nurse or Supervisor, assesses the need for patient restraint *After assessment, chooses least restrictive restraint method 2. Restraint Order *RN initiates order only if LIP is not available *Within one hour, RN consults with LIP and together, they identify ways to help the patient regain control . . . 3. Patient Exam/Order Time Limit *Adult patient (age 18 or greater) - Initially, LIP examines within 4 hours. Order is time specific and limited to 4 hours. RN may reassess and reorder in 4 hour time periods up to 8 hours. LIP then re-evaluates and reorders every 8 hours. *Youth/child (age 17 or younger) - Initially, LIP examines within 2 hours. Order is time specific and limited to 2 hours (ages 9 to 17) or 1 hour (age <9). RN may reassess and reorder every one or two hours up to 4 hours. LIP re-evaluates and reorders every 4 hours. 4. Patient Education *As soon as possible, explain rationale for restraint/seclusion and the behavior that must be met for its discontinuation. 5. Monitoring of the patient in restraint. *Every 15 minutes *Requires assessment, as appropriate, to type of restraint or seclusion including: *signs of injury from restraint . . . Affect/Behavior . . . *Seclusion without restraint - may be monitored continuously via audiovisual monitoring after the first hour. 6. Discontinuation of restraint *Restraints are terminated as soon as possible but may later be reapplied within the time-limit of an order if patient behavior warrants. . . ." NOTE: A new revision to the restraint policy added the following types of restraints, effective August 2010: "Restraint Information. Roll Belts. . . . Soft Limb Holders . . . Hand Control Mitts. . ." The policy did not include the use of side rails or the use of a geriatric chair as a type of restraint.

During interview on 08/31/10 at 11:30 a.m., an administrative nursing staff member (#1) stated the hospital did not have a policy and procedure for the use of leather locked restraints on the psychiatric unit or a policy regarding criteria used to determine the use of the two seclusion rooms on the psychiatric unit.

- Review of Patient #11's closed record occurred on August 30 - September 1, 2010. The record identified admission to the inpatient mental health unit on 04/20/10 with a diagnosis of senile dementia. The Adult Psychiatric Admission Data Sheet identified nursing diagnoses of anxiety, sleep pattern disturbance, and acute confusion. The nursing staff documented "Family support" as an identified strength for the patient and "Cognitive ability" as a weakness.

The "Nursing Rounds" documentation identified staff placed Patient #11 in the "quiet room" at 6:32 p.m. on 04/21/10. The notes indicated Patient #11 remained in this room for the majority of her hospital stay until discharge to the emergency room on 04/22/10. The documentation also identified the use of a geriatric chair while in the quiet room, but failed to indicate if staff used the tray table on the chair.

The "Nursing Progress Notes" identified the following:
04/21/10 at 10:36 p.m. - "Pt [patient] very anxious, delusional, confused, frantic . . . Staff attempted to redirect pt. and she then flopped to the ground and began rolling around. Pt. resisted staff when they attempted to help her up. Pt. was eventually taken to the quiet room by three staff and placed on bed. She continued to act irrational . . . Pt. rolled around on the bed and then onto the floor. She grabbed her glasses and twisted the frames and caused one of the lenses to pop out.
. . . Pt. also swung at staff when they attempted to asssist (sic) her up to the bed. Pt continued to yell out through much of shift, rolling on the floor, banging on the door, refused all medications. Despite getting off the bed and rolling around and then kicking and hitting door, pt. refused to get up off of floor. 2 staff had to assist pt. up to the bed.
. . . Pts right hand middle finger appeared to be bruised."
04/22/10 at 5:58 a.m. - "Patient complained of pain whenever she was touched by staff. She said her leg, shoulder and hip were broken. She would not stay in bed throughout the night. She does have a purple and red bruise to her left shoulder."
04/22/10 at 1:10 p.m. - "Pt spent the morning sitting in the gerichair in the quiet room. She was hyperverbal while speaking to staff . . . She expressed excitement as staff entered her room throughout the morning, and requested that they stay longer and talk. She even thanked one staff member for getting so close to her . . . Pt did complain of feeling stiff, and felt like maybe something might be broken, but was unable to describe details of her discomfort. . . ."
04/22/10 at 1:32 p.m. - "Spoke with patient's husband, [name], regarding large bruised area to Patient's left shoulder/chest area. . . ."
(NOTE: A computed radiology exam on 04/23/10 confirmed Patient #11 had a "Displaced comminuted fracture of the distal clavicle.")
04/22/10 at 3:41 p.m. - "pt sent to ER at 1530 [3:30 p.m.] due to mental status change. . . ."

The ambulance note, dated 04/22/10 at approximately 3:30 p.m., stated ". . . According to nursing staff, pt. has blacked out 3x [times] in the last hour, w/ [with] several falls. . . . We find above pt. sitting in a recliner, alert, confused and combative, pt. is pushing and trying to get out of the chair. . . . I then hold her hand and talk to her and she calms down, no longer fighting. . . ."

The nurse's notes identify placement of Patient #11 in the "quiet room" when she became agitated and confused. The notes failed to identify which of the two seclusion rooms staff used for Patient #11, with the exception of one "Nursing Rounds" note on April 22 which identified "quiet room 1." The medical record failed to identity if staff locked the door to this room and failed to identify the frequency of staff monitoring during the time the patient occupied this room. Hospital staff failed to assess the use of this room as seclusion and to evaluate the effect it had on Patient #11's affect and behavior. Documentation in the medical record showed Patient #11's behavior did not improve after placement in the "quiet room" and at times escalated. The nurse's notes identified Patient #11 sitting in a geriatric chair in the quiet room. The medical record lacked evidence staff assessed the use of the geriatric chair as a type of restraint for Patient #11 and whether staff attempted to use a less restrictive chair. The medical record lacked evidence of a physician's order for use of the seclusion room and/or use of the geriatric chair.

- Review of Patient #20's medical record occurred 08/31/10, and showed the facility admitted the patient to the mental health unit on 05/01/10. Nurses notes indicated on the evening of 05/06/10, "Patient was down in the lounge and thought people were talking about his acne and they were talking about a girl on tv with clear skin, patient started yelling and threw a chair, patient was escorted to the quiet room, he was yelling and cursing, doctor was called and patient was ordered meds to help calm him down and he was told he would be sleeping in the quiet room, patient was jumping and tapping the camera, making obscene hand gestures and showing his naked bottom." The record lacked evidence staff attempted less restrictive alternatives prior to placing Patient #20 in seclusion following the above described incident.

