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******************************************************* ***UPDATE - AMENDMENT #1*** The Purpose of this Amendment is to Provide Answers to Questions. QUESTION #1 - The workload breakdown in the PWS (page 8) is structured simply by the number of drugs per sample batch, can you provide the specific drug types for each? ANSWER #1 - A.) The PWS lists 6 possible Hazardous Drugs that a client could request. These are the only 6 requested at this time in any combination. They are: 5-Fluorouracil, Methotrexate, Ifosfamide, Cyclophosphamide Monohydrate, Doxorubicin Hydrochloride, and Paclitaxel. B.) For Example, when a client wants "2" drugs reported, it could be a combination of any 2 of the above. One Client could request Methotrexate and Paclitaxel. Another Client could request 5-Fluorouracil and Ifosfamide. Both are only requesting "2" but the actual drugs are net set. Historically, 17 clients only wanted 1 drug reported for each sample. (each one though could have been unique) QUESTION #2 - Is the Government or the Contractor to supply the wipes? ANSWER #2 - The Government will supply the wipes. QUESTION #3 - Please confirm that the government will be taking the samples and not the Contractor's technicians (i.e., the contract is 'lab only'). ANSWER #3 - The client (government) will collect the samples; nothing would be collected by the contract lab. ******************************************************** As part of the DCPH-A mission, the Lab Sciences (LS) Directorate requires the analysis of wipe/swab samples for the presence of hazardous drugs in support of pharmacies and Military Treatment Facilities (MTFs) within the Department of War (DoW). This analysis is mandated for the MTFs using Chemotherapy drugs to ensure their cleaning procedures are effective to ensure safety of the MTF staff and to avoid cross-contamination. The directives that mandate this semi-annual testing requirement are United Stated Pharmacopiea (USP) 800: Handling Hazardous Drugs and Technical Bulletin-Medical (TB-MED) 515: Occupational Health and Indutrial Hygiene Guidance for the Management, Use and Disposal of Hazardous Drugs. There is no acceptable level of occupational exposure to Hazardous Drugs. The LS Directorate of the DCPH-A is the only government laboratory to perform this hazardous drugs analysis as required. While LS does have the analytical capability to perform hazardous drugs analyses, as a sole source for this effort, there is a need to have back-up laboratory capability for instances of instrument down-time or over-capacity situations. Objectives for this Requirement are as follows: The Contractor shall perform analysis on wipe/swab samples provided by the Government for Hazardous Drugs contamination. The Contractor shall perform the sample analysis within the stated turnaround time (TAT) identified in the Outsource Document and identified in the PWS. The Contractor shall provide Quality wipe/swab analysis for various hazardous drugs as identified in …
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