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Based on observation, interview and record review, the hospital failed to ensure that its restraint policy and procedure was implemented, for one sampled patient (Patient 4). There was no documented evidence that, Registered Nurses attempted to utilize the least restrictive methods of restraint and document the ineffectiveness of those measures, prior to implementing more restrictive devices which included the use of dual restraints: bilateral soft wrist restraints and 4 side rails.

Findings:


On 9/11/12 a record review was initiated. Patient 4 was admitted to the hospital on 8/28/12, with diagnoses that included dementia, failure to thrive, and pneumonia, per a physician progress note dated 9/10/12.

Per a nursing Fall Risk assessment, dated 9/10/12 at 8:00 A.M., Patient 4 did not have a history of falls and was a "moderate" fall risk. She required the use of an assist device to walk. Low and moderate fall prevention strategies included frequent observations, use of a bed alarm, physical therapy consult, and bed in low position. High fall risk interventions, which included bed near the nurses' station, use of safety devices were not implemented. The patient's mental status was assessed as "disoriented or restless."

A review of physician's orders, dated 8/29/12, revealed that Patient 4 was prescribed Ativan (anti-anxiety medication) intravenously (IV) as needed for anxiety.

On 9/9/12, per day shift nursing progress notes, Patient 4 was "resting quietly with her bed alarm on." On 9/9/12, the evening shift nursing progress notes documented that the patient pulled out her intravenous (IV) line and initially refused to have it re-inserted. Per the note, an IV was reinserted later in the shift, which required the assistance of 3 nurses. Per the note, the patient was "extremely agitated" when touched.

On 9/10/12 at 10:00 A.M., per a nursing progress note, Patient 4 was agitated and tried to climb out of bed. At 10:00 A.M., per the nursing notes, dual restraints were implemented which included bilateral soft wrist restraints, and the use of 4 bed rails in the up position. At 10:50 A.M., the physician was notified and new orders were received. At 11:33 A.M., 2 milligrams (mg.) of IV Ativan (anti-anxiety medication) was administered to the patient, and at 11:50 A.M., 5 mg. of IV Haldol (anti-psychotic medication) was administered. At 1:00 P.M., the patient was "resting comfortably in no distress or discomfort." There was no documented evidence that less restrictive methods had been attempted by nursing staff and were unsuccessful, prior to the implementation of dual restraints.

Per the 9/10/12 physician progress note, the patient was extremely agitated and pulled out her IVs. Per the note, the patient had been calm up until that point. A psychiatric evaluation was planned.

Per the initial restraint order, dated 9/10/12 at 10:55 A.M., the reason for restraint was prevention of harm to self from pulling out IVs/tube, cognitive impairment and inability to follow instructions regarding safety measures. Alternative methods that were attempted included: verbal re-orientation, offered toileting, fluids, food, diversional activity and use of bed alarm.

Per nursing notes, dated 9/11/12 at 4:00 A.M., the patient refused to have a straight urinary catheter inserted, but stated "she will use the bed pan and call when she needs to urinate."

On 9/11/12, multiple observations of Patient 4 were conducted with the The Medical Surgical Assistant Nurse Manager (MSANM).

On 9/11/12 at 11:10 A.M., Patient 4 was observed on her side in bed trying to pull herself up using an upper bedrail. All 4 side rails were in the up position. The bed alarm was in the on position. The patient responded appropriately to questions. Patient 4 stated that she was uncomfortable and wanted to sit up. Patient 4 was calm and did not make attempts to get out of the bed. Two soft wrist restraints were observed lying on top of the patient. Both were attached to the bed, but not to the patient. Each wrist restraint was velcroed together, as if it were still attached to the patient's wrists. The MSANM and the Director of Nurses repositioned the patient, per the patient's request. Patient 4 remained calm and demonstrated no signs of agitation or combativeness. Patient 4's room was the furthest room down the hallway from the nursing station. It was an L-shaped room and patient 4's bed could not be visualized from the doorway.


