HT9410Q2004 0005 Questions and Answers.pdf

About the HT941026Q2004 0005 Questions and Answers

QUESTION 1. Our reading of the solicitation package indicates that pricing is to be submitted on a per-MTF basis:

• Attachment 3 (Quote Sheet) is structured with a unique SLIN per MTF under each period CLIN (e.g., 0001AA – Naval Hospital Camp Pendleton; 0001AB – Naval Hospital Bremerton; 0002AA – Madigan AMC, etc.), each containing volume columns for every test type and a single CPRR/Total cell at the row's end.

• The Combined Synopsis/Solicitation, page 6 (Factor 4: Price), directs Quoters to "submit a firm-fixed-price for all contract line item numbers (CLINs) identified."

• We interpret this to mean a separate CPRR is to be submitted for each MTF/SLIN combination per period.

GOVERNMENT RESPONSE: CSS and Quote Sheet have been updated. CSS has been updated to reflect “The Quoter shall use Attachment 3 (Quote Sheet) to submit a firm-fixed-price for all contract line item numbers (CLINs) and subcontract line item numbers (SLINs) identified.”

QUESTION 2. Please confirm that the intended CPRR pricing structure as reflected in the Attachment 3 column layout.

a. In our experience we usually see pricing per assay, example being PT/PTT has its own price, D-Dimer and others have a unique price as do other specialty tests.

b. Also, is the intent to have one price across all facilities? Example PT/PTT has the same price at Madigan as it does at USNH Camp Pendleton? Or is there a custom price at each site/MTF?

GOVERNMENT RESPONSE: CSS and Quote Sheet have been updated.

QUESTION 3. Being that there is a phased approach, can we assume a minimum of 5-years usage for each MTF? Or will the end date for all be 5-years from the original award date?

a. If the end date is the same for all with a varied or TBD start date (example: “Either 10/1/2026 or 10/1/2027* TBD - Depends on MTF requesting to exercise Option” which is from Enclosure A), there’s challenges for vendors to determine the actual CPRR for the quotation and expected use life of the equipment.

GOVERNMENT RESPONSE: The 12-month base delivery period plus four (4) 12-month option periods and the inclusion of the option IAW 52.217-6, shall not exceed 66 months from time of award. The base delivery period is anticipated to start 1 October 2026.

QUESTION 4. Attachment 2 Technical Submission Form R38, Shelf-life management of reagents (tracking on-board shelf-life) (reagents good for at least one week on-board for PT/APTT/Fibrinogen/D-dimer). This requirement is unduly restrictive. Only one vendor has onboard reagent stability for one week for PT/APTT. Please consider changing this to requirement and instead of requiring a specific on-board stability, asking the vendors to explain how their solution is efficient with reagents and consumables.

GOVERNMENT RESPONSE: Attachment 2 Technical Submission Form has been updated.

QUESTION 5. Enclosure A Site Specific Information, Row 6, Column E, Please confirm that the 99th Medical Group requires one analyzer to be on an automation line and one analyzer to be countertop.

GOVERNMENT RESPONSE: From Lab: The preference is two (2) analyzers. We’ve had times where we have needed to use the backup analyzer as the main unit was down for various reasons. We are busy enough to need both Coagulation analyzers.

The main analyzer is near the capacity of what can fit. Something similar can fit, but not too much larger (maybe a few inches to about foot on all sides). The area is near a stationary counter in the front, and a water pole in the back (about 3 inches behind). There is a walkway in the back of the analyzer. On the side that doesn’t connect to the Aptio, there is a small counter for supplies and is utilized by the chemistry department (their only counter space), which may be able to go out another foot, but not much more as there is a walkway and a desk in front of a wall. The walkway is for people to access to Hematology section, as well as the Aptio centrifuges. An analyzer more than slightly larger than the current solution may not fit.

As for the smaller analyzer, it fits on the stationary counter about perfectly.

QUESTION 6. 1-Enclosure A Site Specific information Estimated Workload Column M, Mixing Studies + 2- Attachment 3 Quote Sheet Coag Quote Sheet, Row 19, Mixing Studies, Please specify how many of each kind of mixing study for the facilities that will be performing both PT and PTT mixing studies.

Madigan – Madigan does not separate PT and PTT mixing studies; if a mixing study is ordered, both PT and PTT missing studies are performed.

NMCSD – Unable to confirm.

Attachment 3 Quote Sheet Questions for Clarification:

QUESTION 7. Please confirm tests listed which do not match those listed on Enclosure A, tab “Estimated Annual Workload” and pages 1-2 of Combined Synopsis document.

i. Tests to be Removed from Attachment 3 to match the other documents include:

1. Factor XII

2. Factor XIII

3. Platelet Aggregation.

GOVERNMENT RESPONSE: CSS, SOW, and Quote Sheet have been updated.

