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.

SUMMA HEALTH SYSTEM 525 EAST MARKET STREET AKRON, OH 44309 Aug. 10, 2011
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0202
Based on observations and staff interviews, the facility failed to ensure that 2 out of 2 staff members were educated in regard to the proper application of restraints. This included Staff O and Staff P in regard to Patient 2's vest restraint application.

Findings include:

Per observation on 08/09/11 at 10:20 AM, Patient 2 was physically restrained with bilateral soft wrist restraints, bilateral soft ankle restraints and a vest restraint while lying in bed. The vest restraint was observed to be on backwards as the ties on the vest restraint were in the back instead of the front as product information directs. The product information also states as a warning, "A restraint applied incorrectly or worn backwards may result in serious injury or death from suffocation, chest compression or patient escape."

At 02:30 PM, Patient 2 was observed without the vest restraint. Interviews were conducted with Staff O and Staff P who were in Patient 2's room to reposition him/her. The vest restraint was still in the room and when the surveyor asked for a demonstration of how the vest was applied, Staff P picked the vest restraint up and demonstrated how the ties on the vest are to be in the back. Staff O agreed with the application technique described by Staff P. These findings were verified by Staff I who was with the surveyor throughout the observation and interview process.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on medical record reviews and staff interviews, observations of restrained patients, documentation in 7 of 10 medical records reviewed where the patient had been physically restrained, lacked documentation consistent with hospital policy relating to physical restraints. This includes an individualized assessment of the patient's medical or behavioral state or condition for 1 out of 10 patients reviewed ( Patient 2), every two hour documentation, the type of restraint, justification of the restraint and documentation of the use of the physical restraint on the nursing trifold document. This includes Patient 1, 2, 3, 5, 6, 7 and 9.
The facility census was 391.

Findings include:

Per medical record review on 08/09/11, Patient 1 was noted to have been placed in 4 point leather restraints on 07/03/11 at 4:22 PM. The only other nursing note in regard to the restraint was when the patient was released at 9:30 PM on 07/04/11. Interview of the nursing staff caring for this patient revealed that one of the nurses had started to "wean" the patient off of the leather restraints and had progressed to soft wrist restraints only. There was no documented evidence in the medical record of this "weaning" of restraint.

Per medical record review on 08/09/11, Patient 2 lacked evidence of every two hour restraint monitoring on 08/08/11. The record lacked documentation at 04:00 AM or 06:00 AM as is required every two hours while restrained. Per review of documentation on 08/05/11 of nursing notes revealed physical restraints were in use from 03:00 PM-12:00 AM on 08/05/11 but the trifold nursing note which requires documentation of every two hour release, offering of fluids/nutrition and offering of toileting was not completed. On 08/03/11 bilateral soft wrist restraints were applied at 08:00 PM without documentation which addresses the need. The nurses work 12 hour shifts from 7:00 AM-07:30 PM and 07:00 PM-07:30 AM.

Per medical record review on 08/10/11, Patient 3 was described in nursing notes on 08/07/11 at 09:20 AM to be pulling on restraints. However, when the nursing trifold documentation was reviewed, no justification or type of restraint was listed. These findings were verified by Staff I on 08/10/11 at 09:30 AM.

Per medical record review on 08/10/11, Patient 5 was physically restrained on 08/06/11 at 07:30 PM with a "Posey". Since the Posey company makes several types of restraints, the type in use was not specific. This was confirmed by Staff N at 12:10 PM.

Per medical record review on 08/10/11, Patient 6 was restrained with bilateral soft wrist restraints on 08/07/11 at 10:00 PM. Documentation on 08/09/11 from 0800-08:00 PM reflected the patient did not have restraints in use. However, per interview with Staff L, he/she documents the restraints are "off" during the release time every two hours. This interpretation was consistent with what Staff M stated. However, nurses in MICU documented the restraint was "off" only when it was removed and not in use. This inconsistent documentation of restraints was verified by Staff N on 08/10/11 at 3:15 PM.

Per medical record review on 08/10/11, Patient 7 had the right wrist restrained from 08/07/11 when ordered at 05:00 PM. However, review of the trifold nursing note revealed no restraint or justification was documented until 08/08/11 at 08:00 AM when Staff M completed his/her first assessment and found the patient with the right wrist restraint in place. This was confirmed on 08/10/11 at 3:25 PM by Staff N.

