The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

UNIVERSITY OF VIRGINIA MEDICAL CENTER 1215 LEE STREET CHARLOTTESVILLE, VA 22908 Jan. 23, 2013
VIOLATION: PATIENT RIGHTS Tag No: A0115
The Conditions of Participation for Patient Rights was not met based on the facility staffs failure to ensure restraints were not applied without a physician's order, were properly applied, were applied only in accordance with physician's orders, did not ensure a physician's assessment was completed within the required time frames, and did not ensure the intervention or restraints were utilized to ensure patient safety and rights to be restrained in the least restrictive manner.

Deficient practice was determined in multiple standards:
A 154;
A 166;
A 167;
A 168;
A 175; and
A 392.

See the above citations.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observation, record review and staff interview, the facility staff failed to ensure the privacy for two of 13 current patients was maintained, Patients #'s 10 and 25. Patient privacy curtains or doors were not closed during personal care.

Findings:

1. Patient # 10 was observed in her room on 1/16/2013 at approximately 11:45 a.m. A registered nurse (Staff # 16) administered medication through a gastrostomy tube without closing the curtains or the door to a common hall. The patient was exposed and her abdomen and unclothed lower body were exposed. A housekeeping staff member also entered and left the room twice, passing by the exposed patient four times as she was assisted into bed.
Staff # 15 was interviewed at this time and she stated the nurse should have pulled the curtains.




2. An observation was conducted on 01/15/2013 at 10:04 a.m. with Staff # 50 and Staff # 39, while standing at the nurse's station. The observation revealed Patient # 25, sitting in a chair in front of the open door of his/her room utilizing a receptacle for the collection of urine. A facility staff was present in Patient #25's room and failed to pull the curtain to offer Patient #25 privacy. The staff failed to prevent those outside the room from observing the exposed patient, during urination. The surveyor informed Staff #39 of the observation. Staff #39 verified Patient #25 was utilizing a receptacle for the collection of urine and verified the facility's staff' failure to provide privacy.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and interview, the facility staff failed to ensure eight of 8 patient's were free from unnecessary restraints, Patient #'s 17, 12, 13, 16, 21, 22, 24 and 18.

Multiple restraint types were simultaneously used, patient restraint assessments were not consistently conducted, restraints were applied-at times, without a physician's order. Physician's did not consistently assess the patient's according to hospital policy, when a restraint was ordered or renewed. Patient # 17's restraint was improperly applied.

Findings:

1. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Further review of the record revealed the patient also had physician's ordered continuous restraints due to "...dementia and inability to of family to stay or sitters..." (physician note 1/12/13). On 1/12 and 1/13/13 "behavioral restraints" were ordered, to include right wrists and ankle and four side rails, continuous for four hours. During this time frame, the hospital policy directed a nursing assessment be conducted every fifteen minutes for behavioral restraints. The clinical record did not evidence the patient was assessed per policy. The clinical record also did not evidence a physician's assessment was conducted within one hour of the order for a behavioral restraint-per hospital policy or consistently assessed within 24 hours when non-behavioral restraints were ordered. The nursing restraint flow sheets, physician's orders, physician's progress notes and restraint policy were reviewed with Staff # 51. The 1/13/2013 flow sheets did not evidence nursing restraint assessment were conducted from 7:00 a.m. until 7:00 p.m., although the patient remained in continuous restraints for "pulling on lines." The orders and flow sheets revealed that at times this patient was concurrently restrained with bilateral hand mitts, four point limb restraints and four side rails preventing him from leaving his bed and pulling on medical devices.

The patient's plan of care did not accurately reflect modifications of the plan, based on the physician's orders, actual implemented restraints, and did not provide individualized interventions to attempt restraint reduction or the least restrictive means to attempt to maintain the patient's safety. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation. The plan of care did not address the patient's psychological assessment or response to the use of restraints.

Documentation in the clinical record did not evidence consistent implementation of the physician's orders, consistent physician or nursing assessments per policy, intermittent release of the restraints for hygiene, range of motion or meals, and did not evidence least restrictive alternates to restraints were attempted. The patient was interviewed and although confused, appeared cooperative and did not appear distressed, anxious or negatively effected by the restraint implementation. Staff # 51 confirmed the above findings and no further data was presented to evidence the restraints were ordered, applied or monitored according to hospital policy.

2. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. A white board on the wall at her bedside stated the mitts were to be removed if "not agitated." The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints. The nursing restraint flow sheet did not document the side rail restraints. The clinical record revealed at times this patient was restrained with bilateral mitts, bilateral wrist restraints and four side rails. The care plan did not include individualized interventions, release or least restrictive interventions to reduce the number of restraints. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation.

The clinical record did not consistently include a physician's face to face assessment of the patient within 24 hours of ordering the restraint. The nursing restraint flow sheets did not consistently evidence an assessment of the restraint application by a registered nurse every two hours, according to hospital policy. The patient's representative was interviewed on 1/17/13 at 10:00 a.m. and stated the patient would possibly attempt to get out of bed without assistance. The patient representative stated she was appropriately informed and approved of the hand mitts to prevent removal of medical devices. The patient was assessed and had no negative outcomes from the use of the restraints.

3. Patient # 13's clinical record included a physician's order for a "behavioral restraint"-for soft wrist restraint to the left wrist "danger to self." The physician did not document a face to face assessment of the patient within one hour of the order to restrain the patient. The physician's order was acknowledge by a registered nurse, but the nursing restraint flow sheet did not include any restraint assessments

Continued review of Patient # 13's clinical record was conducted with Staff # 51. The record review revealed inconsistent physician and nursing assessments of the patient's restraints, including the timeliness of a face to face assessment by a physician, or assessments by a registered nurse per policy. No physician's note evidenced an assessment of the patient's response to the restraint use. No further documentation was presented to evidence compliance with hospital policy.

4. Patient # 16's clinical record was reviewed with Staff # 51 on 1/22/2013. The clinical record revealed a 12/20/2012 at 2:27 p.m. Nurse Practitioner's order for non-behavioral restraints, including concurrent "roll belt, four side rails, bilateral hand mitts and bilateral wrist restraints" due to "removing essential equipment." ON 12/20/12 at 2:13 a.m. for 24 hours-a "non-behavioral" restraint order was written for "agitation-trying to get OOB (out of bed) unable to redirect." No nursing restraint flow sheets were located in the clinical record after 12/20/12 st 11:00 p.m., although the restraints continued through 12/21/2012 at 8:15 a.m. The care plan did not include individualized plan to reduce the restraints or alternatives to attempt. No physician's note documented the justification of the concurrent use of multiple restraints (four rails, mitts, wrists and a roll belt at one time). The documentation did not evidence monitoring of the patient's behaviors for which the patient was restrained-attempting to get out of bed. The order was not for a behavioral restraint. No further documentation was present to evidence the patient's restraints were applied, monitored or implemented in accordance with hospital policy.

