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Based on record review, document review, and staff interview, it was determined the facility failed to protect Patients' rights by not allowing Patients to refuse treatment (see Tag A 131) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN) (see Tag A 169). This failure has the potential to cause harm to Patients receiving care at the facility.

Cross Reference:
Patient Rights Informed Consent: §482.13(b)(2)
Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN):
§482.13(e)(6)

Based on record review, document review, and staff interview, it was determined the facility ordered a PRN (as needed) physical restraint (brief physical hold) order to ensure administration of a daily ordered medication injection without the Patients consent in one (1) of twelve (12) Patients, (Patient #10). This failure has the potential to cause harm to Patients receiving care at the facility.
Findings include:

A review was conducted of Patient #10's medical record (MR). The Patient was admitted on 04/29/22 with a diagnosis of severe manic bipolar disorder. The Patient was ordered an Invega Sustenna IM (Intramuscular) injection on 06/29/23 at 1:30 p.m. On 06/29/23 at 2:03 p.m., an order states, "Patient may have hands on order if needed for Invega Sustenna Injection". The Patient accepted the medication at that time. On 07/06/23 at 10:20 a.m., a "Psychiatric Emergencies" note states in part: "Patient was informed that [patient #10] had Invega Sustenna [used for Schizoaffective Disorder] IM due today and initially Patient was willing for the injection, lay down in the hallway floor in the fetal position and stated, 'go ahead and do it, it's all on camera and you guys are going to get it, it's against my will' ... few minutes later patient got up and started pacing back and forth in the hall stating 'I'm not going to take it, you'll have to wrestle me down.' Several attempts to deescalate the Patient unsuccessful due to Patient not being able to focus and overtaking staff. Code 4 [General Assistance} called Patient was resistant and dropped [patient #10's] weight and placed in brief physical hold at 10:16 [a.m.] medicated with injection at 10:17 [a.m.] and released at 10:17 [a.m.]." It should be noted there is no documentation in the medical record that the patient advocate was involved in a second opinion medication as required by "W. Va. Code R. § 64-59-8 - Right to Refuse Treatment". It should also be noted that there is no documentation in the medical record that an alternative medication was discussed with the patient's Health Care Surrogate (HCS) or there was no evidence that the opinion of a second qualified provider was completed for Invega Sustenna.

A review of a document titled "Master Treatment Plan" dated 06/22/24 at 1:00 p.m. states in part, Nursing had requested this meeting due to concerns that the HCS (health care surrogate), {states surrogates name} had informed them that she could not grant permission, per DHHR (Department of Health and Human Resources) policy for second opinion medications to be administered by injection to {states Patient #10's name} unless it was given in an emergency situation only and not due to patient refusal of medication. HCS indicated that the NNMB (Mildred-Mitchell Bateman Hospital) could decide to give the patient second opinion medication in spite of the DHHR policy and by doing so accept the liability should it cause patient harm. MMBH personnel will continue to follow policy MMBHE011. It should be noted the DHHR policy is the W. Va. Code R. § 64-59-8 - Right to Refuse Treatment",

A review of the Food and Drug Administration Website for Ivega Sustenna Injection and suspension states in part, The medication is used to treat Schizophrenia and Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants. It should be noted Ivega Sustenna Injection medication is not approved for use in Bipolar disorder (Patient #10's diagnosis). https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf

A review conducted of policy, titled "Informed Consent/Right to Refuse Treatment", effective 06/09/23, states in part: "Procedures: ... III. Exceptions to Informed Consent/Right to Refuse Treatment. A. In those instances when an involuntary committed patient rejects any proposed treatment and all attempts at negotiating an acceptable alternative have failed than the most conservative least intrusive treatment approach which is recognized as usual and customary for the diagnosed condition in which produces minimal potential side effects may be imposed over the objections of the patient if all of the following conditions are documented in the medical record: 1. The patient's refusal is a product of his or her illness; 2. The proposed treatment is recognized as appropriate, effective and within accepted standards of practice; 3. The proposed treatment is approved by the medical director; 4. The opinion of a second qualified practitioner concurs with the proposed treatment and; 5. The patient Advocate is provided an opportunity to raise legitimate concerns on the part of the patient."

