Welcome! To Improved Endoscope Reprocessing
This site is dedicated to helping you evaluate and enhance your endoscope reprocessing methods and procedures while improving patient and occupational safety, lowering costs, and minimizing repair costs of the devices.
Launched on October 1st, 2012 as an empty shell, we have begun adding useful content and soon will start responding to inforation requests made on our Questions and feedback page.
Bronchoscope Reprocessing at Harvard School of Medicine
Ed Plant at Harvard's Beth Israel Deaconess Medical Center reviews Handling & Reprocessing of Bronchoscopes
For more information on the ProShield, click HERE.
FDA/CDC/VA Endoscope Reprocessing Guidelines
Preventing Cross-Contamination in Endoscope Processing
Safety Communication from FDA, CDC, and the VA
Issued November 19, 2009
This communication cautions healthcare facilities, including hospitals, ambulatory care facilities and private practices, about the risks to patients if flexible endoscopes and their accessories are not processed properly, and recommends steps to reduce these risks. It is being issued jointly by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs, and has been reviewed by The Joint Commission. The communication also reminds manufacturers of endoscopes and endoscope processing equipment of their responsibilities in helping assure proper endoscope processing in healthcare facilities.
The Public Health Problem
If flexible endoscopes or endoscopic accessories are not properly processed, patients can be exposed to body fluids and tissue contaminants from prior patients, which can result in the transmission of pathogens and affect large numbers of people. Recent reports to FDA of processing errors with flexible endoscopes have highlighted the continuing importance of this issue. Reported errors included the use of improper accessories for endoscopy irrigation set-ups, improper reprocessing intervals for reusable endoscopy accessories, failure to discard single use accessories, and failure to follow the manufacturer's instructions for endoscope reprocessing.
Flexible endoscopes are fundamentally difficult to clean and disinfect or sterilize. Because of this, it is essential that facilities establish a quality system program that covers all aspects of endoscopy procedure management. Adequate patient protection can only be achieved by vigorous compliance with such a program.
General Recommendations for Healthcare Facilities
* Establish an institutional program for endoscope processing, along with written procedures for monitoring adherence to the program and a chain of accountability. Ensure that those responsible for endoscope processing understand the importance of this job and that they maintain proficiency in performing it for each type of endoscope they handle.
* Train employees to set-up, clean, disinfect or sterilize, and store endoscopy equipment properly. Periodically retrain and assess competence. Endoscopy is a constantly evolving technology, so it is essential to stay up to date with the specifics of each device your institution uses.
* Instruct staff to read and follow the endoscope manufacturer's instructions for use. People responsible for reprocessing endoscopes must have the manufacturer's instructions available for each endoscope and its accessories, because various endoscopes and their accessories often must be processed differently (e.g., most flexible endoscopic equipment cannot tolerate steam sterilization).
* Be sure staff members understand that the cleaning and disinfecting of endoscopes are two separate processes. Thorough cleaning of the endoscope must be done first, in order to remove gross contamination and debris. Without this step, the endoscope cannot be effectively disinfected or sterilized. Cleaning should begin immediately after use by thoroughly flushing the channels and rinsing/wiping the outside of the endoscope. This must be followed by a very thorough cleaning with brushes, concentrating especially on the channels. Only then is the endoscope ready for high level disinfection, which can be done manually or in an automatic endoscope reprocessor (AER). During disinfection, the high level disinfectant must contact every contaminated surface/channel for the time recommended by the disinfectant manufacturer.
* Be sure that the AER or sterilizer is compatible with the endoscope. Before using an AER, confirm that it properly fits the endoscope. Adhere to the AER or sterilizer instructions that specify which endoscope makes and models it can process. And be sure that the instructions for endoscopes, AERs and germicides do not contradict one another. If you become aware that instructions are contradictory, inform the endoscope and AER manufacturers as well as FDA.
* Be sure that endoscopes or accessories that contact sterile tissue are sterilized before each use, and that endoscopes that contact intact mucous membranes (e.g., the respiratory and gastrointestinal tracts) undergo at least high-level disinfection before each use.
For more specific recommendations, see "Endoscopy Processing for Healthcare Facilities" below. Also see the reference section, which includes citations to other guidelines and documents that provide more comprehensive information.
Adverse Event Reporting for Healthcare Facilities
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect a reportable adverse event associated with endoscopes and endoscope processing, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA's understanding of and ability to communicate the risks associated with devices, and assist in the identification of potential future problems associated with medical devices.
We also encourage you to report any medical device adverse events related to endoscopes and endoscope processing that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA's voluntary reporting program. This can be done on-line by filing a voluntary report
1, by phone at 1-800-FDA-1088, or obtain the fillable form <http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm>
2 online, print it and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Responsibilities of Manufacturers
* Be sure that the instructions for processing your flexible endoscopes and accessories are easily accessible to users, that they are complete and easy to understand, and that the steps follow in logical sequence.
* Be sure that updated versions of reprocessing instructions are communicated promptly to users.
