Chapter 5: Regulations and Standards
Define a Repeat OSHA violation rating.
(A violation of any standard regulation or rule where), upon re-inspection, a substantially similar violation is found. (These carry penalties of up to $70,000).
The FDA Regulates WHAT?
- Sterilants - High Level Disinfectants - The manufacturer of ALL Medical Devices
What are the levels of FDA Medical Device Classifications?
-Class 1 (low risk) -Class 2 (potential threat) -Class 3 (most stringently regulated)
What does OSHA impact on Central Service include?
-Employee exposure to hazardous and/or toxic chemicals. -Employee exposure to Blood borne Pathogens. -Protect employees from other potential hazards.
List examples of Federal regulatory agencies.
-Food and Drug Administration (FDA) -Centers for disease control (CDC) -Department of Transportation (DOT) -Environmental protection agency (EPA) -Occupational safety and Health Administration (OSHA) -The Center for Medicare and Medicaid services
Infections and hospital negligence includes and is not limited to WHAT?
-Foreign object retained after surgery. -Air embolism. -Blood incompatibility. -Falls and trauma. -Surgical site infection, etc...
The EPA is responsible for minimizing WHAT?
-Greenhouse gasses Any gas such as carbon dioxide (C02), Methane (CH4), halogenated fluorocarbons (HCFCS) and ozone (O3) which contribute to potential climate change. -Minimizing Toxic Emissions -Regulating the Re-use of Solid Wastes -Controlling indoor air pollution -Developing and enforcing pesticide regulations.
What are examples of Class 3 medical devices.
-Heart valves. -Infant radiant Warmers. -Pacemakers. -Other implants.
Each product's label must contain WHAT?
-Product Ingredients. -Directions for Use. -Product Precautions and Warnings. -Directions for Storage and Disposal. -The EPA Registration Number.
Single Use Devices (SUDS) can be labeled as?
-Single use. -One Time Use. -(Softgoods, Sterilized by manufactures).
What are examples of class 2 medical devices.
-Sterilizers -Biological Indicators -Chemical indicators -Packaging
What are examples of class 1 medical devices?
-Ultrasonic cleaners. -Most hand-held surgical instruments.
What are examples OSHA violation ratings?
-Willful -Serious -Repeat -Failure to Abate
Beginning in 2000, medical facilities were required to report suspected medical device-related deaths within HOW much time of the event.
10 days
In what YEAR did CMS stop reimbursing hospitals for patients that acquired any of the specific infections/events while in the hospital.
2008.
Define regulatory standards.
A comparison benchmark that is mandated by governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties.
Define Medicaid.
A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines.
Define Medicare.
A federal medical insurance program that primarily serves those over age 65 years of age(regardless of income), and people under 65 with certain disabilities and people of all ages with end-stage renal disease.
Define best practice.
A method or technique that has consistently shown results superior to those achieved by other means.
Define Medwatch.
A safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense or use.
Define standard.
A uniform method of defining basic parameters for processes, products, services, and measurements.
Define a serious OSHA violation rating.
A violation in which there is substantial probability that death or serious injury could result (and the employer knew or should have known of the hazard. These violations carry fines up to $7000).
Define a willful OSHA violation rating.
A violation that the employer intentionally and knowingly commits. (These carry fines and penalties of $5000 to $70,000).
Define statute.
A written law adopted by a legislative body that governs a city, state or country.
AORN provides WHAT?
AORN is dedicated to providing optimal care to the surgical patient.
What is a 510k application?
Also known as a Pre-market notification. It demonstrates that the new product coming out is substantially EQUIVALENT OR BETTER THAN THE OLD ONE.
Define U.S. Food and Drug Administration.
Also known as the FDA is the federal agency responsible for ensuring foods, cosmetics, human and veterinary drugs, and more are safe and effective for public use.
ANSI is an abbreviation for _________________________________.
American National Standards Institute
What is a medical device recall?
