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Based on review of a clinical record, interviews, review of hospital documentation and review of hospital polices and procedures, the hospital's governing body failed to ensure the quality of care provided by the medical staff and/or the contracted services and/or that there was a process in place to evaluate the contracted services.

Please reference A 49, A 83 and A 84.

Based on review of the clinical record, interviews and review of hospital documentation for one patient (Patient #4) that required a consultation, the hospital failed to ensure that the consultation was completed in a timely manner. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the admission history and physical, completed by the resident physician (MD #22) on 8/19/09 at 6:45 A.M., identified that Patient #4 required a consultation by an orthopedic physician for the left leg pain/weakness and left foot numbness. The attending physician (MD #21) on 8/19/09 at 1:10 P.M. identified that an orthopedic consultation is required. A progress note, dated 8/20/09 at 6:45 A.M. by MD #22, reflected that the medical team was awaiting the orthopedic consultation and a second note, on 8/20/09 at 10:35 A.M. written by MD #21, identified that the orthopedic consultation was pending for this patient. On 8/21/09 at 6:45 A.M. a progress note by MD #22 identified that the orthopedic physician had not evaluated the patient and a second note by MD #22 at 5:16 P.M. reflected that MD #18, an orthopedic physician, was called regarding the orthopedic consultation for Patient #4. The clinical record, dated 5/21/09 at 5:30 P.M. identified that MD #18 completed an orthopedic consultation for Patient #4 which identified that the patient had left peroneal palsy of the foot. Interview with MD #21, on 5/6/10, identified that a consultation does not routinely take three days to complete. Interview with MD #18, on 5/6/10, identified that a consultation is usually completed within a day.

Based on review of the clinical record, interviews, review of hospital policy and procedure and review of hospital documentation for one patient (Patient #4) that the hospital staff carried out a Code Green and/or had locked restraints applied by contracted staff, the hospital governing body failed to ensure that the contracted service was providing services in accordance with the contract. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient's behaviors are identified as not safe and/or not in control and restraints may need to be applied. Two locked restraints were applied according to physician orders. In addition, documentation by RN #6 reflected that during the Code Green, a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
In addition interview with Security Managers #1 and #2 and the Director of Safety and Security, on 5/6/10, identified that Security Staff #1 responded to a Code Green involving Patient #4 on 8/21/09 and Security Staff #1 did not have the required training for participation in the Code Green and/or application of restraints, named Crisis Prevention Institute (CPI). Interview with Security Staff #1, on 5/7/10, identified that he/she participated in the Code Green with Patient #4 on 8/21/09, he/she held the patient ' s right arm down prior to the application of the locked restraints and he/she did not have the CPI training. Review of Security Staff #1 ' s personnel file identified an evaluation, dated 1/25/09, identified that Security Staff #1 needed to complete the CPI training. Review of hospital documentation identified that Security Staff #1 was involved in twenty-four Code Greens, from date of hire (6/18/08) to date of resignation (8/26/09).
Review of the hospital policy and procedure, titled Application of Four Point Behavioral Restraints & Emergency Restraining (Code Green), identified that hospital staff will be trained and competent in restraining practice and application. A second hospital policy and procedure, titled Restraint/Seclusion, identified that education must be part of the employee ' s initial orientation and will be ongoing for all staff involved with application of restraints.
Review with the Director of Safety and Security of the thirty-two Security staff members on 5/7/10, it was identified that eight Security staff did not have the required CPI training and had been involved in Code Greens with patients in the past and two of those eight were working on 5/7/10.
In addition, interview with the Director of Safety and Security, on 5/7/10, identified that he/she does not have a process to ensure that the security contractor staff provided services according to the contract and/or there is no mechanism to report to the hospital quality department the provision of services by the contractor. Interview with the Director of Risk Management, on 5/10/10, identified that the hospital does not have a mechanism to ensure that contracted services are carried out according to the contract.
Review of the quality committee meeting minutes and the governing body meeting minutes for the past two years, did not identify and/or address issues/concerns regarding the services provided by contractors.