* Be sure that instructions for each AER specify which endoscope makes and models it can process. And be sure that the instructions for endoscopes, AERs and germicides do not contradict one another. If you become aware that instructions are contradictory, you should proactively notify your customers and provide necessary recommendations.
* Evaluate and recommend reprocessing products and AERs that can be used with your endoscope. Be sure your instructions for use clearly list any reprocessing products that are not compatible with your endoscope. If possible, conduct or facilitate training for personnel in healthcare facilities on the proper processing of your endoscopes or accessories.
* Use your complaint files, as well as information provided by your field staff, to monitor problems in the processing of your endoscopes and accessories.Consider this information in the design of future endoscopes.
* If possible, work with other manufacturers to help ensure that various makes and models of endoscopes, endoscope accessories and AERs are compatible. For example, AER manufacturers should be sure that their AER's channel connections fit properly on the endoscopes specified for use with their product.
* Investigate any reports of infection or pseudoinfection clusters associated with your device so you can take appropriate corrective action. Report to FDA any information or actions that are subject to reporting under current regulations.
* Remember that you must report to FDA no later than 30 calendar days after becoming aware of information that reasonably suggests that:
* One of your devices has caused or contributed to a death or serious injury or,
* One of your devices has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Obtaining Additional Information
A. Establish an institutional program and procedures for monitoring adherence to the program
1. Establish a comprehensive Quality Assurance and Safety Program for all aspects of all endoscopy procedures. It is senior level management's responsibility to establish such a program and to assign responsibility for its implementation. The program should:
a. Identify all staff involved in endoscopy procedures, as well as all departments, if appropriate. Include supervisors and all staff involved in these activities, specifying their position descriptions and responsibilities.
b. Establish set-up, break-down and reprocessing (i.e., cleaning and disinfecting or sterilizing) procedures for each type of endoscopy performed by your facility.
c. Identify all endoscopes, endoscope accessories and endoscope reprocessing equipment used in your facility, including: manufacturer, models, serial numbers or hospital specific equipment tag numbers, and unique device identifiers (UDIs). Include location within the facility, age, and status (e.g., maintenance schedule).
d. Establish and document training programs for all staff responsible for the set-up, disassembly, and reprocessing of endoscopy equipment. The program should outline schedules for periodic retraining.
e. Develop procedures and responsibilities for tracking the useful life of endoscopes and accessory equipment, including equipment and supplies for reprocessing. These procedures should address specification evaluation, acquisition management, scheduled maintenance, and removal of equipment from use.
f. Using information in product labeling, assure that the endoscopes and accessories used in your facility are compatible with your reprocessing equipment and supplies. If the labeling is unclear regarding compatibility, contact the manufacturer. Ensure that new equipment is compatible with your existing products.
g. Review and update procedures at regular intervals
h. Disseminate procedures to all involved staff, post procedures in prominent locations, and ensure all staff know where full copies of the procedures are located.
2. Establish appropriate standard operating procedures (SOPs) for preparing endoscopes for patient contact. Be sure this information does not conflict with the instructions from the manufacturers of the endoscopes, AERs, and liquid chemical sterilants/high level disinfectants (LCS/HLD). Ensure that your staff adheres to these procedures.
a. Confirm that you have the correct versions of the instructions for the endoscope models used at your facility.
b. Confirm that you have the correct versions of the instructions for the AERs used in your facility.
c. Provide staff with written device-specific instructions for every endoscope model and reprocessing system you use. This may include more detailed explanations than the original manufacturers' instructions. Inform manufacturers, as well as FDA, if you believe their instructions are unclear or inadequate.
d. Review the written reprocessing instructions from the AER manufacturers to be sure that they apply to the endoscopes used in your facility, and that they are correctly implemented.
3. Implement a comprehensive quality control program for reprocessing endoscopes and their accessories. Your reprocessing program should include:
a. Visual inspections and testing of the equipment to identify conditions that may affect the cleaning or disinfecting processes, such as testing for leaks, examination for cracks, and checking the integrity of fiber optic bundles.
b. Assurance that all manufacturer-recommended maintenance schedules and services are performed for all endoscopes and AERs used in your facility.
c. The use of appropriate process monitors as recommended by your AER and germicide manufacturers.
d. Records of the use of each endoscope, including model, serial number, and unique hospital identifier or standardized unique device identifier. Records should document the patient upon whom the endoscope was used, the date and time of use, the room location of use, and the type of procedure involved. Records should also show the system (particular model and serial number of the AER if applicable) used to reprocess the endoscope and the initials of the person(s) responsible for reprocessing the scope.
e. A method for detecting clusters of infections or pseudoinfections associated with endoscopic procedures (e.g., a surveillance system). If a cluster is discovered, this should be reported to the manufacturer of the endoscope, the endoscope accessories, the AER, and the germicide.
f. Documentation of all training for all staff.
g. Documentation of all repairs for all equipment.
h. Documentation of the introduction (and withdrawal from use) of all endoscopes, endoscope accessories, AERs and AER accessories such as scope connection devices.
