Failure to Obtain Informed Consent for Psychoactive Medication
Summary
The facility failed to obtain informed consent for the administration of Ativan (lorazepam), a psychoactive medication, for a resident with severe cognitive impairment. The resident was admitted with diagnoses including dementia, anxiety disorder, and psychosis, and was determined by a physician to lack the capacity to understand and make decisions. The resident's Minimum Data Set assessment confirmed severe cognitive impairment and indicated the use of antianxiety medication. A physician order was present for Ativan to be administered as needed for inconsolable yelling. However, upon review of the resident's medical record, the Social Services Director was unable to locate a signed informed consent for the use of Ativan. Further investigation confirmed that the resident's responsible party had not provided documented consent for the medication. Interviews with facility staff, including the Director of Nursing, confirmed that facility policy requires informed consent to be obtained and documented prior to administering psychoactive medications, especially when the resident is unable to provide consent. The policy specifies that consent must be obtained from the resident's representative if the resident is not capable. Despite this, there was no evidence that informed consent was obtained or documented for the use of Ativan in this case.
Plan Of Correction
Corrective Action: Resident 77's informed consent for use of Ativan was obtained and verified by a licensed nurse from RP1 on 4/16/25. Other Residents Affected Identification: All residents taking Psychotropic Medications are at risk for deficient practice. On 4/17/25, all residents on Psychotropic Medications were reviewed for completion of Informed Consents. No other residents were affected by the deficient practice. Measures and Systemic Changes: On 04/17/2025, the DON initiated in-service to Licensed Nurses and SSD to ensure that consents are obtained prior to giving psychotropic medication. Upon admission, any residents receiving psychotropic medications shall be audited by the Medical Records to verify if the informed consent has been completed. During weekly Behavior Management Meetings, the IDT shall monitor and audit the compliance of informed consent verification, and the copy of the audit will be provided to the administrator, DON, and the IDT. Findings on the audit will be addressed by the SSD and IDT immediately. MONITORING PERFORMANCE: Medical Records will audit psychotropic medications once weekly for 3 months or until substantial compliance is achieved, reporting any deficits to the DON for follow-up. Issues and trends, along with a copy of the report, will be forwarded to the DON/Administrator for further review and immediate corrective action as necessary. The DON/Designee will present the results to the QA Committee for monthly review for the next 3 months and quarterly thereafter or until substantial compliance is achieved. Upon admission, any residents receiving psychotropic medications shall be audited by the Medical Records to verify if the informed consent has been completed. During weekly Behavior Management Meetings, the IDT shall monitor and audit the compliance of informed consent verification, and the copy of the audit will be provided to the administrator, DON, and the IDT. Findings on the audit will be addressed by the SSD and IDT immediately. MONITORING PERFORMANCE: Medical Records will audit psychotropic medications once weekly for 3 months or until substantial compliance is achieved, reporting any deficits to the DON for follow-up. Issues and trends, along with a copy of the report, will be forwarded to the DON/Administrator for further review and immediate corrective action as necessary. The DON/Designee will present the results to the QA Committee for monthly review for the next 3 months and quarterly thereafter or until substantial compliance is achieved.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with dementia, glaucoma, and cataracts had long-standing scheduled orders for Brimonidine and Latanoprost eye drops, consistent with an ophthalmology visit summary and a care plan goal to prevent negative consequences of vision loss. The physician orders were later changed from scheduled to PRN administration, but review of the EMR and nursing notes showed no documentation that the resident’s representative was informed of this change. In an interview, the representative stated she was upset about not being notified, and a regional nurse consultant confirmed there was no evidence that either the resident or the representative had been informed, resulting in a cited deficiency related to failure to ensure the resident and representative were fully informed about changes in treatment.
Two residents with cognitive and behavioral disturbances received IM Haldol for acute episodes of agitation, paranoia, and physical aggression after refusing PO medications and nonpharmacological interventions were ineffective. In both cases, providers ordered one-time IM Haldol doses on multiple occasions, and family members were notified of the orders and involved in communication about the residents’ behaviors and treatment. One resident’s family later filed a grievance regarding IM Haldol use, and informed consent was documented only for Trazodone. Facility leadership confirmed there was no documentation that the risks or side effects of Haldol were discussed with either resident or their responsible parties prior to administration.
A resident with multiple medical conditions, including metabolic encephalopathy and Generalized Anxiety Disorder, was started on BuSpar 10 mg BID following a psychiatric evaluation, but the responsible party was not properly informed of this new psychotropic medication order. Nursing notes lacked documentation of the psychiatrist’s assessment or any notification to the responsible party, even though the MAR showed the resident received two doses. The responsible party later reported learning of the medication only during an in-person visit and expressed concern due to the resident’s prior adverse reactions to psychotropic drugs. Conflicting accounts from two ADONs about when and how the responsible party was notified, combined with the absence of required documentation, demonstrated noncompliance with the facility’s policy on notifying and documenting changes in a resident’s condition or treatment.
