Compliance with Infection Control Conditions for Coverage in ASCs

<p>In May 2009, the Centers for Medicare &amp; Medicaid Services (CMS), under the auspices of the Hospital Outpatient Prospective Payment System final rule, introduced revisions to the ambulatory surgery center (ASC) Conditions for Coverage (42 CFR 416.2 &ndash; 416.52). Included in the new conditions for coverage (CFCs) was a rigorous focus on demonstrated infection prevention and control knowledge and practice in an ASC. In 416.51 Conditions for coverage&mdash;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, qualified and licensed professional who has training in infection control; it must be an integral part of the ASC&rsquo;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.</p>

By Kelly M. Pyrek

In May 2009, the Centers for Medicare & Medicaid Services (CMS), under the auspices of the Hospital Outpatient Prospective Payment System final rule, introduced revisions to the ambulatory surgery center (ASC) Conditions for Coverage (42 CFR 416.2 – 416.52). Included in the new conditions for coverage (CFCs) was a rigorous focus on demonstrated infection prevention and control knowledge and practice in an ASC. 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, qualified and licensed 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.

"Even though the literature is rife with outbreaks of infections or patients developing an infection due to improper reprocessing or safe injection technique, I witness examples of these often while assisting many hospitals, surgery centers, and endoscopy suites," says Libby Chinnes, RN, BSN, CIC, an infection prevention and control consultant and principal of South Carolina-based IC Solutions, LLC. Some of the same concerns are witnessed repeatedly.  Some real life examples that come to mind include, but are not limited to:  sterilization of surgical instruments such as scissors in the 'closed' position; common practice (usually due to space issues and design) of mixing clean and dirty items such as wrapping clean instruments in endoscopy on top of closed trash cans or storage of clean scope in a container on top of dirty containerized scope; wrapping instruments in surgical corridors due to space issues; wearing dirty PPE to take scopes out of automatic reprocessors once cycle is complete; manufacturer’s step by step instructions for reprocessing different models of endoscopes not available or posted in the room where reprocessing occurs; temperature and humidity of decontamination area nor sterile storage area are monitored in reprocessing areas nor actions taken/documented when limits exceeded; unlabeled medications on top of anesthesia carts in a 'cleaned' OR; many staff unsure of protocol to clean and disinfect glucometers; no written protocol for handling of a positive biological indicator; reprocessing staff who have worked in the position for years and have little ongoing training, competencies, or certification; lack of availability of current standards and guidelines for reprocessing; lack of trained supervisory oversight in reprocessing areas, etc.  In fact, the Joint Commission requires that organizations reduce the risk of infections associated with medical equipment, devices, and supplies and has found that recently that this area was one of the top five non-compliant requirements for hospitals, critical access hospitals, and ambulatory and office-based surgery facilities. Much of this has centered on findings of improper high-level disinfection and sterilization of equipment. They have also recently issued a sentinel event alert on misuse of vials and safe injection practices." 

In a recent session of the Ambulatory Administrator Boot Camp sponsored by the Association of periOperative Registered Nurses (AORN), Terri Link MPH, BSN, CNOR, CIC, ambulatory education specialist at AORN, presented "Effective Infection Prevention Programs," in which she reviewed the interpretive guidelines for the infection control conditions of coverage. She emphasized that the ambulatory facility's infection control program must:
• Provide a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases
• Be based on nationally recognized infection control guidelines
• Be directed by a designated, licensed healthcare professional with training in infection control
• Be integrated into the ASC’s QAPI program
• Be ongoing
• Include actions to prevent, identify and manage infections and communicable diseases
• Include a mechanism to immediately implement corrective actions and preventive measures that improve the control of infection within the ASC

The ambulatory care setting, such as an ASC, presents unique challenges for infection control, because: patients remain in common areas, often for prolonged periods of time; surgical prep, recovery rooms and ORs are turned around quickly; patients with infections/communicable diseases may not be identified; and there is a risk of infection at the surgical site. Furthermore, due to the short period of time patients are in an ASC, the follow-up process to identify infections associated with the ASC requires gathering information after the patient’s discharge rather than directly. It is essential that ASCs have a comprehensive and effective infection control program, because the consequences of poor infection control can be very serious. In recent years, for example, poor infection control practices related to injections of medications, saline or other infusates in some ASCs have resulted in the transmission of communicable diseases, such as hepatitis C, from one patient infected with the disease prior to his/her ASC visit to other ASC patients, and a requirement to notify thousands of other ASC patients of their potential exposure.

