what federal agency do healthcare facilities report equipment that results in a patient injury?

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

Full Answer

Who is responsible for filing incident reports in a hospital?

The busiest hospital personnel, nurses, and doctors are mainly responsible for filing incident reports. Due to their busy and often overworked schedule, they sometimes fail to report incidents.

What should be included in the report of an injury?

In case of injury, the reporting staff must record the injury level and cause in the report. If the incident involves an in-patient at the hospital, their medical records will reflect the treatment and diagnosis of the injury. However, for others, it might be required to follow up and record their injury diagnoses.

When is a medical device death or serious injury report required?

The document was designed to provide guidance to user facilities, manufacturers, and importers to use for determining when an adverse event involving a needlestick, or a device intended to prevent a needlestick, would require the submission of a mandatory medical device death, serious injury, or malfunction report to the FDA.

Do nursing facilities comply with federal requirements for reporting allegations of abuse or neglect?

Nursing Facilities’ Compliance With Requirements for Reporting Allegations of Abuse or Neglect (OEI-07-13-00010) 21 Data Analysis We reviewed the submitted documentation for the 301 sampled allegations of abuse or neglect to determine whether nursing facilities complied with Federal regulations.

Which government agency is most likely to regulate patient safety in the workplace?

Occupational Safety and Health Administration OSHA administers the Occupational Safety and Health (OSH) Act. Safety and health conditions in most private industries are regulated by OSHA or OSHA-approved state plans.

What is the role of regulatory agencies regarding client assessment?

They work with health care providers and consumers to promote a high quality of care, to investigate complaints about care, and work to protect the Medicare trust fund and ensure that payments are made for only medically necessary services.

What is one of the responsibilities of health care regulatory agencies quizlet?

Oversee health policies and respective regulations; Responsible for disease monitoring and surveillance in their communities. -Set standards for and accredits, ambulartory care centers, hospitals, behavioral health and long-term care facilities.

Which healthcare accrediting agency monitors safety practices in the healthcare environment?

The Joint Commission accredits and certifies over 22,000 health care organizations and programs in the United States.

What is a regulatory agency in healthcare?

Regulatory agencies thus monitor individual and corporate healthcare practitioners and facilities; inform the government about changes in the way the healthcare industry operates; ensure higher safety standards; and attempt to improve healthcare quality and follow local, state, and federal guidelines.

What does the CMS regulate?

The CMS oversees programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces. CMS collects and analyzes data, produces research reports, and works to eliminate instances of fraud and abuse within the healthcare system.

What is the federal agency that is responsible for implementation of all rules regulations and health related policies governing the Medicare program?

The federal agency that oversees CMS, which administers programs for protecting the health of all Americans, including Medicare, the Marketplace, Medicaid, and the Children's Health Insurance Program (CHIP).

Which of the following agencies is responsible for protecting human health and environment?

The U.S. Environmental Protection Agency (EPA) is responsible for the protection of human health and the environment.

What federal regulatory organization oversees hospital performance patient quality reimbursement and administers the Affordable Care Act?

Ensuring the Affordable Care Act Serves the American People CCIIO oversees the implementation of the provisions related to private health insurance.

What does JCAHO stand for in healthcare?

the Joint Commission on Accreditation of Healthcare OrganizationsIn 1953, JCAH began accrediting hospitals. The Social Security Amendments of 1965 passed by Congress stated that hospitals accredited by JCAH were permitted to participate in the Medicaid and Medicare programs. In 1987, it became the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

What is JCAHO called now?

In 1987 the company was renamed the Joint Commission on Accreditation of Healthcare Organizations (JCAHO, pronounced "Jay-co"). In 2007 the Joint Commission on Accreditation of Healthcare Organizations underwent a major rebranding and simplified its name to The Joint Commission.

Which government agency is responsible for research into health care safety?

The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the safety and quality of healthcare for all Americans.

What form do you submit to FDA for adverse event?

The MDR regulation requires that device manufacturers must submit medical device adverse event reports to the FDA, on FDA Form 3500A , whenever the manufacturer becomes aware that one of their manufactured devices may have caused or contributed to a death or serious injury.

When should you report a malfunction?

A malfunction that is or can be corrected during routine service or device maintenance should be reported if the malfunction is likely to cause or contribute to a death or serious injury if it were to recur. You do not need to report a malfunction if it is not likely to result in a death or serious injury.

What is the MDR form?

The Medical Device Reporting (MDR) regulation, 21 CFR Part 803, requires that user facilities must submit medical device adverse event reports, on FDA Form 3500A, to the FDA and the device manufacturer whenever the facility become aware that a device used at the facility may have caused or contributed to a patient death.

What is malfunction in medical terminology?