5. Patient # 21's restraints were not implemented, monitored or assessed in accordance with hospital policy. Patient # 21's clinical record was reviewed with Staff # 51 on 1/22/13. The clinical record revealed inconsistent assessment of the restraint application or physician's assessment within the required time frames to include: On 4/13/2012 a Nurse Practitioner ordered "non-behavioral" restraints-side rails X 4, soft mitts and wrist restraints X 2. A physician's or nurse practitioner's face to face assessment was not completed to assess the patient's response or need for the restraints, per hospital policy. No further documentation was presented to evidence the patient was assessed or monitored per policy.

6. Patient # 22's restraints were not monitored or released in according to hospital policy. The patient's clinical record evidenced physician's order for bilateral wrist restraints due to the patient's attempt to remove essential equipment. When the patient's condition declined and nurse's notes evidenced the physician's ordered criteria for release from restraint was met, the restraints were not documented as being released.

7. Patient # 24's physical restraints were not implemented or monitored according to hospital policy. Patient # 24's clinical record evidenced orders for non-behavioral restraints due to the patient's attempt to remove essential medical equipment. The record did not evidence the patient was consistently assessed to include a restraint assessment by a physician within 24 hours of the implementation of wrist restraints at times four point restraints. The nursing restraint flow sheets did not consistently evidence that physician's ordered restraints were implemented as ordered. On 8/3/12 the flow sheets documented side rails were implemented x 4 with no order; 8/4/12 side rails were raised x 4 without order; 8/4/12-bilateral lower limb restraints were ordered, but not implemented: 8/5/12 the side rails were ordered x 4 but were not implemented; 8/6/12 the type of restraint to be used was not documented by the nurses. The flow sheets evidenced continuous restraints were implemented from 8/6/12 through 8/8/12 although no order was present for restraints applied from 8/7/12 through 8/8/12 at 10:30 p.m. Bilateral wrists and 4 side rails were ordered 8/6/12 at 8:07 p.m. and re-ordered on [DATE] at 10:30 p.m. No order was present for the applied restraints 8/7/12 at 8:07 p.m. through 8/8/12 at 10:30 p.m.




8. Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Staff #12 an active ED staff was able to fully access Patient #18's ED EMR. Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The documented "Behaviors" for applying the bilateral wrist included "Agitated, Self-injurious; Attempting to disrupt therapies; Uncooperative." The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated additional "Behaviors" displayed by Patient #18, which required "4 pt (point) locked" restraints. The ED documentation from 00:15 a.m. through 8:00 a.m., indicated Patient #18's additional behaviors were "calm", profane, "spitting" on staff, but no documentation for the bilateral restraint of the patient's lower extremities.

Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient was in "4 pt locked" restraints from 07/20/2012 at 00:15 a.m., through discharge from the ED on 07/20/2012 at 3:18 p.m., when the patient was transported to an inpatient unit. Review of nursing assessments and documentation of monitoring Patient #18 had occurred approximately every fifteen-minutes per facility policy until 1:00 p.m. Nursing documented at 1:00 p.m., 2:00 p.m. and the last documentation at 2:35 p.m. that the patient had been assessed to ensure the required components of behavioral restraints had been addressed. Nursing did not document the restraints were removed prior to transporting Patient #18 to the inpatient unit. The nursing documentation at 2:35 p.m. simply documents the "Behavioral Restraints" were "Continued" no further assessment documented.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 verified the ED documentation did not specify what behaviors occurred, which prompted ED staff to moved from bilateral wrist restraints to "4 pt locked" restraints. Staff #12 verbally acknowledged if Patient #18's bilateral wrist were restrained, the patient would not be able to follow through with threats to leave the ED after displaying "Self-injurious" behaviors. Staff #12 verified Patient #18's ED EMR did not have consistent fifteen-minute assessments and monitoring by nursing staff for behavioral restraints after 1:00 p.m. on 07/20/2012. Staff #12 reported Patient #18's EMR did not indicate if the patient had been transported in "4 pt locked" restraints, or they had been discontinued prior to transport.

Review of the facility's policy and procedures titled "No. 0159 Restraint and Seclusion of Patients" in part read "C. Policy [name of facility] is committed to minimizing the use of restraint or seclusion. All patients have the right to be free from restraint or seclusion of any form imposed as a means of coercion, discipline, retaliation, convenience, or for reasons of insufficient staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member or others, and must be discontinued at the earliest possible time. D. 1. The term restraint includes either a physical restraint or a drug that is being used as a restraint. A 'physical restraint' is any manual method or physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... E.. Procedure: 1. The following apply to all types of restraint/seclusion: a. Restraint or seclusion may only be used when the least restrictive interventions have been determine ineffective ... C. The decision to use a restraint shall always be based on an individual assessment of the patient's current, specific situation. This assessment shall include consideration of what constitutes the least risk for the patient; risk of what might happen if the device/intervention is not used versus the risk posed by the restraint ... K. Documentation of all aspects of the restraint or seclusion episode in the medical record is required: A description of the patient's behavior and the intervention used. Alternative or other less restrictive intervention attempted. The patient's condition or symptom(s) that warrant the use of the restraint or seclusion. The patient's response to the intervention(s) used, including the rationale for continued use of the intervention. Criteria for discontinuation of restraint and time of discontinuation ... 2. Restraints for Non-Behavioral Management ... b. Monitoring of Patient: i. Trained staff shall observe the patient every hour or more frequently. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... 3. Seclusion and Restraint for Behavioral Management ... pf. Monitoring of patients: i. Trained staff shall observe patients continuously in person. Documentation of observations/ necessary care is required every 15 minutes. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... "

An interview was conducted on 01/22/2013 at 9:24 a.m., with Staff #17 during review of Patient #18's EMR. Staff #17 verified facility staff failed to document assessment, monitoring and the required components for the least restrictive or continued use of physical restraints.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and interview, the facility staff failed to ensure the use of physical restraints was utilized in accordance with the patient's plan of care for five of 8 patient's review, who were restrained, Patient #'s 17, 12, 13, 16, 24. The nursing plans of care were not individualized or revised to reflect the actual type of restraint, restraint renewal or alternate methods to attempt to reduce restraint use. The physician's did not consistently order restraints that were used, or include the attempts at the reduction of restraint use as part of the patients' overall plan of care.

1. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Further review of the record revealed the patient also had physician's ordered continuous restraints due to "...dementia and inability to of family to stay or sitters..." (physician note 1/12/13). On 1/12 and 1/13/13 "behavioral restraints" were ordered, to include right wrists and ankle and four side rails, continuous for four hours. During this time frame, the hospital policy directed a nursing assessment be conducted every fifteen minutes for behavioral restraints. The clinical record did not evidence the patient was assessed per policy. The clinical record also did not evidence a physician's assessment was conducted within one hour of the order for a behavioral restraint-per hospital policy or consistently assessed within 24 hours when non-behavioral restraints were ordered. The orders and flow sheets revealed that at times this patient was concurrently restrained with bilateral hand mitts, four point limb restraints and four side rails preventing him from leaving his bed and pulling on medical devices.

