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North Shore Medical Center - FMC Campus was determined to be out of compliance with the Condition of Participation (COP) at Patient Rights (482.13) during a complaint inspection, CCR #2010010979, that was conducted on 10/20/10. This failure culminated in the unexpected death of patient #2 and has the potential to affect any other patient in the facility.

North Shore Medical Center - FMC Campus failed to demonstrate the need for chemical restraint for patient #2 and failed to demonstrate that, if the need existed, less restrictive alternatives were attempted first. At the repeated objections of the patient, the patient was forcefully put on the floor on 10/6/10 at 9:20 PM and given an injection of Haldol, Ativan and Benadryl. The patient was then carried to his/her room and found to be without respirations. A code was called and the patient was pronounced dead on 10/6/10 at 9:53 PM. The cause of death is unknown at this time.

Patient #2 came into the facility voluntarily on 10/3/10 with complaints of suicidal ideation and was admitted to the facility ' s thought disorder unit. The 10/3/10 initial psychiatric evaluation determined that the patient was competent to provide informed consent.

Clinical record documentation shows that the patient was seen by a medical physician daily and that there were no acute medical abnormalities with the exception of mildly elevated white blood cells.

Nursing documentation from 10/3/10 through 10/6/10 at 8:40 PM indicates that the patient was cooperative and compliant with medications and therapeutic groups.

A nursing note on 10/6/10 at 8:40 PM documents that another patient reported being hit several times by patient #2. The patient making the accusation had no visible injuries other than "some pink marks on the face and neck." Rather than asking patient #2 about the reported altercation, the nurse asked patient #2 if s/he was hearing voices. The patient refused to answer and the nurse "cautioned" the patient to be careful and not to hit anybody. Nursing documentation on 10/6/10 from 8:40 PM through 9:18 PM indicates that the nurse repeatedly tried to talk patient #2 into going into his/her room and taking medication to "calm down" and the patient repeatedly refused. No documentation was found to indicate what behaviors the patient was exhibiting that required "calming down." No documentation was found to indicate that the patient was exhibiting any threatening behaviors towards anyone during this time, only that s/he was angry and refused to go to his/her room and take medication. The nurse documented calling a Code Strong at 9:00 PM and the Code Strong Team arrived on the unit. The patient continued to refuse to go to his/her room and be medicated. The nurse documented that at 9:18 PM, the patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her and the patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly. The patient was then carried to her/his room, put in the bed and found to be without respiration. A Code Blue was called and attempts to resuscitate the patient were unsuccessful. The patient was pronounced dead on 10/6/10 at 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self.

During interviews with hospital staff who were present and involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to a member of the code strong team attempting to physically escort the patient to her/his room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

An interview with the patient's treating psychiatrist revealed that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems and that the patient was responding positively to the prescribed medication regimen and getting ready for discharge.

A review of the facility ' s investigation of this event, to date, found no evidence that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser and that the facility has identified no inappropriate actions on the part of their staff.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or, if so, what alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful; no patient behaviors were documented to indicate that an emergency or crisis situation existed and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

The effect of these failures resulted in violations of patient #2's right to care in a safe setting, right to be free of harassment and right to be free of restraints.

It was determined the findings of this survey represented a crisis situation in which the health and safety of the patients are at risk. A determination of Immediate Jeopardy was made on November 1, 2010 during administrative review for the COP A115 and standards at A144, A145, A154, A164, A165, A167, A186 and A187.
Additional deficiencies were identified at A178, A184.

Based on record review and interview, the facility failed to protect the rights of 1 of 3 patients reviewed (#2) to receive care in a safe setting, as evidenced by: failure to provide an appropriate and adequate assessment of the patient and the situation prior to restraining the patient and administering psychotropic medications.
It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.