On 9/11/12 at 11:20 A.M., an interview was conducted with RN 6, who was the patient's primary nurse. Per RN 6, Patient 4 required bilateral wrist restraints to prevent her from removing the IV in her left hand. Per RN 6, the patient had been combative and tried to get out of bed yesterday, so all 4 side rails were in the up position. A joint observation of Patient 4 was conducted with RN 6. There was no IV in the patients left hand. RN 6 was surprised to see that the bilateral wrist restraints, as well as the IV, were not in place. Patient 4 was sitting up in bed, with 4 bed rails in the up position. The bed alarm was on, and CNA (Certified Nurse Assistant) 1 was seated at the bedside with the patient. The patient was calm and watching television.


On 9/11/12 at 1:30 P.M., an interview was conducted with LVN 6. Per LVN 6, the patient had managed to free herself from the wrist restraints, and pulled out her IV when she did.


On 9/11/12 at 12:00 P.M., Patient 4 was observed in bed watching television. There was no IV, and the wrist restraints were off. The two upper bed rails were in the up position, and the lower bed rails were in the down position. The bed alarm was on. There was no CNA or sitter assigned to the patient. The patient was calm and made no attempts to get out of bed. The MSANM was unable to explain why the 2 lower rails were in the down position.

On 9/11/12 at 1:45 P.M., Patient 4 was observed sitting up in her bed watching the television. The two upper bed rails remained in the up position. The two lower bed rails were down. The bed alarm remained on. The resource nurse, RN 5 had just placed a new peripheral IV into Patient 4's right arm and left the room to obtain dressings. RN 5 left the patient with the 2 upper bed rails in the up position, 2 lower rails were down, and the bed alarm was on. The patient's arms were not restrained. During RN 5's absence, the patient made no attempt to grab or remove her IV. In addition, the patient made no attempt to get out of the bed. When RN 5 returned to the room, she was instructed by the MSANM to "wrap the patient's arm and IV with a bandage so that it could not be so easily removed", rather than reapplying wrist restraints. RN 5 wrapped the patients arm, replaced the lower bed rails in the up position, so that now all 4 bed rails were up, and left the room. The patient still made no attempt to remove her IV or the bandage, nor did she attempt to get out of bed.


On 9/11/12 at 2:00 P.M., an interview and record review was conducted with the MSANM. The MSANM acknowledged that there was no documented evidence to suggest that less restrictive methods had been attempted and were unsuccessful, prior to the implementation of bilateral wrist restraints and 4 bed rails in the up position. The MSANM acknowledged that, per the nurses' notes, Patient 4 made one attempt to get out of bed, and there was no evidence that the bed alarm had been ineffective. In addition, the MSANM acknowledged that an attempt should have been to place the patient in a room nearer to the nurses station for closer observation, and not the furthest room with no capability to visualize the patient from the doorway.

Based on observation, interview and record review, the hospital failed to ensure that one patient's (Patient 4) bilateral wrist restraints were applied appropriately. As a result, Patient 4 was able to remove both restraints, and in the course of doing so, dislodged her intravenous (IV) line. The medical and nursing indication for the wrist restraints was to prevent the patient from pulling out her IV.

Findings:

On 9/11/12 at 11:10 A.M., Patient 4 was observed on her side in bed trying to pull herself up using an upper bedrail. All 4 side rails were in the up position. The bed alarm was in the on position. The patient responded appropriately to questions. Patient 4 stated that she was uncomfortable and wanted to sit up. Patient 4 was calm and did not make attempts to get out of the bed. Two soft wrist restraints were observed lying on top of the patient. Both were attached to the bed, but not to the patient. Each wrist restraint was velcroed together, as if it were still attached to the patient's wrist. Patient 4's room was the furthest room down the hallway from the nursing station. It was an L-shaped room and patient 4's bed could not be visualized from the doorway.

The Medical Surgical Assistant Nurse Manager (MSANM) was present for all observations and interviews.

