1. Reason the patient was transferred from Wesley Glen to the hospital.

2. Reason for the use of restraints.

3. Information about the cardiac defibrillator.

They must also report this patient's death to the FDA because it might be related to the implanted medical device.

Weedn, V. W. (2022, September). HIPAA and access to medical information by medical examiner and Coroner Offices. Academic forensic pathology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459398/#:~:text=It%20is%20critical%20for%20medical,deaths%20falling%20within%20their%20jurisdiction.

a) Hospital Restraint/ Seclusion CMS-10455

b) Must report a suspected medical device-related death to both the FDA and the manufacturer

c)Cause of death/ death certification

A patient's death is required to be reported to a medical examiner/coroner because the law requires that a death that is suspicious in nature be reported to a medical examiner or coroner. The physician must provide the cause of death and sign the death certificate, and the funeral director has the responsibility for filing the death certificate. If the physican thinks that the cause of death is suspicious in nature, it must be reported to a medical examiner or coroner. Medical examiners/Coroners have the right to receive medical info needed to investigate a case without authorization and might have subpoena powers to collect such information. They may also require an autopsy of the deceased, depending on the circumstances of the death.

They must notify the FDA of the possibility that the patient's implanted cardiac defibrillator had some bearing on his death. This should be done through the Safety Information and Adverse Event Reporting Program or Medwatch.

Citation: Husgen J. Product liability suits involving drug or device manufacturers and physicians: the learned intermediary doctrine and the physician's duty to warn. Mo Med. 2014 Nov-Dec;111(6):478-81. PMID: 25665231; PMCID: PMC6173549

• An immediate and thorough investigation into the cause of the patient's bruises

  • Interviews with all staff members who had contact with the patient and a reasonable opportunity to inflict harm

  • Review of surveillance video, if available

  • Disciplinary action including termination and reporting to law enforcement of suspected abusers

• Re-training of all staff on laws and policies related to elder abuse and reporting requirements

Hospital mitigation plan:

• Investigation of the use of restraints during the patient's encounter

• Disciplinary action to the fullest extent of hospital policy and law if restraints were misused

• Re-training of all staff involved in any way in patient restraint

Federal regulations require the reporting of a death to appropriate authorities when a patient was placed in restraints prior to their death. CMS Conditions of Participation (CoP) requires healthcare entities to report deaths that occurred within 24 hours after the patient was removed from the restraints. The hospital must report the death to the CMS regional office no later than the close of the business day following the patient’s death.

The date and time of death must be documented in the patient’s medical record.

The facility must record the death in an internal log or other system within 7 days of the patient’s death.

The death would also be reported to a state agency as determined by state law.

The hospital must also report the death to the FDA if the death is thought to be from the medical device.

Both the hospital and the senior living facility should always report cases of suspected elder abuse to local law enforcement immediately or as soon as practicably possible.

Moving forward when the hospital receives a medical device alert, they should begin contacting patients who have those devices immediately.

https://oag.ca.gov/dmfea/mandated-reporter

https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/health-information-of-deceased-individuals/index.html

The patient’s death was suspicious and therefore it is considered a reportable death. The hospital is required by law to report it to the medical examiner/coroner. There are a few reasons why the patient’s death was suspicious. First the physician noted that the patient had multiple bruises on his back, buttocks, and thighs which can be indicators of elder abuse. Secondly the physician noted that the patient had been receiving alerts to contact their physicians for a follow-up with a device with an active alert. This could be seen as neglect because the patient was not receiving the care he needed. Abuse and neglect are required to be reported according to 45 CFR 164.512(c)(1) which states that a covered entity may disclose protected health information of an individual that they reasonably believe to be a victim of abuse, neglect, or domestic violence. Thirdly the patient died a few hours after being admitted into the hospital and sedated for aggressive behavior. With all three of these events, the hospital was required to report the patient’s death.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E

According to the FDA, the patient's death must be reported because user facilities must report a suspected medical device-related death to both the FDA and the manufacturer.

In regards to the use of restraints on the patient prior to death at the hospital, I would recommend an investigation into the use of the restraints to ensure the restraints were justified and used properly or if the restraints contributed to the patient's death.

Source: https://www.bricker.com/industries-practices/health-care-industry/insights-resources/resource/hipaa-privacy-regulations-uses-and-disclosures-for-which-an-authorization-or-opportunity-to-agree-or-object-is-not-required-decedents-%C2%A7-164512g-360#:~:text=A%20covered%20entity%20may%20disclose,duties%20as%20authorized%20by%20law.

Yes, the medical examiner and coroner do have a right to receive this patient's information. This includes demographics and details of the death. State laws do not conflict with HIPAA, as this falls under permissible without authorizations for public interest and benefit exceptions.

Given the state of the patient's body, with bruising all along his backside, they may also want to contact law enforcement, or possibly social services.

Also, they need to contact the FDA regarding the implanted defibrillator.

