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Based on observation, clinical record review, and interview it was determined the facility failed to assure the least restrictive restraint was utilized for one of one inpatient with an enclosure bed. (Patient #2) of patients restrained at the time of the complaint investigation. Without a determination by staff that the less restrictive measures were ineffective, it could not be assured Patient rights were maintained. The failed practice affected Patient #2 and had to potential to affect all restrained. The findings were:

A. The facility "Restraints" policy and procedure was reviewed on 06/07/12 at 0900 and revealed "Alternatives to restraint: Prior to every application of restraint consideration must be given to the possibility of using an alternative method that is less dangerous and less restrictive than restraint. Such alternatives may include alteration of the physical environment (i.e. lights left on, removal of unnecessary equipment from the room), additional equipment (i.e. chair positioning devices), using mechanical electronic signaling devices or personal supervision by staff or family.

B. On 06/11/12 at 1348, Chart review of Patient #2 record revealed on 06/08, 06/06, 06/02, and 06/01, the clinical record lacked documentation an alternative to restraint was attempted every 24 hours per policy.

C. The findings were confirmed by the CNO (Chief Nursing Officer) on 06/11/12 at 1348.

Based on observation, review of Manufacture's Guidelines for Use, restraint policy and procedure and interview, it was determined the facility failed to assure wrist restraints were secured to the moveable part of the bed frame as required according to manufactures instructions for use and facility policy. Failure to apply the restraint according to Manufacture's Guidelines had the potential to cause injury to Patient #11. The failed practice affected Patient #11 and had the potential to affect any other patient admitted to the facility with orders for wrist restraints. The findings were:

A. Observation on 06/07/12 at 0900 revealed Patient #11 was supine in bed with bilateral wrist restraints in place. The restraints were attached to the right and left side of the non-moveable portion of the bed frame.

B. A copy of the manufacture's instruction sheet, for "Proper Application and Care of Medline Limb Holders" was provided by the CNO (Chief Nursing Officer) at 06/07/12 0900 and reviewed. Application instructions stated "Bed use - attach ties to the moveable portion of the frame using quick release ties." The warning stated "Serious injury or death may result if this device is not properly applied or there is not sufficient monitoring." Under "Safety Precautions" it stated "Always attach Medline Patient Safety Products to bedspring frames that move with the patient."

C. The facility policy "Restraints" was provided by the CNO and reviewed on 06/07/12 at 0900. Page five of the policy, "General Information" stated "Any device connected to the patient bed should be connected to the bedspring frame (the portion that moves with the mattress and the patient.) This connection should be via a quick release buckle (if available on the product) or by a quick release knot (clove-hitch).

D. The CNO, Certified Nursing Assistant (CNA) #2 and Registered Nurse (RN) #4 confirmed at the time of observation the wrist restraints were secured to the portion of the bed frame that did not move with the patient (i.e. when the head was raised or lowered).

E. The findings were confirmed by the CNO at 0915 on 06/07/12.


Based on observation, review of Manufactures guidelines for use, restraint policy and procedure and interview, it was determined the facility failed to assure all side rails were raised with the use of a Vail bed (CamTech by Safe-T Care enclosure type bed) as required per manufactures guidelines for use. Failure to follow the Manufactures guidelines for use created the potential for injury to Patient #2. The failed practice affected one of one patient (Patient #2) with an enclosure bed (Vail Bed) and had the potential to affect any other patient admitted to the facility with orders for an enclosure bed type restraint. The findings were:

A. Observation on 06/07/12 at 1415 revealed Patient #2 was supine in bed, with an enclosure system on the bed. There were three of four side rails on the bed that were not raised.

B. On 06/07/12 at 1012, the Manufactures Guidelines were received from the CNO for the enclosure (or Vail) bed in use at the facility for Patient #2. A copy of the product "Safe-T care manufacturing Product Operation Manual (Model HD)" was reviewed and revealed "Caution. The following precautions and contraindications should be noted and adhered to when using the enclosure system." "Always leave side rails in the up position except when moving the patient from the bed."

C. The facility policy "Restraints" was reviewed and did not include a policy and procedure related to the use side rails of an enclosure or "Vail" bed.

D. Review of the clinical record for Patient #2 revealed on 06/01, 06/02, 06/05 through 06/07/12, the documentation on the "24 hour Daily Care Record" revealed the side rails were elevated "x (times) 2". The findings were confirmed with the DON on 06/11/12 with review of the chart from 1347 through 1400.

E Certified Nursing Assistant (CNA) #2 and Registered Nurse (RN) #4 confirmed 06/07/12 at 1415 that three side rails were not raised on Patient #2's bed. RN #4 was asked how she determined what side rails were to be elevated, if any. She stated "it depends on what kind of bed it is. Some like this one (Patient #2 bed) the rails aren't supposed to be up." The CNO was present during the interview. Reviewed with Registered Nurse #4 and the CNO the Safe-T Care Manufacturers Guidelines for use that stated to "always leave the side rails in the up position except when moving the patient" from the bed. The CNO and RN #4 confirmed on 06/07/12 at 1430 that the bedside rails were not in the up position.

Based on clinical record review and interview, it was determined the facility failed to assure all restraint use was ordered by a physician and failed to assure a restraint order was obtained when released and not directly observed by staff for one closed record (Patient #1) and one (Patient #2) open record of 10 patients records reviewed. Failure to obtain an order from the physician for the use of restraint when the restraint was removed and the patient was not under direct observation by staff constitutes restraint use on a PRN or as needed basis. This failed practice affected Patient #1, #2 and had the potential to affect any patient who required restraint. The findings are:

A. Review of Patient #1 (closed record) on 06/07/12 revealed on 05/11/12 - 05/13/12, there was not a current written order for the use of wrist restraints. Documentation on 05/12/12 revealed Nursing Progress Note documentation that "Family took off patient's restraints while they are in room". At 1915 on 05/12/12, Nursing Progress notes stated "Restraints applied to BUE (Bilateral Upper extremities). There was no documentation to reflect a physician had been notified and an order obtained for restraint to be re-applied. The findings were confirmed by the CNO at 1430 on 06/07/12.

B. Review of Patient #2's clinical record revealed there was no reason listed for the use of a vail bed on 06/01 - 06/02/12, 05/29 - 05/30/12. On 06/10/12 on the "24 hour Daily Care Record" page 3, it states "Restraints/ protective devices" and the device is "Vail Bed Seclusion" In an interview with the CO (Chief Nursing Officer) on 06/11/12 revealed "that was a mistake by the nurse it was a vail bed, not seclusion."

C. The findings were confirmed on 06/11/12 at 1358 by the CNO.