Chapter 6

OSHA penalty: An employer who willfully/repeatedly violates requirements of section 5 or rules promulgated under section 6

$5,000-$70,000 fine

AAMI is a voluntary organization, so why is it important to comply with these standards?

-AAMI standards are a key resource for healthcare guidelines bc many of their documents have been approved by the American national standards institute (ANSI) -noncompliance is cited by regulatory and voluntary organizations that inspect healthcare facilities.

American society of heating, refrigeration, and AC engineers (ASHREA)

-ANSI/ASHREA/ASHE standard 170: ventilation of health care facilities -this standard identifies the operating parameters for healthcare heating, ventilation, and AC (HVAC)

FDA labeling document

-FDA expressed concern about the potential for disease transmission caused by improperly reprocessed medical devices... so they released document "Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities" -holds both manufacturer and user responsible

FDA enforcement requirements for healthcare facilities reprocessing single-use devices

-FDA requires anyone who processes single-use devices (SUDs) to obtain and comply with FDA 510(k) directives to reprocess SUDs To obtain approval, the facility must... 1. prove it can properly clean and sterilize the product to manufacturers standards every time 2. show it is able to test the product to prove the standards have been met in all reprocessing areas, including decontam, disinfection, and sterilization

Centers for Disease Control and Prevention (CDC)

-Federal agency -works to promote health and quality of life by preventing and controlling disease, injury, and disability, and by responding to health emergencies -developed the first practical recommendation for isolation technique and guidelines for infection control. -2008: released "Guideline for disinfection and sterilization in healthcare facilities" which is widely used by other agencies/facilities.

Class 3 devices

-HIGH RISK -heart valves, pacemakers, and other life-sustaining devices. -manufacturers of class 3 devices must obtain a premarket approval (PMA) from the FDA to demonstrate product safety and efficacy.

Class 1 devices

-LOW RISK devices -most handheld surgical instruments, hospital beds and ultrasonic cleaners. -subject to "general controls" which include registration and device listing, medical device reporting, and quality system regulation and labeling

Class 2 devices

-MEDIUM RISK -pose potential risks great enough to warrant higher level of regulation -most types of sterilization equipment, BIs, and chem indicators. -general controls alone are insufficient to assure safety and effectiveness and existing methods are available to provide such assurances; in addition to complying with general controls they are subject to special controls... such as performance standards, post market surveillance studies and specific guidelines of special labeling

The occupational exposure to bloodborne pathogens standard

-OSHA guideline -outlines employee safety in all areas of facility as they relate to potential exposure from bloodborne pathogens. -Non compliance (not following rules for transport of contaminated instruments or not wearing PPE) results in heavy fines.

ANSI/AAMI ST79: comprhensive guide to steam sterilization and sterility asssurance in health care facilities

-One of most widely used documents in SP -addresses processes that affect all types of sterilization -need current version in facilities -used in surverys

Class 2: Less Serious Risk Recall

-There is a possibility that the product will cause a temporary or medically reversible adverse health problem; or a remote chance that the device will cause serious health problems - manufacturer must notify customers and sometimes ask them to inform the products recipients -generally no press release.

Class 1: High risk Recall

-There is a reasonable chance the product will cause serious health problems or death -manufacturer must notify customers and direct them to notify the product recipients (notification must include name if device, lot/serial number, the reason for recall, and instructions to correct avoid or minimize the problem.) -manufacturer must also issue press release to notify the public (FDA may issue its own; plus info on website)

FDA MedWatch

-Voluntary reporting of device related problems (medical device malfunctions, labeling inadequacies, inadequate IFU, etc.) -Safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious health problems suspected to be associated with the drugs and medical devices they prescribe, dispense, or use.

Medical device recalls

-an action taken to address a problem with a medical device -this action can be initiated when a device is defective and/or poses a health risk. -can be instituted voluntarily by the manufacturer, distributor or other interested party, or they can be mandated by the FDA. -FDA monitors all mandated recalls to ensure actions taken by the manufacturer and adequate.

Centers for Medicare and Medicaid (CMS)

-federal -responsible for the operation of Medicare, Medicaid, and the state children's health insurance program -also an agency that administers the standards of the Health Insurance and Portability and Accountability Act (HIPPA) -the agency performs both announced and unannounced visits and if standards aren't followed, the facility can lose funding including Medicaid and Medicare payments

Occupational safety and health administration (OSHA)

-federal -protects workers from occupationally caused illnesses and injuries. -many OSHA regulations and standards are represented in laws passed by congress

U.S. Department of Transportation (DOT)

-federal gov. agency -dedicated to ensuring a fast, safe and efficient transportation system. -focused on the transportation of minimally processed instrumentation for repair or reprocessing, and the transportation of hazardous/radioactive wastes. -inspects and cites organizations for statue violations.

