Strategies for Effective Management of the Sterile Processing Department

Transcription

1 Strategies for Effective Management of the Sterile Processing Department Objectives Upon completion, participants will be able to... 1) explain the importance of instrument reprocessing for infection prevention, 2) identify where best practices for sterilization and HLD are found and explain some common errors, 3) describe some recent lawsuits involving improper instrument reprocessing, and 4) discuss how computers can assist with instrument management and compliance with manufacturer s IFUs. SPD Education & Training Healthcare personnel performing sterile processing duties (e.g. decontamination, inspection, preparation, packaging, sterilization, sterile storage and distribution) must be properly trained to execute these critical tasks efficiently and effectively. Efficiently in order to reprocess instruments sets on time and complete, and effectively to make sure they are indeed sterile. Of course, sterile is most important because a non-sterile instrument in the OR, is like a loaded gun. 1

2 SPD Education & Training The Sterile Processing Department (SPD) plays a an important role in infection prevention efforts, particularly in relation to surgery patients. As failing to follow HLD and/or sterilization best practices can result in infections, which causes harm to patients and increased costs to the healthcare facility. Best Practices In the U.S., instrument reprocessing best practices are detailed in AAMI Standards, AORN Perioperative Standards and Recommended Practices, along with other documents, such as SGNA which focuses on flexible gastrointestinal endoscopes. It is important to know All national survey organizations now audit healthcare facilities for strict compliance with standards, guidelines, and MFG s instructions for use (IFU). 2

3 The Centers for Medicare & Medicaid Services (CMS) recently revised their Survey and Certification document to include more stringent audits in the areas of infection control and sterilization. Areas of emphasis, include: Compliance with nationally recognized standards/documents. Formal training in areas of infection control and sterilization. Compliant cleaning, sterilization and monitoring procedures. Established criteria for flash sterilization. Reference: CMS Infection Control Surveyor Worksheet, Exhibit 351, AAAHC - The Accreditation Association for Ambulatory Healthcare recently added an infection control chapter to their standards handbook. Infection control highlights included: Adhering to standards, guidelines, and manufacturer s instructions for cleaning, disinfection, and sterilization of instruments, equipment, supplies, and implants. Reference: OR Manager Magazine, Volume 26, Number 2, 2010 July 20, Joint Commission Online Focus on sterilization and high-level disinfection processes Beginning in 2010, surveyors have spent additional time during surveys evaluating the cleaning, disinfection and sterilization processes. In 2011, Joint Commission surveyors received in-depth training on sterilization processes. This education was provided in collaboration with AAMI and included a review of all aspects of the AAMI ST79 guideline on steam sterilization. Thereafter, a similar educational module was delivered on HLD of endoscopes. 3

4 Effective Management of SPD It is critical to have these important references for proper facility design, writing Policies & Procedures, training personnel and passing your Accreditation Surveys. To ensure PATIENT SAFETY! Sterilization Best Practices Point of Use pre-clean to prevent soil from drying. Reprocessing Areas clean & disinfect in Decontamination area, inspect & assemble in Prep & Packaging area, package & sterilize in Sterilization area, maintain sterility in Sterile Storage area. Quality Assurance documentation & record keeping. ANSI/AAMI ST79:A4:2013 Considered the bible of sterilization, this comprehensive guide to steam sterilization in healthcare facilities covers all aspects of facility design, personnel and reprocessing procedures. Order Code: AAMI ST:79 List Price: $ plus shipping Member Price: $ plus shipping 4

5 ANSI/AAMI ST58:2013 Provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the FDA for use in hospitals and other health care facilities. Order Code: ST58 List Price: $ plus shipping Member Price: $ plus shipping Association of perioperative Registered Nurses Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings Order Code: MAN-014 List Price: $ plus shipping Member Price: $ plus shipping reprocessing of Surgical instruments Point of Use (Surgery) Failure to wipe off gross soil from instruments and/or flush lumens with sterile water Delay in transporting soiled instruments to the decontamination area Failure to spray instruments with pre-clean solution Transporting without using a closed container and/or without a biohazard label 5