The patient's plan of care did not accurately reflect modifications of the plan, based on the physician's orders, actual implemented restraints, and did not provide individualized interventions to attempt restraint reduction or the least restrictive means to attempt to maintain the patient's safety. Physician's and nurse's notes did not consistently include assessments of the patient's phycological response to the restraint implementation. The plan of care did not address the patient's psychological assessment or response to the use of restraints and did not address the types and need for multiple, concurrent types of restraints that were used. The plan of care was not updated to reflect changes in the restraint use when the type of restraint was changed.

2. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. A white board on the wall at her bedside stated the mitts were to be removed if "not agitated." The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints. The nursing restraint flow sheet did not document the side rail restraints. The clinical record revealed at times this patient was restrained with bilateral mitts, bilateral wrist restraints and four side rails. The care plan did not include individualized interventions, release or least restrictive interventions to reduce the number of restraints. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation.

3. Patient # 13's clinical record included a physician's order for a "behavioral restraint"-for soft wrist restraint to the left wrist "danger to self." The physician did not document a face to face assessment of the patient within one hour of the order to restrain the patient. The physician's order was acknowledge by a registered nurse, but the nursing restraint flow sheet did not include any restraint assessments

Continued review of Patient # 13's clinical record was conducted with Staff # 51. The record review revealed inconsistent physician and nursing assessments of the patient's restraints, including the timeliness of a face to face assessment by a physician, or assessments by a registered nurse per policy. No physician's note evidenced an assessment of the patient's response to the restraint use. The plan of care was not individualized to reflect the patient's needs, alternate interventions to attempt for restraint reduction or the type of restraint to be used. No further documentation was presented to evidence the use of restraints was conducted in accordance with the patient's plan of care.

4. Patient # 16 's clinical record was reviewed with Staff # 51 on 1/22/2013. The clinical record revealed a 12/20/2012 at 2:27 p.m. Nurse Practitioner's order for non-behavioral restraints, including concurrent "roll belt, four side rails, bilateral hand mitts and bilateral wrist restraints" due to "removing essential equipment." On 12/20/12 at 2:13 a.m. for 24 hours-a restraint order was written: "non-behavioral" for "agitation-trying to get OOB (out of bed) unable to redirect." The care plan did not include individualized plan to reduce the restraints or alternatives to attempt. No physician's note documented the justification of the concurrent use of multiple restraints (four rails, mitts, wrists and a roll belt at one time). The documentation did not evidence monitoring of the patient's behaviors for which the patient was restrained-attempting to get out of bed. The order was not for a behavioral restraint. No further documentation was present to evidence the patient's care plan included the actual type of restraints that were applied, alternate interventions or restraint reduction activities.

5. Patient # 24's physical restraints were not implemented or monitored according to hospital policy. Patient # 24's clinical record evidenced orders for non-behavioral restraints due to the patient's attempt to remove essential medical equipment. The record did not evidence the patient was consistently assessed to include a restraint assessment by a physician within 24 hours of the implementation of wrist restraints at times four point restraints. The nursing restraint flow sheets did not consistently evidence that physician's ordered restraints were implemented as ordered. On 8/3/12 the flow sheets documented side rails were implemented x 4 with no order; 8/4/12 side rails were raised x 4 without order; 8/4/12-bilateral lower limb restraints were ordered, but not implemented: 8/5/12 the side rails were ordered x 4 but were not implemented; 8/6/12 the type of restraint to be used was not documented by the nurses. The flow sheets evidenced continuous restraints were implemented from 8/6/12 through 8/8/12 although no order was present for restraints applied from 8/7/12 through 8/8/12 at 10:30 p.m. Bilateral wrists and 4 side rails were ordered 8/6/12 at 8:07 p.m. and re-ordered on [DATE] at 10:30 p.m. No order was present for the applied restraints 8/7/12 at 8:07 p.m. through 8/8/12 at 10:30 p.m.

The patient's plan of care was not individualized to include the type and use of restraints, least restrictive alternates to the patient's safety that could be utilized, and was not modified when the orders were changed.




8. Review of Patient #18's electronic medical record (EMR) on 01/16/2013 at approximately 3:46 p.m., with Staff #17 revealed the patient had been restrained on 07/28/2012. Review of Patient #18's care plan related to restraints did not reveal the interventions were individualized. During the review of Patient #18's EMR with Staff #17, Staff #17 acknowledged the care plan did not specifically reflect Patient #18. Staff #17 reported the care plans were a part of the electronic system, which employed check off boxes and comment spaces. Staff #17 reported if only the check off boxes were used without additional information placed in the comment section related to the patient the care plan was general in nature.

Review of Patient #18's EMR on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Staff #12 verbally confirmed the "entire ED chart is the patient's plan of care." Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated additional "Behaviors" displayed by Patient #18, which required "4 pt (point) locked" restraints. The ED documentation did not include an assessment (care plan) for the restraint of Patient #18's lower extremities. The ED EMR did not include documented criteria (care plan) for discontinuation of the patient's "4 pt (point) locked" restraints.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 verified the ED documentation (care plan) did not specify what behaviors occurred, which prompted ED staff to moved from bilateral wrist restraints to "4 pt locked" restraints. Staff #12 reported the ED documentation (care plan) did not include documented criteria (care plan) for discontinuation of the patient's "4 pt locked" restraints.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and interview, the hospital staff failed to ensure the use of physical restraints was implemented in safe and appropriate techniques, in accordance with hospital policy for eight of 8 patients reviewed, who were restrained (Patient #'s 17, 12, 13, 16, 17, 18, 21, 22, and 24). Restraints were not properly applied, Physician's orders were not consistently obtained/written for restraints, least restrictive restraints were not attempted, and alternate interventions were not documented.

Findings:

1. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Further review of the record revealed the patient also had physician's ordered continuous restraints due to "...dementia and inability to of family to stay or sitters..." (physician note 1/12/13). On 1/12 and 1/13/13 "behavioral restraints" were ordered, to include right wrists and ankle and four side rails, continuous for four hours. During this time frame, the hospital policy directed a nursing assessment be conducted every fifteen minutes for behavioral restraints. The clinical record did not evidence the patient was assessed per policy. The clinical record also did not evidence a physician's assessment was conducted within one hour of the order for a behavioral restraint-per hospital policy or consistently assessed within 24 hours when non-behavioral restraints were ordered. The nursing restraint flow sheets, physician's orders, physician's progress notes and restraint policy were reviewed with Staff # 51. The 1/13/2013 flow sheets did not evidence nursing restraint assessment were conducted from 7:00 a.m. until 7:00 p.m., although the patient remained in continuous restraints for "pulling on lines." The orders and flow sheets revealed that at times this patient was concurrently restrained with bilateral hand mitts, four point limb restraints and four side rails preventing him from leaving his bed and pulling on medical devices.

