Common Deficiencies Part One with links to injection safety and vaccine handling toolkits

In Part One of our discussion, we will address one of the most common deficiencies cited by our surveyors in 2020. TCT surveyors have documented this citation at both the standard and condition level based on the severity of the deficient practice.

1. The Standard: ADM 11.0.3

The Deficiency:  Not following manufacturer’s instructions for dispensing, labeling, storage and disposal of drugs and biologicals, specifically for the following:

Single Dose and Multi-dose Vials

Dating and Storing of single dose vials (SDV) – Dating a SDV and returning it back to the drug inventory is a deficient practice according to manufacturer instructions, CDC guidance for use of SDVs and TCT Quality Standards.

Not properly dating multiple dose vials (MDV) – Multi-dose vials must be labeled and dated properly per organization’s policy and manufacturer’s instructions.

Not disposing of expired vials – Expired vials must be disposed of properly per organization’s policy

Not following storage instructions (refrigeration etc) – All drugs and biologicals must be stored according to manufacturer’s instructions and the organization’s policy

Here is the link to the latest guidelines from the CDC:

https://www.cdc.gov/injectionsafety/
https://www.cdc.gov/injectionsafety/cdcposition-singleusevial.html
https://www.cdc.gov/injectionsafety/providers/provider_faqs_singlevials.html
https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html

Important Information on Vaccine Handling from the CDC and USP:
Pleases follow the links below for the latest information on vaccine handling including Covid-19.

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html
https://www.usp.org/covid-19/vaccine-handling-toolkit