B. Train, retrain, and establish a chain of accountability for endoscope processing procedures
1. Provide and document comprehensive and intensive training for all staff assigned to reprocessing endoscopes to ensure that they understand how to perform their assigned duties and the importance of proper reprocessing of all endoscopes used in your facility. All staff involved in endoscope reprocessing should be identified, provided appropriate education for their duties before beginning, observed for competence, and retrained at designated intervals. Training should include:
a. Instruction in proper procedures, equipment connections, and which items are single use only and must be discarded after each use and which items are to be reprocessed after each use.
b. Hands-on training for each endoscope and AER used at your facility, using the written instructions provided with each make and model. Work should be closely supervised until competency is documented for each reprocessing task from cleaning through storage of the endoscope.
c. Additional training and documentation of competency whenever a new model of endoscope or AER is introduced into your facility
d. Frequent reminders to all staff not to deviate from the written instructions for preparing endoscopes for patient contact.
2. Re-evaluate and document competency at periodic intervals.
II. Technical Aspects
A. Read and the follow the manufacturer's operating manual and instructions for use.
1. Clean, disinfect or sterilize, and assemble the endoscope according to the endoscope manufacturer's instructions.
2. Follow the endoscope manufacturer's instructions for high level disinfection or sterilization. If you do not use an AER, or in the absence of technical instructions for automated reprocessing of your endoscope, follow the manufacturers' recommendations for the detergent products and liquid chemical sterilant/ high level disinfectant products used at your facility. Be sure staff understands that enzymatic detergent solutions are single use and must be discarded after every use.
3. Check with your endoscope manufacturers to determine whether your endoscopes can be reprocessed in an AER and the steps that should be taken before reprocessing. Not all endoscopes can be reliably reprocessed in an AER. For example, the elevator-wire-channel of most duodenoscopes cannot be accessed by the AER. Such devices require manual reprocessing (manual cleaning and high level disinfection) for that channel, if not for the entire device. If not specifically indicated in the AER labeling, it is advisable to ask the AER manufacturer if the endoscope model you are using has been tested with their system.
4. Compare the reprocessing instructions provided by the endoscope and AER manufacturers and resolve any conflicting recommendations. Contact the manufacturers to resolve any conflicts, particularly when they involve the use of channel connections or capping/non-capping of specific lumens or channels.
B. Manually clean endoscopes before disinfection or sterilization
1. Make sure that all staff who handle soiled endoscopes understand the importance of manually cleaning the endoscope thoroughly before it is disinfected or sterilized, and that they have access to and comply with the endoscope manufacturer's instructions. It is imperative that staff flush all endoscopes immediately following each clinical procedure. Use of an enzymatic cleaner that is compatible with the endoscope is important in breaking down proteins that make up a large portion of common soil. In addition, staff should meticulously remove any debris or residuals collected in or on the endoscope, perform leak tests, and visually inspect the endoscope to ensure that it is in proper working order in accordance with the endoscope manufacturer's recommendations. These steps are critical regardless of whether your facility manually reprocesses endoscopes or uses an AER.
2. Make sure that flexible fiberoptic endoscopes used as semi-critical devices undergo at least high level disinfection before each use. Semi-critical devices are those that contact intact mucous membranes such as the respiratory tract and the gastrointestinal tract. Most flexible fiberoptic endoscopes are semi-critical devices and require high level disinfection between patients.
3. Make sure that endoscopes used as critical devices are sterilized before each use. Critical devices are those that contact sterile tissue or the vascular system.Endoscopes used in normally sterile body sites are critical devices and must be sterilized.
a. Low temperature sterilizers are available for reprocessing thermolabile flexible endoscopes. Some endoscopes, especially rigid ones, can be steam sterilized. Before sending an endoscope for sterilization, be sure to check the manufacturer's instructions for both the endoscope and the sterilizer to be sure that the devices are compatible and that the sterilizer is able to sterilize devices with the lumen length and diameter of the endoscope to be reprocessed.
b. Sterilization with a liquid chemical sterilant may not convey the same sterility assurance as sterilization achieved using thermal or low temperature chemical gas/plasma/vapor sterilization methods. Liquid chemical sterilants should be limited to reprocessing only critical devices that are heat-sensitive and incompatible with other sterilization methods. For more information see Guidance for Industry and FDA Reviewers: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073773.htm>4. Also refer to the CDC/HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
4. Incorporate a final drying step in your reprocessing protocol, as long as this is not listed as a precaution or contraindication in the manufacturer's instructions. This applies whether you manually reprocess your endoscope or use an AER. Studies have demonstrated that a final drying step that includes flushing all channels with alcohol, followed by purging the channels with air (to remove the alcohol), greatly reduces the possibility of recontamination of the endoscope by water-borne microorganisms. After reprocessing, store endoscopes in a manner that will minimize the likelihood of contamination or collection/retention of moisture. ---
References Center for Disease Control and Prevention/Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities
Multi-society guideline for reprocessing flexible gastrointestinal endoscopes, 2003, Gastrointestinal Endoscopy, 2003, 58:1:1-8.
