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CMS interpretive guidelines one year later: Is your facility in compliance with all the changes?


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It’s been one year since the Centers for Medicare & Medicaid Services (CMS) released changes to its interpretive guidelines for infection prevention and control, adding new requirements related to MDROs, bioterrorism, ambulatory care, and leadership.

These changes were largely designed to bring the guidelines into step with current IC practice standards, says Sue Dill Calloway, RN, MSN, JD, director of hospital risk management at OHIC Insurance Company, The Doctor’s Company, in Columbus, OH. Prior to the update, the guidelines were outdated, Dill Calloway says.

Although there were few changes to the actual hospital Conditions of Participation—the federal requirements hospitals must meet to receive Medicare and Medicaid reimbursement—much explanation was added under the interpretive guidelines, and state surveyors will be interpreting the regulations differently as a result, said Candace Friedman, BS, MT(ASCP), MPH, CIC, director of IC and epidemiology at the University of Michigan Health System in Ann Arbor.

Friedman spoke at the September 18 HCPro audio conference, “CMS Interpretive Guidelines: Understand Changes and Challenges for Infection Control and Restraint.”

Review the following key changes to the interpretive guidelines to ensure that your facility is in compliance:

Monitor MDROs. Organizations need to follow CDC guidelines for MDROs and decide which specific MDROs to monitor, said Friedman. If their monitoring reveals transmission of MDROs, they must take steps to identify breeches in IC practices.

Assess ambulatory care. Under these changes, your IC program needs to examine all sites within the organization, not just those on its main campus, said Friedman.

Focus on where to screen patients for potentially contagious diseases. “For example, pediatric rashes can be quite important. It may be appropriate to ask important screening questions of patients or family members to determine how to manage patients who have a rash that may be communicable,” said Friedman.

Facilities must also take measures in ambulatory settings to identify and address risk factors. One such risk factor may be the potential for infectious disease transmission in common waiting areas.

“Your facility needs to decide how you are going to physically separate patients,” Friedman said. “You’ll also need to focus on how to use respiratory etiquette and whether to institute isolation precautions for those patients.” Focus on cleaning practices in these waiting areas to make sure that they appropriately address risk, she added.

Respond to communicable disease outbreaks and bioterrorism. Facilities must prepare a response strategy enumerating steps staff members should take to reduce the potential for infectious disease transmission and identify exposed individuals during and after an outbreak. IC staff members should become involved in any emergency preparedness activities.

Implement surgical prophylaxis. If appropriate, facilities need to implement surgical prophylaxis as a means of preventing infections.

Promote bundles to prevent bloodstream infections. This is the sole reference to bundles in the CMS document, said Friedman, adding that if your facility has instituted bundles, it’s important to include information about them in your program description.

Maintain a log of infection and communicable disease incidents. This is not a new CMS requirement but one that was revised to permit the use of electronic logs instead of paper documents, said Friedman.

CMS has a list of items that facilities must log, and you must be able to show documentation for these items if a surveyor requests it. Be certain you have examples readily available, whether they are in written or electronic form.

“Surveyors will ask to see this information,” Friedman said, adding that the information must be secure, up to date, HIPAA-compliant, and accessible.

Engage leadership. CMS requires the CEO, medical staff leader, and director of nursing to address problems identified by the IC program. These individuals must also lead this program with quality improvement (QI) initiatives and any related training programs that might be available.

Staff members must be able to report IC problems to these leaders so the surveyor can note their involvement.

Meet basic standards

In addition to the guidelines above, Friedman said, facilities must:

Outline their infection prevention and control program. Facilities must note how the program is developed, implemented, and maintained.

Have documents that detail the elements of the program. For example, these documents must show how surveillance is conducted, who is responsible for the program, and how it is linked to QI. They must include a description that addresses the scope and complexity of the program and how it focuses on the facility’s services.

Be able to evaluate and outline what role IC activities play in ambulatory services, if applicable.

Monitor for surgical site infections if it is appropriate for the institution.

Maintain a sanitary environment. Surveyors will likely perform visual inspections to check for cleanliness and look for compliance with IC initiatives, such as hand hygiene.

Follow nationally recognized IC practices and guidelines. Reference the guidelines you used to create your policies and procedures wherever appropriate. The surveyor will likely be familiar with HICPAC (formerly the Hospital Infection Control Practices Advisory Committee) guidelines, so note them if you’re in compliance.

Conduct active surveillance on patients and staff members. CMS defines surveillance as detection of infections, collecting and analyzing data, and performance monitoring and intervention. “One of the major pieces here is language stating that facilities must monitor all locations within the organization,” said Friedman.

Document surveillance activities. Store and analyze the data and have reports ready to show the CMS surveyor. These documents must be routinely presented to groups within the facility.

Include information in these reports that demonstrates to the surveyor how you’re analyzing surveillance information and using it as a basis for interventions. Include a statement that your facility is following recognized surveillance practices.

There is no specific mandate from CMS addressing what type of surveillance your facility should perform, whether targeted or hospitalwide.

“It doesn’t matter, as long as the institution has determined what indicators to measure and how information will be collected and evaluated. As long as you have something that outlines what you’re going to do and the rationale for it, that’s sufficient for the surveyor,” Friedman said.

Monitor interventions for effectiveness.

Comply with OSHA’s bloodborne pathogen’s standard.

Designate the position of the IC officer in writing. “An easy way to do that is to include it in the program description,” said Friedman. Surveyors will likely review the personnel file of IC officers, so the institution needs to ensure that those officers are qualified. One method is to make sure that they are certified in IC and that they maintain their qualifications through education, training, or continuing certification in IC.

Integrate the IC program into the QI program. “There must be some kind of link between IC and QI. It doesn’t need to be official; you just need to show that the QI program can support IC efforts and that there are integrated efforts,” said Friedman.

Meet requirements for staffing and resource levels based on their patient census. Although this rule doesn’t state the number of hours required for IC staff members, it does state that the facility must have sufficient resources to cover the program.

Develop and implement policies to reduce infections and communicable diseases. Hospital policies need to consider all locations.

For example, if you have a hospital policy governing IV practices, be aware that the policy will also apply to IV use in off-site locations, such as infusion centers or home care, said Friedman. Think about those sites when writing your policy.