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Accreditation and Infection Control

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1 Accreditation and Infection Control
Marcia R Patrick, MSN, RN, CIC Tacoma, WA November 7, 2013

2 I have nothing to declare No off-label use of medications will be discussed Use of brand names and images is for illustration only, no endorsement is implied

3 Objectives Be familiar with the salient points of the CMS Infection Control Worksheet Discuss three critical injection practices to prevent transmission of bloodborne pathogens in the ASC Describe at least three critical elements in safely and adequately performing high- level disinfection in the ASC

4 Centers for Medicare and Medicaid Services- CMS
Requires all ASCs that accept money from CMS meet specific Infection Control requirements Result of disease outbreaks in ambulatory pts. IC requirements included in all accreditation surveys Accreditation Association for Ambulatory Health Care (AAAHC) American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) American Osteopathic Association (AOA) The Joint Commission (TJC) A good idea regardless of accreditation surveys! It’s all about patient safety

5 Licensed, qualified IC person Written Infection Control Plan
CMS, con’t. Requires: Licensed, qualified IC person Written Infection Control Plan Which IC standards are being followed- CDC (various), AORN, specialty, etc. Surveillance plan for infections Method of notifying DOH of reportable dz Education of staff in infection control

6 CMS, con’t. Hand hygiene- wash or alcohol-based hand sanitizer, appropriate times Use of gloves, other personal protective equip. Needle and medication safety: One needle, one syringe, one patient, one time Single dose vials are single patient use Proper placement & use of sharps containers Sterilization & disinfection Environmental cleaning Point of care testing devices (blood glucose)

7 Goals of an Infection Prevention and Control Program
Protect patients Protect workers Ensure compliance with infection prevention and control regulations and other requirements, guidelines and recommendations Promote “zero tolerance” for infections The requirements for ASCs are all about safety- patient safety and employee safety. There have been many outbreaks of disease related to poor practices in ASCs and outpatient areas. These rules will help address those issues. Examples: Poor medication practices- using a bag of saline to draw flush solution, using a contaminated syringe; improper cleaning of endoscopes; failure to have safety needles and other sharps to protect workers; dangerous sharps passing in the OR causing injury to scrub techs..

8 Elements of the Infection Surveillance, Prevention & Control Program
Risk Assessment based on services provided, locale, population Written Infection Prevention and Control Plan Authority Statement Infection Control Service description Surveillance Plan There are certain elements that must be included in your ISPC Program, especially if you are accredited. These include: Risk assessment IC department composition and authority Description of your Surveillance activities Your Goals & objectives Prevention & control strategies Communication & Reporting Emergency Management & planning Evaluation of the Effectiveness of your program Educational activities We will discuss the written plan further on in the lecture. First we want to discuss the Risk Assessment that the overall written Plan including Goals & Objectives is taken from. 8

9 Elements, continued 6. Goals and Measurable Objectives
7. Prevention & Control Strategies 8. Communication and Reporting 9. Emergency Management & Planning 10. Education 11. Evaluation of Program Effectiveness

10 Facility Risk Assessment
Provides a basis for infection prevention activities and annual surveillance plan Identify at-risk populations in your facility- high volume, high risk, or problem-prone procedures Assist in focusing surveillance efforts Meet regulatory and other requirements The purpose of the risk assessment is to act as a guide for your annual infection control plan. A comprehensive assessment will identify patient populations at risk and alert you to potential areas to target in your surveillance processes. Your Risk Assessment should be incorporated into your plan. Required by Joint Commission. Yes it is required. So let’s talk about what to include and how to summarize the information . . . 10

11 Facility Risk Assessment
Epidemiologic principles to address Volumes Populations served General and specialty services Staff Surveillance data Geographic location and size Epidemiologically important organisms Ask your finance department for information on patient volumes for the prior year. You will need to know volumes by gender and by service, as well as the numbers of most common procedures. I generally ask for the top 10 surgical procedures done. To find out what populations you serve, ask for the number of admissions by age group. And make a note in your assessment of any other commonalties such as rural groups, or specific ethnicity. List your general and specialty services provided. If your facility is a trauma center state the level of care. If any new services have been added in the past year, note those as well. Find out from Employee Health or Human Resources, how many employees the facility has. Include those at off-site clinics and satellite centers if you are responsible for infection control at those locations. Finally, include any important surveillance data from the past year. For instance, if you have been following one particular type of surgery for 2 years and have never seen a surgical site infection, it would be feasible to recommend dropping that target. If, in the course of your daily surveillance, you happen to notice a number of infections in a population you are not formally monitoring, you may want to recommend adding that target to your list for the next year. 11

12 Facility Risk Assessment
Assessment Summary Who is at risk for infection What types of infections Recommendations to reduce risks 12

13 Surveillance Plan Surveillance methodology – how
Surveillance indicators/events - what Risk assessment - why Reasons for selecting indicators Committee/leadership recommendations New services, procedures, treatments Comparative databases used Outbreak identification and response Briefly explain the surveillance program: Surveillance methodology used – for example, targeted, all surgeries, or combination; process surveillance Surveillance indicators/ events selected and why they were selected. The indicators and events that you monitor, both the outcomes and the processes, should be based on: Your Risk Assessment (may include such things as a population or procedure associated with high morbidity or mortality) Committee & leadership recommendations New services, procedures, and treatments Explain if you compare your data with any external databases, such as NHSN or others Explain how you identify and respond to outbreaks. Note that you have a written policy/procedure for identifying and responding to outbreaks. 13

14 Authority Statement Example: The Board of Directors (Medical Director/Quality Committee) authorizes and supports the Director (Manager/etc.) of Infection Prevention to institute appropriate infection control measures within the facility. This includes authority to employ whatever methods necessary when, in their judgment, there is a reasonable possibility of immediate danger to any patient(s), personnel or others in the facility. Another requirement for your Plan includes a formal statement granting authority to the Infection Prevention & Control Department. This may be as short as a paragraph or several pages in length. This should be located in the Plan for your program. It gives you the authority to act to protect patients and staff from a perceived infection threat. 14

15 Infection Prevention & Control Service
Composition Based on organization size, type, services, needs, regulations & requirements Personnel: number, qualifications, core competencies, (office) location, hours Medical Director/Epidemiologist/ID consultant Leadership support Authority Reporting structure, other responsibilities Explain the composition of your IC department. The composition and number and types of personnel should be based on your organization’s size, type, services, needs, regulations & requirements. Note the number of personnel: number and their qualifications; office location and hours; specify if there's a Medical Director/Epidemiologist. Make a note about leadership support, including support staff, resources for ongoing training, and computer support. Include what type of authority the personnel have (for instance, can the IP institute isolation [precautions if needed) Identify the individuals who have broader authority – e.g., to shut down a unit or stop construction Note if the IP manages a separate department or is a member of another department. In a small facility, the IP usually wears several hats and manages other areas. List the other areas, such as Director of Nursing, Employee Health, Staff Development, or Performance Improvement. 15

