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Based on staff interview and document review the facility failed to promote and protect each patients ' rights as evidenced by: failing to honor a patient ' s right to refuse medication, failing obtain informed consent for a surgical procedure (A0131), failed to follow the facility seclusion policy (Patient #6) (A0167), and failed to obtain orders for restraint (A0168).
Cross Reference:
§482.13(e)(4)(ii) Restraint and Seclusion Policy
§482.13(e)(5) Restraint and Seclusion Orders
§482.13(b)(2) Informed decisions

Based on staff interview and document review, it was determined the facility failed to honor the patient's right to refuse treatment by administering medication to a patient after the patient refused the medication in one (1) of two (2) medication administration records reviewed in the survey sample (Patient #6). Additionally, the facility failed to obtain informed consent for surgical procedures in two (2) of four (4) procedures reviewed in the survey sample (Patients #'s 1 and 5).

Findings:

The hospital's policy, Patient Rights was reviewed and reads in part:

"...BHS (Behavioral Health) staff maintains patient human rights including the following:...Right to participate in decisions regarding services including..c. Give or not give informed consent to receive psychotropic medications, electroconvulsive therapy, surgical procedures, and/or to participate in human research. Emergency exception. If immediate treatment is required to avoid harm, death, or injury to patient/others."

The medical record for Patient #6 was reviewed on October 16, 2024. The record indicated that the patient was placed in a physical hold by security to administer an intramuscular injection of Zyprexa after the patient disrobed and refused to put clothes on while on the unit and on the unit patio. The medical record indicated the patient refused the medication and had to be held by security in order for it to be administered. The medical record contained documentation that the patient was receiving behavioral health treatment and admitted to the facility on a voluntary basis. The medical record contained no documentation that the patient was a danger to themselves or others, or of an emergent situation requiring the use of Zyprexa after being refused by the patient.

During an interview on October 16, 2024, at 12:06 PM, Staff Member #18 indicated that Patient #6 refused the injection and had to be held down by security for it to be administered. Staff Member #18 stated that the patient disrobed and was unable to be redirected. Staff Member #18 indicated that the nurse, the charge nurse, and the physician collaborated and decided "it was in the patient's best interest" to protect their privacy and safety to administer the medication against the patient's wishes.

An interview was conducted with Staff Member #20 on October 16, 2024 at 2:30 PM. Staff Member #20 indicated that patients could be administered medication even if they refuse in two (2) circumstances. First, if a patient was hospitalized involuntarily, a court order could be obtained to administer "medications over objection" and the patient could have medications injected after refusing them. The second circumstance would be in the event of an emergency when the patient was a danger to self or others, medications could be given to a patient even after the patient refused.

The medical record for Patient #6's did not contain documentation indicating that the circumstances surrounding the administration of Zyprexa after patient refusal constituted an emergency that required immediate treatment to avoid harm, death, or injury to the patient or others as defined in hospital policy.



The hospital's policy, Informed Consent for Treatment was reviewed and reads in part:

"Surgical and Invasive Procedures. Written informed consent will be obtained for all surgical or invasive procedures. An "invasive procedure" is any diagnostic or therapeutic intervention that is not part of routine, general care, and that requires specific informed consent as determined by the Medical Staff....The physician or health care practitioner who is to perform the surgery or procedure will be responsible for obtaining the informed consent of the patent and/or legally authorized representative to a proposed surgical or invasive procedure. When obtaining informed consent, the physician, his/her professional associate or designee will be responsible for discussing:...the recommended treatment or procedure to be preformed...the risks, side effects, and potential hazards of the proposed treatment or procedure. The physician, his/her professional associate or designee and the consenting party will sign, time and date the consent to operation or procedure form."

The medical record for Patient #5 was reviewed on October 16, 2024. The record indicated the patient was admitted to the hospital on January 23, 2024 with worsening NSTEMI (Non-ST-Elevation Myocardial Infarction (Heart Attack). The patient had a cardiac catheterization on January 24, 2024. The medical record contain no documentation that informed consent was obtained from the patient before the procedure.

An interview was conducted with Staff Member #5 on October 16, 2024 at 10:00 AM who confirmed the absence of informed consent for the cardiac catheterization on Patient #5.

The medical record for Patient #1 was reviewed on October 16, 2024. The record indicated the patient underwent a planned procedure to insert endobronchial valves (EBV) via bronchoscopy on January 23, 2024. The informed consent dated and signed by the patient and surgeon on January 23, 2024 describes the procedure in part... "Fiberoptic bronchoscopy with endobronchial and/or transbronchial or transmural needle biopsy; an exam to diagnosis [sic] lung problems that provides a direst view of your breathing passages that may be used to gather tissue samples."

The informed consent failed to describe the planned procedure of implanting the EBVs or what if any additional risks beyond the bronchoscopy could be incurred with insertion of the valves.

Based on staff interview and document review, it was determined the facility placed a patient in seclusion without meeting the seclusion criteria as outlined in hospital policy for (1) of one (1) secluded patient reviewed in the survey sample (Patient #6).

Findings:

The hospital's policy, Seclusion was reviewed and reads in part:

"...Seclusion 1. The involuntary confinement of a patient alone in a room or an area where the patient is physically prevented from leaving. 2. Seclusion may only be used for the management of violent or self-destructive behavior and is limited to the inpatient units on BHS (Behavioral Health)...A comprehensive assessment of the patient must determine that the risks associated with the use of seclusion are outweighed by the risk of not using the procedure."