Based on review of the clinical record, interviews, review of hospital policy and procedure and review of hospital documentation for one patient (Patient #4) that the hospital staff carried out a Code Green and/or had locked restraints applied with contracted staff, the hospital ' s governing body failed to ensure that the contracted service was providing services in a safe manner. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition, documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again. The physician was informed and MD #16 ordered an x-ray of the right humerus at 2:40 A.M. on 8/21/09. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
In addition, interview with Security Managers #1 and #2 and the Director of Safety and Security, on 5/6/10, identified that Security Staff #1 responded to a Code Green involving Patient #4 on 8/21/09 and Security Staff #1 did not have the required training for participation in the Code Green and/or application of restraints, named CPI. Interview with Security Staff #1, on 5/7/10, identified that he/she participated in the Code Green with Patient #4 on 8/21/09, he/she held the patient ' s right arm down prior to the application of the locked restraints and he/she did not have the CPI training. Review of Security Staff #1 ' s personnel file identified an evaluation, dated 1/25/09, identified that Security Staff #1 needed to complete the CPI training. Review of hospital documentation identified that Security Staff #1 was involved in twenty-four Code Greens, from date of hire (6/18/08) to date of resignation (8/26/09).
Review of the hospital policy and procedure, titled Application of Four Point Behavioral Restraints & Emergency Restraining (Code Green), identified that hospital staff will be trained and competent in restraining practice and application. A second hospital policy and procedure, titled Restraint/Seclusion, identified that education must be part of the employee ' s initial orientation and will be ongoing for all staff involved with application of restraints.
Review with the Director of Safety and Security of the thirty-two Security staff members on 5/7/10, identified that eight were did not have the required CPI training and had been involved in Code Greens with patients in the past and two of those eight were working on 5/7/10.
In addition, interview with the Director of Safety and Security, on 5/7/10, identified that he/she does not have a process to ensure that the security contractor staff provided services according to the contract and/or there is no mechanism to report to the hospital quality department the provision of services by the contractor. Interview with the Director of Risk Management, on 5/10/10, identified that the hospital does not have a mechanism to ensure that contracted services are carried out according to the contract.

Based on review of clinical record, interviews, review of hospital documentation and reviews of hospital polices and procedures, the hospital failed to ensure that patient ' s rights were protected.

Please reference A 165, A 166, A 175, A 179 and A 194.

Based on review of the clinical record, interviews and review of hospital policy and procedure for one patient (Patient #4) who had locked restraints applied, the hospital failed to ensure that the least restrictive interventions were trialed prior to the application locked restraints. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. Documentation identified that RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. RN #6 documented that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture. Interview with Nurse Manager #5, on 5/6/10, identified that there is no documentation that least restrictive alternatives were trialed prior to the application of the locked restraints for this patient. Interview with RN #6, on 5/6/10, identified that he/she attempted to reorient the patient and called a Code Green prior to application of the locked restraints on Patient #4. Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that least restrictive alternatives are trialed prior to application of physical restraints and these alternatives include medications for symptom management, involvement of family members, use of a safety companion, modification of the physical environment, decrease the stimulation, verbal de-escalation and/or substitute activities.

Based on review of the clinical record, interview and review of hospital policies and procedures for one patient (Patient #31) that required restraints, the hospital failed to ensure that the patient ' s plan of care reflected the patient's need for the restraints. The findings include:

Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. The patient ' s past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M., the staff utilized restraints, a vest and/or bilateral wrist, for this patient for violent and/or aggressive behaviors. Review of the patient's plan of care did not identify and/or address this problem including the need for restraints. Interview with Nurse Manager #6, on 5/11/10, identified that there is no plan of care that identified that Patient #31 had violent and/or aggressive behaviors and restraints were used. Review of the hospital policy and procedure, titled Medical/Surgical Patient Care Record Guidelines, identified that all patient problems are identified and/or addressed. In addition, a second hospital policy and procedure, titled Restraint/Seclusion, identified that the patient ' s plan of care must be updated to reflect use of the restraint.