16 Goals & Objectives Identify & prioritize goals
Based on risk assessment Team effort & leadership approval Goals should address at least: Limiting acquisition & transmission of pathogens Limiting unprotected exposure to pathogens Enhancing hand hygiene Minimizing risk associated with procedures, devices & equipment Develop measurable objective(s) The next step is to identify goals that you want to attain. Your goals should be based on your risk assessment. You should develop them in conjunction with others in your organization and present them to your management for review and approval. You should also prioritize your goals: identify which are the most important. If you’re Joint Commission accredited, your goals should address these four issues: Limiting acquisition & transmission of pathogens among patients, residents, visitors, personnel & others (isolation precautions, surveillance methodologies, etc.) Limiting unprotected exposure of personnel to pathogens (in other words, the use of gowns, gloves, and other PPE) Enhancing hand hygiene Minimizing risk associated with procedures, devices & equipment. Once you identify some goals, then you develop measurable objectives so you measure how well you attained your goals. Here are some examples of goals and objectives [see next slides]. 16

17 Program Goals Provide cost-effective program
Healthcare Associated Infections = increased cost Infection Control programs = decreased cost Limited reimbursement from CMS for preventable harm, also other payers In today's competitive marketplace, anything that impacts the bottom line of a facility’s budget is up for scrutiny. It is a well-known fact that healthcare-acquired infections increase the cost of care. But IC programs that reduce and/or prevent HAIs will provide important cost savings for the facility. New procedures and products introduced to implement the IC program have the potential to increase cost. Healthcare facilities are no longer reimbursed for the expense of items used in the provision of care. Rather, they are reimbursed in lump sums according to diagnoses. So it will be important to weigh any increased costs against the potential benefit of the item. It is also important to bring the evidence-based literature and recommendations to the table when there are discussions about cost. Example: In 2003, CDC published an updated Guideline for the Prevention of Healthcare-associated Pneumonia. The guideline recommends the development of a comprehensive oral-hygiene program (that might include the use of an antiseptic agent) for patients who are at high risk of developing HA pneumonia. When recommending a new oral care kit for use with ventilated patients in our hospital, we knew there would be a significant cost increase with the adoption of the new product. So our proposal to the Products Committee included a graph of VAP rates for the critical care areas (which were well above national comparison data), the estimated cost for a VAP infection, and the cost of use of the kit for each ventilated patient. We estimated a significant cost savings by the end of the year as a result of more effective oral care and we were right! 17

18 Prevention & Control Strategies
Identify prevention & control strategies Base on risk for transmission, care setting, diseases in community Hand hygiene program Minimize risk associated with procedures, devices, equipment Identify prevention & control strategies that will help you reach your goals Base your goals & strategies on the risk for acquisition & transmission of infection in your care setting and diseases in community . For instance, if you know that lap choles seem to result in complications, infections, that may be a procedure you’d like to monitor. Make sure that your strategies address the ASC hand hygiene program, specific methods for minimizing or preventing risks associated with medical procedures, devices, and equipment, and preventing infection in personnel. In ASC, process indicators are very appropriate. For example, you may decide to monitor the process of cleaning and high-level disinfection of colonoscopes. You might watch how they’re currently processed, check the manufacturer’s recommendations, review the entire process to ensure it’s done correctly, and that each person performing this function does it consistently and correctly. This is especially important if there are staff that don’t do it often, only to cover vacations or days off of the “regular” person. Make sure that you note that you keep up-to-date with new regulations, requirements, and guidelines, and that you incorporate them into your program and your plan by updating your polices and procedures. 18

19 Communication & Reporting
Communication systems Internal External Reports What is reported How it is reported (written, verbal) Who receives the information How often Communication systems Internal: You should have systems to communicate with all health care providers, students, volunteers, and medical staff in your organization about infection prevention & control strategies, including their responsibilities in preventing infection. Where does your data go? You should also have a system for communicating with visitors and patients if needed. External: Make sure that you have a system for reporting communicable diseases and other reportable conditions to the health department Delineate in your plan what types of reports you send, who receives them, and how often you send them. 19

20 Education Education & training for
Health care providers, ancillary staff New employee orientation, competency evaluations Annual and as needed infection control education Leaders Infection Prevention and Control personnel List offerings for the year – Plan a calendar You should include your plan for education & training for Health care providers, including physicians, volunteers, and students Leaders and managers who can help you implement your infection prevention and control interventions The IC personnel, such as conferences and professional meetings How do you know your staff is competent to do their jobs? Should be competency evaluation tools for the major job functions- objective criteria that can be observed and “yes” they did it or “no” they didn’t. Especially important for multi-step, complex procedures like scope processing, instrument processing. Initial and annual competencies should be done. Consider listing at least some of your planned offerings for the year 20

21 Emergency Management & Planning
Must involve collaboration Internal External (local emergency mgmt, health dept.) Plan for Recognition Response (including influx of infectious pts.) Containment Communication (internal & external) Also note in your plan, any activities that you are involved in regarding emergency management and planning. Include any committees and task forces that you serve on: internal committees such as Safety or Emergency Management Committee and external such as your city or state Emergency Management programs Make sure your Emergency Management Plan is mentioned in your ISP&C Plan and includes mechanisms for Recognizing an event, such as an outbreak of flu in your community Responding to an event, including an influx of infectious patients or an influx of injured patients Containing infection if persons with infection are admitted, and a Communication system that will continue to function, both internally and externally in an emergency. Know what the role of your facility is in the overall community disaster plan. 21

22 Evaluation of Program Effectiveness
Evaluate goals & program, ability to meet Measure success or failure, why Rate reduction- highlight accomplishments! Processes improved/Compliance improved Infection Control Program resources Personnel Non-personnel (computers, clerical support) Collaborate Establish new goals and objectives You should have a plan for evaluating: your goals and objectives (did you meet your measurable objectives?) the success or failure of your strategies for preventing & controlling infections and other adverse events, for instance, were you able to reduce infection or fall rates or improve health care processes, such as hand hygiene and influenza vaccination rates In other words, you should have a plan for formally evaluating the goals and the ISP&C program at least annually and whenever risks significantly change in your population There should also be an annual assessment of the IC Program resources Personnel: number, qualifications, competency Non-personnel: computers and technology support Assign one person the responsibility for ensuring that the annual evaluation & redesign (as needed) is done; however, this person should obtain input from many others, including the IP, the IP’s administrator, the committee that oversees the IC program in your organization, frontline health care providers, managers, and other leaders throughout the organization. 22

23 IC Program vs. Written IC Plan
The written Plan documents the existence of your IC Program The Plan should incorporate all the elements required or included in your program Reviewed and updated as things change, at least annually

24 Tips for Developing Written Plan
Identify regulations & requirements Identify guidelines you will use Develop outline of Infection Prevention and Control program Can use the examples given Network with others Consider incorporating your plan into your annual report Here are some tips to consider when you develop your plan There is a sample provided with the handouts Identify regulations & requirements – these will vary depending on the type of facility in which you work. We’ll discuss various regulations and other types of requirements tomorrow Develop an outline that describes what your infection surveillance, prevention and control program should look like – include all of the various components that have been presented this week Then figure out what you plan to do next year and draft a Table of Contents for your plan. Network with others from similar facilities and those you meet here to share information and ideas on what to include both in your program and in your plan You should consider incorporating your plan into your annual report. You should prepare an annual report that includes all the work that you do and you should distribute that report widely: to Administration, to the Chief of the Medical staff, the Director of Nursing, and anyone else who should know about you and your infection surveillance, prevention and control program. How many of you work for an administrator who knows little about you and your program? You can avoid that by presenting them with a comprehensive annual report and a specific plan that demonstrates your plans, goals & objectives for the following year. 24

