CENTRAL SERVICE (CS) TECHNICIANS PERFORM MANY IMPORTANT
|
|
- Dora Jennings
- 5 years ago
- Views:
Transcription
1
2 by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting LEGAL ISSUES: Regulations That Protect the Healthcare Worker and Their Patients LEARNING OBJECTIVES 1. Identify the three major federal regulatory agencies governing work in Central Service 2. Outline major provisions of the Clean Air Act Amendments, Safe Medical Devices Act (including medical device reporting), MedWatch program and Labeling Document 3. Address the U.S. Food and Drug Administration Enforcement Priorities Document applicable for reprocessing single-use devices CENTRAL SERVICE (CS) TECHNICIANS PERFORM MANY IMPORTANT tasks on a daily basis. These tasks may be very simple, such as recording the area temperature and humidity levels, or very challenging, such as processing complex instrumentation. Several government agencies have issued regulations to protect the healthcare worker while they perform important tasks like processing or using the instrumentation. Patients are also protected by these regulations because the guidance provided allows the healthcare worker to process and use the devices correctly. This lesson plan will address a few of the key government agencies and the regulations they enforce for the protection of healthcare workers and their patients. OBJECTIVE 1: IDENTIFY THE THREE MAJOR FEDERAL REGULATORY AGENCIES GOVERNING WORK IN CENTRAL SERVICE The Occupational Safety and Health Administration (OSHA) is the part of the U.S. Department of Labor that provides guidelines 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. 1 The OSHA regulations of most relevance to CS pertain to occupational exposure to potentially toxic chemicals and bloodborne pathogens. 2 Also, the General Duty Clause of the Occupational Safety and Health Act (Sections 5[a] [1]) allows OSHA to intervene in a matter of worker protection, even if there is no applicable regulation. 3 These regulations cover the use of personal protective equipment (PPE) and have set exposure limits to chemicals, such as ethylene oxide (EtO) and glutaraldehyde. The General Duty Clause has provisions for reporting worker safety issues, and for the protection of those that report those issues. State OSHA offices exist in 26 states. This series of self-study lessons on CS topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM), and can be used toward CRCST re-certification or toward nursing credits. Pfeidler Enterprises and IAHCSMM both offer grading opportunities. Earn Continuing Education Credits Online: Nursing Credit: Pfiedler Enterprises will award nursing credit for this Self-Study Lesson Plan. Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP 14944, for 1 contact hour. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. In order to receive credit you must go to and complete the test, evaluation and registration forms. Once completed, you will be directed to print your certificate of completion. Scoring: IAHCSMM will award credit for this Self- Study Lesson Plan toward the renewal of a CRCST certification. To receive IAHCSMM credit, please visit for online grading (nominal fees will apply). Each online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward CRCST re-certification of 12 CEs. For more information: For questions or problems about Nursing Credits available for this lesson plan, please contact tonia@pfiedlerenterprises.com. For questions about IAHCSMM Credit available for this lesson plan, please contact us at or mailbox@iahcsmm.org.
3 Their standards may be more (but not less) restrictive than those of the federal OSHA agency. When in doubt, the most stringent standard (federal or state) should always be followed. U.S. ENVIRONMENTAL PROTECTION AGENCY The mission of the U.S. Environmental Protection Agency (EPA) is to protect human health and the environment. 4 The EPA enforces federal laws pertaining to air and water pollution and other environmentally-related statutes. It coordinates and supports research and anti-pollution activities at the state and local levels. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) gives the EPA responsibility to regulate pesticides to ensure their effectiveness and safety. This includes all products with antimicrobial claims, such as sterilants, disinfectants and sanitizers. The antimicrobials Division of EPA s Office of Pesticide Programs evaluates and registers surface disinfectants and sanitizers. The approval process involves the review of manufacturers labeling claims and safety and effectiveness data. Labels on EPA-approved products must provide the product s EPA registration number, ingredient information, precautions and warnings, and directions for storage, use and disposal. CS professionals must read all applicable labels and follow the specific directions when using chemicals of any kind. U.S. FOOD AND DRUG ADMINISTRATION The U.S. Food and Drug Administration (FDA) is part of the U.S. Department of Health and Human Services. The FDA s Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. 5 The CDRH regulates the manufacture of all medical devices and requires premarket clearance of new medical devices. The level of regulation applicable to a medical device depends upon its FDA classification. Class I devices are relatively simple, low-risk products, such as ultrasonic cleaners and most hand-held surgical instruments. They are subject to general controls, which include postmarket requirements, such as registration and device listing, medical device reporting, corrections and removals, quality system regulation, labeling and, if non-exempt, a premarket notification application [510(k)]; however, most Class I devices are exempt from pre-market submission requirements. 6 Class II devices pose potential risks great enough to warrant a higher level of regulation. They may be subject to performance standards or other special controls, such as post-market surveillance study, specific guidelines or special labeling. Manufacturers of most Class II devices must submit premarket notification applications [510(k)] to the FDA before they introduce a new product. The manufacturer must use the 510(k) application to demonstrate that the new product is equivalent to a product already on the market. Class II devices include most types of sterilization-related equipment and products, such as EtO and steam sterilizers, and biological and chemical indicators. 