HospitalInspections.org

Based on a review of documentation and clinical records, the facility failed to protect the patient's right to make informed decisions regarding his or her care.

Findings:

The clinical records for 10 patients were reviewed.

A psychoactive medication was signed by patient #1's parent/guardian on 5-29-19. There was no time recorded to indicate the time when the form was signed. The following medications were all listed on the same psychoactive medication consent form:
* Zyprexa (antipsychotic)
* Vistaril (antihistamine)
* Desyrel/Trazodone (anti-depressant)
* Cogentin (anti-cholinergic)

Review of the clinical records for 9 additional patients (patients #2 through #10) revealed that 8 of those 9 records (#2, #3, #4, #6, #7, #8, #9 & #10) contained psychoactive medication consent forms that each listed multiple, psychoactive medications.


The psychoactive medication consent form for patient #1 contained an area addressing antipsychotics, whereby the nurse obtaining informed consent was to address the possibility of tardive dyskinesia and assess the patient for any abnormal, involuntary movements. This area of the consent form was not completed, although patient #1 was prescribed an antipsychotic medication. A review of clinical records for 9 additional patients (patients #2 through #9) revealed that 4 of these 9 patients (patients #3, #6, #7 & #8) were prescribed an antipsychotic medication, but the consent form did not provide documentation that the patient had been informed of the possibility of tardive dyskenia or had been assessed for any abnormal, involuntary movements.


The psychoactive medication consent form for patient #1 contained an area addressing anti-depressants, whereby the nurse obtaining informed consent was to address the risks associated with taking anti-depressants, such as the increased risk of suicide. The individual giving informed consent was to indicate with a check-box whether or not they had been informed that "in patients 24 years of age or younger, antidepressants may increase the risk of suicidal thinking and behavior (suicidality) as compared to placebo." This area of the consent form was not completed, although patient #1 was prescribed an anti-depressant. A review of clinical records for 9 additional patients (patients #2 through #9) revealed that 4 of these 9 patients (patients #3, #6, #7 & #8) were prescribed an antidepressant medication, but the consent form did not provide documentation that the patient had been informed of the possibility of an increased risk of suicidal thinking and behavior (suicidality).


The psychoactive medication consent form for patient #1 contained an area addressing the use of Desyrel/Trazodone, where the individual giving consent was to indicate with a check-box that they had been informed of the risk of prolonged erection if the patient being prescribed the medication was male. This area of the consent form was not completed, although patient #1 was prescribed Desyrel/Trazodone. A review of clinical records for 9 additional patients (patients #2 through #9) revealed that 2 of these 9 patients (patients #3 & #7) were male patients prescribed Desyrel/Trazodone, but the consent form did not provide documentation that the male patient had been informed of the possibility of prolonged erection.


The same psychoactive consent form for patient #1 contained an area where the individual giving consent was to indicate with a check-mark each of the following key points:
* "I have had the opportunity to ask questions and receive answers about the treatment. The information I have relied upon to make the decision to consent to treatment, including full disclosure of each of the above subjects has been fully explained to me."
* "I understand that my consent may be revoked orally or in writing prior to or during the treatment period."
* "I have been informed that written materials regarding the proposed treatments above are available to me upon request."
* "I understand that if I have additional questions about the proposed treatments above, including approximate length of care or alternate medications available for the treatment of my condition, that I may direct these questions to my physician."
None of the check-boxes preceding any of the above statements had been checked to indicate agreement for patient #1's psychactive medication consent form. A review of clinical records for 9 additional patients (patients #2 through #9) revealed that the clinical records for 4 of these 9 patients (patients #3, #6, #7 & #8) consent psychactive medication consents forms that contained no documentation (by indicating with a check mark) that the above key points had been addressed.