Review of the medical record completed on 08/10/11 revealed that Patient 9 was restrained with bilateral soft wrist restraints on 08/08/11 from 10:00 AM-06:00 PM, but Staff L documented the restraints were "off" stating the restraints were removed briefly every two hours for 5-15 minutes. Review of the documentation is not clear as to whether the restraints are on or off and/or when removed to exercise the patient's limbs every two hours. This was confirmed by Staff N on 08/10/11 at 3:35 PM.

Per medical record review on 08/09/11, Patient 2 was admitted on [DATE] with hyponatremia, community acquired pneumonia, [DIAGNOSES REDACTED] and history of alcohol abuse. This [AGE] year old who weighed 87.9 pounds at admission was confused and experienced delirium tremors on 08/02/11 for which he/she was intubated and placed on a ventilator. The treatment interference protocol for physical restraints was implemented on 08/02/11. Initially bilateral soft wrist restraints were used. On 08/05/11, at 12:30 AM, bilateral soft ankle restraints were placed. Per interview with Staff I, the unit manager, on 08/09/11 at 03:45 PM, on 08/06/11, when nursing documentation addressed the use of soft restraint only, a vest restraint was in use and not documented. Patient 2 was extubated on 08/05/11 but remained confused and attempting to get out of bed. Also, Patient 2 attempted to remove the indwelling urinary catheter and IV. Per physical therapy notes written on 08/05/11 at 12:00 PM, Patient 2 was up walking in the hallway which he/she tolerated well. Per nursing notes on 08/05/11 at 09:30 AM, Patient 2 told the nurse, "I want to smoke" as the patient was trying to climb out of bed.

Patient 2 was observed on 08/09/11 at 10:25 AM, in bed lying on his/her back restrained with bilateral soft wrist, bilateral soft ankle restraints and a vest restraint. All of these restraints were tied to the bed frame. Interview with Staff O, the vest restraint is on because the patient tries to sit up. No physician order has been obtained to decrease nicotine withdrawal. The patient appeared restless but not combative at that time Patient 2 was observed at 02:15 PM and the surveyor asked Staff O, the assigned RN, why Patient 2 required four point soft restraints and a vest restraint, he/she replied, " (The patient) tried to kick us yesterday." When observed at 02:30 PM on 08/09/11, the vest restraint had been removed and Staff O and Staff P were changing Patient 2's position from the back to the left side. Patient 2 was not exercised when the restraints were released nor did he/she attempt to climb from bed, pull on tubing or kick staff. When Staff O was asked at 04:32 PM on 08/09/11 why the patient was not being ambulated or up in a chair, his/her response was, " I don't think it is safe. Someone might get hurt." Per nursing notes, Patient 2 had not been out of bed since 12:00 PM on 08/05/11 and the nurses were documenting he/she was on bed rest. When the surveyor asked to see the physician order for bed rest, none could be found. Staff O had been Patient 2's assigned nurse on 08/08/11 and 08/09/11. These findings were witnessed by Staff I, the unit manager.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
Based on medical record review, review of the facility policy and procedure in regard to restraint use and staff interview, the facility failed to ensure that the use of the restraint was part of the patients plans of care. This affected 4 out of 10 patients that were reviewed for restraint use. Patients 1, 2, 3, and 4.

The facility census was 391.

Findings include:

On Tuesday, 08/09/11 and Wednesday, 08/10/11, the closed medical record of patient 1 was reviewed. The patient was noted to have been in 4 point leather restraints advanced to 2 point soft wrist and restraint removal beginning at 4:22 PM on 07/03/11 until 9:30 PM on 07/04/11. There was no documented evidence the use of restraints was care planned for this patient or evidence of a plan to use a less restrictive restraint to no restraint was care planned. The patient was in an Intensive Care Unit where the staffing was noted to be 2:1.




Per medical record review on 08/09/11, Patient 2 had been physically restrained since 08/02/11 with bilateral soft wrist restraints, bilateral soft ankle restraints or a vest restraint or a combination of wrists and ankles or wrist, ankles and vest restraints. Review of Patient 2's plan of care revealed no mention of the use of these restraints. This was confirmed by Staff I on 08/09/11 at 04:30 PM.

Per medical record review on 08/10/11, Patient 3 had been physically restrained with soft bilateral wrists on 08/05/11, 08/07/11 and 08/08/11 per the treatment interference protocol which is applicable in the critical care areas for prevention of pulling on tubes and attempts to get out of bed. Per review of the patient's plan of care, the use of the restraints was not addressed on the plan. This was confirmed on 08/10/11 at 09:30 AM by Staff I.