Spaulding EH. The role of chemical disinfection in the prevention of nosocomial infections. In: Brachman PS, Eickhoff TC, eds. Proceedings of the International Conference on Nosocomial Infections, 1970. Chicago, IL: American Hospital Association: 1971, pp. 247-254. Favero MS, Bond WW. Chemical disinfection of medical and surgical materials. In: Block SS, ed. Disinfection, sterilization, and preservation, 5th ed. Philadelphia: Lippincott Williams Wilkins, 2001, pp. 881-917.
FDA, Center for Devices and Radiological Health. Guidance for Industry and FDA Reviewers: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants <https://mail.ccf.org/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073773.htm> 7/High Level Disinfectants, January 3, 2000.
FDA, Center for Devices and Radiological Health. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance <https://mail.ccf.org/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080268.pdf> 8, April 1996.
Spaulding EH. Chemical disinfection and antisepsis in the hospital.
J. Hosp Res, 9:5-31, 1972. Association for the Advancement of Medical Instrumentation. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR12:2004, Arlington, VA: AAMI, 2004. Technical Information Report. Association for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58:2005, Arlington, VA: AAMI, 2004. Joint Commission Resources: 2009 Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Update
2. Oakbrook Terrace, IL: The Joint Commission, 2009. (Electronic version: Joint Commission Resources: The Joint Commission E-dition, E-dition v22.214.171.124: Jul. 1, 2009.) -
Key Words; endoscope & Tee Protector Sleeve for Transport & Reprocessing
FDA Video - Endoscope Reprocessing
FDA Concerns about Endoscope Reprocessing
Unannounced CMS Inspections
Unannounced CMS infection control inspections go nationwide in 2012
Will your facility Pass an unannounced Government Inspection of your Endoscopy Procedures and SOP's?
The inspectors are looking for the possibility of cross contamination and the potential for HAI's.
At stake are Federal Medicare reimbursement funds!
Endoscopy procedures are specifically identified as an area of concern and evaluation.
"...... the process outlined in the CMS survey is anything but cursory, calling for two surveyors to do a thorough review that is expected to take two days. Moreover, the draft survey instructions encourage inspectors to "drill down" on identified problems and look for deficiency patterns across units and practices.
"This might include widening [inspection] scope, conducting additional staff or patient interviews, making additional observations, and/or reviewing policies, procedures, additional records or other pertinent documentation," the CMS survey advises inspectors."
"We want to focus more on the bedside on the patients and procedures than has been done in the past," says Daniel Schwartz, MD, MBA, chief medical officer of the CMS Survey and Certification Group. "We don't want the surveyors sitting in a room scouring through policies and procedures for four to six hours." In that regard, the CMS instructs surveyors to trace and observe patient care during an entire episode of care.
We are asking the question: What is the hospital doing to prevent these infections?"
The survey tool describes the patient tracing component as follows: "During a surgical procedure or endoscopy, the surveyor should follow the patient through the pre-procedure holding area, into the operating room or endoscopy suite, and then into the post-procedure holding area," the document reads.
This allows the surveyor to assess infection control and prevention of infection transmission in all locations and by all healthcare personnel involved in that episode of care." In addition, the CMS is distributing the survey tool to the Joint Commission and other accrediting organizations, meaning the same approach and similar questions may be asked during an accreditation survey typically done every few years to deem CMS condition of participation status.
Use of the ProShield with flexible endoscopes and TEE Probes goes a long way in answering their standard question "what is being done to prevent cross contamination infections?"
Actual Text of the Survey Document:
III. Single Use Devices, Sterilization, and High-level Disinfection Additional instructions:
Pre-cleaning must always be performed prior to sterilization and high-level disinfection.
Sterilization must be performed for critical equipment (i.e., instruments and equipment that enter normally sterile tissue or the vascular system, such as surgical instruments)
High-level disinfection must be performed for semi-critical equipment (i.e., items that come into contact with non-intact skin or mucous membranes such as reusable flexible endoscopes, laryngoscope blades)
Observations are to be made of staff who perform equipment reprocessing (e.g., surgical techs), unless these activities are performed under contract or arrangement off-site from the ASC.
May 16,2012 Update:
The Centers for Medicare and Medicaid Services (CMS) continues to hone an infection control survey slated for use in the nation’s hospitals by the end of the year, using expert feedback and “pre-testing” results to create a 42-page tool that assesses a wide array of issues. The writing on the wall? It says that all of this will eventually be tied to CMS payouts and reimbursements. Why? Because that’s what CMS does better than anybody.
The survey includes sections on infection control programs and resources, coordination with other quality improvement programs, having systems in place to address multidrug resistant organisms, antibiotic stewardship, employee health, hand hygiene, needle use, environment services and cleaning and reprocessing of equipment.
Created in partnership with the Centers for Disease Control and Prevention, the CMS survey has been generally receiving favorable remarks for its design and attention to detail by experts contacted by Hospital Infection Control & Prevention. Indeed, some see it as an eventual game-changer, particularly as CMS begins adding the assessments into its conditions of participation and possibly factoring survey results into coverage and reimbursement formulas.