A malfunction is the failure of a device to meet its performance specifications or to perform as intended. If you are an importer or manufacturer of a device, you must report a malfunction when it is likely to cause or contribute to a death or serious injury if the malfunction were to recur.

When was the MDR document issued?

On August 9, 1996 , the FDA published a guidance document entitled “MDR Guidance Document and Exemption – Needlesticks and Blood Exposure – E1996003.” The document was designed to provide guidance to user facilities, manufacturers, and import ers to use for determining when an adverse event involving a needlestick, or a device intended to prevent a needlestick, would require the submission of a mandatory medical device death, serious injury, or malfunction report to the FDA.

Do importers have to report adverse events?

Device importers must also submit adverse event reports to the device manufacturer whenever they become aware that one of their imported devices has malfunctioned, and such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.

Do manufacturers have to report adverse events to FDA?

Device manufacturers must also submit adverse event reports to FDA whenever they become aware that one of their manufactured devices has malfunctioned, and such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.

What are the trades in healthcare?

These include mechanical maintenance, medical equipment maintenance, housekeeping, food service, building and grounds maintenance, laundry, and administrative staff.

What chemicals are used in pathology?

Some of the potential chemical exposures include formaldehyde, used for preservation of specimens for pathology; ethylene oxide, glutaraldehyde , and paracetic acid used for sterilization; and numerous other chemicals used in healthcare laboratories.

What are high risk areas of a facility?

Some examples of areas of a facility that may be identified as high-risk include: bathing rooms, extended care wings, and diagnostic units (e.g., radiology, emergency department, spinal unit, orthopedics department).

How does safe patient handling help?

Safe patient handling practices reduce the risk of the patient falling or experiencing other negative outcomes. In addition, implementing safe patient handling practices will reduce a healthcare facility's financial burden with regard to patient claims and workers' compensation claims.

What are some examples of high risk patient handling tasks?

Some examples of patient handling tasks that may be identified as high-risk include: transferring from toilet to chair, transferring from chair to bed, transferring from bathtub to chair, repositioning from side to side in bed, lifting a patient in bed, repositioning a patient in chair, or making a bed with a patient in it.

What should healthcare employees be trained in?

The education and training of healthcare employees should be geared towards assessment of hazards in the healthcare work setting, selection and use of the appropriate patient lifting equipment and devices, and review of research-based practices of safe patient handling.

What is OSHA's online resource?

OSHA has developed a series of online resources to help hospitals develop and implement safe patient handling assessments, policies, procedures, programs, training, and patient education. Beyond Getting Started: A Resource Guide for Implementing a Safe Patient Handling Program in the Acute Care Setting.

Why is assistive equipment important?

Explaining planned lifting procedures to patients prior to lifting and enlisting their cooperation and engagement can increase patient safety and comfort, and enhance their sense of dignity.

Why are nurse injuries so expensive?

Along with higher employer costs due to medical expenses, disability compensation, and litigation, nurse injuries also are costly in terms of chronic pain and functional disability, absenteeism, and turnover. As many as 20% of nurses who leave direct patient care positions do so because of risks associated with the work.

Why is reporting important in healthcare?

Reporting can also make healthcare operations more economically effective. By gathering and analyzing incident data daily, hospitals’ can keep themselves out of legal troubles. A comprehensive medical error study compared 17 Southeastern Asian countries’ medical and examined how poor reporting increases the financial burden on healthcare facilities.

How many medical errors remain unreported?

When an event results in an injury to a person or damage to property, incident reporting becomes a must. Unfortunately, for every medical error, almost 100 errors remain unreported. There are many reasons for unreported medical incidents, but not knowing when to report is one of the most common ones. Unfortunately, many patients and hospital ...

What is an incident in healthcare?

An incident is an unfavourable event that affects patient or staff safety. The typical healthcare incidents are related to physical injuries, medical errors, equipment failure, administration, patient care, or others. In short, anything that endangers a patient’s or staff’s safety is called an incident in the medical system.

Why is incident reporting important?

Improving patient safety is the ultimate goal of incident reporting. From enhancing safety standards to reducing medical errors, incident reporting helps create a sustainable environment for your patients. Eventually, when your hospital offers high-quality patient care, it will build a brand of goodwill.

What are near miss incidents?

#2 Near Miss Incidents 1 A nurse notices the bedrail is not up when the patient is asleep and fixes it 2 A checklist call caught an incorrect medicine dispensation before administration. 3 A patient attempts to leave the facility before discharge, but the security guard stopped him and brought him back to the ward.

How much of healthcare is wasted?

Even the World Health Organisation (WHO) has estimated that 20-40% of global healthcare spending goes waste due to poor quality of care. This poor healthcare quality leads to the death of more than 138 million patients every year. Patient safety in hospitals is in danger due to human errors and unsafe procedures.

How long does it take to file an incident report?