On 9/11/12 at 11:20 A.M., an interview was conducted with Registered Nurse (RN) 6, who was the patient's primary nurse. Per RN 6, Patient 4 required bilateral wrist restraints to prevent her from removing the IV in her left hand.

On 9/11/12 at 11:22 A.M., a joint observation of Patient 4 was conducted with RN 6. There was no IV in the patients left hand. RN 6 was surprised to see that the bilateral wrist restraints, as well as the IV, were not in place.

On 9/11/12 at 11:23 A.M., an interview was conducted with Certified Nurse Assistant (CNA) 1. Per CNA 1, she found Patient 4 in bed without her wrist restraints on at approximately 11:15 A.M. Per CNA 1, she observed that the patient's IV had been pulled out and tangled up in one of the wrist restraints. Per CNA 1 she informed LVN 6, because the patient's primary nurse, RN 6, was busy.

On 9/11/12 at 1:30 P.M., an interview was conducted with Licensed Vocational Nurse (LVN) 6. Per LVN 6, it appeared that the patient had managed to free herself from the wrist restraints, and pulled out her IV when she did.

On 9/11/12 at 2:00 P.M. an interivew was conducted with RN 6. RN 6 confirmed that the purpose of bilateral wrist restraints was to prevent the patient from pulling out her IV. RN 6 acknowledged that the medical and nursing indication for the bilateral wrists had not been met when the patient dislodged her IV in the course of removing her own wrist restraints.

On 9/11/12 at 2:00 P.M., the MSANM acknowledged that the wrist restraints could not have been applied appropriately to the patient. The MSANM acknowledged that if the restraints had been applied and secured appropriately, the patient should not have been able to remove them and/or the IV.

Based on interview and document review, the hospital failed to ensure that Pharmacy Performance Improvement (PI) data pertaining to nursing medication practices and processes that was reported to physicians and hospital leadership was accurate. There was a discrepancy between the reported PI data pertaining to medication pass audits performed versus the number of completed medication pass audit sheets that were available for review.

Findings:

An interview and joint document review of medication pass audits and data were conducted with the Director of Pharmacy (DOP) and the Chief Operating Officer (COO) on 9/12/12 at 9:35 A.M. The DOP stated that the pharmacy staff performed 9 medication pass audits on random nurses per week since March 2012 to present day. He explained that the medication pass audits were part of the hospital's performance improvement action plan to identify medication errors or any issues related to the safe administration of medication.

A review of the hospital's Organizationwide Performance Improvement (PI) Plan 2012 was conducted. The plan's PI strategy was a coordinated, comprehensive, and continuous effort to measure and assess the performance of all care and services provided at the hospital. According to the plan, it indicated that PI data was collected to monitor the stability of existing processes, identify opportunities for improvement, identify changes that will lead to improvement, and sustain improvement.

An interview and joint review of the hospital's QAPI data from their 2012 PI Reports and medication pass audit sheets for the month of July 2012, August 2012 and September 2012 were conducted with the DOP on 9/12/12 at 10:10 A.M. The PI report data indicated that there were a total of 39 medication pass audits performed in July, 52 in August and 9 in September. However, the DOP was only able to produce 8 actual medication pass audit sheets for July, 6 in August and zero for September. He was unable to explain why there were was a discrepancy in the number of reported medication pass audits performed and actual audit sheets to validate the accuracy of the PI report data pertaining to nursing medication practices and processes.

An interview with the COO was conducted on 9/13/12 at 11:15 A.M. The COO acknowledged that there was a discrepancy between the Pharmacy PI report data relative to nursing medication practices and processes versus the actual number of medication pass audits performed by pharmacy staff. He acknowledged that the DOP should have been able to validate the accuracy of data that had been reported by pharmacy and reflected in the Hospital's 2012 PI Reports.

