Even as CMS makes a bold push into regulating antibiotic stewardship programs, the agency is inspecting hospitals and finding common, recurrent problems.
In particular, hospital infection control programs are not always following the manufacturer’s instructions for the use and cleaning of devices and they are often not in compliance with their own written policies, says Karen Hoffmann, RN, MS, CIC, FSHEA, infection prevention consultant at the CMS.
Hoffmann updated the inspection findings recently in Charlotte, NC, at the APIC annual meeting.
“Again, all of the manufacturer’s instructions have to be followed,” she says. “No matter what you say, [unless] you have something from the manufacturer that gives you a personal waiver from following the instructions.”
CMS and its state inspectors will first verify if you have an active and effective surveillance program in place, and evaluate if the program is meeting the needs of patients and staff throughout the complex
“That should be a question they are asking,” she says. “How are you doing that?
State agencies and other deemed authorities inspecting for CMS typically arrive unannounced and immediately begin an impromptu tour with a critical eye.
“State agencies will often do a walkthrough immediately upon arrival, and what they are looking for is a sanitary environment,” Hoffmann says. “That’s just the way they do their survey process. They are looking for those ‘oops’ things going on before you can put out a warning that a state agency is in your facility. If they see some practice that looks out of whack, that’s when they will want to see your policy. They will interview the staff and they might interview patients or residents. They will really look hard at issues of isolation precautions, injection safety, and the cleaning [of the] environment.”
It wasn’t always this way. CMS is continuing a startling transformation from benign payer to infection prevention enforcer. The flashpoint for this metamorphosis came in 2008, when CMS inspectors visited a Las Vegas endoscopy clinic but failed to notice the flagrant reuse of single-dose vials and other needle safety violations. After tens of thousands of patients had to be tested for bloodborne pathogens and lawsuits and criminal proceedings made the national news, CMS made a fateful culture change that continues today.
“They really have a mandate to provide good care,” Hoffmann told APIC attendees.
A former IP working in hospitals and public health, Hoffmann says CMS has undergone a culture change that aligns its mission more directly with IPs in terms of patient safety.
“One of the things I’ve been very impressed with is that [many employees] came from the provider side before they started at CMS, so they do — believe it or not — have a sensitivity to this,” she says. “It’s just getting everybody [together] on the latest, evidence-based guidance. That is really what we have been trying to do there the last five years. What I hear them say when there is a decision to be made is, ‘Are the [CMS] recipients at risk of care?’ They are really focused on that and it is really a quality and safety direction they have gone in.”
In doing so, CMS is bound by regulation to enforce its Conditions of Participation, meaning inspections that are currently being conducted to oversee basic aspects of infection control will soon be established for antibiotic stewardship.
Among the most frequent hospital citations currently are some aspect of a “dirty environment,” she says.
“It doesn’t say in the interpretative guidance if you have layers of dust, tape, and mold you will get a citation, but I guarantee you that is considered an unsanitary environment,” Hoffmann says.
Also commonly cited are leaking washers and sinks, holes in walls, and missing floor or ceiling tiles.
“These are not new, but they keep citing them so they must be out there,” she says. “So you need to [look for] those places.”
Reflecting lapses in clinical areas, hospitals are being cited for placing clean endoscopes in dirty bins or hanging them in a way that invites contamination. “Not within a cabinet — they are actually touching the floor,” she says. “I’ve actually seen that.”
Another frequent hospital citation is untrained staff, and inspectors still report healthcare workers using unsafe injection practices or using cleaning products inappropriately.
“They will grab the bottle and ask a housekeeper what is the contact time for this,” Hoffmann says. “How much of an area to you cover using that wipe? Those kind of ‘in-use’ questions are practical.”
Other common violations include patient care staff not abiding by basic infection control practices — “everything from hand hygiene to isolation,” she says.
Healthcare workers so frequently misuse patient exam gloves, it is one of the most commonly cited deficiencies in inspections. According to Hoffmann, the most frequent CMS citations involving gloves include the following:
- thinking double-gloving protects against puncture injury,
- not having gloves accessible in locations where they are needed/used,
- failure to clean hands after removing gloves,
- moving from patient to patient without cleaning hands and changing gloves, and
- using alcohol hand rubs to “wash” gloves rather than changing them.
When that last one drew a surprised reaction from the APIC audience, Hoffmann said, “It still happens.” In other citation trends, if your records show evidence of a “cluster investigation” or something suggestive of an outbreak, CMS inspectors will want to know how the issue was resolved.
“If you recognize a problem but can’t show documentation of a conclusion to that [discovery], that can be problematic,” Hoffmann says.
With CMS and its deemed authority accreditors like The Joint Commission being more transparent about citations and deficiencies, IPs should be well aware of the expectations, says Susan Dolan, RN, MS, CIC, president of APIC.
“I think as IPs, we are fairly aware of the issues they are seeing in other hospitals; it gives us a heads-up,” she tells Hospital Infection Control & Prevention. “I think the one area that is a common problem is disinfection and cleaning of equipment. Every individual facility should be following the manufacturer’s recommendations and your own written policies and procedures. Make sure they are evidence-based and you are following national guidelines.”
IPs can help by doing observational rounds and meeting with staff who are doing cleaning and disinfection.
“Our challenge is to make sure we have the correct policies and procedures in place, the proper training and the proper auditing and inspections,” Dolan says.
There continues to be confusion about “immediate use” steam sterilization, formerly called “flash sterilization,” Hoffmann notes.
“The bottom line is that you only can use immediate-use steam sterilization for urgent needs — [for example], you drop an instrument and you don’t have a replacement,” she says. “It can’t be done routinely.”
Other common problems are not verifying the efficacy of a high-level disinfection solution before use, and not following the manufacturer’s instruction for pre-cleaning of scopes.
CMS are particularly focusing on proper cleaning and disinfection of duodenoscopes, which have been linked to outbreaks of carbapenem-resistant Enterobacteriaceae (CRE).
“[Inspectors] will ask for the manufacturer’s instructions as well those for the automated endoscopy reprocessors,” Hoffmann says. “Then they will observe the duodenoscopes being reprocessed and ask the responsible staff to demonstrate how they are adhering to manufacturer’s instructions and any new guidance.”