Nurse's notes and variance reports stated the following:
* Variance report, 05/07/10 at 8:20 a.m. - "Pt [patient] in QR [quiet room]. Continues to yell, curse, et [and] come out of the QR. Pt is very agitated et aggressive towards staff. Has not yet been assaultive." The variance report indicated staff would not allow Patient #20 to leave the quiet room, even though the door may not have been locked.
A "Security Flow Sheet" attached to the variance report showed staff placed Patient #20 into "seclusion" at 8:20 a.m. on 05/07/10, and the patient remained in seclusion until 4:10 p.m. on 05/08/10 (thirty-two hours).
* Variance report, 05/07/10 at 9:35 a.m. - "Pt continued to escalate from earlier incident. Remains out of control, yelling, et cursing, et aggressive towards staff. Manpower called et injections given. Patient remains in seclusion. Patient will not redirect and all other less restrictive alternatives attempted." The record lacked evidence of the specific less restrictive alternatives attempted and the results of those alternatives.
* Variance report, 05/07/10 at 1:15 p.m. - "Pt woke up approximately 1230 [12:30 p.m.] et immediately started banging on the door and yelling. Pt was given tray. He was calm at that time. Pt then wanted out of the QR et broke his tray in pieces et was yelling, swearing et aggressive to staff. Manpower was called et injections were given."
* Nurse's note, 05/07/10 at 3:58 p.m. - "Pt c/o [complains of] pain in rt [right] hand related to punching walls, door and window in QR #1. Pt was administered prn [as needed] Tylenol with good relief, pt was also given ice pack and pt 'ate it' . . . Pt hand does have abrasions on knuckles and appears bruised . . . pt is still pacing in QR #1 and occasionally yelling, pt appears calmer at this time."
* Variance report, 05/07/10 at 8:30 p.m. - "Pt was already in QR in locked seclusion. He had not calmed despite medications, diversions, limit setting, and explanations. Pt continued to pound and kick the door, walls, scream and yell, and then wrapped a sheet around his neck in an attempt to choke himself. Staff and Dr. [doctor] decided 4 point keyed leather restraints would be needed. A manpower was called. . . ." Nurses note for the same incident stated, ". . . Pt subsequently placed in 4 point restraints. He continued to yell out periodically throughout remainder of shift. He would calm for periods, then yell profanities at staff. . . ."
* Variance report, 05/08/10 at 3:15 a.m. - "Pt has been awake all night and has been yelling at staff while locked in quiet room #1. He started the evening in 4 point restraints, but appeared to chew through all 4 of them within 2 minutes time frame around 2:30 a.m. He initially used the broken restraints to swing them at the door, ceiling and mattress. He paced around the bed in his room and would rest for short periods before returning to yelling and pounding. Around 0315 [3:15 a.m.] patient broke the window in the quiet room, and proceeded to remove the broken glass pieces. He was eventually able to reach out the window and unlock two of the deadbolts on the door. . . . police called for assistance in again returning the patient to 4 point restraints. . . . At 0640 [6:40 a.m.] pt broke the leather restraint on his right leg. Pt continued to yell at staff for the rest of the shift."
* Nurse's note, 05/08/10 at 3:01 p.m. - "Pt has been in the quiet room for the entire shift and in 4 point restraints. Pt yelling and cursing at staff. Breakfast was brought in by staff this morning and pt kicked milk at staff because he didn't want to be fed. Pt affect is bland with agitation. . . . pt did get one foot out of the restraints and was being belligerent so a manpower was called so that IM [intramuscular] medication could be given and the restraint could be put back on."
* Nurse's note, 05/08/10 at 8:48 p.m. - "Pt was calm and in one of four restraints at the beginning of the afternoon. He was calm and had no aggressive or assaultive behaviors. He was allowed to shower and come to the lounge at 1610 [4:10 p.m.] due to his good behavior and verbalized understanding of the conditions of his release. . . ."

Review of physician orders for restraints included an initial order for seclusion at 12:00 p.m. on 05/07/10 for a four hour time period; a renewed order at 4:30 p.m. on 05/07/10 for seclusion for a four hour time period; and an order dated 05/07/10 at 8:44 p.m. for "Keyed leather, order valid for 4 hrs, [hours] Evaluate patient, order Restraint Continue Behavioral if indicated."

The orders lacked evidence of review and renewal for seclusion and locked leather restraints at least every four hours. In addition, the simultaneous use of seclusion and physical restraints lacked evidence of continuous monitoring.

The record lacked evidence of evaluation of the escalation in the patient's behavior after placement in the seclusion room and when simultaneously placed in leather four point restraints and seclusion; and the impact the use of seclusion and restraints placed on the safety of Patient #20, as well as staff.

- Observation on the medical unit, on 08/31/10 at approximately 1:00 p.m., showed Patient #9 asleep in bed with two half side rails raised on both sides of the bed (for a total of 4 half rails). During interview on 08/31/10 at 1:10 p.m., a supervisory nursing staff member (#9) stated staff raise all four side rails because Patient #9 is confused and "slithers" out of bed, or his "legs go off the side of the bed."

Review of Patient #9's current medical record occurred on August 31 - September 1, 2010. The medical record identified an admission date of 08/28/10, and medical diagnoses of urinary tract infection, dehydration, and dementia with psychosis. The nursing assessment identified Patient #9 as being at high risk for falls. Hospital staff initiated the restraint of "full side rails" at 3:00 p.m. on 08/28/10. Staff documented the following on the restraint initiation form: "Behavior Requiring Medical Restraint: Cognitive impairment that interferes with medical care . . . Behavior Description . . . Pt has a history of dementia and tries to climb out of bed, family was at bedside for awhile but pt began climbing as soon as they left. Medical Pre-Restraint Alternatives Attempted: Comfort measures, Presence of family/visitors. . . . Other: . . . Discussed restraints with the wife before she left
. . . She stated she would agree because they have used them before with previous admissions. . . ."

The physician's History and Physical Report for Patient #9 identified "The patient is to be carefully monitored, as he is at risk for fall (sic) and may require restraints as needed. . . ." The medical record identified physician's orders for the use of full side rails.

Hospital staff initiated full side rails when Patient #9 attempted to "climb" out of bed after his family left the room. The record lacked evidence hospital staff thoroughly and individually assessed Patient #9 for the safety risk of using full side rails. The use of side rail restraints for the prevention of falls on a confused patient had the potential to result in serious injury if Patient #9 attempted to climb over the side rails. The staff failed to use the least restrictive methods and approaches for Patient #9's confusion and falls prior to initiating full side rail restraints.

- Review of Patient #16's medical record occurred on 08/31/10 and showed the facility admitted the patient on 05/08/10. A variance report and a nurses note, dated 05/11/10, showed facility staff found Patient #16 "lying on right side on floor with port intact and catheter intact. Hematoma to right side of cheek, skin tears to right hand and wrist, skin tear to right knee. . . . Patient returned to bed with assist of 3. MD [medical doctor] notified. Roll belt applied. Bed alarm found in patient's pocket." The variance report showed Patient #16 fell as a result of "Trying to sit on BSC [bedside commode]." The variance report also showed Patient #16 had three side rails raised at the time the patient exited the bed and fell.

The record lacked evidence of assessment of Patient #16 for least restrictive interventions prior to the application of the roll belt including assessment of the patient's care related needs and revisions to the plan of care to respond to the identified care needs of the patient.

The record also lacked assessment of the impact the raised side rails had on the patient's ability to exit the bed safely.

- Review of Patient #17's record occurred on 08/31/10 and showed the facility admitted the patient on 05/09/10. Patient #17's medical record and a variance report, dated 05/12/10, showed the patient experienced a fall on either 05/12/10 or 05/13/10. Dates in nurse's notes and the date on the variance report did not correlate, but both described the following: A security guard noticed Patient #17 squatting by her bed, holding onto the bed, and notified a nurse.

Following the above described fall, the variance report indicated the facility implemented the following action(s): "More frequent checks, bed alarm on, new order for roll belt."

The record lacked evidence the facility determined the need for the roll belt restraint as necessary and/or least restrictive. The facility implemented the roll belt restraint at the same time as they implemented the use of a bed alarm and increased monitoring. In addition, the record lacked evidence of assessment of the cause/reason Patient #17 attempted to get out of bed. The record identified Patient #17 as "very confused," however, the record lacked evidence the facility attempted to determine, through a process of assessment, whether the patient experienced an unmet care related need necessitating getting up unassisted.