The patient's plan of care did not accurately reflect modifications of the plan, based on the physician's orders, actual implemented restraints, and did not provide individualized interventions to attempt restraint reduction or the least restrictive means to attempt to maintain the patient's safety. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation. The plan of care did not address the patient's psychological assessment or response to the use of restraints.

Documentation in the clinical record did not evidence consistent implementation of the physician's orders, consistent physician or nursing assessments per policy, intermittent release of the restraints for hygiene, range of motion or meals, and did not evidence least restrictive alternates to restraints were attempted. The patient was interviewed and although confused, appeared cooperative and did not appear distressed, anxious or negatively effected by the restraint implementation. Staff # 51 confirmed the above findings and no further data was presented to evidence the restraints were ordered, applied or monitored according to hospital policy.

2. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. A white board on the wall at her bedside stated the mitts were to be removed if "not agitated." The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints. The nursing restraint flow sheet did not document the side rail restraints. The clinical record revealed at times this patient was restrained with bilateral mitts, bilateral wrist restraints and four side rails. The care plan did not include individualized interventions, release or least restrictive interventions to reduce the number of restraints. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation.

The clinical record did not consistently include a physician's face to face assessment of the patient within 24 hours of ordering the restraint. The nursing restraint flow sheets did not consistently evidence an assessment of the restraint application by a registered nurse every two hours, according to hospital policy. The patient's representative was interviewed on 1/17/13 at 10:00 a.m. and stated the patient would possibly attempt to get out of bed without assistance. The patient representative stated she was appropriately informed and approved of the hand mitts to prevent removal of medical devices. The patient was assessed and had no negative outcomes from the use of the restraints.

3. Patient # 13's clinical record included a physician's order for a "behavioral restraint"-for soft wrist restraint to the left wrist "danger to self." The physician did not document a face to face assessment of the patient within one hour of the order to restrain the patient. The physician's order was acknowledge by a registered nurse, but the nursing restraint flow sheet did not include any restraint assessments

Continued review of Patient # 13's clinical record was conducted with Staff # 51. The record review revealed inconsistent physician and nursing assessments of the patient's restraints, including the timeliness of a face to face assessment by a physician, or assessments by a registered nurse per policy. No physician's note evidenced an assessment of the patient's response to the restraint use. No further documentation was presented to evidence compliance with hospital policy.

4. Patient # 16 's clinical record was reviewed with Staff # 51 on 1/22/2013. The clinical record revealed a 12/20/2012 at 2:27 p.m. Nurse Practitioner's order for non-behavioral restraints, including concurrent "roll belt, four side rails, bilateral hand mitts and bilateral wrist restraints" due to "removing essential equipment." On 12/20/12 at 2:13 a.m. for 24 hours-a "non-behavioral" restraint order was written for "agitation-trying to get OOB (out of bed) unable to redirect." No nursing restraint flow sheets were located in the clinical record after 12/20/12 st 11:00 p.m., although the restraints continued through 12/21/2012 at 8:15 a.m. The care plan did not include individualized plan to reduce the restraints or alternatives to attempt. No physician's note documented the justification of the concurrent use of multiple restraints (four rails, mitts, wrists and a roll belt at one time). The documentation did not evidence monitoring of the patient's behaviors for which the patient was restrained-attempting to get out of bed. The order was not for a behavioral restraint. No further documentation was present to evidence the patient's restraints were applied, monitored or implemented in accordance with hospital policy.

5. Patient # 21's restraints were not implemented, monitored or assessed in accordance with hospital policy. Patient # 21's clinical record was reviewed with Staff # 51 on 1/22/13. The clinical record revealed inconsistent assessment of the restraint application or physician's assessment within the required time frames to include: On 4/13/2012 a Nurse Practitioner ordered "non-behavioral" restraints-side rails X 4, soft mitts and wrist restraints X 2. A physician's or nurse practitioner's face to face assessment was not completed to assess the patient's response or need for the restraints, per hospital policy. No further documentation was presented to evidence the patient was assessed or monitored per policy.

6. Patient # 22's restraints were not monitored or released in according to hospital policy. The patient's clinical record evidenced physician's order for bilateral wrist restraints due to the patient's attempt to remove essential equipment. When the patient's condition declined and nurse's notes evidenced the physician's ordered criteria for release from restraint was met, the restraints were not documented as being released.

7. Patient # 24's physical restraints were not implemented or monitored according to hospital policy. Patient # 24's clinical record evidenced orders for non-behavioral restraints due to the patient's attempt to remove essential medical equipment. The record did not evidence the patient was consistently assessed to include a restraint assessment by a physician within 24 hours of the implementation of wrist restraints at times four point restraints. The nursing restraint flow sheets did not consistently evidence that physician's ordered restraints were implemented as ordered. On 8/3/12 the flow sheets documented side rails were implemented x 4 with no order; 8/4/12 side rails were raised x 4 without order; 8/4/12-bilateral lower limb restraints were ordered, but not implemented: 8/5/12 the side rails were ordered x 4 but were not implemented; 8/6/12 the type of restraint to be used was not documented by the nurses. The flow sheets evidenced continuous restraints were implemented from 8/6/12 through 8/8/12 although no order was present for restraints applied from 8/7/12 through 8/8/12 at 10:30 p.m. Bilateral wrists and 4 side rails were ordered 8/6/12 at 8:07 p.m. and re-ordered on [DATE] at 10:30 p.m. No order was present for the applied restraints 8/7/12 at 8:07 p.m. through 8/8/12 at 10:30 p.m.




8. Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Staff #12 an active ED staff was able to fully access Patient #18's ED EMR. Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The documented "Behaviors" for applying the bilateral wrist included "Agitated, Self-injurious; Attempting to disrupt therapies; Uncooperative." The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated additional "Behaviors" displayed by Patient #18, which required "4 pt (point) locked" restraints. The ED documentation from 00:15 a.m. through 8:00 a.m., indicated Patient #18's additional behaviors were "calm", profane, "spitting" on staff, but no documentation for the bilateral restraint of the patient's lower extremities.

Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient was in "4 pt locked" restraints from 07/20/2012 at 00:15 a.m., through discharge from the ED on 07/20/2012 at 3:18 p.m., when the patient was transported to an inpatient unit. Review of nursing assessments and documentation of monitoring Patient #18 had occurred approximately every fifteen-minutes per facility policy until 1:00 p.m. Nursing documented at 1:00 p.m., 2:00 p.m. and the last documentation at 2:35 p.m. that the patient had been assessed to ensure the required components of behavioral restraints had been addressed. Nursing did not document the restraints were removed prior to transporting Patient #18 to the inpatient unit. The nursing documentation at 2:35 p.m. simply documents the "Behavioral Restraints" were "Continued" no further assessment documented.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 verified the ED documentation did not specify what behaviors occurred, which prompted ED staff to moved from bilateral wrist restraints to "4 pt locked" restraints. Staff #12 verbally acknowledged if Patient #18's bilateral wrist were restrained, the patient would not be able to follow through with threats to leave the ED after displaying "Self-injurious" behaviors. Staff #12 verified Patient #18's ED EMR did not have consistent fifteen-minute assessments and monitoring by nursing staff for behavioral restraints after 1:00 p.m. on 07/20/2012. Staff #12 reported Patient #18's EMR did not indicate if the patient had been transported in "4 pt locked" restraints, or they had been discontinued prior to transport.

