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3019 FALSTAFF RD

RALEIGH, NC 27610

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on hospital policy and procedure review, hospital document review, medical record review and physician and staff interviews, the hospital staff failed to obtain informed consent for psychotropic medications for 3 of 12 patients sampled (Patient #1, #2, #3).

Review of the "Informed Consent for Psychotropic Medications" revised, 09/2012 revealed "Policy" ..."All patients receiving psychotropic medication will be provided information by a physician and will give informed consent before such medications are administered...Definition of terms as follows: Psychotropic medication means any medication customarily prescribed for the treatment of symptoms of severe mental and emotional disorders...Procedure...article 2. The physician shall complete the written consent form (Informed Consent for Psychotropic Medication)."

Review of the "Patient Authorization and Treatment Consent for Medication" revealed "I, (Patient/guardian name), understand that due to my/my child's diagnosis, which is (diagnosis) my/my child physician, Dr. (physician's name) has recommended that I/he/she receive the following medication(s): Medications: (name of medications)...Understanding of all the above, I hereby provide my informed consent to Dr.(name of physician) to provide (name of medication) to me/my child...Signature of Witness...Date and Time."

1. Open medical record review of Patient #1 revealed a 17 year old admitted by IVC (involuntary commitment) on 04/01/2013 due to self injurious behavior, increased agitation, and depression, at Respite pending transfer to a pediatric residential treatment facility. Further record review revealed a past history of bipolar disorder since age 8 with two prior suicide attempts by "overdose and running into traffic" and self injurious behavior. Medical record review revealed the "initial plan to assess the patient's treatment needs while admitted to the adolescent psychiatric unit where we shall monitor safety and administer therapy and adjust medications to alleviate the current exacerbation of mood symptoms until the patient is safe and ready to transfer to the PRTF (pediatric residential treatment facility." Further record review revealed the patient is currently receiving Depakote (mood stabilizer) dosing continues to be adjusted for therapeutic effect, Lexapro (anti-depressant) 20 mg (milligrams) po (orally) daily, and hydroxyzine (has anti-psychotic properties) 50 mg (milligrams) po (orally) daily. Review of the (Name of Hospital) "Informed Consent of Psychotropic Medications" form for Patient #1 contained no signature to authorize the administration of Psychotropic medications to Patient #1.

Interview on 05/31/2013 at 1040 with Physician #1 revealed "Consent for psychotropic drug administration should be obtained immediately upon admission" and if not obtained at that time the consent should be obtained as soon as the patient gains clarity. Further interview revealed "I would expect the consent for psychotropic medications to be obtained within 3 days and if not I should be made aware the consent has not been obtained and why."

Interview on 05/31/2013 at 1045 with the Director of Nursing revealed "The consent for psychotropic medication administration should be obtained upon admission and if not should be obtained subsequently." Interview confirmed the hospital staff did not follow hospital policy to obtain consent for psychotropic medication administration. Interview confirmed there was no signature on the hospital "Informed Consent of Psychotropic Medications" form for Patient #1.

Interview on 05/31/2013 at 1045 with the Assistant Director of Nursing revealed the consent for psychotropic drug administration should be obtained "as soon as possible after the physician deems the patient competent to sign the consent."

Interview on 05/31/2013 at 0924 with the Quality Director revealed "It is my expectation for consent to administer psychotropic medications to be obtained once the patient's condition is stable and psychosis has resolved."

2. Open medical record review of Patient #2 revealed a 37 year old admitted IVC (involuntary committed) on 05/08/2013 after increased "episodes of going off on others for no reason and being destructive in the house by setting fire to the bathroom."

Review of the (Name of Hospital) "Informed Consent of Psychotropic Medications" form revealed Names of Medications: Haldol (anti-psychotic medication), Ativan (anti-anxiety medication) , Cogentin (anti-psychotic medication)..., physician signature, and date of 05/17/2013 at 0805 with no evidence of Patient #2's signature authorizing consent for the administration of psychotropic medications.

Interview on 05/31/2013 at 0930 with Physician #2 revealed "We may give the first dose of the psychotropic medication, one dose, to stabilize the patient or prevent withdrawal from a current medication, but by the second day the physician should obtain informed consent for the psychotic medications."

