Steris Article on Environmental Monitoring

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2. CHL Self-Study Lesson Plan CHL SELF-STUDY LESSON PLAN JANUARY / FEBRUARY 2017 Communiqué 29 www.iahcsmm.org 28 Communiqué JANUARY / FEBRUARY 2017 www.iahcsmm.org equipment. 1 With the Occupational Safety and Health Act of 1970, Congress created the Occupational Safety and Health Administration (OSHA), a division of the U.S. Department of Labor. The purpose of OSHA is to assure safe and healthful working conditions for working men and women by setting and enforcing standards – and by providing training, outreach, education and assistance. The employer bears the onus of responsibility for worker safety. OSHA is responsible for: • E stablishing regulations to protect e mployees in the workplace; • D riving workplace safety through its H azard Communication Standard; • P rimary modes of communication, i ncluding Safety Data Sheets (SDSs, f ormerly known as Material Safety Data S heets or MSDSs) and product labeling. Under a department’s quality management system, documents should be controlled. SDSs should be reviewed on an annual basis, and the most current versions should be available at points of use. 4 On OSHA’s website, www.osha.gov, a helpful PDF version that explains Hazard Communication SDSs is provided. The Hazard Communication Standard (HCS) requires chemical manufacturers, distributors or importers to provide SDSs to communicate risks of hazardous chemical products. As of June 1, 2015, the HCS requires new SDSs to be in a uniform format and include the section numbers, headings, and associated information under the headings. Employers must ensure that SDSs are readily accessible to employees. The National Institute for Occupational Safety and Health (NIOSH) is the U.S. federal agency responsible for developing new knowledge in the field of occupational safety and health and transferring that knowledge into practice. The Occupational Safety and Health Act of 1970 established NIOSH. NIOSH is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. NIOSH has more than 1,300 employees from a diverse set of fields, including epidemiology, medicine, nursing, industrial hygiene, safet y, psycholog y, chemistr y, statistics, economics, and many branches of engineering. NIOSH works closely with the Occupational Safety and Health Administration (OSHA). Another organization that addresses safety and health is the Centers for Medicare & Medicaid Services (CMS), a division of the Department of Health and Human Services (HHS). One of CMS’s programs, Hospital Compare, is a consumer-oriented website that provides information on how well hospitals provide recommended care to their patients. This information can help consumers make informed decisions about where to go for quality healthcare. Consumers may compare hospitals based on their overall star rating, summarizing up to 64 measures of quality shown on Hospital Compare. CMS is responsible for: • E nsuring that the voices and needs of t he populations they represent a re present as the agency develops, i mplements and evaluates its programs a nd policies. • E nsuring all CMS beneficiaries have a chieved their highest level of health, a nd that disparities in healthcare q uality and access have been eliminated. It is critical that CS department leaders understand the role the department plays in supporting the healthcare facility through CMS requirement compliance. Providing safe, clean and sterile medical devices for use in clinical procedures is the first step in supporting these CMS quality initiatives and, ultimately, making patients safer. Knowing the right questions to ask manufacturers is also important. CS leaders should do their homework and research the resources available, including white papers, regulations and guidelines, before accepting third party interpretation of requirements. If further clarification and confirmation is needed, leaders should consult with representatives from OSHA or NIOSH to gain a better understanding of these requirements. INDUSTRY GUIDELINES The Association for the Advancement of Medical Instrumentation (AAMI) is a part of the American National Standards Institute (ANSI) and represents the U.S. on medical devices and processing (cleaning, disinfection, sterilization) at the International Organization for Standardization (ISO). AAMI provides published standards, recommended practices and technical information reports (TIRs) that support healthcare facilities and the many processes that contribute to quality patient care. In addition to AAMI, many other professional organizations provide evidence-based practice guidelines to support various healthcare professionals/ disciplines. Organizations such as the Association of periOperative Registered Nurses (AORN) and the Association of Surgical Technologists (AST), for example, provide nurses and surgical technologists with guidance and support. OBJECTIVE 2: REVIEW THREE COMMON WORKPLACE HAZARDS: CHEMICAL/STERILANT INHALATION, SKIN CONTACT AND EYE CONTACT Leaders in the CS department are ultimately responsible for the protection of personnel, visitors and staff working within their department. In a quality management system (QMS), safety processes are addressed as part of human resources; “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” 4 The work environment itself must also be addressed because work environment conditions can have an adverse effect on product quality. The department should document the requirements for the work environment and the procedures to monitor and control the work environment. 