Review of the facility's policy and procedures titled "No. 0159 Restraint and Seclusion of Patients" in part read "C. Policy [name of facility] is committed to minimizing the use of restraint or seclusion. All patients have the right to be free from restraint or seclusion of any form imposed as a means of coercion, discipline, retaliation, convenience, or for reasons of insufficient staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member or others, and must be discontinued at the earliest possible time. D. 1. The term restraint includes either a physical restraint or a drug that is being used as a restraint. A 'physical restraint' is any manual method or physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... E.. Procedure: 1. The following apply to all types of restraint/seclusion: a. Restraint or seclusion may only be used when the least restrictive interventions have been determine ineffective ... C. The decision to use a restraint shall always be based on an individual assessment of the patient's current, specific situation. This assessment shall include consideration of what constitutes the least risk for the patient; risk of what might happen if the device/intervention is not used versus the risk posed by the restraint ... K. Documentation of all aspects of the restraint or seclusion episode in the medical record is required: A description of the patient's behavior and the intervention used. Alternative or other less restrictive intervention attempted. The patient's condition or symptom(s) that warrant the use of the restraint or seclusion. The patient's response to the intervention(s) used, including the rationale for continued use of the intervention. Criteria for discontinuation of restraint and time of discontinuation ... 2. Restraints for Non-Behavioral Management ... b. Monitoring of Patient: i. Trained staff shall observe the patient every hour or more frequently. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... 3. Seclusion and Restraint for Behavioral Management ... pf. Monitoring of patients: i. Trained staff shall observe patients continuously in person. Documentation of observations/ necessary care is required every 15 minutes. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... "

An interview was conducted on 01/22/2013 at 9:24 a.m., with Staff #17 during review of Patient #18's EMR. Staff #17 verified facility staff failed to follow the facility's policy and procedure. Staff #17 reported the policy required staff to document assessment, monitoring and the required components for the least restrictive or continued use of physical restraints.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, record review and interview the facility staff failed to obtain or follow physician orders for restraints for four of eight patients reviewed with restraints in the survey sample. (Patients #18, #17, 12 and 24.)

The findings included:

1. Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Staff #12 an active ED staff was able to fully access Patient #18's ED EMR. Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The documented "Behaviors" for applying the bilateral wrist included "Agitated, Self-injurious; Attempting to disrupt therapies; Uncooperative." Patient #18's ED EMR did not contain a documented order by a physician or licensed independent practitioner (LIP) for the bilateral wrist restraints.

The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated additional "Behaviors" displayed by Patient #18, which required "4 pt (point) locked" restraints. The ED documentation from 00:15 a.m. through 8:00 a.m., indicated Patient #18's additional behaviors were "calm", profane, "spitting" on staff, but no documentation for the bilateral restraint of the patient's lower extremities. Patient #18's ED EMR did not contain a documented order by a physician or licensed independent practitioner (LIP) for the 4-point restraints. A nursing entry on 07/20/2012 at 00:15 a.m., read in part "... Verbal order given per [the physician's name] ..." A nursing entry on 07/20/2012 at 8:01 a.m., in part read "MD contacted for continuation of order (behavioral restraint) ..."

Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient was in "4 pt locked" restraints from 07/20/2012 at 00:15 a.m., through discharge from the ED on 07/20/2012 at 3:18 p.m., when the patient was transported to an inpatient unit. Patient #18's ED EMR did not have an order by a physician or licensed independent practitioner (LIP) for the discontinuation of his/her 4-point restraints. The nursing documentation at 2:35 p.m. simply documents the "Behavioral Restraints" were "Continued" no further assessment documented. The documentation in Patient #18's EMR did not clearly indicate if the patient had been transferred in four point restraints or continued in four point restraints initially on the inpatient unit.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 stated, "I do not see an order by the physician or resident for the restraints. The note indicated they had a verbal order but no order was documented in the chart." Staff #12 reported Patient #18's EMR did not have a physician's order to discontinue the patient's four point restraints prior to transport to the inpatient unit.

Review of the facility's policy and procedures titled "No. 0159 Restraint and Seclusion of Patients" in part read "C. Policy [name of facility] is committed to minimizing the use of restraint or seclusion. All patients have the right to be free from restraint or seclusion of any form imposed as a means of coercion, discipline, retaliation, convenience, or for reasons of insufficient staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member or others, and must be discontinued at the earliest possible time. D. 1. The term restraint includes either a physical restraint or a drug that is being used as a restraint. A. physical restraint' is any manual method or physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... E.. Procedure: 1. The following apply to all types of restraint/seclusion: ... G. The use of restraint or seclusion requires the order of a physician or licensed independent practitioner (LIP) who is responsible for the care of the patient ..."

2. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Further review of the record revealed the patient also had physician's ordered continuous restraints due to "...dementia and inability to of family to stay or sitters..." (physician note 1/12/13). On 1/12 and 1/13/13 "behavioral restraints" were ordered, to include right wrists and ankle and four side rails, continuous for four hours. During this time frame, the hospital policy directed a nursing assessment be conducted every fifteen minutes for behavioral restraints. The clinical record did not evidence the patient was assessed per policy. The clinical record also did not evidence a physician's assessment was conducted within one hour of the order for a behavioral restraint-per hospital policy or consistently assessed within 24 hours when non-behavioral restraints were ordered. The nursing restraint flow sheets, physician's orders, physician's progress notes and restraint policy were reviewed with Staff # 51.

Documentation in the clinical record did not evidence consistent implementation of the physician's orders, consistent physician or nursing assessments per policy, intermittent release of the restraints for hygiene, range of motion or meals, and did not evidence least restrictive alternates to restraints were attempted. The patient was interviewed and although confused, appeared cooperative and did not appear distressed, anxious or negatively effected by the restraint implementation. Staff # 51 confirmed the above findings and no further data was presented to evidence the restraints were ordered, applied or monitored according to hospital policy.

3. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints.

The clinical record did not consistently include a physician's face to face assessment of the patient within 24 hours of ordering the restraint. The nursing restraint flow sheets did not consistently evidence an assessment of the restraint application by a registered nurse every two hours, according to hospital policy. The patient's representative was interviewed on 1/17/13 at 10:00 a.m. and stated the patient would possibly attempt to get out of bed without assistance.