QUESTION 8. Please confirm Period of Performance test quantities listed for base year when comparing to Enclosure A tab listing “Anticipated Start date of Deliveries”. (Example:

Twentynine Palms lists a start date of 10/1/2026 but reflects no test volumes for the Base year.)

QUESTIN 9. Quoting Structure:

i. (Preferred Option) Please consider updating the quote document to accept a separate

CPRR for individual tests and assays to replace the currently reflected single blended CPRR for all tests together per site. This alone would reduce risk to both the vendor and the government for over/under billing from combining low cost with very expensive tests.

A. Require a single blended CPRR across all MTFs for each separate individual tests. This would reduce potential mid-contract CPRR adjustments should test volumes shift from one MTF to another. (Display on Attachment 3 in Rows: 20, 41, 62, 83, 104, and 125)

B. PT + APTT (combined CPRR) – Over a 5-year POP, this alone would eliminate 660 additional invoiced line items.

ii. (Secondary Option if above is not acceptable.) Please consider updating the quote document to accept a separate CPRR for test groupings instead of each individual test. This would help to reduce post-award administrative line items for billing while also reducing risk to both the vendor and the government for over/under billing from combining all tests into a single CPRR.

A. Combined CPRR groups:

1. PT + APTT

2. Fibrinogen (not combined)

3. D-Dimer (not combined)

4. Heparin (not combined)

5. Specialty Tests (Including All other listed tests)

Feedback received in response to Amendment 0002:

1. What sites reflecting a full 12-month test volume during the base year (delivery range 10/1/26 – 9/30/27) plan to install and go live after 10/1/2026? (Example: Camp Pendleton originally showed a 2/1/27 go live)

GOVERNMENT RESPONSE: The annual test quantities should be adjusted to account for less than 12 months.

2. Because 10/1/26 is fast approaching, is it possible some of the sites may choose to extend their current contract with their incumbent to allow additional time for site-specific analyzer validation signoffs? (Examples: Tripler and Madigan as they have an extensive test menu and previously listed with go live of TBD.)

Listed on New Attachment 3 Quote Sheet (attached) Deliveries 10/1/26 – 9/30/2027:

• Naval Hospital - Camp Pendleton

• Naval Hospital – Bremerton

• Naval Hospital – Twentynine Palms

• Madigan AMC

• Tripler AMC

• Travis AFB

• Elmendorf AFB (JBER)

• Luke AFB

Deliveries 10/1/27 – 9/30/2028:

• Naval Hospital – San Diego

• Nellis AFB

• Weed ACH

GOVERNMENT RESPONSE: The Government’s intent to exercise an option is non-binding and therefore, even if the Government notifies the contractor of the intent to exercise the option, the Government is not obligated.

QUESTION 10. Being that the DIC Panel (Madigan) is comprised of: PT, aPTT, Fibrinogen, D-Dimer, may the 1,800 panels be added individually to the tests?

• Example:

Test Volume DIC Panel Total with panel

PT 12,000 1,800 13,800

aPTT 8,000 1,800 9,800 Fibrinogen 1,000 1,800 2,800 D-Dimer 2,400 1,800 4,200

GOVERNMENT RESPONSE: No. However, clarification is required to prevent inadequate annual workload numbers. SOW Enclosure A and Quote Sheet have been updated.

QUESTION 11. From Question 3, 9 & 10 from previous: The answer was the goal is to have all MTFs transitioned by 1 October 2027, can the vendors assume a total of 5 years of use for each site instruments are placed?

o Example if Madigan transitions on 1 October 2027, can the vendor assume those instruments will remain for a total of 5 years?

o The basis of this is, the final year test volumes are half which reduces the next fiscal year placement to 4.5 years in total.

GOVERNMENT RESPONSE: No, vendors cannot assume a total of five (5) years of use for each site instruments are placed. The 12-month base delivery period plus four (4) 12-month option periods and the inclusion of the option IAW 52.217-6, shall not exceed 66 months from time of award. The base delivery period is anticipated to start 1 October 2026.

QUESTION 12. From Question 5 from previous: The Government’s response states that vendors should perform a site-specific assessment to “optimize CPRR via the By the Box” and that billing is best applied monthly based on a site CLIN with QTY = 12.

o Please clarify whether vendors may propose separate By-the-Box CLINs for lower-volume tests such as D-Dimer and specialty assays, or whether all reagent/test pricing must be incorporated into a site-specific monthly CPRR billing model.

GOVERNMENT RESPONSE: Each test menu currently at each specified MTF determines what is on contract for that MTF. SOW Enclosure A and Quote Sheet have been updated.

