CMS sharpens IC regs in ambulatory centers

Call for designating a trained professional

The Centers for Medicare & Medicaid Services (CMS) recently announced that a final rule will appear in the Nov. 18, 2008, Federal Register detailing changes to the agency's outpatient ambulatory surgical center (ASC) payment system. The infection control requirements — including comments and responses by the CMS — are summarized as follows:

Condition for Coverage: Infection Control. (§416.51)

The proposed infection control CfC was divided into two standards. Under standard §416.51(a), "Sanitary environment," we would require the ASC to provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. We proposed to allow the ASCs to have flexibility in designing their own infection control program that would meet CMS regulations and also meet the needs of their particular facility.

The second proposed standard at §416.51(b), "Infection control," would require the ASC to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The program would be required to designate a qualified professional who has training in infection control, integrate the infection control program into the ASC's QAPI program and be 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. Because the prevention and control of infection is so critically important to overall patient and staff health and safety, we have proposed to elevate the current standard-level requirement to a condition-level requirement and expand the requirements to include the designation of a qualified professional to direct the infection control program.

Comment: A few commenters asked for clarification regarding the requirement that the designated professional have training in infection control. One commenter suggested the inclusion of examples of nationally recognized organizations that ASCs may seek out for guidance and continuing education. Other commenters suggested the designated infection control individual be identified as an infection control professional rather than infection control officer.

Response: We are not mandating one specific set of guidelines or infection and control standards that an ASC must employ but rather, it must consider, select and implement from nationally recognized guidelines [i.e., those by the Centers for Disease Control and Prevention]. Hospitals and hospital organizations as well as national health care organizations also would have information regarding infection control. Training in infection control is available through a variety of services such as health care organizations, professional associations, and government entities. At this time, we will continue to allow the ASCs the flexibility in setting up the infection control program in a manner which best meets the organization's needs. Moreover, we expect that the ASC will be able to provide verification of staff training and current competency related to infection control standards of practice. We do not find that it is necessary to associate a title with the qualified professional who directs the program.

Comment: Several commenters requested flexibility in designating an infection control professional to serve multiple facilities that are under common ownership.

Response: 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 on-site visits by the designated individual, and the ability of each facility to respond to an infection control issue in a timely manner. We will address these and other issues in more detail in subregulatory guidance.

Comment: One commenter questioned the rationale for elevating infection control to the condition level. A commenter noted that requiring the program to be under the direction of a designated professional who has training in infection control, should not be necessary in the smaller ASC setting.

Response: The infection control requirement located at §416.44(a)(3) currently requires both large and small ASC organizations to establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to appropriate authorities. Considering the huge growth in the ASC industry since we issued the current ASC regulations in 1982, we believe that 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.