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ABILENE BEHAVIORAL HEALTH LLC 4225 WOODS PLACE ABILENE, TX Oct. 24, 2013
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of facility documentation and interviews with facility staff and patient family, the facility failed to follow its own policy of informed consent regarding psychoactive medications and to honor the withdrawal of such consent in 1 of 10 patient records reviewed.

Findings were:

A review of the patient record for Patient #1 revealed she was a [AGE]-year-old female voluntarily admitted to Acadia Abilene on 6/8/13. The history and physical on that date noted the patient's chief complaint: "This patient was seen at Eastern Memorial Hospital where she was characterized as having hallucinations and aggressive behavior." The history of present illness stated in part, "Patient lives in an assisted-living facility. She has been previously diagnosed with [DIAGNOSES REDACTED]..."
Admitting diagnoses included [DIAGNOSES REDACTED]
? Axis I: Psychosis, not otherwise specified.
? Axis II: Deferred.
? Axis III: [DIAGNOSES REDACTED], [DIAGNOSES REDACTED], diabetes. Medical staff to investigate and probably treat other problems.
? Axis IV: Moderately severe.
? Axis V: 20, last year unknown.

The history and physical also stated "Length of stay, 7 to 10 days. DISCHARGE PLAN: stabilize, move to less restrictive setting."

Psychoactive Medication Consents were present in the patient's record for Neurontin, Ativan, Zoloft, and Elavil. The consents had been signed by the daughter of Patient #1 on 6/9/13. Psychoactive Medication Consents for hydroxyzine, Depakote, and Risperdal were likewise signed by the patient's daughter on 6/13/13. Admission documentation revealed the patient took Glipizide for diabetes.

Documentation accompanying Patient #1 from the assisted living facility where she resided showed a check beside "Medical Power of Attorney: [name of Patient #1's daughter]."

The medical record included a "General Durable Power-of-Attorney" executed on March 4, 2004 by Patient #1 naming her daughter Attorney-in-Fact. The form did not specifically mention or overtly grant the power to make medical decisions for Patient #1.

The Admission Assessment for Patient #1 on 6/8/13, stated, in part "...Pt lives at an assisted living facility, dx with [DIAGNOSES REDACTED]. Pt very confused, unable to provide information."

A nursing admission Multidisciplinary Progress Note on 6/8/13 at 6:30 p.m. stated, in part "Pt assisted to sit, pt confused, disoriented. Spot u BS = 134 ..."

A Family/Support System Communications Note on 6/14/13 at 5:00 p.m. stated "Left msg for daughter to discuss d/c planning." Another Note on 6/18/13 at 9:00 a.m. stated "Left msg with daughter." A different phone number was tried for the daughter on 6/21/13 at 2:30 p.m. This note stated, "Spoke with daughter regarding pt. tx, verified previous number and [illegible] number listed on facesheet. Gave daughter update on pt's status and discussed d/c planning." These notes were not made by the patient's case manager, but were entered by the Director of Social Services of the facility, Staff #6. This individual left the employ of the facility approximately three months after the patient's treatment. There is no reference to the daughter's threatening a complaint or having issues with the patient's treatment.

A nursing Multidisciplinary Progress Note on 6/22/13 at 1:00 p.m. stated, in part "Pt daughter called after speaking with her mother. She states her mother is not making any sense and she wants her mother taken off the medications she is on, the new medication, especially the Risperdal. She is ok with mood stabilizer, but feels Risperdal is causing mother's problem ...Informed daughter, I would notified [sic] the Dr., and ask him to call her."

Dose change medication orders in the medical record for Patient, related to Risperdal included, in part:
"6/11/13 2:08p.m ....Risperdal 0.5mg p.o. BID for mood/psychosis ...
6/20/13 09:15a.m ....Change Risperdal to 0.5mg p.o. every HS ...
6/24/13 4:30p.m ....D/C Risperdal ...
6/28/13 1400 ...Restart Risperdal at 0.25mg p.o. BID psychosis ...
7/3/13 1330 ...Increase Risperdal to 0.25mg p.o. q a.m. and 0.5mg p.o. qhs for Psychosis due to Bipolar Disorder ...
7/5/13 1045 ...Increase Risperdal to 0.5mg p.o. q a.m. and 0.75mg p.o. qhs for Psychosis/agitation
7/8/13 1000 ...Change Risperdal schedule to q 1900 (instead of qhs)

Physician's Daily Progress Notes included the following notations:
6/20/13 stated, in part "...Will ? Risperdal to 0.5 q HS only. Stay at current VPA (valproic acid generic for Depakote) dosage ..."
6/24/13 at 9:30 p.m. stated, in part "Dementia @ baseline. ? Aricept vs. Namenda. Will D/C Risperdal @ family request. Monitor closely for any psychosis. Depakote ER is @ excellent level. Keep @ current dosage."
6/25/13 at 10:30 a.m. stated, in part "Some exacerbation of dementia from baseline may be related to depression vs. medication effect. Will further reduce sedation side effects."
6/28/13 at 2:10 p.m. stated, in part "Add Risperdal to address psychosis & delusion that appears to be returning ..."
7/2/13 at 2:30 p.m. stated, in part "Mania & depression both improved. Pt mostly at baseline w/[DIAGNOSES REDACTED]. FSBG very elevated; order IM (internal medicine) consult to evaluate."
7/3/13 at 1:30 p.m. stated, in part "Increase Risperdal slightly at bedtime to improve delusions most like R/T (related to) Bipolar Disorder ..."
7/5/13 at 7:00 p.m. stated, in part "Increase Risperdal further to better stabilize mood and reduce paranoia ..."