An action taken to address a problem with a medical device that violates the FDA regulations.
OSHA may conduct WHAT kind of visits?
Announced and Unannounced.
CMS conduct what kind of visits?
Announced and unannounced visits.
Define Greenhouse gasses.
Any of the gases that absorb solar radiation are responsible for the greenhouse effect, including carbon dioxide, methane, ozone, and fluorocarbons.
Define APIC.
Association for Professionals in Infection Control and Epidemiology
AAMI is an abbreviation for _______________________________________.
Association for the Advancement of Medical Instrumentation
AORN is an abbreviation for ________________________________.
Association of Perioperative Registered Nurses
Define The Centers for Medicare and Medicaid (CMS)
CMS is a federal agency responsible for the operation of Medicare and Medicaid and the State Children's Health Insurance Program.
Define CDC
Center for Disease Control Federal agency that collects and analyzes data about infectious diseases. They work to promote the health and quality of life by preventing and controlling disease, injury and disability, and by responding to health emergencies
What is a pre-market clearance.
Checks the effectiveness and safety of the products. Products goes through rigorous testing before it can be released to the public for use. After testing is done, FDA then classifies devices base on risks it can pose and it's intended use.
The USP-NF creates and revises standards for WHAT?
Creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements.
Define DOT.
Department of Transportation Federal Government agency that is dedicated to ensuring a fast, safe, and efficient transportation system.
Professional associations do WHAT for CS functions?
Develop and promote voluntary standards that set the foundations for good work practices.
AAMI uses advisory groups apart of AAMI to develop WHAT?
Develop recommended practices and standards.
Define class 1 medical classification.
Devices that are low risk. Subject to general controls, exempt from pre-market submission requirements.
All WHAT must be registered with the EPA and All products must meet strict labeling requirements.
Disinfectants and sanitizers
_______ regulates medical waste incinerators?
EPA
What is ANSI's mission?
Enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards and ensuring their integrity.
Define EPA.
Environmental Protection Agency The EPA's purpose is to protect human health and the environment by writing and enforcing regulations based on laws passed by Congress.
The level of regulation placed on any device depends upon how the ______ classifies the device such as a Class 1, 2, and 3.
FDA
Define a failure to abate OSHA violation rating.
Failure to correct a prior violation (may result in penalties of up to $7000 per day).
True or False. TJC surveys may be announced only.
False TJC surveys may be announced and unannounced.
True or False. TJC conduct off-site type of surveys (inspections) of healthcare facilities.
False, on-site.
True or False. The Joint Commission is NOT independent, Not-for-profit, or an organization.
False. The Joint Commission IS independent, Not-for-profit, and an Organization
What is Pre-Market approval?
For BRAND NEW PRODUCTS being released especially Class 3 medical devices that are most stringently regulated. Ex: Heart valves and pacemakers
Define voluntary standards.
Guidelines or recommendations for best practices to provide patient care. Industry, nonprofit organizations, trade associations and others develop these.
TJC sets __________________________ standards and protects _____________________.
HEALTHCARE QUALITY STANDARDS, PATIENTS or VISITORS.
Define Class 1 FDA recalls.
HIGH RISK and there is a chance the product will cause serious health problems or death.
DOT regulates labeling and containment of WHAT?
Hazardous waste, Bio hazard items and minimally processed items for transport.
Define HIPAA.
Health Insurance Portability and Accountability Act Protects patients medical records and other personal health information.
Define FDA Class 3 medical devices.
High risk or most stringently regulated devices. Require pre-market application/Clearance and extensive testing demonstrating their safety and effectiveness before approval.
ISO is an abbreviation for _____________________________________.
International Standards Organization.
Define Class 2 FDA recalls.
LESS SERIOUS RISK and there is a chance the product will cause temporary or reversible health problems. There is a remote chance the device will cause serious health problems.
Define Class 3 FDA recalls.
LOW RISK and there is a little chance that using or being exposed to the product will cause health problems.