That could get the attention of senior hospital administrators and greater empower infection prevention programs, but the CMS program is still in a pilot phase. There are some areas of the survey — i.e., the aforementioned emphasis on antibiotic stewardship — that cannot be cited under current CMS regulation.
“We are still trying to emphasis the basics. We are having surveyors spend more time at the bedside,” says Daniel Schwartz, MD, MBA, chief medical officer of CMS’s Survey and Certification Group in Baltimore, MD. “But there are some things that we want to emphasize that we know are not in the regulations – that we are not able to cite.”
The Text of the Origial Article Follows:
(AHC Newsletters Via Acquire Media NewsEdge) Unannounced CMS infection control inspections go nationwide in 2012 'We are asking the question: What is the hospital doing to prevent these infections?' By Gary Evans, Executive Editor An unannounced inspector from the Centers for Medicare and Medicaid Services (CMS) walks into the hospital and summons the infection preventionist. Looking down at a clipboard, he asks: "What were the last two hospital acquired infections that were serious preventable adverse events in the hospital, [meaning they caused] patient harm or death following development of the infection? What was done about each?" Prepare now, because this is coming. Those questions and a slew of others are contained in a CMS draft document called "Acute Care Hospital Infection Control Tool for Surveyors" obtained by Hospital Infection Control & Prevention. As we previously reported in our July issue, the largest payer of health care in the country is rapidly developing a national inspection program for infection control in hospitals.
There are the inevitable concerns and caveats, as hard-pressed IPs face increasing scrutiny from yet another regulatory agency. No stranger to these real-world concerns, a veteran IP nevertheless made the big-picture point that puts the flurry of CMS initiatives in hospitals and most recently dialysis centers in perspective.
"It certainly is good for patients," says Russ Olmsted, MPH, CIC, an infection preventionist at St. Joseph Mercy Health System in Ann Arbor, MI.
The draft survey for CMS inspectors is being trialed in 10 states, Washington D.C. and Puerto Rico. The tool will be refined as warranted based on the evaluation, with the final product expected to debut in all 50 states in October 2012. The CMS has created a survey tool for a sweeping assessment of infection prevention, using a patient tracer approach similar to the Joint Commission to follow key issues through the care process. The pressure is on, but infection preventionists who pivot toward this initiative by reviewing the CMS expectations and making hospital senior administration well aware of them are poised for empowerment.
"It certainly has the potential for that," says Olmsted, the 2011 president of the Association for Professionals in Infection Control and Epidemiology. "The good news is that it's consistent with Joint Commission requirements, but also it will be highlighting infection prevention practices in the acute care setting. It's certainly very detailed. I was really impressed with the scope of this." Despite the breadth of the assessment, all the measures and expectations fall under CMS authority in its standard: 42 CFR 482.42 Condition of Participation (CoP): Infection Control.
"It's built on the CoP for acute care hospitals the foundation for it is already well established," he says. "It looks at a number of key areas that include safe injection practices and hand hygiene. It includes quite of bit of detail on the prevention practices pulled from CDC guidelines. It's pretty good in that sense. I will say it looks like it is moving along that similar trajectory [as other CMS initiatives]. CMS really is adopting CDC guidelines in terms of infection prevention." The long arm of the law? Indeed, though CMS officials seem somewhat reluctant to say it quite that directly, the agency is essentially codifying the voluntary infection control guidelines by the Centers for Disease and Prevention. The agency was involved in creating the CMS survey questions and the draft document is under review by the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC). Though the CMS may be wary of being perceived as the "infection control police," there is growing national impatience with the status quo of strictly voluntary guidelines in a new era of patient advocacy and healthcare reform.
"The questions from the tool were primarily chosen from the CDC guidelines as well as other nationally recognized guidelines such as the AORN," explains Karen Hoffmann, RN, MS, CIC, infection prevention specialist at the CMS and one of the principals behind the survey program. "These guidelines of course are generally recognized as standards of practice. They won't be any big surprise to the infection preventionists. We created this set of questions and tools to reflect all areas of the hospital." Asked if there were nevertheless some elements of a dreaded "unfunded mandate" in all this, Hoffman emphasized that the CMS expects administrative support for the IPs facing the inspectors and their questions.
"Hospital administration plays an important role in infection control with administrative support and financial resources to make infection control an institutional priority [and] really to see that the measures on this tool are actually in place and implemented," she tells HIC. "I don't think that this is going to create a burden or a problem. In actuality, it is going to be a real asset to them used as a self-assessment tool. It represents the minimal standards of infection control practice." Still, the process outlined in the CMS survey is anything but cursory, calling for two surveyors to do a thorough review that is expected to take two days. Moreover, the draft survey instructions encourage inspectors to "drill down" on identified problems and look for deficiency patterns across units and practices.