4. Patient # 24's physical restraints were implemented without physician's orders. The nursing restraint flow sheets did not consistently evidence that physician's ordered restraints were implemented: On 8/3/12 the flow sheets documented side rails were implemented x 4 with no order; 8/4/12 side rails were raised x 4 without order; 8/4/12-bilateral lower limb restraints were ordered, but not implemented: 8/5/12 the side rails were ordered x 4 but were not implemented; 8/6/12 the type of restraint to be used was not documented by the nurses. The flow sheets evidenced continuous restraints were implemented from 8/6/12 through 8/8/12 although no order was present for restraints applied from 8/7/12 through 8/8/12 at 10:30 p.m. Bilateral wrists and 4 side rails were ordered 8/6/12 at 8:07 p.m. and re-ordered on [DATE] at 10:30 p.m. A physician order was not present for the applied restraints 8/7/12 at 8:07 p.m. through 8/8/12 at 10:30 p.m.

Employee # 51 reviewed the clinical record and acknowledged the above information. No further documentation was presented during the survey to evidence the patient's physical restraints were consistently implemented in accordance with a physician's/appropriate clinician's order or according to hospital policy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on observations, record reviews and interviews the facility staff failed to assess and monitor restrained patients in accordance with the facility's policy and procedure for seven of eight restrained patients in the survey sample. (Patients #18, #17, # 12, #13, #16, #21, and #24.)

The findings included:

1. Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated an additional assessment of Patient #18's "Behaviors", which required "4 pt (point) locked" restraints. The ED documentation in the "Behavior Restraints" flow sheets from 00:15 a.m. through 8:00 a.m., indicated Patient #18's additional behaviors were "calm", profane, "spitting" on staff, but no initial or continued assessment for the bilateral restraint of the patient's lower extremities. Patient #18's ED EMR did not contain a documented order by a physician or licensed independent practitioner (LIP) for the bilateral wrist restraints or for the "4 pt locked" restraints.


Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient was in "4 pt locked" restraints from 07/20/2012 at 00:15 a.m., through discharge from the ED on 07/20/2012 at 3:18 p.m., when the patient was transported to an inpatient unit. Review of the "Behavior Restraints" flow sheets for 07/20/2012 from 1:00 p.m., until Patient #18's discharge from the ED did not include every fifteen-minute check as required by the facility's policy and procedures. Nursing documentation on Patient #18's "Behavior Restraints" flow sheets occurred at 1:00 p.m., 2:00 p.m. with the last documentation at 2:35 p.m., which only addressed the patient's "4 pt locked" restraints "continued." Patient #18's EMR did not contain an assessment of his/her restrained extremities at the time of discharge from the ED.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 verified Patient #18's EMR did not have orders for either restraint from a physician or a licensed independent practitioner (LIP). Staff #12 reported the ED documentation did not specify what behaviors had occurred, which prompted ED staff to moved from bilateral wrist restraints to "4 pt locked" restraints. Staff #12 acknowledged the nursing documentation did not include an initial assessment of the patient's behaviors, which required restraining each of the patient's extremities. Staff #12 verbally acknowledged if Patient #18's bilateral wrist were restrained, the patient would not be able to follow through with threats to leave the ED after displaying "Self-injurious" behaviors. Staff #12 verified Patient #18's ED EMR did not have consistent fifteen-minute assessments and monitoring by nursing staff for behavioral restraints after 1:00 p.m. on 07/20/2012. Staff #12 reported Patient #18's EMR did not document the assessment and condition of Patient #18's extremities prior to discharge and transport to the inpatient unit. Staff #12 acknowledged the facility staff failed to follow the requirements as established in the facility's policy and procedure for patient restraints.

Review of the facility's policy and procedures titled "No. 0159 Restraint and Seclusion of Patients" in part read "C. Policy [name of facility] is committed to minimizing the use of restraint or seclusion. All patients have the right to be free from restraint or seclusion of any form imposed as a means of coercion, discipline, retaliation, convenience, or for reasons of insufficient staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member or others, and must be discontinued at the earliest possible time. D. 1. The term restraint includes either a physical restraint or a drug that is being used as a restraint. A 'physical restraint' is any manual method or physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... E.. Procedure: 1. The following apply to all types of restraint/seclusion: a. Restraint or seclusion may only be used when the least restrictive interventions have been determine ineffective ... C. The decision to use a restraint shall always be based on an individual assessment of the patient's current, specific situation. This assessment shall include consideration of what constitutes the least risk for the patient; risk of what might happen if the device/intervention is not used versus the risk posed by the restraint ... G. The use of restraint or seclusion requires the order of a physician or licensed independent practitioner (LIP) who is responsible for the care of the patient ...K. Documentation of all aspects of the restraint or seclusion episode in the medical record is required: A description of the patient's behavior and the intervention used. Alternative or other less restrictive intervention attempted. The patient's condition or symptom(s) that warrant the use of the restraint or seclusion. The patient's response to the intervention(s) used, including the rationale for continued use of the intervention. Criteria for discontinuation of restraint and time of discontinuation ... 2. Restraints for Non-Behavioral Management ... b. Monitoring of Patient: i. Trained staff shall observe the patient every hour or more frequently. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... 3. Seclusion and Restraint for Behavioral Management ... pf. Monitoring of patients: i. Trained staff shall observe patients continuously in person. Documentation of observations/ necessary care is required every 15 minutes. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... "

An interview was conducted on 01/22/2013 at 9:24 a.m., with Staff #17 during review of Patient #18's EMR. Staff #17 verified facility staff failed to obtain physician or LIP orders for restraints as well as document assessments, monitoring and other required components for the use of physical restraints.

2. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Further review of the record revealed the patient also had physician's ordered continuous restraints due to "...dementia and inability to of family to stay or sitters..." (physician note 1/12/13). On 1/12 and 1/13/13 "behavioral restraints" were ordered, to include right wrists and ankle and four side rails, continuous for four hours. The clinical record did not evidence a physician's assessment was conducted within one hour of the order for a behavioral restraint-per hospital policy or consistently assessed within 24 hours when non-behavioral restraints were ordered. The nursing restraint flow sheets, physician's orders, physician's progress notes and restraint policy were reviewed with Staff # 51. The orders and flow sheets revealed that at times this patient was concurrently restrained with bilateral hand mitts, four point limb restraints and four side rails preventing him from leaving his bed and pulling on medical devices. The restraints were re-ordered as "non-behavioral." The ordering clinicians did not consistently or thoroughly document the patient's need for non-behavioral/behavioral restraint, or assessment of the patient within the required time frame after ordering a restraint. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation. Staff # 51 confirmed the above findings and no further data was presented to evidence the restraints were ordered, applied or monitored according to hospital policy.

3. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints. No physician's or nurses notes included an assessment of the patient's phycological response to the restraint implementation.

The clinical record did not consistently include a physician's face to face assessment of the patient within 24 hours of ordering the restraint. The patient's representative was interviewed on 1/17/13 at 10:00 a.m. and stated the patient would possibly attempt to get out of bed without assistance. The patient representative stated she was appropriately informed and approved of the hand mitts to prevent removal of medical devices.