25 Tips, con’t. Demonstrate collaboration throughout plan
Leaders, managers, caregivers & others Collaborate in program development, implementation, evaluation, and assessment of resources Assign responsibility for annual review Include the essential elements Distribute your plan widely Make sure that you demonstrate throughout your plan all those with whom you collaborate and how important team work is for IP & C It’s essential that you work with others in order to provide an effective ISPC program. We have to work with leaders, managers, frontline caregivers & other personnel—personnel at all levels of our organization: from the Administrators to the physicians to the housekeeping staff. These people should be involved in developing your program, implementing it, evaluating it, and ensuring that you have adequate resources to do what has to be done (you cannot do this by yourself) Be sure you designate who’s responsible for conducting the annual review of both your program and your plan and for making any changes that are needed Include at least the essential elements that I’ll cover next; and Make sure to distribute your plan widely to those who have the authority and ability to help your accomplish your plan for your ISP&C program 25

26 Hand Hygiene Single most important procedure for preventing healthcare-associated (nosocomial) infections Underwood MA. APIC Text 2005 The above statement is not in the 2002 CDC Hand Hygiene Guideline, but I think it’s still valuable and true. CDC Guideline for Hand Hygiene in Healthcare Settings, 2002 26

27 Definitions Antiseptic – antimicrobial substances (e.g. alcohol, CHG, triclosan) applied to the skin to reduce microbial flora Alcohol-based hand rub – alcohol-containing preparation applied to the hands to reduce the number of viable microorganisms Antimicrobial soap – detergent containing antiseptic agent Waterless antiseptic agent – an antiseptic agent that does not require use of exogenous water Alcohol-based hand rubs are alcohol-containing preparations designed for application to the hands for reducing the number of viable microorganisms on the hands (usually 60 – 95% concentration). Antimicrobial wipes are not a substitute for an alcohol-based hand rub or an antimicrobial soap. They can be useful for patients, such as for cleaning hands before meals. Antimicrobial soaps are detergents containing an antiseptic agent. We’ll talk more about those agents on the next slide. Visibly soiled hands show visible dirt or contamination with proteinaceous material, blood, or other body fluids (e.g., feces, urine). Waterless antiseptic agents are antiseptic agents that do not require use of exogenous water. After application, hands are rubbed together until the agent has dried. 27

28 Why we use hand sanitizers
A 24-year-old man who had quadriplegia due to a traumatic spinal cord injury was found on routine surveillance cultures to have methicillin-resistant Staphylococcus aureus (MRSA) colonization of his anterior nares. He had no history of MRSA infection or colonization. To assess the potential implications of the patient's MRSA carriage for infection control, an imprint of a health care worker's ungloved hand was obtained for culture after the worker had performed an abdominal examination of the patient. The MRSA colonies grown from this handprint on the plate (CHROMagar Staph aureus), which contained 6 µg of cefoxitin per milliliter to inhibit methicillin-susceptible S. aureus, are pink and show the outline of the worker's fingers and thumb (Panel A). With the use of a polymerase-chain-reaction assay, the mecA gene, which confers methicillin resistance, was amplified from nares and imprint isolates. After the worker's hand had been cleaned with alcohol foam, another hand imprint was obtained, and the resulting culture was negative for MRSA (Panel B). These images illustrate the critical importance of hand hygiene in caring for patients, including those not known to carry antibiotic-resistant pathogens. New England Journal of Medicine A 24-year-old man who had quadriplegia due to a traumatic spinal cord injury was found on routine surveillance cultures to have methicillin-resistant Staphylococcus aureus (MRSA) colonization of his anterior nares. He had no history of MRSA infection or colonization. To assess the potential implications of the patient's MRSA carriage for infection control, an imprint of a health care worker's ungloved hand was obtained for culture after the worker had performed an abdominal examination of the patient. The MRSA colonies grown from this handprint on the plate (CHROMagar Staph aureus), which contained 6 µg of cefoxitin per milliliter to inhibit methicillin-susceptible S. aureus, are pink and show the outline of the worker's fingers and thumb (Panel A). With the use of a polymerase-chain-reaction assay, the mecA gene, which confers methicillin resistance, was amplified from nares and imprint isolates. After the worker's hand had been cleaned with alcohol foam, another hand imprint was obtained, and the resulting culture was negative for MRSA (Panel B). These images illustrate the critical importance of hand hygiene in caring for patients, including those not known to carry antibiotic-resistant pathogens.

29 Opportunities for Hand Hygiene
Before entering patient room Before touching patient Before donning gloves Before handling meds, linen, clean supplies Between dirty and clean tasks After touching patient or their environment After handling soiled linen, dressings, etc. On removing gloves On leaving the room

30 Surgical Hand Antisepsis
State of the science: waterless surgical scrub solutions Alcohol-based surgical hand-scrub Prewash hands and forearms with non-antimicrobial soap, dry, then apply per manufacturer's instructions Antiseptic surgical hand-scrub Chlorhexidine (CHG) & Povidone Iodine (PVI) most common Waterless surgical scrub solutions are generally well tolerated. Must clean under nails using supplied pick. Eliminates need for scrub sink. Scrubbing with a brush for 2-6 minutes not recommended. The brush can irritate skin and actually increase colonization with skin flora increasing the risk to patients. Some antimicrobial scrubs are very drying, can lead to skin problems. 30

31 Artificial Nails HCWs more likely to harbor gram negative pathogens on their fingertips Outbreak of Pseudomonas aeruginosa in NICU attributed to artificial fingernails Artificial fingernails epidemiologically implicated in several other outbreaks Do not wear artificial fingernails or extenders when having direct contact with patients at high risk (e.g., those in intensive-care units or operating rooms) (IA) Artificial nails are not appropriate for HCWs who touch patients, patient equipment or supplies, or who wear gloves for protection, as the nails will easily go through the tip of the glove. CDC has a 1A recommendation that HCWs in contact with high-risk patients, which they define as ICU and OR, do not wear artificial nails. The increase in MDROs makes them risky for ANY patient contact! Modified HICPAC Categorization Scheme* for Recommendations Category IA A strong recommendation supported by high to moderate quality evidence suggesting net clinical benefits or harms 31

32 Jewelry Skin underneath rings is more heavily colonized than comparable areas of skin on fingers without rings Study: 40% of nurses harbored gram-negative bacilli (e.g., E. cloacae, Klebsiella, and Acinetobacter) on skin under rings & certain nurses carried the same organism under their rings for several months In a more recent study involving >60 intensive care unit nurses, multivariable analysis revealed that rings were the only substantial risk factor for carriage of gram-negative bacilli and S. aureus and that the concentration of organisms recovered correlated with the number of rings worn Rings are not appropriate in the OR Earrings/necklaces must be covered in OR CDC Guideline for Hand Hygiene in Healthcare Settings, 2002

33 Safe Injection, Infusion and Medication Vial Practices in Healthcare

34 Maintaining Sterility
Perform hand hygiene before accessing and preparing medications Disinfect (scrub) all vial tops & IV ports/hubs, locks with alcohol for 15 seconds before accessing (includes needleless systems) Let dry 15 seconds A needle should never be left inserted into a medication vial septum for multiple uses This provides a direct route for microorganisms to enter the vial and contaminate the fluid Use 5 micron filter needle for ampule

35 Maintaining Sterility
A new sterile needle and syringe used for each injection and each entry into vial Do not use bags or bottles of intravenous solution as a common source of supply for more than one patient Leftover parenteral medications should never be pooled for later administration Single-use medication vials (e.g., propofol) should never be used for more than one patient Assign multi-dose vials to a single patient whenever possible N.Y. Hepatitis Outbreaks Linked to Propofol Reuse An investigation into a pair of hepatitis outbreaks in New York City has revealed that the same anesthesiologist was responsible for spreading 7 cases each of hepatitis B and C. through the reuse of single-use vials of propofol. The authors urge all GI physicians to keep an eye on and maintain high standards for the injection, medication handling and other infection control practices of all team members in the procedure rooms.

