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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 114
Legal Aspects of Standards and Recommended Practices
[Reprinted from Communiqué: September/October 2010]

Managers and their Central Sterile Supply Department (CSSD) employees are confronted with significant challenges as they reprocess complex instruments and medical devices. They must be concerned about patient safety, and they have a duty to perform their tasks accurately and within professional and industry standards and guidelines. At the same time, they must also comply with all of the federal, state, and local laws, codes, and ordinances that govern our profession.

CSSD managers and staff must be well-versed in the standards and recommended practices that are used as guidelines for the safe practice and handling of instrumentation and medical devices. With the ever-changing healthcare workplace, new challenges constantly emerge that directly impact patient and staff safety and the environment, and strain the limited resources allocated to successfully complete tasks.

What are the legal concerns that affect CSSD personnel as they successfully incorporate the various Standards and Recommended Practices into the day-to-day operation of their department? What do the various legal terms mean? These issues are addressed in this Self-Study lesson.

Objective 1: Define applicable terms and provide examples of how they apply to the Central Sterile Supply Department profession.

A recommended practice contains guidelines for the use, care or processing of a medical device or system. Without addressing device performance per se a recommended practice describes procedures and practices that will help ensure that a device is used safety and effectively, and that its performance is maintained.”¹ A guideline is an official recommendation indicating how something should be done or what sort of action should be taken in a particular circumstance.

These recommended practices and guidelines are created by a body of healthcare experts, industry representatives, and governmental officials. The recommended practices are supported by scientific evidence and past best practices and are intended to meet the clinical needs of CSSD professionals to provide a safe environment for patient and staff. Their application is voluntary, and at the discretion and professional judgment of the user.

Let’s take a look at one of the most recent standards, ANSI/AAMI ST79, that incorporates several previous standards and recommended practices into one document.² It details the rationale for the method that should be used to provide the appropriate care and handling of contaminated items. This is important to CSSD professionals because contaminated items pose a health risk to the staff who are handling the devices and to the patient during the next use.

All CSSDs handle contaminated items and must develop procedures and policies to guide staff in their handling. ST79 details the separation of waste material from reusable items, the care and handling of the items at point of use, material containment, and transport protocols.³ It also details the off-site transport of contaminated items between healthcare facilities and states that certain “non-waste” products are considered to be “infectious substances” by the US Department of Transportation (DOT). It has provided parameters that describe infectious and infectious products.⁴

Regulations are “rules and administrative codes issued by governmental agencies at all levels: municipal, county, state, and federal. They are adopted under authority granted by statutes, are enforceable by law, and often include penalties for violations.⁵ Regulations are not voluntary and, typically, several agencies may have responsibility for enforcement.

In the example above, a failure to properly train staff in the care, packaging, separation, and transport of contaminated surgical instruments from an off-site surgical center to a decontamination room could open a healthcare facility to a state or federal inspection and subsequent fines for any regulation violations. For example, a spill of improperly containerized contaminated instruments during transport could expose a driver to hazardous material. The Occupational Safety and Health Administration (OSHA) requires that measures be in place to limit exposure(s) and to facilitate the safe clean-up of any spills. An exposure plan and staff safety training relating to exposures are requirements of all healthcare facilities and are detailed in applicable regulations. It would be prudent to have these safety measures in place before implementing off-site transport of contaminated surgical instruments.

Safety procedures must be developed and incorporated into the policy and procedure (P+P) manual of every facility. Then initial training for new staff and ongoing training for all CSSD personnel are required to ensure that appropriate procedures are consistently followed.

A policy is a course of action or a program of actions adopted by a person, group or government, or the set of principles upon which they are based. Each healthcare facility should have a detailed manual of procedures detailing the actions that a prudent professional should take in a situation. Policies must meet a variety of facility, federal, state, and local requirements and incorporate professional best practices based upon the standards and recommendations from a body of experts. In litigation, facility policies will be considered the “floor” or proper conduct. Meaning, at a minimum, employees must follow their facility’s own policies.

The concept of best practice, a slang term used in the business world, arises from the management tool known as “benchmarking.”⁶ CSSP professionals should be well versed in ways to measure and objectively determine the best method for implementing strategies that help achieve desired results. In a court of law, you may be challenged to measure your policies and procedures against what is considered to be an industry “best practice.” How your facility’s processes compare to best practice determines whether the course of action taken was reasonable, as we will discuss below.

ST79, for example, states that “instruments with lumens should be brushed using a brush of the correct size for the lumen, then rinse.”⁷ If a facility has a policy that does not address this cleaning step, a sterilization failure as a result of potential residual biological burden could result. In a civil case where a patient was alleged to have been injured due to contaminated instruments, your facility’s P+P manual will be examined by the expert witnesses presented by the attorney of the plaintiff (the party bringing the court action) as to whether the failure to adopt the industry best practice of cleaning lumens with a brush helped to cause the patient’s injury.

The defendant’s (healthcare facility’s) attorney would likely note the “voluntary” nature of the application and use of the AAMI Standard cited previously. However, unless your facility can offer a detailed study or manufacturer’s guideline that indicates that the brushing of lumen is not required for a particular instrument, your actions would be judged against the body of evidence as presented in ST79.

