Questions and Answers dtd 6.10.24.docx

Questions and Answers

Recommendation/Question #1 Section 4.1.7 describes environmental wipe sampling for hazardous drugs and CLIN 13 and 26 cover the pricing. However, the SOW isn’t clear on the type and number of analytes for each surface sample, which means that pricing can vary widely. Based on past sampling, we recommend that each sample be analyzed for the following compounds:

1. Cyclophosphamide monohydrate

1. Fluorouracil

1. Ifosfamide

1. Methotrexate

1. Platinum-containing drugs

This is only a recommendation, but it would be important for the PWS to define what analysis should be performed so that all contractors are quoting apples-to-apples.

Answer:

The requirement for the solicitation has been revised in the Performance Work Statement, dated 6.6.24. Section 4.1.7 now reads:

Environmental wipe sampling for hazardous drug (HD) surface residue shall be performed routinely as outlined by USP <800> for facilities that request such services. Samples should be obtained and be analyzed at the minimum for cyclophosphamide, fluorouracil, ifosfamide, methotrexate and platinum containing compounds. Additional hazardous drug assays may be requested by the facility pending availability of the specific assay in the hazardous wipe sampling kit utilized by the contractor. Facilities shall provide the contractor the number of samples requested and the desired analysis for each sample. Results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available. Reference Appendix A for sample by location details.

Recommendation/Question #2 I can tell by the low CLIN quantities that this surface sampling represents and AREA rather than a single sample. The last contract defined the area… but the government will get better pricing if you break this out PER SAMPLE LOCATION. For instance, let’s say we sample a hazardous drug buffer room. There are two BSCs in the room. We take a sample in each BSC, one floor sample, one work surface sample and one sample in the room pass through. That’s 5 samples collected in that area. Next we sample the hazardous drug ante room. We collect one on the floor and one on the small bench. That’s 2 samples collected in the area. We don’t know the total samples in advance, so we would have to price an area sample to cover up to 5 locations (even though we only collected 2 in the ante room). We make extra money this way, but it’s more effective for the gov’t to just make us give a price PER SAMPLE location. Then, we can only charge for what we collect.

Answer:

The agency has revised the Compounding Certification Site Requirements via Appendix A, dated 6.7.24. The document contains the number of hazard surface samples per facility.