6 Class III devices are the most stringently regulated. These include heart valves, infant radiant warmers, pacemakers and other implants, and lifesustaining devices significantly different from products already on the market. Manufacturers of new Class III devices must obtain pre-market approval (PMA) from the FDA by submitting extensive test data demonstrating product safety and effectiveness. 6 OBJECTIVE 2: OUTLINE MAJOR PROVISIONS OF THE CLEAN AIR ACT AMENDMENTS, SAFE MEDICAL DEVICES ACT (INCLUDING MEDICAL DEVICE REPORTING), MEDWATCH PROGRAM AND LABELING DOCUMENT The EPA and FDA have issued numerous regulations that affect CS. Some of the most significant include: 1990 CLEAN AIR ACT AMENDMENTS The 1990 Clean Air Act Amendments established a regulatory program administered by the EPA to protect the stratospheric ozone layer. 7 In January 1996, production of the ozone-depleting chlorofluorocarbons (CFCs) used in 12/88 EtO sterilant mixtures was phased out. An alternative gas mixture using hydrochlorofluorocarbons (HCFCs) was developed, approved under the Clean Air Act, and is now a replacement for the CFC sterilant mixture. National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations were also established in the 1990 Clean Air Act Amendments; these were updated in NESHAP regulations established national emission standards for EtO for commercial sterilization facilities. There are no established national emission standards for EtO used by hospitals, but it is important to know about state or regional regulations that may exist. As of July 25, 1997, hospitals are affected by further Clean Air Act Amendments designed to reduce air pollution from medical waste incinerators. Full compliance with these standards has closed most of all hospital incinerators. The options of retrofitting existing equipment, choosing off-site disposal, or finding new technology presented a considerable financial challenge. MEDICAL DEVICE REPORTING Until 1990, FDA regulations applied exclusively to medical device manufacturers. With the passage of the Safe Medical Devices Act of 1990, however, healthcare facilities became subject to user reporting requirements. 8 Before this Act, medical device manufacturers were required to notify the FDA whenever they learned of
4 NURSING LESSON PLAN patient deaths or serious injuries that may have been caused by or contributed to by their devices, and whenever they learned of a device malfunction that, if it recurred, could cause a death or serious injury. Healthcare personnel are the manufacturers primary source of this information. Under updated Medical Device Reporting regulations in effect as of March 27, 2000, user facilities (hospitals, ambulatory surgical facilities, nursing homes or outpatient treatment facilities which are not physicians offices) [21 CFR803.3(f)] must report suspected medical device-related deaths to the FDA and the manufacturers within 10 workdays. User facilities must report medical device-related serious injuries only to the manufacturer within 10 workdays. If the manufacturer is unknown, the serious injury should be reported to the FDA. A serious injury is an injury or illness that is life-threatening, results 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 function or permanent damage to a body structure [21CFR 803.3(bb)(1)]. An annual report of deaths and serious injuries must also be submitted to the FDA on January 1 of each year. While end users of therapeutic or diagnostic devices are more likely to be directly affected by the law than are CS personnel, certain sterilization failures may have to be reported if they can be linked to patient illnesses. THE FDA MEDWATCH PROGRAM The FDA MedWatch program provides a vehicle to notify the FDA about medical device malfunctions, labeling inadequacies and other problems, including those involving other products regulated by the FDA, such as drugs and biologics. In recent years, the FDA has used both the voluntary and mandatory reporting programs to collect information about specific potential problems. 2 LABELING DOCUMENT The FDA is concerned about the potential for transmitting infectious diseases caused by improper reprocessing of medical devices. In April 1996, it released a document, Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: FDA Reviewer Guidance, to help FDA reviewers who evaluate pre-market approval applications for medical devices. On March 17, 2015, the FDA issued an updated document titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff. This new document supersedes the April 1996 guidance document. 7 The updated document was created to coincide with the development of new complex, reusable medical device designs, which are more difficult to reprocess. In addition, there has also been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. The new guidance reflects the scientific advancements. Manufacturers of reusable medical devices are responsible for producing and supplying labeling that bears adequate instructions for use (IFU), including directions on preparing a device for use (e.g., Cleaning, disinfecting, sterilizing, etc.). The FDA guidance tells manufacturers to use FDA-recognized test methods. During the validation testing manufacturers should ensure users will be able to successfully understand and follow the IFU. They should take into considerations human factors to ensure reprocessing staff can accomplish the specific recommended reprocessing procedures. For instance, if users need to wear PPE, such as goggles, full-length face shields, heavy-duty utility gloves or liquidresistant covering with sleeves, then the validation study participants should also wear them. In addition, manufacturers must also comply with specific criteria that mostly involve reprocessing instructions when they submit medical device applications to the FDA for evaluation. Prior to the validation studies, manufactures should consult relevant clinical practice guidelines and recommendations for infection prevention and control published by professional societies and associations, standards developing organizations, and government agencies. For example, during testing the manufacturers should consider commonly-used sterilization cycles and avoid the need for any extended sterilization exposure times. The newly-updated FDA labeling document places the responsibility for safe and effective reprocessing of medical devices with both the manufacturer and user: Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use. 9 The users are responsible for ensuring that they have the facilities and equipment to execute the instructions, and that the instructions are followed. These criteria and the subsequent IFU are useful for users selecting equipment to be able to successfully reprocess the devices. OBJECTIVE 3: ADDRESS THE U.S. FOOD AND DRUG ADMINISTRATION ENFORCEMENT PRIORITIES DOCUMENT APPLICABLE FOR REPROCESSING SINGLE-USE DEVICES In August, 2000, the FDA released its final guidance document titled Enforcement Priorities for Single-Use Devices Devices (SUDs) Reprocessed by Third Parties and Hospitals. All hospitals and third-party reprocessors reprocessing SUDs must be in compliance with the pre-market and post-market requirements outlined in the enforcement document. The document does not currently apply to