A review of the "West Virginia Health Care Surrogate Services Social Services Manual", states in part: "G. Decision-Making for the Incapacitated Adult ... Note: Though the Health Care Surrogate has decision making authority for health care matters, there are limits to what a Health Care Surrogate can do. Specifically, appointment of a health care surrogate cannot GUARANTEE that the adult will be compliant with a recommended course of treatment and/or medical care. While the health care surrogate does have a responsibility to authorize appropriate care/treatment, and to educate the adult to the extent possible about the benefits and consequences of compliance/failure to comply, they cannot force the adult to exercise good judgment, take medications as prescribed, comply with medical procedures, etc. Also, as the incapacitated adult's authorized representative the Department does have access to the health information necessary to carry out our responsibilities as Health Care Surrogate [HIPAA Privacy Rule 45 CFR. I64.502(g)]."

A review of "W. Va. Code R. § 64-59-8 - Right to Refuse Treatment", states in part: "8.1. General. As a participant in the program planning process, the patient has the right to exercise a voice in his or her program plan and to object to or refuse aspects of the plan. 8.2. Use of Internal Discussion, Negotiation and Grievance Procedure. The patient's right to object to or refuse treatment is recognized as legitimate and shall be responded to in accordance with the provisions of the patient grievance procedure if informal discussion and negotiation do not resolve differences. 8.3. Alternatives Offered and Provided. The treatment team for any patient who has refused psychotropic medications or other recommended therapy shall meet and work to ensure that an agreed-upon effective alternative treatment is offered and provided if the patient consents. 8.4. Oral Refusal Overrides Prior Written Consent. An individual patient's oral refusal to accept medication or other treatment always overrides prior written consent except in emergency situations as defined in this rule or as required by the applicable standard of care. 8.5. Last Resort Procedure When Patient Refuses Treatment. In those instances when an involuntarily committed patient rejects any proposed treatment and all attempts at negotiating an acceptable alternative have failed, then the most conservative, least intrusive treatment approach that is acceptable under the applicable standard of care for the diagnosed condition and which produces minimal potential side effects may be imposed over the objections of the patient if all the following conditions are documented in the patient's medical record: 8.5.1. The patient's refusal is a product of his or her illness; 8.5.2. The proposed treatment is recognized as appropriate, effective and within accepted standards of practice; 8.5.3. The proposed treatment is approved by the clinical director; 8.5.4. The opinion of a second qualified practitioner concurs with the proposed treatment; and 8.5.5. The patient advocate is provided an opportunity to raise legitimate concerns on the part of the patient."

An interview was conducted with the Medical Director (MD) and Assistant Medical Director (Asst MD) on 07/11/23 at 2:52 p.m. Regarding Patient #10, the MD and Asst MD state, "We have harmed [Patient #10] by not treating [patient #10]. It is less harmful to briefly hold [Patient #10] than to not treat [Patient #10]. [Patient #10] is suffering and stuck in this hospital. [Patient #10] is going to bring harm to [Patient #10's] self by their behavior and other Patients threatening to harm [Patient #10]. To give Patients medications when they refuse, if we follow our policy and state guidelines, has been the process here for the past twenty (20) years. It is the process of both state hospitals and all the private psychiatric hospitals in the state. The Patient's HCS was involved in the decision and did ask questions about other treatment options. The last time the Patient received these [Invega] injections, [patient #10] had no side effects. [Patient #10] is already doing so much better after the first two (2) injections. We were doing [Patient #10] more harm than good by letting [Patient #10] make [Patient #10] own medication decisions on what [Patient #10] would and would not take and choosing [Patient #10] own doses. Other Patients started attacking [Patient #10] due to [Patient #10's] behaviors. Anytime [Patient #10] has been discharged from a psychiatric hospital successfully, it was on a long-acting injection. The Patient never gains insight into [Patient #10] illness despite the medication."

A telephone interview was conducted with the HCS of patient #10 on 07/12/23 at 8:51 a.m. Regarding patient #10 receiving injections against [Patient #10] wishes using a brief physical hold, the HCS states, "During a case conference, I told them I couldn't give them permission to give the Patient a medication [patient #10] doesn't want. We discussed the medication and why the patient needed it. I conferred with my supervisor just to be certain our policy is we cannot force a patient to take medications. Afterwards, I did not hear anything back from the facility. The Patient called me [Patient #10's] self and told me they held [Patient #10] down and gave [Patient #10] the injection. The facility did not notify me of the physical hold, or that they were doing a physical hold to give the medication on July sixth. I feel it is against the Patient's civil rights to force a medication on [patient #10] like that."

