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Based on record review, review of policy and procedure, review of professional literature, review of the Hospital's Plan of Correction (POC) and revisit information/documentation, and staff interview, during the onsite revisit completed 12/07/10, the Hospital failed to ensure restraint use in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient for 1 of 2 active patients (Patient #94) restrained. Failure to ensure the use of restraints in accordance with the order of a physician or LIP has the potential for inappropriate use of restraint, which could result in physical or psychological harm.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for restraint use. Federal regulations require staff to obtain an order from the physician or LIP prior to the application of restraint. In an emergency situation, the need for a restraint intervention may occur so quickly staff cannot obtain an order prior to the application of restraint. In these emergency application situations, staff must obtain the order either during the emergency application of the restraint or immediately (within a few minutes) after staff apply the restraint. The failure to immediately obtain an order is viewed as the application of restraint without an order.

Review of the policy "Restraints" occurred 12/07/10. This policy, revised September 2010, stated, ". . . Policy: It is [name of hospital] commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/her self or others. Leaders and patient caregivers strive to create a safe environment where restraint use can be prevented or where alternatives to restraint can be employed. . . . All clinical staff completes annual 'Restraint Use' competencies. . . . Procedure: A. Restraint use for Medical and Surgical care (to support physical healing): . . . 2. Restraint Order *RN [registered nurse] initiates order only if LIP is not available *Notify LIP within 12 hours (immediately if significant change in patient condition) to obtain verbal or written order . . . C. Restraint Protocols: . . . 2. Restraint Protocol Order *RN [registered nurse] uses assessment . . . and determines need for restraint *LIP issues a patient-specific order authorizing the use of restraint protocols . . ."

The hospital's policy on restraint use for Medical and Surgical Care allows the RN to initiate a restraint order if the LIP is not available and to notify the LIP within 12 hours (immediately if significant change in patient condition) to obtain verbal or written order. This policy does not comply with the regulation requiring a physician or other LIP to order restraints or seclusion prior to application, unless it is an emergency situation, in which staff would obtain an order during or immediately after application of the restraint or seclusion.

Review of the policy "Side Rail Policy - Draft" occurred 12/07/10. This policy, adopted November 2010, stated, ". . . SUBJECT: Appropriate assessment and use of side rails on patient's [sic] beds. PURPOSE: To provide best practice assessment, guidelines for use and information to all staff regarding appropriate side rail use for the hospitalized patients. POLICY: It is the policy of [name of hospital] to provide patients with a safe . . . bed environment. Safe use of side rails during patient's hospitalization is based on assessing the patient's needs, strengths, weaknesses and preferences individually. Side rail use will factor the patient's condition, behaviors, history and environmental factors. PROCEDURE: 1. . . . Side rails evaluation is needed to assess the relative risk of using the bed rail compared with not using if for an individual patient. All side rail use will be based on the individual needs of the patients. . . . 4. The use of four side rails to prevent the patient from exiting the bed would be considered a restraint. The risk presented by side rail use should be weighed against the risk presented by the patient's behavior as determined by individual assessment. 5. The use of side rails place the patient at greater risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail. . . ."

Review of the facility's POC, dated 11/19/10, occurred 12/07/10. Review of pages 73-74, stated, "It is the policy of [name of hospital] that the use of a restraint . . . must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient . . . and authorized to order restraints . . . by hospital policy in accordance with state law. . . . 3) A) Policy and Procedures for Restraint . . . have been reviewed and revised as needed to meet regulatory requirements. B)Nursing Staff education completed on 11/18/10, 11/19/10, 11/22/10, 11/23/10, 11/24/10 for regulatory requirements for obtaining a physicians order for the use of Restraint . . . 5) A) Nurse Managers will be responsible for reviewing restraint . . . use on a per incident basis for ensuring physician orders, per regulatory standard, were obtained. . . ."

Review of Patient #94's active medical record occurred December 06-07, 2010, and identified the Hospital admitted this patient on 12/02/10 with diagnoses of right lower lobe pneumonia, hypoxemia, and coffee ground sputum. Patient #94's Nursing Interactive Flowsheets, dated 12/02/10 at 6:00 p.m. and 8:00 p.m., identified the patient as awake, alert, restless, and in bed. The flowsheets showed upper and lower side rails elevated times two (four side rails up), and identified "safety" as the rationale for side rail use. Patient #94's Assessment Forms-Nursing Rounds, dated 12/02/10 at 6:00 p.m. and 8:00 p.m., identified the same information as the above flowsheets.

Review of Patient #94's record lacked documentation of the least restrictive interventions, or alternatives staff implemented and attempted before elevating all four side rails on the patient's bed. The record lacked evidence staff assessed the use of four side rails as a restraint for Patient #94 and lacked a physician's order for the initiation of the four side rails.

Patient #94's Restraint Forms, dated 12/02/10 at 8:35 p.m., showed soft limb restraints (a type of soft canvas restraint applied to the extremities and tied to the bed) ordered and applied to each upper extremity due to cognitive impairment interfering with medical care, interference with medical devices/tubes/dressings, and mechanical ventilation protocol. The form showed comfort measures, device protection, and reality orientation as alternatives attempted before staff applied the soft limb restraints. The form also indicated full (four) side rails. Review of the Nursing Interactive Flowsheet, Activity Forms-Adult Activities of Daily Living, and Assessment Forms-Nursing Rounds, dated 12/02/10 at 10:00 p.m., identified Patient #94 as awake, resting, and uncooperative. The flowsheets showed upper and lower side rails elevated times two (four side rails) and identified access to bed controls, patient request, and patient restrained as the rationale for side rail use. The record identified elevation of all four side rails on Patient #94's bed until 12/02/10 at 11:45 p.m.

On 12/02/10 at 8:35 p.m., the record showed nursing staff failed to obtain an order for the utilization of all four side rails. Nursing staff utilized two forms of restraint on Patient #94 (soft limb and four side rails) from 8:35 p.m. to 11:45 p.m., a three hour time frame, without evidence of a physician order for the side rails. In addition, the record lacked evidence to support Patient #94's need for the two restraints. The record lacked evidence staff assessed the use of four side rails as a restraint for Patient #94 and implemented the least restrictive interventions or alternatives while continuing to utilize all four side rails along with soft limb restraints.

During an interview on the afternoon of 12/06/10, an education nurse (#18) stated the facility considers elevation of four side rails as a restraint and confirmed elevation of four side rails on Patient #94 from 6:00 p.m. to 11:45 p.m. on 12/02/10. The nurse (#18) stated Patient #94's medical record lacked a physician order for the utilization of four side rails and the reason for the elevated side rails.

During an interview on the afternoon of 12/07/10, an administrative nurse (#2) confirmed the facility developed more extensive education on patient safety and side rail documentation, but the facility had not provided this education to all staff.


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