The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until a member of the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to protect the rights of 1 of 3 patients reviewed (#2) to be free of harrassment, as evidenced by: due to an unwitnessed and unsubstantiated allegation by another patient, patient #2 was repeatedly asked by nursing staff to go to his/her room to be medicated with psychotropic medications without evidence of an appropriate assessment of the patient and situation and without evidence that the patient was displaying any threatening behaviors; the patient repeatedly refused and a Code Strong was called; this resulted in security and other personnel arriving on the unit and attempting to get the patient to go to his/her room to be medicated; it is only evidenced that after repeated verbal attempts by facility staff and when staff attempted to physically escort the patient to her/his room, that the patient attempted to hit a staff member. The patient was then forced to the floor, injected with psychotropic medication and, shortly thereafter, died. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to protect the rights of 1 of 3 patients reviewed (#2) to be free of restraint, as evidenced by: failure to demonstrate that the immediate physical safety of patient #2 or others was at risk prior to initiating restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to demonstrate that restraint was used for 1 of 3 patients (#2) only when less restrictive interventions were determined to be ineffective to protect the patient or others, as evidenced by: no evidence that patient #2 was exhibiting any threatening behaviors to warrant restraint and/or that less restrictive measures were attempted and found to be ineffective prior to initiating restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to demonstrate that the type of restraint used for 1 of 3 patients (#2) was necessary and the least restrictive intervention that would be effective to protect the patient or others, as evidenced by: no evidence that patient #2 was exhibiting any threatening behaviors to warrant restraint and/or that less restrictive measures were attempted and found to be ineffective prior to initiating restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to ensure that the use of restraint was implemented in accordance with safe and appropriate techniques, as determined by hospital policy and State law, for 1 of 3 patients reviewed (#2,) as evidenced by: no evidence that patient #2 was exhibiting behaviors that warranted the need for restraint prior to staff attempts to initiate restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to ensure that when restraint or seclusion is used for the management of violent or self destructive behavior, the patient is seen face to face by a physician within 1 hour after the initiation of the intervention for 1 of 3 patients reviewed (#1,) as evidenced by: documentation of the use of seclusion for patient #1 on 10/18/10 from 5:00 PM to 6:15 PM with no evidence of being seen by the physician face to face within one hour of seclusion initiation.

The findings include:

Record review for patient #1 reveals that the patient was placed in seclusion on 10/18/10 at 5:00 PM and continued in seclusion until 6:15 PM. No evidence was found to indicate that the physician saw the patient face to face after 1 hour of seclusion, as per hospital policy.

During an interview with the Director of Behavioral Health on 10/20/10 at 2:40 PM, she stated that she had spoken to the physician regarding the 1 hour face to face evaluation for patient #1 and that the physician confirmed that he did not do the 1 hour face to face evaluation; she added that the 1 hour face to face only applies to restraints, not seclusion. When asked where that could be found in the facility policies and procedures, she responded, "It's implied."

Review of the hospital's policy and procedure reveals that a 1 hour face to face evaluation by the physician is required for restraints and/or seclusion.

Based on record review and interview, the facility failed to ensure that, when seclusion was used for 1 of 3 patients reviewed (#1,) a one hour face to face medical and behavioral evaluation was documented, as evidenced by: documentation of the use of seclusion for patient #1 on 10/18/10 from 5:00 PM to 6:15 PM with no evidence of being seen by the physician face to face within one hour of seclusion initiation.

The findings include:

Record review for patient #1 reveals that the patient was placed in seclusion on 10/18/10 at 5:00 PM and continued in seclusion until 6:15 PM. No evidence was found to indicate that the physician saw the patient face to face after 1 hour of seclusion, as per hospital policy.

During an interview with the Director of Behavioral Health on 10/20/10 at 2:40 PM, she stated that she had spoken to the physician regarding the 1 hour face to face evaluation for patient #1 and that the physician confirmed that he did not do the 1 hour face to face evaluation; she added that the 1 hour face to face only applies to restraints, not seclusion. When asked where that could be found in the facility policies and procedures, she responded, "It's implied."

Review of the hospital's policy and procedure reveals that a 1 hour face to face evaluation by the physician is required for restraints and/or seclusion.

Based on record review and interview, the facility failed to ensure that the medical record of 1 of 3 patients reviewed (#2) contained documentation of the necessity of restraint or any less restrictive measures attempted prior to the initiation of restraint, as evidenced by: no evidence that patient #2 was exhibiting any threatening behaviors to warrant restraint and/or that less restrictive measures were attempted and found to be ineffective prior to initiating restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.

Based on record review and interview, the facility failed to ensure that the medical record of 1 of 3 patients reviewed (#2) contained documentation of the symptoms that warranted the use of restraint, as evidenced by: no evidence that patient #2 was exhibiting any threatening behaviors to warrant restraint prior to initiating restraint. It was determined this failure represented a crisis situation at the level of Immediate Jeopardy in which the health and safety of the patients are at risk.

