Vendor Questions and Answers for HT0014-25-R-0022 revised 04112025.docx

Vendor Questions and Answers for Solicitation # HT0014-25-R-0022

I am noticing that some of the verbiage is still referring to the existing system and it sounds like the solicitation is for the maintenance of the existing platform.

This solicitation is open for all interested vendors. This is recompete of 3 previous/current contracts within WRNMMC. HT001420P0126, HT001422P0135, and HT001422P0178. The interested vendor should include all necessary agreements to satisfy the refit.

Can you please confirm that the intent is to look at vendors who are offering a replacement solution of your incumbent vendor? Please see verbiage below that I am referring to:

From the Performance Work Statement:

The Walter Reed National Military Medical Center, Bethesda, Maryland, Directorate of Clinical Support requires the maintenance, annual complete system revalidation, and technical support of our existing (government-owned via prior procurement/installation) environmental monitoring system for 1,200 system inputs, divided into 7 management nodes (with the option for expansion).

The intent is to look at options and further determine if the replacement is reasonable. The solicitation does not guarantee the replacement of our existing system.

Section 1.8 States that “Any travel to the WRNMMC campus will be covered by this contract without any additional billing on the part of the contractor.”

To keep your costs low, we typically offer remote service. Will you consider this option?

Our current need will remain the same to offer support remotely and services in person.

Will you accept a cellular-based, self-contained solution that does not use your infrastructure or interface with any of your other business systems?

The opportunity to switch to a cellular based service will be reviewed and determined amongst members.

If yes, would you agree that this removes several of the technical requirements (i.e. onsite support, NESSUS scans, deletion of 1.16; 1.17.1; 6.7.4.1 through 6.7.4.3.; 6.7.5.2 N/A

If you move to another Vendor, do you expect them to support equipment purchased from your current provider?

It is understood the current equipment would not be compatible with any other vendor. Any interested vendor will need to supply all individual equipment.

What features are most important to your users that are not listed in this RFP?

N/A

Will you accept edits to these sections?

Section 3.2 - We will require support from a member of your Facilities or TSMP team TBD with valid justification.

Section 3.3 - Some of our equipment will require AC power which must be provided.

TBD with valid justification.

Section 4.1 - change to:

Remote maintenance TBD with valid justification.

Biannual NIST certification TBD with valid justification.

Section 5.1.2 (a) change to Remote TBD with valid justification.

Section 5.1.2 (d)add “within 5 business days” TBD with valid justification.

What is the process for being granted an exception to the requirement listed in section 6.5.15 Any products that provide or support UC, acquired or operated by the DoD Components, shall be certified for interoperability and information assurance (IA) as set forth in Department of Defense instruction. NUMBER 8100.04, unless granted a waiver in accordance with DODI 8100.04, DOD Unified Capabilities (UC). Request for waivers instruction may be found on page 22/23 here, DOD Instruction 8100.04

On Pages 15/16 PWS it states Annual validation will be documented in keeping with all health care industry quality requirements and performance standards.

At SmartSense, we offer different components of system validation services, to ensure we provide the best possible solution, I’d like to understand your specific requirements for 'complete system validation.' This will help us align with the approach and make sure we meet your needs effectively.

Our complete system validation procedure is run on four important processes,

1. Installation qualification - equipment installation adheres to manufacturer specifications

2. Operational qualification - systematic testing, ensuring equipment operates efficiently and safely, meeting all predefined operational standards

3. Performance qualification - assess your equipment's performance over time to ensure it consistently meets all quality system demands

4. Custom Validation Protocols - equipment fully complies with industry standards set by authorities such as the FDA, CDC, WHO, etc. Enforce validation strategies to align with the specific challenges and regulatory environments of each industry (ex: Blood bank, Pharmacies, Clinics). It is important to include your individualized version of our complete method of validation so we may determine if the potential vendor and WRNMMC can align smoothly.

1.1. States “technical support of our existing (government-owned via prior procurement/installation)” - please confirm that you are aware we would implement new equipment and not be maintaining the current equipment.

Correct.