Interview on 05/31/2013 at 1040 with physician #1 revealed "I was unaware consent for psychotropic medication administration had not been obtained for Patient #2." Interview further revealed Physician #1 said Patient #2 had been "clear and oriented enough to give informed consent for psychotropic medications for a while." Interview revealed Physician #1 stated his signature on the "Informed Consent of Psychotropic Medications" form indicated the patient's readiness to sign the consent form. Interview confirmed the hospital staff did not follow hospital policy to obtain consent for psychotropic drug administration.

Interview on 05/31/2013 at 1043 with the Director of Nursing revealed "The consent for psychotropic medication administration should be obtained upon admission and if not should be obtained subsequently." Interview confirmed the hospital staff did not follow hospital policy to obtain consent for psychotropic medication administration.

Interview on 05/31/2013 at 1045 with the Assistant Director of Nursing revealed the consent for psychotropic drug administration should be obtained "as soon as possible after the physician deems the patient competent to sign the consent."

Interview on 05/31/2013 at 0924 with the Quality Director revealed "It is my expectation for the consent to administer psychotropic medications to be obtained once the patient's condition is stable and psychosis has resolved."


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3. Closed medical record review on 05/30/2013 of Patient #3 revealed a 29 year old female admitted by IVC (involuntary commitment) on 05/04/2013 for depression. Review of the Physician's Discharge Summary dated 05/13/2013 revealed Summary of Hospital Course: "...Leaxapro (anitdepressant) was gradually tapered and discontinued. The patient was placed on Risperidone (antipsychotic)...This eventually consolidated to 0.75mg at bedtime. She was started on Lithobid (anitdepressant) 300 mg t.i.d. (three times a day)...Condition on discharge: Improvement of affect, improved mood. She was not suicidal. Not homicidal. Not delusional. Concentration was normal. Judgement and insight were regard as fair. She is oriented X 4...While chronic issues persisted, the patient did not require further acute inpatient care ...the patient indicated that she was feeling significantly better, and was ready for discharge..." Continued review of the medical record revealed the patient was discharged to home on 05/13/2013.

Review of the (Name of Hospital) "Informed Consent of Psychotropic Medications" form for Patient #1 revealed no consent for authorizing the administration of psychotropic drugs.

Interview on 05/31/2013 at 0930 with Physician #2 revealed "we may give the first dose of the psychotrophic medication, one dose, to stabilize the patient or prevent withdrawal from a current medication, but by the second day the physician should obtain informed consent for the psychotrophic medications."

Interview on 05/31/2013 at 1040 with Physician #1 revealed "Consent for psychotropic drug administration should be obtained immediately upon admission" and if not obtained at that time the consent should be obtained as soon as the patient gains clarity. Further interview revealed "I would expect the consent for psychotropic medications to be obtained within 3 days and if not I should be made aware the consent has not been obtained and why."

Interview on 05/31/2013 at 1045 with the Assistant Director of Nursing revealed the consent for psychotropic drug administration should be obtained "as soon as possible after the physician deems the patient competent to sign the consent." Continued interview confirmed there was no consent found in the record for patient #3.

Interview on 05/31/2013 at 0924 with the Quality Director revealed "It is my expectation for consent to administer psychotropic medications to be obtained once the patient's condition is stable and psychosis has resolved."

NC00088892, NC000889307, NC00088534

PATIENT VISITATION RIGHTS

Tag No.: A0215

Based on review of hospital policy, review of documents, staff interviews, and medical record review the hospital staff failed to allow clinically appropriate visitation for 1 of 1 patients (Patient #3).

The findings include:

Review of the hospital's policy and procedure "Patient Rights" dated 11/12 revealed "...13. The patient has the right to consent to receive the visitors the patient designates, including, but not limited to, spouse ...another family member, or a friend ...All visitors shall enjoy full and equal visitation privileges consistent with the patient's preferences. The hospital may impose clinically appropriate limitations on patient visitation when visitation would interfere with the patient's care, whether the reason for limiting or restricting visitation is infection control, disruptive behavior of visitors, or the patient's or patient's roommate's need for rest or privacy."