6 sterilization of Surgical instruments Reprocessing area (Decontamination) Not wearing proper PPE Not having a 3 section sink to soak-wash-rinse Not having an ultrasonic cleaner Not having sinks or an ultrasonic of sufficient size Testing some, but not all mechanical cleaners Not having MFG s IFUs Not following MFG s IFUs F (132 C) Pre-vacuum reprocessing of Surgical instruments Reprocessing area (Prep & Pack) Not inspecting 100% of instruments, Not using inspection lamps and/or lens, Cleaning instruments and/or rigid containers, Assemble hinged instruments in the closed position, Using improper materials (i.e. marking pens, tape and/or wrap inside trays, sterilization tape on rigid containers, peel pouches or count sheets inside trays). Improper use of lot control labels. 6

7 reprocessing of Surgical instruments Sterilization Improper loading of sterilizers, Incorrect sterilization mode and/or parameters, Not enough dry time for type of load, Wet packs, Not allowing sterilized packs to cool to room temperature, Placing sterilized items to cool near AC vent. reprocessing of Surgical instruments Storage Placing sterile items in a high traffic area, Improper ceiling tiles and/or storage shelves, Dust on storage shelves, Putting clean items on top of sterile items, Exceeding temperature and/or humidity ranges, Stacking wrapped packs on top of each other. KimGuard and One-Step Wraps (Directions For Use) Caution: Do not stack trays. Stacking trays can result in damage of the wrap caused by undue pressure from the weight. Improper storage Trademarks of Kimberly-Clark Corp. 7

8 Effective Management of Sterilization It is critical to have these important references for proper facility design, writing Policies & Procedures, training personnel and passing your Accreditation Surveys. To ensure PATIENT SAFETY! How Many of You Reprocess Flexible Endoscopes using HLD? Flexible endoscopes are some of the most challenging devices for HCWs to reprocess due to their unique design and complex reprocessing steps. As with sterilization, to effectively manage HLD, you have to follow best practices. HLD Best Practices Point of Use pre-clean to prevent soil from drying. Reprocessing Area perform leak test, manual cleaning & rinsing, high level disinfection (manual or automated), rinsing, drying and storage. Quality Assurance documentation & record keeping. 8

9 Association of perioperative Registered Nurses Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings Order Code: MAN-014 List Price: $ plus shipping Member Price: $ plus shipping SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes These updated (2012) Standards are for use in all settings where gastrointestinal endoscopy is practiced. They complement the SGNA document titled Guideline for the Use of High Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes. reprocessing of Flexible Endoscopes Point of Use (Procedure Room) Not wearing proper PPE, Not having MFG s IFUs, Reprocessing delay (multiple procedures and/or with procedures performed at night or on the weekend), Failure to clean all channels (even if unused, fluid and debris can enter channels at the distal tip), Transporting without using a closed container and/or not labeled with biohazard id. 9

10 reprocessing of Flexible Endoscopes Leak Testing Not having the MFG s IFU available, Use of damaged water resistant cap, Overlooking pressurization of scope prior to immersion, Incomplete angulation of the distal tip in all directions during leak test, Not following the MFG s IFUs for reprocessing a damaged scope. reprocessing of Flexible Endoscopes Manual Cleaning Failure to fully submerge endoscope, Failure to submerge for the required length of time, Neglecting to dilute the detergent per the MFG s IFU, Using worn, damaged or improper brushes, Failure to use MFG s validated cleaning adapters, Damaged/improperly reprocessed cleaning adapters, Failure to thoroughly rinse. reprocessing of Flexible Endoscopes Manual HLD Using a sink or basin of insufficient dimensions, Using a solution after it s expiration date, Not MRC testing prior to each use. AER Failure to manually clean and/or rinse before using the AER. 10

