RFQ FA442724Q0058 - QUESTIONS RESPONSE Chemistry and Immunoassay Solication 24Jul2024.pdf

# Reference Question Response

1 What is the total available power for Chemistry/Immunoassay area?

Reference electrical schematics in Attachment - DGMC Lab Electrical Schematics

2 What is the summary of each power output line in Volts and Amps?

Reference electrical schematics in Attachment - DGMC Lab Electrical Schematics

3 How many Data port lines are available in the Chemistry/Immunoassay area? 54 Data Ports available.

4 How many days per week will you store patient sample tubes before discarding? Tubes will be stored for 7 days. see revised SOW 4.2.6

5 How many patient sample tubes do you plan to store (Archive) per day?

700 samples roughly would be stored per day. See revised

SOW 4.2.6

Will the current water system that feeds Chemistry/Immunoassay be removed when current vendor exits?

The existing water purification system will be removed when current vendor exits. The new vendor will be responsible to provide and install one if their system requires it.

Solicitation FA 442724Q0058 Questions/Responses

Part 1 Description of Services Page 3 1.2 Scope: The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in Part 4 for the Clinical Lab located at David Grant Medical Center, Travis AFB. In addition, the Contractor shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system…

Please clearly define all deliverables within the “supplies, materials” classification.

Refer to section 1.2 Scope. The Contractor shall provide a total cost of the turnkey operation of equipment which includes the supplies & material to accomplish that.

QUILITY CONTROL

Please identify which Control vendor you use? DGMC currently uses Technopath and BioRad

9 Are you open to using other Control vendors? Refer to SOW sections 1.1 & 1.2

10 Are you using QC software, and are we to include the software license for this? The QC software will be Government furnished.

10 Please also share the quantity and list numbers for controls today

The quanities in Part 6 , Attachment 2, includes both patient test volumes and controls.

Part 4 Technical Requirement Page 6/24

4.1.3 The analyzer must perform at least

1500 tests per hour and analyze at least 400 samples simultaneously.

4.1 Instrumentation refers to "two chemistry and

immunoassay platforms," while 4.1.3 refers to "analyzer."

Requesting clarification demonstrating that 4.1.3 aligns with "two chemistry and immunoassay platforms," i.e., the total proposed solution

Refer to revised Statement of Work, dated 24Jul24, Section 4.1.3

4.1.4.3 Procalcitonin: =< 25 min

Please change Procalcitonin requirement to <30 min.

Refer to revised SOW dated 24Jul2024, requirements removed.

4.1.5 Quality Control and Calibrators

will be storable onboard the analyzer until they are entirely consumed or reach expiration. The operator will have the ability to program frequency of calibration and QC, and the analyzer will automatically perform calibration and quality control functions by accessing onboard calibration and QC material.

ALL quality control material used by the system will have onboard storage capability, allowing quality control for ALL testing assays to be performed using onboard quality control material. The storage module that houses the onboard quality control and calibrators will not share that storage space with anything except for quality control and calibrator material. The analyzer will provide enough storage space to house all quality control and calibrator material used by the system at all times.

These requirements, as written, are source-limiting. 4.1.5:

Request "must" and "ALL" be changed to "prefer." Refers to revised statement of work, dated 24Jul2024

4.1.5.1 If quality control and calibration

material cannot be stored onboard the analyzer, the contractor will provide directly loadable quality control and calibration material. Directly loadable quality control and calibration material will be loadable on the analyzer using the quality control or calibrator’s original container. No quality control or calibration material provided by the contractor will require pour-off of the material into another container for performance. All quality control and calibration material provided will come bar-coded by the manufacturer, and this barcode will be readable by the analyzer.

No quality control or calibration material will require manual programming for performance. ALL quality control and calibration material provided by the contractor will have this direct-load capability.

These requirements, as written, are source-limiting and dependent upon the QC manufacturer, which could be a 3rd-party if Travis AFB prefers the 3rd-party vendor.

Request confirmation that the prevailing statement is that the preference is that “quality control and calibration material provided by the contractor will have this direct-load capability” (per the final sentence of this requirement).

Refer to Revised SOW, dated 24Jul24, Section 4.1.5.1 the government does not state preference or objects to third party vendor.

4.1.6.9 Analyzer requires check for

humidity exposure and the ability to determine the appropriate operating humidity.

Request clarification that this requirement is not meant to refer to the instrument monitoring internal temperature, not potentially variable overall laboratory conditions (i.e., humidity).

Refer to revised SOW dated 24Jul 2024, Section 4.1.6.9

4.1.7 The contractor will not provide

additional equipment outside this integrated analyzer to perform any tests outlined in Part 6, attachment 2.

