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Based on observation, interview and record review, the hospital failed to protect and promote each patient's rights when physical restraints were applied without appropriate assessments, without working care plans, not in accordance with hospital policy and procedure and without a physician's order. The hospital also failed to ensure telemetry monitors were applied as appropriate, provide necessary care and failed to ensure appropriate nursing care plans were developed to meet the needs of the patients. This cumulative effect impacted the rights of patients to be free from physical restraints and impact the rights of patients to receive appropriate care to meet their needs.

The hospital staff failed to assess the indications for the use of side rails. These failures had the potential to restrict the rights of the patients to be free from physical restraints. (A 154)

The hospital failed to ensure working care plans were developed for the use of restraints and failed to ensure they were in accordance with their treatment plans. Such failure had the potential to cause the use of restraints unnecessarily. (A 166)

The hospital failed to ensure the application of restraints was according to the hospital's policy and procedure. These failures had the potential to result in application of a restraint without need for it.
(A 167)

The hospital staff failed to obtain physician's orders prior to the application of restraints. (A 168)

The hospital nursing services failed to ensure telemetry (electronic transmission of heart rhythm between distant points) patients were placed back on telemetry monitors after the completion of scheduled procedures that occurred off the unit. This had the potential for these patients to sustain unnoticed abnormalities in heart rhythms. (A 392)

The hospital failed to provide necessary care for patients which had the potential to place their health at risk. (A 395)

The hospital's nursing services failed to ensure appropriate nursing care plans addressing the use of physical restraints were developed and/or evaluated based on the ongoing assessment of patients' needs for patients. This had the potential to impact the care delivered. (A 396)

Based on observation, interview, and record review, the hospital staff failed to assess the indications for use of side rails for four of 13 sampled patients (1, 2, 3, and 5). For Patient 1, 2 and 3 the hospital failed to assess the indication for the use of three half rails for three of 13 patients (Patient 1, 2, and 3). For Patient 5 the hospital failed to assess the need for four half side rails. These failures had the potential to restrict the rights of the patients to be free from physical restraints.

Findings:

1. During an initial tour of the third floor on August 31, 2010 at 2:35 PM, observation of Patient 1 and Patient 2 both were in bed with three half rails up. Patient 3, had three half rails up, was getting out of bed independently from the side where the half rail was down.

On September 1, 2010 at 10:15 AM, Patient 1, 2, and 3's clinical records were reviewed. All three patients did not have assessments on use of side rails in their records.

The hospital's plan of correction submitted on August 23, 2010 was reviewed on September 1, 2010 at 8 AM. Under the "Restraint/Side Rail Education" issue, it read, "Nursing notes should indicate when side rails are in place, the indications for use and when and why they are removed."

On September 1, 2010 at 11:30 AM, during a concurrent interview and record review, the Nurse Manager (NM 1) stated, after reviewing these three patients' clinical records, there was no documentation that the above three patients were assessed for three side rails. When asked regarding the hospital's acceptable practices on the use of three half rails, the Director of Risk and Compliance stated the new hospital policy on "Side Rails" only addressed two and four side rails. It did not include three side rails.



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2. During an observation in the Intensive Care Unit (ICU), on October 31, 2010 at 2:22 PM, Patient 5 was noted to be lying in bed in no apparent distress with all four side rails up. The patient's family member was lying next to the patient in a recliner chair.

During an interview with Registered Nurse (RN) 3, on August 31, 2010 at 2:22 PM, she indicated the family member of the patient places the side rails up and down. She stated, normally if all four side rails are up in the bed, it would be considered a "restraint" but in this case it was the family member who was placing the side rails up and down and therefore it was not considered a restraint.

During an interview with RN 4, on August 31, 2010 at 2:27 PM, she indicated there was no assessment for Patient 5's side rail use.

During an interview with the family member of Patient 5 on September 1, 2010 at 10:30 AM, she indicated she did not manipulate the side rails of the bed when the patient was in the ICU.

The clinical record for Patient 5 was reviewed on September 1, 2010 at 10:35 AM. During the review there was no documentation in the clinical record the patient was agitated or in need of restraints secondary to an assessed need.

The hospital's policy and procedure titled, 'RESTRAINT, USE OF, was reviewed on August 31, 2010 at 4 PM. The policy statement read in part, "The decision to use restraint/seclusion will not be driven by diagnosis but by a comprehensive individual assessment." Under the heading titled, "Criteria and Limitations" it read, "The use of restraint is limited to those situations for which there is adequate and appropriate clinical justification as well as proof that the use of alternatives poses more risk then restraint/seclusion and alternatives have been considered and attempted as appropriate... In addition to adequate and appropriate clinical justification, the following must be met when restraint/seclusion is used... The use of restraint/seclusion is based on the assessed needs of the patient..."

During an interview with the Chief Nursing Officer 1 for the Southwest hospital campus, on September 1, 2010 at 1:45 PM, after reviewing Patient 5's record, she indicated the nursing documentation concerning this patient indicated the patient was alert and oriented while in the ICU. No additional documented evidence was provided the patient was appropriately assessed for the use of all four side rails prior to and during the application.

Based on observation, interview, and record review, the hospital failed to ensure three of 13 patients (1, 4, and 5 ) had working care plans in place and the use of restraints were in accordance with their treatment plans. Such failure had the potential to cause the use of restraints unnecessarily.

Findings:

1. During an initial tour of the third floor on August 31, 2010 at 2:35 PM, observed Patient 1 in bed sleeping with three half rails up.

