Injection safety issues related to the improper use of needles, syringes, and vials continue to put patients at risk of bloodborne and bacterial infections in ambulatory care clinics and outpatient surgery centers.
Though numerous outbreaks have occurred over the years, accreditation surveyors are still finding basic lapses that put patients at risk of infections that may go undetected unless they occur in a cluster.
“The earlier that a potential outbreak is identified and investigated, the better,” says Joseph Perz, DrPH, MA, an epidemiologist who has investigated numerous injection safety outbreaks at the CDC. “The flip side of that is that unless you have a large outbreak with a large number of cases, sometimes it’s hard to use the statistical methods and analytics that empower us to get to a definitive root cause.”
Perz spoke at a recent CDC webinar that featured an inspector’s eye view of ambulatory settings as described by Pamela Dembski Hart, BS, MT, ASCP, CHSP, founder of Healthcare Accreditation Resources in Plymouth, MA.
“Primarily, I work with ambulatory surgery centers, which include anything from pain management, endoscopy centers, oral surgery centers, cosmetic, and internal medicine,” Hart says. “This is actually my view of what I witness when I’m on site.”
Hart walked through a sobering set of slides and photos of clear violations of injection safety in various settings, beginning with an ambulatory surgery center that had pre-drawn syringes and multi-dose vials in the same area where they are about to be administered.
“I’m careful about having a discussion in front of other people, patients, et cetera,” she says. “So when the opportunity arises, I explain that this is a direct violation of CMS requirements, CDC recommendations, and also the most current APIC paper that came out January 2016, [which] specifically stated that multi-dose medication vials used for more than one patient must be stored [and] labeled appropriately. They should not enter the immediate patient care area.”
In several outbreaks investigated by the CDC, reuse and improper reentry into vials was shown to contaminate the medication, setting up a scenario of cross-transmission of hepatitis C and other pathogens if small amounts of blood are aspirated into the vial.
“We try to discuss this in detail,” Hart says. “Again, it’s a case-by-case basis. It depends on the individual. Sometimes they say, ‘yes, absolutely, thanks for telling us.’ They’re positive. But I have heard probably too frequently that a partition will be put up or they will use a different room when the surveyors or an accrediting body comes to inspect.”
Citing other examples of what she commonly sees, Hart showed a photo of a controlled substance narcotics in the same area as other medication vials. Another example was a single-dose vial used on multiple patients at a pain clinic. The vial label read, “Discard unused portion. One procedure only.”
“It is a myth that 50ml vials are intended for more than one patient,” she says. “The fact is that the label clearly states otherwise. And when I had this discussion at the pain management center, they were unaware.”
Red Flags
Hart sometimes sees pre-filled syringes of varying volumes, raising a red flag of possible reuse.
“[Here are some] IV bags — several of them had been pre-spiked,” she says about another site visit. “Some were stored in a closet on the floor. Some were hanging. They said they could be used weeks later.”
Another common problem she finds is inconsistent labeling and use of medication beyond expiration dates.
“We had expired meds in this area, but the bottle on the right shows only one date,” Hart says, explaining a shelf of medications. “When I asked what that meant, they did not know. I said, ‘Is that an expire date? Is that a prep date?’ I’d like to use ‘beyond use date’ or a BUD because then I know it’s a no-brainer. If there’s a BUD and it says 5-1, that bottle should not be there on 5-2.”
Similarly, some medications contain no preservatives and should be disposed within a short time period after opening, but are sometimes found opened and undated in some facilities, she says. To address such issues, Hart helps facilities set up medication cart checklists and other ways of sorting and identifying medications and vials.
“The solution is multifaceted,” she says. “You need management commitment. All staff have to actually support that the criteria is implemented, but it comes from management. I find often that the people that are more the first-line preparers, workers, clinical staff — they understand this, but they don’t get the support to implement it. Everyone needs to be trained initially, annually, and as needed.”
A good approach is training staff about incidents that have been found in similar facilities, many of which have been investigated by the CDC.
“This isn’t meant to be punitive, but we need random and unannounced surveys,” she says. “Competency exams are a must for license renewal. We cannot turn our back on safety. We took a vow: First, do no harm.”