U.S Environmental Protection agency (EPA)

-federal regulatory agency -responsible for minimizing greenhouse gases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing chemical regulations -regulates emission standards for ethylene oxide (EO) sterilization (no national emission standards) -federal insecticide, fungicide, and rodenticide act (FIFRA) -1990 clean air act amendments

International Organization for Standardization (ISO)

-non governmental, international organization -brings together experts to developed voluntary, consensus based standards -provides state of the art specifications (helps efficiency)

Society of Gastroenterology Nurses and Associates (SGNA)

-nonprofit -dedicated to safe and effective practice of gastroenterology and endoscope nursing -develops standards and guidelines related to processing of flexible endoscopes

Association for the Advancement of Medical Instrumentation (AAMI)

-nonprofit voluntary consensus organization -compromised of healthcare tech professionals. -research and develop standards and technical information reports (TIRs)

Association of periOperative Registered Nurses (AORN)

-professional organization who develops nationally recognized guidelines. -not regulatory, but regulatory officials look for compliance with AORN guidelines, and surveying agencies also refer to them when reviewing SP areas

U.S. Food and Drug Administration (FDA)

-regulatory agency -responsible for ensuring that medical devices are safe and effective for patient care -regulates the manufacture of all medical devices, sterilants, HL disinfectants, packaging materials, sterilizers, and quality monitors (BI)

Instructions for use (IFU)

-required by the FDA -should contain detailed instructions on how to properly process and use the product. This includes disassembly, cleaning, assembly, disinfection, and sterilization instructions.

"Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities"

-requires manufacturers to comply with certain criteria (mostly reprocessing instructions) when they submit medical device applications to the FDA for evaluations -manufacturer is responsible for... 1. supporting the claim of reuse with adequate labeling and complete reprocessing instructions 2. The validation/documentation of tests, which shows that the instructions are adequate and can be reasonably executed by users. User is responsible for... 1. confirming they have the facilities and equipment to execute instructions 2. ensuring instructions are followed.

General Duty clause of the occupational safety and health act

-requires that each employer provide each employee with a work place that is free from recognized hazards that are harming or likely to harm employees. -have to provide PPE

Medical device reporting requirements

-requires user facilities to report suspected medical device related deaths to the FDA and device manufacturer within 10 days of the event. -users must report device related serious injuries only to the manufacturer within 10 days (unless manufacturer is unknown then it is reported to FDA).

Class 3:Low Risk Recall

-the use of a product is not likely to cause adverse health consequences. -the manufacturer must notify customers -no press release.

Reasons for OSHA inspections...

1. complaints through OSHA's whistleblower protection program 2. rate of workplace accidents 3. high-hazard targets 4. referrals 5. follow-ups from previous visit

In 2008, CMS stopped reimbursing hospitals for patients that acquired...

1. foreign object retained after surgery 2. SSI

All EPA-approved products must contain the following label information

1. product ingredients 2. directions for use 3. product precautions and warnings 4. directions for storage and disposal 5. EPA registration number 6. Exp date

Regulatory standards

A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties.

Medicaid

A federal and state assistance program that pays for health care services for low income individuals. -run by state and local governments within federal guidelines.

Medicare

A federal program of health insurance for persons 65 years of age and older -also for people under 65 with certain disabilities, and people of all ages with end stage renal disease

Best practice

A method or technique that has consistently shown results superior to those achieved by other means.

Standard

A uniform method of defining basic parameters for processes, products, services and measurements.

Statue

A written law adopted by a legislative body

What do insurance companies and other 3rd parties take into account when determining whether to reimburse healthcare insurance claims?

Accreditation

AAAHC

Accreditation Association for Ambulatory Health Care

ACHC

Accreditation Commission for Health Care: surveyors use an educational approach to help facilities enhance quality services

AAAASF

American Association for Accreditation of Ambulatory Surgery Facilities: quality of healthcare in outpatient facilities

OSHA (state)

Approx 25 states and 2 territories have state OSHA offices which typically follow the same penalty criteria as those at the federal level

When soiled instruments are transported between healthcare and repair facilities...

DOT regulations for labeling and packaging must be followed. -proper biohazard labeling and containment State/local regulations can be more restrictive.

American National Standards Institute (ANSI)

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.

greenhouse gases

Gases such as carbon dioxide, methane, nitrous oxide, water vapor, and ozone in the atmosphere which are involved in the greenhouse effect.