TJC is used as a __________ of organizational quality?
Measurement.
Who sets emissions standards for industrial Ethylene Oxide Sterilization Facilities?
National Emissions Standards for Hazardous Air Pollutants (NESHAP).
Define NFPA.
National Fire Protection Association International organization that works to reduce the burden of fire and other hazards.
OSHA is an abbreviation for what?
Occupational Safety and Health Administration
Define class 2 medical classification.
Pose a potential risk. Considered to pose potential risks great enough energy to warrant a higher level of regulation.
What is OSHAs primary role?
Protect workers from occupationally-caused illnesses and injuries.
Define Technical Information Reports (TIRs)
Reports developed by experts in the field that contain valuable information needed by the healthcare industry. TIRs have not undergone the formal approval system that standards are submitted to and may needed further evaluation by experts. TIR may be revised or withdrawn at any time because they address a rapidly-evolving field or technology.
What does the Safe Medical Devices Act of 1990 require from Healthcare Facilities?
Requires Healthcare Facilities to report medical device malfunctions to the FDA and manufacture.
Loss in TJC accreditation may result in WHAT?
Result in forfeiture of Medicare and Medicaid reimbursement payments.
Define Regulation.
Rules issued by administration agencies that have the force of law.
NFPA set WHAT?
Sets fire safety standards.
The USP-NF sets standards for WHAT?
Sets standards for packaging, labeling, bacteriological purity, pH, and mineral content.
SUDs is an abbreviation for _________________________.
Single Use Devices
What are submitted to ANSI for approval?
Standards, from other organizations such as AAMI.
Define Health Insurance Portability and Accountability Act (HIPAA).
The HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates, and gives patients an array of right with respect to that information.
The Centers for Medicare and Medicaid is also one of the agencies that administers the ______________________ kind of standards?
The Health Insurance Portability and Accountability Act (HIPAA) standards
TJC is an abbreviation for ____________?
The Joint Commission. (Formally) JCAHO. Joint Commission on Accreditation of Healthcare Organizations.
Failing to follow CMS standards may result in the WHAT?
The loss of all federal funding to a facility, including Medicare and Medicaid payments.
How many categories are there of FDA recalls?
Three
True or False. Even though AAMI is a voluntary organization, its Recommended practices and standards are used by regulatory organizations that inspect health care organizations?
True
True or False. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) gave the EPA responsibility to regulate all products with antimicrobial claims, such as Sterilants, Disinfectants, and Sanitizers.
True
True or False? Many CDC Guidelines and Recommendations are incorporated into healthcare facility policies and procedures and other agencies rely heavily on them.
True
True of False. AAMI is Voluntary organization?
True.
True or False. ISO is a non-governmental standards organization.
True.
True or False. ISO is globally based.
True.
True or False. Standards groups such as AAMI submit standards which are granted ISO status based on the consensus of the membership.
True.
True or False. The APIC is a voluntary international organization.
True.
True or False. The APIC works with the CDC and other related agencies to adopt standards for infection/disease prevention
True.
True or False. The EPA also administers the 1990 Clean Air Act Amendments which created a regulatory program to protect the earth ozone layer.
True.
True or false. Medical device recalls can be voluntary.
True.
USP-NF is an abbreviation for ______________________________________.
United States Pharmacopoeia national formulary
Define standards (AAMI).
Voluntary guidelines representing a concensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use.
When can medical device recalls be enforced?
When the device is defective and/or poses a risk to health.
Manufacturers must obtain an EPA registration number for every _________, ________, and __________ (for EPA FIFRA requirements).
chemical sterilant, disinfectant, and sanitizer
Regulatory officials look for _______________ with AORN standards, Recommended practices and guidelines.
compliance.
The CDC issues ____________________________ kind of guidelines?
infection control.
USP-NF is important to CST'S who work with WHAT?
purified water or water sterilized for irrigation.
Serious injuries must be __________.
reported