On September 1, 2010 at 10:15 AM, during a concurrent review, Patient 1's clinical record indicated he was admitted on August 30, 2010 to the floor with confusion and tremors (uncontrollable shaking that possibly related to drug withdrawal). Patient 1 was put on bilateral wrist restraints (a belt type of restraint that is used to tie a person's wrist to bed frame) and a belt restraint to tie his chest to the bed. On August 31, 2010, it was documented that his mental status and tremors had improved and the belt restraints and wrist restraints were gradually taken off. By 6 PM that day, Patient 1 was completely off belt restraints. At this time, Supervisor for the floor (Registered Nurse [RN] 1) stated Patient 1 was to be discharged.

While reviewing Patient 1's plan of care initiated on his admission, the care plan titled, "Altered Mobility Related to use of restraints due to:" did not reflect the wrist and belt restraints that were used since his admission. The Director of Risk and Compliance (DRC) was informed of the findings.

2. On September 1, 2010 at 1:50 PM, Patient 4 was observed in bed with both wrists tied to his bed frame and he had four side rails up. He was under custody and therefore, his ankles were shackled to the bed. Patient 4's charge nurse (RN 2) explained the reason for the wrist restraint and all rails up were meant to keep him from pulling his tubes and rolling off the bed.

On September 1, 2010 at 2:08 PM, Patient 4's care plan was reviewed. His care plan titled, "Altered Mobility Related to use of restraints due to:" was blank. At 3 PM, the DRC was informed of this issue.

On September 1, 2010 at 4 PM, the hospital's policy and procedure on "Use of Restraint" was reviewed. On Page 11 of this policy, it read, "Plan of care: Documentation should reflect: i. Evidence of assessment of the identified behavior and its related circumstances or the LTC (long term care) medical condition requiring restraint... iv. Description of interventions." The hospital staff failed to assess Patient 4's needs to continue the restraint nor initiate a care plan to reflect his treatment plan.



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3. During an observation in the Intensive Care Unit (ICU), on October 31, 2010 at 2:22 PM, Patient 5 was noted to be lying in bed in no apparent distress with all four side rails up. The patient's family member was lying next to the patient in a recliner chair.

During an interview with RN 3, on August 31, 2010 at 2:22 PM, she indicated the family member of the patient places the side rails up and down. She stated, normally if all four side rails are up in the bed, it would be considered a "restraint" but in this case it was the family member who was placing the side rails up and down and therefore it was not considered a restraint.

During an interview with RN 4, on August 31, 2010 at 2:27 PM, she indicated there was no assessment for Patient 5's side rail use and she was downgraded in acuity and therefore was awaiting a bed on the Medical Surgical floor.

During an interview with the family member of Patient 5 on September 1, 2010 at 10:30 AM, she indicated she did not manipulate the side rails of the bed when the patient was in the ICU.

The clinical record for Patient 5 was reviewed on September 1, 2010 at 10:35 AM. During the review there was no documentation in the clinical record the patient was in need of restraints secondary to an assessed need and therefore there was no care plan developed to address the use of the all four side rails.

The hospital's policy and procedure titled, "SIDE RAILS" read in part under the procedure subheading, "...B. Elevation of all (4) side rails (head and foot of the bed) is considered a restraint device..."

The hospital's policy and procedure titled, "RESTRAINT, USE OF", was reviewed on August 31, 2010 at 4 PM. Under the procedure subheading it read in part, "...2. The patient's written care plan must contain the following documentation: a. Evidence of assessment of the identified behavior and its related circumstances requiring restraint/seclusion. b. Outcome oriented goal related to restraint/seclusion use. c. Discontinuation of the restraint."

During an interview with the Chief Nursing Officer 1 for the Southwest hospital campus, on September 1, 2010 at 1:45 PM, after reviewing Patient 5's record, she indicated the nursing documentation concerning this patient indicated she was alert and oriented while in the ICU. No additional documented evidence was provided the hospital followed its restraint policy and procedure in ensuring there was a care plan for the use of all four side rails up for Patient 5.

Based on observation, interview and record review, the hospital failed to ensure the application of restraints for two two (5 and 6) of 13 patients was according to the hospital's policy and procedure. For Patient 5, the hospital failed to ensure there was a physician's order and the patient was properly assessed prior to the application of full side rails, according to the hospital's policy and procedure. For Patient 6 the hospital failed to ensure the type of the restraints that was applied was according to the physician's order and that an appropriate assessment was conducted based on the actual applied restraint(s). These failures had the potential to result in application of a restraint without need for it.

Findings:

1. During an observation in the Intensive Care Unit (ICU), on October 31, 2010 at 2:22 PM, Patient 5 was noted to be lying in bed in no apparent distress with all four side rails up. The patient's family member was lying next to the patient in a recliner chair.

During an interview with Registered Nurse (RN) 3, on August 31, 2010 at 2:22 PM, she indicated the family member of the patient places the side rails up and down. She stated, normally if all four side rails are up in the bed, it would be considered a "restraint" but in this case it was the family member who was placing the side rails up and down and therefore it was not considered a restraint.

During an interview with RN 4, on August 31, 2010 at 2:27 PM, she indicated there was no assessment for Patient 5's side rail use and she was downgraded in acuity and therefore was awaiting a bed on the Medical Surgical floor.

During an interview with the family member of Patient 5 on September 1, 2010 at 10:30 AM, she indicated she did not manipulate the side rails of the bed when the patient was in the ICU.

The clinical record for Patient 5 was reviewed on September 1, 2010 at 10:35 AM. During the review there was no documentation in the clinical record the patient was agitated or in need of restraints secondary to an assessed need. There was also no physician's order for the four side rails up.

