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Based on record review, policy review, observation and interview, it was determined the facility failed to protect and promote the rights of patients as evidenced by failure to ensure that all patient's are free from restraint (A 154); failure to appropriately define restraint (A 159); failure to identify and attempt less restrictive methods prior to restraint use (A 164): and failure to incorporate State Law in hospital restraint policy (A 167) in 1 of 1 patient records in which application of restraints was reviewed and observed.

Based on record review, policy review, observation and interview, it was determined the facility failed to ensure the patient's right to be free from physical restraint in 1 of 1 patient records (pt #7) in which application of restraints was reviewed and observed. Findings include:

1. Review of Procedure #L 6000-001, titled "Restraint - Nonpsychiatric Care Unit: Non-Aggressive/Non-Assaultive and Aggressive/Assaultive" last revised 02/2010 stated in Section III.3.2: "Any use of restraint is initiated and renewed pursuant to an individual order by a licensed independent practitioner. Individual orders provide the framework for ensuring clinical justification of restraint use based on the patient's assessed needs and clinical condition to protect the patient's rights, dignity and well-being." This policy also states with regard to patient monitoring: "Patients in restraints are monitored according to applicable hospital policies and procedures, applicable state law, individual orders, according to individual patient needs. Monitoring determines the patient's physical and emotional well-being, ensures that the patient's rights, dignity and safety are monitored and determines if less restrictive methods are possible."

2. Direct observation of Pt. #7 on 4/19/2010 at 12:20 PM reveals bilateral hand mitts on which velcro at the wrist. The patient is somewhat obtunded and unable to remove the mitts. The Medical Record of Pt. #7 does not contain a physician order for the mitts or nursing documentation to include application of the mitts or circulation and sensitivity checks of the hands.

3. During interview on 4/19/2010 at 12:25 PM, the Director of Medical/Surgical Services and RN Mgr CCU were questioned about the lack of a physician order and subsequent nursing documentation for the application of the mitts as a restraint with the response that "mitts are not considered a restraint by hospital policy."

Based on interview and review of agency policy, it was determined the facility policies and procedures failed to properly define restraints. Findings include:

At 12:45 PM, a review and discussion of Lakeland Healthcare Policy-Procedure: Restraint - Non-psychiatric Care Unit: Non-Aggressive/Non-Assaultive and Aggressive/Assaultive was completed with the Director of Quality Services, Director of Medical/Surgical Services and DON. Section II.2. states "Non-Aggressive/Non-Assaultive: This restraint includes the use of soft limb and lap belts." Each hospital staff member present confirmed that the policy and practice of Lakeland Hospital is that mitts are not considered restraint as described in policy. Through discussion and review of the Federal Regulations all hospital staff present stated understanding of the requirements and that the existing policy and practices are not in compliance.

Based on record review, observation and interview, the facility failed to document the least restrictive interventions used by staff to protect the patient and others from harm prior to the introduction of more restrictive measures for 1 of 1 (# 7) patient restrained. Findings include:

1. Direct observation of Pt. #7 on 4/19/2010 at 12:20 PM reveals bilateral hand mitts on which velcro at the wrist. The patient is somewhat obtunded and unable to remove the mitts. The medical record of Pt. #7 does not contain a physician order for the mitts or nursing documentation to include application of the mitts or circulation and sensitivity checks of the hands.

2. The clinical record review for patient #7 failed to document evidence that less restrictive measure had been implemented and determined to be ineffective to protect this patient prior to the application of hand mitts.

3. During interview on 4/19/2010 at 12:25 PM, with the Director of Medical/Surgical Services and RN Mgr CCU confirmed the above findings.

Based on interview and review of agency policy, it was determined the facility failed to incorporate State Law into the facility restraint policy. Findings include:

1. Michigan Law entitled "MICHIGANPUBLIC HEALTH CODE", Act 368 of 1978, 333.20201 states at Sec. 20201. 2.(l): A patient or resident is entitled to be free from mental and physical abuse and from physical and chemical restraints, except those restraints authorized in writing by the attending physician for a specified and limited time or as are necessitated by an emergency to protect the patient or resident from injury to self or others, in which case the restraint may only be applied by a qualified professional who shall set forth in writing the circumstances requiring the use of restraints and who shall promptly report the action to the attending physician. In case of a chemical restraint, a physician shall be consulted within 24 hours after the commencement of the chemical restraint.

2. Review of Lakeland Healthcare Policy-Procedure: "Restraint - Non-psychiatric Care Unit: Non-Aggressive/Non-Assaultive and Aggressive/Assaultive" (last updated 02/2010), II. D. defines a Licensed Independent Practitioner (LIP) as "Any individual permitted by law and by LRHS to provide care, treatment and services, without direction or supervision, within the scope of the individual's license and consistent with individually granted clinical privileges. This may include a physician, nurse practitioner or physician assistant."

3. As noted in the state law above, nurse practitioner and/or a physician assistant work under the supervision of a physician and cannot be considered an LIP for the purpose of restraint orders.

3. On 4/19/2010 at 2:10 PM during a review and discussion of the federal regulations and state law with the Director of Quality Services, Director of Medical/Surgical Services and DON, each verbalized an understanding of the requirements and that the existing policy and practices are not in compliance.