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TEXAS VISTA MEDICAL CENTER 7400 BARLITE BLVD SAN ANTONIO, TX 78224 Jan. 23, 2019
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on observation, records reviewed, and interviews the facility failed to ensure for Patient #1; or his representative (as allowed by State Law) the right to make informed decisions regarding his care and treatment; regarding the treatment of psychoactive medications, unless an emergency. Specifically,

1.) On 6/3/18, Patient #1 presented to the facility voluntarily and received an injection with multiple psychotropic medications without providing informed consent prior to administration and,

2.) Alternatively, the facility's documentation did not warrant the administration of these injected psychotropic medications on 6/3/18 as a psychiatric emergency; in accordance with state law. Staff documentation did not present that Patient #1 was in imminent physical or emotional harm to himself or others because of threats, attempts, or other acts; posing immediate threat or danger to warrant an emergency injection of psychotropic medications.

This affected Patient #1's rights reviewed with a complaint lodged on his behalf for rights violations.

Findings included:

Review of the Complaint Intake Information for Complaint Number TX 722 contained an email dated 6/4/18 from Patient #1's representative that stated the following:

Patient #1's representative took him to the facility's Emergency Department (ED) for hallucinations and complaint of feeling like he was about to "pass out." Patient #1 had a history of schizophrenia. Patient #1's representative also reported to the facility she had Medical Power of Attorney (MPOA) on behalf of Patient #1 in the event it was necessary. Patient #1's representative indicated that while Patient #1 was in the triage area by the nurse's station; "a nurse [RN-A] came over and harshly injected him with a medication that she refused to tell us and without any warning. She did not give him notice, instead administered it roughly scaring him. He was calmly sitting in a chair not violent or agitated when she gave it." The representative stated she gave report to the ER staff; who was very rude and then was asked to sit back in the ER waiting room because she could not be back in the mental health area. She said she never saw Patient #1 again.

Review of Patient #1's record revealed he signed patient rights and responsibilities on 6/3/18 which indicated the rights to receive as much information about any proposed treatment or procedures as you or your designated representative may need in order to give informed consent or to refuse the course of treatment, and to make treatment decisions that reflect your wishes. Except in emergencies, this information shall include a description of the procedure or treatment, the medically significant risks involved in the treatment, alternate course of treatment or non-treatment and the benefits involved in each and to know the name of the person who will carry out the procedure or treatments.

Review of the Patient's Bill of Rights revised by Texas Department of Human Services (TDHS) dated 12/20/11 that is provided to patient's indicated the patient has the right not to be given medication you don't need or too much medication, including the right to refuse medication. You may be given appropriate medication without your consent if: "Your condition or behavior places you or others in immediate danger."

Review of the facility's Policy Titled Restraint and Seclusion, dated 6/4/18 indicated the definition of Emergency Medication was "a psychoactive medication that is used to treat the signs and symptoms of mental illness in a psychiatric/behavioral emergency, for patients with a primary psychiatric diagnosis and receiving mental health services when other interventions are ineffective or inappropriate."

1.) Review of Patient #1's medical records revealed the following for 6/3/18:

At: 12:31 [PM]- Presented to ED, documenting "Hallucinating."
12:31- Registration Paperwork completed and signed by Patient #1 (Notice of Privacy Practices, Patient Rights and Responsibilities, Patient Admission Agreement and Consent)
12:38 Triage Assessment documented- Decompensated Schizophrenia, Disoriented X 4 (not oriented to person, place, time, and event).
12:38 Individual (Ind.) Observation (Obs.) Note, completed by Technician (Tech) staff A documented, "Alert."
12:45 Ind. Obs. Note documented, "Anxious, Pacing."
12:57 Ind. Obs. Note documented, "Anxious, Pacing."
13:01 Medical Screening Examination (MSE) initiated, by facility provider Family Nurse Practitioner (FNP)- A. Patient is "just babbling answers refuses to answer questions."
13:03 Behavioral Nurse Assessment by Registered Nurse (RN)-A documented "Impaired Cognition."
13:13 ED MSE Screening FNP-A note; I have performed a medical screening evaluation and further evaluation is needed to rule out an Emergency Medical Condition (EMC).
13:14 Laboratory levels ordered (included CMP, CBC, TSH, Alcohol level, Acetaminophen level).
13:15 Ind. Obs. Note documented- "Appears Sleeping." Completed by Tech- A
13:30 Ind. Obs. Note documented- "Appears Sleeping." Completed by Tech-A
13:45 Ind. Obs. Note documented- "Appears Sleeping." Completed by Tech-A
13:58 FNP-A Provider Orders (PO) administration of medications: haloperidol (Haldol) 5 milligrams (mg), diphenhydramine (Benadryl) 50mg, and Lorazepam (Ativan) Intramuscular (IM), Injection, Once, NOW.
16:49 RN-A nursing note documented, Patient resting quietly, medication effective-less agitated.

