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|NORTHLAKE BEHAVIORAL HEALTH SYSTEM||23515 HIGHWAY 190 MANDEVILLE, LA 70448||April 9, 2019|
|VIOLATION: PATIENT RIGHTS: INFORMED CONSENT||Tag No: A0131|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on record review and interview, the hospital failed to ensure the minor patient's representative/guardian had the right to make informed decisions regarding his/her care. This deficient practice was evidenced by:
1) failure to provide the information needed in order for the patient's representative/guardian to make an "informed" decision to consent for Depo Provera treatment prior to administration of the medication for 1 (#2) of 5 (#1- #5) patients reviewed for consents from a total patient sample of 5; and
2) failure to ensure consents were obtained from the patient's legal guardian for 2 (#3, #5) of 5 (#1- #5) patients reviewed for consents from a total patient sample of 5.
1) Failure to provide the information needed in order for the patient's representative/guardian to make an "informed" decision regarding consent for Depo Provera treatment prior to administration of the medication.
Review of the hospital's policy titled," Medication Consent", Department: Medical Staff, Policy #: CC-2001, revealed in part:
Purpose: This policy details elements of informed consent and the obligations of licensed prescribers in obtaining and documenting informed consent for each psychotherapeutic medication prescribed.
Definitions: Informed Consent: A patient's authorization to undergo a specific medical intervention after discussion of the following elements: 1. Nature and diagnosis of the patient's condition 2. The nature and purpose of a proposed treatment. 3. The risks and benefits of the proposed treatment. 4. Possible treatment alternatives and associated risks and benefits. 5. The risks and benefits of no treatment.
Procedures: B. If the patient is under 18 years of age and not otherwise emancipated, the following procedure will be followed: 1. Patient medication educational information should be reviewed with the minor patient's parent/guardian. 2. The child will be given information about the proposed medication commensurate with his/her education level. 3. The medication consent should then be obtained and documented from the minor's parent or legal guardian and filed into the health record. 4. If written consent cannot be obtained, documentation of oral consent must be made in the patient's record. 5. A physician should not proceed with the use of medication in children without the consent of the parent or guardian. However, if a child is in imminent risk and an emergent situation exists and the parent or guardian cannot be contacted, only then can medication (sufficient to treat the emergency) be given without previous consent. Children's Code only requires that a physician prescribe all medication in writing. 3. All patients, regardless of admission or legal status, must be provided with medication education and information. Indication and rationale for all medication interventions must be documented in the patient's record. 4. In cases of children and adolescents, this policy applies to the guardian.
Review of Patient #2's medical record revealed the patient was a [AGE] year old male with an admission date of [DATE] with diagnoses including Bipolar Disorder, Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, and Sexually Inappropriate Behavior. Further review revealed the patient was in DCFS custody and his assigned case worker/legal guardian was S4CaseWorker. The patient's legal status was Formal Voluntary Admission. The patient was discharged on [DATE].
Review of Patient #2's physician's orders revealed the following orders:
2/7/19 at 9:45 a.m. Place patient on Visual Contact level of observation due to sexual inappropriateness and unpredictable behavior.
2/7/19 at 6:47 p.m.: Transfer patient to Unit "B" on short side due to sexually inappropriate behaviors. Remain on Visual Contact.
Review of Patient #2's Therapy Progress notes revealed the following entry, dated 2/13/19 at 10:57 a.m., by S3Counselor: Therapist also informed that she was asked by S9RN (Charge RN) to discuss a medication for the patient and obtain consent, as S9RN had been unsuccessful in reaching Patient #2's DCFS guardian previously. Therapist reported the name of the medication is called Depo Provera and it is a medication being considered for the patient to help with impulse control. Therapist reported that the medication is an injection with a duration of 90 days and asked if she gives consent. S4CaseWorker stated, "Yes, that is fine.", and therapist reported that she would inform S9RN and MD.
Review of the medication consent forms for Patient #2 revealed the following entry, dated 2/13/19 at 2:00 p.m., by S8LPN: Verbal consent obtained for Depo from patient guardian S4CaseWorker.
Further review of Patient #2's physician's orders revealed the following order dated 2/15/19 at 9:07 a.m. that was documented as telephone order read back from 6MD by S9RN: Depo Provera (a contraceptive injection for women that contains the hormone progesterone) 150 mg IM every 90 days until otherwise notified for ISB (inappropriate sexual behavior) reduction. 1st dose now.