The event that triggered much of the scrutiny aimed at ASCs was the identification in 2008 by the Southern Nevada Health District of a cluster of individuals who developed acute hepatitis C infection and who had undergone procedures at the Endoscopy Center of Southern Nevada in 2007. According to the official report, Outbreak of Hepatitis C at Outpatient Surgical Centers: Public Health Investigation Report (December 2009), during an investigation by the CDC and a number of state and local health authorities, unsafe injection practices were identified that placed patients at risk for exposure to bloodborne pathogens. Authorities believed that disease transmission occurred through a combination of unsafe injection practices that were reported by clinic staff members, identified in clinic documentation, and observed by investigators. The reuse of syringes to access vials could have introduced the blood of patients (and any viruses therein) into vials of propofol, and the vials were then reused for subsequent patients, thus transmitting contamination to those patients. As a result of the investigation, the clinic notified approximately 50,000 of its patients of a possible exposure and recommended they be tested for hepatitis C, hepatitis B and HIV.

Phenelle Segal, RN, CIC, a Florida-based consultant and principal of Infection Control Consulting Services., LLC, says that unsafe injection practices persist in ASCs despite high-profile outbreaks such as the one in Nevada. "Many of the facilities believe that they are practicing correctly but during my consulting travels, I have not seen any facilities with 100 percent compliance even if it is something small such as labeling a vial. I remind them, if you are coming up for Joint Commission or AAAHC accreditation and are not going to reuse the multi-dose vial, when they open that vial they need to sign it and date it on the spot, because even if they throw it out immediately after the case ends, if they have an unannounced visit from CMS, the surveyor will not wait for the end of the procedure to watch them throw that vial away. If it is not labeled, the facility will be cited."

When it comes to safe injection practices, observations by surveyors will focus on the injection practices of staff preparing and administering medications and performing injections (such as anesthesiologists, certified registered nurse anesthetists, nurses). Practices assessed by the surveyor include whether or not needles and syringes are used for only one patient; whether or not the rubber septum on a medication vial is disinfected with alcohol prior to piercing; if medication vials are always entered with a new needle or new syringe; if medications that are pre-drawn are labeled with the date and time of draw, initials of the person drawing, medication name, strength and discard date and time; if single dose (single-use) medication vials are used for only one patient; and if multi-dose injectable medications are used for only one patient. The surveyor will also check to see if all sharps are disposed of in a puncture-resistant sharps container and if the sharps container(s) are replaced when the fill line is reached.

Chinnes says she sees improvement in this arena. "Many staff can now cite the principles of safe injection practice, such as one needle, one syringe, one patient, which are now part of Standard Precautions, due to increased training and discussion by IPs and others in orientation and annual updates," she says. "I believe more staff are now looking for breaks in technique and speaking up when witnessing such acts.  The key, however, is to apply these same principles such as with cleaning and disinfection of glucometers, dedication of a multi-dose vial of medication to one patient, and using insulin pens for one patient only without sharing." 

The Survey Process
AORN's Terri Link reviewed the survey process, explaining that a CMS surveyor will use the Infection Control Surveyor Worksheet, which is used to facilitate assessment of compliance with the infection control-related conditions for coverage. Link emphasized that the surveyor will be looking for the ASC's documented compliance with nationally recognized infection control guidelines such as those from the Centers for Disease Control and Prevention (CDC) and AORN. Equally important is the presence of a licensed healthcare professional qualified through training in infection control and designated to direct the ASC’s infection control program. While CMS does not specify the amount of time this individual must spend in the ASC directing the infection control program, 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.
CMS surveyors also look for the level of infection control training that ASC staff members receive and how they receive this education and training, whether through an in-service, computer-based training or other options, and which personnel receive the training, including medical/nursing staff, other staff providing direct patient care, staff responsible for on-site sterilization/high-level disinfection, as well as cleaning staff. Surveyors check the frequency of staff infection control training (upon hire, annually or periodically/as needed), and if there is documentation confirming that training is provided to all categories of aforementioned staff.

Link emphasized that surveyors will scrutinize a number of infection prevention and control-related practices, including:

Hand Hygiene
Observations by surveyors will focus on staff directly involved in patient care, and the hand hygiene practices will be observed not only during the case being followed, but also while the surveyor is making other observations in the ASC throughout the survey. Interviews are used primarily to provide additional evidence for what the surveyor has observed, but may in some cases substitute for direct observation to support a citation of deficient practice.

