1. Infection Control Surveyor Worksheet
Using the CMS ASC
Infection Control Surveyor Worksheet
Note that this is based on the CMS Survey tool, not the tools of other organizations such as the AAAHC, etc. They each have their own tools. The requirements are slightly different for each organization.
Also note that you will hear different terminology; CMS uses Infection Control, others Infection Prevention.         
                                                          
Kathleen Meehan Arias, MS, MT(ASCP), CIC
Maryland Ambulatory Surgery Association
Columbia, MD – November 7, 2012

2. Objectives
State at least three elements of infection prevention and control that are surveyed using the CMS Infection Control Surveyor Worksheet (ICWS)
Identify at least two common problems, gaps and practice deficiencies related to infection prevention that can be detected using the ICWS
We’re not just looking at “regulatory compliance” but especially at “patient safety.” This is NOT just a paper exercise to pull out when a surveyor comes in.
Disclaimer: References to specific brands of products and supplies are for illustration only and do not represent an endorsement of the product by APIC or the speaker

3. How many of you have had a CMS survey in your ASC?

4. Development of the ASC ICWS
Initial tool developed by CDC as part of Nevada Outbreak investigations.
$ 10 million ARRA funding made it possible to increase ASCs surveys & implement ICWS nation wide
CMS is surveying 1/3 of all nonaccredited ASCs in the current fiscal year
Some accrediting organizations are also using the ICWS
Original goal: collect ICWS from 1500 ASCs

5. Locating the ICWS on CMS Web Site
CMS Home (
Medicare
Survey & Certification General Information
Policy & Memos to States (left side of screen)
Memo SOM
Comprehensive Revision Appendix L
Included at the end of the document

6. No Deficiency Standard Level Condition Level Immediate Jeopardy
CMS Survey Outcomes
No Deficiency
Standard Level
Condition Level
Immediate Jeopardy
Surveyors may rate a center along a continuum of having no deficiencies all the way to that of immediate jeopardy. CMS defines “immediate jeopardy” as a situation in which the Ambulatory Surgery Center’s (ASC) noncompliance with one or more conditions for coverage (CFC) has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient. Surveyors may direct the attention of the center’s staff to address an immediate and significant concern affecting patient care.
Per CMS: “Determining the Citation Level of Deficiencies
Citing noncompliance at the appropriate level, i.e., standard- or condition-level, is critical to the integrity of the survey process.
The regulations at 42 CFR state, “The decision as to whether there is compliance with a particular requirement, condition of participation, or condition for coverage depends upon the manner and degree to which the provider or supplier satisfies the various standards within each condition.” When noncompliance with a particular standard within the Conditions for Coverage is noted, the determination of whether the lack of compliance is at the Standard or Condition level depends upon the nature of the noncompliance – i.e., how serious is the deficiency in terms of its potential or actual harm to patients - and extent of noncompliance – i.e., is there noncompliance with the CfC stem statement, or how many different regulatory requirements within a CfC are being cited for noncompliance, or how frequent was a given noncompliant practice, etc. One instance of noncompliance with a standard that poses a serious threat to patient health and safety is sufficient to find condition-level noncompliance. Likewise, when an ASC has multiple standard-level deficiencies in a CfC, this may add up to pervasive non-compliance and could be sufficient to find condition-level noncompliance. Determinations of citation level for complaint surveys follow the same process that is applied to full surveys; the only difference is that the complaint survey itself is generally limited to the CfCs implicated in the complaint.”
Per reference number 2, the wide range of variables and circumstances make it difficult for CMS to come up with a specific description for standard and condition level. Rather than painting themselves into a corner re a definition, they just use vague language like this – and deal with the many, many specifics, examples and variables when they do surveyor training.
References:
CMC State Operation s Manual(SOM) Appendix L, Guidance for Surveyors, Ambulatory Surgery Centers (ASC).
2) Personal Communication with Marilyn Hanchett, APIC, formerly of CMS
Terminology used in CMS ICWS
Includes instructions to surveyors regarding when/at what level to cite specific deficiencies

7. How can we use the ICWS to improve healthcare practices and outcomes?
The goal of this session is to illustrate how we can use checklists and the information obtained from using them to improve healthcare practices and outcomes