A resident with multiple medical and psychiatric diagnoses, who was cognitively intact, repeatedly requested to be transferred to the hospital during episodes of acute symptoms such as chest pain, low blood sugar, and gastrointestinal distress. Despite these requests, nursing staff deferred to the PCP, who typically ordered in-house treatment and monitoring rather than approving a hospital transfer. Staff interviews confirmed that the resident's right to self-determination and participation in care decisions was not honored, in violation of facility policy and resident rights regulations.
A resident with severe cognitive impairment sustained a skin tear during a mechanical lift transfer, but the responsible party was not notified of the incident or new wound care orders. Staff interviews revealed confusion about notification responsibilities, and the facility's policy requiring timely notification of the resident's representative was not followed.
A resident's court-appointed guardian was not notified about the initiation or charges for therapy services, nor was informed consent obtained for dental services after the resident switched to private pay. The resident, who had significant cognitive and medical issues, received multiple therapy and dental services without proper guardian notification or updated consent documentation.
Failure to Notify Resident Representative of Change in Ophthalmic Medications
Penalty
Summary
The deficiency involves the facility’s failure to notify a resident’s representative of a change in the resident’s ophthalmic medication regimen. The resident had multiple diagnoses including cognitive communication deficit, aphasia, dementia, bilateral open-angle glaucoma, bilateral age-related cataracts, and vitreous degeneration of the right eye. The care plan, initiated in 2018, identified the resident as being at risk for decreased visual function due to cataracts, with goals to prevent negative consequences of vision loss and approaches that included administering medications as ordered and obtaining ophthalmology consultations as needed. A quarterly MDS assessment showed a Brief Interview for Mental Status score of 06, indicating severe cognitive impairment. The resident had long-standing physician orders for Brimonidine eye drops twice daily and Latanoprost eye drops once daily, consistent with an ophthalmology after-visit summary that specified Brimonidine 0.2% twice daily and Latanoprost 0.005% at bedtime. On a later date, the physician orders for both Brimonidine and Latanoprost were changed from scheduled administrations to as-needed (PRN) medications for glaucoma. Review of the nursing progress notes for the period surrounding this change showed no documentation that the resident’s representative was notified of this alteration in treatment. During an interview, the resident’s representative reported being upset that she had not been informed when the eye drops were changed from scheduled to PRN. A Regional Nurse Consultant confirmed there was no evidence that either the resident or the resident’s representative had been notified of the medication change. This lack of notification formed the basis of the cited deficiency, which was investigated under two complaint numbers.
Lack of Informed Consent for IM Haldol Use in Two Residents
Penalty
Summary
The deficiency involves the facility’s failure to ensure residents and/or their responsible parties were informed of the risks of antipsychotic (Haldol) use prior to administration. For one resident with muscle wasting, difficulty walking, chronic venous hypertension with ulcers, CHF, and moderate cognitive impairment, behavior notes documented episodes of severe agitation, paranoia, physical and verbal aggression, refusal of oral medications, and rejection of care. In response, an NP ordered a one-time IM dose of Haldol, and later that same day a physician ordered a second one-time IM dose after the resident again became severely agitated and refused oral medications, including PRN Ativan. The resident’s son was notified of the orders and was present during some of the episodes, but there was no documentation that the risks of Haldol use were discussed with either the resident or her son. Subsequent documentation for this same resident showed continued severe paranoia, delusions, refusal of medications and care, and combative behavior, leading to additional IM Haldol administrations. Notes indicated that attempts had been made to initiate oral antipsychotic medication but were unsuccessful due to refusals, and that non-pharmacological interventions were not effective. The facility informed the family that there were no other interventions staff could initiate in the nursing setting and that the resident would benefit from transfer to a geriatric psych facility. Despite multiple Haldol injections and ongoing communication with the family about the resident’s condition and care needs, the corporate nurse later verified there was no documentation that the risks of Haldol had been discussed with the resident or her son. For a second resident with diagnoses including a left humerus fracture, metabolic encephalopathy, abnormal gait and mobility, history of falls, heart disease, and parkinsonism, the care plan identified risk for complications related to psychoactive medication use. The resident had intact cognition and required assistance with ADLs. Behavior notes documented episodes of paranoia, belligerence, attempts to crawl out of bed, physical aggression toward staff, refusal of PO medications, and belief of being held without permission, leading an NP to order IM Haldol on two separate occasions for safety after nonpharmacological measures were ineffective. A grievance was later filed by the family regarding the use of IM Haldol for an acute change in behavior, and an informed consent form for Trazodone was signed by the resident’s wife with potential side effects reviewed. However, there was no documentation that Haldol side effects or risks were discussed with the wife prior to either IM Haldol administration, and the corporate nurse confirmed the absence of such documentation.