The medical record for Patient #6 was reviewed on October 16, 2024. The record indicated the patient was "yelling and disrobing out on the milieu and on the patio" the morning of October 10, 2024. Nursing documentation indicated the patient was unable to be redirected and refusing medication. Security staff physically held the patient for three (3) minutes to administer an antipsychotic injection after the patient refused the medication. A few minutes later, the patient walked out of their room and sat on the unit floor unclothed. The patient was then given an injection of lorazepam; haldol, and benadryl. The time the above medications were administered was not clear from nursing staff documentation. The patient was then placed in seclusion from 10:20 AM - 10:55 AM. The physician documented that the "patient was becoming increasingly agitated and required security to be called as patient was attempting to disrobe and is sitting on the floor in the group room area."

An interview was conducted with Staff Member #18 October 16, 2024, at 12:06 PM. Staff Member #18 indicated that on October 10, 2024, Patient #6's day started out "okay" but then the patient was unable to be redirected. The patient was continuously disrobing on the patio and in the milieu. Staff Member #18 indicated that the patient was first given an as needed injection of Zyprexa and then given a one time dose of lorazepam, haldol, and benadryl because the patient continued to disrobe and would not remained clothed. Staff Member #16 indicated that Patient #6 stated they "did not want to hurt us", and the patient did not display any violent behaviors toward the staff. The patient was then taken to the seclusion room because they would not remain clothed. Staff Member #16 confirmed the patient was not displaying any violent or self-destructive behaviors.

Based on staff interview and document review, it was determined the hospital failed to obtain an order for restraint in one (1) of three (3) patient records reviewed in restraint in the survey sample (Patient #6).

Findings:

The hospital's policy, Restraints was reviewed and reads in part:

"...Definitions...a physical or mechanical hold or device used to manage behavior..a physician or psychiatric nurse practitioner order is needed for restraint."

The medical record for Patient #6 was reviewed on October 16, 2024. The record dated October 11, 2024 indicated that the patient was... "disrobing out on the milieu and on the patio. Patient unable to be redirected at this time and was escorted to room. Patient offered medication at this time but refused. Patient continued to be uncooperative and would not stay clothed. Doctor authorized to give IM Zyprexa. Security called and patient was put into a physical hold for three (3) minutes to give medication."

The medical record for Patient #6 contained no documentation of a physician order for the physical hold.

An interview was conducted with Staff Member #2 during record review on October 16, 2024 who confirmed the lack of orders for the physical hold.

An interview was conducted with Staff Member #18 at 12:00 PM on October 16, 2024 who indicated a physician order was required to physically hold a patient for medication administration.

Based on staff interview and document review, it was determined the hospital failed to ensure that the times medications were administered were documented accurately, the response to as needed medications were assessed and documented, and the medication orders were followed in one (1) of two (2) medication administration records reviewed in the survey sample (Patient #6).

Findings:

The hospital's policy, Administration of Medication was reviewed and reads in part:

"...Prior to administration, the administering health care professional discusses any unresolved concerns about the medication with the patient's licensed independent practitioner, prescriber, and/or staff involved with the patients care, treatment and services...Medication administration is documented on the e-Medication Administration (e-MAR) for any unit live on e-MAR....Documentation of the effectiveness of PRN (as needed) medication should be charted on the medical record."

The medical record for Patient #6 was reviewed on October 16, 2024. The record contained documentation that the patient was ordered the following as needed medications: Zyprexa injection 5 mg every 6 hours intramuscularly (IM) for severe agitation. Administration instructions: Maximum of 3 doses of 10 mg administered 2-4 hours apart per 24 hours. Separate from IM lorazepam by at least two hours. The medical record also contained orders dated October 10, 2024 for one time medication administration: haldol injection 7.5 mg once and lorazepam injection 1 mg IM once, and Benadryl injection IM once.

The medication administration record indicated that haldol and lorazepam were administered at 10:09 AM and Benadryl and Zyprexa were administered to the patient at 10:10 AM on October 10, 2024.

Conversely, a nursing progress note dated October 10, 2024 indicated the nurse administered IM Zyprexa and a few minutes later administered Haldol, Benadryl, and Lorazepam together, conflicting with information recorded in the medication administration record.

Staff Member #20 provided documentation that indicated Zyprexa was retrieved form the medication dispensing unit at 9:40 AM and the Haldol, Lorazepam, and Benadryl were not dispensed until 10:00 AM.

An interview was conducted with Staff Member #18 on October 16, 2024 who indicated that the medications should be recorded accurately on the medication administration record. Staff Member #18 recalled administering Zyprexa and then administering lorazepam, haldol, and benadryl together after "some time" had gone by, but was unable to recall how much time elapsed between medication administrations.

Staff Member #20 provided documentation that indicated Zyprexa was retrieved form the medication dispensing unit at 9:40 AM and the Haldol, Lorazepam, and Benadryl were not dispensed until 10:00 AM. However, there was no documentation in the medical record to determine what times these medications were actually administered.

Nursing documentation revealed that at 10:21 AM on October 10, 2024 after being given as needed Zyprexa and the one time dose of haldol, lorazepam, and benadryl that the patient "apologized and laid in bed." The record does not indicate if a therapeutic response to the Zyprexa was attained or whether or not the patient was assessed for the effectiveness of the Zyprexa before being administered additional injected agents to control disrobing behavior. There was also no documentation in the medical record as to why the administration instructions of the Zyprexa not to be given within two hours of IM lorazepam were not followed.