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Tag No.: A0131
A-Based on record review and staff interview, the facility failed to ensure that patients received written medication education information on psychoactive medications before administration.
Findings included:
Review of 25 TAC, Chapter 414.404 stated, in part,
(a) The treating physician, registered nurse (RN), licensed vocational nurse (LVN), physician's assistant (PA), or registered pharmacist (RPh) will explain to the patient and to the patient's legally authorized representative, the information in paragraphs (1) - (10) of this subsection in simple, nontechnical language in the person's primary
language, if possible. If the explanation is not provided by the treating physician, he or she must confirm the explanation with the patient and the patient's legally authorized representative, within two working days, not including weekends or legal holidays:
(1) the nature of the patient's mental illness and condition;
(2) the name of the medication and the beneficial effects on the patient's mental illness or condition expected as a result of treatment with that medication;
(3) the probable health and mental health consequences to the patient of not taking the medication, including the occurrence, increase, or reoccurrence of symptoms of mental illness;
(4) the existence of generally accepted alternative forms of treatment, if any, that could reasonably be expected to achieve the same benefits as the medication and why the physician rejects the alternative treatment;
(5) a description of the proposed course of treatment with medication including any necessary evaluations and lab work;
(6) the fact that side effects of varying degrees of severity are a risk of all medication;
(7) the relevant side effects of the medication, including:
(A) any side effects which are known to frequently occur in most persons;
(B) any side effects to which the particular patient may be predisposed; and
(C) the nature and possible occurrence of the potentially irreversible symptoms of tardive
dyskinesia;
(8) the need to advise mental health facility staff immediately if any of these side effects occur;
(9) an instruction that the patient may withdraw consent at any time without negative actions on the part of staff; and
(10) the patient's rights under this section.
Medical record review of patient #1 revealed that psychoactive medications had been administered without documented evidence that medication education was provided to the patient.
Patient #1 was administered the following psychoactive medication on 6/6/17 without providing the patient with medication education: Haloperidol (Haldol) 5mg 2 tabs oral (10 mg), Olanzapine (Zyprexa Zydis) 10 mg oral, and Zolpidem (Ambien) 10 mg oral. The "Consent To Treatment With Psychoactive Medication" form for the above medications stated, "Emergent Medication - Refused to sign 6-6-17/2050." The signature of treating physician to confirm explanation given by PA, Rph, RN or LVN giving explanation was missing.
The above findings were confirmed by the Chief Executive Officer-Pavilion on the afternoon of 9/12/17.
B - Based on a review of documentation, interview, and observation, the facility failed to comply with patient rights by not always obtaining consent to treatment with psychoactive medication, as medications were administered to patients without a signed or executed consent form.
Findings include:
Review of 25 TAC, Chapter 414.405 stated, in part,
(a) Informed medication consent must be obtained for each individual medication, not by medication class.
(b) Informed consent for the administration of each psychoactive medication will be evidenced by a completed copy of the department's form, Consent to Treatment with Psychoactive Medication (MHRS 9-7 form (or other format including the same information) executed by the patient or his or her LAR. A copy Continued From page 41 of which may be obtained by contacting TDMHMR, Office of Policy Development, P.O. Box 12668, Austin, TX 78711-2668.
(1) Any time the medication regimen is altered in a way that would result in a significant change in the risks or benefits for the patient, an explanation of the change will be provided to the patient and the patient's legally authorized representative. The explanation will include notification of the right to withdraw consent at any time.
(2) A new consent will be obtained if a change to a different medication is prescribed.
(c) If the patient or his or her LAR consents to the administration of psychoactive medication but refuses or is unable to execute the form, a witness to the consent will be obtained. The consent and its witnessing will be documented in the patient's medical record or on the MHRS 9-7 form (or other format including the same information) and placed in the medical record. The witness will confirm this consent by signing the consent form.
Facility document entitled "Patient Rights and Responsibilities" guide given to all patients stated in part, "11. Patients have the right to be informed about treatment expectations, progress and outcomes. It is the policy of Pavilion to fully disclose to the patient and family significant other as desired, outcomes of care including errors, adverse occurrences and outcomes that differ significantly from expectations. The attending physician shall keep the patient and family /significant other as desired, informed of treatment expectations, progress and outcomes of care during the course of hospitalization. The physician/designee shall promptly inform the patient and family/significant other as desired, when an error, adverse occurrence or outcome of care that differs significantly from expectations occurs."
Medical records of patient #1 revealed that oral (PO) psychoactive medications had been administered and consent form stated in part, "emergent medication-Refused to sign"
Patient #1 was administered the following psychoactive medication on 6/6/17: Haloperidol (Haldol) 5mg 2 tabs oral (10 mg), Olanzapine (Zyprexa Zydis) 10 mg oral, and Zolpidem (Ambien) 10 mg oral. The consents to the administration of psychoactive medication indicated that the patient refused to sign. No witness signature was observed on the three medications consents listed above.
The above findings were confirmed by the Chief Executive Officer-Pavilion on the afternoon of 9/12/17.