"This might include widening [inspection] scope, conducting additional staff or patient interviews, making additional observations, and/or reviewing policies, procedures, additional records or other pertinent documentation," the CMS survey advises inspectors. "For example, hand hygiene concerns noted while observing patient treatment or health care worker activities should prompt the team to widen the scope of review related to hand hygiene. Is this a concern on other units? Are competencies related to infection control practice documented and up to date in personnel files? Do hospital policies and procedures reflect current practice in the hospital, i.e. is the hand hygiene concern limited to one practitioner or broadly to hospital infection control processes and systems? Surveyors are not limited to the use of the tool and are encouraged to use their judgment and survey expertise in assessing infection control compliance." Attacking a longstanding problem The onsite, random survey follows a flurry of other CMS reporting and pay-for-performance initiatives aimed squarely at the longstanding problem of health care associated infections (HAIs). For example, in order to receive full CMS Medicare payments in 2012 dialysis facilities must submit three months of data on infections and antibiotic use to the CDC's National Healthcare Safety Network. The aggressive CMS agenda is part of broader federal public health efforts including the Department of Health and Human Services (HHS) national "Action Plan to Prevent Healthcare-Associated Infections." In addition, the recently formed broad collaborative dubbed the Partnership for Patients has the stated goal of decreasing healthcare acquired conditions by 40% in the next two years. With HAIs comprising a major portion of those events, the CMS seeks a dynamic new approach to infection prevention.
"We want to focus more on the bedside on the patients and procedures than has been done in the past," says Daniel Schwartz, MD, MBA, chief medical officer of the CMS Survey and Certification Group. "We don't want the surveyors sitting in a room scouring through policies and procedures for four to six hours." In that regard, the CMS instructs surveyors to trace and observe patient care during an entire episode of care.
"Those patient tracers are meant to emphasize some of the HAIs that are mentioned in the HHS action plan MRSA, C. diff and surgical site infections," he tells HIC. "We want the surveyors out looking at how the hospital is trying to prevent those infections from being transmitted. That's kind of the change here. We are asking the question: What is the hospital doing to prevent these infections?" The survey tool describes the patient tracing component as follows: "During a surgical procedure or endoscopy, the surveyor should follow the patient through the pre-procedure holding area, into the operating room or endoscopy suite, and then into the post-procedure holding area," the document reads. "For a radiology test, such as a CT scan, the surveyor should be present at the patient's room when the patient is transported to the radiology department and then remain with the patient as they are returned to their room. If a patient on contact precautions must have a test done in a location other than their room, the surveyor should be present as the patient is taken for the test and as they are returned to their room. This allows the surveyor to assess infection control and prevention of infection transmission in all locations and by all healthcare personnel involved in that episode of care." In addition, the CMS is distributing the survey tool to the Joint Commission and other accrediting organizations, meaning the same approach and similar questions may be asked during an accreditation survey typically done every few years to deem CMS condition of participation status.
"They are certainly welcome to use the tool although there is no requirement that they do so," Schwartz says. "The [CMS inspections] are unannounced." At least at this juncture, the program is more of a consultation and no penalties or citations are expected to be levied. "The only things that we would cite them for is if 'immediate [patient] jeopardy' is seen," he says. "We certainly couldn't ignore that." Again, all aspects of the survey and inspection process reflect requirements and expectations already in place in the CMS conditions of participation, he emphasizes.
"The health and safety standards have not changed so this really should not be a burden on the hospitals," he says. "The expectation here is that they are paying attention to infection control and infection prevention in their facilities. This is just a way for the surveyors to best assess that condition of participation." After the testing phase and survey revisions, CMS surveyors will begin training in earnest before flanking out to the nation's hospital infection prevention programs. "We're planning in-person training in Baltimore probably in the March  timeframe," Schwartz says. "After the training this [will expand to] all 50 states. We are going to ask each state to use each tool at least once by the end of the fiscal year 2012." CMS plays 20 questions: Know these answers A draft hospital inspection tool developed by the Centers for Medicare and Medicaid Services (CMS) instructs surveyors to ask infection preventionists the following questions. The objective of the survey is to "broadly assess the infection control program and systems in the facility; evaluate communications structure(s), program processes, supporting systems, and the integration between the Infection Prevention and Control program and other key hospital programs." Questions • Please tell me about the IC program from a process perspective i.e. how do you learn about specific cases of hospital associated infections, patients needing isolation precautions, unsanitary conditions etc., and what processes do you follow to track and address these concerns? • Please tell me about the Infection Prevention and Control program structure.
• How is your (IC) time organized in a typical workweek? • Tell me about the process for development of the infection control plan including when and how often is it developed, is it based on a risk analysis, who participates in its development, who approves the plan, when is each plan effective? • Tell me about ongoing infection control activities that you monitor that are not linked to the QAPI program.
• Who participates in the development of infection control program related policies and procedures and who approves new policies or updates? • How do you ensure that the hospital environment is sanitary? • What systems and processes does the hospital use to ensure each of the following: • Prevention of infections and communicable diseases • Investigation of infections and communicable diseases • Control of infections and communicable diseases.
