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Based on record review and interview, the hospital failed to ensure a written physician's order was received prior to the initiation of restraints for 2 patients (#s 23 and 24) of 10 patients reviewed for restraint use, out of 25 sampled patients. Findings:

Patient #23

Record review on 7/2/10 and 7/6/10 revealed the Patient was admitted to the hospital on 6/22/09 for severe trauma following a motor vehicle accident. Nursing documentation indicated Patient #23 had frequent episodes of restlessness, agitation, hitting out at staff, trying to fling self out of bed and removing oxygen tubing.

Review of the Medical Restraint Order form revealed the form had spaces for the date and time of the order and had listings of several reasons for restraints and types of restraints for the physician to circle, as well as a space to document restraint reasons or types that were not listed. Following the statement "I have evaluated the patient and there is significant justification for the use of restraints", there was a space for the ordering physician's signature. In addition, the lower portion of the form included 2 areas for "Restraint Reorder - every 24 Hours", with the same statement for the physician to sign, as well as spaces for Renewal Date and Time.

Review of the 24 - Hour Medical Restraint Flowsheet revealed spaces for every 2 hour nurses' documentation of the restraint/s used and the patient's assessments.

Further record review revealed Posey vest restraints (a restraint vest with long straps crossing in the front of the vest, which are then tied to either side of the bed or chair) were applied without a written physician's order on the following dates:

7/23/09 - order did not include vest restraint: only bilateral mitts ordered;

7/24/09 - renewal of the 7/23/10 order;

7/25/09 - no restraint orders or renewals written;

7/28/09 - order did not include vest restraint: only bilateral mitts ordered;

7/29-30/09 - renewals of the 7/28/10 order;

8/6-7/09 - no restraint orders or renewals written, and "8/6, 8/7 - no restraints" was handwritten on the 8/9/09 restraint order;

8/22/09 - order did not include vest restraints: only bilateral mitts and bilateral wrist restraints ordered; and

8/23-24/09 - renewals of the 8/22/10 restraint order.

In addition, bilateral wrist restraints were applied without a written physician's order on the following dates:

7/27/09 - renewal of order written on 7/25/09 that did not include wrist restraints: only bilateral mitts, vest and 4 siderails were ordered;

8/5/09 - renewal of order written on 8/4/09 that did not include wrist restraints: only vest and 4 siderails were ordered;

8/10/09 - order did not include wrist restraints: only bilateral mitts, vest and 4 siderails were ordered; and

8/11-12/09 - renewals of the 8/10/09 order.

As a result, a Posey vest was used to restrain Patient #23 during a period of 11 days, and both the Patient's left and right wrists were restrained during a period of 5 days, without written physician's orders authorizing the use of these restraints.


Patient #24

Record review on 7/2/10 and 7/6/10 revealed the Patient was admitted to the hospital on 3/26/10 for continued medical care following a hospital admission and work up for altered mental status.

Review of Medical Restraint Orders and 24 Hour Medical Restraint Flowsheets revealed a Posey vest restraint was applied without a written physician's order on 4/20/10. The 4/20/10 order did not include a vest restraint: only bilateral wrist restraints and 4 siderails were ordered.

As a result, a Posey vest was used to restrain Patient #24 without a written physician's order that authorized the use of this restraint.

During an interview on 7/2/10 at 9:10 am, the Director of Nursing (DON) stated the restraint order form had been changed and was now a daily order form, without the spaces for restraint order renewals. The DON disclosed the facility had a consultant who worked with them to revise both the order form and the facility's policy for restraints.

Although regulatory language states that a physician's order is required prior to the application of patient restraints (or immediately after, in an emergency situation), review of the Patient Restraint policy, revision date 1/2010, revealed the following:

Licensed Independent Practitioner (LIP) Order
a. If the LIP is not available, a registered nurse may initiate restraint in advance of a LIP order
i. If restraint was necessary due to a significant change in the patient's condition, the LIP shall be contacted immediately for an order.
ii. Otherwise, the LIP must be notified and a restraint order obtained within 24 hours of its initiation.

Review of the Restraint Competency Assessment form, required to be completed by all direct care staff during orientation, revealed the statement "An order must be obtained within 12 hours of a patient being placed in restraints / seclusion by a licensed independent practitioner for non-behavioral reasons." During an interview on 7/6/10 at 11:40 am, neither Staff Educator #1 nor Staff Educator #2 was able to provide the regulatory basis for this statement. Staff Educator #2 stated that during new employee orientation they go over the hospital's Patient Restraint policy prior to staff completing the Restraint Competency Assessment.

When asked about an annual review of restraint competency, Staff Educator #1 explained that the hospital holds a Skills Fair every September, with Restraints & Seclusion information presented. After reviewing the restraint information, all direct care staff are required to complete a 4 question true/false test. A copy of this test was reviewed with Staff Educator #1 at 12:10 pm, who confirmed the answer to question #1, "Restraints are at the discretion of the nurse. No MD order is required" was "b. False".

During an interview on 7/6/10 at 11:55 am, the Assistant Director of Nurses confirmed that "Our practice is that if you are going to put restraints on anybody, you have to have an immediate order - the physician has 24 hours to sign it, but you must have an immediate order."