Review of Patient #2's medication administration record revealed on 2/15/19 at 1:00 p.m. S8LPN administered Depo Provera 150 mg via IM injection.
In an interview on 4/9/19 at 11:16 a.m. with S3Counselor, she indicated she had been asked by S9RN - Charge Nurse to get consent for Depo Provera for Patient #2 when she spoke to S4CaseWorker. She reported the charge nurse told her to tell S4CaseWorker the medication was to help the patient to control impulses related to sexually inappropriate behavior, that it was an injectable medication, and it was given every 90 days. S3Counselor reported that was the information she had provided to S4CaseWorker. She confirmed she had not been told about alternative therapies, side effects, health risks, and long-term effects of the drug and therefore had not relayed any information regarding those areas to S4CaseWorker when she obtained the consent. S3Counselor also confirmed she was not allowed to administer the medication as a counselor. S3Counselor indicated she had told S9RN-Charge Nurse she had obtained consent from S4CaseWorker and she thought the charge nurse had then passed it on to S6MD.
In an interview on 4/9/19 at 11:38 a.m. with S8LPN, she reported she had been told by S9RN -Charge Nurse that they had received consent for the Depo Provera injection from S4CaseWorker. S8LPN indicated she had filled in the medication consent form based on information given to her by S9RN. S8LPN confirmed she had not spoken personally to S4CaseWorker to obtain the verbal consent for Depo Provera that she had documented.
In an interview on 4/9/19 at 12:10 p.m. with S6MD, he confirmed Patient #2 was an adolescent male patient he had treated during the patient's hospitalization . He further confirmed the patient had received treatment with Depo Provera in an effort to control the patient's inappropriate sexually acting out behaviors. S6MD indicated treatment of adolescents with Depo Provera to control sexually acting out behaviors was not very common, but it was not unheard of. He indicated this was the first time he had used the Depo Provera treatment in an adolescent male patient in his 15 years of practice. S6MD confirmed he had not personally obtained the consent and had asked S9RN - Charge Nurse to obtain the consent for administration of Depo Provera. S6MD had not been aware that S3Counselor had obtained the consent. S6MD was told the only information relayed in obtaining the consent was the name of the medication, that is was an injectable medication given every 90 days, and that it was being used to control sexual impulses and he agreed the information provided should have been more detailed and should have included potential alternative therapies, health risks, side effects, and long term health effects. S6MD indicated the information would have been better explained if it had been a physician or a nurse obtaining the consent.
The S9RN, the Charge RN referenced in the above interviews was not available for interview.
In an interview on 4/9/19 at 3:43 p.m. with S4CaseWorker she confirmed she had been assigned to Patient #2 and was his guardian. S4CaseWorker reported she had not been called by anyone from the hospital to obtain consent for the Depo Provera injection that had been administered to Patient #2.
2) Failure to ensure consents were obtained from the patient's legal guardian.
Review of Patient #3's medical record revealed he was a [AGE] year old male admitted on [DATE] at 10:38 p.m. with diagnoses of Paranoid Schizophrenia; Major Depressive Disorder; and Mild Intellectual Disabilities. He was discharged on [DATE] at 10:40 a.m. Patient #3 was in DCFS custody.
Further review of the medical record revealed the patient's legal status was PEC (dated 12/19/18 at 1:00 p.m.) due to the patient being a danger to self. The name of the nearest guardian was listed as Patient #3's foster mother.
Additional review of Patient #3's medical record revealed the following consents were obtained as verbal consent by Patient #3's foster mother:
a) "Client Contact Information" sheet dated 12/19/18 at 10:48 p.m indicating the primary contact was the patient's foster mother. The alternate or secondary box was left blank. A notation on the top of the form indicated "DCSF Custody" with the name and phone number for S5CaseWorker and S14Sup.
b) "Your Rights as a Hospital Patient" dated 12/19/18 at 10:49 p.m.
c) "Assignment of Hospital Benefits and Record Release" dated 12/19/18 at 10:50 p.m.
d) "Request for Minor's Voluntary Admission" dated 12/19/18 at 11:05 p.m.
e) "Tuberculin Screening Questionnaire and Consent" dated 12/19/18 at 11:03 p.m.
