Here Come the Surveys- Are You Ready?

HHS has announced plans to use the $9 million provided by the American Recovery and Reinvestment Act passed earlier this year to conduct infection control surveys in 1300 non-accredited ambulatory surgery centers in 43 states in the next 12 months. The focus of the surveys will be on the ASCs compliance with the new Medicare Conditions of Coverage and Infection Control protocols. The surveys were sparked by the numerous healthcare-aquired infection cases reported last year, including hepatitis C and methicillin-resistant Staphylococcus aureus. The announcement was made in an HHS press release, a full copy of which is available here.

We have been covering the topic of infection control on this blog for several months now and it is certainly a hot button topic for ASCs, and will continue to be as reports come in across the country of ASCs being surveyed.

If your facility is not accredited or believe for any other reason that you could potentially be surveyed in the upcoming months, it is important to review your facilities policies covering infection control and ensure you are following the new Medicare Guidelines. If you feel your facility needs assistance in reviewing your infection control program, or any other aspect of the surgery center’s operations, contact Ortmann Healthcare Consultants. We have been working through the new Medicare regulations and have a firm understanding of their impact on ASCs. We can help, so call us today at 803-252-7979.

ASC Infection Control Case Study

Executive Summary
The following blog was contributed by an ambulatory surgery center specializing in gastrointestinal procedures. They have offered this case study as an example for benchmarking and infection control and quality improvement activities for ambulatory surgery centers. This study was conducted as part of their Quality Management program and their process for analyzing and reviewing the data and incorporating the appropriate improvement process is an excellent example of the type of Quality Improvement/Infection Control review Medicare and Accrediting bodies would expect to find in an excellent surgery center.

Case Study
On the initial testing date, five scopes were randomly cultured to ensure that the equipment was properly disinfected. The endoscopes were swabbed in the biopsy channel
and on the tip using sterile dual swabs. These swabs were then put back into the tubes and pushed down into the growth medium.

Results
The center received the results with three out of the five showing a moderate growth of bacillus species. The scopes that were tested are as follows:

• Colonoscope #2-no growth
• Colonsocsope #4-no growth
• Endoscope #C-moderate growth bacillus species
• Colonoscope #8-moderate growth bacillus species
• Endoscope #B-moderate growth bacillus species

The results were received too late to request an identification of the bacillus species. The G.I. techs were interviewed to determine possible causes for the positive test results. Out of this, it was determined that the scopes had been swabbed with alcohol with one of the non-sterile swabs that are used in the ORs to transfer tissue samples into the formalin. This was done with the same swab. It was then determined that the tests were inaccurate.
The G.I. techs were re-educated about sampling techniques to ensure accuracy of future testing. The staff was given an in service on reprocessing the scopes with a module that was produced by SGNA and a reprocessing chart was placed in the scope washing area.
To date, there have been no reported post procedure infections; however, it was felt that the center needed to assess the risk to the patients. Research into bacillus spores revealed that there are many species of bacillus and that the spores can only be inactivated using sterilization. The scopes can not withstand any type of sterilization.

An assessment was made of the following areas:

• Single use items are not being reused
• Testing of the OPA with every load and documented properly
• Hand Hygiene
• The scopes are hung in the scope cabinet immediately after reprocessing
• All steps followed in the SGNA guidelines for scope reprocessing
• All of these measures were found to be accurately performed

On a later testing date, all of the scopes were swabbed for culture to ensure that the previous test results were inaccurate. The results concluded seven of twelve scopes tested positive for bacillus spores. The results of the second swab cultures are as follows:

• Colonsocope #2-bacillis species(not anthracis)
• Colonoscope #1-bacillis species (not anthracis)
• Colonoscope #4-bacillis species (not anthracis)
• Colonoscope #5-no growth
• Colonoscope #3-no growth
• Colonoscope #7-no growth
• Endoscope #E-no growth
• Colonoscope #C-bacillus species
• Colonoscope #8-bacillus species
• Endoscope # B-no growth
• Endoscope #D-gram positive rods (oxidase-negative)
• Colonoscope #6-gram positive rods (oxidase-negative)

(None of these were ID’d by the lab.)