Continued review of the PO for 13:58 revealed no documentation by the Provider within the PO's or Patient #1's record to indicate why the order for these psychotropic medications were necessary; and other less intrusive forms of treatment that were rejected.

Review of Patient #1's ED medical record revealed Patient #1 nor Patient #1's representative consented to the use of the ordered psychotropic medications administered on 6/3/18 for Haldol and Ativan. There was not a documented discussion with Patient #1 or Patient #1's representative regarding the risks or benefits of receiving psychotropic medication and there was no consent signed or verbal consent noted in medical record for this treatment.

The facility's Director of Pharmacy presented the facility's procedures for "Acute Medication management of Agitated or Aggressive Patients" dated 10/5/17. These procedures where an effort to ensure patient and staff safety, "start with CPI [Crisis Prevention Institute], verbal de-escalation techniques." If immediate medication management is needed; in an effort to prevent self-injury or injury to other patients and/or staff, consider immediate placement into ER room 6. The procedure indicated for Agitation; prescribing/dosing is Zyprexa 10mg IM. For "Violent Patients" prescribing/dosing is Haldol 10mg IM, Benadryl 50mg IM, and Ativan 2mg IM. For Psychosis; prescribing/dosing is Haldol 5mg IM

During an interview with facility administration stated there was not a policy or procedure regarding the use of emergency medications for psychiatric emergencies.

2.) Review of Patient #1's medical records for 6/4/18 revealed at 11:15 AM, PO for Olanzapine (Zyprexa) 10mg tablet, 1tab oral, once.

Further review of Patient #1's record revealed there was not consent obtained for the administration of the psychotropic medication Olanzapine (Zyprexa) 10mg tablet from Patient #1.

During a phone interview on 1/21/19 at 07:30PM with Patient #1's representative stated the following:
She walked Patient #1 back to the triage area. While in the triage area; he was asked questions and was not making much sense and she had to answer the questions for him. She stated then Patient #1 was being taken to a room in the "psych [psychiatric] area" and he was refusing to go into the room; saying he wasn't feeling well and "it was not a psych issue." She stated she was not bringing him in for mental health issues; but for hallucinations; seeing black spots/visual disturbances, not feeling well, looked dehydrated, complaint of chest pain, and feeling like he was going to pass out. She stated he was given an injection of medication during triage "fast and it startled him; he was calm at the time." She was there and witnessed the medication injection. She stated it happened in front of the Nurse's station chair by triage, sitting in the hallway when they injected him because he would not go to the "psych room." She described the room as a door with a lock. They were trying to get him to go back to the room, but he was refusing. She stated that Patient #1 asked why they were putting him in the "psych ward" and why did he go straight back to "mental health" he was not feeling well; and they should have ruled out medical before putting him in the mental health/psych part. She stated Patient #1 became agitated because of the way the hospital staff were "handling everything" by placing him in the "psych holding area." Patient #1's representative stated she questioned the nurse when she went to inject Patient #1 with unknown medications; and asked if she was going to explain to Patient #1 what they were giving him; and she was immediately told to go to the waiting room, that family/friends could not be back in the psych area. Patient #1's representative indicated they gave him unknown mediation without telling him what it was; and she was questioning the nurse because she thought they were not ruling out medical issues first; he was "not feeling good." She stated she tried to explain to the female nurse in the mental health area that Patient #1 had a recent change in meds to Abilify, monthly injection and he doesn't take meds by mouth - only takes an injection. She stated the staff documented he was not taking meds; which was not accurate because he was getting an injection now monthly. Patient #1's representative stated she was told later that Patient #1 had diagnosis of dehydration and hypokalemia and was admitted to the inpatient psychiatric floor.