The findings include:

Record review for patient #2 reveals that the patient came into the facility via ambulance through the emergency room on 10/3/10 with complaints of suicidal ideation. The patient resided in an assisted living facility and, apparently, had not taken medications for 2 weeks due to suspicion of a new nurse at the assisted living facility. Home medications listed included Prozac, Depakote, Cogentin and Risperdal. The patient ' s diagnoses were listed as: Bipolar disorder, suicidal ideation, urinary tract infection, hypertension, allergic rhinitis, obesity and tension headache. The patient signed receipt of patient rights and signed that s/he did not wish to make an advance directive on 10/3/10. The patient was examined by the emergency room physician on 10/3/10 at 11:53 PM and found without physical abnormalities. The patient acknowledged a history of alcohol abuse but stated that s/he had not consumed alcohol since August 2010. A toxicology screen was positive for opiates. An electrocardiogram performed in the emergency room showed a normal sinus rhythm though " RSR or QR pattern in V1 suggests right ventricular conduction delay " but no significant change from an 8/29/10 electrocardiogram. The patient was documented as being allergic to penicillin. The patient left the emergency room and was admitted to the facility ' s 4 West Unit on 10/4/10 at 5:42 AM as a voluntary admission. Emergency room documentation showed no evidence that the patient was exhibiting behavioral problems.

Physician admission orders for the 4 West Unit included to resume the patient ' s home medications of Risperdal, Cogentin, Depakote and Prozac. In addition, Cipro was ordered to be started, after a specimen was obtained for culture, for 7 days for possible urinary tract infection. An order for Haldol 5 mg with Ativan 2 mg and Benadryl 50 mg po/IM was also given for every 6 hours as needed for agitation.

The initial psychiatric evaluation was done for patient #2 on 10/3/10 and the psychiatrist determined that the patient was competent to provide informed consent. The patient was also seen by a medical physician on 10/3/10 for a comprehensive physical exam with no abnormalities found. Prozac was increased from 20 milligrams to 40 milligrams daily.

On 10/4/10, the physician decreased patient #2 ' s Risperdal from three times daily to twice daily.

Clinical record documentation shows that patient #2 was seen by a medical physician daily and, on 10/6/10, the physician documented that there were no abnormalities with the exception of mildly elevated white blood cells; the urine culture was negative for growth and the Cipro was discontinued.

Nursing documentation from 10/3/10 through 10/6/10 indicates that the patient was cooperative and compliant with medications and therapeutic groups though maintained minimal interaction with peers. The nursing assessment documented on 10/6/10 for the 8:00 AM to 4:00 PM shift indicates no problems or abnormalities with the patient. The every 15 minute observation flow sheet for 10/6/10 shows no patient distress, problems or abnormalities until 9:30 PM when a code blue was called.

A nursing note on 10/6/10 at 8:40 PM documents the following: patient visible on unit; alert and oriented times 3; patient is quiet and calm; denies suicidal/homicidal ideation; no interaction with peers noted; another patient was seen moving swiftly and frightened and said that patient #2 had hit him/her a few times to her/his neck; (patient #2) was observed standing nearby; when (patient #2) was asked if s/he was hearing voices, s/he refused to answer; patient was cautioned and told to be careful and not to hit anybody; patient was encouraged to stay away from the other patient; patient seemed angry but was not saying anything.

The 10/6/10 nursing note is documented as continued at 9:00 PM as follows: patient (#2) was encouraged to go to his/her room so that we could talk to her/him further and medicate him/her to calm her/him down; patient got more angry and stated that that s/he would not go to his/her room; after several minutes spent by staff trying to calm her/him down and encourage him/her to take the medication to help her/him calm down and think clearly so as not to hit anybody else; this was during a Code Strong that was called at 9:00 PM.

The 10/6/10 nursing note is documented as continued at 9:18 PM as follows: patient tried to hit staff when the Code Strong staff held him/her and lowered her/him to the floor in order to medicate him/her; patient was given Haldol 5 milligrams, Ativan 2 milligrams and Benadryl 50 milligrams intramuscularly for agitation.

The 10/6/10 nursing note is documented as continued at 9:53 PM as follows: patient was taken to his/her room to be observed and restrained if necessary but patient was quiet and not fighting when I was told that the patient was not breathing; a code was called and CPR (cardiopulmonary resuscitation) commenced by registered nurse; the code team continued trying to resuscitate the patient but the patient was pronounced dead at 9:53 PM.