The hospital's policy and procedure titled, "RESTRAINT, USE OF", was reviewed on August 31, 2010 at 4 PM. The policy statement read in part, "The decision to use restraint/seclusion will not be driven by diagnosis but by a comprehensive individual assessment." The policy continued and read, "Licensed Independent Practitioner (LIP) For the purposes of ordering restraint or seclusion, an LIP is any practitioner permitted by State law and hospital policy as having the authoring to independently order restraint..." Under the heading titled, "Criteria and Limitations" it read, "The use of restraint is limited to those situations for which there is adequate and appropriate clinical justification as well as proof that the use of alternatives poses more risk then restraint/seclusion and alternatives have been considered and attempted as appropriate... In addition to adequate and appropriate clinical justification, the following must be met when restraint/seclusion is used... The use of restraint/seclusion is based on the assessed needs of the patient..."

During an interview with the Chief Nursing Officer (CNO) 1 for the Southwest hospital campus, on September 1, 2010 at 1:45 PM, after reviewing Patient 5's record, she indicated the nursing documentation concerning this patient indicated she was alert and oriented while in the ICU. No additional documented evidence was provided that the hospital followed its restraint policy and procedure in ensuring there was a physician's order and the patient was appropriately assessed for the use of all four side rails prior to and during the application.

2. During an observation on September 1, 2010 at 3:05 PM, Patient 6 was noted lying in bed with right and left upper side rails up and right and left lower side rails down. The patient had a waist support applied and a soft wrist restraint to the left wrist. At 3:25 PM, she was again observed with the waist support applied and the soft tie to the left wrist. The upper side rails were up and the lower side rails were down.

The clinical record for Patient 6 was reviewed on September 1, 2010 at 3:10 PM. The latest physician's order dated and signed by the physician on September 1, 2010 indicated the patient was attempting to get out of bed and pulling on tubes and lines. The restraints ordered by the physician included, soft wrist restraint to left wrist, full side rails, and a body belt. Although through observation, the patient did not have full side rails up.

The "PATIENT RESTRAINT DOCUMENTATION ACUTE MEDICAL-SURGICAL RESTRAINT" form dated September 1, 2010 was reviewed. According to the restraint form, the patient had a "Belt" and "Full Side Rails" applied. There was no indication on this form the patient was being monitored every two hours for the use of the left wrist restraint.

During an interview with RN 5, on September 1, 2010 at 3:45 PM, he was informed there was inconsistency between the observation of the applied restraints for Patient 6, the physician's order and the patient restraint documentation form. He indicated he was aware of the inconsistencies.

The hospital's policy and procedure titled, 'RESTRAINT, USE OF, was reviewed on August 31, 2010 at 4 PM. The Procedure subheading read in part, "1. Requirement for orders for ALL FORMS of Restraint/Seclusion a. The use of restraint...must be in accordance with the order of a physician or other licensed independent practitioner....f. The order will include the specific reason for restraint/seclusion, the type of restraint, and specified time period..." The Documentation subheading read in part, "1. Each episode of restraint/seclusion, must contain the following documentation in the patient's medical record...d. the written or verbal order for restraint/seclusion use consistent with the requirements of this policy. e. The type of restraint(s) utilized and the parts of the patient's body restrained..."

Based on observation, interview, and record review, the hospital staff failed to obtain physician's orders prior to application of restraints for two of 13 patients (4 and 5) which resulted in violation of Patient 4 and Patient 5's right to be free from unnecessary restraints.

Findings:

1. On September 1, 2010 at 1:50 PM, Patient 4 was observed in bed with both wrists tied to his bed frame and four side rails up. His ankles were both shackled to the bed. Patient 4 's charge nurse (Registered Nurse [RN]) 2 explained the reason was to keep him from pulling his tubes and the possibility of rolling off bed. She stated Patient 4 had been on these restraints since his admission, August 23, 2010.

On September 1, 2010 at 2:08 PM, Patient 4's "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER" was reviewed. It was noted that on August 25, and August 28, 2010, Patient 4's physician signed a blank "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER" order without completing any information such as "RESTRAINT JUSTIFICATION," "TYPE OF RESTRAINT," and "LENGTH OF RESTRAINT." Furthermore, a licensed staff noted the blank order on both days without clarification. After further review, it was again noted that another "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER," written on August 29, 2010, did not complete "TYPE OF RESTRAINT" nor "LENGTH OF RESTRAINT." This order, was also noted by a licensed nurse.

On September 1, 2010 at 3 PM, the Director of Risk and Compliance (DRC) was notified of the finding.

The hospital's policy and procedure on "Use of Restraint" was reviewed on September 1, 2010 at 4 PM. Under Procedure "B. Orders for Restraint," it read, "e. The order will include the specific reason for the restraint, the type of restraint, location of restraint and specific time period ..." The hospital failed to clarify physician's orders when orders were incomplete and continued to restrain the patient without authorization.



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2. During an observation in the Intensive Care Unit (ICU), on October 31, 2010 at 2:22 PM, Patient 5 was noted to be lying in bed in no apparent distress with all four side rails up. The patient's family member was lying next to the patient in a recliner chair.

During an interview with RN 3, on August 31, 2010 at 2:22 PM, she indicated the family member of the patient places the side rails up and down. She stated, normally if all four side rails are up in the bed, it would be considered a "restraint" but in this case it was the family member who was placing the side rails up and down and therefore it was not considered a restraint.

During an interview with RN 4, on August 31, 2010 at 2:27 PM, she indicated there was no physician's order for Patient 5's side rail use.

During an interview with the family member of Patient 5 on September 1, 2010 at 10:30 AM, she indicated she did not manipulate the side rails of the bed when the patient was in the ICU.

The clinical record for Patient 5 was reviewed on September 1, 2010 at 10:35 AM. During the review there was no physician's order for the four side rails up.