During a phone interview on 1/21/19 at 08:15PM with RN-A stated the following:
She did not remember Patient #1 specifically but stated when she administered medications she explains to the patient each medication and makes sure the patient is not allergic. RN-A stated that family or friends should not be back in the mental health area; "no family is allowed to be in the psych area."
RN-A indicated that if the patient is asleep or calm and the medication is for a psychiatric behavioral emergency then she wouldn't give the medication if the patient was calm. RN-A indicated if the patient was agitated then you would get an order only if agitated; and if the patient was calm at the time of administration; then you wouldn't give it. RN-A stated psychotropic medication orders can also be for treating psychiatric symptoms; you can give medications that are specifically to treat the symptoms. RN-A stated that emergency medications are a "one time, stat" order and the "B-52" (B-52 is traditionally known for Benadryl-50mg, 5mg haloperidol, and 2mg of lorazepam) is for an emergency treating patients.

During an interview on 1/23/19 at 02:30 PM with FNP-A Provider confirmed he ordered the medications for Patient #1 on 6/3/18 at 13:58 for the administration of haloperidol (Haldol) 5 milligrams (mg), diphenhydramine (Benadryl) 50mg, and Lorazepam (Ativan) IM, Injection, Once, Now. The FNP-A stated he would have ordered those medications due to a "threat;" that Patient #1 was "refusing to cooperate, babbling, and agitated." The FNP-A stated he ordered those medications for his psychiatric condition; Schizophrenia but confirmed he did not obtain informed consent from Patient #1 or his representative. The FNP-A confirmed the order did not include if the medications were ordered as an emergency medication based on behaviors/threat; or to treat the psychiatric symptoms presenting. The FNP-A confirmed the order did not include why the order was necessary for those psychotropic medications; and did not include less intrusive forms of treatment, if any, that the physician had evaluated but rejected. The FNP-A stated the electronic records platform did not have that information included within the medication orders when ordering and he also did not include that information.

Observations were conducted in the facility's Emergency Department on 1/17/19 at 02:00 PM. There were 2 rooms designated specifically for Psychiatric Emergency Patients labeled, "Mental Health Intake" and Mental Health Assessment. There was a nursing station directly across from the 2 rooms with seating in the hallway.

STATE LAW:
Review of the Texas Administrative Code (TAC) Chapter 404, Subchapter E; Rights of Persons receiving Mental Health Services Rule 404.154 (16) The right to be free from unnecessary or excessive medication, which includes the right to give or withhold informed consent to treatment with psychoactive medication, unless the right has been limited by court order or in an emergency.

Further review of the TAC Chapter 414, Subchapter I; Rights and protections of persons receiving mental health services regarding consent to treatment with psychoactive medication- Mental Health Services Rule 414.410:
(b) If a physician issues an order to administer psychoactive medication to a patient without the patient's consent because of a psychiatric emergency, then the physician will document in the patient's clinical record in specific medical or behavioral terms:
1.) why the order is necessary;
2.) other generally accepted, less intrusive forms of treatment, if any, that the physician has evaluated but rejected; and
3.) the reasons those treatments were rejected.

The TAC defines Psychiatric emergency, in part; as a situation in which, in the opinion of the physician, it is immediately necessary to administer medication to a patient to ameliorate the signs and symptoms of that patient's mental illness and to prevent:
(A) imminent probable death or substantial bodily harm to the patient; or
(B) imminent physical or emotional harm to others, because of threats, attempts, or other acts the patient makes or commits.
VIOLATION: PATIENT VISITATION RIGHTS Tag No: A0216
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review the facility failed to ensure their written policies and procedures regarding the visitation rights of patients included those settings with clinically necessary or reasonable restrictions and/or limitations for visitation in which the hospital placed on such rights; and reasons for the clinical restriction or limitations. Specifically,

1.) The facility's visitation policy did not include the limitations or restriction of rights the hospital placed on patients that present to the Emergency Department (ED) for Psychiatric (psych) circumstances and/or Mental Health Assessment; and are placed in the ED designated psych area, Room's 1 and 2 for Mental Health Intake or Mental Health Assessment rooms; which are not permitted the right to have visitors for support based on the clinical setting and safety of others, and

2.) The facility failed to inform Patient #1 and his representative/support person during registration or triage of his restricted/limitation of visitation rights when Patient #1 was then sent to ED psych room 1.

This facility practice was not in accordance with the basic patient rights and facility policies; and affected Patient #1 reviewed with a complaint on his behalf of rights violations.