4. Patient # 13's clinical record included a physician's order for a "behavioral restraint"-for soft wrist restraint to the left wrist "danger to self." The physician did not document a face to face assessment of the patient within one hour of the order to restrain the patient. The physician's order was acknowledge by a registered nurse, but the nursing restraint flow sheet did not include any restraint assessments

Continued review of Patient # 13's clinical record was conducted with Staff # 51. The record review revealed inconsistent physician and nursing assessments of the patient's restraints, including the timeliness of a face to face assessment by a physician. No physician's note evidenced an assessment of the patient's response to the restraint use. No further documentation was presented to evidence compliance with hospital policy.

5. Patient # 16 's clinical record was reviewed with Staff # 51 on 1/22/2013. The clinical record revealed a 12/20/2012 at 2:27 p.m. Nurse Practitioner's order for non-behavioral restraints, including concurrent application of a "roll belt, four side rails, bilateral hand mitts and bilateral wrist restraints" due to "removing essential equipment." On 12/20/12 at 2:13 a.m. for 24 hours-a "non-behavioral" restraint order was written for "agitation-trying to get OOB (out of bed) unable to redirect." No physician's/nurse practitioner's note documented the justification of the concurrent use of multiple restraints (four rails, mitts, wrists and a roll belt at one time). The documentation did not evidence monitoring of the patient's behaviors for which the patient was restrained-attempting to get out of bed. The order was not for a behavioral restraint. No further documentation was present to evidence the patient's restraints were applied, monitored or implemented in accordance with hospital policy.

6. Patient # 21's restraints were not implemented, monitored or assessed in accordance with hospital policy. Patient # 21's clinical record was reviewed with Staff # 51 on 1/22/13. The clinical record revealed inconsistent assessment of the restraint application or physician's assessment within the required time frames to include: On 4/13/2012 a Nurse Practitioner ordered "non-behavioral" restraints-side rails X 4, soft mitts and wrist restraints X 2. A physician's or nurse practitioner's face to face assessment was not completed to assess the patient's response or need for the restraints, per hospital policy. No further documentation was presented to evidence the patient was assessed or monitored per policy.

7. Patient # 24's physical restraints were not monitored according to hospital policy. Patient # 24's clinical record evidenced orders for non-behavioral restraints due to the patient's attempt to remove essential medical equipment. The record did not evidence the patient was consistently assessed to include a restraint assessment by a physician within 24 hours of the implementation of wrist restraints and at times, four point restraints.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, record review, and interview the facility's nursing staff failed to deliver care in accord with nursing standards of practice related to:

1. Compliance with accepted infection control practices for three of four nurses observed during medication passes, and
2. Obtaining and following physician or licensed independent practitioner (LIP) orders for physical restraints for four of eight restrained patients included in the survey sample. (Patient #18, # 17, # 12 and # 24.)

The findings included:

1. Observations during a medication pass conducted on 01/14/2013 from 2:25 p.m. through 2:39 p.m., Staff #10 revealed the staff did not perform hand hygiene prior to putting on gloves. Staff #10 left Patient #3's room to retrieve a 500 ml (milliliter) bag of IV (intravenous) solution from the IV bins behind the nurse's station. Staff #10 re-entered Patient #3's room with the IV solution, gloved but did not perform hand hygiene prior to gloving.

An interview was conducted on 01/14/2013 at 2:39 p.m., with Staff #10. Staff #10 acknowledged he/she had not performed hand hygiene prior to re-entering Patient #3's room or prior to putting on gloves.

Observations during a medication pass on 01/15/2013 at 10:08 a.m., with Staff #6 revealed staff failed to clean the septum of the medication vial prior to withdrawing medication. Staff # 6 retrieved a vial of Famotidine from the automated medication dispensing system. Staff #6 removed the flip top, punctured the vial's septum with the needle/syringe and withdrew the medication.
[According to www.Lifescript.com online medication reference: "Famotidine is a medicine is used to prevent or treat gastroesophageal reflux disease, heartburn, acid indigestion and other syndromes caused by huge amounts of stomach acid."]
An interview conducted on 01/15/2012 at 10:08 a.m., with Staff #6. Staff #6 stated, "This is not a re-entry into multidose vial so I did not clean the top. The top is sterile." Staff #6 reported not being aware the septum under the flip top on a medication vial was not sterile and should be cleaned prior to entry. Staff #6 reviewed the medication vial and did not find information the septum of the vial was considered sterile.
During a medication pass observation conducted on 1/16/13 at approximately 11:45 a.m. with Registered Nurse # 51, she was observed to don gloves prior to the administration of medications via peg tube (tube surgically inserted into the stomach). The nurse did not remove the gloves prior to picking up multiple cups located on the medication cart. The nurse removed one cup from the stack and replaced the remaining stack back on the cart, without removing the gloves. The RN finished this medication pass and removed her gloves, and used hand sanitizer. The nurse did not remove the cups from the medication cart and proceeded to the next patient's room and proceeded to administer medications.
According to Centers for Disease control and Prevention (CDC) "The following Injection Safety checklist items are a subset of items that can be found in the CDC Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care.
The rubber septum on a medication vial is disinfected with alcohol prior to piercing ..."
According to Centers for Disease control and Prevention (CDC) "Examples of situations when hand hygiene is indicated:
? Before and after direct patient contact,
? Before and after glove changes,
? Before procedures, such as administering intravenous medications,
? Before and after contact with vascular access,
? Before and after dressing changes ...
? After contact with items/surfaces in patient ' s area ...
? Remember - glove use does not preclude the need for hand hygiene after removing gloves. "

2. Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient had been restrained in the Emergency department (ED). Review of the documentation revealed ED staff had placed Patient #18 in bilateral wrist "Behavioral Restraints" on 07/19/2012 at "2250 (8:50 p.m.)" for pulling out his tracheostomy tube. The ED documentation revealed on 07/20/2012 by 0015 (00:15 a.m.) Patient #18 had been placed in "4 pt (point) locked" restraints. The ED documentation did not indicated an additional assessment of Patient #18's "Behaviors", which required "4 pt (point) locked" restraints. The ED documentation in the "Behavior Restraints" flow sheets from 00:15 a.m. through 8:00 a.m., indicated Patient #18's additional behaviors were "calm", profane, "spitting" on staff, but no initial or continued assessment for the bilateral restraint of the patient's lower extremities. Patient #18's ED EMR did not contain a documented order by a physician or licensed independent practitioner (LIP) for the bilateral wrist restraints or for the "4 pt locked" restraints.