36 IV Solutions Sanitize hands before any contact with IV tubing or bag handling or change Keep IV bags in plastic overwrap until ready for use (if out, date & discard in 30 days) Begin administration within one hour of spiking IV bag/bottle (USP 797) or a soon as possible (APIC)- otherwise discard bag

37 IV Solution & Syringe Labeling
NEVER set an unlabeled syringe down or leave it unattended NEVER administer a medication from an unlabeled syringe that you did not draw up & have control of from time drawn up to time given NEVER draw up an oral or topical liquid into an injection syringe Unattended syringes of medications may be tampered with, become non-sterile, could be switched with something else… Never give a medication that you didn’t draw up- you’re betting your license and possibly your livelihood! In one case, a patient was injected in the spine with a clear solution poured into a small , unlabeled sterile cup on the sterile field. The operator thought it was Lidocaine. It turned out to be an antiseptic solution to be used to clean the injection site before the procedure. The patient died several days later.

38 Expiration Discard medications upon expiration or any time there are concerns regarding the sterility Date multidose vials when first entered & discard at 28 days or manufacturer’s expiration date, whichever is first Discard unopened vials at manufacturer’s expiration date Discard opened single dose vial/ampule discarded immediately after use on patient Discard prepared syringes at end of procedure-do not save for next case

39 Irrigating Solutions Best if irrigation solutions are discarded between patients Warming irrigation solutions: T max <113°F, lower (104°) if IV fluids included (record temp daily) NEVER warm in microwave (any pt care item!) Medication containing irrigations: obtain from Pharmacy - single patient use These irrigants usually contain no preservatives, so cannot be used past 24 hours of opening. Microwaves heat unevenly, can burn the patient. Same for towels, sheets, blankets. NEVER in the microwave!

40 Eye Drops, Ointments, Ear Drops
Hand hygiene before & after Glove if contact with mucous membranes anticipated Administer all eye & ear products using “no touch” technique to prevent contamination If break in technique discard the container ASAP Prefer single patient use

41 Topicals Sanitize hands
Prevent contamination of bulk containers; use smallest available Small size can be dedicated to single patient and then discarded Remove desired amount with a sterile applicator or tongue blade (no double-dipping) or squeeze onto a sterile gauze in a clean area

42 Cleaning, Disinfection, Sterilization

43 Risks in Invasive Procedures Both Inside and Outside the Traditional OR
Improper environment Inadequate cleaning, disinfection, and sterilization Staff not trained adequately Antiquated equipment Borrowed equipment Improper use of equipment Compromised cleaning procedures It is important to mention the risks associated with the performance of surgical procedures outside the hospital or traditional setting. Overall, the patients have less co-morbidities and so the risk of infection is less. This is changing as the number of and invasiveness of procedures performed in these settings is increasing. The setting and environment in which surgery is performed is critical to the prevention of infection both in hospitals and in settings outside the traditional OR. In centers where surgery is performed outside the hospital, several risks have been identified. These risks, however, may also exist in traditional settings. Insist that the same processes are followed, no matter where surgery is being done. Inadequate sterilization and disinfection processes pose a risk especially outside of the hospital where trained CSPD personnel is not available. 43 43 43

44 Definitions Cleaning: removal of all soil from objects/surfaces
Decontamination: removal of all pathogenic microorganisms from objects to ensure they are safe to handle Disinfection: elimination of many or all pathogenic organisms with the exception of bacterial spores Sterilization: complete elimination, destruction of all microbial life Emphasize that cleaning must occur before instruments can be safely disinfected, decontaminated or sterilized. Organic material will cause process to be ineffective. This will be covered in detail in later slides. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 44 44


46 Cleaning Defined as the physical removal of all visible soil, dust, and other foreign materials Effective cleaning will reduce microbial contamination on environmental surfaces & equipment Cleaning is the first and most important step before disinfection or sterilization can occur The first step in any disinfection process is Cleaning. If material is not removed from the item the disinfectant cannot penetrate and disinfect or sterilize. Talking point: Use the example of dried food on a plate prior to insertion into a dishwasher. The dried food will emerge ‘clean’ from the dishwasher but still remain as dried food on the plate. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 46 46

47 Presoaking Prevents soils & proteins from drying on the instruments
Softens soils and assists with removal Prevents biofilm development Presoaking the instruments should ideally occur immediately following the surgical procedure Sprays, foams, available Presoaking is one way to begin the cleaning process. This is very important. Enzyme presoaks break up blood and protein matter. They can make the job of cleaning easier and more efficient. These also prevent blood from drying on instruments while they are waiting to be cleaned. Biofilm can begin developing in minutes. Presoaking instruments immediately will prevent this. AAMI ST ; p. 53 47 47

48 Enzymatic Detergents Detergents are defined as substances capable of dislodging, removing and dispersing solid or liquid soils from a surface being cleaned Enzymatic detergents usually consist of a detergent base with a neutral pH to which one or more enzymes and a surfactant is added These are similar in concept to the presoaks. They are very beneficial to the cleaning efficiency. The main benefit is on protein matter. AAMI ST79, 2010, 7.5.2, p.55 48 48

49 Manual Cleaning Follows presoaking
Instruments washed submerged under water to prevent potential exposure to microorganisms through aerosolization Use a basket to lift out sharp items Staff must wear PPE including eye and face protection Some endoscope washers may allow you to eliminate manual cleaning Talking point: Stress that the HCW should be wearing appropriate PPE (goggles, gloves, mask, & gown) when processing these instruments. Also, this area must be physically separated from the clean instrument area. Some washers may complete manual cleaning all together, however, it is a good idea to clean and remove gross debris first. OSHA: don’t put hands into sink or basin with sharps, use a basket or strainer to remove items so they can be seen to prevent sharps injuries. AAMI ST 79, 2010, 2.17, p.8 49 49

50 Ultrasonics for Delicate Instruments (e.g. eye instruments)
Effectiveness is based on cavitation: sonic waves generate minute bubbles on instrument surface Bubbles then expand, become unstable, then collapse or implode Implosion generates very localized vacuum areas that literally dislodges/sucks off the soil Must clean machine per instructions Advantage: Process can overcome problems of poor equipment design by removing soil from inaccessible crevices. Disadvantage: Equipment requires preventative maintenance and attention to operative procedures. If sonic cleaner does not have a rinse cycle, loosened particles can remain on the equipment and must be hand rinsed. Also delicate items may be damaged by the implosions. The ultrasonic machine must be emptied and cleaned per manufacturer guidelines to prevent overgrowth of pathogenic organisms AAMI ST79, 2010, , p. 57 50 50