• Tell me about the infection control log, i.e. what goes into the log and how is it utilized within infection control program activities? • Tell me about the following systems dealing with infections and communicable diseases (whether hospital acquired or not): • Systems for identifying infections and communicable diseases? • Systems for reporting infections and communicable diseases? • Systems for investigating infections and communicable diseases? • Systems for containing and controlling infections and communicable diseases? • What is the screening process for patients presenting in the ED and for new admissions • What is the bed management process for patients placed on an isolation status? • What is the hand-off process to communicate isolation status and is that hand-off process consistent throughout the hospital? • How are healthcare personnel (HCP) trained in infection control systems, processes, practices, strategies? How often Competency assessments? Documentation? • Tell me about the communications systems between the infection control program and QAPI? • Looking at the facility layout, which areas are not included in Quality Assessment and Performance Improvement (QAPI) activities related to infection prevention and control? Ask as open ended first, and then ask about specific areas.
• What are the infection control related QAPI indicators for select units and service areas? (Include outpatient services and contract services) • Is the hospital tracking the infection prevention/control quality indicators in contract areas (if applicable)? • Tell me about infection prevention/control patient safety activities.
• What were the last two hospital acquired infections that were serious preventable adverse events in the hospital (i.e. patient harm or death following development of the infection).
• What was done about each of the last two serious hospital acquired infections? • Describe the antibiotic stewardship program, if one exists, and efforts to prevent MDROs.
• Tell me about infection prevention/control training process for non-paid staff, environmental staff, and clinical staff i.e. how often, how much is covered, and are competencies assessed and documented in personnel files or elsewhere? A snapshot of the CMS inspection program A draft inspection tool for hospital infection control developed by the Centers for Medicare and Medicaid Services (CMS) includes the following key elements.
42 CFR 482.42 Condition of Participation (CoP): Infection control: The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.
(a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases.
(1) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.
(2) The infection control officer or officers must maintain a log of incidents related to infections and communicable diseases.
(b) Standard: Responsibilities of chief executive officer, medical staff, and director of nursing services. The chief executive officer, the medical staff, and the director of nursing services must (1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and (2) Be responsible for the implementation of successful corrective action plans in affected problem areas.
The survey: This Infection Control Tool provides a new survey structure for assessing hospital compliance with the Infection Control CoP. Use of the tool should not replace the important critical thinking skills that surveyors use in the full and comprehensive evaluation of each hospital's infection control program, and is not intended to limit survey process. If surveyor's observations raise concerns, they can widen scope, review medical records, review policies and procedures, and/or conduct additional interviews to deepen their level of inquiry in order to assess potential infection control deficiencies.
Use of the tool can improve the CMS survey process by standardizing the approach, providing a consistent, evidence-based framework for focused surveyor observations, and standardizing and simplifying important survey documentation. The pre-test period is intended to evaluate the efficacy and ease of use of the tool, use surveyor feedback and input to improve the tool, and determine its impact on the hospital's infection control efforts. Your participation in the pretest involves change that can be difficult and a new survey process that is structured. It does, however, provide an opportunity for you to give your opinion on how to make this tool a welcomed addition for your colleagues when it is finalized.
Modules and sections: The questions are organized into sections (e.g. hand hygiene) and the sections are organized into Modules (e.g. Critical Care Module). The modules and sections are designed and organized to assist surveyors in the assessment of compliance with the CMS infection prevention and control requirements. Some sections that are labeled "tracers" are meant to highlight specific procedures or activities that can cause infections.
These "tracers" include questions concerning hospital prevention activities for CAUTI (catheter associated urinary tract infection), SSI (surgical site infection), CLABSI (central line associated blood stream infection), and VAP (ventilator associated pneumonia). This is not an exclusive list of HAIs that hospitals should address in their programs. Hospital infection prevention and control programs must also include provisions to address other infectious disease such as MRSA, Clostridium difficile, hepatitis, TB, and influenza.
Five Modules: 1: Program Scope and Design 2: General Location 3: Critical Care 4: Invasive Procedures 5: Environmental Services and Sterile Reprocessing • Note that Modules 2, 3, and 4 include the same initial nine sections (hand hygiene, injection practices and sharps safety, environmental cleaning, personal protective equipment, point of care devices, noncritical device reprocessing, single use device reprocessing, urinary catheter tracer, and central line tracer).
Survey Process: After the entrance conference and hospital tour, one surveyor begins the interview process using Module 1 (suggested "open ended" questions) and the other begins to complete Modules 2-5. With guidance provided in Module 1 of the tool, surveyors evaluate the infection prevention and control program (based primarily on interview and review of documentation) including: • Infection control/prevention program and resources • Systems to identify, report, investigate, and control communicable disease and infection • Systems to control transmission of MDROs, promote antibiotic stewardship, and surveillance • Personnel education system/infection control training CMS questions for employee health For the infection preventionist who also covers occupational health, the draft hospital inspection guideline by the Centers for the Medicare and Medicaid Services (CMS) includes an evaluation of employee health programs. The CMS survey tool lists these discussion points and questions to ask employee health professionals and education directors: • Tell me how health care workers are trained in infection control systems, processes, practices, and strategies? (How often; Competency assessments; Documentation) • Tell me about the hospital system for identifying and addressing employee exposure events including blood-borne pathogen exposure events, needle-sticks, and other sharps incidents.