Review of the hospital's policy and procedure "Visitation Guidelines" dated 8/12 revealed "PURPOSE: to establish age limits for visitors, time of visiting hours and days of the week when visiting is allowed ...3. Visiting hours for 1-West (Chemical Dependency) are as follows: a. Saturday Family Group 10:00am - 11:30am/ open visiting 11:30am - 1:30pm; b. Sunday open visiting 11:30am - 1:30pm ...4. Visiting hours for 1-East (Adult Psych) are as follows: a. Tuesday and Thursday open visiting 6:30pm - 8:00pm; b. Saturday Family Group 1:00pm - 2:00pm/open visiting 2:00pm - 4:00pm; c. Sunday open visiting 1:00pm - 3:00pm

1. Closed medical record review on 05/30/2013 of Patient #3 revealed a 29 year old female from Burma admitted by IVC (involuntary commitment) on 05/04/2013 for depression. Review of the physician's History and Physical dated 05/04/2013 revealed "...a 29 year old married female from Burmese, who located to the United States about 5 years ago. She is married and lives with her husband in Durham. She was referred by (name of facility) because of worsening depression, isolation, and confusion ...The patient lives with her husband and 3 children. She has social support systems..." Continued review of the medical record revealed the patient was admitted to the 1-West (substance abuse) unit on 05/04/2013 and remained on this unit until discharge from the facility on 05/13/2013. Continued medical record review revealed physician's orders dated 05/09/2013 (5 days after admission) at 1530 for a telephone order written by the RN#1 (registered nurse) "Family may visit tonight on unit". Continued review of the orders revealed an order written by the physician on 05/12/2013 (8 days after admission) at 0910 "Husband may visit outside visiting hours."

Interview on 05/30/2013 at 1441 with the named patient's social worker (SW) revealed "this patient had no substance abuse problems but she was admitted to the substance abuse unit because there were no beds on the other unit ...the visiting hours on the substance abuse unit are restricted to weekend visiting and the unit this patient should have been on, if there had been a bed, would have more liberal visiting hours for Tuesday and Thursday as well as the weekend ...The substance abuse unit has only Saturday and Sunday visiting days ...even if the patient is not admitted for substance abuse they have to follow the same visiting hours unless the physician will write an order for more liberal visitation ...she was admitted on a Saturday and when I saw her on Monday (05/06/2013) (2 days after admission) she was wanting her husband to visit. I recall telling her nurse (name) that she (the patient) wanted to see her family ...the nurse usually gets an order from the physician..."

Interview on 05/30/2013 at 1602 with the admissions office supervisor revealed "Unit 1-West is our dual diagnosis unit typically psychiatric diagnosis and substance abuse, mostly substance abuse ...I think the substance abuse unit has scheduled visiting hours on Saturday and Sunday ...this patient would have been admitted to 1-East (psychiatric unit) but most likely this unit (1- East) was full and we placed her on 1-west (substance abuse) ..."

Interview on 05/31/2013 at 0840 with the administrative staff revealed "if a non-substance abuse patient is admitted to the substance abuse unit generally if we get a request or call from the family wanting to visit outside the posted visiting hours we notify the physician to get an order ...I see on the chart the nurse wrote a one time visit order on 05/09 (Thursday) (5 days after admission and 3 days after requested visitation on 05/06/2013)) and then there is an open visiting order on 05/12 (8 days after admission) ...The order on 05/09 should have been written like the order on 05/12 so the husband could visit his wife during the week on Tuesdays and Thursdays as well as the Saturday and Sunday visitation ...it's not clinically necessary to restrict a non substance abuse patients' visiting hours ...we should try to get the more liberal visiting hours like 1-East for these patients ...this patient's visiting hours were restricted because of the unit she was on not based on her clinical condition." Interview confirmed the patient's visitation hours were restricted without a clinical reason.

Interview on 05/31/2013 at 0923 with the administrative staff revealed "patients admitted to the substance abuse unit with other diagnosis should have visiting hours that are based upon clinical diagnosis instead of unit restricted hours. This patient should have been allowed to visit with her family because she was placed on this unit because no other bed was available. Based upon the clinical diagnosis the order to see her family should have been obtained prior to the dates in the chart. Based upon her clinical diagnosis she should have had the same visiting hours as the patient's on 1 East and I do not see that happening until 05/12/2013." (8 days after admission). Interview confirmed the patient's visitation restrictions were not clinically based.

The physician for the patient was not available for interview.

NC00088892, NC00088534