A cross reference of the positive scopes and the AER unit revealed no relevant information. These results were concerning and the investigation became much more aggressive, including the following checks and measures:

• All enzymatic cleaner were assessed for proper concentration and use.
• The fan in the scope cabinet was checked and found to be functioning properly.
• Verification that the filters are being changed per manufactures guidelines.
• Verification that the AER manufacturing instructions were being followed.
• Verification of the proper amount of alcohol is being used.

(These measures were and are being done accurately)

Other steps and measures that were taken:

• All valves were thoroughly disinfected and all containers that house the valves were also disinfected.
• The sinks were disinfected in between scopes.
• The scope cabinet was thoroughly cleaned and disinfected.

(These measures have been adopted and will be used in the center)

Further investigation on infection control from the National Center for Continuing Education revealed high level disinfection is all that is required for semi critical equipment-endoscopes. The module states the high level disinfection destroys all forms of microbial life except high numbers of bacterial spores.
In addition, the center contacted their managing firm, the manufactures of the AER, the scope manufactures, and other center directors for assistance.
It was suggested that the center use another technique to test the scopes. On September 20th the scopes were retested using 20 cc of sterile water thru the lumen of the endoscopes at the biopsy port and collected in a sterile specimen container at the tip.
On September 24th Quest Diagnostics called the center director with the results from the sterile water tests through the scopes. The samples from scopes 7 and 8 had leaked out of the container and the remaining ten samples showed no growth. This has lead to the conclusion that the lumens of the scopes are being disinfected properly.
The Johnson and Johnson Field Service technician tested the AER and found it to be functioning properly and the settings for wash times and soak times per manufactures recommendations. A test was conducted on a scope immediately after it was removed from the AER and it was found to have excess water. The psi on the AER was increased to improve water removal from the scopes.
Water samples were taken to determine the effectiveness of the filters on the AER. These were taken at the Inlet and Outlet valves, the basin, and the drain outlet. A sample of the tap water was also taken as a control.
The water testing revealed several clues as to the possible source of the positive spore tests.

• Tap water- heavy growth of gram positive rods
• Unit #1
  o Water inlet-heavy growth positive rods
  o Filter outlet-heavy growth gram positive rods
  o Basin Fill- light growth gram positive rods
  o Drain- no growth
• Unit #2
  o Water inlet-heavy growth positive rods
  o Filter outlet-heavy growth gram positive rods
  o Basin Fill- light growth gram positive rods
  o Drain- no growth

The filters appear to be removing most contamination from the water. Manufacturers directions for the filters state that the device does not treat the water and the filter should be sanitized on a regular basis.
The Fujinon representative observed the steps in reprocessing for breaks in technique. No breaks were noted, however, he did offer several tips. Another in service on reprocessing was done for the staff.

Conclusion
According to the standards of practice by SGNA, ASGE, Advanced Sterilization, and Fujinon, the scopes that are being used are being disinfected adequately. The center will continue to monitor every patient for post operative infections and retest the endoscopes at intervals to be determined by the QM committee.
It was determined that the bacillis spores most likely came from the tap water and the AER is doing its job. The center will also be sterilizing the filters and AER’s between the monthly filter changes with the manufacturers recommended product.
As an extra measure for the improvement in infection control, the scopes will be wiped with alcohol immediately prior to being taken into the O.R.

Infection Control For Ambulatory Surgery Centers

Infection Control is a hot topic for all ambulatory surgery centers today. Ambulatory surgery centers are under closer scrutiny than ever when it comes to infection control practices due to changes in Medicare law/regulations and the government funds available to several states for special infection control inspections. Your ASC has to be prepared in this area, for the safety of your patients and so that your ASC is not shut down after an inspection.

The new Medicare regulations concerning ASCs include the following:
In 416.51 Conditions for Coverage—Infection Control, an ASC must maintain an infection control program that minimizes infections and communicable diseases. The facility must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice, and the infection prevention program must include documentation that the ASC has considered, selected and implemented nationally recognized infection control guidelines, such as those issued by the Centers for Disease Control and Prevention (CDC). The program must be implemented under the direction of a designated and qualified professional who has training in infection control; it must be an integral part of the ASC’s quality assessment and performance improvement program; and it must contain a plan of action for preventing, identifying and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

So basically, your ASC must maintain an infection control program that

1. Provides a sanitary environment for surgical services,
2. Is based on nationally recognized infection control guidelines,
3. Is directed by a designated health care professional with training in infection control,
4. Is integrated into the ASC’s Quality program;
5. Is ongoing;
6. Includes actions to prvent, identify and manage infections and communicable diseases;
7. Includes a plan to immediately implement corrective actions and preventative measures that will improve the control of infection within the ASC.

