HospitalInspections.org

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Based on observation, interview, and document review, the Hospital failed to meet the requirements for the Condition of Participation for Patient Rights.

Failure to establish and implement policies and procedures for restraint or seclusion risks physical and psychological harm, loss of dignity, and violation of patient rights which can lead to negative patient outcomes.

Findings included:

1. Failure to obtain appropriate non-violent restraint orders places patients at risk for harm due to inappropriate application of restraint or restraint type.

Cross Reference: A 0159

2. Failure to obtain a physician's written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type.

Cross Reference: A 0168

3. Failure to ensure staff limit the use of restraints to the least restrictive intervention risks serious physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0174

4. Failure to follow approved policies and procedures for restraint or seclusion use risks physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0175

5. Failure to ensure medical staff receive restraint and seclusion training risks patient injury or decline in status from improper application, assessment, or removal.

Cross Reference: A 0176

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.13 Patient Rights was NOT MET.
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Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to appropriately order the application of non-violent restraints for 1 of 3 non-violent restraint patients reviewed (Patient #205).

Failure to obtain appropriate non-violent restraint orders places patients at risk for harm due to inappropriate application of restraint or restraint type.

Findings include:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion Policy, 964.00," PolicyStat ID #12719679, last approved 12/22, showed the following:

a. Virginia Mason Fransciscan Health does not use side rails as a restraint.

2. Document review of the hospital's policy and procedure titled, "Fall Prevention and Management," PolicyStat ID 12592642, last approved 04/23, showed the following:

a. All patients will be assessed at the time of admission, every shift, upon transfer to another level of care, and after a fall.

b. Interventions for high fall risk include maintaining a safe environment, considering moving the patient closer to the nurse's station, use of a bed alarm, applying a fall mat with the non-beveled edge next to the bed, and use of a virtual companion or sitter.

c. Use of a posey vest or side rails is not included in the Morse Falls Assessment and Interventions Tool.

3. On 03/20/24 between 1:55 PM and 3:15 PM, Investigator #2 and the Intensive Care Unit Nurse Manager (Staff #201), and the Medical/Telemetry and Orthopedic Unit Based Educator (Staff #207) reviewed the medical record of Patient #205 who was an 88-year-old male admitted to the Orthopedic Unit on 10/10/23 with a diagnosis of generalized weakness secondary to hyponatremia and recurrent falls. The review showed the following:

a. On 10/10/23 at 10:58 PM, Patient #205 had a provider order for non-violent restraints to include four side rails.

b. On 10/11/23 at 6:28 PM, Patient #205 had a provider order for non-violent restraints to include four side rails.

c. On 10/10/23 at 10:58 PM, Patient #205 had a provider order for non-violent restraints to include four side rails.

4. At the time of the review, Staff #201 verified the non-violent restraint order and interventions ordered.
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Item 1 - Timely order for restraint

Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to obtain a physician's order for the application of nonviolent behavioral restraints in a timely manner for 1 of 3 non-violent restraint patients reviewed (Patient #908).

Failure to obtain a physician's written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion Policy, 964.00," PolicyStat ID 6436707, last approved 06/19, showed that if a provider is not available at the time of the assessment indicating the need for restraint and least restrictive measures have failed, a Registered Nurse may initiate a restraint to protect the patient, staff, or others from harm. An order is obtained from the provider as soon as possible after initiation.

2. On 03/20/24 and 03/21/24, Investigator #9 and Nurse Educator (Staff #908) reviewed the medical record of Patient #908 who was a 69 year old admitted on 11/22/20 for altered mental status. The review showed that Patient #908 was placed in a posey vest on 11/25/20 at 5:30 AM for attempting to get out of bed. The patient had right and left wrist restraints applied on 11/25/20 at 9:30 AM for pulling out the intravenous line. The wrist restraint order was entered at 6:39 PM (a period of approximately 9 hours) after the application of the restraint.

3. At the time of the review, Staff #908 verified the timing of the provider order for restraint.

Item 2 - Violent restraint orders

Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to obtain a physician's order for the application of a chest strap restraint for 1 of 3 violent restraint patients reviewed (Patient #907).

