Attachment E - Question and Answer 10-8-24.docx

Question and Answer

1. Are you looking for the contractor to conduct regular (daily, monthly, quarterly, etc.) sampling as part of this solicitation, or to oversee the collection of these samples by facility personnel?

No sampling is required. However observation of collection would be included in survey of of the SPS water system as referenced in 2.1 in the SOW. The contractor will provide a database for the facility to log and track testing results as referenced in 3.19.5

2. Following the initial survey, should existing equipment be found in need of repair or replacement to comply with AAMI ST108 standards, will this work fall under this contract?

No, when issues with equipment or parts of the water system are identified it will be the responsibility of the facility to fix or address these issues.

3. AAMI (Association for the Advancement of Medical Instrumentation) recently published a new standard that establishes the quality of water used to process reusable medical devices. Is one output of the Comprehensive Water Management Program to provide direction on the requirements for water quality necessary to effectively process medical devices intended for patient use?

Yes, please refer to 3.6 of the SOW

4. Are there any VA-specific guidelines or preferences for determining control limits, or should we rely solely on industry standards like AAMI ST108:2023?

AAMI ST108:2023 are the guidelines for the determining control limits.

5. Is the VA Pittsburgh Healthcare System (VAPHS) currently experiencing consequences of using water that is of inadequate quality during the cleaning and sterilization of medical devices?

No, SPS has a contingency in place if water quality is inadequate by AAMI-ST108 guidelines.

6. Can we successfully propose services in addition to the NAISC code specified - 541380 - Testing Laboratories and Services? This is the NAICS Code that will be applied to this RFQ, no other is necessary.

7. Can the VA provide more details on the expected composition of the Water Management Team (WMT)? Are there specific roles or departments that must be represented/interviewed?

The contractor will provide a recommendation for the composition of the Water Management Team and suggest role to be filled by those suggested parties, refer to SOW section 3.1. The contractor should have experience with this type of work and the requirement for a facility Water Management Team. The facility will review the contractors suggestions for WMT involvement and roles and decide if those roles and actions are appropriate for our facility.

8. Concerning the technical capability requirements in the proposal instructions, can the VA clarify if certifications or specific qualifications are required for the "certified analyst" mentioned? What other certifications will be required from the contractor personnel?

Certified Water Technologist (CWT)

9. In section 3.18, the SOW mentions a 90-day work plan development, and 1 year program facilitation timeline. Can the VA provide more details on the expected activities, milestones and deliverables within these timeframes?

This timeline will be created by the contractor based off the deliverables listed in 3.0 in the SOW. The contractor will utilize the deliverables and plan a 90 implantation to present to the SPS Chief. This WMP include implementation on continued support for the remainder of the contract year, refer to SOW section 3.19 for continued support references.

10. Will quarterly reviews of the WMP performance require regular site visits of the facility to ensure conformance or will the VA provide data and feedback so that the contractor can discuss received data, provide recommendations to the WMP, edit the WMP accordingly, and advice the VA on the WMP?

While an initial on-site assessment is required, the VA will provide data and feedback to vendor that will be utilized for the WMP. Quarterly reviews can be done via Teams meetings, these quarterly reviews may be incorporated into the facility water safety meeting or may be a standalone meeting.

11. Question: A CWT credential is not relevant for development of an SPS water management plan. Would the Government confirm that other more relevant certifications (e.g., ASSE 12080, a state-issued water treatment and distribution operator, etc.) would also be acceptable?

Answer: An ASSE 12080 certification would be acceptable. However, most importantly we require a vendor with successful prior expertise in creating a WMP for Sterile Processing Services critical and utility water for a government entity based off the AAMI Technical Information Report or AAMI Standards; specifically AAMI TIR 34 and AAMI ST108.

12. Reference: Att. C, Price Schedule “This is a five-year Indefinite-Delivery, Indefinite Quantity (IDIQ) contract. Accordingly, all quantities are estimates only and are not ordered upon award of this contract. Funds are obligated via task orders issued against this contract.”

Question: Given that the price submitted in the SF 1449 is not expected to be the actual value of the award, it will be a challenge to compare proposals offering very different solutions and pricing models. Would the Government consider including CLINs for specific unit costs or NTE rates for specific scope / deliverables, such as (1) the water management

Answer: You as the vendor are to estimate the pricing for five years and fill in the CLIN schedule. This is to be a fixed price. The total contract value will be based of the price offered and expected usage for the five years.