The record lacked evidence of monitoring Patient #17's reaction and safety related problems with the restraint. In addition, the record lacked evidence of physician orders for the initiation of the restraint and review and renewal of the order at least every twenty-four hours.

An interview with an administrative staff member (#1), occurred on the morning of 09/01/10, to request evidence of the restraint monitoring completed while Patient #17 remained in restraints and physician orders for the use of the restraint. Information provided by the facility failed to include evidence of restraint monitoring and physician orders for the roll belt restraint the facility implemented following the fall experienced by Patient #17.

- Review of Patient #19's medical record and a variance report, dated 05/20/10, showed the facility admitted the patient on 05/20/10 to the facility's mental health unit. The record showed Patient #19 presented to the emergency room during the early morning hours of 05/20/10 with suicidal ideation, and the facility admitted the patient to the mental health unit.

Nurses notes following admission stated:
* 05/20/2010 at 6:30 a.m. - "Patient was an admission on the night shift. . . . Per report from ER [emergency room] patient has been on suicide watch for the last week and would not contract for safety. . . . She was calm during the intake process. She spent the rest of the shift asleep in the quiet room."
*05/20/10 at 5:38 p.m. - "Patient spent the morning in the quiet room with the door unlocked as she spent the night there after being admitted. Patient contracted for safety and was let out for lunch. Patient ate meals with a good appetite. Patient came up shortly after going to her room after lunch and told staff she hurt herself with an eraser and showed staff a burn mark on her right wrist and forearm. Patient was instructed to go back to the quiet room and was compliant with this. Around 2 p.m. patient wanted to come out and was instructed by the doctor she had to stay in there for a couple more hours and if she had no behaviors then she could come out. After the doctor left [the] patient left the quiet room and barricaded herself in her room. It took several staff to open the door and when patient refused to go back to the quiet room staff [four staff members according to variance report] had to carry patient back to the quiet room. Patient screamed, kicked, hit, and tried to bite staff. Patient was sat on the bed and when staff let go patient rushed for the door and tried to get out again. Staff again had to hold patient down on the bed all the while patient was flailing limbs trying to kick and hit staff and bite. . . . Patient screamed extremely loud for about 5-10 minutes. Patient was ordered to be put into 4 point restraints and these were put on while patient was resisting and shouting. Patient was told multiple times that if she calmed down and stayed in quiet room that she would not need to be in restraints however patient refused to listen to staff repeatedly yelled, 'shut up.' Once patient was in restraints patient continued to yell and did get out of her right wrist restraint. Patient put back in and told that if she quit fighting that she could get out. Patient said it was hurting her and patient instructed to stop pulling on restraint and it would not hurt. Patient did calm down after this and was able to talk calmly to staff. . . . Patient was taken out of her right wrist restraint at 5 p.m. and at 5:30 p.m. was taken out of her right leg restraint. Patient had no behaviors at this time and ate supper . . . Patient is contracting for safety at this time and denies any self harm thoughts. At 6:30 p.m. left leg and left arm released from restraints and patient allowed to return to assigned room . . . Patient does have eraser burns and self harm scratches on bilateral forearms. . . Patient verbalized understanding of criteria for discontinuing restraints and re-initiation of restraints as well, patient affect is bland and will smile at times. . . ."

The record lacked evidence of the reason staff placed Patient #19 in the "quiet" room initially during the night shift on 05/20/10. The record indicated staff prevented Patient #19
from leaving the "quiet room" even though the door remained unlocked. This approach would constitute seclusion, however, the record lacked a plan and orders for seclusion until an order, dated 05/20/10 at 2:33 p.m., stated, "Continuing Restraint Orders Daily - Order Details - 05/20/10 14:32:00 [2:32 p.m.], Constant order. Review Information: N/A [not applicable]." The order did not include orders for specific restraint/seclusion measures and did not include time limits for the use of the restraints.

The record lacked evidence of any additional orders regarding physically restraining and the seclusion of Patient #19. The medical record identified Patient #19 as a thirteen year old. Patient #19's medical record showed the patient remained physically restrained while in seclusion from 2:15 p.m. until 6:45 p.m. on 05/20/10, without evidence of review of the patient by a licensed practitioner and renewal of the orders at least every two hours.

The record lacked evidence of injuries/harm Patient #19 may have incurred as a result of the manual restraint/holding by staff and the four-point restraints applied and resisted by Patient #19. The nurses notes identified a self-inflicted burn mark to Patient #19's right wrist and forearm shortly after lunch on 05/20/10. After the episode involving staff members' manual removal of the patient from her room, staff holding the patient down on the bed in the seclusion room, the application of the four point restraints, and the patient's resistance to the restraints, the nurse's notes identified Patient #19 had "eraser burns and self harm scratches" on bilateral forearms. The record lacked evidence facility staff assessed the additional injuries for cause and determined if the patient sustained additional injuries as a result of the restraining mechanisms.

The record lacked evidence facility staff determined the least restrictive means of managing Patient #19's behavior(s) prior to placing the patient in seclusion during the night of admission to the facility and lacked evidence of alternative interventions other than returning the patient to seclusion following the patient's self-admission of harming herself with an eraser. The record failed to provide evidence the facility removed/eliminated items and opportunities for Patient #19 to inflict self-harm other than through the use of seclusion and/or restraint.

- Reviewed on 09/01/10, Patient #25's medical record included the following nurse's note, dated 04/28/10 at 6:27 a.m. - "Pt. was awake for part of the night in the gerichair in quiet room 2, resting on and off. She was quiet and showed no aggression." The record identified Patient #25 experienced a fall while in a facility observation room prior to admission to the mental health unit.

Patient #25's record lacked evidence of an assessment for the use of the seclusion and restraint, lacked evidence of attempted less restrictive interventions, lacked evidence of monitoring of Patient #25 while secluded and restrained, lacked physician orders for the use of seclusion and restraints, and lacked evidence of the time Patient #25 was in seclusion and physically restrained.

During an interview on the morning of 09/01/10 with an administrative staff member (#1) the staff member indicated the facility had no additional information regarding the need for placement of Patient #25 in seclusion and in restraints.

- Review of Patient #2's current inpatient record occurred on August 30 - September 1, 2010. The medical record identified admission to the mental health unit on 08/14/10 with a diagnosis of dementia with behavioral disturbance.

Review of "Nursing Rounds" notes identified staff brought Patient #2 to the "quiet room" at 2:45 a.m. on 08/15/10 as he got out of bed, yelled in the hallway, and could not be redirected. Documentation of "Nursing Rounds" identified placement of Patient #2 in the "Seclusion Room" off and on from 08/15/10 to 08/18/10. The notes do not identify whether staff placed Patient #2 in Room #1 or Room #2, nor do they identify if the door is closed and/or locked, with the exception of one note which identified "quiet room observation door open."

Review of Nursing Progress Notes for Patient #2 from 08/15/10 and 08/16/10 identify the patient as irritable, agitated, and difficult to re- direct. The notes indicated "one-to-one with staff" due to his wandering and impulsivity and "pt is sleeping in the quiet room so staff can watch him." Hospital staff failed to assess the use of this room as seclusion and to evaluate the effect it had on Patient #2's affect and behavior. Staff failed to implement the least restrictive interv

Based on record review, policy and procedure review, professional reference review, and staff interview, during the complaint investigation completed 09/01/10, the hospital failed to ensure the use of restraint and/or seclusion only in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient for 1 of 1 current patient (Patient #2) and 5 of 5 closed records (Patients #11, #17, #19, #20, and #25) reviewed of patients restrained and/or secluded. Failure to ensure the use of restraints and/or seclusion only in accordance with the order of a physician or LIP has the potential for inappropriate use of restraint or seclusion, which could result in physical or psychological harm.