1.6 Period of performance for the Base Contract Year will be 01 May 2025 through 30 April 2026, with four (4) subsequent Option Years’ Correct.

Do you have a VOC decision date?

N/A.

Do you have a timeline for when you expect the new system to be implemented/live by date?

NLT JUNE 2025

Will you consider a longer term to recognize a more favorable price?

N/A

1.7.1 The Place of Performance does not identify any Pharmacy type locations? Please provide a complete list of locations/departments as it will impact pricing.

The work shall be performed at Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland 21889 in the workspaces occupied by the Department of Pathology and any tenant installation users requiring the use of open monitoring points within the Department of Pathology’s existing 4-nodes (Node 1 &2 – Pharmacy- Building 9, 8, 10, 39 and operating spaces in between. Node 3 --Transfusion Service, Building 9; Nodes 4 & 5—Main Laboratory (operating spaces in several buildings on campus); Node 6—Armed Services Blood Bank Center, (operating in several spaces on the Walter Reed National Military Medical Center, Bethesda, campus) and Node 7- Department of Nutrition.

Section 1.8 states There will be no travel requirement beyond the spaces identified in paragraph 1.7.1., (i.e., WRNMMC, Bethesda, Maryland, campus for the performance of annual system revalidation and on-site system repair, when required to maintain functionality.) This seems to be in conflict with section 5.1.3 where it states Dedicated Labor Hours. The contractor will provide a dedicated part-time technician to be available one day bi-weekly at WRNMMC. This technician will focus on system maintenance, troubleshooting, and ensuring system optimization.

o Can you please clarify the expectations of the on-site support? Are you requiring on-site support bi-weekly on Fridays 8 am – 4:30 pm?

The on-site support is currently responding and scheduling bi- weekly, however any travel to the WRNMMC campus should be included in the proposal and will not bill as additional cost.

What services will an on-site technician be providing to WRNMMC?

Service all locations utilizing Temperature Environmental Monitoring System.

Respond promptly and schedule service calls with clinicians, addressing technical issues and resolving them with precision.

Provide ongoing technical support to ensure the uninterrupted functionality of the environmental monitoring system.

If a vendor can remotely support trouble shooting and provide training; will Walter Reed accept remote vs on-site support?

TBD with valid justification. WRNMMC is open to reviewing modernization.

Section 5.1.1. States Annual Recalibration and Servicing o Why is annual vs biannual NIST certification required?

These are services proposed by the Contractor and incorporated by reference, herein.

o If the Vendors NIST calibration is valid for 24 months, Is WRNMMC expectation that annual calibration is completed? Or is WRNMMC okay with following the standards of the vendors recalibration cycle of every 24months?

The entire TMD system (from the refrigerator/freezer unit sensor to the remote monitoring station and telephone or alerting mechanism) must be tested at least monthly DHA A.I.

NUMBER 4140.01. However, with justification the system calibration standards can be reviewed.

On the SF1449 form states WRNMMC is requesting a QTY of 470? This contradicts PWS section 5.13 it states “Installation of New Nodes and Additional Monitoring Points. The proposal includes the installation of additional nodes (maximum 8), as well as the addition of new monitoring points (up to a total of 700) to expand coverage and meet the growing needs of WRNMMC’s critical environments.”

o Can you please confirm how many assets this project includes? Is it 470, 700 or 1200 (initial paragraph) Due to daily inventory changes the current monitoring points is 520 inputs. The proposal would need to cover 520 inputs plus an additional 280 inputs for future expansion, totaling 800 inputs. The total amount of 1200 has been reduced to 800.

o Please complete chart below to identify the qty of each type of sensor required.

Fridge/Freezer w/Glycol(-40c-120c)

Temp and Humidity (-40cto 60c; 0-100%R)

Extended Range Probe (-200c-200c)

Ambient Temperature only (-40c to 60C)

Given the importance of data security and compliance, how important is it to you that a vendor is directly SOC2 audited and compliant, rather than relying on a third-party cloud provider's SOC2 compliance? What value would the added assurance of working with a vendor that undergoes independent audits for full transparency and accountability mean to WRNMMC TBD with justification.