This requirement, as written, is source-limiting.

Requesting adjustment to account for temporary menu gaps which may be resolved by contract implementation or shortly thereafter, thereby adding “it is preferred that” prior to the statement.

Refer to revised SOW, dated 24 Jul 2024, Sections 4.1.7 & 4.19

4.3.2 The data management system must

store at least 2 years of patient results and quality control for each interfaced instrument.

The duration of storage depends upon test volume, server size, etc. Please change "must" to "prefer."

Refer to Section 4.3.2 of the Revised SOW, dated 24Jul24, this is the government requirement.

4.3.23 The Contractor will provide a

middleware solution and full IT support as defined below at no additional cost to the Government throughout the life of the contract.

The requirement states that 'the Contractor will provide a middleware solution and full IT support as defined below...'. Please clearly define what 'full IT support' includes.

Refer to revised SOW, dated 24 Jul 2024. Section 4.3.23

4.7.5 Reagents must have a minimum

unopened shelf-life of six (6) months, and controls must have a minimum unopened shelf life of at least six (6) months upon receipt by the Government.

Please change “must” to “prefer” to have a minimum unopened shelf-life of six (6) months and controls too.

Refer to revised SOW, dated 24Jul24, Section 4.7.5 government will not change this requirement

4.7.6 The Contractor shall sequester

quality control materials and test reagents where possible to minimize the amount of lot variations sent to the laboratory

Please change the contractor “shall” to “prefer” to sequester quality control materials and test reagents where possible to minimize the amount of lot variations sent to the laboratory.

Refer to revised SOW, dated 24Jul24, Section 4.7.6 government will not change this requirement

4.7.7.1 All reagents/reagent packs shall be

provided as follows: Be provided by the manufacturer of the equipment

Please change “shall” to “prefer” Refer to revised SOW, dated 24Jul24, Section 4.7.7.1 government will not change this requirement

4.7.7.10 The Contractor shall provide

linearity materials for all testing that spans the vendor's published analytical measuring range (AMR) every six-months

Please confirm if the proposal should include the cost of linearity in the CPRR pricing

All cost associated with this requirement shall be all inclusive and should be included in CPRR pricing.

4.14 Systems must function with a 100%

up-time and ability to perform patient testing 100% of the time. This pertains to having dual platforms

Many factors beyond the contract’s control (i.e., operator error) can impact uptime. Request that "must" be modified to "prefer."

Refer to revised SOW, dated 124 Jul 2024, section 4.14 government will not change this requirement.

4.19 Dimensions The analyzers and

automation solution must fit within a 24’ by 52’ space while allowing for multiple operator movement, reagent storage, and bench space, further, the analyzer must be able to navigate through doorways that are 42” wide by 83” tall.

Please provide a CAD drawing of the laboratory to complete this assessment Reference Attachment 5-DGMC Lab Electrical Schematics.

Part 6 Attachment (2) page 19/24 Estimated Workload Data. Estimated Quantities Column.

Please specify if this is patient test volume or overall test volume (including tests run on calibrators, controls, etc.)

Refer to Revised SOW, dated 24Jul24, Part 6 Attachment 2, quantities include patient test volumes and controls.

Question #20: Combined Synopsis Page 9 252.237-7024(b) The offeror shall provide with its offer a written plan describing how it will continue to perform the essential contractor services listed in attachment ___, Mission Essential Contractor Services, dated ________, during periods of crisis.

Please provide the information that would fill in the current blanks

Refer to revised Combined Synopsis Solicition Chemistry and Immounoassay System, dated 23 Jul 2024

As indicated in multiple FDA safety alert communications, assays that use free capture streptavidin/biotin in their assay methodology have been demonstrated to show interference with lab test results, which can lead to misdiagnosis and medical error. Will Biotin interference be considered during your evaluation process?

Evaluation will be conducted in accordance with the Solication, Addendum FAR 52.212-2

What are the specific ratings and capacity of the electrical power, DI water, and data that will be available in the space provided for our instrumentation?

Refer to Attachment 5 - DGMC Electrical Schematics.

Will ATO certification for Middleware systems that are required to fulfill the SOW be considered along with instrument ATO certification?

Refer to revised SOW dated 24Jul 2024, Section 1.3.3

31 Can DGMC provide a CAD of the space allowed for our instrumentation? Refer to Attachment 5 - DGMC Electrical Schematics.

32 Will the ATO need to be completed or in process, as it may take time to complete? Refer to revised SOW, dated 24 July 2024, Section 4.3.3

What is the process for obtaining a quote for any construction modifications that might be necessary to accommodate our proposed instrumentation?