Findings include:

Review of hospital policy "Restraints/Seclusion" occurred on 09/01/10. This policy, dated 05/2008, stated, "Purpose: To outline the components necessary for safe use of restraints when utilized to protect the patient or others from injury. Policy: . . . commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/her self or others. . . . strive to create a safe environment where restraint use can be prevented or where alternatives to restrain can be employed. . . . 2. Restraint Order *RN initiates order only if LIP [licensed independent practitioner] is not available *Notify LIP within 12 hours (immediately if significant change in patient condition) to obtain verbal or written order 3. Patient Exam/Order Time Limit *LIP examines pt. [patient] and writes renewal order within 24 hours of initiation. Renewal order and re-exam required at least every 24 hours . . . 4. Monitoring of the patient in restraint * At least every 2 hours *Requires observation, direct interaction or examination by a nurse or LIP 5. Discontinuation of Restraint *Restraints are terminated as soon as possible
. . . Restraint use for Behavioral Health Care. 1. Assessment *Patient Admission Assessment Data - Use to identify ways of mitigating patient's behavior, therefore minimizing the need to use restraint or seclusion. *The RN, in collaboration with the Charge Nurse or Supervisor, assesses the need for patient restraint *After assessment, chooses least restrictive restraint method 2. Restraint Order *RN initiates order only if LIP is not available *Within one hour, RN consults with LIP and together, they identify ways to help the patient regain control . . . 3. Patient Exam/Order Time Limit *Adult patient (age 18 or greater) - Initially, LIP examines within 4 hours. Order is time specific and limited to 4 hours. RN may reassess and reorder in 4 hour time periods up to 8 hours. LIP then re-evaluates and reorders every 8 hours. *Youth/child (age 17 or younger) - Initially, LIP examines within 2 hours. Order is time specific and limited to 2 hours (ages 9 to 17) or 1 hour (age <9). RN may reassess and reorder every one or two hours up to 4 hours. LIP re-evaluates and reorders every 4 hours. 4. Patient Education *As soon as possible, explain rationale for restraint/seclusion and the behavior that must be met for its discontinuation. 5. Monitoring of the patient in restraint. *Every 15 minutes *Requires assessment, as appropriate, to type of restraint or seclusion including: *signs of injury from restraint . . . Affect/Behavior . . . *Seclusion without restraint - may be monitored continuously via audiovisual monitoring after the first hour. 6. Discontinuation of restraint *Restraints are terminated as soon as possible but may later be reapplied within the time-limit of an order if patient behavior warrants. . . ."

Federal regulations require staff obtain an order from the physician or LIP prior to the application of restraint or seclusion. In an emergency situation, the need for a restraint or seclusion intervention may occur so quickly staff cannot obtain an order prior to the application of restraint or seclusion. In these emergency application situations, staff must obtain the order either during the emergency application of the restraint or seclusion or immediately (within a few minutes) after staff apply the restraint or seclusion. The failure to immediately obtain an order is viewed as the application of restraint or seclusion without an order.

The hospital's Restraint/Seclusion policy on restraint use for behaviors allows the RN to initiate a restraint order if the LIP is not available and within one hour, consult with the LIP to identify ways to help the patient regain control. The policy stated the LIP will then give an order whether or not to continue the restraint.

The hospital's policy on restraint use for Medical and Surgical Care allows the RN to initiate a restraint order if the LIP is not available and to notify the LIP within 12 hours (immediately if significant change in patient condition) to obtain verbal or written order. This policy does not comply with the regulation requiring a physician or other LIP to order restraints or seclusion prior to application, unless it is an emergency situation, in which staff would obtain an order during or immediately after application of the restraint or seclusion.

- Review of Patient #2's current inpatient record occurred on August 30 - September 1, 2010. The medical record identified admission to the mental health unit on 08/14/10 with a diagnosis of dementia with behavioral disturbance.

Review of "Nursing Rounds" notes identified staff brought Patient #2 to the "quiet room" at 2:45 a.m. on 08/15/10 as he got out of bed, yelled in the hallway, and could not be redirected. Documentation of "Nursing Rounds" identify placement of Patient #2 in the "Seclusion Room" off and on from 08/15/10 to 08/18/10. The notes failed to identify whether staff closed and/or locked the door to the seclusion room, with the exception of one note which identified "quiet room observation door open."

Hospital staff failed to assess the use of this room as seclusion and to evaluate the effect it had on Patient #2's affect and behavior. Staff failed to implement the least restrictive intervention to manage Patient #2's behavior prior to placement in the seclusion room. The record lacked evidence of a physician's orders for the initiation and continuation of seclusion from 08/15/10 to 08/18/10.

- Review of Patient #11's closed record occurred on August 30 - September 1, 2010. The record identified admission to the inpatient mental health unit on 04/20/10 with a diagnosis of senile dementia.

The "Nursing Rounds" documentation identified staff placed Patient #11 in the "quiet room" at 6:32 p.m. on 04/21/10. The notes indicated Patient #11 remained in this room for the majority of her hospital stay until discharge to the emergency room on 04/22/10. The documentation also identified the use of a geriatric chair while in the quiet room, but failed to indicate if staff used the tray table on the chair.

The nurse's notes identified placement of Patient #11 in the "quiet room" when she became agitated and confused. The medical record failed to identify if staff locked the door to this room and failed to identify the frequency of staff monitoring during the time the patient occupied this room. Hospital staff failed to assess the use of this room as seclusion and to evaluate the effect it had on Patient #11's affect and behavior. Documentation in the medical record showed Patient #11's behavior did not improve after placement in the "quiet room" and at times escalated. The nurse's notes identified Patient #11 sitting in a geriatric chair in the quiet room. The medical record lacked evidence staff assessed the use of the geriatric chair as a restraint for Patient #11 and whether staff could have used a less restrictive chair. The medical record lacked evidence of a physician's order for use of the seclusion room and/or use of the geriatric chair.

- Review of Patient #17's record occurred 08/31/10 and showed the facility admitted the patient on 05/09/10. Patient #17's medical record and a variance report dated 05/12/10 showed the patient experienced a fall on either 05/12/10 or 05/13/10, as dates in nurses notes and the date on the variance report did not correlate. Both described the following: A security guard noticed Patient #17 squatting by her bed, holding onto the bed, and notified a nurse.

Following the above described fall, the variance report indicated the facility implemented the following action(s), "More frequent checks, bed alarm on, new order for roll belt." The record lacked evidence of physician orders for the initiation of the restraint and review and renewal of the order at least every twenty-four hours.

- Review of Patient #19's medical record and a variance report dated 05/20/10, showed the facility admitted the patient on 05/20/10 to the facility's mental health unit. The medical record showed Patient #19 presented to the emergency room during the early morning hours of 05/20/10 with suicidal ideation, and the facility admitted the patient to the mental health unit.