8. ICWS Part 1 – General Information
Examples
Facility Name
Location
CMS Certification Number
Year opened for operation
Date of most recent federal survey
Does ASC participate in Medicare via accredited “deemed” status?
By: AAACN; AAAASF; AOA; TJC
The survey tool starts out asking about demographics.
AAACN: Accreditation Association for Ambulatory Health Care
AAAASF: American Association for Accreditation of Ambulatory Surgery Facilities
AOA: American Osteopathic Association
TJC: The Joint Commission
All may accredit ambulatory facilities, but are invited in.
CMS just shows up
You will probably need to provide some of these details to the surveyor.

9. How are Your Services Provided?
Contract
Employee
Other
Anesthesia
Env Cleaning
Linen
Nursing
Pharmacy
Sterilization/
Reprocessing
Waste Mgmt
The survey tool starts out asking about demographics.
AAACN: Accreditation Association for Ambulatory Health Care
AAAASF: American Association for Accreditation of Ambulatory Surgery Facilities
AOA: American Osteopathic Association
TJC: The Joint Commission
All may accredit ambulatory facilities, but are invited in.
CMS just shows up

10. Infection Control Program: ICWS Required Elements
Written plan
Qualified, licensed professional to direct the program
Selection of nationally recognized guidelines
Evidence of compliance with selected guidelines
Surveillance system, including notifiable disease reporting per State requirements
Staff education & training
A conditional level citation means the conditions of participation for Medicare are not being met and may mean suspension of payments.
The governing body of the ASC must be the one to determine who the IP will be, what criteria they must meet and what training will be expected; what the scope of the program will include, what surveillance will be done, where surveillance data will be reported, to whom, frequency and what will be done with the information; determine the goals and objectives and methods for the program.
Without support from the top, the IP will not be successful.
Meeting minutes of whatever committee is involved should reflect the decisions and approval of the program, review of data, identification of problems, solutions, etc. This may be an all-encompassing committee or in a large facility, a subcommittee.

11. National Guidelines Guideline for Isolation Precautions (CDC)
Guideline for Hand Hygiene (CDC or WHO)
Disinfection & Sterilization in Healthcare Settings (CDC)
Environmental Infection Control in Healthcare Settings (CDC)
Perioperative Standards & Recommended Practices (AORN)
Specialty Guidelines (SGNA, Ortho, etc.)
Other
SGNA is the Society of Gastroenterology Nurses and Associates- they are the scope people. There is a joint guideline on scope cleaning
Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2009)
Guidelines for the Use of High Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes (2007)
Statement on Reprocessing of Water Bottles Used During Endoscopy (2009)
Statement on Reprocessing of Endoscopic Accessories and Valves (2009)
Reminder: staff must have easy access to any guidelines you use and reference in the description of your facility program.

12. How Many IC Hours per Week?
On average, how many IC hours per week?
Note: §416.51(b)(1) does not specify the amount of time the person must spend in the ASC directing the infection control program, but it is expected that the designated individual spends sufficient time on-site directing the program, taking into consideration the size of the ASC and the volume of its surgical activity.
The time needed may depend on how strong the existing programs is- perhaps minor adjustments are all that is needed, in other cases, if there is no existing program, or the ASC performs complex procedures or high volumes, more hours per week may be necessary. The proof is in the pudding- if all IC requirements are being met, the time will probably be considered adequate. If not, it won’t.

13. ASC sends emails or survey forms to patient home post procedure
What is Your System to Identify and Track Infections? What is Your Surveillance Method?
ASC sends s or survey forms to patient home post procedure
ASC sends letter/survey forms to surgeon post procedure
ASC follows-up with primary care provider
Physician/Surgeon obtains infection information at post-op visit and notifies ASC
ASC calls patients post-op
Supporting documentation required
Various methods may be employed. As long as they are effective, they will probably be acceptable. Others may include asking the hospital IPs to notify if they see an ASC patient admitted for post-op infection; calling the offices and asking the office or clinic nurses or receptionists, etc. What works in one setting may not be effective in another.