Failure to obtain a physician's written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion Policy, 964.00," PolicyStat ID 12719679, last approved 12/22, showed the following:

a. Restraint and Seclusion require an order from a Physician or Licensed Provider.

b. The order must include the type, reason, and duration.

c. The type of restraint must include the device and location/laterality.

2. On 03/22/24 between 9:10 AM and 10:00 AM, Investigator #9 and the Nurse Manager of the Emergency Department (Staff #901) reviewed the medical record of Patient #907 who was a 39-year-old brought into the Emergency Department on 03/19/24 evaluated for altered mental status. The review showed that on 03/19/24 at 6:30 PM, a chest strap restraint was applied in addition to the 4-point locking restraints. Investigator #9 found no evidence of an order for the chest strap restraint.

3. At the time of the review, Staff #901 verified the documentation and stated that there isn't usually an order for the chest strap restraint as it is included in the policy.
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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff limited the use of restraints to the least restrictive intervention that would be effective to protect the patient, staff member, or others from harm for 1 of 3 patients with non-violent restraint orders reviewed (Patient #205).

Failure to ensure that staff limit the use of restraints to the least restrictive intervention risks serious physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion Policy, 964.00," PolicyStat ID #12719679, last approved 12/22, showed the following:

a. Restraints are any physical or chemical method, or mechanical device or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body.

b. The hospital uses restraint and seclusion only when less restrictive interventions are ineffective.

c. Non-violent restraints are used when behaviors interrupt medical healing such as protecting dressings, lines, tubes, or catheters or for safety when the patient is unable to comprehend or comply with instructions.

d. Alternate strategies for interference with medical treatment include assessing for pain and discomfort related to the treatment, reviewing the need for treatment/interventions, changing continuous intravenous (IV) medication to intermittent or use other routes as soon as possible, placing the IV in the least restrictive/intrusive sites, covering IV with tubing/gauze/stockinette/wristbands.

e. A virtual companion is a staff member who is trained to provide remote observation of a patient to promote safety. A virtual companion may be used as a least restrictive alternative to non-violent restraint.

f. Virginia Mason Franciscan Health does not use side rails as a restraint.

2. Document review of the hospital's policy and procedure titled, "Fall Prevention and Management," PolicyStat ID 12592642, last approved 04/23, showed the following:

a. All patients will be assessed at the time of admission, every shift, upon transfer to another level of care, and after a fall.

b. Interventions for high fall risk include maintaining a safe environment, consider moving the patient closer to the nurses station, use of a bed alarm, applying a fall mat with the non beveled edge next to the bed, and use of a virtual companion or sitter.

c. Use of a posey vest or side rails is not included in the Morse Falls Assessment and Interventions Tool.

3. On 03/20/24 between 1:55 PM and 3:15 PM, Investigator #2 and the Intensive Care Unit Nurse Manager (Staff #201), and the Medical/Telemetry and Orthopedic Unit Based Educator (Staff #207) reviewed the medical record of Patient #205 who was an 88-year-old male admitted to the Orthopedic Unit on 10/10/23 with a diagnosis of generalized weakness secondary to hyponatremia and recurrent falls. The review showed the following:

a. On 10/10/23 at 10:58 PM, Patient #205 was assigned a virtual companion, bed alarm was used, they were placed in vest restraint, left and right wrist soft restraint with 4 side rails up at the same time for being unable to follow instructions and agitation. The patient remained with all methods of restraint until their death on 10/13/23 at 7:15 AM (a period of 56 hours).

b. On 10/11/23 from 2:00 AM through 6:00 AM (a period of approximately 4 hours), restraint flow sheet documentation showed the patient was asleep.

c. On 10/12/23 from 6:00 AM through 10:00 AM (a period of approximately 4 hours), restraint flow sheet documentation showed the patient was asleep.

d. On 10/13/23 from 10:00 PM through 4:00 AM, AM (a period of approximately 6 hours), restraint flow sheet documentation showed the patient was asleep.

4. At the time of the review, Investigator #2 found no evidence that the least restrictive intervention was attempted before additional interventions were implemented.