The surveyor will look to see if all patient-care areas have soap and water available and/or alcohol-based handrubs available, and if alcohol-based handrub is available in patient care areas, whether it is installed as required. The surveyor will determine if staff perform hand hygiene after removing gloves; before direct patient contact; after direct patient contact; before performing invasive procedures (e.g. placing an IV); and after contact with blood, body fluids, or contaminated surfaces (even if gloves are worn). Regarding gloves, the surveyor will look to see if staff wear gloves for procedures that might involve contact with blood or body fluids; wear gloves when handling potentially contaminated patient equipment; and remove gloves before moving to the next tasks and/or patient.

Segal says she still sees issues relating to lack of hand hygiene compliance, mostly by anesthesiology personnel. "I don't believe we have made as much progress as is necessary with respect to getting anesthesia personnel to understand that just because they are not working in the sterile field, does not mean they do not have to practice strict hand hygiene," she says. "I think it will always be an issue now that we are so connected to our smartphones and tablets, like an umbilical cord. The anesthesiologist or the CRNA  either work on their iPad or do something personal on their cell phones, and then they get up to do something for the patient, but I don't see the hand sanitizer being used -- even though it is perfectly accessible on the anesthesia supply cart. I have talked to them at the time I am observing their practices when I consult in ASCs and one reason they won't use it is because they don't agree that these inanimate objects they touch, such as an IV line, are directly responsible for surgical site infections (SSIs). And nothing makes me more concerned than when I hear that. They say, 'Show me evidence that a cell phone is contributing to an SSI,' so I tell them infection prevention is not only about SSIs, it's about HAIs."

Segal explains that it's a question of potential cross-contamination. "They are contaminating the environment with these dirty cell phones and tablets that have been everywhere. I have watched the processes -- the OR has been prepped for the next patient, so cleaning between cases has been performed and a lot of the staff are doing a very good job with environmental surface cleaning. But then the anesthesia personnel come in, and they set their contaminated cell phone or tablet down on a surface that has just been cleaned. Then the circulator comes in and puts down something on that same surface that will later be used near the patient. Now it will not go into the sterile body but it will be used somewhere close by. I think this cell phone era has created additional challenges related to environmental cleaning and hand hygiene that we need to address."

Another issue Segal notes is that pertaining to waterless surgical scrubs. "These products are being used routinely but there are many surgical personnel who don't understand the proper technique required," she says. "They don't understand the mechanical scrubbing action needed, under the nails, around the cuticles and all of the areas of the hands that are a haven for organisms. If these products are not being used appropriately, I advise the facility to have the manufacturers' sales reps come back in and do a demonstration for staff."

Single Use Devices, Sterilization, and High-Level Disinfection
Infection preventionists already know the following basics of proper practices relating to disinfection and sterilization:
- 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)

The surveyor will observe staff performing equipment reprocessing, unless these activities are performed under contract or arrangement off-site from the ASC. Practices that the surveyor will assess include: If single-use devices are reprocessed, they are devices that are approved by the FDA for reprocessing; and if single-use devices are reprocessed, they are reprocessed by an FDA-approved reprocessor.

Regarding sterilization, the surveyor will check if critical equipment is sterilized and determine whether or not sterilization procedures were performed onsite. If instruments and devices are reprocessed onsite, the surveyor will look at the method(s) of sterilization used. Practices that will be scrutinized include whether or not Items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to sterilization; medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before packaging and sterilization; whether or not a chemical indicator is placed in each load; whether or not a biologic indicator is used at least weekly and with all implantable loads; whether or not each load is monitored with mechanical indicators (e.g. time, temperature, pressure), and if documentation for each piece of sterilization equipment is maintained and up to date and includes results from each load. The surveyor also will examine if items are appropriately contained and handled during the sterilization process to assure that sterility is not compromised prior to use; if, after sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised; if, after sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised; and if sterile packages are inspected for integrity and compromised packages are reprocessed.

Regarding high-level disinfection (HLD), the surveyor will look to see if semi-critical equipment is high-level disinfected or sterilized onsite or if a third party is contracted to provide for HLD off-site. If the HLD process is performed onsite, the surveyor will check: the specific method of high-level disinfection (manual or automated); if items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to HLD; if items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to HLD; whether or not medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before high-level disinfection, and whether or not HLD equipment is maintained according to manufacturer instructions. Also checked by the surveyor will be whether or not chemicals used for HLD are: prepared according to manufacturer instructions; tested for appropriate concentration according to manufacturer’s instructions; replaced according to manufacturer’s instructions; are documented to have been prepared and replaced according to manufacturer’s instructions.