Patient #1 was discharged on [DATE]. The Discharge Summary stated, in part "The patient was showing disorientation and confusion, mostly increased during the evening time which indicates sundowning. She cleared up significantly with some reduction in her medications ...We recommended that the patient have a more secured nursing home facility than her current situation due to her fluctuating mental status. However, the daughter and the patient do not agree to this plan and wish to return her back to her less secured standard assisted living facility ...Ammonia level has come down to within normal limits." The final diagnoses were listed as:
o Axis I: Bipolar I disorder, most recent episode manic severe with psychotic features
o Axis II: None.
o Axis III: Multiple medical conditions including hypertension, [DIAGNOSES REDACTED], diabetes and a left heel ulcer in a healing state
o Axis IV: Need for assisted living and lack of social support
o Axis V: GAF: 50.

In a telephone interview with the daughter of Patient #1 on the morning of 10/23/13 at approximately 11:30 a.m., she stated, in part "...My mother had [DIAGNOSES REDACTED] - I understand what that means. Her moods were all over the map. We just needed to get her stabilized. They heard she had dementia and they just drugged her." The daughter stated "...When I read the side effects of Risperdal I couldn't believe it. She's a diabetic. I was appalled. Now she has to have insulin injections - that's what we're dealing with. I told the psychiatrist when I finally got to talk to him, that I was worried about her medications. He didn't have a clue about what was going on - he's a child and adolescent psychiatrist. I told him I didn't want my mother on Risperdal."

"At first when I told the psychiatrist I didn't want my mom on the Risperdal, they decreased the dose and my mother got better. She cleared up some. Then they increased it again. I told the psychiatrist I wanted her off that medication or I was going to come get her."

In a second telephone interview with the daughter of Patient #1 on the morning of 10/25/13 at 9:30a.m., when asked if she also had medical power of attorney for her mother, she stated, "Yes, I do. If I didn't send the right power of attorney to that place, they should have let me know. But I most definitely have both. I've made all her medical decisions for a while now."

In an interview with the psychiatrist treating Patient #1, Staff #3, on the afternoon of 10/23/13 at 2:10 p.m. in the facility conference room, he stated he remembered speaking with the patient's daughter and that there had been disagreement over the patient's medications. He said, "I'm primarily child and adolescent, so I'm supervising [the facility nurse practitioners]. It was a mix of coverage in her [Patient #1's] case ...The daughter ...had some kind of concern about the medications the mother was on and that they were causing the problems ...I believe the daughter wanted her off the Risperdal and the Depakote because she thought they were causing these problems and causing her to have the symptoms ...I continued to use the medications even though the daughter thought she should be off them. As the treating practitioner, I felt that she needed to stay on the medications ..."

In an interview with Patient #1's case manager, Staff #10, on the afternoon of 10/23/13 at approximately 2:25 p.m. in the facility conference room, she was asked if she remembered Patient #1, and if she remembered speaking to the patient's daughter. In response she said, in part "You mean the patient's medical power of attorney? Yes, she said that she wanted to be involved in her [the patient's] treatment and be provided updates. We did that..."

A review of Facility Policy #PR.8, entitled "Patient Consent for Psychoactive Medication - Typical, Emergency, & Court Ordered Procedure" revealed the following, in part:
"Informed Consent: Is defined by the State of Texas as consent given by a person when each of the following conditions have been met: ...
b. Comprehension of information: the person giving consent has been informed of and comprehends the nature, purpose, consequences, risks, benefits of and alternatives to the decision, and the fact that withholding or withdrawal of consent shall not prejudice any future provision of care and service;...
Legally Authorized Representative:... the guardian of the person of an adult; or the person to whom the authority to make health care decisions is delegated under a durable power of attorney for health care ...
Refusal of Administration of Psychoactive Medication: Actions that include the following: a. The patient or legally authorized representative communicates orally, through sign language, or in writing that he/she refuses psychoactive medication; ...
PROCEDURE: ...
2. h. An instruction that the patient may withdraw consent at any time without negative actions on the part of the staff; ...
13. Any time the medication regimen is altered in such a way as to significantly change the risks or benefits for the patient, as determined by the prescribing physician, an explanation of the change will be provided to the patient and/or his/her legally authorized representative. This explanation will include notification of the right to withdraw consent at any time ..."

There is evidence to support the allegation that the facility did not respond to a revocation of consent for psychoactive medication by the individual holding a durable power of attorney for this patient. There was no proof in the patient ' s medical record that the patient's daughter held a medical power of attorney for the patient. However, there appears to have been a general consensus among practitioners that she did have the authority to make medical decisions for her mother. A Durable Power of Attorney was available in the patient chart declaring the daughter as Attorney-In-Fact for her mother. If the patient's daughter held medical power of attorney, the facility did not respond appropriately when the daughter requested her mother be taken off Risperdal. If the Durable Power of Attorney was insufficient to grant the daughter the authority to make medical decisions for her mother, and no other document existed granting her that authority, then medication consents for psychoactive medication were not obtained from the patient by the facility prior to medication administration. In either case, there is evidence to substantiate the allegation that the facility did not follow policy and regulation regarding medication consent.

The above findings were confirmed in an interview with the Chief Executive Officer and other administrative staff the afternoon of 10/24/13 in the facility conference room.