Bringing transparency to federal inspections
Tag No.: A0131
Based on a review of documentation and interview, the facility failed to ensure the right of patients (as allowed under State law) to make informed decisions regarding his or her care.
Finding included:
The Texas Administrative Code Title 25 Part 1 Chapter 441 Subchapter 1 Consent to Treatment With Psychoactive Medication--Mental Health Services RULE §414.403 Definitions states in part,
"The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:
(1) Capacity--A patient's ability to:
(A) understand the nature and consequences of a proposed treatment, including the benefits, risks, and alternatives to the proposed treatment; and
(B) make a decision whether to undergo the proposed treatment...
(3) Informed consent--Consent given by a person or the person's legally authorized representative when each of the following conditions have been met:
(A) Comprehension of information. The person giving the consent has been provided the information outlined in §414.404 of this title (relating to Information Required To Be Given) and has the capacity to give consent; and
(B) Voluntariness. The consent has been given voluntarily."
The Texas Administrative Code Title 25 Part 1 Chapter 441 Subchapter 1 Consent to Treatment With Psychoactive Medication--Mental Health Services RULE §414.405 Documentation of Informed Consent states in part,
"(a) Informed medication consent must be obtained for each individual medication, not by medication class."
Facility based policy entitled, "PSYCHOACTIVE MEDICATION ADMINISTRATION/CONSENT - TEXAS" stated in part,
"POLICY:
Medications are administered to patients by qualified licensed personnel in compliance with
regulatory bodies after verbal informed consent has been provided by the patient ...
l. Only licensed prescribers are allowed to provide orders for medications. All medications require an order which is written on the physician/NPP order form and must contain the
name, dose, time to be administered, route, and indication ...
o Assist physician/NPP on providing information and obtaining signed informed consent form from patient/family members on all newly prescribed psychotropic medications."
Review of 5 patients medical records at the facility in June 2024 revealed the following regarding psychoactive medication consents:
4 of 5 patients had documentation on their psychiatric evaluations stating, "as per today's evaluation patient does not appear to have the capacity to make medical decisions." These 4 patients all signed or gave verbal consents for the administration of psychoactive medications. 2 of the patients listed below had documented dementia.
* Patient #16 signed consents for Trazadone, Gabapentin, and Zoloft, all three medications were administered to the patient.
* Patient #17 signed consent for Depakote, and Risperdal, both medications were administered to the patient.
* Patient #19 verbally consented to Zoloft, Trileptal, Seroquel, Zyprexa, and Aricept, all of these medications were administered to the patient.
* Patient #20 consented to Vistaril, Zyprexa, Celexa, Seroquel, Risperdal, Remeron, Trazadone, Aricept, and Nameda, all of these medications were administered to the patient.
In interview on 06/19/24, staff member #4 [Medical Director], was asked about the use of the phrase "patient does not appear to have the capacity to make medical decisions" which could call into question whether the patients were giving true informed consent. Staff member #4 replied, "Capacity is evaluated by the doctor and can fluctuate. Competency is a legal term by a judge. The capacity at that time can fluctuate." Regarding psychoactive medication consents, staff member #4 stated, "At the time they offer the patient medication, they may have capacity, we cannot have the final judgement. We were trained to use the phrase 'the patients appears', such as having hallucinations, we don't know if they are having them, but it looks like they responding to internal stimuli."
Staff member #4 added, "Capacity can be evaluated by any medical professional; based on their own understanding and if the patient is able to consent and understand risks and benefits and say if they don't want to take medications. They (Patients) go in and out the capacity, it improves over time, by the end they usually are better, but they fluctuate over time."
Staff member #4 verified that the current psychoactive medication consents utilized at the facility do not contain any area to document that the patient appears to have capacity at the time the psychoactive medication consent was obtained by medical staff.
Based on the above information, it cannot be determined that the 4 patients listed above had capacity per the Texas Administrative Code definitions, to give informed consent for psychoactive medications at the time the consents were obtained. The above findings were verified with staff members #1 and 2 on 06/19/24.