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This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 112
Regulations and Standards Impact Safe Instrument Processing
[Reprinted from Communiqué: May/June 2010]

No one at any organizational level within the Central Sterile Supply Department (CSSD) has a more important obligation than to ensure that the instruments and other devices for which they are responsible are consistently processed according to standards. CSSD personnel have some important allies in their campaign of processing excellence: governmental agencies that issue and administer regulations and voluntary associations that develop and promote guidelines that impact processing standards and protocols.

Objective 1. Discuss the role of several federal agencies in the regulation of processing procedures in Central Sterile Supply Departments (CSSDs).

Several federal agencies administer enforceable regulations that impact sterile processing departments.¹

The Department of Health & Human Services (HHS) houses three agencies that directly impact hospitals:

• Food and Drug Administration (FDA). The FDA has issued numerous regulations that apply to CSSD professionals including those related to:
  • Medical device classification. This system determines the level of regulation placed on medical devices and places instruments in three categories: Class I (low risk and least regulated), Class II (potential risk and moderate regulation), and Class III (high risk and most stringent regulation).
• Pre- and post-market requirements. These regulations specify what medical device manufacturers must do to ensure that new devices will be safe and effective for their intended use.
• Medical device reporting requirements. Healthcare facilities must report suspected medical device-related deaths and injuries. The MedWatch program encourages the voluntary reporting of device-related problems.
• Reuse of single use devices (SUDs). Hospitals that reprocess SUDs must comply with the FDA’s pre- and post-market requirements.
• Centers for Medicare & Medicaid Services (CMS). This agency administers the Medicare program (hospital and medical insurance and prescription drug coverage for seniors), Medicaid (medical expense coverage for low income persons under the age of 65) and the Children’s Health Insurance Program (CHIP) for low-income children.
• Centers for Disease Control and Prevention (CDC). Although CDC guidelines are not considered regulatory, other agencies rely heavily on them and review healthcare facilities for compliance with them. Many CDC guidelines are incorporated into the policies and procedures of healthcare facilities, including their protocols for instrument processing following exposure to prions.

Other federal regulatory agencies also have a significant impact on CSSD personnel.

Occupational Safety and Health Administration (OSHA). The primary role and responsibility of OSHA is to protect workers from occupationally-caused illnesses and injuries. Violation of its regulations and standards can create severe fines and also endanger accreditation by The Joint Commission. Two OSHA regulations are of critical importance to CSSD personnel. The Occupational Exposure to Bloodborne Pathogens Standard outlines employee safety in all areas of the healthcare facility as they relate to potential exposure from bloodborne pathogens. OSHA has also issued guidelines for the safe use of Ethylene Oxide Sterilization (EtO).

Environmental Protection Agency (EPA). This agency is responsible for minimizing greenhouse gases and toxic emissions, regulating the re-use of solid wastes, controlling indoor air pollution, and developing and enforcing pesticide regulations. The EPA administers two acts that are very important to CSSD personnel. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates pesticide safety and effectiveness, and it impacts all antimicrobial products, including disinfectants and sanitizers. The 1990 Clean Air Act Amendments created a regulatory program to protect the earth’s ozone layer, and healthcare facilities must use an approved ethylene oxide (EtO) sterilant mixture. Another regulation affects the use of medical waste incinerators. Because the cost of retrofitting existing incinerators is usually very high, some hospitals are returning to reusable items, and this creates an increased workload in these CSSDs.

Agency for Healthcare Administration (AHCA). All healthcare facilities must be licensed by the government. While AHCA’s primary function is inspection of new and renovated facility constructions, annual facility inspections are also performed. This inspection process is in cooperation with OSHA to help ensure that facilities continue to be safe for workers and patients. For example, if a facility decides to install a new EtO sterilizer, permits, inspections and/or testing would be required by at least four agencies: AHCA, OSHA, EPA, and FDA.

