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Tag No.: A0131
Based on interviews, record and policy review, the facility failed to ensure that prescribers attempted to explain the risks and benefits and provide a written summary of common adverse effects prior to administering psychotropic medications as specified by facility policy for 3 of 3 patients (#9, 13, #14). Findings include:
1. Patient #9 was admitted 6/21/11. On that date Psychiatrist #5 stated: "I am going to offer her Risperdal 1 mg. twice a day...we will get a court order for treatment."
2. On 7/26/11 and 7/28/11, review of patient #9's clinical record revealed no documentation to show that she was informed of possible benefits or side effects of Risperdal, in written or verbal form, prior to her death. After the patient's death, a form titled, "Psychiatric Discharge" makes a general statement that: "She had refused to sign consent for the Risperdal but this medication was explained to her." No specifics on whom explained the medication when or why the patient did not sign the consent was noted.
3. A form titled, "Voluntary Patient Consent to Receive Psychotropic Medication" listing Risperdal was blank in patient #9's record, including the sections for offering the patient explanation of the drug and its side effects and providing written or verbal information. There is no notation regarding the patient's refusal to sign the form or receive information.
4. The Medication Administration Record showed administration of Risperdal to patient #9 on 7/23/11 and 7/25/11. (There was no restraint involved in either of these medication administration events.)
5. The above findings were confirmed by the Director of Patient Care Services on 7/28/11 at approximately 1500 hours.
6. On 7/28/11 at approximately 1530 hours Nurse #1 was asked to explain the facility's policy and procedures for providing psychotropic drug information to patients and obtaining consent. Nurse #1 stated that the signing of the consent to receive a psychotropic medication may not be done at the same time that the medication's effects and side effects are explained to the patient, according to her understanding of facility policy.
7. The facility's only consent form for psychotropic medications is titled "Voluntary Patient Consent to Receive Psychotropic Medication." It states: "I have offered the patient an opportunity for further explanation of this drug and its side effects. It has check off boxes for provision of written and verbal information. Per interview with the Quality Manager on 7/28/11 at approximately 1400 hours, it is facility practice to offer psychotropic medications to both voluntary and involuntary patients and provide information on risks and benefits and obtain patient consents prior to administration.
8. On 7/28/11 at approximately 1530 hours, review of patient #13 and patient #14's clinical records revealed that psychotropic medications had been administered without completion of the "Voluntary Patient Consent to Receive Psychotropic Medication." These findings were verified by the Director of Patient Care Services.
Tag No.: A0392
Based on interview and record review the facility failed to ensure that patient #9 was not neglected by providing close monitoring while starting a new psychotropic medication and failing to report an abnormal pulse reading to the physician prior to administration. Findings include:
(1) On 7/25/11 at approximately 1440 hours patient #9 was found to be unresponsive and subsequently pronounced dead.
(2) On 7/25/11 at 0700 patient #9's pulse was documented as 46, in the sub-normal range. (The Mayoclinic.com, a normal heart rate is 60-100 beats per minute.) The patient's previous pulse readings, from 6/21/11-6/23/11, ranged from 90-95 so a reading of 45 represented a significant drop.
(3) On 7/25/11, at 0900 hours, patient #9 received her second dose of Risperdal. There was no documentation that a physician was notified of the patient's drop in pulse rate prior to administering Risperdal on 7/25/11. The facility did not have policies and procedures in place specifying when a physician should be notified of a change in vital signs. These findings were verified by the Director of Patient Care Services on 7/28/11 at approximately 1500 hours.
(4) On 7/25/11 other patients on the unit demonstrated the effects of possible drug ingestion from non-prescription drugs. Following an internal investigation it was determined that patient #9's roommate may have supplied Klonopin, a Central Nervous System depressant, to other patients on the unit. At this time it is unknown whether patient #9 had this medication in her system at the time of death. Autopsy results are pending.