Unannounced CMS infection control inspections go nationwide in 2012

'We are asking the question: What is the hospital doing to prevent these infections?'

By Gary Evans, Executive Editor

An unannounced inspector from the Centers for Medicare and Medicaid Services (CMS) walks into the hospital and summons the infection preventionist. Looking down at a clipboard, he asks: "What were the last two hospital acquired infections that were serious preventable adverse events in the hospital, [meaning they caused] patient harm or death following development of the infection? What was done about each?"

Prepare now, because this is coming. Those questions and a slew of others are contained in a CMS draft document called "Acute Care Hospital Infection Control Tool for Surveyors" obtained by Hospital Infection Control & Prevention. As we previously reported in our July issue, the largest payer of health care in the country is rapidly developing a national inspection program for infection control in hospitals.

There are the inevitable concerns and caveats, as hard-pressed IPs face increasing scrutiny from yet another regulatory agency. No stranger to these real-world concerns, a veteran IP nevertheless made the big-picture point that puts the flurry of CMS initiatives in hospitals and — most recently — dialysis centers in perspective.

Russ Olmsted"It certainly is good for patients," says Russ Olmsted, MPH, CIC, an infection preventionist at St. Joseph Mercy Health System in Ann Arbor, MI.

The draft survey for CMS inspectors is being trialed in 10 states, Washington D.C. and Puerto Rico. The tool will be refined as warranted based on the evaluation, with the final product expected to debut in all 50 states in October 2012. The CMS has created a survey tool for a sweeping assessment of infection prevention, using a patient tracer approach similar to the Joint Commission to follow key issues through the care process. The pressure is on, but infection preventionists who pivot toward this initiative by reviewing the CMS expectations — and making hospital senior administration well aware of them — are poised for empowerment.

"It certainly has the potential for that," says Olmsted, the 2011 president of the Association for Professionals in Infection Control and Epidemiology. "The good news is that it's consistent with Joint Commission requirements, but also it will be highlighting infection prevention practices in the acute care setting. It's certainly very detailed. I was really impressed with the scope of this."

Despite the breadth of the assessment, all the measures and expectations fall under CMS authority in its standard: 42 CFR 482.42 Condition of Participation (CoP): Infection Control.

"It's built on the CoP for acute care hospitals — the foundation for it is already well established," he says. "It looks at a number of key areas that include safe injection practices and hand hygiene. It includes quite of bit of detail on the prevention practices pulled from CDC guidelines. It's pretty good in that sense. I will say it looks like it is moving along that similar trajectory [as other CMS initiatives]. CMS really is adopting CDC guidelines in terms of infection prevention."

The long arm of the law?

Indeed, though CMS officials seem somewhat reluctant to say it quite that directly, the agency is essentially codifying the voluntary infection control guidelines by the Centers for Disease and Prevention. The agency was involved in creating the CMS survey questions and the draft document is under review by the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC). Though the CMS may be wary of being perceived as the "infection control police," there is growing national impatience with the status quo of strictly voluntary guidelines in a new era of patient advocacy and healthcare reform.

Karen Hoffmann"The questions from the tool were primarily chosen from the CDC guidelines as well as other nationally recognized guidelines such as the AORN," explains Karen Hoffmann, RN, MS, CIC, infection prevention specialist at the CMS and one of the principals behind the survey program. "These guidelines of course are generally recognized as standards of practice. They won't be any big surprise to the infection preventionists. We created this set of questions and tools to reflect all areas of the hospital."

Asked if there were nevertheless some elements of a dreaded "unfunded mandate" in all this, Hoffman emphasized that the CMS expects administrative support for the IPs facing the inspectors and their questions.

"Hospital administration plays an important role in infection control with administrative support and financial resources to make infection control an institutional priority [and] really to see that the measures on this tool are actually in place and implemented," she tells HIC. "I don't think that this is going to create a burden or a problem. In actuality, it is going to be a real asset to them — used as a self-assessment tool. It represents the minimal standards of infection control practice."