Physician documentation of the Code Blue on 10/6/10 states that the patient was recently sedated for aggressive behavior and, soon thereafter, was found to be asystole; code blue was called and CPR was started; advanced cardiac life support protocols followed; patient intubated and epinephrine, atropine and Amiodarone were administered; rhythm converted from asystole to V-Fib, back to asystole; time of death 9:53 PM.

No documentation was found that anyone had witnessed or attempted to substantiate that patient #2 had in fact hit another patient. No documentation was found during the patient ' s entire hospital stay, up until the code strong team attempted to physically escort the patient to his/her room, to indicate that patient #2 was exhibiting any threatening behaviors towards staff, other patients or self to warrant the need for medication and/or restraint. The nurse did not document that she asked patient #2 about the alleged altercation with another patient instead, she asked patient #2 if s/he was hearing voices.

On 10/20/10 at 2:51 PM, an interview was conducted with the behavioral health technician that was present on the unit during this 10/6/10 event. He states that patient #2 was walking around in the halls when approached by the nurse and told that s/ he needed to go to his/her room to be medicated; he states that the patient backed up against the wall and stated that s/he was not taking the medications and would fight. When asked if the patient was exhibiting any threatening behaviors, he responded, " No, but the patient did say that they would have to fight her/him to get him/her in his/her room to take a shot. " When asked what started the confrontation, he responded that patient #2 hit another patient. When asked if he had witnessed this, he responded, " No. " He stated that when security personnel arrived on the unit, a male nurse started to take the patient by the arm to escort her/him to his room and the patient "tried to hit the male nurse and that's when s/he was taken down and given a shot." When asked if the patient walked to her/his room afterwards, he responded, "No, we had to carry him." He states that when they got the patient to his/her room and put her/him in the bed, he noticed that the patient wasn't breathing and immediately told the nurse.

On 10/20/10 at 3:01 PM, an interview was held with 2 security personnel who were present during this event. Both state that they were called to the unit because patient #2 had hit another patient; both stated that when they arrived on the unit, patient #2 was standing at the nurse ' s station and refused to go to his/her room or take medication and said that they would have to fight her/him to do so. When asked if the patient was exhibiting any threatening behaviors, one of the security officers replied, "He was just stubborn." This security officer continued, stating that a male nurse started to take the patient's arm to escort him/her to his/her room and the patient punched him (the male nurse,) breaking his glasses and that's when " we took him to the floor and the nurse gave him a shot. " When asked if the patient walked to his room afterwards, he responded, " No, s/he had to be carried. "

On 10/20/10 at 3:20 PM, a telephone interview was conducted with the RN charge nurse who was present during this event. She states that she saw another patient running towards the nursing station and this patient stated that patient #2 had hit her/him. When asked if she had witnessed the alleged altercation, she responded that she had not. When asked if the accuser had any visible injuries, she responded that the patient had "some pink areas on his/her neck and face" and that patient #2 was observed to be standing in the hallway. She continued by stating that she then asked patient #2 if s/he was hearing voices and the patient would not talk to her. She stated that she asked the patient (#2) to go to his/her room to talk and get medication to help her/him calm down. When asked what behaviors the patient was exhibiting that required " calming down, " she responded by saying that the patient was just standing up against the wall, looking angry, and that s/he (patient #2) had a history of hearing voices and that she didn't know what the patient was thinking or what s/he might do. She states that the patient continued to refuse to go to her/his room and be medicated and that patient #2 also stated that s/he was allergic to some medications. She stated that a Code Strong was called and when security arrived on the unit, the patient was taken down and medicated. When asked if the patient walked to her/his room afterwards, she stated that she didn't know because she went back to doing what she was doing before all of this had started. She stated that when the behavioral health technician notified them (staff) that the patient wasn't breathing, a code blue was called and CPR was started.

On 10/20/10 at 3:36 PM, an interview was conducted with the LPN who had administered the injection to patient #2, just prior to his/her death. She states that the behavioral health technician told her that patient #2 had hit another patient and she responded, "Well, I guess I need to get a shot ready." When asked if she had witnessed the alleged altercation between the 2 patients, she stated that she had not. She stated that she prepared the injection of Haldol, Ativan and Benadryl and went to where the patient was, keeping the injection syringe out of sight because, "I don't want them to see me coming at them with a shot." She stated that when personnel took the patient to the ground, she exposed the patient ' s buttock, administered the injection and then personnel carried the patient to his/her room. The LPN made no mention of assessing the patient ' s need for the medication prior to preparing the injection for the patient.

