MODIFIERSJW AND JZ AND SINGLE- AND MULTI-USEVIALS

https://www cdc gov/injectionsafety/providers/provider faqs singlevials html

?Vials that are labeled as single-dose or single-use should be used for only a single patient as part of a single case, procedure, injection There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients [3,6?9].

?Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient ? ?

The Joint Commission surveys many facilities for compliance with the Medicare Conditions of Participation. They survey effective processes and procedures for infection control, one of which provides that hospitals should have a policy that single use vials should be used for only one patient: https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/sentinelevent/sea 52 pdf

Effect ive processes and procedures

1. Develop and implement effective evidence-based organization-wide standardized policy and procedures for the prevention of the misuse of vials The policy should apply to all staff who administer injections to patients, and should address the following:

Single-dose/ single-use vials Mult iple-dose vials

- Use a single-dose/single-use vial for a single patient during the course of a single procedure. Discard the vial after this single use; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etcThe One & Only Campaign from the CDCand Safe Injection Practices Coalition emphasizes ONEneedle, ONEsyringe, ONLYONE time Medications in single-dose/single-use vials lack antimicrobial preservatives and are therefore at greater risk to become contaminated and serve as a source of infection when used inappropriately. See campaign resources, including video

- If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of dosage, use a new needle and new syringe for each entry.21 Note: USP797 states that single-dose/single-use vials opened in less than ISO Class 5 air quality be used within one hour, with any remaining contents discarded Single-dose/single-use vials opened in ISO Class 5 air quality can be used up to six hours.22

- Do not combine or pool leftover contents of single-dose/single-use vials Do not store used single-dose/single-use vials for later use, no matter what the size of the vial.3

- Unopened single-dose/single-use vials may be repackaged into multiple single-dose/single-use containers (e g , syringes), which should be properly labeled, including the expiration date and a beyond-use date (which is different from the manufacturer assigned expiration date) This repackaging should be performed only by qualified personnel in ISO Class 5 air conditions in accordance with standards in the United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding ? Sterile Preparations. Also, follow the manufacturer?s recommendations pertaining to safe storage of that medication outside of its original container 3,22

CMSissued the following Memorandum in 2012 outlining guidance for reuse or repackaging of single-use vials, as well as the infection control requirements with which providers and suppliers must comply under Medicare: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/ Downloads/Survey-and-Cert-Letter-12-35 pdf

Under certain conditions, it is permissible to repackage single-dose vials or single use vials (collectively referred to in this memorandum as ?SDVs?) into smaller doses, each intended for a single patient: The United States Pharmacopeia (USP) has established standards for compounding which, to the extent such practices are also subject to regulation by the Food and Drug Administration (FDA), may also be recognized and enforced under §§501 and 502 of the Federal Food, Drug and Cosmetics Act (FDCA). These USPcompounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations (?USP?).

Under USP, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient Among other things, these standards currently require that:

- The facility doing the repackaging must use qualified, trained personnel to do so, under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area. All entries into a SDVfor purposes of repackaging under these conditions must be completed within 6 hours of the initial needle puncture

- All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date (BUD), based on an appropriate determination of contamination risk level in accordance with USP, by the licensed healthcare professional supervising the repackaging process

- Administering drugs from one SDVto multiple patients without adhering to USPstandards is not acceptable under CMSinfection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately

- Deficiency Citation Policy: Healthcare facilities that do not adhere to USPstandards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USPmust not be cited solely on the basis of this practice

Readers may wish to peruse our previous paper regarding appropriate use of JZ/JW modifiers at the link below: https://apps.para-hcfs.com/pde/documents/New%20Modifier%20JZ%20Required%20When %20Reporting%20Payable%20Drugs%20(November%202022).pdf

According to an MLN Fact Sheet published in December, 2022, Medicare will require all 340(B) entities, including Critical Access Hospitals, which submit claims for separately payable Part B drugs and biologicals to report modifier ?JG?or ?TB?on claim lines for drugs acquired through the 340(B) discount program.

The MLN is available at the following website: www cms gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use340b-modifier pdf