Nurse's notes following admission stated:
* 05/20/2010 at 6:30 a.m. - "Patient was an admission on the night shift. . . . Per report from ER [emergency room] patient has been on suicide watch for the last week and would not contract for safety. . . . She was calm during the intake process. She spent the rest of the shift asleep in the quiet room."
*05/20/10 at 5:38 p.m. - "Patient spent the morning in the quiet room with the door unlocked as she spent the night there after being admitted. Patient contracted for safety and was let out for lunch. Patient ate meals with a good appetite. Patient came up shortly after going to her room after lunch and told staff she hurt herself with an eraser and showed staff a burn mark on her right wrist and forearm. Patient was instructed to to go back to the quiet room and was compliant with this. Around 2 p.m. patient wanted to come out and was instructed by the doctor she had to stay in there for a couple more hours and if she had no behaviors then she could come out. After the doctor left [the] patient left the quiet room and barricaded herself in her room. It took several staff to open the door and when patient refused to go back to the quiet room staff [four staff members according to variance report] had to carry patient back to the quiet room. Patient screamed, kicked, hit, and tried to bite staff. Patient was sat on the bed and when staff let go patient rushed for the door and tried to get out again. Staff again had to hold patient down on the bed all the while patient was flailing limbs trying to kick and hit staff and bite. . . . Patient screamed extremely loud for about 5-10 minutes. Patient was ordered to be put into 4 point restraints and these were put on while patient was resisting and shouting. Patient was told multiple times that if she calmed down and stayed in quiet room that she would not need to be in restraints however patient refused to listen to staff repeatedly yelled, 'shut up.' Once patient was in restraints patient continued to yell and did get out of her right wrist restraint. Patient put back in and told that if she quit fighting that she could get out. Patient said it was hurting her and patient instructed to stop pulling on restraint and it would not hurt. Patient did calm down after this and was able to talk calmly to staff. . . . Patient was taken out of her right wrist restraint at 5 p.m. and at 5:30 p.m. was taken out of her right leg restraint. Patient had no behaviors at this time and ate supper . . . Patient is contracting for safety at this time and denies any self harm thoughts. At 6:30 p.m. left leg and left arm released from restraints and patient allowed to return to assigned room . . . Patient does have eraser burns and self harm scratches on bilateral fore-arms . . . Patient verbalized understanding of criteria for discontinuing restraints and re-initiation of restraints as well, patient affect is bland and will smile at times. . . ."

The medical record lacked evidence of the reason staff placed Patient #19 in the "quiet" room initially during the night shift on 05/20/10. The record indicated staff prevented Patient #19 from leaving the "quiet room" even though the door remained unlocked. This approach would constitute seclusion. The medical record lacked evidence of orders for seclusion until an order dated 05/20/10 at 2:33 p.m. which stated, "Continuing Restraint Orders Daily - Order Details - 05/20/10 14:32:00 [2:32 p.m.], Constant order. Review Information: N/A [not applicable]." The order did not include specifics for restraint/seclusion measures and did not include time limits for the use of the restraints.

The medical record identified Patient #19 as thirteen years old. The medical record lacked evidence of any additional orders regarding physically restraining and the seclusion of Patient #19. Patient #19 remained physically restrained and in seclusion from 2:15 p.m. until 6:45 p.m. on 05/20/10, without evidence of review of the patient by a licensed practitioner and renewal of the orders at least every two hours.

- Review of Patient #20's medical record occurred 08/30/10 and showed the facility admitted the patient to the mental health unit on 05/01/10. Nurse's notes on the evening of 05/06/10 stated, "Patient was down in the lounge and thought people were talking about his acne and they were talking about a girl on tv with clear skin, patient started yelling and threw a chair, patient was escorted to the quiet room, he was yelling and cursing, doctor was called and patient was ordered meds to help calm him down and he was told he would be sleeping in the quiet room, patient was jumping and tapping the camera, making obscene hand gestures and showing his naked bottom."

A "Security Flow Sheet" showed Patient #20 remained in seclusion from 8:20 a.m. on 05/07/10 until 4:10 p.m. on 05/08/10 (thirty-two hours). In addition, the flow sheet showed while Patient #20 remained in seclusion, staff applied four point restraints at 8:42 p.m. on 05/07/10. The patient remained physically restrained until both the restraints and the seclusion ended at 4:10 p.m. on 05/08/10.

Physician orders for restraints included an initial order for seclusion at 12:00 p.m. on 05/07/10 for a four hour time period; a renewed order at 4:30 p.m. on 05/07/10 for seclusion for a four hour time period; and an order dated 05/07/10 at 8:44 p.m. for "Keyed leather, order valid for 4 hrs, [hours] Evaluate patient, order Restraint Continue Behavioral if indicated."

Patient #20's physician orders lacked evidence of review and renewal of the seclusion and the locked leather restraints at least every four hours.

- Review of Patient #25's medical record occurred 09/01/10. A nurse's note, dated 04/28/10 at 6:27 a.m., stated, "Pt. was awake for part of the night in the gerichair in quiet room 2, resting on and off. She was quiet and showed no aggression."

Patient #25's medical record lacked evidence of the amount of time Patient #25 remained in seclusion and restraints and lacked physician orders for the use of seclusion and restraints.

During an interview on the morning of 09/01/10, an administrative staff member (#1) indicated the facility had no additional information regarding the time Patient #25 remained restrained and secluded and did not provide information regarding physician orders for the use of seclusion and restraints for Patient #25.

Based on record review and variance report review, during the complaint investigation completed 09/01/10, the facility failed to ensure a physician or licensed independent practitioner renewed orders for restraints and seclusion at least every two hours for 1 of 1 sampled patient 9-17 years of age (Patient #19) and every four hours for 1 of 1 sampled adult patient (Patient #20) restrained in excess of 4 hours. Failure to review and renew restraint orders at specified times limits/prevents the release/ending of restraints at the earliest possible time.

Findings include:

- Reviewed on 08/31/10, Patient #19's medical record and a variance report dated 05/20/10 showed the facility admitted the patient on 05/20/10 to the facility's mental health unit. The record showed Patient #19 presented to the emergency room during the early morning hours of 05/20/10 with suicidal ideation, and the facility admitted the patient to the mental health unit.

Nurse's notes following admission stated the following:
*05/20/2010 at 6:30 a.m. - "Patient was an admission on the night shift. . . . Per report from ER [emergency room] patient has been on suicide watch for the last week and would not contract for safety. . . . She was calm during the intake process. She spent the rest of the shift asleep in the quiet room."
*05/20/10 at 5:38 p.m. - "Patient spent the morning in the quiet room with the door unlocked as she spent the night there after being admitted. Patient contracted for safety and was let out for lunch. Patient ate meals with a good appetite. Patient came up shortly after going to her room after lunch and told staff she hurt herself with an eraser and showed staff a burn mark on her right wrist and forearm. Patient was instructed to go back to the quiet room and was compliant with this. Around 2 p.m. patient wanted to come out and was instructed by the doctor she had to stay in there for a couple more hours and if she had no behaviors then she could come out. After the doctor left [the] patient left the quiet room and barricaded herself in her room. It took several staff to open the door and when patient refused to go back to the quiet room staff [four staff members according to variance report] had to carry patient back to the quiet room. Patient screamed, kicked, hit, and tried to bite staff. Patient was sat on the bed and when staff let go patient rushed for the door and tried to get out again. Staff again had to hold patient down on the bed all the while patient was flailing limbs trying to kick and hit staff and bite. . . . Patient screamed extremely loud for about 5-10 minutes. Patient was ordered to be put into 4 point restraints and these were put on while patient was resisting and shouting. . . . Patient was taken out of her right wrist restraint at 5 p.m. and at 5:30 p.m. was taken out of her right leg restraint. Patient had no behaviors at this time and ate supper . . . Patient is contracting for safety at this time and denies any self harm thoughts. At 6:30 p.m. left leg and left arm released from restraints and patient allowed to return to assigned room. . . ."

