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Tag No.: A0131
Based on a review of facility documentation and staff interviews, the facility failed to ensure that information specific to individual psychoactive medications was provided to each patient so that he/she could make an informed decision regarding treatment in 9 of 10 patient charts reviewed [Patients #1-8 and #10].
Findings were:
A review of patient clinical records revealed the facility Medication Consent forms were titled by class of medication. Side effects of the class of medication were supplied to the patient, but no information regarding side effects of the specific medication was given to the patient. Thus the patient was unable to give informed consent regarding the specific medication.
The clinical record for Patient #1 included a consent form for "Antipsychotics/Mood Stabilizers" medication signed by the patient on 8/31/14. The form included a check-marked box to the left of the word "Seroquel." The list of medications which could be checked on the consent form included 18 possible medications as well as a blank box next to the word "Other." There were two additional medication consent forms in the record of Patient #1 for "Antipsychotics/Mood Stabilizers." One was for Zyprexa and another for Risperdal. For all three medications mentioned, Patient #1 received exactly the same medication information.
As another example, the clinical record for Patient #2 included a consent form for "Antipsychotics/Mood Stabilizers" medication signed by the patient on 9/29/14. The form included a check-marked box to the left of the word "Seroquel." The list of medications which could be checked on the consent form included 18 possible medications as well as a blank box next to the word "Other." Another mediation consent form was for "Anticonvulsants" also signed by Patient #2 on 9/29/14. The form included a check-marked box to the left of the word "Depakote." The list of medications which could be checked on the consent form included 6 possible medications as well as a blank box net to the word "Other." These were only two examples of the medication consents by class that were included in the clinical record of Patient #2.
In an interview with Director of Nursing and the Performance Improvement/Risk Management Director on the afternoon of 12/10/14 in the facility conference room, the Director of Nursing was asked if information regarding side effects specific to each medication was supplied to the patient. She stated, "We have information sheets we give out regarding the type or class of medication. We didn't realize you needed to give information that regarding a specific drug."
Facility Policy entitled Informed Consent for Medication Administration, last revised 10/2012, stated in part: "Before administering psychoactive medication to any patient the treating physician shall explain to the patient and/or the patient's legally authorized representative, the following in a simple, non-technical language (this information may be given by the nurse if the treating physician cannot be present, but the treating physician must confirm the explanation with the patient and/or his legally authorized representative within two (2) working days:...
The side effects of medication including any side effects which are known to frequently occur in most persons, any side effects to which the particular patient may be predisposed..."