In addition, the surveyor will check if instruments requiring high-level disinfection are: disinfected for the appropriate length of time as specified by manufacturer’s instructions or evidence-based guidelines; and disinfected at the appropriate temperature as specified by manufacturer’s instructions or evidence-based guidelines. The surveyor will also look to see if Items that undergo high-level disinfection are allowed to dry before use, and, following high-level disinfection, if items are stored in a designated clean area in a manner to prevent contamination.

Segal reports that she is seeing an overall improvement in sterilization practices in ASCs, but there remains a breakdown in processes related to high-level disinfection, she says. "There are steps staff should be taking -- they are there in the instructions for use -- but they are not reading that, so one of the biggest violations I am finding is the lack of temperature monitoring for Cidex and for OPA," Segal says. "I am also seeing an increasing number of facilities moving away from doing HLD -- of course not in the GI suite or other invasive procedure areas where they are using AERs -- but I am talking about soaking instruments. I am also seeing more use of hydrogen peroxide as a HLD solution. So improvement is there, triggered by a greater awareness and understanding because when CMS or AAAHC surveyors walk in, they are so fixated on sterilization."

Environmental Hygiene
Surveyors are keen on whether or not an ASC is upholding the conditions for coverage related to providing a sanitary environment. CMS dictates that ASCs must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice, including:
• Techniques for food sanitation if employee food storage and eating areas are provided;
• Techniques for cleaning and disinfecting environmental surfaces, carpeting, and furniture;
• Techniques for disposal of regulated and non-regulated waste; and
• Techniques for pest control. These activities must be conducted in accordance with professionally recognized standards of infection control practice.

AORN's Terri Link emphasized that using the specific questions on the infection control survey worksheet related to environmental infection control can help guide infection preventionists on identifying trouble spots:
• Observe throughout the ASC the cleanliness of the waiting area(s), the recovery room(s), the OR/procedure rooms, floors, horizontal surfaces, patient equipment, air inlets, mechanical rooms, supply, storage areas, etc.
• Interview staff to determine whether cleaning/disinfection takes place at the appropriate frequencies, using suitable EPA-registered agents. Ask for supporting documentation to confirm what staff say in interviews.
• Determine whether the ASC has a procedure for decontamination after gross spills of blood or other bodily fluids.

According to CMS, the ASC must provide and maintain a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases. All areas of the ASC must be clean and sanitary. This includes the waiting area(s), the pre-surgical prep area(s), the recovery room(s), and the operating or procedure rooms. The ASC must appropriately monitor housekeeping, maintenance (including repair, renovation, and construction activities), and other activities to ensure a functional and sanitary environment. Policies and procedures for a sanitary and functional environment should address the following:
• Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal or external construction/renovation
• Maintaining safe air handling systems in areas of special ventilation, such as operating rooms

When it comes to environmental infection control, the surveyor will observe staff performing environmental cleaning. He or she will check: if  operating rooms are cleaned and disinfected after each surgical or invasive procedure with an EPA-registered disinfectant; if operating rooms are terminally cleaned daily; if high-touch surfaces in patient care areas are cleaned and disinfected with an EPA-registered disinfectant; and if the ASC has a procedure in place to decontaminate gross spills of blood.

"I do think that environmental cleaning is improving," Segal notes. "I always make sure -- because this is what a lot of the surveyors will ask -- that staff members know what the dwell time is for the product they are using. I would say that in 70 percent of the surgery centers I have been in, most of the staff actually know the dwell time, how long the surface needs to remain wet. I want them to explain to me what that actually means when you are using a product with a three-minute wet time -- sometimes they don't understand it has to wet for that duration of time. I am also seeing, overall, better technique with respect to making sure that everything is wiped down properly. Where there is still a learning curve is anesthesia. They are not always as compliant with the wiping down of the anesthesia cart when they are preparing for the next case. They will sort of clean the cart, take their gloves off and not use the alcohol handrub, put on a clean pair of gloves and start prepping for the next patient. That's in violation of good practices. Cleaning efficacy also often depends on the size of the facility, who is yelling at them to get the next patient in -- I go into ASCs where turnover is very hectic -- and facilities such as eye surgery centers can be problematic in their cleaning practices."