The record lacked evidence of the the reason staff placed Patient #19 in the "quiet" room initially during the night shift on 05/20/10. The record indicated staff prevented Patient #19
from leaving the "quiet room" even though the door remained unlocked. This approach would constitute seclusion. The record lacked a plan and orders for seclusion until an order dated 05/20/10 at 2:33 p.m. stated, "Continuing Restraint Orders Daily - Order Details - 05/20/10 14:32:00 [2:32 p.m.], Constant order. Review Information: N/A [not applicable]." The order did not include orders for specific restraint/seclusion measures and did not include time limits for the use of the restraints.

The record lacked evidence of any additional orders regarding physically restraining and the seclusion of Patient #19. The medical record identified Patient #19 as a thirteen year old. Patient #19's medical record showed the patient remained physically restrained while in seclusion from 2:15 p.m. until 6:45 p.m. on 05/20/10 without evidence of review of the patient by a licensed practitioner and renewal of the orders at least every two hours.

- Review of Patient #20's medical record occurred 08/31/10 and showed the facility admitted the patient to the mental health unit on 05/01/10. Nurse's notes on the evening of 05/06/10 stated, "Patient was down in the lounge and thought people were talking about his acne and they were talking about a girl on tv with clear skin, patient started yelling and threw a chair, patient was escorted to the quiet room, he was yelling and cursing, doctor was called and patient was ordered meds to help calm him down and he was told he would be sleeping in the quiet room, patient was jumping and tapping the camera, making obscene hand gestures and showing his naked bottom."

A "Security Flow Sheet" showed Patient #20 remained in seclusion from 8:20 a.m. on 05/07/10 until 4:10 p.m. on 05/08/10 (thirty-two hours). In addition, the flow sheet showed while Patient #20 remained in seclusion, staff applied four point restraints at 8:42 p.m. on 05/07/10, and the patient remained physically restrained until both the restraints and the seclusion ended at 4:10 p.m. on 05/08/10.

Physician orders for restraints included an initial order for seclusion at 12:00 p.m. on 05/07/10 for a four hour time period; a renewed order at 4:30 p.m. on 05/07/10 for seclusion for a four hour time period; and an order dated 05/07/10 at 8:44 p.m. for "Keyed leather, order valid for 4 hrs, [hours] Evaluate patient, order Restraint Continue Behavioral if indicated."

Patient #20's physician orders lacked evidence of review and renewal of the seclusion and the locked leather restraints at least every four hours.

Based on record review, review of variance reports, review of facility policy/procedure, and staff interview, during the complaint investigation completed on 09/01/10, the facility failed to provide continuous monitoring for 3 of 3 sampled patients (Patient #19, #20, and #25) with seclusion and physical restraints used simultaneously. Failure to provide continuous monitoring during simultaneous use of seclusion and restraints placed patients at risk for a lack of response to care related needs and adequate monitoring to ensure the safety of the patient.

Findings include:

Review of the facility's policy/procedure "Restraints/Seclusion"occurred on 08/31/10. This policy, reviewed/revised 08/2010, failed to address specific policies/procedures related to the simultaneous use of seclusion and restraints including the need for continuous monitoring.

- Review of Patient #19's medical record and a variance report dated 05/20/10 showed the facility admitted the patient on 05/20/10 to the facility's mental health unit. The record showed Patient #19 presented to the emergency room during the early morning hours of 05/20/10 with suicidal ideation, and the facility admitted the patient to the mental health unit.

Nurse's notes from 05/20/10 at 5:38 p.m. stated, "Patient spent the morning in the quiet room with the door unlocked as she spent the night there after being admitted. Patient contracted for safety and was let out for lunch. Patient ate meals with a good appetite. Patient came up shortly after going to her room after lunch and told staff she hurt herself with an eraser and showed staff a burn mark on her right wrist and forearm. Patient was instructed to go back to the quiet room and was compliant with this. Around 2 p.m. patient wanted to come out and was instructed by the doctor she had to stay in there for a couple more hours and if she had no behaviors then she could come out. After the doctor left [the] patient left the quiet room and barricaded herself in her room. It took several staff to open the door and when patient refused to go back to the quiet room staff [four staff members according to variance report] had to carry patient back to the quiet room. Patient screamed, kicked, hit, and tried to bite staff. Patient was sat on the bed and when staff let go patient rushed for the door and tried to get out again. Staff again had to hold patient down on the bed all the while patient was flailing limbs trying to kick and hit staff and bite. . . . Patient screamed extremely loud for about 5-10 minutes. Patient was ordered to be put into 4 point restraints and these were put on while patient was resisting and shouting. Patient was told multiple times that if she calmed down and stayed in quiet room that she would not need to be in restraints however patient refused to listen to staff, repeatedly yelled, 'shut up.' Once patient was in restraints patient continued to yell and did get out of her right wrist restraint. Patient put back in and told that if she quit fighting that she could get out. Patient said it was hurting her and patient instructed to stop pulling on restraint and it would not hurt. Patient did calm down after this and was able to talk calmly to staff. . . . Patient was taken out of her right wrist restraint at 5 p.m. and at 5:30 p.m. was taken out of her right leg restraint. Patient had no behaviors at this time and ate supper . . . Patient is contracting for safety at this time and denies any self harm thoughts. At 6:30 p.m. left leg and left arm released from restraints and patient allowed to return to assigned room. . . ."

The record included a "Security Flow Sheet" indicating staff monitored Patient #19 at fifteen minute intervals from 2:15 p.m. until 6:45 p.m. on 05/20/10. The nurses notes, plan of care, and physician orders lacked evidence of continuous monitoring of Patient #19 during the simultaneous use of seclusion and physical restraints.

- Review of Patient #20's medical record occurred 08/31/10 and showed the facility admitted the patient to the mental health unit on 05/01/10. Nurse's notes on the evening of 05/06/10 stated, "Patient was down in the lounge and thought people were talking about his acne and they were talking about a girl on tv with clear skin, patient started yelling and threw a chair, patient was escorted to the quiet room . . ."

Nurse's notes and a variance report showed Patient #20's behavior escalated after being placed in seclusion, and at 8:42 p.m. on 05/07/10, while the patient remained in seclusion, staff placed the patient in four point leather locked restraints.

A "Security Flow Sheet" showed Patient #20 remained in seclusion and leather locked restraints from 8:42 p.m. on 05/07/10 until 4:10 p.m. on 05/08/10. The flow sheet indicated staff monitored Patient #20 every fifteen minutes during this time period. The nurse's notes, plan of care, and physician orders lacked evidence of continuous monitoring of Patient #20 during the simultaneous use of seclusion and physical restraints. In addition, the above referenced variance report and nurse's notes indicate continuous monitoring did not occur due to the occurrence of incidents allowing the patient to chew through all four leather restraints, break another leather restraint, break the glass in the seclusion room door, and open two of the deadbolt locks on the door's exterior, with no evidence of intervention prior to these incidents, and the use of an approximate time of occurrence when documenting each incident. The flow sheet showed Patient #20 urinated on the floor during the simultaneous use of seclusion and physical restraints. The lack of continuous monitoring did not allow staff to address/meet the patient's care related needs.

- Review of Patient #25's medical record occurred 09/01/10. A nurse's note dated 04/28/10 at 6:27 a.m. stated, "Pt. [patient] was awake for part of the night in the gerichair in quiet room 2, resting on and off. She was quiet and showed no aggression."