One of the difficulties for some ASCs is to know how to go about designating a health care professional with training in infection control. The Interpretive Guidelines to the law explain that this professional must be designated in writing. An organizational chart, specific policy and job description would be ways to accomplish this. The ASC must determine this individual has had training in the methods of infection control. The interpretive guidelines do not specify what this training must be or the number of hours that should be devoted to this task. But the ASC should be able to demonstrate that this individual has received training in infection control courses or by attending meetings given through professional societies such as APIC and SHEA.

Infection Control Today appears to be a great source for assistance in this area. They have newsletters, a great web site, weekly newsletters, etc. In fact for more information on Infection Control requirements for ASCs, click here for a nice recap article.

Another interesting concept for Infection Control training is Infection Control Today’s “Virtual Conference” that is coming up February 9-10, 2010. This is a free conference, setup like traditional onsite conferences, but it is virtual. You attend from your own site, via the web. There is a full day of speakers, an exhibit hall, a chat room for networking and a resource center. The agenda includes 11 infection control sessions, each lasting about one hour each. Attendees can receive CE credits, which will help to demonstrate that the health care professional in your ASC is receiving ongoing training. Oh, and did I forget to mention—it’s FREE!

I think the hardest thing about a virtual conference or any sort of webinar is dedicating the time to the training with all the office distractions around. If you really wish to get the most out of the training, you will have to pretend that you are out of town and have nothing to do but go to the conference, just as if you were truly at a traditional conference.

This is the fourth year of the conference and other than the testimonials on the web site, I can’t speak to its quality. I do think, though, it’s worth a look, and if it lives up to its advertising, it could be a good way to get some extra infection control training.

Submitted by Chris McMenemy, VP Administration

Ortmann Healthcare Consultants

A notice to all ASCs accredited by AAAASF

Medicare has recently announced that the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) is conditionally approved for an extension of its deeming authority until May 26, 2010. In order to maintain this deeming authority, AAAASF has made changes to their survey and reporting procedures.

According to the Medicare release issued November 27, “Review of AAAASF’s renewal application revealed that AAAASF has ongoing, serious, widespread areas of non-compliance, specifically (1) an inability to provide accurate and timely data on deemed providers; (2) lack of complete and accurate deemed facility survey files; and (3) an inadequate surveyor training and evaluation program. If it is determined that an accreditation organization has failed to adopt requirements comparable to Medicare conditions of participation, a conditional approval of the accreditation organization’s deeming authority for a period of up to 1 year may be granted. During that time the organization may make changes to its surveys and policies so that they are comparable to Medicare requirements. AAAASF has been put on a 180 day probationary period. Within 60 days after the end of AAAASF’s probationary period, a final determination will be made as to whether or not AAAASF’s ASC accreditation requirements are acceptable.”

This decision could have serious implications for many surgery centers who received accreditation/deemed status certification through AAAASF, especially if their deeming authority is revoked. Accreditation is optional for surgery centers, excluding those in states without licensure regulations that have instituted mandatory accreditation, and in many cases is a faster way to achieve Medicare certification than relying on the state agency to perform such surveys. The other options for accreditation/deemed status for ambulatory surgery centers includes Accreditation Association for Ambulatory Health Care (AAAHC) and the Joint Commision.

Update: A full copy of the CMS release is available on the AAAASF website.

Ortmann Healthcare Consultants will continue to monitor this story and provide updates as necessary!

Merry Christmas and Happy New Year

Ortmann Healthcare Consultants would like to wish its readers and clients a safe and happy holiday. We will be back in the New Year with new postings, and with everything happening in healthcare in the coming year, there should be plenty of material available for discussion! See you next year!

Question of the Day: Can an ASC share space with a Medical Office?

