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LOWELL, MA 01854

PATIENT RIGHTS

Tag No.: A0115

Based on record review and interview, the Hospital failed to identify opportunities for improvement and changes that will lead to improvement through data collected for 1 Patient (#4), who was ordered for an as needed (PRN) chemical restraint of Olanzapine (an antipsychotic medication) intramuscular (IM) injection out of a sample of 10 Patients.

Refer to A-0169

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on record review and interview, the Hospital failed to remove orders for the use of restraint that were written as a
standing order or on an as needed basis (PRN) for 1 Patient (#4), who was ordered for an as needed (PRN) chemical restraint of Olanzapine (an antipsychotic medication) intramuscular (IM) injection out of a sample of 10 Patients.

Findings include:

Review of CMS regulation 482.13(e)(6) indicated the following:
-Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

Review of the Hospital Policy Titled "Restraints and/or Seclusion", revised February 2022, indicated the following:
-The term "restraint" includes either physical or chemical restraint.
-Chemical restraint: A medication used as a restraint is a medication used to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical of psychiatric condition.
-The decision to use a restraint or seclusion is not driven by diagnosis, but by the individualized patient assessment.

Review of the Hospital Performance Improvement Plan, dated 2023 indicated the following:
-The Board delegates and directs the Hospital Administration and Medical Staff to: Implement performance improvement efforts and Assess and Priorities the performance improvement activities.

Upon request for a log of patient deaths within 24 hours of restraint from the Hospital, the Surveyor was provided 2 cases which did not include Patient #4's death while in restraints.

Patient #4 was admitted to the Hospital Emergency Department on 11/1/22 and subsequently admitted to the R4 inpatient unit with diagnoses including acute kidney failure, hypertension, schizoaffective disorder, and bipolar disorder.

Review of Patient #4's medical record indicated Patient #4 had become aggressive and assaultive on 11/4/22. Patient #4 was physically restrained in a 2-point restraint with soft wrist cuffs on 11/4/22. Patient #4 was also administered 2.5mg (milligrams) of Olanzapine intramuscularly. Patient #4 was evaluated by the Psychiatric Nurse Practitioner on 11/4/22; the Psychiatric Nurse Practitioner ordered Olanzapine 5 mg by mouth twice daily PRN for agitation for Patient #4. The Psychiatric Nurse Practitioner also ordered Olanzapine 5mg IM injection 5 mg 2 times daily PRN for agitation, if unable to tolerate the oral dose for Patient #4. Patient #4 continued to be physically and verbally abusive to staff from 11/4/22 through 11/6/22. On 11/6/22 at 1:04 P.M., Patient #4 was evaluated by MD #1; Patient #4 continued to be in bilateral wrist restraints and was disoriented and lethargic. On the evening of 11/6/22 Registered Nurse (RN) #2 documented Patient #4 was increasingly agitated and attempting to hit staff; RN #2 administered a dose of IM Olanzapine to the Patient at 6:36 P.M. on 11/6/22. RN #2 documented she had notified MD #1; Patient #4's medical record failed to indicate a physician ever evaluated Patient #4 during his/her episode of aggressive behavior and increased agitation, nor after the administration of the IM Olanzapine. Patient #4 was later found unresponsive on 11/6/22 at 7:38 P.M., Cardiopulmonary Resuscitation (CPR) was initiated, however, Patient #4 expired at the Hospital.

Further review of Patient #4's medical record indicated Patient #4's death had been recorded in the Hospital Mortality Log in the Regulatory Compliance Department as of 11/7/22.

During an interview with RN #2 on 1/19/23 at 8:07 A.M., she said she had cared for Patient #4 2 days in a row (11/5/22 and 11/6/22) on the 7:00 A.M. - 7:00 P.M. shift. She said Patient #4 had been constantly attempting to hit and kick Hospital staff even while in 2-point bilateral wrist restraints. She said Patient #4 was at times compliant with his/her medications, and other times would just spit them out. She said while repositioning the Patient on 11/6/22, the staff released one of his/her restraints to reposition the Patient safely. She said Patient #4 was violent and attempting to hit staff and jump out of the bed. She said a code gray was called and security staff responded to help with Patient #4. She said Patient #4 refused any medication at that time, and she administered IM Olanzapine to Patient #4. She said there was no physician present during the code gray response. RN #2 said she administered the IM Olanzapine because Patient #4 was combative and needed to be calmed down. She said staff were able to restrain Patient #4, and she sent a message to MD#1 regarding the event and passed this information on in report to the oncoming RN.

During an interview with MD #1 on 1/19/23 at 10:48 A.M., she said the nurses working on the unit were good with communicating changes in Patient conditions. She said Patient #4 was a difficult Patient due to his/her behaviors and psychiatric conditions. She said she requested a psychiatric consult for Patient #4, and the Psychiatric Nurse Practitioner ordered the olanzapine for better control Patient #4's mood and behaviors. MD #1 said she would not order a standing intramuscular PRN dose of an antipsychotic medication. She said she did not question the order for the IM olanzapine placed by the Psychiatric Nurse Practitioner.

During an interview with the Psychiatric Nurse Practitioner #1 on 1/29/23 at 12:30 P.M., she said she did not recall much regarding Patient #4, however, psychosis could have been causing Patient#4's behaviors. She said when ordering an intramuscular psychotropic medication, she will link in to an order for an oral dose of that medication with parameters to attempt administration of the oral dose first. She said she will create the orders and send a message to inform a patient's attending physician. She said once the medications are ordered, the nurses caring for a patient can use their discretion for administration of the medications based on the orders, instructions, and parameters set in the medication orders.

During an interview with MD #2 on 1/19/23 at 1:34 P.M., he said he will usually only order one-time doses for an as needed IM medication such as an antipsychotic/psychotropic medication. He said he was unable to recall much regarding Patient #4. He said it was reported to him on 11/4/22 that Patient #4 was unsafe and climbing out of his/her bed and interfering with his/her medical care; he ordered a one-time dose of IM Olanzapine and physical restraint for Patient #4.

Despite Patient #4's medical record being reviewed and Patient #4's death having been recorded in the Hospital Mortality Log in the Regulatory Compliance Department as of 11/7/22, no action had been taken by the Hospital to address the standing PRN IM antipsychotic order and subsequent intramuscular 5mg dose of Olanzapine administered on 11/6/22 without a physician's evaluation.