CMS SOM App. H, Tag V143

§494.30(b)(2) - Ensure that clinical staff demonstrate compliance with current aseptic

techniques when dispensing and administering intravenous medications from vials and

ampules; and

Interpretive Guidance § 494.30(b)(2)

Safe injection practices are critical to prevent transmission of infections in the dialysis setting.

Medication administration from vials, ampules, and bags is common during dialysis and

therefore increases the potential for unsafe and inappropriate injection practices.

Opened multiple-dose vials should be handled aseptically and used and discarded in accordance

with the manufacturer’s set time frames and/or other accepted standards for use (e.g., US

Pharmacopeia). Staff preparing medications should clean the septum of any multi-use vial with

alcohol before inserting the needle and the injection port before using the port to administer a

medication.

Facilities may not fill syringes with saline from the single dose saline bag or IV tubing connected

to the patient at the dialysis station.

When saline syringes are required for vascular access care or to flush medications, facilities

should obtain syringes pre-filled with sterile saline from a manufacturer, Food and Drug

Administration (FDA)- registered outsourcing facility, or pharmacy whenever possible.

If pre-filled syringes are not available and the facility needs to use alternative procedures to

secure saline flushes, the following safe injection practices should be considered :

• Syringes with sterile saline for an individual patient are filled in a dedicated clean

area removed from the patient treatment area. Although not required, a clean room

separate from the patient treatment area is the preferred location.

• Prepare syringes for an individual patient as close as possible to the time of

administration to prevent compromised sterility or stability.

• Use aseptic technique for disinfection of saline vials prior to entry and follow the

suggested standards from the Association for Professionals in Infection Control and

Epidemiology (APIC) and the Institute for Safe Medication Practices (ISMP) when

preparing saline flushes, including:

o Medication containers labeled single-dose or single-use (e.g., saline bags, single

dose vials, ampules) may not be used to prepare more than one syringe for

vascular access care or to flush medications.

o Any unused saline in the opened single-dose or single-use container must be

discarded and may not be stored for future use on the same patient.

• If multi-dose vials are used to prepare saline flush syringes, they must be dated upon

opening and discarded within 28 days unless the manufacturer specifies a different

date for that vial. The beyond-use date should never exceed the manufacturer’s

expiration date.

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The facility must have a mechanism in place to ensure expired medications are not available for

use.

Resources: Medication Preparation; Medication Administration; FAQs for Single-dose/Single-use Vials; FAQs for Multi-dose vials; Injection Safety Checklist for Outpatient Settings.