HospitalInspections.org

Based on policy and procedure review, clinical record review and interview, it was determined the facility failed to obtain medication consent for 9 (#1 and 3-#10) of 10
(#1- #10) patients who received a new medication or dosage change. The failure to obtained consent did not allow the parent or guardian necessary information in order to exercise their right in making informed decisions regarding their child's care. The failed practice had the potential to affect all minors on census and all minors admitted to the facility. Findings follow:

A. Review of the Clinical Services-Patient Rights/Legal Informed Consent Guidelines Policy #1290 on 10/11/12 at 1130 revealed "It is the policy of Vista Health to obtain informed consent for the following: ... Utilization of psychotropics including antipsychotics for adults and utilization of all medications for minors..."

B. Review of the Clinical Services- Informed Consent for Medications Policy and Procedure #1287 on 10/11/12 at 1140 revealed "When an attending physician or designee determines a patient would benefit from the administration of a medication, (for adults: psychotropics including antipsychotics; for minors: all medications) the attending physician or designee will:

Contact the patient or parent/guardian to discuss:
1. The condition for which the medication is to be used.
2. The reason for taking such medication...
3. The type, dosage, range, frequency of administration and the route...
4. Possible side effects.

Obtain the patient's or legal guardian's signature as indicated on the Medication Consent form prior to administration of the medication. Verbal consent may be obtained by phone in the absence of the legal guardians, physical presence...

C. Review of Patient #1's clinical record revealed the following:
1) Review of the medication consent for the initiation of Guanfacine and Tenex revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of the Physician orders revealed on 08/02/12, discontinue Guanfacine 1 mg twice daily; new order, Guanfacine 1 mg by mouth three times daily. Melatonin 6 mg was discontinued on 09/13/12; new order Melatonin 9 mg by mouth every night.
3) Review of the Medication Administration Record (MAR) revealed Guanfacine 1 mg by mouth three times daily was initiated on 08/02/12 and Melatonin 9 mg by mouth every night (HS) was initiated on 09/13/12.
4) The clinical record lacked evidence of an informed consent to increase Guanfacine on 08/02/12 from 1 mg twice daily to 1 mg three times daily prior to administration; and no evidence of an informed consent to discontinue Melatonin 6 mg on 09/13/12 and increase Melatonin to 9 mg by mouth every night prior to administration.

D. Review of Patient #3's clinical record revealed the following:
1) The medication consent for the initiation of Vyvanse revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed Vyvanse 50 mg was increased to 60 mg on 10/04/12.
3) Review of the MAR revealed Vyvanse 60 mg was initiated on 10/05/12.
4) The clinical record revealed there was no evidence the staff obtained informed consent for the dosage change prior to the administration.

E. Review of Patient #4's clinical record revealed the following:
1) The medication consent for the initiation of Zyprexa 10 mg revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed Zyprexa 10 mg every night was ordered on 10/06/12 and decreased to 7.5 mg on 10/09/12.
3) Review of the MAR revealed Zyprexa 7.5 mg was initiated on 10/09/12.
4) The clinical record lacked evidence of informed consent for the change made to Zyprexa.

F. Review of Patient #5's clinical record revealed the following:
1) The medication consent dated 08/08/12 for the initiation of Trazodone revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed Trazodone was discontinued on 10/02/12.
3) Review of the MAR revealed Trazodone was discontinued on 10/02/12.
4) The clinical record lacked evidence of informed consent for the change made to the Trazodone.

G. Review of Patient #6's clinical record revealed the following:
1) The medication consent dated 10/05/12 for the initiation of Melatonin revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed on 10/08/12, discontinue Melatonin.
3) Review of the MAR revealed Melatonin was discontinued on 10/08/12.
4) The clinical record lacked evidence of informed consent for the change made to Melatonin.

H. Review of Patient #7's clinical record revealed the following:
1) The medication consent dated 10/04/12 for the initiation of Risperdal and Trileptal revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed on 10/08/12, Risperdal 1.5 mg twice daily and Trileptal 150 mg three times a day; on 10/11/12, Risperdal was increased to 2 mg twice daily and Trileptal was increased to 150 mg every a.m. and p.m. and 300 mg every night.
3) Review of the MAR revealed Risperdal and Trileptal was initiated on 10/11/12.
4) The clinical record lacked evidence of informed consent for the increase made to Risperdal and Trileptal.

I. Review of Patient #8's clinical record revealed the following:
1) The medication consent dated 09/20/12 for the initiation of Risperdal and Topamax revealed "I request that I or another legal guardian be notified of dosage changes (including increases/decreases in dosage and intervals or discontinuation of medication) in a reasonable amount of time, usually within 24 hours unless there are extenuating circumstances."
2) Review of Physician's Orders revealed on 09/24/12, Risperdal was increased to 0.5 mg in the a.m. and 1 mg every night (HS) and Topamax was increased to 25 mg in the a.m. and 75 mg in the HS.
3) Review of the MAR revealed Risperdal and Topamax was initiated on 09/25/12.
4) The clinical record lacked evidence of informed consent for the increase made to Risperdal and Topamax.

J. Review of Patient #9's clinical record revealed the following:
1) Review of the Physician Admission Orders dated 09/20/12 revealed Abilify 15 mg every HS.
2) Review of the medication consents revealed there no evidence of consent for Abilify 15 ordered on 09/20/12.
3) Review of the MAR revealed Abilify 15 mg was initiated on 09/20/12.

K. Review of Patient #10's clinical record revealed the following:
1) Review of the Physician Admission Orders dated 10/07/12 revealed medications listed as Prozac 10 mg daily, Melatonin 6 mg every HS, Topamax 25 mg twice daily and Trazodone 150 mg every HS.
2) Review of the medication consents revealed there no evidence of consents for the medications ordered on 10/07/12.

L. The above findings were confirmed at the time of observation by the Director of Nursing.