Usually, nurses or other hospital staff file the report within 24 to 48 hours after the incident occurred. The outcomes improve by recording incidents while the memories of the event are still fresh.

Who is required to report crimes committed against a resident of a nursing facility?

Section 1150B requires owners, operators, employees, managers, agents, or contractors of nursing facilities (covered individuals) in applicable nursing facilities to report any reasonable suspicion of crimes committed against a resident of that facility to the appropriate entities (e.g., law enforcement . entities).

What percentage of nursing facilities have written policies that prohibit abuse or neglect?

The remaining 24 percent of nursing facilities maintained written policies that prohibit abuse or neglect; however, these policies did not address the Federal requirements related to reporting allegations of abuse or neglect and/or the investigation results.

What is a 6703b(3)?

Section 6703(b)(3) of the Elder Justice Act of 2009 amends the SSA by adding section 1150B.19 Section 1150B requires owners, operators, employees, managers, agents, or contractors of nursing facilities (covered individuals) in applicable nursing facilities to report any reasonable suspicion of crimes committed against a resident of that facility to the appropriate entities (e.g., law enforcement entities).20 The nursing facility’s responsibility to report all allegations of abuse or neglect is separate from a covered individual’s responsibility outlined in Section 1150B.

How many allegations of abuse or neglect were reported in 2012?

In 2012, 53 percent of allegations of abuse or neglect and the subsequent investigation results (1,338 allegations) were reported, as Federally required. Sixty-three percent of allegations of abuse or neglect were immediately reported to the nursing facility administrator or designee and the State survey agency, as required. Further, the subsequent investigation results for 63 percent of allegations of abuse or neglect were reported to the appropriate individuals within 5 working days, as required. See Table 7 for the number and percentage of allegations of abuse or neglect that were reported in compliance with Federal regulations.

What are nursing facilities policies?

Nursing facilities must have policies that prohibit abuse or neglect, which must include policies for reporting alle gations of abuse or neglect and the subsequent investigation results to the appropriate individuals within the required timeframes. In 2012, 76 percent of nursing facilities (11,744 facilities) maintained policies that address Federal regulations for reporting both allegations of abuse or neglect and subsequent investigation results. Ninety-five percent of nursing facilities had policies that reflected Federal regulations for reporting allegations of abuse or neglect. Seventy-six percent of nursing facilities had policies that reflected Federal regulations for reporting subsequent investigation results of allegations of abuse or neglect. See Table 5 for the number and percentage of nursing facilities that had policies that address Federal regulations for reporting allegations of abuse or neglect. 31

What is SSA 1150B?

Under Section 1150B of the SSA, nursing facilities must annually notify covered individuals (i.e., owners, operators, employees, managers, agents, or contractors of nursing facilities) of their obligation to report to the appropriate entities any reasonable suspicion of a crime. Further, nursing facilities must also clearly post a notice specifying employees’ rights to file a complaint under Section 1150B. In 2012, 61 percent of nursing facilities (9,487 facilities) had documentation to support that both of these regulations were met. See Table 6 for the number and percentage of nursing facilities that had documentation to support that Federal regulations related to reporting reasonable suspicions of crimes were met.

What are the rights of nursing facilities?

Nursing facility residents also have “the right to be free from mistreatment, neglect, and misappropriation of property. ”. 4. Further, all Medicare and/or Medicaid-certified nursing facilities must report “alleged violations involving mistreatment, neglect, or abuse, including injuries of .

What is the purpose of Federal Grants for Medical Equipment?

The mission of HHS is to improve the health of Americans by providing effective health and human services. It also aims to promote sound and sustained advances in the sciences underlying medicine, public health, and social services.

What is medical equipment?

Medical equipment help in preventing, monitoring, and treating health conditions. The aim of offering federal grants for medical is to support the processes or services that facilitate the delivery of high-quality and economically-efficient healthcare in the U.S.

What is the purpose of AHRQ?

Agency for Healthcare Research and Quality (AHRQ) The Agency for Healthcare Research and Quality’s mission is to make health care safer, equitable, more accessible, and affordable. Grants from AHRQ support research to enhance and improve the quality, accessibility, and cost-effectiveness of health care.

How long does it take for a nursing home to report an incident?

Nursing Homes must submit a 2-Hour/Immediate Report and a follow up Five-Day Report to the Agency for Health Care Administration. The Immediate Report should be submitted as soon as possible, but no later than 24 hours of discovery of the incident.

How to report nursing home abuse?

Nursing Home Federal Reporting 1 The Immediate Report should be submitted as soon as possible, but no later than 24 hours of discovery of the incident. If the events that cause the allegation involve abuse or result in serious bodily injury, they must be reported within two hours after the allegation is made. 2 The Five-Day Report must be submitted within 5 working days from the date of the incident. Any reports received after that time will be considered out of compliance with the Federal Regulations.