Based on review of clinical records, interviews and review of hospital policy and procedure for two of two patients (Patients #30 and #31) that had restraints ordered by a physician for violent and/or aggressive behaviors, the facility failed to ensure that the staff monitored the patient ' s condition accordingly. The findings include:

1. Patient #30 arrived at the Emergency Department (ED) on 4/6/10 with complaints lethargy, urinary tract infection and decreased fluid intake was diagnosed with dehydration and was admitted to the hospital. Patient #30 ' s past medical history included dementia, urinary tract retention and status post urinary tract infections. Review of the clinical record, dated 4/8/10, identified that the patient was uncooperative and combative-kicking and scratching at staff. The physician order, dated 4/8/10 at 11:32 P.M. directed the staff to apply a vest restraint and bilateral wrist restraints to Patient #30 to address his/her violent and/or aggressive behavior. Review of the clinical record did not reflect documentation that the staff completed on going monitoring and/or evaluation of the patient every fifteen minutes in accordance with hospital policy. Interview with Nurse Manager #6, on 5/11/10, identified that the documentation of the patient ' s condition was not completed every fifteen minutes.

2. Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. The patient ' s past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M. the staff utilized restraints for this patient for violent and/or aggressive behaviors. Review of the clinical record, dated 5/1/110 at 12:05 A.M., identified a physician order that directed the staff to apply bilateral wrist restraints to the patient for violent and/or aggressive behaviors. Review of the Restraint Flow Sheet, from 5/1/10 at 12:00 Midnight to 5:00 A.M., did not reflect documentation that the staff completed on going monitoring and/or evaluation of the patient every fifteen minutes in accordance with hospital policy. Interview with Nurse Manger #6, on 5/11/10, identified that the documentation of the patient's condition was not completed every fifteen minutes.

Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that the Registered Nurse must assess and document the assessment of the patient every fifteen minutes regarding signs of injury, nutrition, hydration, circulation and range of motion in extremities, vital signs, hygiene, elimination, psychological status and readiness for discontinuation of the restraint(s).

Based on review of clinical records, interviews and review of hospital policy and procedure for two of two patients (Patients #30 and #31) that had restraints ordered by a physician for violent and/or aggressive behaviors, the facility failed to ensure that the physicians evaluated the patient accordingly. The findings include:

1. Patient #30 arrived at the Emergency Department (ED) on 4/6/10 with complaints lethargy, urinary tract infection and decreased fluid intake was diagnosed with dehydration and was admitted to the hospital. Patient #30's past medical history included dementia, urinary tract retention and status post urinary tract infections. Review of the clinical record, dated 4/8/10, identified that the patient was uncooperative and combative-kicking and scratching at staff. The physician order, dated 4/8/10 at 11:32 P.M. directed the staff to apply a vest restraint and bilateral wrist restraints to Patient #30 to address his/her violent and/or aggressive behavior. Review of the clinical record did not reflect documentation that the physician completed a face-to-face evaluation of the patient after the application of the identified restraints including the patient's immediate situation, the response to the intervention, the medical and behavioral status and/or the need to continue the restraint. Interview with Nurse Manager #6, on 5/11/10, identified that there was no documentation by the physician after application of the restraint to this patient in the areas identified.

2. Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. The patient's past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M. the staff utilized restraints for this patient for violent and/or aggressive behaviors. Review of the clinical record, dated 5/1/110 at 12:05 A.M., identified a physician order that directed the staff to apply bilateral wrist restraints to the patient for violent and/or aggressive behaviors. Review of the clinical record did not reflect documentation that the physician completed a face-to-face evaluation of the patient after the application of the identified restraints including the patient ' s immediate situation, the response to the intervention, the medical and behavioral status and/or the need to continue the restraint. Interview with Nurse Manger #6, on 5/11/10, identified that there was no documentation by the physician after application of the restraint to this patient in the areas identified.

Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that the physician must complete a face-to face evaluation of the patient within one of the application of the restraint.