Findings included:

Review of the Complaint Intake Information for Complaint Number TX 722 contained an email dated 6/4/18 from Patient #1's representative that stated the following:

Patient #1's representative took him to the facility's Emergency Department (ED) for hallucinations and complaint of feeling like he was about to "pass out." Patient #1 had a history of schizophrenia. Patient #1's representative also reported to the facility she had Medical Power of Attorney (MPOA) on behalf of Patient #1 in the event it was necessary. Patient #1's representative indicated that while Patient #1 was in the triage area by the nurse's station; "a nurse [RN-A] came over and harshly injected him with a medication that she refused to tell us and without any warning. She did not give him notice, instead administered it roughly scaring him. He was calmly sitting in a chair not violent or agitated when she gave it." The representative stated she gave report to the ER staff; who was very rude and then was asked to sit back in the ER waiting room because she could not be back in the mental health area. She said she never saw Patient #1 again.

During a phone interview on 1/21/19 at 07:30PM with Patient #1's representative stated the following:
She walked Patient #1 back to the triage area. While in the triage area; he was asked questions and was not making much sense and she had to answer the questions for him. She stated then Patient #1 was being taken to a room in the "psych [psychiatric] area" and he was refusing to go into the room; saying he wasn't feeling well and "it was not a psych issue." She stated she was not bringing him in for mental health issues; but for hallucinations; seeing black spots/visual disturbances, not feeling well, looked dehydrated, complaint of chest pain, and feeling like he was going to pass out. She stated he was given an injection of medication during triage "fast and it startled him; he was calm at the time." She was there and witnessed the medication injection. She stated it happened in front of the Nurse's station chair by triage, sitting in the hallway when they injected him because he would not go to the "psych room." She described the room as a door with a lock. They were trying to get him to go back to the room, but he was refusing. She stated that Patient #1 asked why they were putting him in the "psych ward" and why did he go straight back to "mental health" he was not feeling well; and they should have ruled out medical before putting him in the mental health/psych part. She stated Patient #1 became agitated because of the way the hospital staff were "handling everything" by placing him in the "psych holding area." Patient #1's representative stated she questioned the nurse when she went to inject Patient #1 with unknown medications; and asked if she was going to explain to Patient #1 what they were giving him; and she was immediately told to go to the waiting room, that family/friends could not be back in the psych area. She stated 30 hours had passed and she was not able to get any information about his condition; other than he was "asleep." She stated she called 3 times over 12 hours and they were refusing to give her any information, and she was not able to visit him while in the ED. Patient #1's representative stated she was told later that Patient #1 had diagnosis of dehydration and hypokalemia and was admitted on [DATE].

During an interview on 1/19/19 at 2:05 PM with ED RN/-B from the Mental Health area stated that patients in the intake psych assessment area could not have visitors because of other patients in the room; "there's no real place for visitors."

During a phone interview on 1/21/19 at 08:15PM with Registered Nurse (RN)-A stated that family or friends should not be back in the mental health area; "no family is allowed to be in the psych area."

Review of Patient #1's Emergency Department Tracking System documented Patient #1 was assigned to ED Psych [room] 01 [bed] A.

Observations were conducted in the facility's Emergency Department on 1/17/19 at 02:00 PM. There were 2 rooms designated specifically for Psychiatric Emergency Patients labeled, "Mental Health Intake" and Mental Health Assessment. One room had 3 hospital type beds, and the other room had 4 recliners' that folded out into beds; and a shared restroom that was kept locked for safety. There was a waiting area outside of the rooms in the hallway that is designated for patients waiting medical clearance and/or going through assessments and safety checks. The Door for Intake was locked, and the door for assessment was open. There was a nursing station directly across from the 2 rooms.

Record review of the facility's Patient Visitation Policy, titled Visitors policy for the Hospital, origination date 01/1994, revealed in part, "All visitors will enjoy full and equal visitation privileges consistent with patient preferences. Each patient (or support person, where appropriate) is informed of his/her visitation rights, including any clinical restriction or limitation on such rights."

The policy did not include any restrictions or limitations for patients in the hospital emergency department in the mental health intake/assessments area of the ED; specifically, Rooms #1 and #2.

Review of Patient #1's Patient Rights and Responsibilities signed on 6/3/18 designated the right to have a family member, friend, or other designated individual, who may or may not be your surrogate decision-maker or legally authorized representative, is allowed to be present with you for emotional support during your course of stay unless the individual's presence infringes on others' rights, safety, or is medically or therapeutically contraindicated.

Patient #1's record did not include documentation that the facility informed Patient #1 or his representative/support person of his visitation rights which included clinical restriction and/or limitation of such rights when he was placed in to ED Psych Room 01.