Department of Transportation (DOT). Its laws relating to healthcare include those concerning the transportation of minimally-processed instrumentation for repair/labeling, and the transportation of hazardous and radioactive wastes. Note: State or local regulations may be more restrictive than federal regulations and, in all cases, regulations with the most stringent provisions apply.

Objective 2. Explain the role of voluntary associations in improving the safety of instrument processing.:

Several professional associations develop and promote voluntary standards that provide a foundation for the procedures and protocols used by CSSD personnel.

Association for the Advancement of Medical Instrumentation (AAMI). AAMI committees research and develop new (or revise existing) Recommended Practices and Standards that address the use, care and processing of devices and systems. These voluntary guidelines represent a consensus of AAMI members that medical instrumentation is safe for patient use. AAMI also develops standards which are recommendations that provide guidance to device manufacturers about design, performance, labeling, and other factors applicable to their instruments. Noncompliance with the standards is cited by regulatory organizations that inspect healthcare facilities.

The Joint Commission. This private, independent not-for-profit organization develops standards for healthcare facilities. Its representatives evaluate healthcare organizations and programs in the U.S. by conducting on-site surveys at least every three years. Failure to comply with its standards can result in the loss of accreditation by the federal and state governments. This, in turn, may cause the loss of millions of dollars in Medicare and Medicaid program payments. The Joint Commission’s Tracer Methodology of unannounced surveys and direct observation and personal contact with everyone involved in patient care has brought the surveyors directly into the operating room and other procedure locations. The Joint Commission’s surveys emphasize continuous improvement in the quality of patient care, and its standards may be incorporated by reference into federal, state and/or local statutes, and then become binding on healthcare facilities.

American National Standards Institute (ANSI). While ANSI does not develop American standards, it provides a neutral arena for interested parties to work toward agreement. Its committee membership is similar to that of AAMI, and standards are submitted to ANSI for approval by other organizations. Examples of ANSI-approved standards include the Recommended Practices and Standards developed by AAMI.

The Association of periOperative Registered Nurses (AORN). This professional organization consists of peri-operative nurses and others who are dedicated to providing optimal care to surgical patients. AORN committees develop nationally-recognized Standards, Recommended Practices and Guidelines, and CSSD personnel must know about those that relate to instrument processing.

The Association for Professionals in Infection Control and Epidemiology Inc. (APIC). APIC members work with other agencies, such as the Centers for Disease Control, to adopt standards for infection/disease prevention. CSSP personnel may interact with their facility’s Infection Control professionals who conduct departmental surveys to ensure compliance with APIC Standards, Practices and Guidelines.

National Fire Protection Association (NFPA). This association is important to CSSD staff members because of the fire safety standards used for the buildings in which they work. As well, NFPA standards address the fire burden of all disposable packaged items stored and used within the facility, the fire standards for patient drapes utilized in the operating room, and wrappers utilized in the CSSD processing area.

United States Pharmacopoeia – National Formulary (USP-NF). The USP-NF creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements. The USP-NF is important to CSSD employees who work with purified water or sterilized water for irrigation.

Society of Gastroenterology Nurses and Associates (SGNA). This non-profit organization collects information and establishes standards and guidelines related to the processing of flexible endoscopes.

Objective 3:

Representatives of regulatory and voluntary organizations look for quality, regulatory and standards compliance, verification of the operation, and evidence of self-monitoring. Signs of quality include well-defined operating parameters and services, and a statement about the mission and goals of the CSSD.

The surveyor/inspector will determine if the department is clean, neat and in good physical repair because this reflects the quality of patient care that is provided.

Record-keeping is paramount for regulatory and standards compliance and must demonstrate consistent adherence to all relevant statutes and departmental policies. For example, OSHA requires facilities using EtO sterilization to maintain extensive utilization records, employee education, area leak testing, employee exposure monitoring, and health screening. These records must be maintained for 30 years beyond termination of employee service.² Note: Other sterilization methods do not require such complex monitoring and, depending on state and facility requirements, records may only need to be retained for three, five or seven years.