The hospital's policy and procedure titled, "RESTRAINT, USE OF," was reviewed on August 31, 2010 at 4 PM. The policy read in part , "Licensed Independent Practitioner (LIP). For the purposes of ordering restraint or seclusion, an LIP is any practitioner permitted by State law and hospital policy as having the authoring to independently order restraint..."

During an interview with the Chief Nursing Officer 1 for the Southwest hospital campus, on September 1, 2010 at 1:45 PM, after reviewing Patient 5's record, she indicated the nursing documentation concerning this patient indicated she was alert and oriented while in the ICU. No additional documented evidence there was a physician's order for the use of all four side rails prior to and during the application.

Based on observation, interview, and record review, the hospital's nursing service failed to evaluate and supervise patient care needs in ensuring patients were free from restraint application and ensuring safe delivery of nursing care in accordance with each individualized care.

The hospital nursing services failed to ensure telemetry (electronic transmission of heart rhythm between distant points) patients were placed back on telemetry monitors after the completion of scheduled procedures that occurred off the unit. This had the potential for these patients to sustain unnoticed abnormalities in heart rhythms. (A 392)

The hospital's nursing services failed to provide necessary care for patients which had the potential to place their health at risk. This failure was evidenced by the facilities failure to report an abnormal cardiac rhythm to the physician timely and the failure to follow physician's orders. (A 395)

The hospital's nursing services failed to ensure appropriate nursing care plans addressing the use of physical restraints were developed and/or evaluated based on the ongoing assessment of patients' needs for patients. This had the potential to impact the care delivered. (A 396)

The cumulative effects of these systemic failures in nursing practices resulted in the failure of the hospital to monitor the provision of quality and safe patient care as mandated in the condition of coverage.

Based on observation, interview and record review, the hospital failed to ensure three telemetry (electronic transmission of heart rhythm between distant points) patients (8, 9, and 10) were placed back on telemetry monitors after completing their procedures off unit which had the potential for these patients to sustain abnormal heart rhythms without being noticed.

Findings:

1. During an observation on August 31,2010 at 1:51 PM, at the Southwest campus, on the second floor where patients' heart rhythms were monitored. It was observed that Patient 8 did not show a heart rhythm on the monitor. Observed Patient 8 in the patient's room watching T.V. in bed with her telemetry box (a device that can transmit the heart rhythm from distance) on her bedside table.

During an interview with Patient 8 on August 31,2010 at 1:51 PM, she stated, "I've been back from procedure at least an hour, because I already had my lunch here."

During an interview with the Monitor Tech (MT) 2 on August 31,2010 at 2:10 PM, she stated, "That's my fault, I forgot to put her back on the monitor."

During an interview with Registered Nurse (RN) 7 on August 31, 2010 at 1:55 PM, he stated, "She went to a procedure at about 11:30 AM. I don't know when she came back."

The Transport Tracking Log, dated August 31, 2010 was reviewed on September 1, 2010. The log indicated that Patient 8 returned to the floor at 11:15 AM. Patient 8's heart rhythm was not monitored for more than an hour and half.



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2. On September 1, 2010 at 8:30 AM, the hospital's "COMMUNICATION NOTES" for August 26, 2010 was reviewed. A note entered at 8:23 AM read, "...(Patient 9) went to x-ray. I stop(ped) tele(metry) and put x-ray pause on her box. At 0920 (9:20 AM) I thought to check her box to see if she was back on tele. and she was. No one called me to tell me she was back."

A second note was entered at 8:37 AM, it read, "...(Patient 10) went to x-ray. I paused the box (telemetry box) and at 0920 (9:20 AM) I checked to see if Pt (patient) was back from x-ray. And no one called me to unpause the box."

On September 2, 2010 at 11:15 AM, during an interview, the MT 3 stated she was stationed on the fifth floor and her responsibility was to monitor the heart rhythms for patients on that floor and on the remote floor, the third floor. She stated she was the one who entered the notes because the nurses on the third floor did not communicate to her when a patient returned to the floor after being off the unit for a procedure. MT 3 added that this had been a problem for a long time on the third floor and the problem remained "About the same" even after the in-service.

On September 1, 2010 at 4 PM, the hospital's plan of correction submitted on August 23, 2010 was reviewed. A new policy with effective date of August 20, 2010 included "The telemetry unit staff with(sic) notify the telemetry monitor technician ... and again upon the patients return to the unit."

Based on observation, interview, and record review, the hospital failed to provide necessary care to four of 13 patients (7, 11, 12, and 13) which had the potential to place their health at risk. For Patient 7, the hospital failed to ensure her change in cardiac rhythm was reported to the physician in a timely manner. This failure had the potential to prevent the timely determination of a probable etiology (cause) for Patient 7's health problem. For Patient 7, the hospital also failed to follow the bed rest order which had the potential to cause episodes of abnormal heart rhythms. For Patient 11, the hospital nursing staff failed to follow physician's order to place him on a heart monitor and accompany him for a procedure off unit. Such failure could put Patient 11 at risk for having abnormal heart rhythms while off unit without supervision. For Patient 12, the hospital failed to ensure he had a physician's order to discontinue telemetry monitoring while off unit for procedures. For Patient 13, the hospital failed to change his battery when his cardiac monitoring device signaled weak battery which had caused nursing staff not being warned when he sustained a life threatening rhythm. The hospital failed to assess Patient 13's need for use of side rails which had the potential to cause his fall from his bed to the floor.