Patient #25's record lacked evidence of an assessment for simultaneous use of seclusion and restraint, lacked evidence of attempted less restrictive interventions, lacked evidence of monitoring of Patient #25 while being simultaneously secluded and restrained, lacked physician orders for the use of seclusion and restraints, and lacked evidence of the time Patient #25 spent in seclusion and physical restraints.

An interview occurred on the morning of 09/01/10 with an administrative staff person (#1) to review the above findings and allow the facility to provide additional information. The facility did not provide additional information indicating staff continuously monitored Patient #19, #20, and #25 when simultaneously secluded and restrained.

13246

Based on review of information submitted by the complainant, record review, policy and procedure review, and variance report review, the hospital failed to ensure the nursing staff developed a plan of care for each patient and implemented appropriate interventions based on the assessment of patient needs for 4 of 4 closed records (Patient #11, #16, #17, and #18) reviewed during the complaint investigation completed 09/01/10 of patients who experienced falls and/or injuries and variance reports of 1 of 2 patients (Patient #80) reviewed during the full recertification survey completed 10/21/10 who experienced falls while attempting to self toilet. Failure to develop and implement a plan of care specific to each individual patient's strengths and needs has the potential to result in the patient not attaining or maintaining their highest practicable level of physical or psychological functioning.

Findings include:

Review of the Inpatient Mental Health Unit's policy, "Patient Assessment Treatment Planning and Discharge Planning," occurred on 09/01/10. This policy, dated August 2008, stated, "POLICY: . . . 2. Each patient shall have a comprehensive interdisciplinary treatment plan based on assessment of patient's needs and strengths. . . . 3. All disciplines represented on the treatment team shall have input into the development of the treatment plan, as determined by the patient's need, and this input shall be documented. 4. Each treatment plan is developed and implemented by the treatment team under the direction of the attending psychiatrist. 5. Patient, family, friends, significant others and community resources, as appropriate, are included in the treatment process to include development and participation. 6. Short term and long term goals are established and are stated in measurable behavioral terms along with the intervention/action required. An initial treatment plan and weekly progress review are conducted to assess progress toward goals, establish new goals and adjust treatment interventions as necessary or desirable. 7. All patients and their families shall be assessed for family/marital therapy needs. Whenever possible, families should be involved in the assessment, planning and implementation of treatment and is considered an important part of treatment. Every effort will be made to keep families informed and involved."

Review of the Inpatient Mental Health Unit's policy, "Behavior Management" occurred on 09/01/10. This policy, dated August 2008, stated, "PURPOSE: provide a safe nonviolent behavior management technique designed to prevent an escalating situation and to provide the best possible care and welfare of the assaultive, disruptive, or out-of-control person(s). POLICY: 1. Implementation *Identify preventative techniques of nonviolent crisis intervention . . . *No procedure that physically hurts/harms, or is a psychological risk to the patient, is allowed. . . ."

- Information submitted by the complainant (dated 05/03/10) to another State agency and forwarded to the North Dakota Department of Health, Division of Health Facilities identified the following allegations/grievances: (1) The complainant admitted his wife (Patient #11) to the facility's mental health unit on 04/20/10. At the time of admission, his wife had no bruises or injuries to her body. (2) On the afternoon of 04/21/10, the facility called and informed the complainant his wife "was acting up" and they were going to put her in the "quiet room." (3) The facility called the complainant on the morning of 04/22/10, and informed the complainant his wife "had some bruising and suggested it might have happened elsewhere," and the ambulance had taken his wife to the emergency room. (4) When the complainant arrived and saw his wife in the emergency room, "I was in shock when I seen the bruising that was on her body. She had bruising on her left shoulder, breast, back, arm, head, knees (both) left hip, and right hand." (5) X-rays taken by the facility also showed the complainant's wife had a fractured clavicle.

Review of Patient #11's closed record occurred on August 30-31, 2010. The record identified admission to the Emergency Room (ER) on 04/20/10 with a medical diagnosis of senile dementia. Review of the ER nurse's notes regarding Patient #11's skin assessment identified her skin as "within normal limits." The assessment identified no pain symptoms. The physician's ER note did not identify bruising of the skin or any pain issues. Hospital staff transferred Patient #11 from the ER to the inpatient mental health unit for admission.

The admission nursing assessment on the mental health unit identified Patient #11's skin as warm, dry and intact, with no documentation of bruising. The assessment also identified no pain. The Adult Psychiatric Admission Data Sheet identified nursing diagnoses of anxiety, sleep pattern disturbance, and acute confusion. Nursing staff documented "Family support" as an identified strength for the patient and "Cognitive ability" as a weakness. The "Health Treatment Plan," dated 04/20/10, identified the following nursing interventions for Patient #11: "administer ordered meds [medications], med education, encourage group, observe thought process and behaviors, assist [with] ADLs [activities of daily living] as needed."

The "Nursing Rounds" documentation identified the following:
April 21, 2010
*12:24 p.m. - "Nurse Quick Assessment: Awake, Agitated, Alert, Calm, Confused, Cooperative, Disorientated, No distress noted, Restless"
*6:32 p.m. - ". . . qr [quiet room]. . ."
*8:36 p.m. - ". . . qr. . ."
*11:52 p.m. - ". . . qr. . ."
April 22, 2010
*1:15 a.m. - ". . . in quiet room."
*2:15 a.m. - "Awake, Agitated, Confused, Disoriented, Restless . . . Laying on floor, pushing herself around . . . In quiet room."
*3:14 a.m. - "Awake, Agitated, Confused, Disorientated, Restless . . . Laying on the floor . . . In quiet room."
*4:09 a.m. - "Awake, Agitated, Confused, Disoriented, Restless, Uncooperative . . . Laying on the floor. . . . In quiet room."
*5:54 a.m. - ". . . Laying on the floor . . . In quiet room."
*7:10 a.m. - "Awake, Agitated, Combative, Confused, Disorientated . . . In geri chair . . . in quiet room."
*9:57 a.m. - "Resting . . . quiet room 1"
*10:17 a.m. - "Awake . . . in gerichair in quiet room"
*10:19 a.m. (Adult Psychiatric Ongoing Assessment) - "Skin Symptoms: Bruising . . ." *1:34 p.m. - "Awake . . . sitting quietly in gerichair . . ."