All employees who have contact with, or work in the vicinity of EtO, peracetic acid, glutaraldehyde, and hydrogen peroxide gas plasma products must receive an OSHA-required annual review of the hazards and safety procedures associated with each product.³ Records to support this will be reviewed by OSHA inspectors.

One point of standard compliance that will be emphasized relates to the documentation of education and proficiency. Appropriate education must be provided for each type of equipment processed. A documented return demonstration of successfully completing the processing steps validates the proficiency. Documentation of new hire orientation, education for new products, devices and processes, and mandatory annual reviews can keep a manager very busy.

Agencies that inspect and/or survey healthcare facilities will also be looking for evidence of quality monitors including “measures of success” related to operation and services.⁴ Straight-forward verification of sterilization cycles is common. Load contents, cycles and parameters are everyday records of sterilization quality monitors. Biological and chemical monitoring of select cycles verifies correct operation of the equipment in use. It is also important to document the recall procedure associated with each specific sterilization process. Utilizing an actual event or staging an event indicates that the process is functional and adequate.

Processes that require qualification testing include any major renovation or repair of sterilization equipment. Changing packaging systems or products, such as rigid containers or wrapping materials, should also be verified as effective with utilization of your facility’s equipment. Changing products for cleaning, disinfection or lubrication should also be evaluated. Even if your facility does not experience frequent changes of this type, periodic documented monitoring of these processes will assure surveyors/inspectors of your level of commitment to high quality care.

Objective 4:

Regulatory agencies and voluntary associations have one common goal: the provision of safe, appropriate, high quality care. When violations of statutes or standards are observed, federal and state agencies can levy fines in amounts determined by severity of the infraction, number of like infractions found, and their level of concern for potential harm to workers or patients.⁵

CMS officials can reduce the amount of funding the facility receives for services rendered to Medicare and Medicaid patients if its standards of minimal expectations of quality patient care are not maintained. No one wants less for their patients or to be paid less for their efforts, so ongoing procedures to ensure compliance with CMS expectations are always in order.

Extreme consequences, including the immediate closure of a facility or service, are possible. An action of this magnitude reflects imminent life-threatening circumstances for the patients or staff. It is a rare, but not unheard of, occurrence that can be initiated by State or Federal agencies.⁶

Summary

The consistent provision of the highest quality disinfection and sterilization services can be a monumental task, and it is a vital link in efforts to provide safe health care. The standards and recommended practices of regulatory agencies and voluntary associations provide a guide for the ongoing efforts needed to provide safe, evidence-based and high quality health care. Focusing on the primary goal of providing safe, high quality care will minimize concerns when interacting with inspection and survey personnel who partner with CSSD personnel in efforts to help all healthcare recipients and providers.

Endnote

1 Information addressing objectives 1 and 2 is based upon Chapter 5 in: Central Service Technical Manual. Seventh Edition. Chicago, IL. International Association of Healthcare Central Service Materiel Management. 2007.

2 Ethylene Oxide. OSHA Safety web site. http://www.oshasafety.org/osha_ethylene_oxide.asp 2003.

3 Introduction to OSHA. Princeton University web site. http://web.princeton.edu/sites/ehs/healthsafetyguide/F1.htm

4 Understand the Quality of Care Measures. The Joint Commission. Web site. http://www.jointcommissionreport.org/background/qualityofcaremeasures.aspx

5 Federal, State, and OSHA Regulations, Statutes, Fines and Penalties. American Professional Safety Trainers Alliance. Web site. http://www.apsta.org/laws-fines.html

6 Utah Administrative Code: Rule R432-3. General Healthcare Facility Rules Inspection and Enforcement. http://www.rules.utah.gov/publicat/code/r432/r432-003.htm

CRCST 112 QUIZ