Based on review of the clinical record, interviews, review of hospital policy and procedure and review of hospital documentation for one patient (Patient #4) that the hospital staff carried out a Code Green and/or had locked restraints applied, the hospital failed to ensure that the staff were trained in participation of Code Green and/or restraint application. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
Interview with Security Managers #1 and #2 and the Director of Safety and Security, on 5/6/10, identified that Security Staff #1 responded to a Code Green involving Patient #4 on 8/21/09 and Security Staff #1 did not have the required training for participation in the Code Green and/or application of restraints, named Crisis Prevention Institute (CPI). Interview with Security Staff #1, on 5/7/10, identified that he/she participated in the Code Green with Patient #4 on 8/21/09, he/she held the patient ' s right arm down prior to the application of the locked restraints and he/she did not have the CPI training. Review of Security Staff #1 ' s personnel file identified an evaluation, dated 1/25/09, identified that Security Staff #1 needed to complete the CPI training. Review of hospital documentation identified that Security Staff #1 was involved in twenty-four Code Greens, from date of hire (6/18/08) to date of resignation (8/26/09). In addition Review with the Director of Safety and Security of the thirty-two Security staff members on 5/7/10, identified that eight were did not have the required CPI training and had been involved in Code Greens with patients in the past and two of those eight were working on 5/7/10.
Review of the hospital policy and procedure, titled Application of Four Point Behavioral Restraints & Emergency Restraining (Code Green), identified that hospital staff will be trained and competent in restraining practice and application. A second hospital policy and procedure, titled Restraint/Seclusion, identified that education must be part of the employee's initial orientation and will be ongoing for all staff involved with application of restraints.

Based on review of a clinical record, interviews, review of facility polices and procedure and review of hospital documentation, the hospital failed to ensure that services provided by contractors were assessed by the quality/performance improvement department in order to improve patient health outcomes and/or that the quality department provided oversight during an adverse event investigation and/or ensured that the Corrective Action Plan (CAP) was implemented as written.

Please reference A 083, A 084, A 194, A 286, A 287 and A 288.

Based on review of the clinical record, interviews and review of hospital policy and procedure for one patient (Patient #4) that sustained and injury during the application of restraints, the hospital failed to ensure that the Registered Nurse reported this event and/or that security staff reported the event in writing to the quality department according to hospital policy and procedure. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient's past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient's behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition, documentation by RN #6 reflected that during the Code Green, a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
Interviews with the Director of Quality, on 5/6/10, and Quality Staff #3, on 5/7/10, identified that this event was reported via telephone call to the quality department (although not from the nurse involved), that Nurse Manager #5 completed the investigation (instead of the Quality Department per policy) into this event and/or provided information to Quality Staff #3 regarding the event. Interview with Nurse Manager #5 on 5/6/10 identified that he/she was not aware of the all hospital staff that were present at the Code Green on 8/21/09. Review of the hospital policy and procedure, titled Adverse Occurrence Reporting, identified that the Quality Department is responsible for gathering and reviewing information relating to the care and treatment of patients involved in an adverse occurrence and it is the responsibility of the staff member involved in the event to complete a report.
In addition, interview with Security Managers #1 and #2 and the Director of Safety and Security, on 5/6/10, identified that Security Staff #1 responded to a Code Green involving Patient #4 on 8/21/09, a report was not completed for that event and a report should have been completed by security regarding this Code Green. Review of documentation, titled Security Tracking Report, with Security Manager #1 and the Director of Safety, identified that a report for a Code Green included identification of the staff present at the code, if any injuries occurred and a narrative of the Code Green. The hospital's investigation did not identify that Security Staff #1 responded to the Code Green involving Patient #4 and/or Security Staff #1 did not have the required training for participation in the Code Green and/or application of restraints, named Crisis Prevention Institute (CPI). Review of the contracted Security Company's documentation, titled Significant Event Reporting, identified that a written report is completed for any event that security is involved with.

Based on review of the clinical record, interviews and review of hospital documentation for one patient that sustained and injury during the application of restraints (Patient #4) the hospital failed to ensure that a comprehensive event investigation was completed. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient's past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition, documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
Interview with Nurse Manager #5, on 5/6/10, identified that he/she was not aware of the hospital staff that was present at the Code Green on 8/21/09 for Patient #4. Interviews with the Director of Quality, on 5/6/10, and Quality Staff #3, on 5/7/10, identified that this event was reported via telephone call to the quality department (although not from the nurse involved), that Nurse Manager #5 completed the investigation into this event and/or provided information to Quality Staff #3 regarding the event. A second interview with Nurse Manager #5, on 5/7/10, identified that his/her investigation consisted of review of Patient #4 ' s chart and discussion of the event with RN #6. In addition, the investigation did not identify that Security Staff #1 responded to the Code Green involving Patient #4 and/or Security Staff #1 did not have the required training for participation in the Code Green and/or application of restraints, named Crisis Prevention Institute (CPI).
Although the quality staff was made aware of the event, the quality department failed to collect accurate and/or complete information regarding the event.

