Regulators: CMS issues infection control survey, OSHA drafts ID reg
January 1, 2015
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Regulators: CMS issues infection control survey, OSHA drafts ID reg
Ebola outbreak could provide momentum for new mandates
By Gary Evans, Executive Editor
The Centers for Medicare & Medicaid Services (CMS) has finalized its long anticipated infection control survey for hospitals, telling its inspectors the requirements are "effective immediately" and can be used to issue citations in unannounced inspections.
The CMS survey was developed in collaboration with the Centers for Disease Control and Prevention, so it essentially codifies a sweeping array of CDC infection prevention guidelines that were heretofore voluntary. In doing so, the CMS continues to raise the profile of infection preventionists, assigning IPs key roles in identifying and reducing infection risks to patients and health care workers.
"The [impact] is going to be huge because it refines the points that are important to emphasize in infection prevention and control programs," says Ruth Carrico, PhD, RN, CIC, assistant professor of health promotion and behavioral sciences at the University of Louisville (KY). "Certainly we know that is a constantly moving target, but [the survey shows] us what we need to be able to demonstrate effectively over time."
To make that possible, the CMS survey requires "hospital leadership, including the CEO, Medical Staff, and the Director of Nursing Services [to ensure that] the hospital implements successful corrective [infection control] action plans."1 That means the CMS survey should not be perceived as an unfunded mandate, as IPs can use the agency requirements as leverage to sustain and increase program resources to prevent health care associated infections (HAIs).
"We need to see if this will motivate the leadership in the hospitals — the CEOs — to invest in infection control," says Denise Cardo, MD, director of the CDC Division of Healthcare Quality Promotion. "[The CMS survey] will empower those programs to do what is needed. It is not just more resources but more empowerment. [Infection control] has to become a priority."
Another potential source of motivation via regulation could come from the Occupational Safety and Health Administration (OSHA), which has drafted an infectious disease standard that would mandate infection control measures to protect health care workers. (See related story, p. 5.)
Charge to surveyors
Issued Nov. 26, 2014, the 49-page CMS infection control survey is similar to the 42-page draft version that has been under review and pilot testing for at least two years. There are some language changes and revisions, and the CMS has deleted a section on the protective environment (i.e., bone marrow transplants) while expanding a section on antibiotic stewardship. The CMS cannot currently cite hospitals on antibiotic stewardship issues, but the agency is widely expected to issue new regulations in the next few years to specifically require such programs. (See related story, p. 4.) While antibiotic stewardship data are being collected "for information only," the survey lists the specific citation "tags" for the vast majority of the measures. The CMS survey calls for inspectors to assess key aspects of employee health and worker training, as well as hand hygiene, injection safety, environmental services, and cleaning and reprocessing equipment. The survey still includes the so-called "patient tracers," where CMS inspectors assess certain points of care. These are central venous catheters, urinary catheters, ventilators and respiratory therapy, spinal injections, point-of-care devices, surgical procedures and isolation precautions.
"The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the Infection Control Condition of Participation (CoPs)," the CMS survey general instructions state. "Items are to be assessed by a combination of observation, interviews with hospital staff, patients and their family/support persons, review of medical records, and a review of any necessary infection control program documentation. During the survey, observations or concerns may prompt the surveyor to request and review specific hospital policies and procedures. Surveyors are expected to use their judgment and review only those documents necessary to investigate their concern(s) or to validate their observations. The interviews should be performed with the most appropriate staff person(s) for the items of interest, as well as with patients, family members, and support persons."
The CMS also has finalized similar surveys to assess Quality Assessment and Performance Improvement (QAPI) and Discharge Planning. The worksheets will be used by state and federal surveyors on all survey activity in hospitals when assessing compliance with any of these three CoPs, the CMS announced. "The hospital industry is encouraged, but not required, to use the surveys as part of their self-assessment tools to promote quality and patient safety," the CMS stated in releasing the final version.
"It’s all part of the risk assessment process," says Carrico, an IP for many years before going into academia. "What is it that we have to do standards and regulations versus what is it that we need to do based on surveillance results. The third thing is what do we want to do? What are those additional things of personal importance to [our facility]? All of that has be taken into consideration to form an infection control strategy."
The CMS survey could also serve as a tool for education in training new IPs on the key aspects of infection prevention, she adds.
CMS: IPs must be qualified, have ongoing training, experience or certification
Identify problems and solve them with quality colleagues
The recently finalized hospital infection control survey by the Centers for Medicare & Medicaid Services includes the following key requirements specifically aimed at infection preventionists and their quality partners. The notations in italics are the CMS instructions to surveyors regarding the specific citation "tags" to cite if the hospital is in non-compliance with the requirements.
Section 1.A. Infection Prevention Program and Resources
1.A.1 The hospital has designated one or more individual(s) as its Infection Control Officer(s).
1.A.2 The hospital has evidence that demonstrates the Infection Control Officer(s) is qualified and maintain(s) qualifications through education, training, experience or certification related to infection control consistent with hospital policy.