Based on interview and document review, the hospital's Quality Assessment and Performance Improvement (QAPI) process failed to identify opportunities for improvement to ensure that medication safety practices had improved and were sustained. Medication pass audits performed by the pharmacy staff were not comprehensive, thorough and inclusive of all elements necessary to determine safe practices pertaining to medication administration.

Findings:

An interview and joint document review of medication pass audits and data were conducted with the Director of Pharmacy (DOP) and the Chief Operating Officer (COO) on 9/12/12 at 9:35 A.M. The DOP stated that the pharmacy staff performed 9 medication pass audits on random nurses per week since March 2012 to present day. He stated that the pharmacy staff performed 3 medication pass audits in each of the following areas: Behavioral Health Unit, Respiratory Therapy, LTAC (Long Term Acute Care- included Intensive Care Unit/Medical Surgical Unit/East Wing). He explained that the medication pass audits were part of the hospital's performance improvement action plan to identify medication errors or any issues related to the safe administration of medication. He stated that the average patient medication profile included 15-20 medications per day.

A review of the hospital's medication pass audit tool revealed the required criteria and elements observed by the pharmacy staff to determine the nursing staffs' medication administration practices and processes. The criteria included the following: hand hygiene observations; appropriate patient identification practices; verbalized or demonstrated the "5 rights": demonstrated the administration of medications via intramuscular, subcutaneous injections; triple checks were performed- correct medications to order, medication administration record (MAR), against the label; took MAR to the patient; demonstrated how to activate the "mini-bag" system, could state which injectable medication solutions can be mixed; and described routine blood glucose process and proper insulin preparation.

A follow-up interview with the DOP was conducted on 9/12/12 at 9:45 A.M. The DOP was asked to explain why the July 2012 and August 2012 medication pass audit tools contained names of medications passed, dosage and how many medications were given, however medication times, shifts and routes were not clear nor documented.

According to the July 2012 and August 2012 data, the following represents the number of medication passes that were audited when the average patient profile contained 15-20 medications per day:

On 7/1/12 (no time of observation), there were 4 medications administered.
On 7/1/12 at 8:00 A.M., there were 11 medications administered.
On 7/1/12 at 11:00 A.M., there were 2 medications administered.
On 7/1/12 at 4:45 P.M., there were 5 medications administered.
On 7/2/12 at 9:45 A.M., there were 5 medications administered.
On 7/3/12 at 9:00 A.M., there were 3 medications administered.
On 7/3/12 at 9:10 A.M., there were 4 medications administered.
On 7/4/12 at 8:10 A.M., there was 1 medication administered.

On 8/16/12 (no time of observation), there were 3 medications administered.
On 8/28/12 (no time of observation), there was 1 medication administered.
On 8/28/12 (no time of observation), there was 1 medication administered.
On 8/28/12 (no time of observation), there were 4 medications administered.
On 8/28/12 (no time of observation), there were 3 medications administered.
On 8/31/12 (no time of observation), there was 1 medication administered.

The DOP stated that the hospital's medication error rate was zero based on the data obtained from all the medication pass audits performed by the pharmacy staff since March 2012. When asked if the audit tool was inclusive of all the necessary elements to determine safe medication administration practices, the DOP acknowledged that the audits did not contain key elements such as times and shifts when audit was performed, the different routes medications were administered (i.e. orally, via feeding tube, intravenous, intramuscular, subcutaneous, inhaled, optic or otic), the number of observed medication administrations compared to the number opportunities (an average patient medication profile contained 15-20 medications per day) and evidence of proper disposal of medication and supplies.

An interview with the COO was conducted on 9/13/12 at 11:15 A.M. The COO acknowledged that the hospital's medication pass audit tool did not capture opportunities for improvement when they did not include necessary elements to determine safe medication administration practices and processes that were relevant to the patient population served, in the hospital's effort to prevent and identify medication errors. He also acknowledged that each audit in July 2012 and August 2012 should have contained more observations of medications administered since an average patient medication profile contained 15-20 medications per day; the documentation of different medication administration routes; the times and shifts the medication pass audits were performed.