QUESTION 13. D-Dimer Test counts for CLIN 0002-X002 (Naval Hospital Bremerton) in Attachment 3 do not reflect the test counts displayed on Enclosure A (117 annually)

GOVERNMENT RESPONSE: SOW Enclosure A and Quote Sheet have been updated.

QUESTION 14. Several test counts for CLIN 0005-X005 (Madigan AMC) do not reflect the same annual test counts shown on Enclosure A.

GOVERNMENT RESPONSE: SOW Enclosure A and Quote Sheet have been updated.

QUESTION 15. Request an additional extension to the current solicitation response due date.

Typically two weeks from the date of the final amendment and changes is sufficient.

GOVERNMENT RESPONSE: See CSS for quotation due date

QUESTION 16: Row 69 of the Technical Submission states:

• All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label. The label will be placed in three (3) or more locations on the container (top & two sides).

Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

Is the container in reference the actual shipping container? Or the individual products contained for which the customer will place on the shelf?

GOVERNMENT RESPONSE: Shipping container.

QUESTION 17: Do you want one rate averaged for the 60 months (for all sites, regardless of when they start)?

GOVERNMENT RESPONSE: The quote sheet is designed for a single Cost Per Reportable Result (CPRR) rate by Analyte that will apply to all active sites, regardless of their individual transition dates, and allows for a varied rate each delivery period. Offerors are expected to propose pricing based on their own calculations, accounting for new equipment installations, equipment replacements, and overall volume changes.

QUESTION 18: Do you want one rate for the Base Year, then a second rate for Option Years 1-4? This would be after the 3 additional sites join in year 2. This is how you currently have calculated the rates.

GOVERNMENT RESPONSE: Yes. Consistent with typical phased transitions, the Government requires one rate for the Base Year (reflecting the initial 8 active sites), and a consolidated rate for Option Years 1 through 4 (reflecting the addition of the 3 transition sites in Year 2). Offerors are expected to propose pricing based on their own calculations, accounting for new equipment installations, equipment replacements, and overall volume changes.

QUESTION 19: Do the first 8 sites get one rate for the entire 60 months, and the 3 sites that join in year 2 get their own rate for the 4 years?

GOVERNMENT RESPONSE: No. The Government’s intent is to maximize economies of scale across all participating locations. Separating rates by site cohort conflicts with this objective. By pooling volumes, the overall pricing structure should reflect a more favorable, unified rate for all sites as the consolidated group expands.

QUESTION 20: Additionally, do you want CPRR or a Fixed Monthly Rate?

GOVERNMENT RESPONSE: The Government requires pricing proposed strictly as a Cost Per Reportable Result (CPRR). Offerors are expected to propose pricing based on their own calculations, accounting for new equipment installations, equipment replacements, and overall volume changes.

QUESTION 21: The Government provides estimated start dates and they are not all 10/1/26 or 10/1/27. The start dates will affect the CPRR rate calculations.

GOVERNMENT RESPONSE: Acknowledged. The Government recognizes that staggered onboarding dates will fluctuate annual testing volumes and impact yearly CPRR calculations.

Offerors must factor these scheduled transition dates into their volume-based pricing models.

QUESTION 22: Navy Hospital Pendleton is 2/1/27 (do we have to pro-rate?)

GOVERNMENT RESPONSE: Yes, pro-rating is required.

QUESTION 23: The 99th Medical Group states 11/17/26 or 11/17/27?

GOVERNMENT RESPONSE: The Government confirms the estimated start date for the 99th Medical Group is 11/17/26; however, that is subject to change if 99th Medical Group requests to exercise an option on the existing contract.

QUESTION 24: The quote states the Base year with 8 sites based on volumes; then OY 1-4 includes all 11 sites. The Mods would run consecutively based on the quote template. Am I interpreting correctly?

GOVERNMENT RESPONSE: Correct. The Base Year will be calculated using the volumes of the initial 8 active Military Treatment Facilities (MTFs). As additional MTFs onboard and join the consolidated effort in subsequent years, they will align with the existing option periods.

All sites will operate under a single, unified Period of Performance (POP) and run on the same administrative schedule.

QUESTION 25: Just seeking clarification in question 10 below:

• I’m not seeing a new quote sheet in SAM.gov or on your email. Is there an update or is the one I’ve attached still apply?

• With the answer “No” I do not follow the following statement “However, clarification is required to prevent inadequate annual workload numbers.”

o We can accommodate the DIC panel, albeit manually, and with that said should we expect further clarification from the government or proceed with the information given?

GOVERNMENT RESPONSE: Please see CSS Coagulation - Attachment 3 Quote Sheet Amendment 0003. DIC Panel test quantity was updated to reflect “0”.