Nursing Investigation Results -

Pennsylvania Department of Health
BRIGHTON REHABILITATION AND WELLNESS CENTER
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

BRIGHTON REHABILITATION AND WELLNESS CENTER
Inspection Results For:
There are 237 surveys for this facility. Please select a date to view the survey results.

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BRIGHTON REHABILITATION AND WELLNESS CENTER - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

Based on an Abbreviated Survey in response to a complaint, completed on June 16, 2020, it was determined that Brighton Rehabilitation and Wellness Center was in compliance with the requirements of 42 CFR Part 483, Subpart B, Requirements for Long Term Care Facilities; however, the facility was not in compliance with the 28. Pa Code, Commonwealth of Pennsylvania Long Term Care Licensure Regulations.

Plan of Correction:

� 201.29(o)(1)&(2) LICENSURE Resident rights.:

(o) Experimental research or treatment in a nursing home may not be carried out without the approval of the Department and without the written approval of the resident after full disclosure. For the purposes of this subsection, ''experimental research" means an experimental treatment or procedure that is one of the following:

(1) Not a generally accepted practice in the medical community.

(2) Exposes the resident to pain, injury, invasion of privacy or asks the resident to surrender
autonomy, such as a drug study.

Observations:

Based on facility documents, U.S. Food and Drug Administration (FDA) documents, facility record and staff interviews it was determined that the facility failed to obtain the necessary approval from the Pennsylvania Department of Health (PA DOH) prior to administering a medication that is not a generally accepted practice in the medical community, is not a currently approved medication by the FDA for treatment of the COVID-19 virus outside of the hospital setting for an "Experimental Post Exposure Prophylaxis" treatment for 205 of 435 residents.

Review of the facility document "Consent for Experimental Post Exposure Prophylaxis During a National Pandemic" stated that medical research is currently underway to determine if a person taking the drug Hydroxychloroquine (Plaquenil) in conjunction with zinc (mineral and a supplement) tablets can be medically prevented from becoming infected with COVID-19. The treatment is not currently approved by the U.S. Food and Drug Administration for preventing a person from being infected with COVID-19. This treatment is an "off-label" use, which means that the drug manufacturers of Hydroxychloroquine, nor the FDA, have said the drug can be, or should be, used to prevent a person from becoming infected with COVID-19. Hydroxychloroquine has few side effects when used for short periods. The most common side effect is upset stomach, some more serious side effects such as injury to the heart may occur, In addition to these risks it may harm you in unknown ways and cause serious injury, sickness, permanent injuries, and/or death.

A review of the FDA "Fact Sheet for Patients and Parent/Caregivers Emergency Use Authorization (EUA) Of Hydroxychloroquine Sulfate for Treatment of Covid-19 in Certain Hospitalized Patients" dated 3/28/20, indicated that there is no FDA approved product available to treat COVID-19. Hydroxychloroquine sulfate (Plaquenil) is an antimalarial medicine approved in the United States for either prevention or treatment of certain types of malaria, lupus erythematosus, and rheumatoid arthritis. Hydroxychloroquine sulfate has not been approved for the treatment of COVID-19. It has been used experimentally to treat certain people with COVID-19, including hospitalized patients. Emergency use has been authorized for adults and adolescents who weigh 50 kg (110 pounds) or more and are hospitalized with COVID-19. There is limited information known about the safety and effectiveness (whether this will make you better) of using Hydroxychloroquine sulfate for hospitalized patients with COVID-19.

A review of FDA "Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Hydroxychloroquine Sulfate Supplied From The Strategic National Stockpile for Treatment of Covid-19 in Certain Hospitalized Patients" dated 4/27/20, indicated that "Instructions for Health Care Providers," revealed that prior to prescribing/dispensing health care provider should follow state and local laws. The health care provider is responsible for reporting medication errors and adverse events (death, serious adverse events) occurring during Hydroxychloroquine sulfate treatment within 7 calendar days from the onset of the event. Serious Adverse Events are defined as: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; congenital anomaly/birth defect; medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

A review of a list provided by the facility "Prophylaxis Consents" on 4/29/20, listed 205 residents that the facility stated had signed the "Consent for Experimental Post Exposure Prophylaxis during a National Pandemic" and received Hydroxychloroquine for the COVID-19 virus.

During an interview on 5/1/20, from 12:20 p.m. to 12:30 p.m. the Nursing Home Administrator, Medical Director and the Director of Nursing, the Medical Director confirmed that the consent provided to the 205 residents and/or representative identifies the treatment as experimental and the use of Hydroxychloroquine is not an approved medical treatment for COVID-19 and the facility failed to obtain the necessary approval from the Pennsylvania Department of Health prior to starting the Experimental Post Exposure Prophylaxis treatment and the facility failed to report medication errors and adverse events occurring during Hydroxychloroquine sulfate treatment.

Plan of Correction - To be completed: 07/07/2020

Preparation, submission, and implementation of this plan of correction does not constitute an admission of or agreement with the facts and conclusion set forth on the survey report. Our plan of correction is prepared and executed to continuously improve the quality of care and to comply with all state and federal regulatory requirements.

The facility cannot retroactively obtain written approval from the Pennsylvania Department of Health (PA DOH) for the use of Post Exposure Prophylaxis Medication (Hydroxychloroquine in conjunction with zinc).

The facility is no longer administering Post Exposure Prophylaxis treatment to medically cleared residents with confirmed consent.

Medical Director and Clinical Leadership will be in serviced on Resident Rights related to experimental research by the Governing Body.

Consultant Pharmacist/designee will perform random audits weekly x4 weeks then monthly thereafter to assure that Post Exposure Prophylaxis Medication (Hydroxychloroquine in conjunction with zinc) is not prescribed.

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