The "Nursing Progress Notes" identified the following:
04/21/10 at 10:36 p.m. - "Pt [patient] very anxious, delusional, confused, frantic . . . Staff attempted to redirect pt. and she then flopped to the ground and began rolling around. Pt. resisted staff when they attempted to help her up. Pt. was eventually taken to the quiet room by three staff and placed on bed. She continued to act irrational . . . Pt. rolled around on the bed and then onto the floor. She grabbed her glasses and twisted the frames and caused one the the lenses to pop out. . . . Pt. also swung at staff when they attempted to asssist (sic) her up to the bed. Pt continued to yell out through much of shift, rolling on the floor, banging on the door, refused all medications. Despite getting off the bed and rolling around and then kicking and hitting door, pt. refused to get up off of floor. 2 staff had to assist pt. up to the bed. Pt. eventually did calm down and remained in bed and fell asleep at about 9 pm. Pts right hand middle finger appeared to be bruised."
04/22/10 at 5:58 a.m. - "Patient complained of pain whenever she was touched by staff. She said her leg, shoulder and hip were broken. She would not stay in bed throughout the night. She does have a purple and red bruise to her left shoulder."
04/22/10 at 1:10 p.m. - "Pt spent the morning sitting in the gerichair in the quiet room. She was hyperverbal while speaking to staff . . . She expressed excitement as staff entered her room throughout the morning, and requested that they stay longer and talk. She even thanked one staff member for getting so close to her . . . Pt did complain of feeling stiff, and felt like maybe something might be broken, but was unable to describe details of her discomfort. Pt was able to transfer herself from the gerichair to the bedside commode. . . ."
04/22/10 at 1:32 p.m. - "Spoke with patient's husband, [name], regarding large bruised area to Patient's left shoulder/chest area. [Name of patient's husband] states that he does not believe that patient fell, and the only thing he can think of, is when patient was in [name of licensed healthcare practitioner] office, patient had fallen back in a chair. . . . patient to be taken to radiology for xray of chest and possible of shoulder as well. . . . patient adamantly denies falling . . ." (The licensed healthcare practitioner's note, dated 04/20/10 at 2:00 p.m., identified the following during the clinic visit: ". . .Then she continues to tell me how the world is going to end . . . and she somewhat slumps over in the chair." The note lacked documentation of a fall or occurrence of injury.)
04/22/10 at 3:41 p.m. - "pt sent to ER at 1530 [3:30 p.m.] due to mental status change. . . . pt displays a blank stare and is unable to communicate with staff . . ."

The ambulance note, dated 04/22/10 at approximately 3:30 p.m., stated ". . . According to nursing staff, pt. has blacked out 3x [times] in the last hour, w/ [with] several falls. . . . We find above pt. sitting in a recliner, alert, confused and combative, pt. is pushing and trying to get out of the chair. . . . I then hold her hand and talk to her and she calms down, no longer fighting. . . ."

The ER physician's note, dated 04/22/10 at 5:31 p.m., identified a diagnosis of pneumonia, with plans to admit the patient to the intensive care unit (ICU). Note: the ER physician also documented "severe ecchymosis . . . to left chest wall into shoulder and back."

The "Nursing Interactive Flowsheet," dated 04/22/10 at 6:26 p.m. on admission to ICU, identified Patient #11 had bruising on her upper back, face, left shoulder, left hip and bilateral knees.

A physician's progress note, dated 04/24/10, stated, ". . . Plan: . . . I talked to her husband, who is really upset about the bruises that the patient has. I told him she had been really psychotic and aggressive . . . He was upset. I stated we are going to try to continue with her treatment and prevent any other trauma on the patient. . . ."

A physician's consult note, dated 04/24/10, regarding "an injury to the left shoulder," identified the following: ". . . tender at the left clavicle, left shoulder . . . She has extensive ecchymosis over the left side of the chest, left clavicle, left shoulder area. This appears to be a couple days old. CT scan of the left shoulder shows a fracture of the clavicle which is quite lateral and very likely intra-articular. . . ."

A physician's progress note dated 04/26/10, stated, ". . . Anemia. This appears to be acute blood loss from her extensive ecchymosis of the left shoulder. Her hemoglobin had been 14, now is 11.0. . . ."

The hospital failed to develop a plan of care for Patient #11 based on input and involvement from family prior to placing her in the "quiet room." Patient #11's behavior did not improve while in the quiet room, and staff failed to evaluate and revise the plan of care. Patient #11 rolled around on the floor in the quiet room, however, the record lacked evidence staff implemented interventions to prevent Patient #11 from getting injured. The record lacked documentation of the frequency of staff monitoring while the patient was in the quiet room. The medical record indicated Patient #11 sustained bruises and a fractured clavicle. The hospital failed to implement a plan of care for Patient #11 that maintained her physical safety and psychological well-being.

- Review of Patient #16's medical record occurred 08/31/10 and showed the facility admitted the patient on 05/08/10. A variance report and a nurse's note, dated 05/11/10, showed facility staff found Patient #16 "lying on right side on floor with port intact and catheter intact. Hematoma to right side of cheek, skin tears to right hand and wrist, skin tear to right knee. . . . Patient returned to bed with assist of 3. MD [medical doctor] notified. Roll belt applied. Bed alarm found in patient's pocket." The variance report showed Patient #16 fell as a result of "Trying to sit on BSC [bedside commode]." The variance report also showed Patient #16 had three side rails raised at the time the patient exited the bed and fell.

The variance report, nurse's notes, and plan of care lacked evidence of an assessment of Patient #16's toileting needs and revisions to the plan of care to ensure required assistance with toileting prior to the implementation of restraints.

- Review of Patient #17's record occurred 08/31/10 and showed the facility admitted the patient on 05/09/10. Patient #17's medical record and a variance report, dated 05/12/10, showed the patient experienced a fall on either 05/12/10 or 05/13/10, as dates in nurses notes and the date on the variance report do not correlate. Both described the following: A security guard noticed Patient #17 squatting by her bed, holding onto the bed, and notified a nurse.

Following the above described fall, the variance report indicated the facility implemented the following action(s), "More frequent checks, bed alarm on, new order for roll belt."

Patient #17's plan of care lacked evidence of the implementation of scheduled "more frequent checks" as an alternative to maintaining the patient's safety rather than implementing the restraint and more frequent monitoring simultaneously.

- Review of Patient #18's medical record occurred 08/31/10 and showed the facility admitted the patient 05/12/10 with diagnoses including: "Probable occipital cerebrovascular accident resulting in total blindness."

A physician's progress note, dated 05/18/10, stated, ". . . Unfortunately, as I mentioned in my previous notes, she has gone blind. It is believed that she may have embolized to her occipital lobe. In any case, she fell down during the early morning. She was wandering around in the corridor unattended. I believe she had slipped out of her room."

A variance report, dated 05/18/10 at 5 a.m., stated, "Heard a loud thud in hallway. Came around the corner to find patient lying on her back with knees up, feet on floor and incontinent of urine. . . . Findings . . . follow-up, Protocols followed regarding fall risk assessments, falling Star sign, nonslip foot wear, side rails X 3, personal bed alarm and hourly rounding."

The variance report lacked evidence facility staff considered and/or determined Patient #18's visual limitations as a contributing factor/cause for the fall. Patient #18's plan of care lacked evidence of interventions to respond to the patient's recent blindness and increased risk for falling including orientation of the patient to her room, consistent placement of equipment, personal items, and care related needs, availability of lighting (record indicated the patient could see shadows), and implementation of an assisted toileting program based on an assessment of the patient's toileting habits/pattern.

- Reviewed on 10/21/10, a variance report showed at 1:30 a.m. on 09/09/10 staff responded to Patient #80's call light and found the patient on the floor. The variance report indicated Patient #80 had attempted to toilet himself unassisted and had "removed the personal alarm so that it would not go off when he got up."

Even though the use of the bed alarm had proven ineffective, the variance report identified staff response/action as follows: "Bed check was again placed on patient. Will continue to monitor patient for any changes in condition." The variance report and Patient #80's medical record, reviewed 10/21/10, lacked evidence the facility assessed the patient's voiding/toileting needs including night time voiding habits and implemented a plan of care to provide necessary/corresponding toileting assistance.

Based on observation, interview, and record review, during the full recertification survey completed 10/21/10, the hospital failed to maintain the building in compliance with the Life Safety Code to ensure the safety of patients. Refer to the CMS-2567 K tags for Life Safety Code.

Based on observation, interview, and record review, during the full recertification survey completed 10/21/10, the hospital failed to meet the applicable provisions of the Life Safety Code. Refer to the CMS-2567 K tags for Life Safety Code.