Chinnes echoes these findings: "I’ve noted increased staff knowledge of contact times for their facility’s specific disinfectants whether for the environment or for instrument disinfection. Many areas are very knowledgeable about high level disinfectant testing, use, and monitoring as well.  However, due to the complexities of the process and staff turnover, this process should always be supervised and monitored."            

Surveillance and Risk Assessment
CMS surveyors will look for a system to actively identify infections that may have been related to procedures performed at the ASC, and the method of  obtaining this information (such as sending e-mails to patients after discharge; following up with their patients’ primary care providers after discharge; or relying on the physician performing the procedure to obtain this information at a follow-up visit after discharge and reporting it to the ASC; as well as evidence of supporting documentation confirming this tracking activity. According to CMS, the ASC must conduct monitoring activities throughout the entire facility in order to identify infection risks or communicable disease problems. The ASC should document its monitoring/tracking activities, including the measures selected for monitoring, and collection and analysis methods. Activities should be conducted in accordance with recognized infection control surveillance practices, such as those utilized by the CDC’s National Healthcare Safety Net (NHSN). Monitoring includes follow-up of patients after discharge, in order to gather evidence of whether they have developed an infection associated with their stay in the ASC. The ASC must develop and implement appropriate infection control interventions to address issues identified through its detection activities, and then monitor the effectiveness of interventions through further data collection and analysis.

Segal says she sees improvement in facilities' post-discharge surveillance efforts. "I am also observing a lot of success with risk assessments, because they are required, and because they are a conscientious approach to good patient care," she says, "not because they need to complete them just to satisfy the requirements of the Joint Commission or AAAHC or CMS. They are purposeful about their goals and strategies, so they are very much following in the footsteps of acute care."

Whether breaches in practice are related to knowledge gaps versus implementation gaps, Segal and Chinnes note that it frequently comes down to resources and making the business case for what facilities need to uphold infection prevention and control best practices.

"I find that so much is cost driven," Segal says. "Decisions are being made with respect to costs, and there are still many facilities that do not want to spend anything extra if they do not have to. I don't believe it's a lack of knowledge at all, but the need for cost effectiveness. That's why when we do have an outbreak of significant magnitude we have to drive the message of addressing potential unsafe practices home to the C-suite. Just because you are not sharing syringes like the practitioner in Nevada did, does not mean that your practices are 100 percent compliant. We have to keep explaining to them the infection prevention imperatives as well as the business case for infection control in the ambulatory care setting. We can't lose sight of the fact that as soon as we pull back on practices or try to cut corners, we are putting ourselves as well as our patients at risk."

Regarding seeing evidence that infection control staff in ambulatory-care settings are making the business case for their programs and resources Chinnes notes, "I believe as IPs in ASC settings receive training in the principles of infection prevention and control that they will be able to back up their recommendations from evidence-based literature and actively observe for risks more in-depth in their centers. Infection prevention is a specialty field and there is much to learn. As the IP receives ongoing training and uses networking with other experts in the field, then they can begin to know what to look for such as in the critical area of reprocessing.  This knowledge of the literature as well as remaining current with ongoing regulations and standards will give them the backing and confidence to present the needs of their programs to leadership in the name of patient safety.  CMS regulations include Conditions for Coverage for Infection Control for ASCs and provide a wonderful tool in their infection control worksheet, available to all centers, to assist in identifying potential and actual threats to patient safety."

Chinnes emphasizes the importance of buy-in by facility leadership and for administrators to be attuned to clinical issues. "It is critical that leadership be attuned to clinical issues such as infection prevention in their centers.  That’s why organizations such as the Joint Commission and others address leadership in their standards.  The IP must be provided with the training (and ongoing education), resources, and staffing, such as time, to be able to coordinate  the program for the facility. Several CEOs in my travels have told me that they do have someone assigned to the role of the IP in their ASC and they have had training in handwashing! While ensuring that hand hygiene stays front and center and is monitored/ reported back to the staff and is always a crucial element of any IP program, infection prevention is so much more. It's culture of safety that encourages every healthcare worker to be comfortable to draw attention to breaks in technique or issues in patient safety.  It involves everything from hand hygiene and safe injection practices, proper reprocessing of dirty instruments for the next patient use, proper antimicrobial use, proper environmental cleaning, sterile technique, food sanitation, to a plethora of other interventions. Clinical issues such as infections can lead to reduced payment for services, loss of facility reputation in the community, and possible loss of accreditation status, in addition to patient morbidity and mortality."

 







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