14. ICWS: Infection Control Staff Education
Frequently Asked Questions
Does everyone need training?
How often must I provide education/inservices?
Who can I use for education program and product support? Are web-based programs acceptable?
Is it OK if I train my own employees even if I’m not an IP or experienced in infection control?
Does CMS approve or endorse education programs?
Staff should receive IC education on hire, as required by regulations such as OSHA, which requires initial and annual training on Bloodborne Pathogens, TB, as well as Fire, Safety, etc. Training should be offered when job tasks or procedures are changed and if problems are identified that can be addressed through education. DOCUMENT!!

15. Infection Control Education: CMS Documentation Requirement
Is training documented?
If training is not provided to appropriate staff upon hire/granting of privileges, with some refresher training thereafter, a deficiency must by cited in relation to 42 CFR (b) and (b)(3).
If training is completely absent, then consideration should be given to condition-level citation, particularly when the ASC’s practices fail to comply with infection control standards of practice.
If it isn’t documented, it didn’t happen.

16. ICWS Part 2: Infection Control Practices Surveyors are expected, as much as possible, to base their findings on observation. Staff interview and documentation review will also be included.
Hand hygiene (including glove use)
Safe injection practices (including use of medication vials)
Disinfection and sterilization
Environmental infection control
Safe use and handling of point of care (POC) testing devices

17. Surveyor Observations
The surveyor is required to examine more than just ASC documentation
How many procedures were observed?
Can the ASC refuse to allow the surveyor to observe in the OR?
The surveyor is not required to obtain the consent of the operating physician prior to observing a surgical procedure. The surveyor may observe any and all cases and activities upon request as needed in order to assess compliance with the Medicare ASC CfCs. An ASC may not condition a surveyor’s ability to observe patient care by, for example, requiring a surveyor to sign any written documents or to present proof of vaccinations. The surveyor, however, must ensure that his/her observation protects patient safety and does not interfere with the operating physician or the surgical procedure.
If a facility denies a surveyor access to ASC activities which must be evaluated to determine compliance with the Medicare ASC CfCs, then the facility has failed to provide evidence of compliance and must be cited accordingly. In addition, the ASC may be subject to exclusion from participation in all Federal healthcare programs in accordance with 42 CFR

18. ICWS: Hand Hygiene What is the compliance in your ASC?
Measured by observation, interview, both
Soap and water available
Alcohol-based hand rubs available
ABHR installed correctly 42 CFR (b)(5)
Need more information on installation?
See NFPA Life Safety Code®
Surveyors will look for observations of proper hand hygiene, will also ask during interviews. Installation has to do with fire codes and limits of the amount of ABHR per smoke compartment. It may depend on the occupancy category of the facility- if business occupancy, standards less stringent. Remind IPs to check LOCAL fire codes as these may be different.

19. Gloves: Some Common Mistakes Seen in CMS Surveys
Failure to clean hands after removing gloves
Moving from patient to patient without cleaning hands and changing gloves
Using ABHR on gloves (rather than changing gloves)
Thinking double gloving protects against puncture injury
Not having gloves accessible in locations where they are needed/used

20. ICWS: Safe Injection Practices are a Survey Priority!
The surveyor will inspect injectable medications, saline, other infusates to make sure that
Needles are used for only one patient
Syringes are used for only one patient
Medication vials are always entered with new needle and syringe
MDV labeled with expiration date 28 days after opening.
In addition to hand hygiene, this is a BIG area of concern as a result of the number of exposures and outbreaks related to ambulatory settings in recent years. Anesthesia is someplace to check carefully, that predrawn meds are correctly labeled and used only on one patient; MDVs are entered with a new needle and syringe and the one needle, one syringe, one time rule is observed.
Needles and syringe packages may not be opened until ready to use. Bulk packages of unwrapped syringes are not meant for clinical use, except perhaps for mass immunizations, and cannot be opened and left in a drawer for later use.
Joint Commission clarification: Expiration of Multi-dose vials

21. Injection Practices The Surveyor Will Also Check:
Single use vials used on only one patient
Manufacturer pre-filled syringes used only on one patient
Bags of IV solution used on only one patient
Medication administration tubing and connectors used on only one patient
Single use vials are used only on one patient- no exceptions!
Prefilled syringes used only on one patient.
Bags of IV solution used on one patient.
Breaches in these practices have led to exposures and outbreaks, and criminal charges being filed.
Reminder: if the product or device is labeled “single use” it CANNOT be used again.