Review of therapist progress notes revealed the following entries by S15LPC:
a) 12/20/18 at 5:21 p.m. "Therapist placed call to patient's foster mother, only listed contact on the medical record" .....Pt's case worker is S5CaseWorker with Orleans Parish DCFS. "Therapist will follow-up with call to DCFS."
b) 12/21/18 at 11:37 a.m. "Therapist left voice message on S5CaseWorker's office phone, requesting a return call regarding patient".
c) 12/21/18 at 11:58 a.m. "Therapist spoke with S14Sup, DCFS Supervisor, to obtain collateral information. Patient in DCFS custody since August 2014".
In an interview on 4/9/19 at 2:08 p.m. with S7RNSup, she was asked to review Patient #3's medical record to determine the legal guardian. After S7RNSup reviewed the medical record, she stated, "Patient #3's foster parent is the legal guardian". After this surveyor reviewed the medical record with S7RNSup, she verified the correct legal guardian for Patient #3 was S5CaseWorker. She agreed the patient's documented contact information was confusing and also inaccurate.
Review of Patient #5's medical record revealed the patient was a [AGE] year old female, admitted on [DATE], with admission diagnoses of Unspecified Mood Disorder and Major Depressive Disorder. Further review revealed the patient's legal status was PEC due to being a danger to self with suicidal ideations. Additional review revealed Patient #5 was in DCFS custody and her assigned caseworker/guardian was S11CaseWorker.
Review of Patient #5's Client Contact Information sheet dated 2/23/19 at 10:45 a.m. revealed the primary contact was listed as S12GrpHomeStaff (marked by a #2). Further review revealed the box indicating the secondary contacts were as follows: S16GrpHomeDir (marked by a #1) and S11CaseWorker (marked by a #3). The form had been documented as a verbal consent from S12GrpHomeStaff.
Additional review revealed the following forms had been documented as verbal consent per S12GrpHomeStaff on 2/23/19 at 10:45 a.m.:
a)Consent for Treatment;
b)Acknowledgement of receipt of Privacy Practices, Patient Rights and Responsibilities, Receipt of Video Surveillance Protocol, and Receipt of Grievance Procedure; and
c)Rights of Notification- Communication with Parent or Guardian.
Review Patient #5's Medication Change Informed Consent document, dated 2/24/19 at 7:00 p.m., revealed a notation indicating verbal consent had been obtained via phone from S13GrpHomeStaff (not listed as a primary or secondary emergency contact/nearest relative for Patient #5) for the following new PRN medications: Lexapro Titrate, Zyprexa Titrate, and Prazosin Titrate.
In an interview on 4/9/19 at 10:05 a.m. with S2DON, she confirmed a patient's assigned DCFS Case Worker is considered their guardian.
In an interview on 4/9/19 at 11:16 a.m. with S3Counselor, she indicated a patient's assigned DCFS Case Worker and Supervisor are the people who act as the patient's legal guardian if they are in DCFS custody. She reported even if the patient was in a foster home, close to being adopted, legally they are still in the custody of the State and the Case Worker should be contacted as the patient's legal guardian to provide consent, if needed.
In an interview on 4/9/19 at 2:08 p.m. with S7RNSup, she indicated when patients are admitted the intake staff reviews the PEC documentation and the face-sheet in order to identify guardianship. She reported the intake staff calls the patient's family, asks if they are the legal guardian, and asks if there is anyone they want to add to the list to be able to receive patient information. She indicated the staff should know the patient's assigned DCFS worker is the patient's guaridian and is the person to be called in order to obtain consents. S7RNSup reported in any situation staff should verify legal guardianship before obtaining patient consents. She indicated if the patient was in DCFS custody and there was a question about guardianship she would call DCFS first to find out the name of the patient's assigned DCFS Case Worker. She agreed they need to educate the nursing staff regarding verification of guardianship when obtaining consents and not just using the face-sheet and documentation on the primary/secondary contact sheet because that information could be inaccurate.
S7RNSup reviewed Patient #5's medical record, during the interview, and indicated S12GrpHomeStaff was the guardian of Patient #5 based upon the face-sheet and documentation on the primary/secondary contact sheet. Upon further review she noted S11CaseWorker was the DCFS Case Worker for Patient #5 and was listed as contact #3. S7RNSup confirmed S11CaseWorker should have been called to obtain consents for Patient #5. S7RNSup also verified S13GrpHomeStaff was not listed on the face-sheet nor on the primary/secondary contact sheet and was not able to provide consent for Patient #5's new medications. She agreed the patient's documented contact information was confusing and also inaccurate.