5 permanent pacemakers, hemodialyzers, healthcare facilities that are not hospitals, or unopened but unused SUDs; however, changes in the document are still possible. 10 PRE-MARKET REQUIREMENTS The FDA retained the use of the device classifications (Class I, Class II, Class III) listed in the Code of Federal Regulations (CFR) to set enforcement priorities for premarket submission requirements. 11 Unless the device is listed as specifically exempt from regulation, a 510(k) submission is required for Class I and Class II devices. Depending upon its type, Class III devices may require either a 510(k) submission or a pre-market approval application (PMA). A 510(k) is not a form, registration or listing. It is a package of information that claims substantial equivalence to one or more legally marketed predicate devices. 11 A PMA is required [although sometimes a 510(k) is adequate] for Class III devices that have not been previously marketed or for an existing device seeking a new intended use. 12 A PMA is more complicated to submit than a 510(k) because substantial equivalence is not involved. One must prove the device has a reasonable assurance of safety and effectiveness for its intended use based on valid scientific evidence. Submission of clinical data is sometimes necessary to prove safety and effectiveness. The FDA requires a satisfactory inspection of a facility before a PMA application is approved. In addition, the PMA must include a comprehensive manufacturing section which clearly identifies all appropriate controls. POST-MARKET REQUIREMENTS Post-market requirements that apply to third-party and hospital reprocessors include mandates applicable to: Registration and Listing (Section 510 of the Act; 21 CFR Part 807) Medical Device Reporting [Sections 519 (a) (b) and (c) of the Act; 21 CFR Part 803] Medical Device Tracking [Section 519(e) of the Act; 21 CFR Part 821] Medical Device Corrections and Removals [Section 519(f) of the Act;21 CFR Part 806] Quality System Regulation [Section 520(f) of the Act; 21 CFR Part 820] Labeling [Section 502 of the Act; 21CFR Part 801] 13 Because regulatory language can be difficult to understand, the FDA website provides printable materials and assistance. 14 IN CONCLUSION Government agencies have issued regulations to protect healthcare workers while they perform important tasks. Regulations have also been set regarding the manufacturing of medical devices and how to effectively process these devices. When Central Service technicians follow the government regulations they not only protect themselves and their co-workers, but they also protect their patients from receiving devices that have defects or have been improperly processed. REFERENCES 1. Occupational Safety and Health Administration Occupational Safety and Health Administration. Regulations: 29 CFR Part Occupational Exposure to Bloodborne Pathogens; Final Rule; Effective March 6, 1992; 29 CFR Part Occupational Exposure to Blood-borne Pathogens; Needlestick and Other Sharp Injuries; Final Rule. Amended and effective April 18, 2001; and 29 CFR Occupational Exposure to Tuberculosis, Proposed Rule, October 17, Occupational Safety and Health Administration. owadisp.show_document?p_ table=oshact&p_id= U.S. Environmental Protection Agency. www2.epa.gov/aboutepa/our-mission-andwhat-we-do. 5. U.S. Food and Drug Administration. OfficeofMedicalProductsandTobacco/CDRH/. 6. U.S. Food and Drug Administration. DeviceRegulationandGuidance/Overview/ ClassifyYourDevice/. 7. U.S. Environmental Protection Agency. Clean Air Act. clean-air-act-text. 8. U.S. Food and Drug Administration. Medical Device Reporting. Safety/ReportaProblem/default.htm. 9. U.S. Food and Drug Administration. deviceregulationandguidance/ guidancedocuments/ucm pdf. 10. U.S. Food and Drug Administration. Guidances/ucm htm. 11. U.S. Food and Drug Administration. Premarket requirements. Food, Drug, and Cosmetic Act (the Act): Sections 510, 513 and 515, and 21 CFR Parts 807 and U.S. Food and Drug Administration. Substantial equivalence decision-making process. Successfully completing a 510(k) notification U.S. Food and Drug Administration. Postmarket requirements U.S. Food and Drug Administration. Code of Federal Regulations. (CFR), Parts ADDITIONAL RESOURCES Healthcare personnel who wish to voluntarily report device problems or potential hazards may call MedWatch (800.FDA.1088) or visit gov/medwatch/report/hcp.htm to report online, or to obtain additional information or forms. PMA information is contained in Sections 513 and 515 of the Act and 21 CFR Part 814. Guidance for preparation of FDA PMA may be obtained at
CENTRAL SERVICE (CS) PROFESSIONALS REQUIRE SIGNIFICANT
by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Safety in Handling Chemical Sterilants LEARNING OBJECTIVES 1. Describe how governmental regulating agencies
More informationCENTRAL SERVICE (CS) PERSONNEL AND THEIR HEALTHCARE
by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Quality Management in Central Service Using a Systematic Approach LEARNING OBJECTIVES 1. Define the terms quality
More informationLegal Implications Recommended Practices
Legal Implications of Standards and Recommended Practices for CS Departments by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT Learning Objectives 1. describe applicable terms and how they apply to the CS
More informationPROCESS IMPROVEMENT AND ENHANCED QUALITY CARE ARE THE
by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Accreditation Surveys Focus on CS LEARNING OBJECTIVES 1. Explain the importance of a successful accreditation
More informationREGULATORY & ACCREDITING AGENCIES
REGULATORY & ACCREDITING AGENCIES OBJECTIVES Describe the differences between an accrediting agency and a regulatory agency Articulate the differences in standards, regulations, guidelines, and their impact
More informationThis course presents the applications of sterile processing theory in the clinical setting.