Still, the process outlined in the CMS survey is anything but cursory, calling for two surveyors to do a thorough review that is expected to take two days. Moreover, the draft survey instructions encourage inspectors to "drill down" on identified problems and look for deficiency patterns across units and practices.

"This might include widening [inspection] scope, conducting additional staff or patient interviews, making additional observations, and/or reviewing policies, procedures, additional records or other pertinent documentation," the CMS survey advises inspectors. "For example, hand hygiene concerns noted while observing patient treatment or health care worker activities should prompt the team to widen the scope of review related to hand hygiene. Is this a concern on other units? Are competencies related to infection control practice documented and up to date in personnel files? Do hospital policies and procedures reflect current practice in the hospital, i.e. is the hand hygiene concern limited to one practitioner or broadly to hospital infection control processes and systems? Surveyors are not limited to the use of the tool and are encouraged to use their judgment and survey expertise in assessing infection control compliance."

Attacking a longstanding problem

The onsite, random survey follows a flurry of other CMS reporting and pay-for-performance initiatives aimed squarely at the longstanding problem of health care associated infections (HAIs). For example, in order to receive full CMS Medicare payments in 2012 dialysis facilities must submit three months of data on infections and antibiotic use to the CDC's National Healthcare Safety Network. The aggressive CMS agenda is part of broader federal public health efforts including the Department of Health and Human Services (HHS) national "Action Plan to Prevent Healthcare-Associated Infections." In addition, the recently formed broad collaborative dubbed the Partnership for Patients has the stated goal of decreasing healthcare acquired conditions by 40% in the next two years. With HAIs comprising a major portion of those events, the CMS seeks a dynamic new approach to infection prevention.

"We want to focus more on the bedside — on the patients and procedures — than has been done in the past," says Daniel Schwartz, MD, MBA, chief medical officer of the CMS Survey and Certification Group. "We don't want the surveyors sitting in a room scouring through policies and procedures for four to six hours."

In that regard, the CMS instructs surveyors to trace and observe patient care during an entire episode of care.

"Those patient tracers are meant to emphasize some of the HAIs that are mentioned in the HHS action plan — MRSA, C. diff and surgical site infections," he tells HIC. "We want the surveyors out looking at how the hospital is trying to prevent those infections from being transmitted. That's kind of the change here. We are asking the question: What is the hospital doing to prevent these infections?"

The survey tool describes the patient tracing component as follows:

"During a surgical procedure or endoscopy, the surveyor should follow the patient through the pre-procedure holding area, into the operating room or endoscopy suite, and then into the post-procedure holding area," the document reads. "For a radiology test, such as a CT scan, the surveyor should be present at the patient's room when the patient is transported to the radiology department and then remain with the patient as they are returned to their room. If a patient on contact precautions must have a test done in a location other than their room, the surveyor should be present as the patient is taken for the test and as they are returned to their room. This allows the surveyor to assess infection control and prevention of infection transmission in all locations and by all healthcare personnel involved in that episode of care."

In addition, the CMS is distributing the survey tool to the Joint Commission and other accrediting organizations, meaning the same approach and similar questions may be asked during an accreditation survey typically done every few years to deem CMS condition of participation status.

"They are certainly welcome to use the tool although there is no requirement that they do so," Schwartz says. "The [CMS inspections] are unannounced."

At least at this juncture, the program is more of a consultation and no penalties or citations are expected to be levied. "The only things that we would cite them for is if 'immediate [patient] jeopardy' is seen," he says. "We certainly couldn't ignore that."

Again, all aspects of the survey and inspection process reflect requirements and expectations already in place in the CMS conditions of participation, he emphasizes.

"The health and safety standards have not changed so this really should not be a burden on the hospitals," he says. "The expectation here is that they are paying attention to infection control and infection prevention in their facilities. This is just a way for the surveyors to best assess that condition of participation."

