[MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

Shea, Joann jshea at tgh.org
Wed Apr 5 05:37:47 PDT 2017

We just had our first interdisciplinary meeting  on the USP 800 regulations to develop out policy, education, PPE guidelines and medical surveillance as our CNO wants us to have everything in place by Jan 2018.    Our pharmacy department is working with the EPIC team to flag the HDs that require specific PPE so they know if they need to double glove, wear face shields, goggles or gown.

   We currently use chemotherapy gloves in our infusion center and oncology unit.   Based on the list of HD,  we will have to provide chemotherapy gloves in most of our patient  care areas.       Originally, we thought we could bring in a chemotherapy glove that was less expensive than the chemo gloves used in oncology.  Our pharmacist said the glove must meet the same standard, D6978, so we are going to explore gloves that meet the standard.     Also, requirements for gowns require closed cuffs so we are also looking for gowns that meet the requirements but are not as expensive as the chemo gowns.

I have been asked to see how other healthcare organizations are handling the PPE requirements.  Are you going to use your current chemotherapy gloves in all areas?   What gowns are you going to use for HDs?  We are thinking of supplying one gown for the nurse administering the HD to last the entire 12 hour shift and provide each nurse with reusable goggles.

Any recommendations or suggestions would be appreciated.  Thank you very much.

[TGH_employee health serv-color]
JoAnn Shea, ARNP, MS, COHN-S
Director, Employee Health & Wellness
Work: 813-844-7692    Cell:  813-789-3441    FAX;  813-844-8144    Email:  jshea at tgh.org

When chemotherapy gloves are required, they must meet American Society for Testing and Materials (ASTM) standard
D6978 (or its successor). Chemotherapy gloves should be worn for handling all HDs including non-antineoplastics and for reproductive
risk only HDs. Chemotherapy gloves must be powder-free because powder can contaminate the work area and can
adsorb and retain HDs. Gloves must be inspected for physical defects before use. Do not use gloves with pin holes or weak
When used for sterile compounding, the outer chemotherapy gloves must be sterile. Chemotherapy gloves should be
changed every 30 minutes unless otherwise recommended by the manufacturer's documentation and must be changed when
torn, punctured, or contaminated. Hands must be washed with soap and water after removing gloves.
7.2 Gowns
When gowns are required, they must be disposable and shown to resist permeability by HDs. Gowns must be selected based
on the HDs handled. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better
protection than those made of uncoated materials. Gowns must close in the back (i.e., no open front), be long sleeved, and
have closed cuffs that are elastic or knit. Gowns must not have seams or closures that could allow HDs to pass through.
Cloth laboratory coats, surgical scrubs, isolation gowns, or other absorbent materials are not appropriate protective outerwear
when handling HDs because they permit the permeation of HDs and can hold spilled drugs against the skin, thereby
increasing exposure. Clothing may also retain HD residue from contact, and may transfer to other healthcare workers or various
surfaces. Washing of non-disposable clothing contaminated with HD residue should only be done according to facility policy
as drug residue may be transferred to other clothing. Potentially contaminated clothing must not be taken home under any
From: MCOH-EH [mailto:mcoh-eh-bounces+jshea=tgh.org at mylist.net] On Behalf Of Thrasher, Terri
Sent: Tuesday, March 21, 2017 10:15 PM
To: MCOH/EH <mcoh-eh at mylist.net>
Subject: Re: [MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

I will have someone send on my behalf as I am currently presenting to the CHA conference.

From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Amy Olson
Sent: Tuesday, March 21, 2017 11:02 AM
To: 'MCOH/EH' <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Subject: Re: [MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

Would you be willing to share your questionnaire?

From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Thrasher, Terri
Sent: Tuesday, March 21, 2017 10:58 AM
To: MCOH/EH <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Subject: Re: [MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

Right now the questionnaire is optional but we get about 80% response.   We are going to start making it mandatory in Feb.

So if someone has a U/A of concern prior to hire we ask them to share the results with their medical providers so they are aware.... We only use it for baseline.   What the person does with it is up to them.

If someone has concerning responses to the annual questionnaire we would have them see the Occ Med provider for next steps.

We also use the questionnaire data to try and determine if we see any correlation in responses (we have a statistician run the results for us).   We also use the information to share with staff so that they can see we are using the learnings to improve our programs for them.

The questionnaire also has questions about PPE use... which tells us the use or lack there of with PPE.   And we ask if they have had an exposure and compare it to our exposure data to see if people aren't reporting what they think is an exposure or not.

From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Swift, Melanie
Sent: Tuesday, March 21, 2017 8:55 AM
To: MCOH/EH <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Subject: Re: [MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

Hi Terry, I'm interested in how these programs are managed and their outcomes. I know that you run a good occ health program. Would you mind to sharing your approach to an abnormal U/A at hire, or a new (changed from baseline) positive response on the annual questionnaire?
Is the medical questionnaire mandatory or optional?
Thanks for sharing,

Sent from my iPhone

On Mar 21, 2017, at 7:46 AM, Thrasher, Terri <Terri.Thrasher at cchmc.org<mailto:Terri.Thrasher at cchmc.org>> wrote:
We do a hazardous drug surveillance medical review questionnaire and u/a on hire.
Annually we do the same surveillance medical review questionnaire.
I don't have a policy..
Since USP800 came out we decided to create one education for the staff (different groups have done different education).   Staff will have to do it at hire and sign an affidavit of understanding.
They will then do the training yearly as well.
From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Amy Olson
Sent: Tuesday, March 21, 2017 8:28 AM
To: 'MCOH/EH' <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Subject: [MCOH-EH] USP 800 Hazardous Drugs Medical Surveillance

I'm interested in what you all are doing for medical surveillance as it relates to hazardous drugs. Specifically what are you doing on hire and what are you doing annually or periodically? Any policies/procedures you would be willing to share would be greatly appreciated.

Amy Olson, BSN, MS, COHN-S
Director, Employee Health and Wellness
Johns Hopkins All Children's Hospital
500 Seventh Avenue South, Suite 103
St. Petersburg, FL  33701
P 727-767-8211 | F 727-767-8399
aolson9 at jhmi.edu<mailto:aolson9 at jhmi.edu>

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