Based on review of the clinical record, interviews and review of hospital documentation for one patient that sustained and injury during the application of restraints (Patient #4) the hospital failed to ensure that the Corrective Action Plan (CAP) was carried out as written. The findings include:

Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
Interviews with the Director of Quality, on 5/6/10, and Quality Staff #3, on 5/7/10, identified that this event was reported via telephone call to the quality department (although not from the nurse involved).
Review of the hospital CAP included that hospital policies and procedures were reviewed and reinforced with all those involved in the case. Review of the hospital CAP with the Director of Quality, on 5/6/10, identified that Nurse Manager #5 and MD#19 provided education to RN #6 and MD #16 respectively. Interview with Nurse Manager #5, on 5/6/10, identified that he/she educated RN #6 on the hospital restraint policy and procedure after the event. Interview with MD #19, on 5/6/10, identified that he/she did not provide any education regarding this event.
The Hospital CAP was not carried out as written as evidenced by hospital investigators were not aware what hospital staff were involved in this event and education was not completed to all those involved in the event according to the written hospital CAP.

Based on review of the clinical records, interviews and review of hospital policies and procedures for two of two patients (Patients #4 and #31) that required comprehensive nursing assessments, the hospital failed to ensure that the staff comprehensively assessed the patient. The findings include:

1. Patient #4 arrived via ambulance at the ED on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient's past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record identified that Patient #4 was a triage level 3 and on 8/17/09 at 6:10 P.M. the patient's vital signs were documented-which included blood pressure, pulse, respirations and temperature. Patient #4 ' s blood pressure, pulse, and respirations were documented at least every four hours from ED arrival until 8/18/09 at 7:00 P.M. although there was no documentation of the patient ' s temperature during this period.
In addition, Patient #4's clinical record identified that on 8/17/09 at 7:20 P.M. the patient had chest pain although there is no documentation of the patient's level of pain from ED arrival to 8/18/09 at 7:00 P.M. Interview with the Nurse Manager of the ED, on 5/7/10 identified that the temperature for this patient was not documented during the identified time period and obtaining a patient ' s temperature is part of obtaining vital signs. Review of the hospital policy and procedure, Vital Signs Monitoring in the Emergency Department, identified that vital signs include temperature, vital signs will be completed at least every two hours and pain is assessed on all patients. A second policy and procedure, titled Pain Assessment, identified assessment of the patient's pain while in the ED includes assessment on admission and at least every four hours.

b. Review of the clinical record identified that on 8/17/09 at 7:02 P.M. Patient #4 ' s blood alcohol level was 455 milligrams per deciliter (mg/dL, negative is 0 mg/dL, intoxication is greater than 100 mg/dL and coma state is greater than 300mg/dL). Review of the clinical record did not reflect documentation that the staff monitored, from ED arrival to 8/18/09 at 7:00 P.M., the patient's Sedation Agitation Scale (SAS). Interview with the Nurse Manager of the ED, on 5/7/10 identified that there is no documentation that the ED staff initiated and/or utilized the SAS for Patient #4 in accordance with hospital policy.
In addition, review of the clinical record, dated 8/18/09 at 4:00 P.M., identified that RN #3 administered the benzodiazepine medication Librium 50 milligrams, route not identified, to Patient #4 and the record does not reflect documentation of the patient ' s pulse oximeter and blood glucose results prior to this medication administration.
Review of the hospital policy and procedure, titled Alcohol Withdrawal Protocol, Use of the SAS, identified that the SAS is to be used for the patient that is identified at risk for alcohol withdrawal-including a blood alcohol level greater than 200 mg/dL, assessment using the SAS of the patient every four hours and/or one hour after administration of any benzodiazepine and prior to the first dose of benzodiazepine the patient ' s pulse oximeter and blood glucose are to be checked and results reported to the physician if less than 90% and/or 70 mg/dl respectively.

2. Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. This patient ' s past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M. the staff utilized restraints, vest and bilateral wrist, for this patient for violent and/or aggressive behaviors. Review of the Restraint Flow Sheet, dated 8/2109 from 3:00 P.M. to 10:45 P.M., did not reflect that the nurse completed assessments of the patient-including circulation of the affected body areas, skin condition, toileting needs, offering food and/or fluids and range of motion of the affected body areas. Interview with Nurse Manager #6, on 5/11/10, identified that there is no documentation regarding nursing assessments of Patient #4 of the identified areas. Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that the nursing assessment includes assessment of the patient's circulation, skin, nutrition and elimination needs and range of motion in the body areas affected.

Based on review of the clinical records, interviews and review of hospital policy and procedure for two of two patients (Patients #4 and #31) that required assistance for ambulation and/or restraints, the hospital failed to ensure that the patient's plan of care reflected the patient's ambulation status and or the use of restraints. The findings include:

1. Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record identified that while Patient #4 was in the ED, from 8/17/09 at 6:10 P.M. to 8/18/09 at approximately 9:00 P.M., the patient had complaints of left leg weakness, left foot numbness and was unable to ambulate. Review of the plan of care for Patient #4 did not identify that the patient had any difficulties/problems with ambulation and/or any interventions to address this problem. Interview with the Nurse Manager #5, on 5/6/10, identified that there is no plan of care that identified that Patient #4 had difficulties with ambulation.

2. Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. This patient ' s past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M. the staff utilized restraints for this patient for violent and/or aggressive behaviors although review of the patient ' s plan of care did not identify and/or address this problem. Interview with Nurse Manager #6, on 5/11/10, identified that there is no plan of care that identified that Patient #31 had violent and/or aggressive behaviors and restraints were used.

Review of the hospital policy and procedure, titled Medical/Surgical Patient Care Record Guidelines, identified that all patient problems are identified and/or addressed.

Based on review of the clinical record, interview and review of hospital policy and procedure for one patient (Patient #4) that was given medication, the hospital failed to ensure that a licensed practitioner ordered the medication. The findings include:

Patient #4 arrived via ambulance at the ED on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record identified that on 8/17/09 at 7:02 P.M. Patient #4 ' s blood alcohol level was 455 milligrams per deciliter (mg/dL, negative is 0 mg/dL, intoxication is greater than 100 mg/dL and coma state is greater than 300mg/dL).
In addition, review of the clinical record, dated 8/18/09 at 4:00 P.M., identified that RN #3 administered the benzodiazepine medication Librium 50 milligrams (route not identified) to Patient #4 and the record does not reflect a physician order for this medication. Interview and chart review with the Nurse Manager of the ED, on 5/7/10 identified that there is no physician order for this medication. Review of the hospital policy and procedure, titled Administration of Medication, identified that a licensed practitioner must order the medication. Review of the General Statutes of Connecticut, Section 20-87a the scope of practice of a Registered Nurse does not include prescribing medication.

Based on review of the clinical records, interviews, review of hospital polices and procedures and review of hospital documentation for four of four patients (Patients #4, #30, #31 and #28) that required a complete medical record, the hospital failed to ensure that the medical records were complete and/or that the medical records were stored in a protected manner. The findings include:

1. Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the physician orders, dated 8/18/09 directed the staff to provide the patient with a low cholesterol two gram sodium diet and to monitor the patient ' s intake and out put. Review of the clinical record, from 8/19/09 to discharge on 8/25/09, identified inconsistent documentation of the meal intakes and/or intake and output amounts for Patient #4. Interview with Nurse Manger #5, on 5/6/10, identified that the documentation of the meals is not complete. Review of the hospital policy and procedure, titled Medical/Surgical Patient Care Record Guidelines, identified that documentation of meal intake includes the amount of the meal consumed, documentation of the intake includes the amount that the patient has eaten and output includes urine, gastric content, bowel movement and/or other.

b. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. The clinical record did not reflect documentation that MD #16 assessed Patient #4 regarding the patient's behavior, the need for restraints and/or the status of the patient's right arm. Interview with MD #16, on 5/6/10, identified that when he/she arrived to the Code Green Patient #4 was attempting to harm self and staff, restraints were applied, he/she ordered and x-ray of the right humerus based on information that RN #6 provided and he/she did not write a note regarding the patient's status at that time and should have written a note. In addition MD #16 added that although he/she completed an assessment of the patient ' s right arm, he/she did not document that assessment. Review of the hospital policy and procedure, titled Application of 4 Point Behavioral Restraints & Emergency Restraining (Code Green), identified that the licensed practitioner will document the rationale for the patient requiring restraints.

c. Further review of the clinical record, dated 8/21/09, identified that after the patient was restrained, a 1:1 sitter was with this patient although the clinical record did not reflect any documentation by the sitter regarding what his/her actions and/or services provided to Patient #4. Interview with Nurse Manager #5, on 5/6/10, identified that there is no documentation by the sitter for this patient for the period after the Code Green to 7:00 A.M. on 8/21/09. Review of hospital policy and procedure, titled Guidelines for the use of Sitters to Provide Close or Maximal Observation and the use of the Sitter Instruction Sheet and Competency Documentation, identified that the sitter is required to complete his /her documentation of patient care on the constant/maximum observation flowsheet.

d. In addition review of the clinical record, dated 8/21/09, physician progress notes at 6:45 A.M. and 10:15 A.M., did not reflect documentation of the status of Patient #4 ' s right arm by either the resident physician, MD #22, and/or the attending physician, MD #21. Interview with MD #21, on 5/6/10, identified that he/she discussed with the nursing staff the condition of the patient ' s arm, assessed the patient ' s right arm, did not document that assessment and he/she should have documented the assessment and was aware that an x-ray of the arm was pending. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.

2. Patient #30 arrived at the Emergency Department (ED) on 4/6/10 with complaints lethargy, urinary tract infection and decreased fluid intake was diagnosed with dehydration and was admitted to the hospital. Patient #30's past medical history included dementia, urinary tract retention and status post urinary tract infections. Review of the clinical record, dated 4/8/10, identified that the patient was uncooperative and combative-kicking and scratching at staff. The physician order, dated 4/8/10 at 11:32 P.M. directed the staff to apply a vest restraint and bilateral wrist restraints to Patient #30 to address his/her violent and/or aggressive behavior. Review of the Restraint Flow Sheet, dated 4/9/10 from 12:00 Midnight to 6:00 A.M. identified that the staff used bilateral wrist restraints for the patient. Review of the clinical record did not reflect documentation that identified the rationale that the vest restraint was not used and/or that the nursing staff communicated to the physician that the patient ' s behaviors were altered using only the bilateral wrist restraints. Interview with Nurse Manager #6, on 5/11/10, identified that documentation reflected that the physician ordered a vest restraint and bilateral wrist restraints for this patient and the documentation reflected that the staff used bilateral soft wrist restraints for the patient on 4/9/10 from 12:00 Midnight to 6:00 A.M. Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that each restraint requires an order from a physician.


3. Patient #31 was arrived to the ED on 4/28/10 with complaints of change in behaviors and abnormal laboratory results, was diagnosed with hypercalcemia, dehydration and agitation and was admitted to the hospital. This patient ' s past medical history included dementia and status post cerebrovascular accident. Review of the clinical record identified that from 4/30/10 at approximately 8:40 A.M. to 5/1/10 at 5:00 A.M. the staff utilized restraints for this patient for violent and/or aggressive behaviors. Review of the Restraint Flow Sheet, dated 8/2109 from 1:00 P.M. to 10:45 P.M., did not reflect documentation regarding the type of restraint that was used and/or the behavior demonstrated by the patient. Interview with Nurse Manager #6, on 5/11/10, identified that there is no documentation regarding the type of restraint used and/or the patient ' s behavior. Review of the hospital policy and procedure, titled Restraint/Seclusion, identified that the nursing assessment includes documentation hourly of the restraint used and the patient ' s behaviors.