After the testing phase and survey revisions, CMS surveyors will begin training in earnest before flanking out to the nation's hospital infection prevention programs. "We're planning in-person training in Baltimore probably in the March [2012] timeframe," Schwartz says. "After the training this [will expand to] all 50 states. We are going to ask each state to use each tool at least once by the end of the fiscal year 2012."

CMS plays 20 questions: Know these answers

A draft hospital inspection tool developed by the Centers for Medicare and Medicaid Services (CMS) instructs surveyors to ask infection preventionists the following questions. The objective of the survey is to "broadly assess the infection control program and systems in the facility; evaluate communications structure(s), program processes, supporting systems, and the integration between the Infection Prevention and Control program and other key hospital programs."

Questions

  1. Please tell me about the IC program from a process perspective i.e. how do you learn about specific cases of hospital associated infections, patients needing isolation precautions, unsanitary conditions etc., and what processes do you follow to track and address these concerns?
  2. Please tell me about the Infection Prevention and Control program structure.
  3. How is your (IC) time organized in a typical workweek?
  4. Tell me about the process for development of the infection control plan including when and how often is it developed, is it based on a risk analysis, who participates in its development, who approves the plan, when is each plan effective?
  5. Tell me about ongoing infection control activities that you monitor that are not linked to the QAPI program.
  6. Who participates in the development of infection control program related policies and procedures and who approves new policies or updates?
  7. How do you ensure that the hospital environment is sanitary?
  8. What systems and processes does the hospital use to ensure each of the following:
  • Prevention of infections and communicable diseases
  • Investigation of infections and communicable diseases
  • Control of infections and communicable diseases.
  • Tell me about the infection control log, i.e. what goes into the log and how is it utilized within infection control program activities?
  • Tell me about the following systems dealing with infections and communicable diseases (whether hospital acquired or not):
    • Systems for identifying infections and communicable diseases?
    • Systems for reporting infections and communicable diseases?
    • Systems for investigating infections and communicable diseases?
    • Systems for containing and controlling infections and communicable diseases?
    • What is the screening process for patients presenting in the ED and for new admissions
    • What is the bed management process for patients placed on an isolation status?
    • What is the hand-off process to communicate isolation status and is that hand-off process consistent throughout the hospital?
  • How are healthcare personnel (HCP) trained in infection control systems, processes, practices, strategies? —How often —Competency assessments? —Documentation?
  • Tell me about the communications systems between the infection control program and QAPI?
  • Looking at the facility layout, which areas are not included in Quality Assessment and Performance Improvement (QAPI) activities related to infection prevention and control? Ask as open ended first, and then ask about specific areas.
  • What are the infection control related QAPI indicators for select units and service areas? (Include outpatient services and contract services)
  • Is the hospital tracking the infection prevention/control quality indicators in contract areas (if applicable)?
  • Tell me about infection prevention/control patient safety activities.
  • What were the last two hospital acquired infections that were serious preventable adverse events in the hospital (i.e. patient harm or death following development of the infection).
  • What was done about each of the last two serious hospital acquired infections?
  • Describe the antibiotic stewardship program, if one exists, and efforts to prevent MDROs.
  • Tell me about infection prevention/control training process for non-paid staff, environmental staff, and clinical staff i.e. how often, how much is covered, and are competencies assessed and documented in personnel files or elsewhere?

  • A snapshot of the CMS inspection program

    A draft inspection tool for hospital infection control developed by the Centers for Medicare and Medicaid Services (CMS) includes the following key elements.

    42 CFR 482.42 Condition of Participation (CoP): Infection control: The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

    (a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases.

    (1) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

    (2) The infection control officer or officers must maintain a log of incidents related to infections and communicable diseases.

    (b) Standard: Responsibilities of chief executive officer, medical staff, and director of nursing services. The chief executive officer, the medical staff, and the director of nursing services must—

    (1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and

    (2) Be responsible for the implementation of successful corrective action plans in affected problem areas.