Failure to Notify Responsible Party of New Psychotropic Medication Order
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident’s responsible party was fully informed of and understood a change in the resident’s medication regimen. A resident admitted with metabolic encephalopathy, peripheral vascular disease, urinary tract infection, kidney calculus, and osteonecrosis of the left femur underwent an admission psychiatric evaluation by a consulting psychiatrist, who diagnosed Generalized Anxiety Disorder and ordered BuSpar 10 mg orally twice daily. The nursing progress notes for the period surrounding this evaluation contained no documentation of the psychiatrist’s assessment or of any notification to the resident’s responsible party about the new BuSpar order. The MAR showed the BuSpar order was entered and that the resident received two doses. The facility’s policy required immediate notification of the resident and authorized representative, with documentation in the medical record, when there was a change in the resident’s mental, physical, or psychosocial status. The resident’s responsible party reported that the facility started the resident on BuSpar and Trazodone for reasons unknown to her, and that she did not learn about the BuSpar until a nurse mentioned it during a visit. She stated the resident had previously experienced adverse reactions to psychotropic medications and that she did not want him on medications that cross the blood-brain barrier. One ADON stated she believed another ADON had notified the responsible party by phone and that she later met in person with the responsible party to discuss the BuSpar order, acknowledging the resident received two doses before discontinuation. The other ADON, however, stated she did not notify the family by phone, that all communication with the responsible party was in person, and that she discussed the BuSpar order with the responsible party at the next in-person visit and believed the resident did not receive any doses. There was no documentation in the medical record of timely notification to the responsible party about the initiation of BuSpar, contrary to facility policy.
Failure to Honor Resident's Right to Hospital Transfer
Penalty
Summary
The facility failed to honor a resident's right to self-determination regarding treatment options, specifically the right to request transfer to a hospital. The resident, who had a history of type II diabetes, hypertension, heart disease, schizophrenia, and other mental health conditions, was cognitively intact as evidenced by a BIMS score of 15. Multiple progress notes documented that the resident experienced various acute symptoms, including pallor, clamminess, twitching, incontinence, difficulty breathing, sweating, shaking, diarrhea, nausea, and chest pain radiating to the left arm. On several occasions, the resident explicitly requested to be transferred to the hospital due to these symptoms. Despite these requests, the nursing staff contacted the primary care provider (PCP), who typically ordered laboratory tests and monitoring rather than approving a hospital transfer. In some instances, the PCP did not return calls, and when contacted, often instructed staff to treat the resident in the facility, stating that hospital care would not differ from what could be provided on-site. The resident's care plan did not document repeated requests for hospital transfer, and staff interviews confirmed that the resident's wishes were not honored, with the PCP's refusal cited as the reason. The Social Services Director and the Interim Director of Nursing both acknowledged that the resident had the right to seek care elsewhere, and the Administrator stated that the resident should have been allowed to go to the hospital if requested. The facility's policy on resident rights, which includes self-determination and participation in care decisions, was not followed in these instances. Interviews with staff and the resident confirmed that the resident's repeated requests to be transferred to the hospital were not granted, and the staff deferred to the PCP's decision rather than honoring the resident's right to choose their treatment options. This resulted in a failure to comply with federal and state regulations regarding resident rights.
Failure to Notify Resident Representative of Incident and Change in Condition
Penalty
Summary
The facility failed to notify a resident's representative of an incident involving the resident, specifically a skin tear sustained during a mechanical lift transfer. The resident, who had diagnoses including hemiplegia, hemiparesis following cerebral infarction, and cognitive communication deficit, was assessed as severely cognitively impaired. Documentation showed that the resident's son was listed as the responsible party and emergency contact. Despite this, there was no record that the son was informed of the skin tear or the subsequent new wound care orders. The son only learned of the injury days later during a visit, after inquiring about his father's comments regarding his foot. Staff interviews revealed confusion and inconsistency regarding notification responsibilities. The ADON stated she did not notify the family because she believed the resident was sometimes alert and oriented, and typically notified the resident directly. The DON admitted to not checking the responsible party information and assumed the resident was his own responsible party. Other staff confirmed the resident's cognitive status fluctuated, with orientation primarily to self and inconsistent recognition of others. Facility policy required notification of the resident's representative within 24 hours of any incident or change in condition, unless otherwise instructed by the resident, but this was not followed in this case.
Failure to Notify Guardian and Obtain Informed Consent for Therapy and Dental Services
Penalty
Summary
The facility failed to notify a resident's court-appointed guardian about the initiation and potential charges for therapy services, as well as failed to obtain informed consent prior to starting dental services. Record review showed that the resident, who had multiple diagnoses including Parkinson's disease, dementia, and malnutrition, was rarely or never understood and had a guardian appointed. Despite multiple therapy orders and treatments, there was no documentation that the guardian was informed of the therapy evaluations, treatments, or the associated charges. Billing statements confirmed that charges were incurred for occupational, speech, and physical therapy, but the guardian was not notified. Additionally, after the resident switched from Medicaid to private pay, there was no evidence that updated consent was obtained for dental services or that the guardian was notified of a dental visit. The previous ancillary consent form had been signed by the resident's wife for other services while the resident was on Medicaid, but no updated consent was documented after the change in payor status. The administrator confirmed that no updated informed consent was obtained and that billing for ancillary services was handled by the service providers, not the facility.
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