Findings:

1. The clinical record for Patient 7 was reviewed on September 1, 2010, at 3:30 PM. Patient 7 presented to the hospital's emergency department with complaints of syncopal (fainting) episodes for two weeks. The following records were also reviewed on September 1, 2010 at 3:30 PM:

a. The Monitor Technician Communication Log dated August 27, 2010, at 7:55 PM indicating Patient 7 had ventricular tachycardia (a life-threatening heart rhythm). MT 1 (Monitor Technician 1) documented in the log she had notified RN (Registered Nurse) 6 of the life-threatening heart rhythm and gave RN 6 the printed strip of the heart rhythm.
b. MT (Monitor Technician) 1 documented in the log Patient 7 previously had ventricular tachycardia at 6:11 PM. A subsequent entry in the log at 9:45 PM, indicated Patient 7 had another episode of ventricular tachycardia.
c. The nurses notes on August 27, 2010, at 10 PM indicated " MT 1 reported a possible VTACH/multiple PVCs (ventricular tachycardia/multiple premature ventricular complexes) that occurred [sic] while patient was out of the bed at 2146 (9:46 PM)."
d. The cardiac rhythm record indicated Resident 7 had five episodes of short runs of ventricular tachycardia at 9:45 PM to 9:46 PM on August 27, 2010. From the first episode of ventricular tachycardia at 6:11 PM up to 9:46 PM on August 27, 2010, Patient 7 had a total of seven episodes of ventricular tachycardia.
e. The nurses notes on August 28, 2010, at 1:30 AM (over seven hours after the first episode of the ventricular tachycardia) indicated RN 6 notified MD (Medical Doctor) 1 of the possible ventricular tachycardia while Patient 7 was ambulating.
f. The NEUROLOGY CONSULTATION dated August 28, 2010 indicated "CT (computerized tomography, a scan to make pictures of a thin slice) of the head which was a negative study. MRI (magnetic resonance imaging, to detect structural abnormalities) and MRA (magnetic resonance angiogram, gives a view of specific blood vessels) of the brain also reported as negative. Carotid ultrasound (test using high-frequency sound waves to create images of the insides of the two large arteries of the neck) negative. IMPRESSION: 1. Syncopal episode, etiology unclear. Diagnosis certainly includes cardiac causes in which the patient complains of some palpitations before and after syncope. RECOMMENDATIONS: 5. Cardiology consult recommended."

During an interview with Nurse Manager 2 on September 2, 2010, at 10:50 AM, she reviewed the electronic clinical record and the closed chart of Patient 7 and was unable to find the printed strip of the abnormal heart rhythm on August 27, 2010, at 6:11 PM. Nurse Manager 2 was unable to find documentation of the RN's evaluation of the heart rhythm changes on the subsequent episodes of ventricular tachycardia; nor did she find a documentation of a much earlier physician notification. RN 6 was not available for interview at this time. Nurse Manager 2 stated Patient 7 had a PICC (peripherally inserted central catheter, a flexible tube that is put into a vein in the arm and threaded up into a large vein just above the heart) inserted earlier that day. RN 6's nursing documentation on August 28, 2010 at 1:30 AM indicated "CXR (chest X-Ray) DONE AT 1600 (4 PM) YESTERDAY SHOWING PICC LINE IS IN THE RT (right) ATRIUM (right upper chamber of the heart)." Nurse Manager 2 stated the PICC may have caused the abnormal heart rhythm. No documentation was found to explore other causative factors for abnormal heart rhythm. Patient 7 was discharged on August 31, 2010. Nurse Manager 2 was unable to find documentation a cardiologist was consulted to see Patient 7.

The hospital's policy and procedure with the title, TELEMETRY MONITOR, PLACING PATIENTS ON AND MONITORING OF effective date June 1994, reviewed/revised August 2010 states in part..."PROCEDURE: The Registered Nurse, Licensed Vocational Nurse, or other patient care personnel: 12. In Meditech (computer software for electronic documentation), RN completes telemetry evaluation at least once every shift or if ECG (electrocardiogram, a visual record of the electrical activity of the heart) changes."

A review of Patient 7's ADMISSION ORDERS dated August 26, 2010, at 4:10 PM indicated an order for bed rest with bedside commode. PHYSICIAN ORDERS on August 29, 2010 indicated an order for "OOB (out of bed) to chair TID (three times a day)." A review of the nurses notes dated August 27, 2010 indicated Patient 7 had been ambulating that day. A documentation on the printed alarm review on August 27, 2010 at 7:55 PM, at 9:45 PM, and at 9:46 PM indicated Patient 7 was ambulating during these episodes of ventricular tachycardia. Nurse Manager 2 stated she will speak to the staff regarding this matter.



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2. The hospital report was reviewed on August 19, 2010 at 12:45 PM. The report read in part, "Patient's telemetry monitor (TM) indicated poor connection. The RN responded to assess the reason for the poor connection and found the patient on the floor unresponsive with shackles attached to his legs per CDCR (California Department of Corrections and Rehabilitation) regulation. Patient was immediately assessed to have no blood pressure apnea (absence of breathing), no pulse, and was pronounced dead by his physician..."

An unannounced visit was made on August 19, 2010 at 2 PM, due to the above hospital reported adverse event.

During an interview with the Director of Risk & Compliance (DRC) on August 19, 2010 at 2 PM, she indicated Patient 13 was on a guarded unit. On the day of the occurrence (August 13, 2010), Patient 13 was found by RN 10 lying on the floor, left side of the bed, breathless and with no pulse, Cardio Pulmonary Resuscitation (CPR) was started. DRC also explained that when Patient 13 was found, he had both ankles shackled but not to the bed. His bed still had three half rails up and he was found on the side of bed where both half rails were in the up position. Nursing assessment was not needed because the hospital did not consider side rails a restraint if there was an access for the patient to get out of bed. Side rails were only considered a restraint if "all four side rails are up".