Per medical record review on 08/10/11, Patient 4 had been physically restrained with bilateral soft wrist restraints since 08/08/11 per treatment interference protocol for the prevention of pulling on tubes. Per review of the patient's plan of care on 08/10/11 at 10:10 AM, the use of the restraints was not addressed on the plan. This was confirmed by Staff I on 08/10/11 at 10:10 AM.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, observations made during the survey and staff interview, the facility failed to ensure that each patient had a timely written and signed order for restraint use. This affected one out of 10 patients reviewed that were noted to have been in restraints. This affected Patient 10.
The facility census was 391.

Findings include:

Per medical record review on 08/10/11 in the surgical intensive care unit (SICU), Patient 10 did not have a physician order for the bilateral soft restraints in use to prevent the unintended removal of tubes used from 07/28/11 at 08:00 PM-07/30/11 at 07:30 AM. Review of the electronic medical record physician order on 08/10/11 revealed the restraints were initially ordered on [DATE], three days after being used. These findings were confirmed with Staff N at 03:40 PM on 08/10/11.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0173
Based on medical record review, review of the restraint policy, observations on all days of the survey and staff interview, the facility failed to ensure that the policy was followed in regard to a written physician progress note and nursing progress note for restraint use for 7 out of 10 patients reviewed. Patients 1, 2, 3, 4, 7, 8 and 10. The facility census was 391.

Findings include:

Per medical record review of Patient 1 on 08/09/11, it was noted that the patient had been in restraints from 4:22 PM on 07/03/11 thru 9:30 PM on 07/04/11. There were no physician progress notes in regard to the restraint use and the continued need for same. The patient had been put in 4 point leather restraints under the Treatment Interference Protocol.

Patients 2, 3 and 4 were in the medical intensive care unit (MICU) while restrained.

Per medical record review on 08/09/11, Patient 2's attending physician failed to address the use of physical restraints in progress notes on 08/03/11, 08/04/11, 08/05/11, 08/06/11 and 08/07/11 as required by hospital policy. When a patient has physical restraints ordered per the treatment interference policy, a physician order is not required every 24 hours. However, the hospital policy requires the physician to acknowledge and justify the continued use of the physical restraint. In the case of Patient 2, the types of physical restraints used included bilateral soft wrists and ankles in addition to a vest restraint. These findings were confirmed by Staff I on 08/09/11 at 04:30 PM.

Per medical record review on 08/10/11, Patient 3 was physically restrained with bilateral soft wrist restraints on 08/05/11, 08/07/11, 08/08/11 and 08/09/11 through 06:00 AM. Off since 08/09/11 at 08:00 AM, the physician progress note written on 08/10/11 at 08:05 AM included marking of a box which stated, "Patient's behavior and or treatment interventions justifies use of restraints". When Staff I was asked for an explanation for why the physician marked that Patient 3 was in restraints when the patient was not in restraints on 08/10/11 at 09:30 AM, no explanation was given.

Per medical record review on 08/10/11, Patient 4 was physically restrained on 08/09/11 at 02:00 AM per the treatment interference protocol to prevent the unintended removal of tubes including an IV, indwelling catheter and endotracheal tube. At 06:20 AM on 08/09/11 when the attending physician examined Patient 4 and wrote a progress note, there was no mention of the physical restraint by the physician. This was verified at 10:10 AM by Staff I on 08/10/11.

Patients 7, 8 and 10 were in the surgical intensive care unit (SICU) while restrained.

Per medical record review on 08/10/11, Patient 7 has been restrained with one soft restraint to the right wrist since 08/07/11 when intubated. The patient's left side is paralyzed. Physician progress notes for 08/08/11 and 08/09/11 did not include the use of the physical restraint per treatment interference protocol. This was confirmed by Staff N on 08/10/11 at 03:00 PM.

Per medical record review on 08/10/11, Patient 8 was physically restrained per treatment interference protocol since 08/06/11 at 04:45 PM. No physician progress notes were found which addressed the ongoing use or justification of the soft bilateral wrist restraints. This was confirmed on 08/10/11 at 3:25 PM by Staff N.

Per medical record review on 08/10/11, Patient 10 was physically restrained from 07/28/11 at 08:00 PM-07/30/11 at 07:30 AM with bilateral soft wrist restraints. No physician progress notes were found which address the use or justification for these restraints. These findings were confirmed on 08/10/11 at 3:45 PM.