22. A Persistent Misconception – and Dangerous Practice!
The lack of a needle does NOT make a syringe reusable. A safety syringe with a blunt cannula (tip) or a luer connector must be used only once.
A syringe is never protected against contamination by changing the needle or by using needleless systems.
Example: 5cc needleless blunt plastic cannula syringe

23. DO CMS & CDC Permit Incremental Dosing? Yes, but only when . . .
A Frequently Asked Question . . .
DO CMS & CDC Permit Incremental Dosing? Yes, but only when . . .
Same syringe, same drug
Required intraoperatively
No opportunity to reuse with another patient
Most common scenario: anesthesia

24. Label Requirements are Strictly Enforced!
ICWS: Medications that are pre-drawn are labeled with the time of draw, initials of the person drawing, medication name, strength and expiration date or time
Reminder: There are NO acceptable “work arounds” or substitute practices to avoid using a label.

25. ICWS: Inspection of Multi Dose Vials
Multidose vials used on > 1 patient
Vial septum disinfected with alcohol before each entry
New needle and syringe used for each access
Vials are dated when first penetrated and discarded in 28 days or manufacturer’s expiration date, whichever comes first
Vials are not stored or accessed in immediate vicinity of the patient
Avoid the use of MDVs wherever possible. Vials should not be stored or accessed in the patient zone. Again, watch anesthesia; also Lidocaine vials that may be entered with a used needle and syringe to draw up additional meds for the same patient. If this happens, discard the vial.
The US Pharmacopeia (USP 2008), A General Chapter <797> Pharmaceutical Compounding Sterile Preparations, requires multi-dose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise. The vial should be labeled to reflect the penetration date or the beyond-use date.
However, the CDC indicates that multi-dose vials can be used until the expiration date, unless there are concerns with sterility.
APIC takes a stance between the two. In its document APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care, it recommends that facilities develop policies based on one guideline or the other, then follow through with those policies.
Reminder: single dose and multi dose vials are not interchangeable. Drug cost/availability does not justify doing so.

26. Surveyors Will Look in More Than One Place for Injection Safety Deficiencies
Important Reminders
Per CDC, medications should be drawn up as close to the time of use as possible.
Do not “carry over” pre drawn syringes from one day to the next; discard at the end of the day
Do not spike & prime your IV bags & sets the day before they will be used
NEVER use a bag of saline to pre fill syringes
NEVER combine the “leftover” contents in partially used vials

27. Sharps Disposal
Sharps disposed of in puncture-resistant sharps containers
Containers are replaced when fill line is reached
NIOSH/OSHA: Mounted 52-56” from floor to slot for standing use
Biohazard labeled
Located at point of use
OSHA Bloodborne Pathogens Standard, 29CFR requires sharps disposal in a rigid, puncture-proof container that is solid on sides and bottom, biohazard labeled, and located at the point of use. This means they can’t be located a distance away that requires more than a few steps travel, and never through a doorway.
NIOSH requires these be installed 52-56” from the floor to the disposal orifice for standing use.

28. ICWS: Disinfection and Sterilization
A Problem Prone Area in Many ASC Surveys!
Precleaning must always be performed
Surgical instruments (entering normally sterile sites or vascular system) must be sterilized
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, etc.)

29. ICWS: Sterilized Items
Appropriately maintained and handled throughout the process
Stored in designated clean areas
Packages inspected for integrity, reprocessed if not intact
No “wet packs”
No rubber bands around sterile supplies, use dividers, containers, etc.
Be careful of drawers- items get crammed in there and are disturbed every time the drawer is opened and someone paws through it (clean hands, please!)
Any package, processed in-house or sent out that is not intact or has water stains must be rejected and discarded or reprocessed.
Cabinets should be closed- have doors. Glass is nice because you can look without touching.