During an interview with RN 10, on August 19, 2010 at 2:30 PM, he stated prior to finding Patient 13 unresponsive on August 13, 2010 at 1 PM, he was in his room at approximately 12 PM. Another registered nurse (RN 11) went to the room around 12:30 PM to care for Patient 13's roommate. RN 11 noticed Patient 13's intravenous (IV) pump was alarming and she was able to disable the alarm. RN 11 informed RN 10 about the pump problem after she came out of the room. Because each room was locked on this guarded unit, he proceeded to find an officer to unlock the door and found Patient 13 on the floor unresponsive. He called the Telemetry Monitor Technician at the desk to ask what the patient's cardiac rhythm was and he was told "it wasn't picking up." He explained when the telemetry monitor is not picking up, it usually meant the leads were off or the battery was dead. He sent someone out to get a new battery. After he replaced the old battery with the new one, the monitor started working, "...of course it was asystole (absence of heartbeat/cardiac arrest)." RN 10 stated the nurses were notified when Patient 13's telemetry monitor device's battery was low by the MT, "It will show up on the monitor they sit to watch."

During an interview with RN 11, on August 19, 2010 at 3 PM, she indicated she went in to Patient 13's room to examine another patient and she heard Patient 13's IV pump "was going off" so she went to tell RN 10. The patient (Patient 13) was fine at the time. She indicated, if the battery was low on the telemetry monitor, "the MT would inform you and we will go in and change them."

During an interview with MT 5, on August 19, 2010 at 3:15 PM, she indicated, on the day of the incident, she paged overhead four different times for a nurse to change Patient 13's battery. She indicated the screen she monitored would signal when a new battery was needed and the alarm would be both audible and visible.

During an interview with MT 3, on August 19, 2010 at 3:45 PM, she stated when the battery for a telemetry monitor needed to be changed, the telemetry screen would signal the battery was weak and then there would be no signal.

The clinical record for Patient 13 was reviewed on August 19, 2010 at 3 PM. A "Post Fall Assessment" completed by RN 10 on August 13, 2010 at 1 PM read in part, "PT (Patient 13) WAS FOUND SUPINE (on back) ON FLOOR, UNRESPONSIVE AND PULSELESS AT 1300...NO INJURIES NOTED AT TIME OF FALL... (Physician X) WAS AT BEDSIDE IMMEDIATELY AFTER PT. WAS FOUND DOWN AND PULSELESS ...WHEN FOUND, PT. WAS APNEIC, PULSELESS AND NO BLOOD PRESSURE."

The physical assessment completed on August 13, 2010 on Patient 13 by RN 10 documented, "...UPON ARRIVAL PT. (patient) WAS PULSELESS, CPR INITIATED." Under the "Telemetry Comments it read, "BATTERY IN TELE (telemetry) BOX DEAD, UPON REPLACEMENT, ASYSTOLE NOTED."

A nursing note entered by RN 10 was noted in Patient 13's clinical record, dated August 13, 2010 at 1 PM, which read in part, "ENTERED PT'S ROOM BECAUSE OTHER RN INSTRUCTED ME THAT LAST TIME SHE HAD BEEN IN THE ROOM, HIS IV PUMP WAS ALARMING. I ENTERED ROOM AND FOUND PT LYING IN A SUPINE POSITION ON THE FAR SIDE OF HIS BED... WITH HIS HEAD TOWARDS THE BED ADN (sic) HIS FEET AWAY FROM IT, ALMOST IN A PERPENDICULAR (sic) POSITION TO THE BED. AT THE TIME OF DISCOVERY PT WAS UNRESPONSIVE, PULSELESS AND APNEIC, SKIN COLOR WAS PALE, NO CYANOSIS NOTED AT THIS TIME. NO OBVIOUS INJURY NOTED FROM FALL...CPR IMMEDIATELY STARTED BY MYSELF, (Physician X) AT BEDSIDE WITHIN A MINUTE OR TWO....CDCR MANAGER...ENTERED ROOM A COUPLE MINUTES LATER AND INFORMED US THAT EARLIER...SHE HAD RECEIVED AN ADVANCE DIRECTIVE FROM PRISON THAT STATED PT. WAS TO BE A DNR (do not resuscitate)...AS SOON AS (Physician X) VERIFIED THE PAPERWORK AND GAVE THE ORDER TO DISCONTINUE CPR, CPR WAS STOPPED. TIME OF DEATH FOR PT. WAS DECLARED TO BE 1305 (1:05 PM) BY (Physician X)."

The "DISCHARGE SUMMARY" by Physician X was reviewed and read in part, "...On the day he (Patient 13) was supposed to have the thoracentesis, the patient was not cooperative... When came to see the patient on 08/13/2010 right at the time I heard a Code Blue. The patient was found on the floor, unresponsive. He was totally pale and unresponsive, no pulse, no BP (blood pressure). His pupils were fixed and dilated. Brief chest compression was done but the patient's code status was not resuscitate... Therefore, no further resuscitation was done and he was pronounced dead..."

The hospital policies and procedures titled, "REMOTE TELEMETRY", "TELEMETRY MONITOR, PLACING PATIENTS ON AND MONITORING OF", "REMOTE TELEMETRY MONITORING - TERMINATING" were reviewed. There was no mention in any of these policies of the need for the RN to be responsible for monitoring the telemetry monitoring device's battery at specified intervals.

During the interview with the DRC on entrance to the hospital on August 19, 2010 at 2 PM, she described Patient 13's bed, at the time of his fall, had both left half rails and the right lower half rail up. The only half rail that was not being used was on the right upper portion of his bed. Patient 13 was found on the left side of his bed where both half rails were in up position.

