Ten Medication Safety Deficiencies to Avoid During Inspections


Here’s how not to get dinged during the next visit from your state health department, accrediting agency or the DEA.

There are a dizzying amount of medication safety requirements and best practices you are expected to comply with every day.

Must-watch areas

Here are the most-cited deficiencies by surveyors, inspectors and regulators, and suggestions on how to prevent them from a pharmacy consultant to more than 200 ambulatory surgery centers in 13 states.

Failure to document receipts for controlled drugs. Receipts from wholesalers for Schedule II controlled drugs from wholesalers must be documented in the column specified DEA Form 222 and on the Controlled Substance Ordering System form, according to Sheldon S. Sones, RPh, FASCP, president of Sheldon S. Sones and Associates and a member of Outpatient Surgery Magazine’s editorial board. Facilities must keep these records for three years, or as otherwise governed by the regulations in your state.

Using single-dose medications for more than one patient. Anesthesia providers must be especially attentive to this issue, which Mr. Sones called a “basic expectation.” Drugs including esmolol, propofol and “the caines” anesthetics all come in single-dose and multiple-dose vials. While they look the same, the single-dose vials are clearly marked as such.

“Single-dose vials often have 20 CCs of a medication in it, but a provider might only need to administer 3 or 5 CCs to a patient,” notes Mr. Sones. “Even though there is medication left, the single-dose medication doesn’t have preservatives or antimicrobials in it, so providers have to heed the markings on the vial and not use it for more than one patient because of the risk of the spread of infection.”

Failure to adequately label medications drawn into syringes. Compliance with this practice is lower than providers’ awareness of it, says Mr. Sones. An anesthesiologist should not draw clear liquids into five or six syringes for use later in the day and place them in a counter or a drawer without labeling them. “All the surveyors look for this,” he says. “You have to identify the contents of the syringe, the strength of the dose, the date and include the initials of who drew it up.”

This does not apply to injections that are given in emergencies or other situations where the medication is administered immediately after it’s drawn into the syringe.

Inadequate witnessing of discarding partial doses of controlled drugs. This is non-negotiable in the eyes of the DEA. If you draw up 100 micrograms of fentanyl but only use 50 micrograms, for example, the remainder has to be discarded into a disposal receptacle designed to render it irretrievable. “That discard has to be witnessed by a colleague in real time,” says Mr. Sones. “If you simply say to the DEA that it was disposed of, but wasn’t witnessed, it’s going to be a bad meeting.”

PREVENT DIVERSION There are many drug-disposal devices on the market that operate differently, but all render discarded medications unusable.

Deficient attentiveness to patient allergies. It’s important that a thorough allergy declaration is in every patient’s chart that includes the manifestations of the allergies. This assists in the assessment of the significance of the side effects of a potential allergic reaction and obviously helps to ensure that drugs aren’t ordered that could trigger an allergy. Some anesthesia teams and nurses place a sticker on the front of a patient’s chart denoting the allergy.

Outdated drugs placed where they could be used. It’s easy for a surveyor to check the expiration dates of your drug supply to see whether your medications are in-date. This is a simple issue that nonetheless plagues some facilities, says Mr. Sones, and the problem is exacerbated by the inconsistent ways drug companies list their expiration dates.

“Some companies list the date, such as June 1, 2024, while others simply will list June 2024,” he explains. “For that reason, we suggest that staff review their stock in midmonth for the upcoming month to ensure nothing will be expired.”

Flawed controlled drug trail. Most ASCs Mr. Sones works with do not have automated storage cabinets and dispensing systems. In lieu of such a system, anesthesia providers should have to sign a form at the start of the day indicating how much of each medication he’s been given for the day. They should also sign a form at the end of the day when they return any unused medication.

“Undeniably and unfortunately, we have diverters,” notes Mr. Sones. “So it’s a major flaw in the trail of control if the doctor who takes those drugs into the OR doesn’t sign for them.”

Commingling similar medications. Different dosages of the same medication should never be stored next to each other in storage areas or on anesthesia carts, says Mr. Sones. If a patient were supposed to be given 0.4 mg of atropine but was given 1 mg instead, the consequences could be catastrophic. Storing by medication type but not clearly separating the different dosages creates an environment that is fertile for errors.

Poor medication security practices. Surveyors expect that you are denying access to medical carts and medication storage rooms to anyone who is unauthorized to access them. It’s a hit on a survey if they walk into an OR, and they can open the drawer of the anesthesia cart and have access to syringes in there.

Also, make sure to lock the cabinetry inside of your medication storage room at the end of the day so no one can access it overnight.

Inadequate medication refrigeration management. Years ago, the only way to know the temperature of a medication refrigerator was to stick a thermometer inside it. Today, a $100 device can transmit ongoing temperature report to your phone or computer. Having the refrigerator hooked up to a backup generator is another way to prevent having to throw out thousands of dollars of medications because they weren’t stored between 36 to 46 degrees for a significant period of time.

Finally, Mr. Sones urges facilities to be consistent. One ASC he works with asks him to come in monthly to check on operations and he says the outcomes there are consistently stellar. “Facilities that want to do the right thing in terms of patient care get the fringe benefit of doing well on survey’s he said. “The best ones realize that yesterday’s home runs don’t win today’s games. You must remain on the tips of your toes because everything is a moving target.” OSM

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