52 Washer Disinfectors Mechanically cleans instruments using a spray action called impingement Impingement is the water force making contact with the instrument Several cycle processes; final step is heated air drying Render instruments safe to handle These vary from the size of a small dishwasher to large enough to push an entire cart full of trays into. Each tray can have many instruments on them but each have to be opened and laid in a manner to facilitate cleaning. Just like when you load a dishwasher at home. Point is, a person still has to handle the instrument trays and get them ready for the machine. Ideally this should be located between the decontamination area and the clean area. May have a front and back door to prevent cleaned instruments from being removed by someone with contaminated gloves. Use “oven mitt” type gloves. 52 52

53 Spaulding Classification for Medical Devices
In 1972, Dr. Earl Spaulding developed a system for classifying medical instrumentation and equipment Non-critical – devices that touch intact skin, environmental surfaces – LOW LEVEL DISINFECTION Semi-critical – devices in contact with intact mucous membranes or skin that is not intact – HIGH LEVEL DISINFECTION Critical - (high risk) devices enter sterile tissue or bloodstream – STERILIZATION Give examples for each risk level: Critical – surgical instruments Semi-critical – endoscopes, respiratory therapy equipment Non-critical – blood pressure cuffs, crutches, EKG leads, bedside tables APIC Text, 2009, p 53 53

54 Device classification Examples Spaulding process classification
EPA Product Classification Critical (enters sterile tissue or vascular system) Implants, scalpels, needles, other surg. Instruments Sterilization-sporicidal chemical; prolonged contact Sterilant/ disinfectant Semi critical (touches mucous membranes) Flexible endoscopes, laryngoscopes, ET tubes, vaginal specula High level disinfection-sporicidal chemical; short contact Hydrotherapy tanks Intermediate level disinfection Hospital disinfectant with label claim for tuberculocidal activity Non critical (touches intact skin) Stethoscopes, tabletops, bedrails, blood pressure cuffs Low level disinfection Hospital disinfectant without label claim for tuberculocidal activity This table demonstrates how to use Spaulding’s classification: 1. Device classification 2. Spaulding process classification 3. EPA product classification. If you are unsure what category an item falls into play it safe and go up a level. Some areas may find it more cost effective and less cumbersome to use a table top sterilizer for non-lumened instruments that need high level disinfection rather than a chemical such as glutaraldehyde. 54

55 Low Level Disinfection
Kills most bacteria, some viruses, some fungi Appropriate for non critical medical devices and environmental surfaces Quaternary ammonium compounds (Quats) are low level disinfectants Many quats are effective against TB and Hepatitis B OK for use on blood spills and in OR environment Many hospital/healthcare disinfectants are quaternary ammonium compounds or Quats. Check to see if the quat being used has a Hep B or TB claim so that it can be used for blood spill clean up. It is more convenient and allows to use one product for environmental surfaces. CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008 55 55

56 Environmental Cleaning and Disinfection
Have a written procedure for cleaning ALL environmental surfaces and equipment What, who, when, how EPA-registered hospital disinfectant/detergent Pop-up wipes very handy for small surfaces Spray bottles discouraged, use nozzle top Use original containers or manufacturer's label ANYTHING that touches a patient must be disinfected before it touches another patient. This includes BP cuffs, pulse ox probes, etc. APIC Text, 2009, Ch 100

57 Intermediate Level Disinfectants
Kills Mycobacterium tuberculosis, vegetative bacteria (e.g. Staphylococcus aureus), most viruses & fungi Most phenolic disinfectants are classified as intermediate level Appropriate for hard surfaces, floors, non- critical medical devices Phenolic disinfectants are used cautiously where there are infants Regulated by the EPA Keep MSDS handy and make sure staff are knowledgeable (especially housekeepers). Make sure proper labeling is used on containers. Association between phenolics and hyperbilirubinemia in newborns. If phenolics are used in unoccupied bassinets, etc. you should have the cleaning staff rinse off the disinfectant with clear water after it has dried (per CDC Environmental Infection Control Guidelines 2003). APIC Text, 2009, Ch 100 57 57

58 High-Level Disinfection
A process (usually liquid chemicals or wet pasteurization) that eliminates: Many or all pathogenic microorganisms on inanimate objects Except large numbers of bacterial spores Short exposure times (<30 minutes) Aldehydes (formaldehyde, glutaraldehyde) ANY instrument that touches mucous membranes must be at least HLD CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008

59 High-Level Disinfection
Any instrument that will touch mucous membranes or non-intact skin Flexible endoscopes Ultrasound probes, vaginal and anal, used with sheath Brushes used to clean instruments for HLD Laryngoscope blades Vaginal specula & related equipment Diaphragm fitting rings Flexible endoscopes generally cannot withstand steam sterilization, so HLD is performed. Rigid scopes should be processed in the autoclave. APIC Text 2009, p.21-6.

60 High Level Disinfection
Endoscopes- GI, GU, can’t tolerate high heat Sometimes for arthroscopes, laparoscopes Large studies of HLD arthroscopes have shown no increased risk of infection compared to sterilized arthroscopes Follow label directions for soak time, temperature, use life, shelf life, product restrictions No OPA for urology scopes per label on some OPA products Use in well-ventilated area, wear PPE Many HLD products are similar: compare NEVER use HLD for environmental cleaning! APIC Text 2009, p.21-3.

61 FDA-Approved Agents for Chemical High-Level Disinfection
Use for temperature-sensitive devices Glutaraldehyde (> 2.0%) Cidex, Metricide, etc.* Ortho-phthalaldehyde – OPA (0.55%) many brands Hydrogen peroxide-HP (7.5%) Sporox Peracetic acid-PA (0.2%) Steris HP (1.0%) and PA (0.08%) Peract HP (7.5%) and PA (0.23%) Endospore (no test strips!) Glutaraldehyde (1.12%) and Phenol/phenate (1.93%) Sporicidin 2% Activated Hydrogen Peroxide (Resert XL) Several companies make glutaraldehyde, don’t just call it all Cidex. Also comes in different strengths -14 day, 28 day. Must be monitored daily for dilution. Hydrogen peroxide gas plasma is the Sterrad. (Vaporized Hydrogen Peroxide is marketed by Steris) HP & PA may be Endospor or Peract PA may be called STERIS machine Glutaraldehyde and phenol/phenate is Sporicidin Each product has different times and temperature ranges. Make sure your automatic washer does perform at the temperature required for the specific product. Make sure you have read the MSDS and marketing info for the product you are using (e.g., Rapicide is HLD in 5” at 35° and Cidex OPA HLD is 12” at 20° C. Glutaraldehyde needs monitoring of exposure limits (OSHA) with badges-make sure employees know not to allow liquid to splash on badge. Ventilation requirements of room need to be reviewed. Consideration with each chemical: damage to instruments, corrosion, and risk of exposure for employees. *Brand names used for illustration only, no endorsement is implied. APIC Text 2009, p.21-3. 61 61

62 High-Level Disinfection
Glutaraldehyde and Ortho-phthalaldehyde – OPA Various formulations and brands Ready to use or requires activation (mixing) 14, 28 and 72 day formulations (maximum use days) Must use test strips to assess concentration prior to each use Minimum Effective Concentration (MEC) specific to each product Product must be rinsed thoroughly Sterile or potable water (dependent upon intended use of instrument) Maintain log Must be neutralized for disposal (Glycine) Glut: Requires air monitoring OPA stains proteins grey, cannot be used with urologic ca patients who undergo repeated cystoscopy. Many states require neutralization of HLDs, glycine works for glutaraldehyde and OPA.

