The following article was originally published in Preventing Infection in Ambulatory Care, the quarterly e-publication from the Association for Professionals in Infection Control and Epidemiology (APIC). To learn more about receiving this resource and joining APIC, visit www.apic.org/ambulatorynewsletter. To learn more about APIC, visit www.apic.org.
Infection prevention and control in ambulatory surgery has become increasingly more relevant to infection preventionists. In addition to the enhanced potential of infections associated with increases in volume, there has been an appreciation for increased infection risk due to independent ambulatory surgery centers (ASCs) and/or endoscopy centers, with little oversight and lax infection prevention activities. ASCs in the United States are reported to be the fastest growing provider participants of Medicare, increasing in number by more than 38% between 2002 and 2007. A 2008 Hepatitis C outbreak in Nevada was traced to poor infection control practices; follow-up surveys throughout Nevada found deficiencies at more than 40% of the ASCs.
On May 18, 2009, the Centers for Medicare & Medicaid Services (CMS) launched a revised set of requirements for ASCs that included new provisions for infection control.
Background and Terminology
Six months earlier, in November 2008, CMS published the Hospital Outpatient Prospective Payment System final rule in the Federal Register, which includes revisions to the ASC in 42 CFR 416.2-416.52. Among the revisions is the addition of a Condition for Coverage (CfC) on Infection Control, 416.51 which states that the ASC "must maintain an infection control program that seeks to minimize infections and communicable diseases." The introductory comments to the requirements in the Federal Register include the rationale behind these requirements. These documents are easily accessed from the Internet, and are fairly straightforward. The CfC elements are listed in the next section.
The State Operations Manual (SOM) Appendix L ASC Comprehensive Revision and companion publication, Infection Control Surveyor Worksheet, describe expectations for meeting the new regulation. The SOM for ASCs offers interpretive guidance for the surveyors on each of the CfCs. The Infection Control Surveyor Worksheet interprets the regulations and provides a check-off list for the surveyor in which to record observations. In the Federal Government Fiscal Year 2010, surveys will be conducted using tracer methodology, familiar to those who have participated in recent surveys by The Joint Commission (TJC).
There are several related news items: First, the CMS has granted TJC authorization to conduct surveys. ASCs accredited by TJC are "deemed" as meeting CMS requirements. This is good news for infection preventionists in institutions with accredited ASCs, whereas the new ASC Infection Control CfCs are fairly consistent with existent TJC standards. TJC recently updated the standards and elements of performance in the Comprehensive Accreditation Manual for Ambulatory Care to align them with CMS requirements for ASCs. TJC changes are also effective May 18, 2009 and are located in TJC website, under the ambulatory care accreditation program.
Secondly, as announced by the Department of Health and Human Services, CMS is expected to use funds from the American Recovery and Reinvestment Act of 2009 (ARRA) to survey ASCs approximately once every three years, using tracer methodology.
Other professional organizations with interest in this topic are the Accreditation Association for Ambulatory Health Care (AAAHC) and the Ambulatory Surgery Center Association. The AAAHC web site includes instructions for downloading the CMS documents, and has the ability to search for updates or tips. (See the end of this article for web links to documents and organizations.)
Preparing for the Survey
Seasoned infection preventionists will realize that good infection prevention and control (IP&C) programs already comply with CMS requirements, and are not really "new" in terms of infection prevention. The emphasis and challenge will be to bring independent ASCs into compliance and to make sure that "hot button" issues are addressed, such as injection safety and endoscopy. Due to CMS citations of the hepatitis cases in endoscopy centers in Nevada, and inclusion of endoscopy on the surveyor worksheet, it is advisable to include endoscopy units.
Where ASCs are part of a larger institution, specify the ASC in your institutional IP&C risk assessment. Clarify that institutional policies and procedures include the ASC.
Independent ASCs will need to develop IP&C programs that cover the CfCs. Initially, if there are perceived numerous lapses in infection control practice, or no IP&C program, this may require hiring a qualified infection preventionist or retaining an infection prevention consultant, and, depending on the size of the ASC, assigning staff and providing training.
A. Standard: Sanitary environment.
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.
While the terminology "functional and sanitary" may seem archaic, an up-to-date IP&C program will meet these goals. According to the surveyor worksheet, the surveyor will observe for hand hygiene, injection practices, sterilization and disinfection of instruments, including endoscopes and environmental cleaning. During your ASC site visits, coach staff (such as nurses or custodians) about responding to surveyors and to be able to demonstrate what they do, as well as describe the rationale, training and orientation for the job, and what they do in the way of infection prevention.
B. Standard: Infection control program.
The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.
Review, revise and develop new policies and procedures based on periodic review of professional organization and governmental agency standards, such as CDC/HICPAC, AORN, APIC, SHEA, OSHA (or your state OSHA), SGNA, ASGE, AAMI, and the state health department. Document the references.
For the IP&C Risk Assessment and Program Plan, address potential risks due to patient population, type of procedures performed, and any past IP&C issues at the ASC. Specific topics are listed under standards (2) and (3) below.