COURSE INFORMATION Course Prefix/Number: SUR 125 Course Title: Sterile Processing Practicum (Central Service Technician) Lecture Hours/Week: 3.0 Lab Hours/Week: 6.0 Credit Hours/Semester: 5.0 VA Statement/Distance
More informationInfection Prevention Checklist Section I: Policies and Practices I.1 Administrative Measures
Infection Prevention Checklist Section I: Policies and Practices I.1 Administrative Measures Facility name:... Completed by:... Date:... A. Written infection prevention policies and procedures specific
More informationINSTRUMENT CLEANING HAS BECOME A TOPIC OF INTEREST IN
Lesson No. CRCST 150 (Technical Continuing Education - TCE) Sponsored by: by Gwendolyn Byrd, CHL, CIS, CRCST CPD Educator, Children s Hospital of Philadelphia Christina Parson, CHL, CIS, CRCST SP Manager,
More informationOf Critical Importance: Infection Prevention Strategies for Environmental Management of the CSSD. Study Points
Of Critical Importance: Infection Prevention Strategies for Environmental Management of the CSSD I. Introduction Study Points Management of the CSSD environment is vital to preventing surgical site infections.
More informationCMS REQUIREMENTS: ESSENTIAL ELEMENTS FOR ASCS
CMS REQUIREMENTS: ESSENTIAL ELEMENTS FOR ASCS Luci Perri, RN, MSN, MPH, CIC, FAPIC Infection Control results OBJECTIVES Identify three areas frequently cited by surveyors State how to avoid two common
More informationREGULATORY & ACCREDITING AGENCIES
REGULATORY & ACCREDITING AGENCIES OBJECTIVES Describe the differences between an accrediting agency and a regulatory agency Articulate the differences in standards, regulations, guidelines, and their impact
More informationEAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY
EAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY Department: Family Practice Dental Clinic Date Originated: 05-31-2006 Date Reviewed: 06-21-2006 Date Approved: Page 1 of 7 Approved by: Department Chairman
More informationEVEN THOUGH THE ACCREDITATION PROCESS HAS BEEN IN PLACE
CIS Self-Study Lesson Plan Lesson No. CIS 263 (Instrument Continuing Education - ICE) Sponsored by: by Christina Poston, CRCST, CIS, CHL, BA ED and Gwendolyn Byrd, CRST, CHL CIS, CFER, GTS Preparing for
More informationHAVING THE CORRECT KNOWLEDGE TO ASK THE RIGHT
Lesson No. CHL 360 (Supervisory Continuing Education - SCE) Sponsored by: by Richard Schule, BS, MBA, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS Director of Clinical Education, STERIS Corporation Implementing
More informationEAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY
EAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY Family Medicine Physical Therapy Date Originated: February 25, 1998 Dates Reviewed: 2.25.98, 2.28.01 Date Approved: February 28, 2001 3.24.04; 9/10/13
More informationCENTRAL SERVICE (CS) IS A VITAL DEPARTMENT IN ANY HOSPITAL
CRCST Self-Study Lesson Plan Lesson No. CRCST 158 (Technical Continuing Education - TCE) by Jon Wood, BAAS, IAHCSMM Clinical Educator Sponsored by: Understanding and Preventing Cross Contamination LEARNING
More informationEAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY
EAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY Office of Prospective Health Infection Control Plan Date Originated: August 26, 2003 Date Reviewed: 10/22/03; 9/04/07; 03/09/10; 9/01/15; Date Approved:
More informationCharles Hughes. Instrument Reprocessing Update: What s New?