Patient #1 received doses of 2 different anti-depressants during his stay; Zoloft and Desyrel/Trazodone.
* Zoloft - patient #1 received doses on 5-30, 5-31, 6-1, 6-2, 6-3 & 6-4-19
* Desyrel/Trazodone - patient #1 received doses on 5-29, 6-2 and 6-3-19

Patient #1 died by suicide the day following his discharge from the facility.

Facility document titled "Basic Rights" states, in part:
"Personal rights
...
14. You have the right to be told about the treatments, medicines, and therapies that your doctor plans to use on you. Your parents or guardian should talk with you to be sure you think the treatments are all right. They have to give the doctor permission to use the treatments, so you should talk to them if you don't like something."

Facility policy 1000.33 titled "Prescribing of Psychoactive Medication" states, in part:
"Policy: To establish standards for prescribing psychoactive medication to patients served in the Cedar Crest Hospital and RTC. This policy is not a clinical guide to prescribing psychoactive medication and is not the only source of information concerning related issues of appropriate practice. Informed consent must be obtained for all psychoactive medication prescriptions (See Policy 1000.34).
...
Procedure:
...
3. Consent and Patient Education: Informed consent for treatment with psychoactive medications will be obtained in accordance with Policy #1000.43(sic) 'Informed Consent for Treatment with Psychoactive Medications'."

Facility policy 1000.34 titled "Informed Consent for Treatment with Psychoactive Medication" states, in part:
"Policy: Informed consent for treatment with psychoactive medication(s) will be obtained from all patients (and/or parent or legally authorized representative - LAR for minors) receiving voluntary or involuntary mental health services.

Except in certain psychiatric emergencies where obtaining informed consent will delay the necessary immediate treatment of the patient, informed consent will be obtained prior to administering psychoactive medication.

Definititions(sic):
...
Informed Consent: consent given by a person or the person's legally authorized representative when each of the following conditions have been met:
* Comprehension of information
* Voluntariness
...
Procedure:
Physician Responsibilities
1. The treating physician, RN [registered nurse], LVN [licensed vocational nurse], PA [physician assistant] or RPh [registered pharmacist] will explain to the patient and his/her legally authorized representative all information contained in the "Consent to Treatment with Psychoactive Medication" Form (See Attachment) in simple, non-technical language in the person's primary language, if possible.
...
3. Informed consent to medication is required to be obtained by individual medication, and not by medication class.
4. Documentation of informed consent by individual psychoactive medication (not medication class) will be evidenced by appropriate completion of the "Consent to Treatment with Psychoactive Medication" Form.
...
Nursing Responsibilities
8. The Nurse on the unit will discuss prescribed medications with the patient at the time of admission or at the time a new psychotropic medication is ordered:
8.1 The discussion will include an explanation of all the components on the 'Consent to Treatment with Psychoactive Medication' Form.
8.1.1 The discussion will be based on approved written medication education/information sheets.
8.1.2 Copies of the medication education sheet(s) will be given to the parent and/or parent/LAR.
8.2 the original medication Education and Consent form is placed in the medical record once appropriately completed and signed."

The above was confirmed in an interview with the CEO, CNO and Director of RM/PI on the afternoon of 11-12-19.

Based on a review of documentation and an interview with staff, the facility failed to make sure the medical records were accurately written, promptly completed, properly filed and retained, and accessible.

Findings were:

A review of the clinical record for patient #1 revealed the following:

Admission orders were given by the tele-medicine psychiatrist and included:
* Lab work to include CBC (complete blood count) with differential, CMP (comprehensive metabolic panel), TSH (thyroid stimulating hormone) with reflex to Free T3/Free T4, urinalysis with culture & sensitivity (if indicated) and a lipid panel.

The clinical record for patient #1 contained no results of the lab work ordered upon admission. In an interview with staff #2 on 11-12-19, staff #2 was asked to review the clinical record to see if he could locate any lab results. Staff #2 was unable to locate any lab results for the lab work ordered, either in the clinical record or with the medical record department.

The above was confirmed in an interview with the CEO, CNO and Direction of RM/PI on the afternoon of 11-12-19.