63 HLD Flexible Scopes Immediately: wet wipe down outside of scope
Take to soiled utility room (cart or tray, “enclosed”) Leak test (if fails, stop and send scope for repair) Initiate cleaning process- enzymatic soak Scrub and flush all channels, ports, valves, etc. Rinse, rough dry Immerse in HLD for product label-designated time, flush and fill all channels to prevent air bubbles Rinse x 3, rinse channels with alcohol, blow dry Hang vertically to store, closed cabinet preferred APIC Text 2009, p.21-3.

64 Automated Endoscope Reprocessors (AERs)
Perform some or all of the functions: leak testing, cleaning, disinfection, alcohol rinse and air drying of scopes MUST ensure all lumens are properly connected to the system Proper connectors must be use correctly each time. APIC Text 2009, p.21-6.

65 Minimum Effective Concentration (MEC) Test Strips
Dilution of chemical occurs during routine use Test strips for monitoring the MEC, specific to each product; test prior to each use, log Do not use test strips beyond expiration date QC test & document when opening a new bottle; refer to manufacturer’s protocol Talking point: Regulators will review documentation records. Most test strips will expire in days. JCAHO watches to see that strips for any testing are dated and that your facility is following policy. Recently, checking to be sure test strips are VALIDATED- 3 strips dipped into HLD reservoir, read as per instructions, 3 strips dipped into a half water, half HLD solution. First set should pass, second set should fail. Document on the log. AORN Perioperative Standards & Recommended Practices, 2012, p. 489 65 65

66 High Level Disinfectant Log
Tray/ Equipment Date Processed Solution Expiration Date Test Strip Expiration MEC Test Result (+ Pass or - Fail) Solution Temperature Solution Soak Time Initials IMPORTANT! Solution must be discarded by expiration date, EVEN when MEC test passes Test Strip Example - Fail + Pass

67 Cleaning/Disinfection in Endoscopy
Key Infection Prevention Interventions for cleaning and processing endoscopes Keep the scope moist – enzymatic soak Transport in covered container Consistent and complete cleaning of all channels Manual cleaning includes Valves Channels Connectors All detachable parts Brushes The processing of scopes in endoscopy requires conscientious compliance to the manufacturer’s recommendations for cleaning, disinfection and drying. Brushes should be proper size and fit for each scope lumen. Brushes should be evaluated prior to use to ensure they are intact and clean prior to use. Preferably disposable but if not must be cleaned and disinfected after use. Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes, 2011 SGNA published updated guidance 9.12 67 67 67

68 Cleaning/Disinfection in Endoscopy Setting (2)
Leak testing and scope inspection Processing: Per manufacturer Chemical Automated endoscope washer- disinfector Use alcohol for final rinse, blow air Hang to dry (vented cabinet designed for hanging and storage of scopes) Do not store in case! Leak testing is performed BEFORE cleaning because if there is a tear in the lumen, the HLD will get into the fibers and damage them. Place scope in a red, biohazard bag or other designated container indicating it is contaminated and send to Biomed or appropriate scope repair facility. Hang vertically, straight down, to dry and store. Vented cabinets are nice, not critical. DO NOT STORE IN CASE- case will be contaminated! 68 68 68

69 Cleaning/Disinfection in Endoscopy Setting (3)
Documentation log Patient name Type of scope - Serial number Date and time of processing Enzymatic soak time if manual Chemical indicator results Machine – bay number Soak time if manual Soak temperature Attach print-out if available Timing starts when last item is added to HLD solution 69 69 69

Today’s Date: ___________________ Results Of Pre-Process Test:___________ Disinfectant: ____________________ Expiration Date Of Test Strips:__________ Activation Date: _________________ Patient Name Processor # Load # Scope Leak Test Cleaning Time Soak temp Rinse Alcohol Purge Initials Included in handouts for today 70 70 70

71 Competency, Process Monitoring
Training of ALL staff responsible for cleaning instruments, scopes, equipment (vacations?) Post the procedure in work area Ensure proper equipment, PPE, supplies available Competency evaluation initially & at least annually Maintain training records Periodic visual monitoring of practice Consider microbiological monitoring if indicated Document training of each individual who will be cleaning & disinfecting scopes and other equipment. Post a detailed cleaning procedure above the sink PPE must be worn, fluid-resistant gown, gloves, face/eye protection Annual competency evaluation by someone who understands the process, also if procedure changes, such as acquiring new scopes, different scopes. Periodically observe to ensure procedures are being followed If transmission via scope is suspected, can aspirate sterile water into a sterile cup and send to lab to see if the organism found in the patient is also found in the scope. Routine preventive maintenance of scopes, scope washers, etc. Second reference is Dr. Rutala’s competency checklist for scope processing AAMI ST , 4.2, p. 37


73 Types of Sterilizers Thermal (Heat)
Moist (Tabletop or large; Gravity, & High Speed Vacuum) Dry Chemical ETO (ethylene oxide, “gas”) Other chemicals- H2O2 gas plasma (Sterrad); Steris Ozone- commercial use Radiation- commercial use Example of a tabletop steam autoclave. For the purpose of this course, the focus will be all types except the Ozone and Radiation methods. These two methods are not readily accessible to the average facility. CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59 73 73

74 Steam Gravity Sterilization
Low cost, quick turnover, no toxic chemicals, accommodates large loads Steam enters the chamber by gravity & displaces air (so steam can penetrate load) Takes longer for steam to reach required temperature May not penetrate complex instruments Advantages – rapid heating and rapid penetration of textiles. Non-toxic, inexpensive, can be used for some liquids. Disadvantages – items must be heat and moisture resistant. Cannot be used to sterilize powders or oils. Gravity type is slower to run a load, may not penetrate complex instruments, only sterilize the surface. Types of Steam Sterilizers A steam sterilizer, also know as an “autoclave,” is a pressure-type vessel with a door or cover, valves to control  the  entry  and  exit  of  steam  and  air,  and monitoring  devices  to  allow  the  operator  to  observe conditions inside. It is designed to hold items and allow steam under pressure to penetrate these items. Steam sterilizers are available in many sizes, ranging from  portable  countertop  to  the  fixed  room-size sterilizer. Effective steam sterilization and exposure time are measured from the moment the thermometer in the discharge line indicates the desired preset temperature. The pressure inside the sterilizer is not an indication of positive sterilization because other factors determine the pressure inside the sterilizer. Pressure  merely  maintains  temperature. CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p 74 74