The program is:
1. Under the direction of a designated and qualified professional who has training in infection control.
There is some controversy about the interpretation of this standard. Does the infection preventionist need to be an employee at the ASC? How much flexibility does the ASC have in defining "designated and qualified?" CMS does not make CIC mandatory. The introduction to the CMS standard states that "There may be rationale for those ASC facilities that are under common ownership to utilize a single infection control professional to direct more than one facility program concurrently. However, we believe that this type of arrangement would potentially hinge on the proximity of the ASCs to each other, the frequency of onsite visits by the designated individual, and the ability of each facility to respond to an infection control issue in a timely manner… Infection control in a surgical facility should be a high priority. All ASCs, regardless of size, must therefore have an infection control program where the person in charge is knowledgeable and is aware of current advances in the field." To ensure the individual continues his/her current knowledge of infection control methodologies and techniques, he/she would need to engage in continuing education in infection control on a frequent, or at least an annual basis.
Where the ASC is part of a larger institution, an infection preventionist can be assigned to the ASC, with assurance that the ASC's administration and medical director are aware of the relationship between IP&C department and the ASC.
It is not clear, however, if a small, independent ASC can retain a consultant. For most experienced infection preventionists, it is incomprehensible that any staff at a small independent ASC without any infection control knowledge or background would be able to respond effectively to all of the IP&C demands, especially while carrying out other functions. While the survey tool allows for contracted services for cleaning, pharmacy, laboratory services or instrument sterilization, there is no specific allowance made for IP&C contracted services. It will be instructive to see if infection preventionist's contracted services are acceptable. IF the consultant has demonstrated qualifications, knowledge, experience, ongoing education, and credentials, and IF the consultant is available for emergencies, such as an SSI cluster, communicable disease exposure, or community outbreak such as the current Novel H1N1 influenza, will that meet the CMS requirements?
On the IP&C Plan, describe the infection preventionist coverage; their credentials (such as CIC, professional activities and special training), responsibilities to the ASC, and approximate time allotted. Identify who is responsible for the IP&C program and accountable in the event of an infection control emergency. Plan to have the infection preventionist available during any CMS survey and to accompany the surveyor if possible.
The program is:
2. An integral part of the ASC's quality assessment and performance improvement program (QAPI).
3. Responsible for providing 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.
These two points are difficult to tease apart functionally. Many common IP&C program components will demonstrate compliance, as long as the documentation addresses the requirements. A few examples:
• Surveillance program includes sentinel or serious adverse events related to infections, method for surgical site infection (SSI) surveillance and follow up.
• Occupational health includes safety sharps, immunizations, TB skin testing, exposure protocols and work restriction policies.
• Hand hygiene and surgical scrub policies and procedures • are in place; observations are performed, strategies for improvement are implemented, such as Plan-Do-Check-Act.
• Standard Precautions are in place for all patients, with evaluation of MRSA, other MDROs, C. difficile, and additional procedures to prevent spread as needed.
• Respiratory Hygiene ("cover your cough") has been instituted.
• Patient skin preparation policies, prophylactic antibiotic guidelines, and patient education on prevention of SSIs are in place.
• The IP observes surgeries, observations are reported to medical and nursing staff, and improvements are documented.
• State and local health department laws on reportable diseases are followed.
• Injection practices follow standard CDC and OSHA standards: no re-use of needles, syringes, single dose vials.
• Where contract services are provided, for example, environmental cleaning, the contract and practices are consistent with IP&C policies.
• Environmental issues are addressed, such as, cleaning procedures and agents, construction and renovation plans, air quality in the operating rooms.
• Procedures for biodisasters and pandemics are developed, in conjunction with the health department, where applicable.
References:
Acute Hepatitis C Virus Infections Attributed to Unsafe Injection Practices at an Endoscopy Clinic, Nevada, 2007. MMWR 57;513-517, 2008.
ASC Association, HHS Announces Infection Control Surveys for ASCs. Surgistrategies, 04/02/2009.
The Joint Commission News Release, 12/12/08.
CDC: Infectious Diseases Recovery Plan, Recovery.gov, 5/15/09.
CMS Condition for Coverage, Federal Register, November 18, 2008; p. 68720 and p. 68809
Resources:
CMS Condition for Coverage, from the Federal Register, November 18, 2008: http://edocket.access.gpo.gov/2008/pdf/E8-26212.pdf, comments on pages 68719, 68790, 68809; CfC for infection control, p. 68813
Infection Control Surveyor Worksheet, CMS May 5, 2009: http://totalsol.vo.llnwd.net/o29/data/1080/infection_control_surveyor_worksheet.pdf
State Operations Manual Appendix L – Guidance for Surveyors: Ambulatory Surgical Centers http://www.cms.hhs.gov/manuals/downloads/som107ap_l_ambulatory.pdf
The Joint Commission www.jointcommission.org
Accreditation Association for Ambulatory Health Care www.aaahc.org
Ambulatory Surgery Center Association www.ascassociation.org