36C24920Q0082-002.pdf

• Under Section B.1, para. 2; Media Fill Testing/Gloved Fingertip testing frequency is labeled as “Varies”. As it is difficult to predict the number of visits over the course of a year, Winergy’s bid reflects conducting all Media Fill Testing/Gloved fingertip testing only during semiannual certification visits. Additional visits to conduct individual testing are not included in the contract price, and may incur additional technical service charges.

• There is a slight discrepancy between Section B.1, para. 5 and Section B.2A, Line Items 8‐13; for clarification Winergy will only be performing required USP, NSF 49, and CETA testing and certification services for all PECs and SECs contained within the contract.

• There is confusion with Section B.2A, Line Item 14 and Section B.3A, Line Item 11; the SOW lists hazardous drug testing of “taxanes”. There are different, widely used chemotherapy agents listed as taxanes. For clarification, Winergy will test for paclitaxel & docetaxel.

• Under Section B.2A, Line Item 4, HEPA filter integrity testing; since detailed information regarding the type and location of the room supply HEPA filters is not available, Winergy is assuming that each HEPA filter is easy to access and that the duct upstream of the HEPA filter has an accessible aerosol inject point. Past VA facilities have had varying levels on HEPA filter systems installed. Some are ideal (HEPA filters installed in the ceiling with upstream aerosol injection ports installed), while others are less than ideal (HEPA filters installed in an interstitial space without upstream ports). Additional labor

Below are the responses:

Bullet Point #1‐We do not want to have all of Media Fill Testing/Gloved Fingertip testing to occur at one time. If for some reason a scheduling conflict happens you have the potential of all your employees being expired on their current qualifications. We are trying to avoid a scenario where all employees expire at the same time.

Bullet Point #2‐There is no discrepancy it is very clear what is listed in B.2A is what the company is to place a bid for. In section B.1‐this specifies the will follow CETA and USP 797, we may be asking for additional test but they must perform to the requirements of CETA and USP 797.

Bullet Point #3‐That is correct agents based on Hazardous Drugs, this is common terminology.

Bullet Point #4‐HEPA filters are in the ceiling of each respective area and are not difficult to test