1 Instrument Reprocessing Update: What s New? 2 Objectives Upon completion, participants will be able to... 1. Explain various national accreditation organizations along with their new survey methods,
More informationMedical Device Reporting. FD&C Act CFR Direct Final Rule 2/28/05. As amended by:
Medical Device Reporting Direct Final Rule 2/28/05 FD&C Act 519 As amended by: Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 FDA Modernization Act of 1997 Authority to require manufacturers,
More informationNJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE. 8:43G-8.1 Central service policies and procedures
NJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE 8:43G-8.1 Central service policies and procedures (a) The hospital's central service shall have written policies and procedures
More informationCertified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline
Certified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline Exam Domains 100-130 1. Safety Management 38-50 (38%) 2. Hazard Control 38-50 (38%) 3. Compliance & Voluntary
More informationComplaint Handling and Medical Device Reporting (MDRs)
Complaint Handling and Medical Device Reporting (MDRs) FDA Small Business Regulatory Education for Industry (REdI) Bethesda, MD September 26, 2013 Andrew Xiao Consumer Safety Officer, Postmarket and Consumer
More informationRESPIRATORY PROTECTION PROGRAM
RESPIRATORY PROTECTION PROGRAM 1.0 PURPOSE The purpose of this Respiratory Protection Program is to protect respirator users at California State University East Bay from breathing harmful airborne contaminants
More informationAmbulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET
Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET Name of State Agency or AO (please print at right): HFAP Instructions: The following is a list of items that must be assessed during
More informationEAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY
EAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY Department: Neurology (Hemby Lane) Date Originated: 2/20/14 Date Reviewed: 6.5.18 Date Approved: 6/3/14 Page 1 of 7 Approved by: Department Chairman Administrator/Manager
More informationQUESTIONS PERTINENT TO PRODUCT SELECTION:
QUESTIONS PERTINENT TO PRODUCT SELECTION: Impact on patient outcomes Impact on patient/staff safety Economic considerations Use the following pages to help facilitate discussion with vendors, write your
More informationEAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY
EAST CAROLINA UNIVERSITY INFECTION CONTROL POLICY Department: Pediatrics-Hem/Onc-Module F Date Originated: 03/6/2012 Date Reviewed: 6/14, 9/12/17 Date Approved: 6/5/12 Page 1 of 8 Approved by: Department
More informationAllied institute of professional Studies N. Broadway. #340. Chicago, IL Page 1
Allied Institute of Professional Studies Course Catalog for 2017-2018 Allied Institute of Professional Studies 4554 North Broadway Street Suite: 340 Chicago, IL 60640 (773) 961-8150 / (773) 709-4228 Effective
More informationBLOODBORNE PATHOGENS
BLOODBORNE PATHOGENS Supplement to Standard Training Module TRAINING REQUIREMENTS OVERVIEW This standard Vivid training module provides a general overview of Bloodborne Pathogens (BBP). It is important
More informationMANY ORGANIZATIONS ARE TAKING A CLOSER LOOK AT THE
Lesson No. CRCST 161 (Technical Continuing Education - TCE) Sponsored by: by Jean Ludwig, MS, RN, CRCST, CCRN SPS Educator and Nursing Service Orientation Coordinator VA Maryland Health Care System Tools
More informationTHE BEGINNING OF THE END OF THE FLASH DANCE, WHICH
Lesson No. CRCST 136 (Technical Continuing Education - TCE) Sponsored by: by Susan Klacik, ACE, BS, CIS, CRCST, FCS CSS Manager, St. Elizabeth Health Center, Youngstown, OH THE FLASH DANCE IS OVER! IUSS
More informationSterile Processing in Healthcare Facilities
Advancing Safety in Health Technology Sterile Processing in Healthcare Facilities PREVIEW COPY Preparing for Accreditation Surveys, 3rd Edition Rose Seavey Sterile Processing in Healthcare Facilities PREVIEW
More informationBLOODBORNE PATHOGENS EXPOSURE PREVENTION POLICY AND PROCEDURE BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN
BLOODBORNE PATHOGENS EXPOSURE PREVENTION POLICY AND PROCEDURE This sample plan is provided only as a guide to assist in complying with the OSHA Bloodborne Pathogens standard 29 CFR 1910.1030, as adopted
More informationDiscussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment
Discussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment Lynne Sehulster, PhD, M(ASCP) Health Scientist Best Practices in Medical Device Cleaning and Disinfection
More informationUniversity of North Dakota Facilities Department Respiratory Protection Program. Table of Contents. 1.0 Introduction Purpose...
University of North Dakota Facilities Department Respiratory Protection Program Table of Contents Section Page 1.0 Introduction...1 2.0 Purpose...1 3.0 Scope...1 4.0 Responsibilities...1 5.0 Respirator
More informationCORPORATE SAFETY MANUAL
CORPORATE SAFETY MANUAL Procedure No. 27-0 Revision: Date: May 2005 Total Pages: 9 PURPOSE To make certain that our employees are duly aware of the hazards of blood exposure or other potentially infectious
More informationCRCST Self-Study Lesson Plan Lesson No. CRCST 136 (Technical Continuing Education - TCE)
Lesson No. CRCST 136 (Technical Continuing Education - TCE) Sponsored by: by Susan Klacik, ACE, BS, CIS, CRCST, FCS CSS Manager, St. Elizabeth Health Center, Youngstown, OH The Flash Dance is Over! IUSS
More informationBLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN
BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN School Name: Eastern Local School District Date of Preparation: August 2, 2000 (Revised August 22, 2002) In accordance with the PERRP Bloodborne Pathogens standard,
More informationDocument issued on: July 8, 2010
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers Document
More informationControlling Office: Director of Clinical Services Effective Date: May 1, Applies to CAMTS: n/a Last Review: January 1, 2018
Statement of Policy Respiratory Program Policy #: SMS-022 Controlling Office: Director of Clinical Services Effective Date: May 1, 2013 Applies to CAMTS: n/a Last Review: January 1, 2018 Policy About 32
More informationSterile Processing: Preparing for Accreditation Surveys. Monday, March 4, 2013, 8-9am & 9:30-10:30am
SESSION TITLE: SPEAKER NAME: SESSION NUMBER: DATE/TIME: CONTACT HOURS: Sterile Processing: Preparing for Accreditation Surveys Rose E. Seavey, MBA, BS, RN, CNOR, CRCST 9015 & 9106R Monday, March 4, 2013,
More informationU-M Hospitals and Health Centers Policies and Procedures
U-M Hospitals and Health Centers Policies and Procedures UMHHC Policy 05-02-006 Safe Medical Device Act Policy Issued: 4/00; Last Reviewed: 10/04; Last Revised: 10/04 Return to UMHHC Policies Table of
More informationINFECTION CONTROL SURVEYOR WORKSHEET
Attachment 2 Exhibit 351 INFECTION CONTROL SURVEYOR WORKSHEET Instructions: The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the infection
More information[Type here] RESPIRATORY PROTECTION PROGRAM
[Type here] RESPIRATORY PROTECTION PROGRAM 1 March 7, 2017 TABLE OF CONTENTS Section Title Page 1. Scope... 1 2. Program Administration and Responsibilities... 1 3. Immediately Dangerous to Life and Health
More informationSuperior Office Safety. Continuing Education Provider # 4967 Approved by the Dental Board of California. CDA Recommended Speaker s Bureau
Superior Office Safety Continuing Education Provider # 4967 Approved by the CDA Recommended Speaker s Bureau Federal & CAL/OSHA Authorized Trainer Diane Arns, BS, holds a Bachelor s Degree in International
More informationInfection Prevention and Control in the Dialysis Facility
Infection Prevention and Control in the Dialysis Facility Objectives 1. Describe the rules governing dialysis facilities specific to infection control. 2. List two areas of concern for infection control
More informationPart I AAMI ST79 Recommended Practice
Infection Prevention Division Attest Sterile U Network Part I AAMI ST79 Recommended Practice June 9, 2011 Welcome! Topic: Part I AAMI ST79 Recommended Practice Facilitator: Jamie Meilahn, 3M Marketing
More informationContact Hours FL (CE version ONLY) Suggested Target Audience. staff that provide care to patients. Page 1 of 8 Updated: 10/30/2017
PA CE 1 Active Shooter Response in Healthcare Settings - An HCCS Regulatory 1/8/2016 1 1 N/A 20 N/A N/A all staff 2 Advance Directives - An HCCS Regulatory 10/15/2015 1 1 N/A 54 N/A N/A all staff 3 Annual
More informationInfection Control (ICE )
Infection Control (ICE ) Exam Outline and Suggested References State Regulations Each state s dental board implements regulations and establishes rules for delegating legally allowable duties to dental
More informationModernizing Hospital Adverse Event Reporting
Modernizing Hospital Adverse Event Reporting 14 December 2016 Sarah H. Stec Not Legal Advice For Informational and Educational Purposes Only Firm Overview More than 1,500 lawyers in 46 offices across 21
More informationCertified Healthcare Safety Long Term Care (CHS-LTC) Examination Blueprint/Outline
Certified Healthcare Safety Long Term Care (CHS-LTC) Examination Blueprint/Outline Exam Domains 100-130 1. Safety Management Principles 31-40 (31%) 2. Hazard Control Concepts 46-60 (46%) 3. Compliance
More information1. Describe the role of the Sterile Processing Department (SPD) within an organizational structure.
LEARNING OBJECTIVES: Sterile Processing University, LLC Module 1: Roles and Responsibilities Part I [Technician] Copyright Sterile Processing University, LLC 2016 All Rights Reserved. This material may
More informationTOP 10 ASC COMPLIANCE FAQs
TOP 10 ASC COMPLIANCE FAQs January2013 Read the 10 most common compliance issues from real ASCs in more than 40 states and our tips on how to solve them. www.pss4asc.com Q 1: When and how often should
More information3.03 Functions of support services personnel Name
3.03 Functions of support services personnel Name Date Directions: Record notes and classroom discussion about the function and responsibilities of support services personnel. Create a therapeutic environment
More informationi. Identifying work areas, processes or tasks that require workers to wear respirators, and evaluating hazards.
St. Norbert College RESPIRATORY PROTECTION POLICY (29 CFR 1910.134) 1. INTRODUCTION - The purpose of this respiratory policy is to establish standard operating procedures to ensure the protection of all
More informationWorksheet: Friend, Foe or Both?
Medicare s ASC Infection Control Worksheet: Friend, Foe or Both? Tammeria Tyler, RN CIC Infection Preventionist Learning Objectives To understand outlined Conditions for Coverage in the ASC Infection Control
More informationPersonal Protective Equipment Program. Risk Management Services
Personal Protective Equipment Program Services Table of Contents I. Program Goals and Objectives... 2 II. Scope and Application... 2 III. Responsibilities... 2 IV. Procedures... 3 V. Training... 5 VI.