30. ICWS Precleaning: Often Incomplete or Incorrect
Instruments are precleaned per manufacturer’s or evidence-based guidelines
Enzymatic cleaners often used
Devices and instruments are inspected for residual soil and recleaned as necessary
Proper cleaning tools are available, in good repair, e.g. scope brushes
Items that are not physically clean cannot be high-level disinfected or sterilized, PERIOD! Thorough cleaning, using an enzymatic cleaner that is changed after each use is a good practice. The enzymatics have no disinfectant properties, so cannot be used all morning or all day, must be changed frequently. Never leave instruments soaking overnight or over the weekend.
Proper tools- brushes, etc., in good repair, must be present. Also PPE- gowns, masks or face shields, heavy-duty gloves
Reminder: precleaning is essential because you cannot sterilize organic matter, debris or dirt!

31. When Instruments are Rinsed, is the Process Adequate?
Adequate rinsing is NOT a “bird bath” technique!
Surveyors know the difference. Make sure your techs do too!

32. Sterilization of Instruments Surveyors will look for documentation that shows . . .
Chemical indicator used in each load
Biological indicator run at least weekly and with each load containing implants
Each load monitored with mechanical indicators for time, temperature, pressure
Documentation maintained for each load for each piece of sterilizing equipment
Equipment has routine preventive checks
Chemical indicators appropriate for the type of sterilization process must be included. Some peel packs have an external indicator built into the pack. The color change just indicates the pack has been processed, it does not “prove” sterility. Both indicators must be checked before using the instrument.
Steam sterilizers that do not print out a “receipt” that indicate successful parameters were met- time, temp and pressure- are not acceptable for use unless someone stands in front of it with a timer to document that the correct parameters were reached.
Some new machines incorporate electronic record keeping for each load, remember to check the numbers. Does not do any good if you do not validate parameters were met.
Sterilizers must be cleaned and maintained per manufacturer’s recommendation. This must be documented along with routine preventive maintenance by a qualified individual, also as specified by the manufacturer.
Hint: if staff think the autoclave works more or less like a microwave, you are probably NOT ready for your next survey.

33. ICWS and “Immediate use” Sterilization
What will trigger a deficiency? What is NOT acceptable?
Performed routinely
Done to avoid purchasing additional instruments
Done to minimize instrument processing times or for staff convenience
The surveyor will look for evidence of
Performing immediate use sterilization often or every load
Instruments are always or usually unwrapped
Instruments are steam sterilized in open trays or not contained/covered in any way
Reminder: an unwrapped instrument must be protected from the time it is removed from the sterilizer until it is delivered to the sterile field.

34. ICWS: Single Use Devices (SUDs)
If reprocessed, the device is approved by FDA for reprocessing by a 3rd party company
Device is reprocessed by an FDA-approved reprocessor
No amb care facilities or ASCs have been approved by the FDA to reprocess
Reprocessing of single use devices in the ASC is illegal and should never be done. This includes suture/staple removal sets, I&D, etc.
Many ASCs may not know about 3rd party reprocessor, they can be a big economic savings in some cases.
Reminder: if you are reprocessing any single use/disposable items in your facility, you are not only in violation of CMS CfCs, you are potentially reportable to the FDA for violation of their reprocessing standards.

35. ICWS: High-Level Disinfection (HLD)
Semi-critical equipment is high-level disinfected
Performed on site or via contract service
Items are precleaned, inspected, recleaned if necessary
Documentation supports that processes are safe and accurate
If performed on site, training and competency evaluation of staff doing the processing must be on file.
If off-site, a contract must be in place.
Examples of manual equipment (top) and automated endoscope reprocessor, bottom.

36. ICWS: High-Level Disinfection
HLD equipment is maintained per manufacturer’s instructions
Automatic Endoscope Reprocessor (AER): Do NOT skip precleaning
Make sure specific reprocessing protocols are in place for each type of scope that you use
Documentation of preventive maintenance
AERs may use glutaraldehyde, exposures are a problem. OPA may help with this although not totally benign. Always use HLDs in a well-ventilated area; be careful not to spill; if not in an AER, keep covered when not putting in or taking out instruments.
PPE required- impervious gown, face shield, heavy-duty gloves, not exam gloves.
Always use a timer- the time starts when the last item goes in, can’t add unless you reset timer to full soak time.
Be sure all items are completely submerged. Remember, single use devices cannot be reprocessed and reused.
Always soak scope brushes with the scope unless disposable, then discard.
Remember: ECRI ranked cross contamination from flexible endoscopes the # 1 health technology hazard in 2010!