Today’s question of the day is a question that is asked of Ortmann Healthcare Consultants frequently. Medicare regulations require the ASC to be a separate and distinct entity from other entities sharing space in a medical office building. The ASC cannot use space in other medical offices as ASC space, even for medical record storage. If the ASC is renting space from another office, the office must be closed while the ASC is open. Also, ASC employees must be ASC specific unless an employee lease agreement is in place and the employees are at the ASC during the hours it is in operation, and not moving back and forth between offices.

The only instance where we have seen an ASC “share” space with other medical offices is through the use of a shared reception area, where a patient enters the building through a shared space, registers with the receptionist at the registration desk and is then shown to the waiting room for the ASC. This waiting room must be specific to the ASC and cannot be shared with other offices.

Happy Thanksgiving

Ortmann Healthcare Consultants wishes you a safe and Happy Thanksgiving! Check back next week for new postings!

Weathering the Storm

Emergency Management Planning is now a requirement for ambulatory surgery centers. An effective policy should be in place to respond to emergencies and the emergency management plan is an essential part of meeting this requirement. CMS has issued a checklist to assist you in writing your plan.
Here are a few key elements from the checklist to include:

• All Hazards Continuity of Operations (COOP) Plan: Develop a continuity of operations business plan using an all-hazards approach (e.g., hurricanes, floods, tornados, fire, bioterrorism, pandemic, etc) that could potentially affect the facility directly and indirectly within the particular area of location. Indirect hazards could affect the community but not the facility and as a result interrupt necessary utilities, supplies or staffing. Determine all essential functions and critical personnel.
• Collaborate with Local Emergency Management Agency: Collaborate with local emergency management agencies to ensure the development of an effective emergency plan.
• Develop Evacuation Plan: Develop an effective plan for evacuation, by ensuring provisions for the following are specified: Identification of person responsible for implementing the facility evacuation plan (even if no outside evacuation order is given), Multiple pre-determined evacuation locations (contract or agreement) with a “like” facility have been established, Evacuation routes and alternative routes have been identified, and the proper authorities have been notified, Adequate food supply and logistical support for transporting food is described, Procedure for protecting and transporting resident/patient medical records, Determine a method to account for all individuals during and after the evacuation.
• Facility Reentry Plan: Describe who will authorize reentry to the facility after an evacuation, the procedures for inspecting the facility, and how it will be determined when it is safe to return to the facility after an evacuation. The plan should also describe the appropriate consideration for return travel back to the facility.
• Review Emergency Plan: Complete an internal review of the emergency plan on an annual basis to ensure the plan reflects the most accurate and up-to-date information. Updates may be warranted for: Regulatory change, New hazards are identified or existing hazards change, After tests, drills, or exercises when problems have been identified, After actual disasters/emergency responses, Infrastructure changes, Funding or budget-level changes,etc.

The Emergency Management Plan should be incorporated into your Policy and Procedure manual. Make sure you staff is briefed on the plan and that its incorporation into the manual is reviewed and approved by the Board of Directors.

If you need further assistance preparing an emergency management plan to meet the new CMS Conditions for Coverage, contact Ortmann Healthcare Consultants at 803-252-7979. We’d be happy to help!

Submitted by Jessica Miller, Director of Regulatory Affairs

Happy Veterans Day!

Ortmann Healthcare Consultants is taking today to remember our Veterans. Thank you for your dedication and commitment to making this country and our world a better place.

OHC is at Becker’s ASC Conference!

Sorry for the recent lack of postings. It’s been a week of computer failings and traveling for the Ortmann team, but we are back on track and excited for this weekend! Ortmann Healthcare Consultants will be at Becker’s ASC Review’s 16th Annual Improving Profitability, and Business and Legal Issues for ASCs Conference. Come and visit us at booth space 28 where we will have information regarding our company and projects, and of course, CANDY! Key members of our consulting team will be there to answer your questions as well, including Chris McMenemy, VP of Administration, and Jessica Miller, Director of Regulatory Affairs. The conference runs October 8-10 at the Westin Hotel and Conference Center in Chicago, Illinois. More information can be found at Becker’s ASC Review.Please stop by our booth and say hello-we hope to see you there!