The Food and Drug Administration (FDA) are responsible for protecting the public by assuring the safety, efficacy, and security of many things, including medical devices. The Center for Devices and Radiological Health (CDRH) unit within FDA oversees safe, effective, and high-quality medical devices and safe radiation emitting products.

https://www.broussard-david.com/medical-products-liability.html#:~:text=Medical%20products%20liability%20arises%20when,defects%20or%20dangerous%20side%20effects.

• Death of the patient within 24 hours after removal from restraint should be reported to the CMS regional office (42 CFR 482.13(e))

• Medical device reporting - the physician found a cardiac defibrillator implanted during the last inpatient visit, which might have been a factor in the patient's death (45 CFR 164.512(b))

• Details on the bruising found on the patient's body to aid in potential investigations

However, there could have been an error made during implantation, implying user error. The manufacturer also did notify the hospital as required when a defect was noticed with the devices.

• Wesley Glen - may be at fault due to potential elder abuse as seen by the patient's bruising, which could have caused more issues within the patient's body that were not immediately detected.

• Hospital - may be at fault for not immediately addressing the implanted device, which was possibly defective.

• Manufacturer - may be at fault for producing and distributing defective implant devices.

For the hospital, a review and update of processes to address medical alerts would be performed. The aim would be to improve response time and take urgent action as quickly as possible.

For the manufacturer, a review of development and assembly procedures should be performed to fix any errors discovered. The manufacturer should also improve on reporting practices to ensure the fastest response from facilities using their devices.

The hospital is required to report this patient's death to the medical examiner/coroner because there is an incident of sudden or suspicious death. The expired patient was physically abusive to himself and others, the unexpected death of the patient needs to be investigated since he was sedated and restraint after 15 hours.

This death also constitutes a serious occurrence or death related to restraint or seclusion, which is required to be reported. Since the patient is over 60 years of age, this case might also be considered abuse of the elderly, which requires reporting as well. 

H.H.S, O. I. G. (2006, September 11). Hospital Reporting of Deaths Related to Restraint and Seclusion (OEI-09-04-00350; 09/06). 

https://oig.hhs.gov/oei/reports/oei-09-04-00350.pdf

1.Name and address

2.Age

3.Marital status

4. Ethnicity

5.Onset of cause of death

6.Place, mode, and manner of injury

7.Place of death

8.Time of death

9.Location of body

10.Information regarding restraints, the defibrillator, and bruising

11.Name of staff reporting, date, and time

12. Name of physician whom pronounced the death.

Wesley Glen Senior Living Facility will need to report:

1. The use of restraints

2.The defibrillator

3. The bruises

4.Information regarding hospitalization

5.Any occurrences

6.Any injury determined by a physician

Weedn V. W. (2022). HIPAA and Access to Medical Information by Medical Examiner and Coroner Offices. Academic forensic pathology, 12(3), 83–89. https://doi.org/10.1177/19253621221102039

The medical examiners and the coroners have the right to receive patient information needed to investigate a case, HIPAA specifically defines exemption to them thru (45 CFR § 164.512(g)(1)) (17) and other relevant exemptions.

As stated, "45 CFR § 164.512—Uses and disclosures for which an authorization or opportunity to agree or object is not required.

A covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity’s information and the individual’s agreement may be given orally."

The one responsible for notifying the hospital that a medical device in use may cause harm to patients is the FDA (Food and Drug Administration). They are responsible to protect the public in ensuring the safety, effectiveness and security of the medical device.

If the death was attributed to the defibrillator, the hospital is responsible in reporting to FDA the death since their is a medical device involved.

The manufacturer may or may not have the liability, it depends on the results of the investigation. if the medical device has any malfunction or defects that the manufacturer did not report to FDA then the manufacturer has a liability. If they have reported any problem on the medical device and FDA ddi not disseminate the information to the hospitals using that certain medical device they will not be at fault.

The manufacturer of the device and the FDA are responsible for notifying the hospital that a medical device in use may cause harm to patients.

(2023, July 27). Medical Device Reporting (MDR): How to Report Medical Device Problems. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

This question will only be answered after the investigation of the medical examiner and coroner's office. If the cause of death is because of the defect of defibrillator (medical device) and the manufacturer did not report to FDA then they are at fault. If the cause of death is due to care negligence or abuse it would need further investigation within the hospital. This is case to case basis we cannot conclude anything without the results of the investigation.

The mitigation plan moving forward would be the following:

1. Initiate an in house investigation to determine the sequence of events and interview all the medical staff that were included in the patient's care.

2. Review and ensure that all the policies and procedures of the hospital are being implemented and in place,

3. Re-educate all the staff on company policies and procedures that have a connection on the events after the investigation results have been determined.

(2023, August 16). Recalls, Corrections and Removals (Devices). https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

(2011, February 18). Your Legal Duty - Reporting Elder and Dependent Adult Abuse. https://oag.ca.gov/sites/all/files/agweb/pdfs/bmfea/yld_text.pdf

A mitigation plan for preventing similar events to the one detailed in this assignment from occurring in the future must incorporate policies requiring mandatory reporting of misconduct or abuse of patients to authorities, so that an investigation can be conducted. Staff who fail to report abuse must be disciplined and possibly prosecuted.