• Tell me about the hospital system for addressing employee post exposure evaluation and follow up.
• Tell me about the hospital system for tracking and trending health care worker infection exposure events.
• Tell me about the system in place for providing Hepatitis B vaccine to health care workers? What personnel are excluded? Are non paid personnel screened? • Tell me about the system in place for screening and addressing tuberculosis.
• Tell me about the system in place for respirator fit testing and storage/availability of respirator equipment.
• Are HCP offered annual influenza vaccine and does the hospital track success rates for HCP ho get the vaccine? • Tell me about the system in place for respirator fit testing and storage/availability of respirator equipment.
• Are HCP offered annual influenza vaccine and does the hospital track success rates for HCP who get the vaccine? • Tell me about infection prevention/control training process for non-paid staff, environmental staff, and clinical staff i.e. how often, how much is covered, and are competencies assessed and documented in personnel files or elsewhere? SOURCE-Hospital Infection Control & Prevention (c) 2011 AHC Media LLC. All Rights Reserved.
Key Words: cms mandated qapi and antimicrobial stewardship, Noscomial Infection
Oatmeal and Endoscopes
So, you forget to put your Oat Meal bowl in the sink and rinse it out, perhaps your dishwasher is in the middle of a cleaning cycle. The soiled bowl (endoscope) sits on the counter for a while. By the time you get to it, the oatmeal has dried. Rinsing and a soaking barely help, you need to chip the residue off with force. Making matters worse, you're in a hurry, you need to use the bowl again right away.
That's exactly what happens to the delicate internal ports of endoscopes when they aren't instantly rinsed. Someone will have to chip away at the debris and hardened protiens that are left inside, often in a hurry, potentially damaging the scope.
Okay, so instead you rinse the bowl out quickly then set it on the counter. You don't have the large bits hardening on the surface, but you now have a possibly harder film that is equally difficult to remove.
Again, that is exactly what happens to endoscopes that are rinsed, then left to dry a little before reprocessing. You have removed the large particles, but you still have a tough-to-remove film of hard protiens that can harbor infectious microbes and risk cross-contamination of patients.
Making matters worse, let's say your oatmeal bowl is made of plastic. That makes the cleaning all that much harder. If you scrape too hard, you'll damage or scratch the bowl. Its harder be sure that you've got the soft plastic surface clean. Exactly the problem with flexible endoscopes, they are made of easily bendable plastics, a surface difficult to clean in the first place. Small surface scratches may not damage the scope, but will for sure, give yet another place for germs to hide.
The best way to handle your oatmeal bowl if you can't immediately completely wash it, is to rinse it, then let is soak until cleaning time. Cleaning it will then be a snap, all residue will quickly and fully be removed by a normal wash cycle, either manual or in your dishwasher.
With the ProShield, that's exactly what you do. You will minimize the cleaning time, minimize cleaning damage, and increase the removal rate of contamination of your flexible endoscopes and TEE probes.
Place the used/dirty endoscope in a ProShield tube, snap the ProShield into one of holders for added convenience. Now flush/rinse the ports by following the manufacturer's recommendations. The ProShield will catch and retain the enzyme soap. The port(s) will not dry out, the soaking process will continue, all remaining films and residue will stay soft and moist. They will be easily removed during standard cleaning cycles, with no additional trauma caused by hard to remove biomass.
The Benefits of using ProShields
The Benefits of Using ProShields
Immediate Reprocessing Begins at Bed Side
- Flush Ports and Begin Soaking Seconds after Procedure ends!
- Continue Soaking during Transport to CPD / Decontam area
- Eliminate Delayed Reprocessing and associated concerns
Greatly Minimize Cleaning Damages
- BioMass stays soft and easily removes
- Ports Brush out with little effort
Patient Experience is Enhanced
- Your Patients see a clean contained Endoscope at their Bed Side
- Addresses Pre-Procedure Clean Handling Questions & Concerns
Transport & Handling Damage is Greatly Reduced
No Chance of bending sections being pinched in drawers
The Insertion Tube Shank is kept Straight eliminating bending and kinking damages
Damage from over-coiling is eliminated.
Saves Money $$$
- Cleaning times are reduced
- Cleaning Damages are Minimized
- Reduced Liability of patient Cross Contamination
- Improved Worker and Staff Safety, Reduced Liability and Infectious Material Contact
Improved Device Inventory Management & Handling
- Expensive Devices never fall prey to "Out-of-Sight Out-of-mind"
- Scopes are always displayed prominently in sight, hanging on wall, in cabinet, or on stands.
- Easily identify and Separate Clean Reprocessed from Dirty Devices
- No Canceled or Delayed cases due to Broken, Missing or misplaced Endoscopes
ASP Cidex Use Video
Manual Reprocessing with CIDEX