4. During a tour of the Medical Record Department, on 5/10/10, with the Director of Health Information Management (HIM) it was identified that Patient #28 ' s record was identified as incomplete. Review of the clinical record identified that Patient #28 was admitted on 3/19/10, the patient died and was discharged on 3/19/10 and the discharge summary had not been completed. Interview with the Director of HIM, on 5/10/10, identified that the discharge summary for Patient #28 had not been completed. Review of the hospital policy and procedure, titled Completion of Medical Records, identified that attending physician must complete the patient ' s medical record within thirty days of discharge. In addition review of the hospital's medical staff rules and regulations identified that the discharge summary will be completed within fourteen days of the discharge.

5. During a tour of the basement medical record storage area, on 5/10/10, with the Director of Health Information Management (HIM) it was identified that approximately twenty one charts in the general area and more than thirty charts in the psychiatric/behavioral health area were not filed but placed atop of the filing cabinets and therefore not protected from fire and/or water damage. Interview with the Director of HIM, on 5/10/10, identified that the records should not be located atop of the filing cabinets.

Based on observations during tour and interview the facility failed to ensure that the basement medical records storage area was secure. The findings include:

During a tour of the basement medical record storage area, on 5/10/10, with the Director of Health Information Management (HIM) it was identified that the outpatient psychiatric/behavioral health medical records storage area was located within the general medical records storage area. Interview with the Director of HIM, on 5/10/10, identified that he/she was not aware if the outpatient psychiatric/behavioral health staff had the key to the general medical records area. Interview and tour of the outpatient psychiatric area, on 5/10/10 with the Manager of the psychiatric/behavioral health medical records, the Director of HIM, and the Nursing Director of behavioral health, identified that the key to the general medical records storage area was kept unsecured in the psychiatric/behavioral health outpatient area where staff provide services to patients.

Based on review of the clinical record, interviews and review of hospital documentation for one of five patients (Patient #4) that required a diagnostic radiological test, the hospital failed to ensure that the test was identified as completed accurately and/or that the test was completed timely. The findings include:

1. Patient #4 arrived via ambulance at the Emergency Department (ED) on 8/17/09 at 6:10 P.M. with complaints of left leg pain and weakness for one week, alcohol intoxication and recent chest pain/pressure and was diagnosed with alcohol intoxication and neuropathy. The patient ' s past medical history included hypertension, myocardial infarction, coronary artery disease, status post fractures and alcohol abuse. Review of the clinical record, dated 8/21/09, identified that at approximately 1:45 A.M. the patient was yelling, hallucinating, attempting to strike at staff and got out of the bed and demonstrated an unsteady gait. RN #6 called a Code Green, an internal hospital request for various staff members to assist the nursing staff when a patient ' s behaviors are identified as not safe and/or not in control and restraints may need to be applied, and two locked restraints were applied according to physician orders. In addition documentation by RN #6 reflected that during the Code Green a staff member heard a click sound and the patient had a history of fractured right arm and possible fracture again, the physician was informed and an x-ray of the right humerus was ordered at 2:40 A.M. on 8/21/09 by MD #16. Review of the x-ray, dated 8/21/09 identified that there was a new distal right humerus fracture and a refracture and widening of the proximal right humerus fracture.
Review of the clinical record identified that Radiology Technician #1 completed the x-ray exam on 8/21/09 at 8:43 A.M. and MD #20, a Radiologist, interpreted the x-ray exam on 8/21/09 at 3:59 P.M. Review of Patient #4 ' s right humerus x-ray image, on 5/6/10, with the Medical Director of Radiology (MD #11) and the Administrative Director of Radiology identified that the x-ray was completed on 8/21/09 at 3:42 P.M. and not at 8:43 A.M. Interview with the Administrative Director of Radiology, on 5/6/10, identified that Radiology Technician #1 should not have entered completed at 8:43 A.M. unless the image was completed.

b. In addition, the x-ray for Patient #4' right humerus was ordered on 8/21/09 at 2:40 A.M. and was not completed until 8/21/09 at 3:42 P.M., thirteen hours and two minutes later. Interview with the Medical Director of Radiology and the Administrative Director of Radiology identified that a routine radiology test is completed within one day.