75 Steam Pre-Vacuum or High Speed Vacuum, Pulse Vacuum
Low cost, quick turnover, no toxic chemicals, accommodates large loads Air is removed (so steam can penetrate load) by a pump before steam at an elevated temperature is rapidly introduced, then rapidly removed at end to facilitate drying Will penetrate complex instruments Advantage: much quicker than Gravity Steam sterilization. For example, a wrapped item sterilized at 133° C or 272° F is sterilized: Gravity Steam - 15 minutes High Speed Vacuum – 4 minutes Also, ETO will take 3-6 hours Disadvantages – same as the Gravity Steam sterilizers except cost of purchasing the sterilizer may be higher. PREVACUUM STEAM STERILIZER.—The prevacuum  steam  sterilizer was  designed to help overcome the trapping of air in the chamber. Trapping  of  air  is  one  of  the  greatest  dangers encountered when using saturated steam under gravity cycles. When  errors  are  made  by  improperly packaging items or overloading the sterilizer chamber, cool air pockets may form resulting in items not being sterilized. The speed and efficiency of the steam sterilizer may be improved by removing air from the chamber with a powerful pump, creating a nearly perfect  vacuum  before  steam  is  introduced  into  the chamber. This procedure allows fast and more positive heat  to  penetrate  the  entire  sterilizer  load.  The improved sterilizer is referred to as the prevacuum steam sterilizer. Full heating of the loads is faster in the prevacuum sterilizer  than  in  the  gravity  displacement  sterilizer. For example, wrapped instruments can be sterilized at 270°F   (131°C)   after   4   minutes   exposure   in   a prevacuum  steam  sterilizer.  Consult  the  manu- facturer’s instructions for specific details on operation and user maintenance information. The  Bowie-Dick  type  test  was  developed  for prevacuum sterilizers to determine if the air has been removed from the chamber during the prevacuum stage. Air must be removed so that steam can penetrate the  load  instantaneously.  It  must  be  understood  that this is not a test for adequate exposure to heat in terms of  time-at-temperature.  A  commercially  prepared Bowie-Dick type test can be used by carefully reading and following the manufacturer’s instructions. CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59 75 75

76 Dry Heat Sterilization
Mechanical convection – more efficient and temperature is more uniform 340°F for 60 minutes, dental 320°F for 2 hours Used for powders and oils that can tolerate high temperatures See AAMI ST40 Advantages: can be used for powders, oils, glass. No corrosion or rust. Disadvantages – penetrates slowly and unevenly. Long exposure times necessary. High temps damage rubber and some fabrics. FYI for speakers: Hot air is the sterilant for dry heat sterilization. The principle behind dry heat sterilization is conduction. Heat is absorbed at the exterior surface AAMI ST79, 2010, 8.5.8, p. 81 CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 68 76 76

77 Low Temperature Sterilization
Ethylene oxide (EtO/EO); Used for heat & moisture sensitive devices Lengthy aeration time must follow each cycle to allow removal of harmful residuals before opening chamber doors EtO/EO is associated with human tumors Alarms, ventilation and training of staff promote safe use of this agent Destroys microorganisms by alkylation (replacement of hydrogen atom in a molecule with an alkyl group) prevents the cell from metabolizing or reproducing. Disadvantages: Cycle time 3-6 hours Requires ETO permeable pkg Cost Toxic to patient & personnel - Must aerate items well before use Must exhaust to the outside Room must have 10 Air Changes (AC) per hour, Temp 70°F with 50% Humidity CDC Guideline for Disinfection & Sterilization in Healthcare Settings , 2008, p. 61 77 77

78 Hydrogen Peroxide Gas Plasma Sterilizer
Notice the size of the sterilizer inside. This may be a big disadvantage when wanting to do large loads or large instruments. Beware caskets placed in this machine cannot be used forever. Limits on length and diameters of lumens. By product is water, non-toxic. CDC Guideline for Disinfection & Sterilization in Healthcare Settings , 2008, p. 61 78 78

79 Packaging for Sterilization
Use the correct wrapper for the type of sterilization to be performed, items to be packaged Wrappers must have a 510k that specifies what it can be used for (ETO, steam, etc.) Same for peel packs AORN Standards & Recommended Practices, 2012, p

80 Peracetic Acid Sterilizer
This may develop a yellow crust inside machine that is not bacterial or fungal growth. It is a chemical deposit. Steris System 1 pictured above, being replaced by the 1e. Unknown how long Steris will support the Steris 1 product. CRITICAL that correct connectors are used for each item. Steris 1 gone by Feb. 2, 2012 Steris 1e FDA Approved 80 80

81 Flash Sterilization- Now Called “Immediate Use Steam Sterilization”
Definition: AAMI: “process designed for the steam sterilization of patient care items for immediate use” AORN: “should be used only when there is insufficient time to sterilize the item by the preferred wrapped or container method” Not recommended outside of the ambulatory surgical center where it can be used in a controlled manner Should never be used as a substitute for sufficient inventory immediate use sterilization is a hot topic. It is defined as a process to make a pt care item available for immediate use using steam sterilization. It is not recommended that this is used outside of the surgical setting where it can be controlled and monitored. It may be tempting to use this in place of purchasing more equipment but it may come with an increased risk of infection for the patient. AAMI ST79, 2010, 8.8, p. 86 81

82 Immediate Use Sterilization
Acceptable only for items: AAMI guidelines for implants AORN guidelines for implants Single instruments only (not trays) Urgently needed Cleaned well Used close to point of sterilization Adequately covered or protected from contamination Use mechanical, chemical, and biological indicators immediate useed item is placed in an open tray to allow rapid steam penetration immediate use sterilization is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use. It also is used when there is insufficient time to sterilize an item by the preferred package method. immediate use sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time. Take item apart, flush lumens. Will staff do this in the surgical area? Possibly not as well as the CSP staff. How far away is the sterilizer from ? AAMI-must have a biological indicator and quarantine till results known. AORN says only immediate use implants in emergency, do a BI and CI with each load and quarantine till results known. AORN Standards and Recommended Practices, 2012, p 82 82

83 Immediate Use Sterilization
Considerations: Risk of burns from hot instruments Recontamination of instruments during transport Keep logs of all immediate using (process surveillance) Monitor number of times used, what procedures, and why – use as dept PI Monitor staff training and performance Review logs and expect PI projects focusing on why it is done and how improvements will be made if done frequently. Education for Surgical staff should be completed and staff’s ability to describe the procedure and precautions should be monitored. Surveyors will ask staff persons if implants are immediate use. AORN Standards and Recommended Practices, 2012, p 83 83

84 Quality Assurance for Steam Sterilization
Critical Parameters for each load Steam Temperature Pressure Time Each of these critical parameters must be met to assure that instruments are adequately sterilized. They are monitored using various methods and indicators. It is important that with each load these parameters are reviewed prior to release of the instrument into the procedure or surgical field. AAMI ST79, 2010, p 84

85 Sterilization Indicators
Class I – External, time, temp, pressure indicator, says item went through autoclave (tape) Class II – Bowie Dick, checks for air removal Class III – Internal, time & temp, rarely used today Class IV – Internal, reacts to two or more parameters, rarely used today Class V – Integrators, melted chemical pellet, reacts to all parameters, all steam cycles Class VI – Emulating indicators, cycle specific Biological – gold standard, shows kill of organisms Class I- the package, tray, etc. went through the autoclave. DOESN’T indicate sterility. Heat sensitive tape. Class II- Bowie Dick used in vacuum sterilizers to ensure air is removed and steam is penetrating. Run each am. Class III – Checks only two parameters, time and temp, not used in healthcare today Class IV- Reacts to 2 or more parameters, rarely used in healthcare today Class V – Integrator for ALL parameters, can be used in all steam cycles, run WITH a BI. Class VI – Emulating indicator, specific ones for different cycles Biological Indicator – demonstrates kill of organisms. AORN Standards and Recommended Practices, 2012, p

