Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that two residents and/or their representatives were properly informed and provided with documented consent regarding the use of psychotropic medications. Review of the Psychoactive Medication Therapy Informed Consent Form logbook revealed that consent forms for multiple psychotropic medications, including Invega, Haldol, Abilify, lithium, Ativan, trazodone, and Zyprexa, lacked signatures from the appropriate residents or their guardians. Specifically, consent forms for one resident were missing the resident's signature, while consent forms for another resident were missing the guardian's signature. Additionally, the electronic medical records for both residents did not contain documentation of informed consent for these medications. Interviews with facility staff indicated confusion and lack of clarity regarding the process for obtaining and documenting informed consent. Social Services staff reported being newly assigned to the task and were unaware of the requirement for guardian signatures when applicable. Administrative nursing staff acknowledged the missing signatures and described a practice of signing consent forms in advance or delegating the task to others, which resulted in incomplete documentation. The facility's policy required discussion of risks and benefits with residents or responsible parties, but this was not consistently documented or followed.