By Elizabeth Srejic
The Centers for Medicare & Medicaid Services (CMS) maintains systems of oversight as part of its general mission to strengthen and modernize healthcare in the United States. Monitoring systems are a crucial component in CMS’s mission, factoring into all four of its strategic goals of better care and lower costs, prevention and population health, expanded healthcare coverage, and enterprise excellence.
In 2009, the American Recovery and Reinvestment Act (Recovery Act) appropriated $50 million to the Department of Health and Human Services (HHS) Office of the Secretary to develop and implement strategies against healthcare-associated infections (HAIs) – a rampant source of societal, clinical and economic harm. CMS received $10 million of these funds which it put toward its own campaign against HAIs. Part of CMS’s campaign included enhancing its systems of oversight at the state level, which notably expanded its total surveillance network.
A few years later, in its published strategy for 2013-2017, CMS wrote, “We are focused on measurably improving care and population health by transforming the U.S. healthcare system into an integrated and accountable delivery system that continuously improves care, reduces unnecessary costs, prevents illness and disease progression and promotes health. We will find better ways to ensure that the right care is accessible and delivered to the right person at the right time, every time.”
In that statement, the stated “measurable improvements” in care; the “integration and accountability” planned for the U.S. healthcare sys-tem; the discussed improvements in care, costs, illness and disease progression; the “right care;” and the “better ways” are now all tracked and analyzed in some way by CMS to help it attain its goals.
Surveying is a form of monitoring designed to assess whether CMS’s certified providers and suppliers participating in Medicare and Medicaid – such as hospitals, ambulatory surgery centers (ASCs), nursing facilities (NFs) and skilled nursing facilities (SNFs) -- are delivering healthcare services at the required levels of quality and safety. When a facility scores well in CMS surveys, the services it offers to patients are more likely to be up to par and meet patient expectations than services offered by facilities with lower scores.
Typically, the survey process entails a surprise visit to a randomly selected institution by a qualified surveyor or “State Agency (SA),” who, after announcing his or her presence to facility administrators, randomly chooses items from the survey worksheet to assess. The premise for un-scheduled, unpredictable surveying is that the lack of warning prevents facilities from finding and correcting breaches, which skews its actual measures of performance and quality and provides a less accurate depiction of how the facility performs “on an average day.”
Although facilities that participate in Medicare and Medicaid cannot predict when a state agency will visit, they can prepare by referring to facility-specific guidelines published online by CMS. These guidelines, according to CMS, are the Medicare Conditions of Participation (CoPs), (or “Requirements” for SNFs and NFs), and the Conditions for Coverage (CfCs), which outline minimum requirements for operating healthcare entities. These stipulations include a set of “conditions,” (or “requirements” in the case of SNFs and NFs), for different types of providers and suppliers subject to certification. Each of these sets comes with an accompanying group of pertinent quality standards. Certified facilities with deficiencies identified in one or more of the subsidiary standards during any given survey are still permitted to participate in Medicare and Medicaid, but they become ineligible if found noncompliant with any of the specified “Conditions” (or insufficiently compliant with the outlined “Requirements,” in the case of SNFs and NFs). CMS states on its website: “The essence of what the SA certifies to CMS is a finding of whether an institution meets each of the CoPs or substantially meets each Requirement for SNFs and NFs applicable to it, and whether each supplier of services meets each CfC applicable to it.”
After surveying a participating facility, the SA prepares the institution’s certification, an official status report sent to the nearest CMS Regional office. If the surveyor identified deficiencies, CMS sends the surveyed institution a "Statement of Deficiencies" (Form CMS-2567) which gives the institution 10 calendar days to respond with a Plan of Correction (PoC) for each identified deficiency. Each PoC must be entered directly onto the form next to its corresponding deficiency, and corrective action must be taken within a period of time deemed reasonable. Exceeding the allotted time allowance to resolve deficiencies still results in loss of certification, despite any actions taken to correct shortcomings over that time.
According to Phenelle Segal, RN, CIC, president of Infection Control Consulting Services (ICCS), a consulting firm that helps healthcare facilities meet CMS’s minimum levels of quality and safety, “CMS developed a surveying technique as a screening tool and assigned each state and health department the responsibility of appointing and providing surveyors to assess certified suppliers and providers participating in Medicare and Medicaid,” she says. “Surveyors randomly choose facilities and show up unannounced, on any given morning on any day of the week, and after speaking with facility administrators begin the survey process. The survey process is very individualized; no specific agenda is followed; it all depends upon the surveyor, the facility and the state. So although surveyors use an official checklist – or surveyor’s worksheet – he or she ultimately chooses which areas will be surveyed, and the results are subject to the surveyor’s interpretation, preferences and techniques. And, since CMS surveys can also be influenced by particulars of the state or the healthcare facility, CMS surveys are essentially alike but not uniform.”
Although CMS surveying could potentially be a stressful experience for facilities still working on their compliance and standards, it is a necessary part of a valuable trend throughout the healthcare industry: using surveillance. Monitoring systems are an effective tool for assessing, enforcing and tracking variables of interest, at federal level through the facility level to individual healthcare workers (HCWs). Studies not only demonstrate that surveillance is an important tool in modern healthcare, but indicate that using a combination of surveillance methods is the best way to maintaining minimum standards of compliance, accuracy, quality and safety, and keep an eye on observed trends.
A diverse array of monitoring solutions are currently available, ranging from low-tech solutions like handwritten logs to high-tech methods such as third-party video assessment and LED displays that broadcast real-time statistics. Surveillance systems also differ markedly in magnitude, from nationwide surveillance at the federal level to monitoring on a smaller scale, such as individual HCWs or minute environments.