Review of Patient #18's electronic medical record (EMR) on 01/17/2013 from 8:47 a.m. through 9:16 a.m., with Staff #12 revealed the patient was in "4 pt locked" restraints from 07/20/2012 at 00:15 a.m., through discharge from the ED on 07/20/2012 at 3:18 p.m., when the patient was transported to an inpatient unit. Review of the "Behavior Restraints" flow sheets for 07/20/2012 from 1:00 p.m., until Patient #18's discharge from the ED did not include every fifteen-minute check as required by the facility's policy and procedures. Nursing documentation on Patient #18's "Behavior Restraints" lowset occurred at 1:00 p.m., 2:00 p.m. with the last documentation at 2:35 p.m., which only addressed the patient's "4 pt locked" restraints "continued." Patient #18's EMR did not contain an assessment of his/her restrained extremities at the time of discharge from the ED.

An interview was conducted on 01/17/2013 at 8:47 a.m. through 9:16 a.m., with Staff #12 during the review of Patient #18's ED EMR. Staff #12 verified Patient #18's EMR did not have orders for either restraint from a physician or a licensed independent practitioner (LIP). Staff #12 reported the ED documentation did not specify what behaviors had occurred, which prompted ED staff to moved from bilateral wrist restraints to "4 pt locked" restraints. Staff #12 acknowledged the nursing documentation did not include an initial assessment of the patient's behaviors, which required restraining each of the patient's extremities. Staff #12 verbally acknowledged if Patient #18's bilateral wrist were restrained, the patient would not be able to follow through with threats to leave the ED after displaying "Self-injurious" behaviors. Staff #12 verified Patient #18's ED EMR did not have consistent fifteen-minute assessments and monitoring by nursing staff for behavioral restraints after 1:00 p.m. on 07/20/2012. Staff #12 reported Patient #18's EMR did not document the assessment and condition of Patient #18's extremities prior to discharge and transport to the inpatient unit. Staff #12 acknowledged the facility staff failed to follow the requirements as established in the facility's policy and procedure for patient restraints.

An interview was conducted on 01/16/2013 at approximately 4:22 p.m. with Staff #1. Staff 31 reported the facility's policies and procedures were evidence based and considered the facility's standards of practice.

Review of the facility's policy and procedures titled "No. 0159 Restraint and Seclusion of Patients" in part read "C. Policy [name of facility] is committed to minimizing the use of restraint or seclusion. All patients have the right to be free from restraint or seclusion of any form imposed as a means of coercion, discipline, retaliation, convenience, or for reasons of insufficient staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member or others, and must be discontinued at the earliest possible time. D. 1. The term restraint includes either a physical restraint or a drug that is being used as a restraint. A 'physical restraint' is any manual method or physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... E.. Procedure: 1. The following apply to all types of restraint/seclusion: a. Restraint or seclusion may only be used when the least restrictive interventions have been determine ineffective ... C. The decision to use a restraint shall always be based on an individual assessment of the patient's current, specific situation. This assessment shall include consideration of what constitutes the least risk for the patient; risk of what might happen if the device/intervention is not used versus the risk posed by the restraint ... G. The use of restraint or seclusion requires the order of a physician or licensed independent practitioner (LIP) who is responsible for the care of the patient ...K. Documentation of all aspects of the restraint or seclusion episode in the medical record is required: A description of the patient's behavior and the intervention used. Alternative or other less restrictive intervention attempted. The patient's condition or symptom(s) that warrant the use of the restraint or seclusion. The patient's response to the intervention(s) used, including the rationale for continued use of the intervention. Criteria for discontinuation of restraint and time of discontinuation ... 2. Restraints for Non-Behavioral Management ... b. Monitoring of Patient: i. Trained staff shall observe the patient every hour or more frequently. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... 3. Seclusion and Restraint for Behavioral Management ... pf. Monitoring of patients: i. Trained staff shall observe patients continuously in person. Documentation of observations/ necessary care is required every 15 minutes. ii. A registered nurse shall assess the patient immediately after restraint application to confirm proper and safe application, note injury related to the restraint application and assess the patient's response to the restraint. Thereafter, a registered nurse shall assess the patient at least every 2 hours ... "


In "Fundamentals of Nursing" 7 th edition, 2009; Patricia A. Potter and Anne Griffin Perry; Mosby, Inc; Page 336. "The physician is responsible for directing medical treatment. Nurses follow physician's orders unless they believe the orders are in error or would harm clients. Therefore you need to assess all orders ... A nurse carrying out an inaccurate or inappropriate order is legally responsible for any harm the client suffers."


3. A registered nurse did not ensure Patient # 17 was assessed and monitored in accordance with hospital policy related to restraint use and application. A registered nurse did not ensure restraints were appropriately applied, and were applied in accordance with physician's orders. Patient # 17 was observed in bed on 1/16/2013 at 2:28 p.m. The patient was observed to have each limb restrained with soft restraints (four point restraints). All four side rails of the bed were raised. The patient's left leg restraint was attached to the lower bed rail.

The clinical record was reviewed with Staff # 51. The physician's order for this date and time did not include the restraint of the left leg or four side rails to be up ("Soft restraint right ankle, right wrist and left wrist"). Documentation in the clinical record did not evidence consistent implementation of the physician's orders. Staff # 51 reviewed the clinical record and hospital policy and acknowledge the above findings and no further data was presented to evidence the restraints were applied according to physician's order.

4. Patient # 12 was observed on 1/16/2013 at 11:50 a.m. in her bed with bilateral mitten restraints on her hands. All four side rails were up on the bed. The patient was asleep and was not awakened by verbal or physical stimuli. The patient's clinical record was reviewed with Staff # 51. The physician's orders did not include four side rail restraints.

The clinical record did not consistently include a physician's face to face assessment of the patient within 24 hours of ordering the restraint. The nursing restraint flow sheets did not consistently evidence an assessment of the restraint application by a registered nurse every two hours, according to hospital policy. The patient's representative was interviewed on 1/17/13 at 10:00 a.m. and stated the patient would possibly attempt to get out of bed without assistance.

5. Patient # 24's physical restraints were implemented without physician's orders. The nursing restraint flow sheets did not consistently evidence that physician's ordered restraints were implemented: On 8/3/12 the flow sheets documented side rails were implemented x 4 with no order; 8/4/12 side rails were raised x 4 without order; 8/4/12-bilateral lower limb restraints were ordered, but not implemented: 8/5/12 the side rails were ordered x 4 but were not implemented; 8/6/12 the type of restraint to be used was not documented by the nurses. The flow sheets evidenced continuous restraints were implemented from 8/6/12 through 8/8/12 although no order was present for restraints applied from 8/7/12 through 8/8/12 at 10:30 p.m. Bilateral wrists and 4 side rails were ordered 8/6/12 at 8:07 p.m. and re-ordered on [DATE] at 10:30 p.m. A physician order was not present for the applied restraints 8/7/12 at 8:07 p.m. through 8/8/12 at 10:30 p.m.

Employee # 51 reviewed the clinical record and acknowledged the above information. No further documentation was presented during the survey to evidence the patient's physical restraints were consistently implemented in accordance with a physician's/appropriate clinician's order or according to hospital policy.