Staff must be trained to understand misconduct towards patients and their responsibility to report, and to recognize signs and how to report suspected abuse. The facility must have a policy of thoroughly investigating all reports of abuse or other misconduct. 

The facility should record all medical devices and medications prescribed to its patients, and keep apprised of all FDA alerts regarding medical device or other medical products. The facility may consider adoption of an EHR system which can send medical device alerts, in general and for patients in the facility who are prescribed recalled devices.

(2019, March 7). Medical Device Defects Leading to Products Liability Lawsuits. Justia . https://www.justia.com/products-liability/types-of-defective-product-cases/medical-devices/

(2014, May 9). Hospital Restraint/Seclusion Deaths to be Reported Using the Centers for Medicare and Medicaid Services (CMS) Form CMS-10455, Report of a Hospital Death Associated with Restraint or Seclusion. https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-14-27-

Wesley Glen and the hospital must report the death to the FDA and the manufacturer of the faulty medical device.

(2023, August 16). Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities

Assuming that there are no other details surrounding the patient’s disposition, it is quite unclear what the cause of death was. Thus, it was correct (and lawful) that the death was reported to the coroner. An independent pathologist/medical examiner conducting an autopsy would be better qualified as a resource to determine cause of death. Toxicology, organ examination (especially the heart, brain, and lungs), and the nature of the bruising could provide clues. This is especially pertinent in this case as there are several potential targets for litigation if legal action is sought by the patient’s family (or the State if criminal activity is involved). The hospital/staff members, the nursing home/its physician(s)/nursing team/care staff, as well as the device manufacturer, could be found liable. 

1. Physician, nurse, and care team on duty during transfer.

2. Active and current licenses, certification, accreditation for senior living care facility, as well as use of restraints.

3. Audits of restraint use (competency of staff members, frequency log (hourly, daily) of restraint use and monitoring, orders for restraints, justification of use, other measures used before restraint use, etc.

4. Activities of daily living (ADL) documentation/logs, to include any use of mobility devices such as a walker, gait belt, etc.

5. List of medications.

6. List of staff members caring for patient in a certain timeframe (ie. last 30 days).

7. Medical records regarding cardiac defibrillator and any follow-up correspondence regarding medical device alert.

List of required items from the hospital:

1. Similar items as stated above; however, since the patient expired shortly after hospital admission, items such as ADL may not be appropriate in this case.

2. H&P

3. Medications ordered and reconciled.

4. Orders for restraint and sedation use.

5. Audits for restraint use to include competency of staff members, documentation of monitoring restraints (time of order and placement of restraints will be reviewed, as well as any existing policy regarding hospital restraint use).

6. Physician, nurse, and other staff members' documentation of the care, treatments, procedures provided to the patient.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A "device user facility" is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician's office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown (Center for Devices and Radiological Health, 2023).

Center for Devices and Radiological Health. (2023, July 27). Medical Device Reporting (MDR): How to report medical device problems. U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#:~:text=Mandatory%20Medical%20Device%20Reporting%20Requirements,-The%20Medical%20Device&text=Manufacturers%3A%20Manufacturers%20are%20required%20to,a%20death%20or%20serious%20injury.

Per the FDA, manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

I understand that some may jump to conclusions regarding this case as a senior patient being abused in a senior living facility. No where in the synopsis of the case did it state that. What I gathered is a 75-year old patient with a cardiac history, as stated in the implanted cardiac defibrillator, who has a history of becoming agitated and physically abusive to himself and others.

I would deduce that the patient may experience sundowners (as seen in the geriatric population) or drug-drug/drug-food interactions that may cause his agitation. Also, since he has a cardiac history, he may likely be on medication that "thins" the blood, which makes the patient at a higher risk of falling and sensitivity to bruising.

1. Ensuring competency training is conducted regarding care of patients throughout the lifespan, mobilizing patients, restraint use and monitoring, de-escalation techniques, alternatives to restraint use, and chemical restraints (sedation) vs. physical restraints (wrist/ankle, bedrails, etc.), reporting deaths, caring for the deceased, reporting medical devices to include malfunction and next steps.

2. Current policies, procedures and protocols regarding restraint use and monitoring (chemical and physical), reporting deaths, reporting medical devices, notifying patients of medical device equipment maintenance and malfunction.

3. Ensuring current licenses, certifications, and accreditation for both facilities and staff members responsible for patient care.

In addition, the hospital must report the suspected death of a patient with medical device that has an alert to the FDA. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Reporting the patient died within 24 hours of arriving to the hospital

How long has the implant been in the patient

How much sedative was given to the patient

How long had the patient been getting agitated and physically abusive

The reason for the bruising

Anything out of the ordinary with the patient

What if there was evidence to prove the hospital had attempted to reach the patient at the senior living and the facility never let the patient leave or schedule an appointment.

What if there was evidence to prove the hospital gave the patient too much sedative that it killed him.

There were only medical alerts to say the patient should see their primary care physician for a follow up, not for a serious matter.

With the bruising, the cause of death could have been from the senior living facility.