More informationCLEANING Reusable Medical Devices. AAMI/FDA Medical Device Reprocessing Summit October 11-12, 2011 Silver Spring, MD
CLEANING Reusable Medical Devices AAMI/FDA Medical Device Reprocessing Summit October 11-12, 2011 Silver Spring, MD CLEAN is defined several ways in the dictionary, one being Free from contamination or
More information3M Sterile U Sterilization Assurance Continuing Education
3M Sterile U Sterilization Assurance Continuing Education Take the Lead in Infection Prevention What to Look For in Your Sterile Processing/Central Sterile Supply (SP/CSSD) Department Martha Young, BS,
More informationINFECTION PREVENTION & CONTROL, INCLUDING PROCESSING ITEMS FOR REUSE, IN GENERAL PRACTICE
INFECTION PREVENTION & CONTROL, INCLUDING PROCESSING ITEMS FOR REUSE, IN GENERAL PRACTICE Rose Griffiths May 2016 Rose.griffiths1@gmail.com M 0425 736 817 Ref: RACGP Infection Prevention and Control Standards
More informationAppendix AX: B Occupational Exposure to Bloodborne Pathogens Exposure Control Plan
Occupational Exposure to Bloodborne Pathogens Exposure Control Plan Employer: Nevada State Health Division Effective Date: May 5, 1992 Compliance Statement: In accordance with OSHA Bloodborne Pathogens
More informationRespiratory Protection Program
Respiratory Protection Program Office of Environmental Health and Safety Revised July, 2012 Cleveland State University Respiratory Protection Program 1 Cleveland State University Respiratory Protection
More informationMedical Device Reporting for Manufacturers
Medical Device Reporting for Manufacturers DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Medical Device Reporting for Manufacturers Prepared by Division of
More informationHouston Controls, Inc Safety Management System
Preparation: Safety Mgr Authority: Dennis Johnston Issuing Dept: Safety Page: Page 1 of 8 Purpose This Bloodborne Pathogen Exposure Control Plan has been established to ensure a safe and healthful working
More informationGAO MEDICAL DEVICES. Status of FDA s Program for Inspections by Accredited Organizations. Report to Congressional Committees
GAO United States Government Accountability Office Report to Congressional Committees January 2007 MEDICAL DEVICES Status of FDA s Program for Inspections by Accredited Organizations GAO-07-157 Accountability
More informationCreating An Effective OSHA Compliance Program
Presents Creating An Effective OSHA Compliance Program Bloodborne Pathogens and Your Course Faculty R. Thomas (Tom) Loughrey, MBA, CCS-P Chairman, CEO & Co-Founder of Economedix Certified Coding Specialist
More information3M Sterile U Network 3M Sterile U Web Meeting January 16, 2014
3M Sterile U Network 3M Sterile U Web Meeting January 16, 2014 Today s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST To hear audio, call 800-937-0042 and enter access code 7333633 Phone lines
More informationDRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: August 5, 2008
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers DRAFT GUIDANCE This guidance
More information42 CFR Infection Control
42 CFR 482.42 Infection Control Dodjie B. Guioa, MBA Hospital/ASC Program Lead Region VI Dallas dodjie.guioa@cms.hhs.gov Condition of Participation Infection Control The hospital must provide a sanitary
More informationFormaldehyde Exposure Control Policy
Formaldehyde Exposure Control Policy POLICY AND PROCEDURES FOR WORKING WITH FORMALDEHYDE Policy: It is Columbia University (CU) policy to maintain formaldehyde exposure below the action level (AL) 0.5
More informationSafety in the Pharmacy
Safety in the Pharmacy Course Practicum in Health Science - Pharmacology Unit I Preparation for Practicum Essential Question Why is safety in the pharmacy important not only to the patient, but the pharmacy
More informationMedical Equipment, Devices, & Supplies
Medical Equipment, Devices, & Supplies BPHC Community Health Centers December 7, 2017 Lisa Waldowski, DNP,PNP,CIC Infection Control Specialist Joint Commission Enterprise Learning Objectives At the conclusion
More informationStudent Guide Preview. Bloodborne Pathogens. in the Workplace
Student Guide Preview Bloodborne Pathogens in the Workplace Bloodborne Pathogens in the Workplace Student Guide Version 7.0 Purpose of this Guide This MEDIC First Aid Bloodborne Pathogens Version 7.0 Student
More informationBLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN
BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN School Name: MSAD #33 Date of Preparation: March 1993 In accordance with the OSHA Bloodborne Pathogens standard, 29 CFR 1910.1030, the following exposure control
More informationResponding to Infection Prevention and Control (IPAC) Complaints. Monali Varia, MHSc, CIC Peel Public Health November 29, 2017
Responding to Infection Prevention and Control (IPAC) Complaints Monali Varia, MHSc, CIC Peel Public Health November 29, 2017 Objectives 1. Understand the local public health role in responding to infection
More informationSPD Continuing Education Programs Last updated 4/23/2015
KNOWLEDGE NETWORK* is a dynamic collection of educational resources designed to provide insight and information on relevant healthcare issues. This value-added service provides knowledge to improve: Patient
More informationTENNESSEE CENTRAL SERVICE TECHNICIAN LAW FREQUENTLY ASKED QUESTIONS
TENNESSEE CENTRAL SERVICE TECHNICIAN LAW FREQUENTLY ASKED QUESTIONS ******* Please note: The International Association of Healthcare Central Service Materiel Management (IAHCSMM) provides the information
More informationOak Grove School District Respiratory Protection Program
Oak Grove School District Respiratory Protection Program District Policy The purpose of this notice is to inform you that Oak Grove School District is complying with the OSHA Respiratory protection Standard,
More informationChallenges in the US Approach to Disinfection and Sterilization
Challenges in the US Approach to Disinfection and Sterilization Lisa Huber, BA, CRCST, FCS Sterile Processing Manager Anderson Hospital IAHCSMM President Objectives Discuss the challenges of communication
