Attachment E - Question and Answer -9-12-24.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.

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