The clinical record for Patient 13 was further reviewed for a side rail assessment. The physical assessment conducted by RN 10, on August 13, 2010 in the morning indicated, under the section titled " SAFETY/RISK," there were "No Restraints." Under the comments section, it read, "NO CLINICAL INDICATION FOR RESTRAINTS." There was also no documentation found to indicate nursing assessed Patient 13's need for the use of three half side rails when in bed or assessed if a less restrictive approach would be appropriate for him.

The hospital policy and procedure titled, "RESTRAINT, USE OF" read in part under the policy statement, "B. The decision to use restraint will be driven...by comprehensive individual assessment, which concludes that for a specific patient at a specific time, the use of less restrictive interventions poses a greater risk than the risk of using a restraint... C. It is recognized that patients in the Guarded Care Unit setting have a population that require additional standards that are required by the California Department of Corrections and Rehabilitation Department (CDCR). When restraints are required for clinical control purposes, the CDCR staff will follow...Hospital Restraint policy..." Under the "Scope and Applicability" subheading it read in part, "A. Restraint may only be used if needed to improve the patient's well being AND less restrictive interventions have been assessed to be ineffective in protecting the patient or others from harm...B. 7. Utilizing devices which serve multiple purposes such as...side rails, when they have the effect of restricting a patient's/resident's movement and cannot be easily removed by the patient, thus constituting a restraint."

The Department's review determined the hospital failed to ensure one patient (Patient 13) received adequate supervision while on a cardiac monitoring device and the hospital did not have an adequate policy and procedure in side rail assessment, had the potential to cause harm to its patients. An Immediate Jeopardy situation was declared and presented to the Chief Executive Officer, the Chief Nursing Officer (CNO), and the Director of Risk & Compliance on August 19, 2010 at 5:30 PM. The hospital revised its policies and procedures to change the battery of monitoring devices every 12 hours and added the side rail assessment to its restraints requirements. On August 24, 2010 at 2:52 PM the Immediate Jeopardy was abated with the CNO and DRC.



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3. On September 1, 2010 at 8:30 AM, the hospital's "COMMUNICATION NOTES" for August 27, 2010 was reviewed. A note entered by a Monitor Technician (MT) 3 read: "(Patient 11) left to sp (Special Procedure @ (at) 726 (7:26 AM). This pt (patient) is a pt of Dr. (Doctor) ... he has a standing order that his pt do not go off ward without tele (telemetry). I told (RN 8) & (RN 9) and they both just stared at me like I was talking to a wall. So by that time the pt already left the floor ... "

On September 2, 2010 at 11:15 AM, during an interview, MT 3 stated she went to RN 8 and RN 9 and requested one of them to go with the patient and put him on a monitor. Neither RN 8 nor RN 9 responded to her request. MT 3 stated, "They ignored it and no one went with the patient." MT 3 stated that she also informed the incident to the charge nurse. At 12:15 PM, during an interview, the Nurse Manager (NM) 1 stated that he was not sure if the patient went for a procedure without being monitored at all. He stated he would talk to RN 9 later.

On September 2, 2010 at 2 PM, Patient 11's clinical record was reviewed. A telephone order, dated August 24, 2010 at 2:20 PM, read, "Patient to wear telemetry with RN (Registered Nurse) present when off ward." Both RN 8 and RN 9 failed to follow the physician's order to provide safe care to Patient 11.

3. On September 1, 2010 at 8:30 AM, the hospital's "COMMUNICATION NOTES" for August 24, 2010 was reviewed. On September 2, 2010 at 10:30 AM, Patient 13's clinical record was reviewed. Patient 13 did not have a physician's order to be off the ward without telemetry monitoring.

On September 2, 2010 at 2 PM, the Director of Risk and Compliance was informed of this finding.



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4. During an interview with MT 4 on August 31, 2010 at 1:55 PM, she stated, "Yes. Patient ( Patient 12) was off the monitor for tests from 8:30 AM till 9 AM, and I do not see an order for being off the monitor in the chart.

The clinical record for Patient 12 was reviewed on August 31,2010. There was no physician's orders found for off telemetry for procedures.

The Plan of Correction dated August 23, 2010 indicates "In case a patient needs to leave the department for a procedure, a physician's order is required to discontinue telemetry."

Based on observation, interview and record review, the hospital failed to ensure appropriate nursing care plans addressing the use of physical restraints were developed and/or evaluated based on the ongoing assessment of patients' needs for three of 13 sampled patients (1, 4 and 5). This had the potential to impact the care delivered.

Findings:

1. During an observation in the Intensive Care Unit (ICU), on October 31, 2010 at 2:22 PM, Patient 5 was noted to be lying in bed in no apparent distress with all four side rails up. The patient's family member was lying next to the patient in a recliner chair.

During an interview with RN (Registered Nurse) 3, on August 31, 2010 at 2:22 PM, she indicated the family member of the patient places the side rails up and down. She stated, normally if all four side rails are up in the bed, it would be considered a "restraint" but in this case it was the family member who was placing the side rails up and down and therefore it was not considered a restraint.

During an interview with the family member of Patient 5 on September 1, 2010 at 10:30 AM, she indicated she did not manipulate the side rails of the bed when the patient was in the ICU.

The clinical record for Patient 5 was reviewed on September 1, 2010 at 10:35 AM. During the review there was no documentation in the clinical record the patient was in need of restraints secondary to an assessed need and therefore there was no care plan developed to address the use of the all four side rails.

The hospital's policy and procedure titled, "SIDE RAILS" read in part under the procedure subheading, "...B. Elevation of all (4) side rails (head and foot of the bed) is considered a restraint device..."