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Based on record review and interview, the hospital failed to ensure restraints were not initiated on a PRN (as needed) basis for 1 patient (#23) of 10 patients reviewed for restraint use, out of 25 sampled patients. Specifically, the hospital failed to obtain a new order when patient restraints, ordered by the physician for a 24 hour period, were discontinued by nursing staff but subsequently reapplied within the same 24 hour period. Findings:

Patient #23

Record review on 7/2/10 and 7/6/10 revealed the Patient was admitted to the hospital on 6/22/09 for severe trauma following a motor vehicle accident. Nursing documentation indicated Patient #23 had frequent episodes of restlessness, agitation, hitting out at staff, trying to fling self out of bed and removing oxygen tubing.

Further record review revealed both right and left wrist restraints were ordered on 8/19/09. Nursing documentation on the restraint flowsheet, dated 8/19/09, indicated bilateral wrist restraints were applied at 7:00 am and removed at 8:00 am. However, at 3:00 pm, both right and left wrist restraints were reapplied and remained on the Patient for the remainder of the day.

As a result, both right and left wrist restraints were applied for a period of 16 hours without a written physician's order authorizing the use of these restraints.

Review of the facility's policy Patient Restraint, review date 1/2010, revealed the following: "Assessment for Discontinuance: The time-limited order does not require applying the intervention for the entire period. The need for restraint should be frequently evaluated and ended at the earliest possible time...A new restraint order must be obtained for any future episodes of restraint."
During an interview on 7/2/10 at 9:10 am, the Director of Nursing confirmed the 1/2010 revision of the facility's Patient Restraint policy was the most recent and was currently in use by the hospital.

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Based on clinical record review, policy review, and interview the facility failed to ensure medications were administered in accordance with the physician's orders for 2 patients (#s 1 and 2) of 6 patients whose medications were reviewed, out of 25 sampled patients. This failed practice placed patients at risk for receiving ineffective doses of medication. Findings:

Patient #1

Record review on 6/30/10 revealed the Patient was admitted on 2/7/08 with diagnoses that included muscular dystrophy (genetic disease causing progressive muscle weakness) and respiratory failure. The Patient's medication regimen included Coumadin (used to prevent and/or treat blood clots).

Review of Patient #1's medication administration record (MAR) for 6/24/10 revealed the order "WARFARIN SODIUM [Coumadin] 4 mg PO [by mouth] every night at 6 pm..." There was no nurse's signature to indicate the medication had been administered. Instead, the following handwritten notation was added: "Hold until discuss with MD [Medical Doctor] INR 3.01" (INR is an abbreviation for the unit used to measure Coumadin level in the body). Further record review revealed the desirable range for the Patient's INR was 2.0-3.0.

On 6/24/10 at 6:44 pm, after being contacted about the Patient's INR, the physician wrote an order to "Change Coumadin to 2mg daily..."

Further record review revealed no documentation in either the medDispense (a medication dispensing system) records or the MAR that the Patient received any Coumadin on 6/24/10, either before or after the physician's order to change the dose from 4 mg to 2 mg.

During an interview on 7/6/10 at 12:45 pm, the Medical Director and the hospital Pharmacist confirmed the Patient had not received Coumadin on 6/24/10 and verified the medication omission error.

Review of the facility's policy "Drug Administration: General", revision date 6/2010, revealed the Drug Administration Procedure included "Verify drugs to be administered with the physician's order. Review the MAR to ensure that the dose is correct..."


Patient #2

Record review on 7/02/10 revealed the Patient was admitted 6/10/10 with diagnoses that included hypertension (high blood pressure), respiratory failure and chronic obstructive pulmonary disease. The Patient's medication regimen included metoprolol (brand name Lopressor; an antihypertensive medication used to treat high blood pressure).

Review of the Patient's Medication Administration Record (MAR) revealed "METOPROLOL TARTRATE...hold for SBP [Systolic Blood Pressure, or the top number] < 110 [less than 110]". However, review of the "Provider's Order Sheet" revealed an "Order clarification", dated 6/19/10, to give metoprolol when "SBP > 100 [greater than 100]".

Further review of the MAR revealed the Patient's blood pressure was 107/61 at 9:00 am on 6/20/10, and was 108/63 at 9:00 pm on 6/25/10. Although on both dates the Patient's SBP was higher than 100, there was no documentation to indicate metoprolol had been administered either time. In addition, documentation on the MAR indicated the Patient's blood pressure was not always checked before administering the medication.

During an interview on 7/1/10 at 1:00 pm, the hospital's Pharmacist confirmed the new parameters had not been transcribed on the MAR after the 6/19/10 physician's order to give metoprolol if SBP greater than 100. In addition, he confirmed metoprolol should have been given on 6/20/10 and 6/25/10 because of the new parameters for the medication's administration.

During an interview on 7/1/10 at 1:15 pm, the Assistant Director of Nurses disclosed that nursing staff would not always obtain a blood pressure immediately prior to administering hypertensive medications. She stated that if some patients had been on their medications for a while and were stable, nurses would refer to a blood pressure reading taken earlier in the day.

Review of the facility's policy "General Principles of Medication Administration", dated 2/2010, revealed "...a. The MAR is checked against the previous days MAR.'s for absolute correctness by the 7P-7A shift daily. ANY MAR errors or omissions should be corrected and the Pharmacy notified...9. The blood pressure will be checked before the administration of antihypertensive and held if appropriate and the physician notified as needed. The blood pressure will be recorded on the Medication Administration Record."