More informationOSHA Inspections: Real Life Story
OSHA Inspections: Real Life Story Stephanie Martin, BSN, RN, CNOR, CASC Administrator St. Augustine Surgery Center August 14, 2012, 6:00 AM August 14, 2012, 6:00 AM The day started like any other... Arriving
More informationOSHA s Revised Bloodborne Pathogens Standard. Outreach and Education Effort 2001
OSHA s Revised Bloodborne Pathogens Standard Outreach and Education Effort 2001 Bloodborne Pathogens Standard 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens Published December 1991 Effective
More informationChoosing the right mask A guide to ASTM barrier protection standards
Choosing the right mask A guide to ASTM barrier protection standards Angela Maxwell, RN e A. Name Sr. Clinical Consultant, Clinical Operations June 21, 2018 Copyright 2015, Cardinal Health. All rights
More informationCentral Sterile Processing and Operative Services: Consults, Leadership Staff, Assessments and Education
Central Sterile Processing and Operative Services: Consults, Leadership Staff, Assessments and Education Angela Lewellyn - SPD Director LaWayne Perkins - National Project Manager Advantage Support Services,
More informationShawnee State University
Shawnee State University AREA: ACADEMIC AFFAIRS POLICY NO.: 5.21 ADMIN. CODE: 3362-5-22 PAGE NO.: 1 OF 13 EFFECTIVE DATE: 6 / 1 8 / 9 3 RECOMMENDED BY: A.L. Addington SUBJECT: BLOODBORNE PATHOGENS APPROVED
More informationUniversity of Chattanooga Respiratory Protection Program. Areas Affected: Employees whose duties require the use of a respirator
University of Tennessee @ Chattanooga Respiratory Protection Program OSHA Standard 29 CFR 1910.134 Effective date: 3/1/2012 Areas Affected: Employees whose duties require the use of a respirator Introduction:
More informationBloodborne Pathogens Cumru Township Fire Department 02/10/2011 Policy 10.5 Page: 1 of 7
Policy 10.5 Page: 1 of 7 Purpose: The Cumru Township Fire Department is committed to providing a safe and healthful work environment for our entire staff, both career and volunteers. In pursuit of this
More informationRESPIRATORY PROTECTION
RESPIRATORY PROTECTION 29 CFR 1910.134 OSHA law requires that engineering controls rather than respirators be used to solve most air contamination problems. Respirators are too often used as a permanent
More informationAS/NZS 4187:2003 AS/NZS
AS/NZS 4187:2014 Incorporating Amendment No. 1 Australian/New Zealand Standard Reprocessing of reusable medical devices in health service organizations Superseding AS/NZS 4187:2003 AS/NZS 4187:2014 AS/NZS
More informationEXPOSURE CONTROL PLAN
BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN SALT LAKE COMMUNITY COLLEGE October 2011 ~ 1 ~ POLICY Salt Lake Community College is committed to providing a safe and healthful work environment for our entire
More informationInfection Prevention and Control in Ambulatory Care Settings: Minimum Expectations for Safe Care
Infection Prevention and Control in Ambulatory Care Settings: Minimum Expectations for Safe Care Melissa Schaefer, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Inspections, Compliance, Enforcement, and Criminal Investigations Husain, Mustafa M, M.D. 23-Jul-08 Department of Health and Human Services Public Health Service Food and Drug Administration Center for
More informationBeyond Ebola: Environmental, OSHA, and Other Regulatory Issues Creating Business Risks to Health Care Providers in the Future
Beyond Ebola: Environmental, OSHA, and Other Regulatory Issues Creating Business Risks to Health Care Providers in the Future William J. Walsh and Gregory S. Narsh Webinar March 25, 2015 Moderated by Mark
More informationCOMPLYING WITH OSHA S BLOODBORNE PATHOGEN FINAL RULE OBJECTIVES
Module B COMPLYING WITH OSHA S BLOODBORNE PATHOGEN FINAL RULE Almost there! OBJECTIVES Provide an overview of the Bloodborne Pathogen (BBP) Standard Highlight OSHA s requirements regarding bloodborne pathogens,
More informationTRAINING. A. Hazard Communication/Right-to-Know Training
XIII. TRAINING A multitude of training requirements are addressed by OSHA and other safety, health and environmental regulations. A summary of these requirements are presented. A. Hazard Communication/Right-to-Know
More informationMODULE 22: Contingency Planning and Emergency Response to Healthcare Waste Spills
MODULE 22: Contingency Planning and Emergency Response to Healthcare Waste Spills Module Overview Present examples of contingencies related to HCWM Describe steps in developing a contingency plan Describe
More informationSTANDARD PRECAUTIONS POLICY Page 1 of 8 Reviewed: May 2017
Page 1 of 8 Policy Applies to: All Mercy Staff, Credentialed Specialists, Allied Health Professionals, students, patients, visitors and contractors will be supported to meet policy requirements Related
More informationEffective Date: 6/15/77. Date Reviewed:
Classification: Radiology Policy Number: 668.027 Subject: ALARA Program for Radiation Exposure Contact Position: Radiology Director Effective Date: 6/15/77 Date Reviewed: Page: 1 of 5 Date Revised: 7/02,
More informationCHEMICAL HYGIENE PLAN
SAMPLE WRITTEN CHEMICAL HYGIENE PLAN For Compliance With 29 CFR 1910.1450 Wyoming General Rules and Regulations Wyoming Department of Workforce Services OSHA Division Consultation Program ACKNOWLEDGEMENTS
More informationMinistry of Labour Occupational Health & Safety and Infection Prevention & Control
Ministry of Labour Occupational Health & Safety and Infection Prevention & Control Presentation to Northern Ontario ICN September 23, 2011 Denise Madsen, RN, BScN, CIC Infection Control Consultant Northern
More informationTEMPLE UNIVERSITY ENVIRONMENTAL HEALTH AND RADIATION SAFETY
Page 1 of 12 ISSUED: 6/94 REVISED: 06/07 Introduction: Purpose The purpose of this program is to ensure the protection of all employees from respiratory hazards through the proper use of respirators. Respirators
More information