A telephone interview was conducted with Physician #2 on 07/12/23 at 11:18 a.m. Regarding Patient #10, Physician #2 states,"[Patient #10] is not agreeable with taking [Patient #10's] medications. [Patient #10] will take partial doses or not take them at all. It's not enough to cause stability. The Patient has taken Invega before with good results, so we decided that this was the best route for [Patient #10]. I don't recall any details of the Patient's Health Care Surrogate being changed in the past couple months. The Patient has not regained capacity at any time that I've been taking care of [Patient #10]. I have no other Patients that I need to take these measures with."

Based on record review, document review, and staff interview, it was determined the facility failed to allow patients to refuse treatment in three (3) out of twelve (12) patients, patients #10, 11, and 12. This failure has the potential to cause harm to all patients receiving care at the facility.

Findings include:

A review was conducted of patient #10's medical record. The patient was admitted on 04/29/22 with a diagnosis of severe manic bipolar disorder. The patient was ordered an Invega Sustenna Intramuscular (IM) injection on 06/29/23 at 1:30 p.m. On 06/29/23 at 2:03 p.m., an order states, "Patient may have hands on order if needed for Invega Sustenna Injection."

A review was conducted of patient #11's medical record. The patient was admitted to the facility on 10/28/21 with a diagnosis of schizoaffective disorder. The patient lacks capacity. The patient was noncompliant with medication and treatment. A nursing order placed on 04/04/22 at 11:21 a.m. states, "may have hands on order for shower if needed."

A review was conducted of patient #12's medical record. The patient was admitted to the facility on 02/14/23 with a diagnosis of Bipolar I Disorder. The patient lacks capacity. The patient was noncompliant with medication and treatment. On 03/05/23 at 8:45 a.m., a nursing order states, "Pt [patient] to take shower, may utilize hands on if necessary." On 06/13/23 at 10:15 a.m., a nursing order states, "May implement hands-on for labs if refusing."

A review of policy, titled "Informed Consent/Right to Refuse Treatment", effective 06/09/23, states in part: "Procedures: ... III. Exceptions to Informed Consent/Right to Refuse Treatment. A. In those instances when an involuntary committed patient rejects any proposed treatment and all attempts at negotiating an acceptable alternative have failed than the most conservative least intrusive treatment approach which is recognized as usual and customary for the diagnosed condition in which produces minimal potential side effects may be imposed over the objections of the patient if all of the following conditions are documented in the medical record: 1. The patient's refusal is a product of his or her illness; 2. The proposed treatment is recognized as appropriate, effective and within accepted standards of practice; 3. The proposed treatment is approved by the medical director; 4. The opinion of a second qualified practitioner concurs with the proposed treatment and; 5. The patient Advocate is provided an opportunity to raise legitimate concerns on the part of the patient."

An interview was conducted with the Medical Director (MD) on 01/12/23 at 1:00 p.m. Regarding the hands-on order, the MD explained they would have to call the provider prior to putting hands on the patient. The MD stated, "We do not use PRN [as needed] restraint orders here. I agree the wording could be revised."

Based on record review, document review and staff interview, it was determined the facility failed to ensure that nursing staff followed their policy and procedure for physician ordered neurological (neuro) check assessments for one (1) of one (1) patient involved in an altercation with staff, patient #1. This failure has the potential to adversely affect patients receiving treatment at the facility.

Findings include:

A review was conducted of Patient #1's medical record. The patient was admitted on 06/23/22 with a diagnosis of borderline personality disorder, intellectual and developmental disability (IDD), and severe recurrent depression. On 05/13/23, Patient #1 was on unit A5; nursing notes documented aggressive, physical, and verbal harassment by Patient #1 toward staff and patients at 1:35 p.m., 3:00 p.m., 3:30 p.m., 6:00 p.m., 7:25 p.m., and 7:40 p.m., culminating in Patient #1 receiving an injury during an altercation with staff during a Calm Every Storm by Crisis Consulting Group (CCG) hold, while receiving a PRN (as needed) injection at 9:24 p.m. Photos in the patient's record revealed patient #1 had a bleeding cut on the bridge of the nose and a slightly swollen and bleeding lip that they received during the altercation.

