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Based on observation, interview, and record review, the facility failed to ensure one (1) of thirty (30) sampled patients (Patient 1) was free of physical restraints (A "restraint" is defined as any physical or chemical means or device that restricts client's freedom to and ability to move about and cannot be easily removed or eliminated by the client) when the use of restraints was not indicated in accordance with the facility's policy and procedures regarding the use of restraints.

This deficient practice resulted in a violation of Patient 1's rights to be free from physical restraints and had the potential to result in a psychological and physical harm.


Findings:
During an observation, on 9/12/2023 at 10:30 A.M., while touring the facility's Direct Observation Unit (DOU), Patient 1 was observed in bed, restrained by two different types of restraints: bilateral wrist restraints (Soft bilateral limb holders on both wrists attached to the frame of the bed) and a vest restraint (A vest restraint worn on the upper body with ties securing the vest to the bed frame).

During a review of Patient 1's History and Physical (H&P-a structures assessment conducted to generate a comprehensive picture of a patient's health and health problems), dated 9/9/2023, the H&P indicated, Patient 1 was admitted for general weakness, urinary tract infection (infection in any part of the urinary system like the bladder and kidneys), confusion, and head injury.

During an interview, on 9/12/2023 at 10:30 A.M., with Patient 1, Patient 1 stated the restraints were applied last night on 9/11/2023, but Patient 1 was not able to state what was the indication for the restraints application.

During a concurrent observation and interview, on 9/12/2023 at 10:33 A.M., with Patient 1's primary nurse (Nurse 1), Patient 1 was observed in Patient 1's room. Patient 1 was observed resting in bed, restrained in a vest, and had bilateral (on each side) soft wrist restraints. The Nurse 1 stated, Patient 1 had both restraints applied last night. The Nurse 1 further stated that bilateral wrist restraints were applied because Patient 1 was agitated and was pulling on medical devices and a vest restraint was applied because Patient 1 was a high risk for fall (unintentional event that results in the person coming to rest on the ground or another lower level).

During a concurrent interview and record review on 9/12/2023 at 10:35 A.M., with Nurse 1, Patient 1's physician's order for restraints, dated 9/11/2023 at 11:09 P.M. was reviewed. The physician's order indicated the clinical reason for both restraints was: "pulling tubes/lines, interfering with dressing, wounds, or devices." The Nurse 1 further stated the clinical indication for the use of a vest restraint was not clearly indicated.

During an interview on 9/13/2023 at 10:51 A.M., with Regional Director of Accreditation, Licensing and Regulations (RD), the RD stated, the facility follows The Centers for Medicare & Medicaid Services (CMS) guidelines when it comes to restraints. The RD further stated, the facility's policy does not have a description of a vest restraint in the facility's policy but should be used on patients to prevent them from moving their torso (upper body) and to restrict their movement in bed. The RD stated, the facility's policy is to use the alternative preventive measures to decrease the need for restraints use such as re- orientation, distraction, a sitter for safety, and if not possible, to use the least restrictive restraint when a restraint is necessary.

During a review of Patient 1's medical record (MR), titled "Nursing Assessment," dated 9/11/2023, the MR indicated, primary registered nurse documented, "Patient 1 getting out of bed unassisted, high risk for fall and pulling out intravenous (IV) lines. New order for vest restraints and bilateral soft wrist
restraints placed."

During a concurrent interview and record review on 09/13/2023 at 11:09 A.M., with Director of Risk and Patient Safety (DRPS), Patient 1's "Nursing Assessment of Restraints" record, dated 9/11/2023, was reviewed. The record indicated, the primary registered nurse (RN) only documented indication for the bilateral restraints and did not document justification for the application of a vest restraint. The DRPS stated, the indication for a vest restraint should be documented in the assessment, but the primary RN did not.

During a review of Patient 1's flowsheet data, titled "Restraint Assessment," dated 9/11/2023- 9/12/2023, the flowsheet data indicated, on the following dates 9/11/2023 at 11:00 P.M., 9/12/2023 at 12:30 A.M., 9/12/2023 at 02:00 A.M., and 9/12/2023 at 6:00 A.M., the following alternatives to restraints were attempted by the primary RN: one to one patient care, diversional activities, increased frequency of nursing rounds, verbal redirection.

During a review of Patient 1's physician's orders, dated 9/11/2023-9/12/2023, the physician's orders
indicated no one to one (a sitter order) order was placed on 09/11/2023-09/12/2023.

During an interview on 09/13/2023 at 11:05 A.M. with Director of Nursing (DON), the DON stated, the facility's policy for restraints use indicates, nurses should attempt the less restrictive interventions such as diversional activities, increased frequency of nursing rounds, and a one to one (1:1) sitter. The DON further stated, if all less restrictive interventions are determined to be ineffective, nurses should document the behavior justifying the need for a restraint use. The DON stated, if a need for restraints is unavoidable, nurses should continuously re-evaluate the need to use restraints and discontinue restraints if the patient no longer shows the behavior requiring restraints application.

During a review of the facility's nursing educational materials, titled "Restraints," dated 7/12/2019, the nursing educational material indicated, "Restraints should only be used to ensure the immediate physical safety of the patient, staff, or others and only when less restrictive interventions have been determined to be ineffective. Rationale for use should be documented and alternatives to restraints should be attempted prior to using a restraint. Vest should be used on patients requiring the greatest level of restriction to provide appropriate medical care."

During a review of the facility's policy and procedures (P&P), titled "Restraint Use," the P&P indicated, "The order for restraints shall include the type of restraint to be applied and shall be based on specific observation that indicate the need for restraint. The choice of safe, effective, and least restrictive method of restraint is determined by the assessment of a registered nurse, in collaboration with the physician, based upon the patient's needs and behavior displayed by the patient including a description of the patient's behavior or symptoms that warranted the use of restraint and the patient's condition. The rationale for the continued use of the intervention should be documented."

The Centers for Medicare & Medicaid Services (CMS) finds the rationale that the patient should be
restrained because he/she "might" fall as inadequate basis for using a restraint. When assessing and care planning for the patient, the hospital should consider whether he/she has a history of falling or a medical condition or symptom that indicates a need for a protective intervention. It is important to note that the regulation specifically states that convenience is not an acceptable reason to restraint a patient. A restraint must not serve as a substitute for adequate staffing to monitor patients.