The hospital's policy and procedure titled, 'RESTRAINT, USE OF, was reviewed on August 31, 2010 at 4 PM. Under the procedure subheading it read in part, "...2. The patient's written care plan must contain the following documentation: a. Evidence of assessment of the identified behavior and its related circumstances requiring restraint/seclusion. b. Outcome oriented goal related to restraint/seclusion use. c. Discontinuation of the restraint."

During an interview with the Chief Nursing Officer (CNO) 1 for the Southwest hospital campus, on September 1, 2010 at 1:45 PM, after reviewing Patient 5's record, she indicated the nursing documentation concerning this patient indicated she was alert and oriented while in the ICU. No additional documented evidence was provided that a care plan was developed for the use of all four side rails up for Patient 5.



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2. During an initial tour of the third floor on August 31, 2010 at 2:35 PM, observed Patient 1 in bed sleeping with three half rails up.

On September 1, 2010 at 10:15 AM, during a concurrent review, Patient 1's clinical record indicated he was admitted on August 30, 2010 to the floor with confusion and tremors (uncontrollable shaking that possibly related to drug withdrawal). Patient 1 was put on bilateral wrist restraints (a belt type of restraint that is used to tie a person's wrist to bed frame) and a belt restraint to tie his chest to the bed. On August 31, 2010, it was documented that he had regained his cognition and had been cooperative. Patient 1 was completely off these restraints by 6 PM that day. There was no documentation to indicate that he was assessed to use three side rails.

While reviewing Patient 1's plan of care initiated on his admission, the care plan titled, "Altered Mobility Related to use of restraints due to:" did not reflect the wrist restraint, the belt restraints, or the three side rails that were used since his admission. The Director of Risk and Compliance (DRC) was informed of the findings.

3. On September 1, 2010 at 1:50 PM, Patient 4 was observed in bed with both wrists tied to his bed frame and he had four side rails up. He was under custody and therefore, his ankles were shackled to the bed. Patient 4's charge nurse (RN 2) explained the reason for the wrist restraint and all rails up were meant to keep him from pulling his tubes and rolling off the bed.

On September 1, 2010 at 2:08 PM, Patient 4's care plan was reviewed. His care plan titled under "SAFETY," read, "9B: Altered Mobility Related to use of restraints due to:" was blank. The nursing staff did not identify the patient's problems, failed to set goals, and did not initiate any interventions.

On September 1, 2010 at 3 PM, the DRC was informed of the above deficient practices.

On September 1, 2010 at 4 PM, the hospital's policy and procedure on "Use of Restraint" was reviewed. On Page 11 of this policy, it read, "Plan of care: Documentation should reflect: i. Evidence of assessment of the identified behavior and its related circumstances or the LTC (long term care) medical condition requiring restraint... iv. Description of interventions." The hospital staff failed to neither assess Patient 4's needs to continue the restraint nor initiate a care plan to reflect his treatment plan.

Based on observation, interview, and record review, the hospital licensed nurses failed to verify the restraint orders for one (4) of 13 patients when restraint orders were left blank or incomplete. This deficient practice had resulted in application of physical restraints by licensed nurses to Patient 4 without justification or authorization.

Findings:

1. On September 1, 2010 at 1:50 PM, Patient 4 was observed in bed with both wrists tied to his bed frame and four side rails up. His ankles were both shackled to the bed. Patient 4 's charge nurse (RN 2) explained the reason was to keep him from pulling his tubes and the possibility of rolling off bed. She stated Patient 4 had been on these restraints since his admission, August 23, 2010.

On September 1, 2010 at 2:08 PM, Patient 4's "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER" was reviewed. It was noted that on August 25, and August 28, 2010, Patient 4's physician signed a blank "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER" order without completing any information. The required information was divided into 4 sections, they were: "RESTRAINT JUSTIFICATION," "TYPE OF RESTRAINT," "LENGTH OF RESTRAINT," and "ORDER." Furthermore, a licensed staff noted the blank order on both August 25 and 28, 2010 without obtaining clarification. After further review, it was again noted that another "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER," written on August 29, 2010, did not have "TYPE OF RESTRAINT" nor "LENGTH OF RESTRAINT" written as required. A review of the pre-printed "ACUTE MEDICAL/SURGICAL RESTRAINT ORDER" form, it was clearly indicated that "All 4 sections MUST Be Completed."

On September 1, 2010 at 3 PM, the Director of Risk and Compliance (DRC) was notified of the finding.

The hospital's policy and procedure on "Use of Restraint" was reviewed on September 1, 2010 at 4 PM. Under Procedure "B. Orders for Restraint," it read, "e. The order will include the specific reason for the restraint, the type of restraint, location of restraint and specific time period ..." The hospital failed to clarify physician's orders when orders were incomplete and continued to restrain the patient without authorization.

Based on observation, interview, and record review, the nursing staff failed to follow the hospital's medical records policy and procedure for one of 13 sampled patients (8) which resulted in his physician's order were written inconsistently.

Findings:

The clinical record for Patient 8 was reviewed on August 31, 2010, the Patient Care Notes dated August 31, 2010 indicated Patient 8 was off the monitor for a procedure from 10:15 AM.

During an interview with RN (Registered Nurse) 7 on August 31, 2010 at 1:55 PM, when asked if he had an off monitor for Patient 8, he stated, "I got the order earlier and didn't write it. I should have written it on time, I will write it now."

During an observation on August 31, 2010 at 1:55 PM, at the hospital's Southwest campus, on the second floor telemetry unit, RN 7 wrote a verbal physician's order dated August 31, 2010 and timed it at 10:15 AM.

The hospital policy and procedure titled "Verbal, Telephone and Written Physician Orders," dated February 1983, read: "Verbal orders are discouraged and will only be accepted under emergency conditions. All verbal orders shall be written as they are received."