4 Employee safety should be a priority with every process carried out in the department. Staff understanding and competence as it pertains to risks associated with chemical and/or sterilant inhalation, skin contact and eye contact can help prevent unnecessary injury. INHALATION SAFETY Respiratory protection from chemicals and/or sterilants is not usually required during normal or routine operation of equipment located in the CS department, as long as safety measures are established and monitored. 3 To ensure safe use of consumable products and operation of processing equipment, the manufacturer’s Instruction for Use (IFU) should always be reviewed in cooperation with regulatory and industry guidelines. Departmental managers should ensure the equipment has been installed properly and is operating in accordance with the manufacturer’s written IFU; this can be accomplished by asking questions of the installation team and reviewing the installation qualification (IQ) documentation. Preventive maintenance, as well as daily care and handling of equipment, also contribute to the ongoing safety and operational performance, which helps ensure staff safety. In addition to industry standards and guidelines, which are becoming increasingly harmonized due to the collaboration of industry experts, ventilation requirements are also specified by the equipment or product manufacturer. When multiple processes are taking place in a specific space or area of the department, air exchanges and ventilation requirements should default to the greater need. For example, if a specific piece of equipment requires five air exchanges per hour, and another product requires 10 air exchanges per hour, then the space should be set for 10 air exchanges per hour to support the greater demand. If additional protection and/or monitoring is required, it is important to consult with the facility engineer and the healthcare organization’s industrial hygienist to identify an appropriate plan. It is also important to review and understand minimum standards, and ensure these are followed. Establishing an annual education and training plan to include measuring operator competence is also essential. There is nothing wrong with exceeding minimum standards, especially if it supports a culture of safety in the department. Personal monitoring should never be taken for granted and employees must understand that 24/7 environmental monitoring is not always enough. Sometimes, a combination of personal and environmental monitoring will meet and even exceed current regulatory requirements; however, it is equally important that the departmental staff also feel their safety needs are being met. Staff confidence can be supported through education and competency development. Personal monitoring devices should also be offered. SKIN SAFETY Ensuring skin protection can be accomplished using various types of personal protective equipment (PPE). Once again, based on the manufacturer’s written IFU, it may not be necessary to wear PPE for skin protection during routine operation, especially if the equipment is a part of a fully-enclosed system. For non-routine exposures, however, it may be necessary to don (put on) chemically-protective gloves, coveralls, and other resistant PPE. If skin contact occurs, the skin should be washed or rinsed in accordance with the manufacturer’s written IFU and the chemical SDS. EYE SAFETY Eye safety is critically important to all departmental personnel and visitors. Departmental managers should ensure The Association for the Advancement of Medical Instrumentation (AAMI) is a part of the American National Standards Institute (ANSI) and represents the U.S. on medical devices and processing (cleaning, disinfection, sterilization) at the International Organization for Standardization (ISO). AAMI provides published standards, recommended practices and technical information reports (TIRs) that support healthcare facilities and the many processes that contribute to quality patient care.

1. CHL Self-Study Lesson Plan JANUARY / FEBRUARY 2017 Communiqué 27 www.iahcsmm.org Sponsored by: by Richard Schule, BS, MBA, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS Director of Clinical Education, STERIS Corporation Lesson No. CHL 359 (Supervisory Continuing Education - SCE) LEARNING OBJECTIVE 1. Identify safety resources that support leadership and management responsibility in the Central Service department 2. Review three common workplace hazards: chemical/sterilant inhalation, skin contact and eye contact 3. Explain the importance of maintaining a safe work environment within the Central Service department Supervisory Continuing Education (SCE) lessons provide members with ongoing education focusing on supervisory or management issues. These lessons are designed for CHL re-certification, but can be of value to any CRCST in a management or supervisory role. Earn Continuing Education Credits: Online: Visit www.iahcsmm.org for online grading at a nominal fee. By mail: Mailed submissions to IAHCSMM will not be graded and will not be granted a point value (paper/pencil grading of the SCE Lesson Plans is not available through IAHCSMM or Purdue Univer - sity; IAHCSMM accepts only online subscriptions). Scoring: Each online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward your CHL re-certification (6 points) or CRCST re-certification (12 points). More information: IAHCSMM provides online grading service for any of the Lesson Plan varie - ties. Purdue University provides grading services solely for CRCST and CIS lessons. Direct any questions about online grading to IAHCSMM at 312.440.0078. Safety in Central Service: Management Responsibility W ITHOUT ARGUMENT, THE PATIENT IS AT THE CENTER OF everything healthcare professionals do; every action may, in some way, affect the patient’s outcome. Just as patients have a right to safe, high quality care, healthcare professionals have the right to work in a safe environment. Certified healthcare leaders are ethically responsible for ensuring that right is protected. Central Service (CS) technicians have the right to know about hazardous chemicals in their workplace and they have the responsibility of knowing their job, remaining alert, learning and following safety rules, attending safety training programs, and participating in all fire and emergency drills. CS departments face unique hazards related to the processes and practices of medical device reprocessing. CS leaders should ask themselves whether they can identify safety resources that support their role and their team’s role in the department; whether they are aware of and able to respond to common workplace hazards in the event they or a colleague become injured; and whether they are able to coach and mentor their team on what is involved in creating and maintaining a safe work environment. OBJECTIVE 1: IDENTIFY SAFETY RESOURCES THAT SUPPORT LEADERSHIP AND MANAGEMENT RESPONSIBILITY IN THE CENTRAL SERVICE DEPARTMENT A sound training program, regardless of the subject or process, begins with a thorough understanding of the educational resources available. There are several safety resources available to CS leaders and technicians. The Eighth Edition of the International Association of Healthcare Central Service Materiel Management’s (IAHCSMM’s) Central Service Leadership Manual, Chapter 17, Central Services Leaders and Safety, Emergency Planning and Disaster Preparedness , addresses safety and identifies several valuable resources to support the department’s safety program. The following section reviews a few resources that can help CS leaders establish an effective safety training program. REGULATORY ORGANIZATIONS The healthcare facility must thoroughly investigate and comply with current federal, state, and local regulatory requirements and codes – including, but not limited to, electrical, fire prevention, safety, and local regulatory requirements and codes – related to the installation, operation and maintenance of processing

3. CHL Self-Study Lesson Plan JANUARY / FEBRUARY 2017 Communiqué 31 www.iahcsmm.org 30 Communiqué JANUARY / FEBRUARY 2017 www.iahcsmm.org appropriate eye protection is available to meet the many physical needs of their staff. In some instances, eye protection may not be necessary, such as during routine operation of fully-enclosed equipment/systems; however, chemical safety goggles should be worn for non- routine situations. Splash-proof goggles or both safety glasses with side shields and a wraparound full-face shield may be required when working with certain chemicals, per the manufacturer’s written IFU. For eye protection, both safety glasses and face shields may be required because many face shields alone do not offer total protection against eye contamination; their use should be considered an adjunct to safety glasses in order to protect facial skin. OBJECTIVE 3: EXPLAIN THE IMPORTANCE OF MAINTAINING A SAFE WORK ENVIRONMENT WITHIN THE CENTRAL SERVICE DEPARTMENT INTERNAL COMMUNICATION As part of the CS department’s QMS, leadership is required to ensure communication processes are established within the department. These communication processes must be appropriate for the department. The effectiveness of the department’s safety program needs to be included in the communication process. Transparency of communication is essential for ensuring technicians in the department have appropriate information on safety issues, warnings and overall knowledge of the chemicals and hazards deployed in the areas where they perform their duties. QUALITY SYSTEMS Environmental programs and QMS are periodically audited for conformance and compliance. Auditors review policies, procedures, maintenance records and logs, training records and documentation. A report of audit findings and nonconformities should be completed for follow-up action. A risk assessment program should also be designed to proactively evaluate the impact on medical device reprocessing as it relates to departmental safety. CONCLUSION Making safety a part of everyday practice is essential for establishing a culture that ensures a safe work environment. Departmental leaders can help ensure there is an understanding of general safety principles, and leaders can also serve as mentors and set the positive examples for others to follow. Committing to workplace safety helps reduce potential hazards. 1 A mature culture of safety becomes a part of the business day and requires very little effort once established; however, all departmental personnel will appreciate knowing they are working in a safe environment. It is the responsibility of all departmental personnel to learn and adhere to all safety requirements, policies and procedures; a zero tolerance for taking shortcuts is important, and departmental leaders must immediately report any safety hazard. Establishing a culture of safety will go a long way toward showing employees that their health and safety are important, and that the work they do every day is valued and supported. REFERENCES 1. International Association of Healthcare Central Service Materiel Management. 