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  • 1.  USP800

    Posted 10-01-2019 14:33
    As our hospital prepares for the USP800 changes this December, I was approached by leadership inquiring if there were any major changes in the laboratory (pharmacy and nursing will have major changes).  What is USP | Ready for
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    What is USP | Ready for
    The purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in health care settings and help promote patient safety, worker safety, and environmental protection. Chapter was written to protect all workers, patients and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared.
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    Other than standard precautions and double nitrile gloving when handing urine from patients on certain antineoplastics, I have not heard of any other updates.  If anyone in the ASCLS community has any updates, please reach out to me.  Thanks!

    Jennifer Hayes
    Laboratory Director
    Oregon State Hospital
    Salem OR

  • 2.  RE: USP800

    Posted 10-02-2019 06:50
    We are working with Employee Health to prepare for the increased volume of unreimbursed testing that will be provided for monitoring these employees. The battle has been do we monitor everyone's lab yearly or only those whose job description indicates probable exposure. Between all employees we are looking at approximately 7000 individuals with unreimbursed testing. The problem with looking at those by job exposure is that many bounce around different areas of the hospital and the different patients they treat. If a nurse is hired for NICU, but there is a low census day and she gets pulled to oncology for that day, there is possible exposure, but it would be difficult to keep up. Mind you the lab was brought in to the discussion after this fiscal year budget was in place and we did not budget for it, otherwise it would be a non-issue if everyone got tested.

    Brandy Gunsolus
    Doctor of Clinical Laboratory Science
    Augusta University Medical Center
    Augusta GA
    (318) 990-1136

  • 3.  RE: USP800

    Posted 10-02-2019 08:08
    ​An assessment was done in our facilities to determine whether lab personnel - especially those coming in contact with patients receiving the specific medications in question - were at risk and Pharmacy and Occ Med determined our personnel did not need more than the standard awareness training.  Their level of contact with the patient for blood collection or EKGs did not constitute a risk for any additional training.  It was also determined that standard universal precaution protocols were sufficient for handling of specimens from these patients.

    Rick Panning
    Senior Administrative Director
    Bloomington MN

  • 4.  RE: USP800

    Posted 10-02-2019 08:36

    I get asked this question often- be careful about your hospital asking the lab to make changes regarding USP800 regulations. The scope for USP800 is limited to those who handle and prepare the hazardous pharmaceuticals. There is nothing in the regulations that require changes for those who handle samples containing metabolites of the hazardous drugs.
    That said, there is language in the regulations that talks about handling patient samples but it is under the section of "direct patient care." There is very little literature about the concentrations of metabolites of cytotoxic drugs in patient samples. what is known is that the highest concentrations are in urine samples.
    As long as staff uses chemical-resistant gloves when handling such urine samples (with other standard PPE), that should be sufficient. There is no need to double-glove or wear extra PPE. There is no need to perform wipe tests in the laboratory.


    Daniel Scungio
    Dan the Lab Safety Man, Inc.
    Williamsburg VA
    (757) 259-5925