07-15-2011 03:47 PM
"We are evaluating the extension of USP797 to nursing personnel for IVs made while pharmacy is closed (we aren’t 24 hours). The question was raised as to exactly what needed to be done in the hood for nursing. Does pulling a single dose out of a SDV need to be done in the hood? Does pulling a med and then diluting it further with saline require the hood? The medication in these instances would be utilized inside 5 minutes after being pulled up, but certainly don’t constitute 'emergency medications'."
07-18-2011 09:26 PM
Please find my response to thequestion from our live presentation:
Q: What if you have isolator hoods, when do you perform glove fingertip sampling?
A: If you are exclusively using an isolator, you should evaluate the ability of the operator to place gloves on the gauntlet sleeves without contaminating them. To comply with the chapter's requirements of wearing sterile gloves, I suggest that you double-glove with the outer most glove being sterile.
Q: We utilize a MIC for IV preparation, how can the glove tip testing be accomodated in this situation?
A: You need to don sterile gloves on the gauntlet sleeve or double glove with sterile gloves being the outer-most glove that would come in contact with components and equipment (syringes, needles, etc).
Q: Is there a process for doing fingertip sampling in a CAI? Is it necessary to don sterile gloves in a CAI?
A: See my two responses above. Isolators are not exempted from the requirement of using sterile gloves.
Q: Why do you prefer plates over paddles for GFT?
A: I have a few reasons. First is cost. These paddles are almost 2-3 times more expensive than plates. According to Dr. Alice Weissfeld, these plates were designed for urine analysis. Thirdly, the dating of these plates are almost 18 months when all other media I have worked with and is commonly used in environmental sampling typically has a shelf life of 30-70 days. We want to have fresh media that will retain its characteristics over time so when inoculated with microorganisms, will support their growth. Lastly, there have been several reports of false negatives. Basically, after touching, spitting or doing other things to grossly contaminate them, no growth was observed.
Q: Please clarify when 3 CFU's are allowed during testing. It should be ZERO CFU's x3 for fingertip testing, so when is it allowed to have 3 CFU's??
A: Please review the slides and the chapter. Initial competency testing requires three separate testing events with ZERO CFUS. 3 CFU's are permitted during routine testing (after being qualified and deemed competent).
Q: Baxa star training, who should go?
A: Anyone who compounds will benefit from attending the Baxa Star Center Training class.
07-19-2011 09:45 AM
Please find my comments after each of your questions.
We are evaluating the extension of USP797 to nursing personnel for IVs made while pharmacy is closed (we aren’t 24 hours). The question was raised as to exactly what needed to be done in the hood for nursing.
Why is nursing using a hood? Is it in a location outside of the pharmacy? For immediate use, the preparation can be compounded in a clean, uncluttered, functionally separate area outside of the pharmacy. Whoever is compounding needs to have documented competence to do so. This can be accomplished by working with your nursing education (or whatever department provides your hospital’s initial and annual competence) and developing an inservice concerning immediate use. Most organizations use a train-the-trainer approach, where pharmacy trains the nursing ed instructors. They, in turn, provide the inservice and oversee the return demonstration of IV mixing.
Does pulling a single dose out of a SDV need to be done in the hood?
If it’s being done by pharmacy to place into another container (i.e. a syringe), yes. If it’s being done for immediate use, no.
Does pulling a med and then diluting it further with saline require the hood? The medication in these instances would be utilized inside 5 minutes after being pulled up, but certainly don’t constitute 'emergency medications.
If it’s being done in a continuous process and meets the immediate use criteria, and going to be immediately administered by the individual who is compounding it, it does not need to be done in a hood. Of course, if pharmacy is available to compound it, it should be done in a hood.
07-21-2011 11:30 AM
Here are my thoughts based on your response. The compounder properly performs personal cleansing and garbing. The compounder enters the buffer room. The compounder properly dons sterile gloves. The compounder then begins the process of garnering the proper supplies to complete the media fill test...i.e media fill components, syringes, needles, evac bags etc. and gathers them together on a counter. The compounder then begins to clean the LAFW where he will be working in by using a wipe with sterile water then a wipe with sterile alcohol. The compounder then has to spray down/wipe down the previously gathered supplies that will be introduced into the direct compounding area with sterile alcohol. So prior to beginning any actual media fill manipulations in the DCA, the compounder has already disinfected his gloved hands TWICE with alcohol, once while cleaning the LAFW and again when wiping the supplies going into the DCA. How then can one meet the requirement of not having disinfected gloves with alcohol when doing the media test? The only way I can think of preventing this is that once everything is in the LAFW, that the compounder then removes the pair of gloves that they did all that work in, and then dons a new pair of gloves and then enters the DCA and begins to peform manipulations. Then sometime during those manipulations, the fingertips are sampled. Is this an acceptable practice?
07-23-2011 11:10 AM
Would replacing gloves be part of your normal compounding practice? If yes, then the procedure you describe would be acceptable since the test is intended to mimic what is done in actual production. I know that there is a call for routine disinfection of gloved hands and components but what if people don't perform these critical steps? Part of this assessment is direct observation of the procedure without coaching the employee. Component and glove disinfection practices need to be part of the employee's compounding ritual whether they are being tested or not. The chapter says: "Immediately prior to sampling, gloves shall not be disinfected with sterile 70% IPA. Disinfecting gloves immediately before sampling will provide false negative results." You can meet the requirements of the chapter by the procedure that you described.
07-25-2011 08:09 AM
if the test is intended to mimic what is done in actual production then why is disinfecting with sterile alchol disallowed by the chapter when performing the test? I mean that is what my compounders do when they compound, they routinely disinfect their gloves with sterile alcohol. Your question of "what if people don't peform these critical steps?" ----well then....if they don't, then they fail the test, like they should fail the test---because their hands have a bioburden that they normally would not if they disinfect with sterile alcohol. With all due respect, I am begininng to understand why there are so many critics of USP 797 among my professional peers.
07-26-2011 07:26 AM
I don't seem to be doing a good job in explaining this matter since we seem to continue to not be on the same page here. With greater respect, it would be my opinion based on the plethora of feedback that I have gotten over the years that you and your peers are in the minority. It is time for pharmacy to advance their willingness to learn new concepts in the area of sterile compounding and infection control practices. We will agree to disagree on this matter. I appreciate your feedback and comments. Thanks.