Your actions, policies and procedures will also be evaluated against what is known as a “Standard of Care.” This refers to the amount of attentiveness, caution and prudence that a reasonable person in the same circumstances would exercise. Failure to meet the standard is negligence, and the person who fails to meet the standard is liable for any damages caused by the negligence. The standard is not subject to a precise definition and must be judged on a case-by-case basis.⁸ Again, healthcare facilities will be compared to reasonable care and actions taken by CSSD professionals and to the standards of care as defined by the Central Sterile Supply Department profession. Would a reasonable CSSD technician brush out a contaminated lumen? According to the AAMI ST79, the answer is “yes.”

Objective 2: Review methods to incorporate Standards and Recommended Practices into a comprehensive policies and procedures manual.

How should the various standards and recommended practices be incorporated into a comprehensive P+P manual? Some companies offer “cookie cutter” or “off the shelf” approaches to the development and writing of CSSD policies. Several claim their template material is based upon standards and recommended practices developed by the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of peri-Operative Registered Nurses (AORN). Purchasers just add unique details to make the policies relevant to their facility. Potential purchasers must conduct the necessary research to determine if this is a viable alternative. Departments with a restricted budget may not be able to invest in this process and, instead, will choose a different method.

Most healthcare facilities write their own P+P manuals based upon a template selected by the facility. The typical document has a header containing information about:

• Document title; example: Steam Sterilization
• The target audience of the document (“All Central Sterile Supply Department staff”)
• The name of the healthcare facility
• Dates that the document was written, reviewed and revised
• Document’s author
• The location of the document within the entire manual

Next, there is typically a policy statement that describes its purpose or goal. In the case of a steam sterilization policy, the policy must clearly address the use of flash sterilization by operating room and/or obstetrical staff. The P+P should describe the policy’s scope, including all personnel who utilize the device.

Because ST79 describes the preparation of instruments for sterilization and their loading and off-loading, sterilizer testing, and sterilization parameters, the writer should consult the document for guidance about how to handle the various device operations as recommended by the body of experts that contributed to ST79.

It is important to include the original equipment manufacturer’s written guidelines when researching and referencing source material for the P+P. These guidelines typically include a major segment with information about the safe and intended operation of the device. The writer could reference selected portions of ST79 to detail the importance of performing each operating step correctly and in compliance with the standard. Pictures and diagrams could help the reader and provide additional details about the safe loading and off-loading of steam sterilizer racks. As well, use of the OEM manual will provide additional and equipment-specific information.

Training with in-services sessions, skills checklists, and hands-on skills labs are examples of venues that provide opportunities for CSSD managers and technicians to review procedures. As they do so, they will gain confidence in the safe handling of instruments, medical devices and the many complex machines used in the profession. ST79 explains that training must be provided on new procedures, and that the department should be staffed with able and competent employees. The use of a well-written P+P manual is the foundation for achieving that goal. It is the joint responsibility of all technicians to familiarize themselves with the various standards, guidelines, recommendations, and regulations that influence/impact the operation of the department.

ST79 recommends that individuals assigned to sterile reprocessing are those who have “demonstrated competence in all aspects of sterile reprocessing: decontamination, preparation, packaging, sterile storage, and distribution of sterile medical devices.”⁹ It also discusses orientation, training and verification of staff competence, and the importance of continuous education. Further, it is recommended that only certified Central Sterile Supply Department technicians work in CSSD and that, at minimum, all newly-employed personnel successfully complete a CSSD certification examination within two years as a requirement of their employment. The reason: only a skilled and certified workforce can meet the ongoing challenges regarding advancements in technology and work processes.

Objective 3: Explain the consequences of failing to incorporate standards and recommended practices within the CSSD.

What are the potential consequences of not addressing CSSD standards and recommended practices? Failure within the scope of the professional practice in the healthcare setting can lead to potentially negative outcomes for both the patients and the facility. The facility and its reprocessing team will be expected to meet the standards of care practiced by all individuals working in similar departments and performing similar tasks. A complete examination of the skills, training, and policies and procedures will occur whenever a patient is harmed. It will be a difficult position to defend if the written policy fails to follow national industry standards. A civil lawsuit argued by a plaintiff’s attorney will explore these standards in an effort to show causation and to place blame for negative outcomes because of a failure to follow these guidelines.

Recently, the Center for Medicare & Medicaid Services (CMS) implemented several new policy mandates regarding healthcare institution reimbursement. Patients who develop a hospital-acquired infection due, for example, to a failure to properly clean and sterilize an instrument may not have their medical expenses reimbursed to the facility that provided the service. This revenue loss will impact the ability of healthcare facilities to render service, pay expenses, and hire and retain employees.

In Conclusion

Efforts should be made to reduce the potential risk to patients and to enhance the abilities of skilled technical staff to effectively process instruments and medical devices. The incorporation of standard practices will help to reduce cleaning and sterilization errors, and reduce the potential for harm to the patients.

Endnotes

1 AAMI. Sterilization, Part I: Sterilization in Healthcare Facilities.
2 ANSI/AAMI ST79: 2006, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities
3 See Reference 2 (Section 6.5.6)
4 49 CFR 173.134 [a] [1]
5 US Legal.com
6 US Legal.com
7 See Reference 2 (Section 7.5.6)
8 US Legal.com
9 See reference 2 (Section 4.2.2)

CRCST 114 QUIZ