    The survey: This Infection Control Tool provides a new survey structure for assessing hospital compliance with the Infection Control CoP. Use of the tool should not replace the important critical thinking skills that surveyors use in the full and comprehensive evaluation of each hospital's infection control program, and is not intended to limit survey process. If surveyor's observations raise concerns, they can widen scope, review medical records, review policies and procedures, and/or conduct additional interviews to deepen their level of inquiry in order to assess potential infection control deficiencies.

    Use of the tool can improve the CMS survey process by standardizing the approach, providing a consistent, evidence-based framework for focused surveyor observations, and standardizing and simplifying important survey documentation. The pre-test period is intended to evaluate the efficacy and ease of use of the tool, use surveyor feedback and input to improve the tool, and determine its impact on the hospital's infection control efforts. Your participation in the pretest involves change that can be difficult and a new survey process that is structured. It does, however, provide an opportunity for you to give your opinion on how to make this tool a welcomed addition for your colleagues when it is finalized.

    Modules and sections: The questions are organized into sections (e.g. hand hygiene) and the sections are organized into Modules (e.g. Critical Care Module). The modules and sections are designed and organized to assist surveyors in the assessment of compliance with the CMS infection prevention and control requirements. Some sections that are labeled "tracers" are meant to highlight specific procedures or activities that can cause infections.

    These "tracers" include questions concerning hospital prevention activities for CAUTI (catheter associated urinary tract infection), SSI (surgical site infection), CLABSI (central line associated blood stream infection), and VAP (ventilator associated pneumonia). This is not an exclusive list of HAIs that hospitals should address in their programs. Hospital infection prevention and control programs must also include provisions to address other infectious disease such as MRSA, Clostridium difficile, hepatitis, TB, and influenza.

    Five Modules:

    1: Program Scope and Design

    2: General Location

    3: Critical Care

    4: Invasive Procedures

    5: Environmental Services and Sterile Reprocessing

    • Note that Modules 2, 3, and 4 include the same initial nine sections (hand hygiene, injection practices and sharps safety, environmental cleaning, personal protective equipment, point of care devices, noncritical device reprocessing, single use device reprocessing, urinary catheter tracer, and central line tracer).

    Survey Process: After the entrance conference and hospital tour, one surveyor begins the interview process using Module 1 (suggested "open ended" questions) and the other begins to complete Modules 2-5. With guidance provided in Module 1 of the tool, surveyors evaluate the infection prevention and control program (based primarily on interview and review of documentation) including:

    • Infection control/prevention program and resources

    • Systems to identify, report, investigate, and control communicable disease and infection

    • Systems to control transmission of MDROs, promote antibiotic stewardship, and surveillance

    • Personnel education system/infection control training


    CMS questions for employee health

    For the infection preventionist who also covers occupational health, the draft hospital inspection guideline by the Centers for the Medicare and Medicaid Services (CMS) includes an evaluation of employee health programs. The CMS survey tool lists these discussion points and questions to ask employee health professionals and education directors:

    • Tell me how health care workers are trained in infection control systems, processes, practices, and strategies? (How often; Competency assessments; Documentation)
    • Tell me about the hospital system for identifying and addressing employee exposure events including blood-borne pathogen exposure events, needle-sticks, and other sharps incidents.
    • Tell me about the hospital system for addressing employee post exposure evaluation and follow up.
    • Tell me about the hospital system for tracking and trending health care worker infection exposure events.
    • Tell me about the system in place for providing Hepatitis B vaccine to health care workers? What personnel are excluded? Are non paid personnel screened?
    • Tell me about the system in place for screening and addressing tuberculosis.
    • Tell me about the system in place for respirator fit testing and storage/availability of respirator equipment.
    • Are HCP offered annual influenza vaccine and does the hospital track success rates for HCP ho get the vaccine?
    • Tell me about the system in place for respirator fit testing and storage/availability of respirator equipment.
    • Are HCP offered annual influenza vaccine and does the hospital track success rates for HCP who get the vaccine?
    • Tell me about infection prevention/control training process for non-paid staff, environmental staff, and clinical staff i.e. how often, how much is covered, and are competencies assessed and documented in personnel files or elsewhere?