There is no large-scale Construction Modification required to the hospital, should the Contractor require minimal changes to the location of the electrical/water/drainage in the facility to support their instrumentation, the Vendor will submit with their proposal a cost estimate for the turnkey operations requirement.

4.1.5 Quality Control and Calibrators will

be storable onboard the analyzer until they are entirely consumed or reach expiration. The operator will have the ability to program frequency of calibration and QC, and the analyzer will automatically perform said functions by accessing onboard calibration and QC material. ALL quality control material used by the system will have onboard storage capability, allowing quality control for ALL testing assays to be performed using onboard quality control material. The storage module that houses the onboard quality control and calibrators will not share that storage space with anything except for quality control and calibrator material. The analyzer will provide enough storage space to house all quality control and calibrator material used by the system at all times.

Refer to revised SOW, dated 24 Jul 2024, Section 4.1.5 is the requirement, 4.1.5.1 is the alternative requirement solution.

We request that these requirements be rewritten or removed due to no vendor being able to fully comply.

- In addition, all non-vendor QC and Cal material requires some programming at some level and 4.1.5.1 seems to contradict the requirement of 4.1.5 "The operator will have the ability to program frequency of

4.1.5.1 If quality control and calibration

material cannot be stored onboard the analyzer, the contractor will provide directly loadable quality control and calibration material. Directly loadable quality control and calibration material will be loadable on the analyzer using the quality control or calibrator’s original container. No quality control or calibration material provided by the contractor will require pour-off of the material into another container for performance. All quality control and calibration material provided will come bar-coded by the manufacturer, and this barcode will be readable by the analyzer.

No quality control or calibration material will require manual programming for performance. ALL quality control and calibration material provided by the contractor will have this direct-load capability.

Revised SOW, dated 124 Jul 2024 section 4.1.5 is the requirement, 4.1.5.1 is the alternative requirement solution.

calibration and QC, and the analyzer will automatically perform said functions by accessing onboard calibration and QC material."

- The following alternative is proposed:

Vendor systems will minimize operator interaction through the use of directly loadable QC and/or onboard

QC.

4.1.9 Contractor will provide a

quantitative Beta HCG assay that provides clinically verified expected ranges for length of pregnancy for each week since last menstrual period (LMP), up to 40 weeks.

How do your clinicians use the expected ranges past the peak at 8-12 weeks after LMP and fall subsequently?

According to the American Pregnancy Association, Beta hCG levels will reach peak levels in the first 8-11 weeks of pregnancy and then decline. With this in mind, what is the clinical relevance of a Beta HCG assay that provides clinically verified expected ranges for length of pregnancy for each week since last menstrual period (LMP), up to 40 weeks? This requirement seems to be exclusionary and clinically irrelevant.

We request the requirement be revised to read, "Contractor will provide a quantitative Beta HCG assay that provides clinically verified expected ranges for length of pregnancy for each week since last menstrual period (LMP), up to 18 weeks"

Refer revised SOW, dated 24 Jul 2024, section 4.1.9 government will not change this requirement.

4.1.10 Contractor will provide a High

Sensitivity Troponin assay with the ability to provide quantitative values up to 20,000 ng/L or higher.

This requirement seems exclusionary and is not clinically relevant. With normal levels of hs Troponin of up to around 53 ng/L reported for some Troponin assays, what is the clinical relevance of measuring Troponin levels up to 20,000 ng/L?

We suggest revising this to "up to 10,000 ng/ml" to encourage competition among vendors.

Refer revised SOW, dated 24 Jul 2024, section 4.1.10 government will not change this requirement.

4.2.8 The optical system within the

system used to read specimen barcodes will be capable of reading barcodes along the entirety of the specimen container, even barcodes placed along the very bottom of the specimen container. The transport device holding specimens will not block the specimen barcode when the barcode is oriented towards the bottom of the specimen container.

This requirement is limited to a single vendor. We request the requirement be revised to read, “The barcode reader within the system allows for recognition and interpretation of DGMC-generated barcode labels on all sample tube types and provides a barcode reading accuracy of 99% or greater"

Refer revised SOW, dated 24 Jul 2024, section 4.2.8 government will not change this requirement.

4.3.17 Provides a graphical view of

patient moving averages enabling the user to easily see when patient results are drifting

This requirement seems very specific to a single vendor.

Request the requirement be revised to read “Provides a mechanism to easily identify and provide notification of drifting patient results utilizing patient moving averages.”

Refer revised SOW, dated 24 Jul 2024, section 4.3 & 4.3.17 government will not change this requirement.

Question Chemisty Analyzers