11 reprocessing of Flexible Endoscopes Storage Oversight in removing all valves and water resistant cap when storing the endoscope, Neglecting to ensure that scopes are hung with all locks in the free position, Crowded and unsecured scope storage areas, Storing in shipment cases. I believe that instrument reprocessing errors can be eliminated with formal training and education of healthcare personnel to comply with best practices all of the time. Effective Management of HLD It is critical to have these important references for proper facility design, writing Policies & Procedures, training personnel and passing your Accreditation Surveys. To ensure PATIENT SAFETY! 11

12 Instrument reprocessing has become very complex! No healthcare facility wants to find themselves in the national news being sued over improper instrument reprocessing. Feb 24, 2012 Today Show - NBC Dirty surgical instruments January, Hospital exposes 18 patients to risk of 'mad cow' disease because surgical tools were not sterilized properly. November, A class-action lawsuit has been launched against a New Brunswick hospital over the use of unsterilized biopsy forceps at a clinicover a 14-year period. April, Maryland Casualty Co. urged a Pennsylvania federal judge to declare that it doesn't have to defend a Pittsburgh medical center against claims it used unsterilized endoscopes on scores of patients. August, A woman from Two Hills has launched a $15-million class-action lawsuit against the East Central Health region, alleging the health authority acted "negligently, carelessly and recklessly" in failing to ensure that tools used on thousands of patients at St. Joseph's General Hospital were properly sterilized. May, The University of Pittsburgh's School of Dental Medicine is accused in a lawsuit of being negligent and using dirty tools to treat a patient. More lawsuits are coming The Chicago Sun-Times reported on January 6, 2014 that the largest outbreak of a superbug CRE in U.S. history has been confirmed at a hospital outside of Chicago, IL. The hospital Advocate Lutheran General linked these critical patient infections of CRE (carbapenemresistant Enterobacteriaceae) to an ERCP (endoscopic retrograde cholangiopancreatography) procedure that uses fluoroscopy and an ERCP endoscope (or, duodenoscope). CRE Outbreak Between January and September of 2013, 243 patients who had undergone ERCP were notified by the hospital of their increased risk of CRE infection. Of the 114 patients who were tested, 38 were either infected or colonized with CRE, with 28 not displaying symptoms of infection. Unfortunately, 10 patients infected, some them critically, has infections of the blood, urine or in wounds. This outbreak involving 38 patients (16% of the total that underwent ECRP) is especially concerning because CRE has a mortality rate as high as 50%. 12

13 CRE Outbreak The CDC reported that a likely contributing factor to this superbug outbreak at Advocate Lutheran General Hospital (Park Ridge, IL) was the improper automated cleaning and/or disinfection of the implicated ERCP endoscopes. The CDC reported that previous studies have shown an association between ERCP endoscopes and transmission of multidrugresistant bacteria; the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection. January 24, 2014 SEATTLE -- A breakdown in training left instruments dirty and opened the doors to dangerous infections for more than 100 patients at Seattle Children's Hospital.. In November, a technician discovered a poorly cleaned colonoscope. Another turned up a few days later. The scope's manufacturer spells out multi-step cleaning instructions to avoid cross-contaminating patients. Dr. Zerr says hospital procedures came up short on those requirements. Doctors say so far nobody has gotten sick, but the errors launched a State Health Department investigation. Lawsuits? The SNYDER Litigation Team Baltimore, MD Post-Operative Infection Caused by Dirty Surgical Instruments Snyder and Snyder s team of experienced medical malpractice attorneys have discovered a shocking problem with contaminated surgical implements. According to a report by the Center for Public Integrity (CPI), the pervasiveness of this issue goes from scrub techs, to doctors and hospitals; even all the way up to manufacturers and oversight organizations such as the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Every one of our medical malpractice attorneys at Snyder and Snyder, strongly advise that you consult an attorney to protect your rights if you or someone you love have suffered from a post-operative infection. 13