A review of a physician order dated 05/13/23 at 11:26 p.m., states: "Neuro checks Q1h [every one hour]; may discontinue after 4hrs [four hours] if WNL [within normal limits]." Neuro checks were documented on 05/14/23 at 2:15 a.m., 6:25 a.m., 7:48 a.m., 8:33 a.m., and 9:30 a.m. Nursing notes dated 05/14/23 at 12:02 a.m., states: "VS (vital signs) obtained; unable to perform Neuro check at this time. Patient stated, 'I just want to go to sleep.' Will continue to monitor." Nursing notes dated 05/14/23 at 1:00 a.m., 4:04 a.m., and 5:04 a.m., states: "Attempted Neuro check, but unable to complete at this time. Patient resting supine, with eyes closed; respirations even unlabored. No s/s [signs/symptoms] of distress observed. Will continue to monitor." Nursing notes dated 05/14/23 at 3:00 a.m. were the same as the note at 1:00 a.m., with the added notation: "VS [vital signs] obtained; BP [blood pressure] improved."

A review of policy, titled "Neurological Assessment", last revised 02/14/22, states in part: "The guidelines for assessing level of consciousness by eliciting verbal and motor responses, and assessing pupillary activity ... document findings clearly, concisely and completely in the progress notes."

A review of personnel training files revealed that the nursing staff involved in the 05/13/23 incident had training in policies and procedures, including contraband, de-escalation, and neuro assessments.

A telephone interview was conducted on 07/11/23 at 1:08 p.m. with Registered Nurse (RN) #1 regarding the 05/13/23 incident involving Patient #1. RN #1 stated, "We got into the room to give a shot, and [Patient #1] had several pens in both hands. Two (2) HSW's [Health Service Workers] got in front to get a CCG hold and all three (3) fell into the bathroom. [Patient #1] was face down and I gave the shot. Then, [HSW #3] and I left. We heard a commotion and returned to the room. [Patient #1] met us at the door bleeding from the lip, if I remember right. I called the nursing supervisor and the physician, who ordered neuro checks.

An interview was conducted on 07/11/23 at 10:40 a.m. with RN #3 regarding the hourly neuro checks that were ordered for Patient #1 following the 05/13/23 incident. RN #3 confirmed that the neuro checks were ordered hourly for Patient #1, and could be discontinued after four (4) normal assessments. RN #3 then confirmed that the neuro checks were not completed as ordered, as the patient either would not cooperate or were sleeping, and that all attempts were documented in the computer. RN #3 stated, "I would have called the on-call provider regarding the inability to complete the first neuro checks, and made a note in the chart. [Patient #1] came to the nursing window about 2:00 a.m. requesting pain medication and an ice pack and I completed a neuro check at that time. I can't remember what the wounds looked like." There was no evidence in Patient #1's record of a nursing note regarding RN #3 contacting Physician #1, and none was provided.

An interview was conducted on 07/11/23 at 12:32 p.m. with Physician #1 regarding the 05/13/23 incident involving Patient #1. Physician #1 stated that they were on call that day and had heard from the floor multiple times regarding Patient #1's escalating behaviors. Physician #1 stated, "I did not hear from the floor again after the call where I ordered the neuro checks. I made my note at the end of the day. I was not notified of any issues with the neuro checks. I saw the photos of Patient #1's injuries in the computer the following day."

An interview was conducted on 07/11/23 at 10:47 a.m. with RN #4 regarding the incomplete neuro checks for Patient #1. RN #4 stated, "The neuro checks should have been completed as written by the physician."

An interview was conducted on 07/11/23 at 11:40 a.m. with the Chief Nursing Executive (CNE) regarding the neuro checks ordered for Patient #1 after the incident on 05/13/23. The CNE stated, "I was concerned about the medications [Patient #1] received that day and not getting the neuro checks every hour as ordered; there was no reason they couldn't be done. I think the documentation was poor."