Voluntary Standards

Guidelines or recommendations for best practices to provide better patient care

National Fire Protection Association (NFPA)

Internation organization -works to reduce fire and other hazards around the world -address fire burden of all disposable packaged items

Department of health services (DHS)

Many states look to their DHS to establish local health safety standards that may mirror federal standards or be more stringent. -A few states include DHA surveyors in the survey process (often random and unannounced)

Can standards and regulations of STATE agencies be less restrictive than federal counterparts?

NO can be more strict though

Is the CDC considered regulatory?

No -but, other agencies rely heavily on their guidelines and review healthcare facilities for compliance -Many CDC guidelines are incorporated into national standards.

OSHA penalty: An employer who received citation for serious violated under section 5 or rules promulgated under section 5

Penalty of up to $7,000 for each violation

Technical Information Reports (TIRs)

Reports developed by experts in the field that contain valuable information needed by the healthcare industry

Regulation

Rules issued by administrative agencies that have the force of law

DOT (state)

Several states have their own regulations for transporting healthcare wastes from facility to landfills/other final disposal sites.

EPA (state)

Some states have EPA offices that regulate biohazardous waste and drain discharge -they also monitor chemicals poured into main sewer lines, and there may be regulations against pouring blood and disinfectant into drains into SP decontamination area.

State Regulatory agencies

State regulatory agencies

T/F: A recall does not always mean the affected product can no longer be uses; it could also mean that the product needs to be checked or repaired.

TRUE

T/F: AAMI publishes many standards and TIR's and many address functions that affect the SPD, including cleaning, sterilization, packaging, and equipment testing.

TRUE

T/F: AORN's Guidelines for perioperative practice has several sections devoted to topics directly affecting the SPD

TRUE

T/F: The joint commission holds the APIC dept. and SP management responsible for cleaning and sterilization outcomes in SPD.

TRUE

T/F: regulations and standards are issued by federal, state, and local governing agencies. Standards are also issued by professional organizations and provide significant assistant to healthcare ppl bc they are developed according to best practice.

TRUE

T/F: every disinfectant and sanitizer manufacturer must obtain an EPA registration number for every covered product.

TRUE -the manufacturer must submit date relating to labeling claims, efficacy and safety. If data is accepted, a registration # is issued -All disinfectants used in SPD and other instrument reprocessing areas must be EPA approved

TJC

The Joint Commission -private, independent, nonprofit organization that develops standards for healthcare facilities -personnel evaluate healthcare organizations and programs in the U.S. by conducting on-site surveys at least every 3 years -unannounced and stay 2-5 days -failure to comply with TJC may result in loss of accreditation by federal and state governments, thus losing Medicare and Medicaid money

Safe Medical Devices Act of 1990

The law requires reporting of all injuries and deaths resulting from medical devices.

Standards (AAMI)

Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use.

Do SP technicians interact with infection preventionists (IP's)

YES -they collect data on HAI's, employee health, and inservice education -surveys

Can OSHA intervene in a matter of worker protection, even if there is no specific regulation that covers the situation?

YES. -conducts announced/unannounced visits

Serious injury

an injury or illness that is life-threatening; resulting in permanent impairment of a body function or permanent damage to body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body structure.

Medical device classifications

class 1, 2, and 3 -the level of regulation placed on any device depends upon on how the FDA classifies it

United States Pharmacopeia-National Formulary (USP-NF)

creates and revises standards for the purity of medicines, drug and dietary substance -important for SP technicians who work with purified or sterilizing water for irrigation.

Emergency Use Authorization (EUA)

during public health emergencies, the FDA may authorize the use of medical countermeasures (MCMs) for a designated time period, in order to strengthen the nation's public health protections. Example: during covid, EUA was implemented to allow the decontamination of N95 face mask since there was a shortage and they were a necessity.

World Health Organization (WHO)

international agency sponsored by the United Nations -improves health conditions -combats disease (especially infectious) and promote general health of people worldwide.

OSHA penalty: an employer who received citation for violating section 5 or 6 and isn't serious.

may be assessed a penalty up to $7,000

What do regulations and standards establish?

minimum levels of quality and safety

DNV GL Healthcare

part of Det Norske Veritas: global independent foundation dedicated to safeguarding life, property and the environment. -accredits acute care and critical access hospitals provides comprehensive as well as primary stroke center certification.

Professional Associations

promote voluntary standards that provide a foundation for processes and practices performed in SP -Some surveying agencies incorporate these standards into their survey requirements

Health Insurance Portability and Accountability Act (HIPPA)

provides federal protections for individually identifiable health info held by covered entities and their business associates and gives patients an array of rights with respect to that info. -protects patients medical records and other personal health info.

Premarket Approval (PMA)

the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Association for professionals in infection control and epidemiology (APIC)

voluntary organization whos members work to prevent HAI's -work with other agencies, such as CDC, to adopt standards for infection and disease prevention