2010. Central Service Leadership Manual. Chapter 17 – Central Service Leaders and Safety , Emergency Planning and Disaster Preparedness , pp. 303-329. 2. International Association of Healthcare Central Service Materiel Management. 2016. Central Service T echnical Manual, Eighth Edition. Chapter 22 – Safety and Risk Management for Central Service , pp. 429-449. 3. Association for the Advancement of Medical Instrumentation. 2013. ST58:2013 Chemical sterilization and high-level disinfection in health care facilities , pp. 3-60. 4. International Standard Organization. 2003. ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, Section 6, Resource Management, Second edition. 5. National Institute for Occupational Safety and Health. 2016. http://www .cdc.gov/niosh. 6. Centers for Medicare & Medicaid Services. 2016. www .cms.gov. RICHARD SCHULE, BS, MBA, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, is the Director of Clinical Education at STERIS Corporation. He is responsible for a team of experienced clinical professionals and a portfolio of surgical and sterile processing continuing education and in-service programs for healthcare professionals. He has more than 32 years of experience in the surgical and sterile processing arenas. Schule is actively involved in the development of national standards and guidelines. CHL Self-Study Lesson Plan Quiz - Safety in Central Service: Management Responsibility Lesson No. CHL 359 (Supervisory Continuing Education - SCE) • Lesson expires January 2020 Sponsored by: 1. Central Service technicians have the ________ hazardous chemicals in their workplace. a. Right to know about b. Right to understand c. Right to use d. Right to choose 2. A sound training program, regardless of the subject or process, begins with a thorough understanding of what? a. Safety Data Sheets b. Resources c. Regulatory requirements d. The student 3. What are the Occupational Safety and Health Administration’ s primary modes of communication? a. Safety Data Sheets b. Material Safety Data Sheets c. Product labeling d. A and C above 4. Which regulatory organization is responsible for establishing regulations to protect employees in the workplace? a . The Association for the Advancement of Medical Instrumentation b. National Institute for Occupational Safety and Health c. Centers for Disease Control and Prevention d. Occupational Safety and Health Administration 5. Which organization is responsible for developing new knowledge in the field of occupational safety and health, and to transfer that knowledge into practice? a. Occupational Safety and Health Administration b. Centers for Medicare and Medicaid Services c. National Institute for Occupational Safety and Health d. Centers for Disease Control and Prevention 6. Which organization is a part of the Department of Health and Human Services (HHS)? a. Centers for Disease Control and Prevention b. Centers for Medicare and Medicaid Services c. Occupational Safety and Health Administration d. National Fire Protection Association 7. Which organization is responsible for ensuring their beneficiaries have achieved their highest level of health and disparities in healthcare quality and access have been eliminated? a. Centers for Medicare and Medicaid Services b. National Institute for Occupational Safety and Health c. Occupational Safety and Health Administration d. Centers for Disease Control and Prevention 8. What does the Association for the Advancement of Medical Instrumentation provide to support healthcare facilities? a. Standards b. Recommended practices c. T echnical information reports d. All the above 9. In a quality management system, which section addresses safety? a. Human resources b. W ork environment c. Product realization d. A and B above 10. In addition to regulatory and industry guidelines, what should also be reviewed to ensure safe use of consumable products and safe operation of processing equipment? a. Manufacturer ’s Instructions for Use b. Manufacturer ’s operational manual c. Manufacturer ’s MedWatch report d . Manufacturer ’s maintenance manual 11. Which document should the manager review to ensure equipment was installed correctly? a. Performance qualification documentation b. Operational qualification documentation c. Installation qualification documentation d. Preventive maintenance documentation 12. What type of monitoring supports inhalation safety? a. Personal monitoring devices b. Breathalyzer c. Environmental monitoring d. A and C above 13. Which types of personal protective equipment support skin safety? a. Chemically-protective gloves and resistant protective clothing b . Hair cover , goggles, mask and apron c. Gloves, apron, shoe covers and face mask d. Hair cover , coverall, gloves and face mask 14. What kind of eye equipment should be used to support eye/vision safety? a. Chemical safety goggles b. Splash-proof goggles c. Safety glasses with side shields and a wraparound face shield d. All the above 15. What should be transparent and what is essential for ensuring technicians in the department have appropriate information on safety issues? a. Safety data sheets b. Health hazards c. Communication d. Audit reports

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