5. On 03/21/24 at 8:30 AM, Investigator #2 interviewed two Registered Nurses (Staff #208 and #209) from the Orthopedic Unit regarding non-violent restraints. During the interview, both RNs indicated that they follow the Provider's order of what restraint type is included on the non-violent restraint order. The routine process is to start with the side rails and vest or side rails and soft limb restraints and add vest or soft limb restraints as necessary.

6. On 03/21/24 at 8:30 AM, Investigator #9 interviewed Nurse Educator (Staff #908) about the education provided to staff regarding restraint use. Staff #908 stated that if a patient is pulling on lines or tubes, soft mitts would come first followed by soft wrist restraints. If a patient would be unsafe getting out of bed, 4 side rails would be used first and if the patient is impulsive and not redirectable and at risk for a fall, a vest restraint would be implemented.
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Based on interview, document review, and review of the hospital policy and procedure, the hospital failed to ensure that staff members accurately documented assessments for 1 of 3 patients in violent restraints reviewed (Patient #908).

Failure to follow approved policies and procedures for restraint or seclusion use risks physical and psychological harm, loss of dignity, and violation of patient rights.

Reference: CFR 42.482.13 (e): (10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner, or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy."

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion Policy, 964.00," PolicyStat ID 12719679, last approved 12/22, showed the following:

a. Each episode of restraint/seclusion is documented in the patient's medical record in accordance with regulatory requirements and hospital-approved standards.

b. Staff members who monitor patients in restraint will receive training in appropriate documentation.

2. On 03/22/24 between 9:10 AM and 10:00 AM, Investigator #9 and the Nurse Manager of the Emergency Department (Staff #901) reviewed the medical record of Patient #907 who was a 39-year-old brought into the Emergency Department on 03/19/24 evaluated for altered mental status. The review showed the following:

a. On 03/19/24 at 5:15 PM, the patient was placed in locking 4-point restraint. Documentation showed the restraint was discontinued at 9:08 PM.

b. After discontinuation of the restraint, documentation (approximately 13 entries into the medical record) from 03/19/24 at 9:15 PM until 03/20/24 at 12:17 AM, showed that the patient was in restraint.

3. At the time of the review, Staff #901 verified the inconsistencies in documentation.
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Based on document review and interview, the hospital failed to implement minimum standards for medical staff who are authorized to order restraints. Record review showed 3 of 3 medical providers authorized to order restraint or seclusion had no documentation to demonstrate initial or periodic training as required (Staff #614, Staff #615, and Staff #616).

Failure to ensure medical staff receive restraint and seclusion training risks patient injury or decline in status from improper application, assessment, or removal.

Findings included:

1. Document review of the hospital's "Virginia Mason Franciscan Health, Franciscan Medical Staff Rules and Regulations," effective 02/27/24, showed that physicians and other practitioners authorized to order restraint or seclusion must have a working knowledge of hospital policy regarding the use of restraint and seclusion.

Document review of the hospital's policy, "Virginia Mason Franciscan Health Restraint and Seclusion Policy, 964.00, PolicyStat ID 12719679," approved 12/22, showed that providers must have a working knowledge of the hospital restraint and seclusion policy. Addendum D: medical staff shall receive training in subjects as it relates to their duties performed under the Restraint and Seclusion Policy. Training shall take place during new employee orientations, and on a periodic basis as indicated by the results of quality monitoring activities and recommendations from Education Services.

2. On 03/21/24 from 10:10 AM to 10:30 AM, Investigator #6 reviewed medical staff personnel files with the Division Director of Peer Review (Staff #610), the Division Manager for Medical Staff Services (Staff #611), the Medical Staff Coordinator (Staff #612), and the Northwest Region Chief Medical Officer (CMO) (Staff #613). The review showed 3 of 3 medical staff records (Staff #614, Staff #615, and Staff #616) did not include documentation of restraint and seclusion training.

3. At the time of the review, Investigator #6 interviewed Staff #610, Staff #611, and Staff #612 about medical provider restraint training. Staff #612 stated that providers received restraint training at New Employee Orientation, but she was not certain of the frequency of subsequent training.
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