RFI Responses_Gloved Fingertip Testing.pdf

RFI RESPONSES

1. On page 31, there is a reference for reports. It mentions staff results, but also room and hoods. Are hoods and clean room inspections included in this solicitation? No. The clean room and hood inspections are currently covered under a separate contract managed by FMS.

Please refer this question to Dr. Mock for further clarification.

2. 0002 on the price sheet, has the annual GFT & MFT as only 3. Does this refer to only 3 personnel will be tested annually? Yes. The quantity refers to 3 oversight personnel, such as supervisors, who require annual GFT/MFT testing. In addition, 52 compounding personnel undergo testing every six months

3. 0005 Service Charge on the price sheet has the number of 6. Does this mean that 6 trips per year will be made by the technician(s): Currently, the same contractor performs both room certification and personnel testing. This results in a total of 12 trips per month completing monthly surface sampling, room certification, and personnel assessments. The quantity of 6 on line 0005 does not reflect the actual number of required visits under the current process

4. Regarding the chemical drug wipes, it states platinum-containing drugs will be tested. Which platinum-containing drugs are being requested? During the most recent visit, the contractor performed hazardous drug surface testing for the following agents: Cyclophosphamide, Ifosfamide, Paclitaxel, Platinum Analogues, and 5-Fluorouracil

5. The price sheet does not list the chemical wipes. Are these wipes to be included with the plates and surfaces samples? Yes. The chemical wipes are to be included with the plates and surface samples

6. 0004 has 114 plates and surface samples. Is the pharmacy providing their own media fill bags and the contractor is just providing incubation. No. Both the media-fill bags and the incubation process are provided and handled entirely by the contractor.

7. Sample Method:

Which sample collection method will be utilized? According to USP797 standards, both single plate and dual plate collection methods are accepted and are determined based on the type of media utilized. single‑plate sampling method

8. CLIN Structure – Definition of “Unit (EA-each)” Across All CLINs Across CLINs 0001–0004, each line item is presented as a unit (“EA”); however, the specific components included within each unit are not defined. Please clarify:

The exact sample types included per unit. (e.g., gloved fingertip (GFT) plates (left and right), Media-fill tests (MFT), surface samples (SS)

The number of each sample type included per unit.

Whether quantities represent complete testing sets or individual sample/test components. Each Unit represents a complete testing set

9. CLIN 0001 – Semiannual GFT and MFT (Qty: 104) :

Please clarify:

The composition of sample type for each unit (GFT (left and right), MFT, SS).

Whether the quantity of 104 represents complete testing sets or individual sample components.

Represents one complete semiannual competency testing set for a single compounding staff member. Each testing set includes: GFT/MFT and surface sampling and Media-Fill Vial

10. CLIN 0002 – Annual GFT and MFT (Qty: 3) Please clarify:

The number and type of samples included per unit. GFT/MFT and surface sampling and Media- Fill Vial

11. CLIN 0003 – New Employee GFT and MFT (Qty: 7) Please clarify:

The number of GFT plates (left and right), MFT, and any surface samples included per unit.

(This is typically 8 GFT, 1 MFT, 1 SS).

Whether surface sampling is included under this CLIN, as it is not described in the Scope of Work but is included in USP797 requirements.

Each unit represents one complete initial competency testing cycle for a new compounding employee. USP 797 requires three consecutive successful GFT and MFT tests before a new employee may perform sterile compounding. Surface sampling included per test, consisting of one surface sample for each of the three testing events, totaling 3 surface samples per unit The quantity of 7 represents seven complete new hire initial competency testing sets, not individual components.

12. CLIN 0004 – Additional Fingertip Plates and Surface Samples (Qty: 114) Please clarify:

Which sample types are included per unit (final GFT plates (left and right), SS, or both).

The number of each sample type included per unit.

Whether quantities represent individual samples, paired samples, or grouped sets.

The quantity of 114 reflects 114 individual plates, which may be used for GFT/MFT plates or surface samples as needed. It does not represent grouped sets

13. CLIN 0005 – Service Charge (Qty: 6)

Please clarify:

What services are included under this line item (e.g., site visits, reporting, logistics, or other activities).

The basis for the quantity of 6 (e.g., per visit, per event, per reporting cycle). service charge associated with each required site visit personnel testing activities.

14. Hazardous Drug Wipe Testing (USP <800>) Hazardous drug wipe testing is included in the Scope of Work but does not appear in the CLIN structure. Please clarify:

Whether this testing is required under the contract.

Yes, hazardous drug wipe testing is required under the contract in accordance with USP 800

If so, under which CLIN it should be included. CLIN 0004

15. CETA-Certified Technician Requirement The Scope of Work requires one to two CETA-certified technicians; however, the applicable services are not specified. Please clarify:

Which activities require CETA-certified personnel.

The CETA-certification requirement applies to the personnel performing these services, even if the CLINs themselves do not separately list a technician qualification line item (notes this required for room certification)

How is this requirement represented within the CLIN structure.

Potentially under services related CLIN