1.A.3 The Infection Control Officer(s) can provide evidence that the hospital has developed general infection control policies and procedures that are based on nationally recognized guidelines and applicable state and federal law
If no to any of 1.A.1 through 1.A.3, cite at 42 CFR 482.42(a) (Tag A-748)
Section 1.B. Hospital QAPI Systems Related to Infection Prevention
The hospital infection prevention program is coordinated into the hospital Quality Assessment and Performance Improvement (QAPI) program as evidenced by:
1.B.1 The Infection Control Officer(s) can provide evidence that problems identified in the infection control program are addressed in the hospital QAPI program i.e., development and implementation of corrective interventions, and ongoing evaluation of interventions implemented for both success and sustainability).
If no to 1.B.1, cite at 42 CFR 482.21(e)(3) (Tag A-0286)
1.B. 2 Hospital leadership, including the CEO, Medical Staff, and the Director of Nursing Services ensures the hospital implements successful corrective action plans in affected problem area(s).
If no to 1.B.2, cite at 42 CFR 482.42(b)(2) (Tag A-0756)
1.B.3 The hospital utilizes a risk assessment process to prioritize selection of quality indicators for infection prevention and control.
If no to 1.B.3, cite at 42 CFR 482.21(a)(2) (Tag A-0267)
Other sections of the CMS survey include requirements in the following areas:
Systems to Prevent Transmission of MDROs and Promote Antimicrobial Stewardship
Infection Prevention Systems and Training Related to Personnel
Injection Practices and Sharps Safety (Medications and Infusates)
Personal Protective Equipment/Standard Precautions
Reprocessing of Semi-Critical Equipment
Reprocessing of Reusable Critical Equipment Instruments and Devices: Sterilization
Single-Use devices (SUDs)
Indwelling Urinary Catheters
Central Venous Catheters
Spinal Injection procedures
Point of Care Devices (e.g. Blood Glucose Meter, INR Monitor)
Isolation: Contact precautions
Isolation: Droplet precautions
Isolation: Airborne precautions
"What this [survey] really is doing is trying to bring clarity to the important aspects of infection prevention," she says. "It’s going to be helpful to translate infection control to other settings. We know that health care is moving away from acute care into all of these other settings. So if we have these type of tools and standards and regulation in other settings that will help improve infection prevention and control in those."
The single largest payer for health care in the United States, the CMS is expected to eventually link the survey to its pay for performance incentives as it continues an unprecedented focus on infection control. The power of the purse can be formidable. For example, a new report by the Agency for Healthcare Research and Quality estimates that 50,000 patient deaths due to hospital-acquired conditions (infectious and non-infectious adverse events) were prevented from 2010 to 2013 due in part to "financial incentives created by the CMS and other payers."2
"I think [the CMS survey] is a very good first step it’s clear just by its existence that there is a need to be looking more closely at what we are doing," says Michael Bell, MD, deputy director of the CDC DHQP. "And having trained eyes to do that I think is a necessary addition to the workplace."
The unfolding CMS agenda has roots in a scathing 2008 GAO report that held the Department of Health and Human Services (HHS) responsible for the "needless suffering and death" caused by infections and cited the need to use "hospital payment methods to encourage the reduction of HAIs."3 While the inertia and entrenched culture of a federal bureaucracy make for a slow change, the CMS and the CDC are forging an unprecedented partnership with the infection control survey and the upcoming push for an antibiotic stewardship regulation.
"We have been talking to CMS leaders and I think [the survey] is a good opportunity for us to work to improve infection control overall and also to see how the programs are working," Cardo says. "I also know that the Joint Commission is motivated, there are several groups that want to use some tools [like the survey] to do that. We are also working with OSHA in terms of PPE. I think the more we work together as federal agencies — with both OSHA and CMS being the ones that can regulate the better it will be for everybody. The more that we are aligned and having the goal of protecting workers and patients the better we are going to be."
Providing a compelling backdrop and potential political momentum is Ebola, which has brought more national attention to infection prevention and occupational health issues in U.S. hospitals since the emergence of HIV in the 1980s. The CDC is trying to translate the intense reaction to Ebola to other HAIs, but the emotional response will be difficult to generate even for infections like Clostridium difficile that kill many more people in the U.S. annually than Ebola ever will.
"The fear is not going to be there, but at least what [Ebola] has revealed is that infection control in U.S. hospitals is not as good as we would like it to be," Cardo says.
Editor’s note: Questions and comments about the infection control survey may be submitted to CMS via email to: [email protected]
- Centers for Medicare and Medicaid Services. Hospital Infection Control Worksheet. Nov. 26, 2014: http://go.cms.gov/1B6NCSV
- Agency for Healthcare Research and Quality, Rockville, MD. 17 Percent Reduction in Hospital-Acquired Conditions. December 2014: http://www.ahrq.gov/news/newsroom/speech/sp120114.html
- Government Accounting Office. Health-Care-Associated infections in Hospitals: Leadership Needed from HHS to Prioritize Prevention Practices and Improve Data on these Infections. 2008: http://www.gao.gov/products/GAO-08-283
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