During the above interviews with staff who were involved in this event, all stated that they had not witnessed the alleged altercation between patient #2 and the accuser and none gave any indication that an attempt was made to verify the accusation; none could describe any threatening behaviors that the patient was exhibiting, prior to the male nurse attempting to take the patient ' s arm to escort him/her to his/her room to be medicated; all stated that the patient was just standing there refusing to go to his/her room to be medicated and told staff that they would have to fight him/her to do so.

On 10/20/10 at 3:45 PM, an interview was conducted with the treating psychiatrist for patient #2. He states that he was not present on the unit during the time of the alleged patient altercation or at the time of the patient's death. He stated that the patient was seen by a medical physician every day of the hospital stay and there were no known acute medical problems. He stated that the patient was responding positively to the prescribed medication regimen and getting ready for discharge. He added that, "Of course, with mental illness, that can change at any moment. "

During a review of the facility ' s investigation of this event (in process,) no evidence was found that the facility made any attempt to interview other patients on the unit to determine if anyone had witnessed the alleged altercation between patient #2 and the accuser. At this point in time, the facility has identified no human factors leading to this event. The facility has identified that there was a possibility of ambiguous performance standards and procedures due to the " Use of Force " policy allowing for a prone position in a Dr. Strong " take down " versus the " Healthy Interventions Training " that stresses semi-prone. The facility identified no barriers to communication in this case. At this point in time, the facility concludes that de-escalation techniques, Dr. Strong and Code Blue responses were carried out in a timely manner and appropriately and that the facility had no control over the patient ' s death. The patient ' s body was released to the medical examiner ' s office and, per the Director of the Behavioral Health Unit, a cause of death has yet to be determined.

During an interview with the Director of Behavioral Health and the Director of Risk Management on 10/20/10 at approximately 4:00 PM, the Director of Behavioral Health stated that she feels that her staff acted appropriately, adding that " they know these patients and their history. " She stated that the staff spent over 20 minutes trying to de-escalate the patient. When asked what behaviors the patient was exhibiting that required de-escalation, she had no response. The Director of Risk Management then asked, " What do you want them to do; wait until they hurt somebody? "

The facility ' s policy and procedure for restraint/seclusion includes the following:
1. Restraints/Seclusion shall be used only when alternative methods are not sufficient to protect the patient or others from injury. (No documentation was found to indicate that patient #2 was exhibiting threatening behaviors or that alternative methods were attempted.)
2. The least restrictive form of restraint/seclusion will be used.
3. The decision to apply restraints/seclusion is based on identified individual needs; consideration is given to the individual ' s rights and well-being; the individual ' s dignity and well-being is preserved during use. (No documentation was found that the alleged altercation between patient #2 and the accuser was witnessed nor was any evidence found that patient #2 was given the opportunity to respond to the allegation.)
4. Restraints/Seclusion are to be used only after the patient has been thoroughly assessed and the individualized alternatives have been unsuccessful, except in emergency or crisis situation when alternative measures would be futile in preventing injury to patient or others, then, the least restrictive form of restraint/seclusion should be used based on the patient ' s assessed needs. The facility ' s policy and procedure includes a list of 14 alternatives to restraint which includes, provide activities and provide 1:1 staff to assist the patient in redirection. (No evidence was found to indicate that patient #2 was assessed or that alternatives were attempted and found to be unsuccessful and no patient behaviors were documented to indicate an emergency or crisis situation and/or that the patient was an immediate threat to self or others.)
5. The facility ' s procedure/methodology for behavioral use of restraints/seclusion states that, the decision to use restraints/seclusion is not based solely on prior history of use or history of dangerous behavior; rather, use is based on the patient ' s needs in the immediate care environment and the interaction of the patient and staff with other patients in that environment; identify alternatives to the use of restraints/seclusion according to the individualized patient assessment and implement as appropriate; if the use of alternatives and de-escalation techniques are ineffective/unsuccessful, a " Mr. Strong " code may be called, depending on the assessment of the patient ' s behavior. The facility ' s policy for required documentation in restraint use includes the circumstances leading to use with evidence of danger to self or others and failure of less restrictive alternatives. This documentation was not found during a review of patient #2 ' s clinical record.