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Air pressures, cleaning, and maintenance critical to sterile compounding areas

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March 1, 2019

Work with your pharmacy and infection control teams to ensure your facility’s sterile compounding area maintains the proper air pressures in the correct areas, ceilings are air-tight, and issues with cleaning, maintenance, and supply storage are addressed.

Also ensure areas are vented correctly and labeled outside so that anyone working around the vent is aware of the hazard.

Problems found connected to sterile compounding areas can — and have — lead to preliminary denial of accreditation and condition-level deficiencies, warns Jennifer Cowel, president of Patton Healthcare Consulting and a former director of service operations for The Joint Commission (TJC).

Pharmacy surveyors and many physician and nurse surveyors with The Joint Commission and CMS now have extensive training in USP <797>, the U.S. Pharmacopeia’s standard on sterile compounding, which in 2015 was adopted into Medicare’s State Operations Manual (SOMA) of interpretive guidelines on implementing the Conditions of Participation (CoP).

Among other problems within the environment of care, hospitals have been cited for:

  • Improper air pressures
  • Openings in ceilings that can allow in outside air and particulates
  • Supplies stored inside compounding areas
  • Sinks too shallow for staff to wash and rinse up to their elbows adequately
  • Cracks in the floors or other surfaces that could not be cleaned sufficiently
  • Moulding along walls that collect dust.

A year or so ago, “you probably never heard of a surveyor come through your sterile compounding area, never focused on it, never asked for things — all that has changed,” says Cowel, who offered a rundown of sterile compounding requirements for a HCPro virtual workshop last fall targeting hot spots in accreditation.

One of four TJC hot spots

Sterile compounding is one of the four hot spots TJC says it is targeting, along with high-level sterilization and disinfection, ligature risk and dialysis infection control.

“The facilities folks have a key part of the compliance puzzle,” notes Cowel—especially in maintaining air pressure relationships.

In particular, “they are responsible for making sure that the [air] from the hazardous compounding hood vents directly outside of the hospital and does not get recirculated.” She warned that the exhaust vent on the roof must be labeled as hazardous so that staff or vendors on the roof are aware of the danger.

Work with your pharmacy staff to ensure that air pressures within the sterile compounding areas are correct and provide the air quality required under International Organization for Standardization (ISO)  standards set out in USP <797>.

For instance, the high-risk compounding area with the primary engineering control (PEC) device such as a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) must have negative air pressure, meaning dirty air is kept inside the room and vented outside the building. [Examples of compounding in this area would be the handling of chemotherapy drugs.]

Compounding rooms for non-high-risk preparations as well as the anteroom where staff wash their hands and put on personal protective equipment (PPE) would have positive pressure, meaning the cleaner air goes to the dirtier air, noted Cowel during the workshop. In which she also provided a graphic illustration of the areas (March PDF on 3/4/19).

Part of Day One documents

Note that Day One documents that must be made available to surveyors now include the final reports for certification or testing of all PEC and secondary engineering controls (SEC) associated with sterile compounding areas, warns Cowel.

That should include any documentation of retesting or corrections made to problems identified in the initial testing. If done by a vendor, do not be afraid of requiring the vendor to come back and do the testing again.
Surveyors will review the PEC certification for completeness, says Cowel. And they will be specific. They may ask how air sampling is done, and it must be automated and not passive.

Certification testing should be done every six months, and when the area is moved or renovated. You must show evidence of action taken when any item out of range and subsequent testing to ensure compliance, according to Cowel’s presentation.

Resources

Examine compounding areas closely for these environmental problems

Include sterile compounding areas on your environmental rounds. Be thorough. Be exacting. You could save your facility a condition-level deficiency if you do (see March PDF).

Surveyors are now trained thoroughly in USP <797>, the sterile compounding standards set out by the U.S. Pharmacopeia and adopted by CMS in 2015, says Jennifer Cowel, president of Patton Healthcare Consulting and a former director of service operations for The Joint Commission (TJC).

Cowel provided details of what surveyors will be looking for during a virtual workshop last year for HCPro.
Those survey will examine rooms minutely, she warns. And so should you. “You’re going to be expecting perfection in certain things.” Surveyors will expect:

  • Floors that are solid, with no rips or tears, because cracks cannot be cleaned adequately. “And they will check corners for dust,” adds Cowel.
  • Ceilings must be made of solid materials. If ceiling tiles are used, they must be caulked in place. You cannot have air from the subspace above the ceiling getting into the compounding area, she said.
  • Sprinkler heads should be flush with the ceiling. If not, check for dust frequently.
  • Walls must be smooth. There can be no cracks, not even a ledge where the flooring meets the walls. Moulding has been cited as a dust collector, she says.
  • There should be a line of demarcation in the ante area, marking where staff are expected to be fully cleaned and in PPE before crossing. Many hospitals mark the line in red, says Cowel.
  • The sink should have a goose-neck faucet that allows hand and arm hygiene. It should be deep enough for staff to wash up to the elbows for at least 30 seconds.
  • Tip: Ask a staff member to perform hand and arm hygiene. If they can’t demonstrate it will work, replace the sink, advises Cowel.
  • Do not have a hand air dryer in the anteroom. It can blow particulate matter around. Provide lint-free towels.
  • Provide supply storage outside the area. Only the supplies needed for compounding use at that time should be brought in to the compounding area, says Cowel.
  • Inspect, repair or replace furniture for problems areas that cannot be cleaned or that collect dust or dirt.


Also ensure that cleaning staff are trained in the needed competencies for compounding areas, and that the training is documented, says Cowel.

For secondary engineering control areas, floors and the easily cleanable work surfaces must be cleaned daily. Walls, ceiling and shelving must be cleaned monthly.

For primary engineering control areas, cleaning must be done:

  • Beginning of each work shift
  • Before each batch preparation is started
  • Every 30 minutes during continuous compounding

If there is a spill, the surface must be cleaned if contamination is suspected.

And importantly, pay attention to mopping.

Mop heads must be unique to the space. Do not share, says Cowel. Ensure a separate mop head is used in each room, and that it is changed out every time. You must prevent particulates from being carried from placed to place, says Cowel.

If anyone complains about such thoroughness, tell them you’re not being obsessive about it, because surveyors are looking for these things. Not only are they “looking for that, they’re citing it.”




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