37. ICWS: Chemicals in High Level Disinfection
Prepared per manufacturer’s instructions
Tested for appropriate concentration per manufacturer’s instructions (dipstick)
Replaced according to manufacturer’s instructions
Documentation of above
Neutralize chemical before discarding (EPA)
Solution must be tested before each use, per label instructions. Use the correct dipstick product, they are brand specific.
Keep a log of the tests. Perform Quality Check (QC) on strips when new bottle of test strips are opened (READ the instructions on the test strip container)
Some solutions require activation; if not activated, not soaking in HLD!
EPA requires neutralization of glutaraldehyde and OPA before disposal, check local and state requirements. Glycine is the neutralizer.
List of chemicals approved as HLD can be found on the FDA website.
Remember: Adverse respiratory reactions and skin sensitivities have resulted from staff exposure to some HLD chemicals. Know the directions for use and warnings specific to the chemical you use.

38. High-Level Disinfection of Endoscopes The surveyor will investigate . . .
Scopes are soaked for length of time specified on product label
If using AER, proper connectors are used
Appropriate temperature is maintained
Scopes are adequately dry before used again
Scopes are correctly stored (per manufacturer directions)
Follow label directions for soaking time, not all products are the same- different brands may have different soak times. Some products have a shorter time if the temperature can be maintained at a higher level, like 77°F/25°C. This can ONLY be done in an automatic endoscope reprocessor.
Drying is a key factor in disinfection- scopes with lumens must be blown dry with forced air then the channels rinsed with alcohol and the scope hung to allow drainage. All accessory caps must be removed.
Reminder: are manufacturer instructions on file and available to staff if/when needed?

39. ICWS: Environmental Infection Control
ORs cleaned with EPA-registered disinfectant between cases/procedures
ORs terminally cleaned daily (includes endoscopy suites)
Special attention to high-touch surfaces
Procedure for cleaning gross blood spills
Blood spills require an EPA-approved disinfectant with a claim for HBV and HIV. No longer is a tuberculocidal germicide indicated. See Bloodborne Pathogens Standard, Exposure Control Plan.
EPA approved hospital germicides can be found at the link provided.
A blood spill kit is required in some jurisdictions. Also chemical spill kits for high-level disinfectants and certain other chemicals that may be in use or stored in the ASC.
Reminder: if you are using a vendor for cleaning, including terminal cleaning of ORs, how do you assure that their services meet infection control standards?

40. Point of Care Testing Devices
Most Common Example: Blood Glucose Monitors
Labeled for multi-patient use
New, auto-disabling lancet used each time
Meter cleaned, disinfected after each use
Follow manufacturer’s instructions
When meters must be shared, the disinfectant must be effective against HBV and HIV.
Dilute bleach solution is also effective but may be too corrosive for some equipment.
Many exposures due to use of single use devices on multiple patients allowing blood from one patient to access the finger stick site of another.
Monitors MUST be designed and designated for multiple patient use and should use strips that go into the machine, never a finger directly on a machine surface.
Wipe down after each use.
If possible, do not take to the bedside, leave outside the door and take the test strip from the patient’s finger stick to the monitor for processing. A safety lancet is required.
The first photo is a non-safety lancet, the second is a pen-like device that has been associated with exposure; the third is safety lancets in various sizes and depths. They are self-retracting.

41. A few more words about using the CMS ICWS to improve infection prevention practices…..

42. Summary The CMS ASC ICWS is a useful tool for assessing compliance
CMS has found infection control practices in many ASCs to be deficient
The ICWS can be used in ASCs to identify gaps in infection prevention and control practices and guide implementation of measures to improve those practices

43. CDC Guidelines and Checklist
CDC Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care at
CDC Infection Prevention checklist for OP settings at
Schaefer MK, et al. Infection Control Assessment of Ambulatory Surgical Centers. JAMA. 2010; 303(22): at

44. APIC Resources at www.apic.org
APIC Home Page provides access to infection prevention guidelines and standards
With over 100 webinars to choose from, the APIC library keeps you current on clinical developments, changing regulations and best practices.