Many contemporary healthcare problems pertain to infection prevention and control practices; for example, the rising incidence of healthcare-associated infections (HAIs) and intractable infections caused by emerging superbugs are two worrisome infection-related challenges faced in modern medicine. The spread of disease also has considerable impact on a smaller scale, as with local norovirus or influenza outbreaks, particularly when they occur within susceptible communities like nursing homes.
Most institutions monitor and enforce specific factors outlined in their facility-specific infection prevention and control plans; a multitude of methods are used to keep track of these factors, such as monitoring and feedback, real-time reminders, environmental testing and video surveillance. The importance of these individualized infection prevention and control plans, achieving published standards, complying with regulations, following specified protocols, and monitoring any other facility-specific techniques, precautions, procedures, technologies, measures or ideals, is not limited to humanitarian reasons; maintaining and following these plans also indirectly helps facilities to prepare for a CMS survey, which generally examines at least one indicator of how well an institution limits communicable disease.
According to a study published in the Journal of the American Medical Association (JAMA), lapses in infection control are common in CMS surveying. For example, among a sample of ASCs in three states, 67.6 percent had at least one deficiency in infection control, and 17.6 percent had lapses identified in three or more of the five infection control categories in CMS surveying. Common lapses included using single-dose medication vials for more than one patient, failing to adhere to recommended equipment reprocessing practices, and incorrectly handling blood glucose monitoring equipment.
According to Segal, ICCS more recently identified the top five infection prevention and control lapses identified during CMS surveying by gathering and analyzing new data on CMS survey deficiencies from CMS-participating facilities.
The first of these five frequent deficiencies is failing to adequately check whether the designated infection control officer has the necessary qualifications for the role. Infection control strategies are typically created and implemented by specialists carrying the Certification in Infection Prevention and Control (CIC®) credential. In addition, a qualified infection control officer should have the necessary experience and participate in ongoing education and training in order to be eligible for such a position.
According to Segal, ICCS noted that these types of deficiencies were common, and successfully remediating them appeared to be relatively challenging.
The second deficiency most often seen is failing to assess, identify, and control facility-specific risks that could negatively influence or prevent successful infection prevention and control. This risk assessment must be consistent with professional standards set forth by any of the official 24 certifying medical specialty boards – particularly in regard to standards surrounding surgery and infection control.
“Surveyors are typically very interested in the operating room, in general,” Segal says. “They often follow patients into the operating room, an area usually of great interest as the busy, riskier operative environment allows for an increased likelihood of infractions, and continue to follow the patient throughout subsequent post-operative phases – following the patient along his or her treatment itinerary is called a tracer – a typical tracer involves following the patient from the moment the patient literally comes in = through the doors of the OR through the moment they arrive at the intensive care unit (ICU) or are discharged.”
The third most common deficiency is failing to adhere to the “Guidelines for Surgical Attire” published by the Association of perioperative Registered Nurses (AORN) in 2015. Common violations include not tying masks tightly enough to mitigate the risk of transmitting microbes from the mouth and nose and not covering all personal clothing with surgical attire when in semi-restricted or restricted surgical areas which are not always correctly identified by personnel. Although undergarments such as T-shirts with a V-neck -- and shirts with sleeves which can be contained underneath the scrub top -- may be worn, personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn, and scrubs must be laundered by an approved company or home laundering. Other common violations concern head and facial hair, including sideburns and the nape of the neck, which should be covered when personnel enter semi-restricted and restricted areas; in addition, a clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn.
The fourth deficiency most often seen includes central processing failures such as inappropriate instrument packaging, particularly in the case of peel pouches; hinged instruments not opened wide enough; clean supplies stored in same room as sterile supplies and inadequate monitoring of the environment in the central processing department.
And the fifth and final deficiency identified by ICCS includes infractions in endoscope reprocessing caused by non-adherence to the official standards and guidelines. Moments of inadequacy or non-adherence most commonly occur when endoscopes are transported from procedure to process rooms, involve temperature and humidity monitoring inside the decontamination room, surround the soaking phase in manual high-level disinfection practices that incorporate soaking, and pertain to personal protective equipment used by employees in the decontamination room.
Segal agrees that the surveying process can potentially involve any member of the healthcare team, meaning that HCWs can directly influence survey results. The impact of personnel is particularly influential in the infection prevention and control portion of CMS surveying, she said, since surveyors commonly ask HCW questions about infection prevention and control.
“A surveyor may stop a HCW randomly in a nursing unit or clinical area and ask a question pertaining to infection prevention and control. Do they know the “dwell time,” or how long a wet disinfectant wipe must sit upon a surface while wet, in order to achieve full results? They’ll randomly question staff about anything and everything, so HCW have to be prepared – they have to talk about hand hygiene, cleaning the healthcare environment, appropriate cleaning and disinfection of items and instruments, and more.”
Above all, Segal acknowledged that each HCW – and all of the other members of personnel who choose to participate in operating an active healthcare facility subject to CMS surveying, can be held accountable for anything in their individual compendium of education, training, skills, standards, guidelines or other competencies. However, in preparing for CMS surveying, the healthcare team should keep their focus on the fundamentals.
“Personnel in facilities subject to CMS surveying should base their planning, practicing, and other preparedness efforts on nationally recognized, official standards and regulations,” she says. “I think it’s extremely important to keep those in mind.”
Elizabeth Srejic is a freelance writer.