14 Medical Negligence Lawyers Orlando, Florida Dirty Surgical Instruments The prospect of facing surgery is a frightening one which should not be made even more troublesome by concerns of negligence by surgeons and hospital staff. Yet, for many patients, routine surgery turns into a nightmare when they discover that one of the most basic elements of hospital safety, the use of sterile surgical instruments, has been neglected. Surgical site infections caused by the use of dirty instruments can mean excruciating pain, prolonged recovery, loss of limbs or organs, and even death. Dirty surgical instruments do not always cause infections at the surgery site. Patients may have to face the horror of exposure to diseases such as HIV, hepatitis, syphilis, or Creutzfeldt-Jakob Disease (mad cow disease). Even when initial test results are negative, these diseases may not show themselves for many months. Patients live in fear of life-threatening illness for themselves, and the possibility of exposing loved ones. Effective Management of SPD You have to dedicate proper resources! Especially when you are reprocessing complex devices, such as orthopeadic instruments, spine, neuro, eyes and flexible endoscopes. Computers assist with Effective Management of SPD Instrument tracking systems can improve productivity by addressing key potential problem areas, including reporting capabilities, lost or damaged instrument issues, training challenges and documentation needs. Today, there are a number of manufacturers offering systems for tracking instrument sets or containers, as well as providing a tools for effective management. Some systems track to the individual surgical instrument and the newest system tracks the manufacturer s IFU for reprocessing endoscopes. 14

15 Surgical Instrument Tracking System The V. Mueller brand IMPRESS Scan instrument management software from Carefusion, uses sophisticated bar code technology to provide information on serialized surgical sets and instruments, including location, repair status, and sterilization method. The software also creates reports on inventory, orders, needs projections, set comparisons, productivity, and more. Surgical Instrument Tracking System Censitrac 's InstrumenTrac electronic instrument tracking & management is the most fully featured and robust instrument level tracking available. You now can achieve 100% tray accuracy with faster assembly times and increase patient safety. Our permanent marking for individual instruments gives you visibility and traceability throughout your facility providing you with full accountability for every instrument and every step of your entire workflow cycle. Flexible Endoscope Tracking System The Medivator s ENDORA Endoscope Tracking System ensures endoscopes get cleaned and disinfected in accordance with each manufacturer s IFU. The system tracks endoscopes through each step of the reprocessing cycle, providing an alert if a breach in any step is detected. ENDORA also monitors endoscope storage, issuing notifications when allowed storage time is exceeded, and provides tools for analyzing productivity, operator performance, endoscope use and inventory management. 15

16 Conclusion It is important to know that accreditation agencies are now looking very closely at sterilization and HLD of instruments when they survey your ASC; however, let s not forget your PATIENTS are looking for strict compliance at all times. So for patient safety reasons, maintaining accreditation, and keeping your facility out of the local and/or national news, effective management of SPD is very important! Questions? Chuck Hughes VP, Infection Prevention Consulting Services Cantel Medical Corp. c/o SPSmedical Supply Corp W. Henrietta Road Rush, NY USA (800) [email protected] Certified as a Health Education teacher, Chuck has worked for over 25 years in the manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA and numerous other organizations, including AAMI and CSA where he contributes to sterilization standards. A popular speaker at regional, national and international healthcare conferences, Chuck has visited thousands of healthcare facilities during his career providing sterilization consulting services that include fee based and complementary audits of instrument reprocessing areas. References & Resources Accreditation Association for Ambulatory Healthcare (AAAHC) 5250 Old Orchard Road, Suite 200 Skokie, IL Association for the Advancement of Medical Instrumentation (AAMI) 1110 North Glebe Road, Suite 220 Arlington, VA Association of perioperative Registered Nurses (AORN) 2170 South Parker Road, Suite 300 Denver, CO Centers for Medicare & Medicaid Services (CMS) 7500 Security Boulevard Baltimore, MD Society of Gastroenterology Nurses and Associates, Inc. (SGNA) 330 N. Wabash Ave. Suite 2000 Chicago, IL The Joint Commission (TJC) One Renaissance Boulevard Oakbrook Terrace, IL