86 Examples of Bowie Dick Tests (for prevac sterilizers only)
Bowie Dick (steam) Uniform color change means OK, monitors efficacy of air removal and steam penetration, run daily before 1st load and 1 pk. per load. Also after initial instillation, relocation and sterilizer repair. 86 86

87 Sterilization Monitoring: Mechanical Indicators
Cycle time, temperature, & pressure is displayed on the sterilizer gauges with each instrument load Printout or graph documents these indicators If these fail, load is no good. These indicate the machine functioned properly. Surveyors may ask for copies of the past autoclave readout tapes. 87 87

88 Sterilization Monitoring: Chemical Indicators (CI)
The CI is a process indicator that signals the item has been exposed to sterilization process (temperature, time, etc.) A CI is affixed to outside of package & used with every load An indicator is also placed inside the pack to verify steam penetration Peel-packs have a single indicator If these fail, load is no good Note chemical indicator for some machines – floats in liquid – does not indicate sterility of device. Studies have been done monitoring the inside of narrow lumen instruments. This is a controversial issue, especially for procedures using scopes for intra-abdominal procedures or in joints. 88 88

89 Sterilization Monitoring: Biological Indicators (BI)
Closest to being the ideal monitor & measure of effectiveness by challenging the sterilization process against a resistant spore (Bacillus sp.) Use BI daily if sterilizer is used frequently Also, use a BI for every implant & EtO run Policy for positive tests- who to notify, id instruments used, recall? “IC Communication” report Many CSP depts perform this with the Microbiology dept monitoring the procedure, performance, results, and QI monitoring. AAMI: If a sterilizer is designed for multiple types of cycles (gravity, prevac, steam flush pressure pulse, or immediate use) then each mode must be tested. Each type of tray configuration for immediate use sterilization should be tested separately. Test each type of steam sterilizer cycle and tray configuration. 89 89

90 Biological Indicators (BI)
Compare capsules for color change at regular intervals Length varies with the product; rapid readout 1-3 hours, or 24 hours Read and record results Positive test = sterilization process has failed due to improperly processed load, failure to meet temperature or exposure parameters, mechanical problems, etc. If rapid testing is used, you can pull instruments before they are used and surgeons don’t have to be notified of failed sterilization of instruments. Yellow tube is a positive test, purple is negative. Want control to be positive. A major concern if instrument was used: was it an implantable? What type of surgery? Surgeon may feel that patient should be given antibiotics or just be aware and watched for signs of infection. Yellow = Positive Purple = Negative 90 90

91 Documentation: Note the Control is positive the Biological is negative
Talking point: Stress the importance of consistently documenting results. In addition, regulatory agencies will review logs for completeness. Logs should be monitored to ensure that machines are functioning. Reports should be made to IC Comm. Note that control on log sheet is always positive. 91 91

92 Positive BIs Remove sterilizer from service until problem resolved
Consider recalling packs processed since last “good” load Check sterilizer records or logs to see if all other critical parameters were met Repeat the BI in 3 separate loads If all are negative and critical parameters are met, place it back into use If one or more continue to be positive Have machine serviced Repeat BI using a different manufacturer or lot of indicators Positive Bis happen from time to time. Sometimes they are due to incorrect use of the BI or are false positive. Other times there may be a problem with your sterilizer. It is important to investigate every positive BI by taking the sterilizer out of service, reviewing load records to ensure all other parameters were met and then repeat the Bis x3. If you end of needing to service the machine be sure to run a test load to make sure it is running properly before you release items into the surgical / procedure area. Do not rely on the service company’s reports or records, have proof it is working to standards. AAMI ST79, 2010, , p. 114 92

93 Storage of Clean/Sterile Supplies
Store at least 8-10” from the floor 18” from the ceiling 2” from outside walls Solid bottom shelf Closed cabinets Avoid overfilled drawers NO RUBBER BANDS! Discuss reasoning behind each 8-10” from floor to prevent contamination from floor cleaning, footwear which is always contaminated 18” from ceiling or sprinkler head (depends on local and state interpretation) to prevent blocking 2” from outside walls to avoid contamination with condensation Don’t stack heavy trays Max tray weight 25 lbs, scale necessary in CS Rubber bands nick the edges of wrappers and can cause loss of sterility; use drawer dividers Don’t overstuff drawers, wrappers will get torn Store sterile with sterile, non-sterile with non-sterile AORN Standards & Recommended Practices, 2012, p. 559 93 93

94 Time-Related vs. Event-Related Sterility
Historically, sterile items had an expiration date… yet items don’t suddenly convert from sterile to non-sterile Event-related sterility states the product does not have an expiration date providing the package is intact (e.g. wrapping intact, package is not wet, etc.) Sterility is event related, not time related! Time-related package is labeled with expiration date (e.g., 2 months) Advantage is: Easy for the staff to police items. Items are repackaged and reprocessed after expiration (if items are reusable). Don’t need the cleaning step. Disadvantage – easy to miss items and these show up during JCAHO and State surveys. Also, staff may rely on date to determine good/bad – fail to check package integrity. Event-related should include rotating items on the shelf to ensure that older items are used first. AORN Standards & Recommended Practices, 2012, p. 560 94 94

95 Reuse of Single Use Devices (SUDs)
Manufacturers cite “single use only” on many of their products (e.g. cardiac caths, orthopedic bits/blades, DVT sleeves, etc.) Re-use of these products can result in significant financial savings Concern with the risk of infection and injury when the devices are re-used Must consider regulatory, medical, ethical, legal, & economic issues before proceeding forward 3rd party reprocessing acceptable when premarket requirements are met (FDA 510(k)) ( Talking point: This can be a very controversial issue as hospitals are always striving to determine methods of providing quality care while saving money. Make sure you are not reprocessing items which are disposable and not used. This falls under the category of “Reprocessing” which has strict federal regulations. 3rd party reprocessors are acceptable to use for reprocessing a SUD. However, the product must meet premarket requirements from the FDA and supplemental validation that states the reprocessed device is substantially equivalent to the original device. Examples include: biopsy forceps, surgical drills and saw blades, metal orthodontic braces. 95 95

96 Vendor-Supplied Equipment
Must wear appropriate attire in OR Name badge; should meet employee criteria for medical screening and immunization Bring written cleaning, disinfection, sterilization instructions from manufacturer of device Equipment Must be delivered to the CS decon for cleaning and sterilization (with instructions) Allow adequate time for processing Record “borrowed” equipment contents, vendor name, patient or case number involved, surgeon name, date and time, keep a log AORN Standards & Recommended Practices, 2012, p. 558 96 96

97 Summary CMS and accreditation requirements are all about patient safety Risk assessment, written plan, evaluation of program, document Hand hygiene, hand hygiene… Safe injection practices Cleaning, disinfection, sterilization Environmental cleaning

98 Thank You!

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