Amend One-CO.pdf

(x)

75H70627Q00001 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Aberdeen SD 57401 115 Fourth Ave, SE Federal Building Aberdeen Area Indian Health Servic

10/09/20260001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

10/09/2026

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

A. Amend RFQ-75H70627Q00001, see attached Questions and Answers.

B. Extend the closing date to November 19, 2026; at 12:00 pm, CST.

There are no other changes made by reason of this amendment.

Period of Performance: 11/01/2026 to 10/31/2031

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

NICHOLE R. LEREW

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Questions & Answers on RFQ 75H70627Q00001 Chemistry Laboratory Coagulation Instrumentation

IHS1519501/IHS1531881

Deadline, October 19, 2026; 12:00 pm CST

1) Will a “Price Schedule Sheet” as referenced under Factor 3 be provided or are responding vendors to provide financial quotes on a vendor created price schedule sheet on company letterhead stationery, as defined on page 3 Section 6?

Answer: The vendor is expected to create a price schedule sheet on company letterhead stationery, as defined on page 3 Section 6

2) Are fibrinogen and Heparin anti-Xa required at any site as accuracy and precision thresholds are listed in section 3.1 Instrumentation Performance but not listed as a required test in the same section? If yes, please provide estimated annual volumes by site.

Answer: No, Fibrinogen and Heparin Xa are not required tests at this time.

3) The base period as reflected on OPTIONAL FORM 336 (page 4 of 7) begins 11/01/2026, before the 11/09/2026 quote due date. Please provide revised periods of performance and clarify the dates shown on option CLINs.

Answer: The Base period will start on the date of contract issuance and will go for 1 year, each option year will go for 1 year. This will be for 5 years or 60 months.

4) Is it possible the Government could evaluate full and open responses for consideration that do not fall under the small business set-aside?

Answer: Yes, we would like to consider all offers.

5) Since the LIS is the system of record, will the Government accept onboard storage below 4,000 records where results are archived to the LIS/middleware in compliance with CLIA retention requirements?

Answer: The government will accept onboard storage ≥2500 records

6) Will the Government revise the ≤5% CV requirement to “precision per the manufacturer's FDA-cleared claims, verified per CLSI EP15,” consistent with the approach for other analytes?

Answer: No we want this to stay at what is in the RFQ or should we go up to 6% (D-Dimer is around 8 – 9% CV) for CA-660

Yes. The Government will replace the uniform ≤5% CV requirement for PT/INR, aPTT, fibrinogen, and D-dimer to” precision requirements consistent with the manufacturer’s claims in the FDA-cleared labeling for the proposed reagent/analyzer combination, verified in accordance with CLSI EP15- A3”.

Offerors shall provide the applicable within-run and within-laboratory precision specifications and supporting labeling, including the sample concentrations or control levels evaluated. Verification shall include clinically relevant normal and abnormal levels, with particular attention to D-dimer performance near the assay’s clinical decision cutoff. Acceptance will require successful verification under CLSI EP15-A3 and laboratory director’s approval of suitability for the intended clinical use.

7) Attachment A uses 2024 volumes +5%, but 2025 actuals already exceed Attachment A estimates at several sites (e.g., Rosebud aPTT +54%, area D-dimer +11%). Because the estimated ranges referenced in section 3.10 Workload Variability is not clearly defined in Attachment A, will the Government provide a more defined estimated range or add a volume-adjustment mechanism (e.g., price reopener if annual volume varies ±15% from Attachment A) to allow acquisition of additional reagents if necessary to accommodate substantially increased or decreased testing volumes?

Answer: The Government has refined the baseline volumes. Please use the volumes below as the baseline for this contract.

Facility PT/INR baseline APTT baseline D-dimer baseline

Cheyenne River 2,150 999 738

Pine Ridge 4,261 2,291 695

Rosebud 2,601 1,485 624

Standing Rock, (Ft. Yates, ND) 906 315 181

Facility PT/INR baseline APTT baseline D-dimer baseline

Turtle Mountain (Belcourt, ND) 1,662 785 1,006

8) Please confirm the number of analyzers expected per site and whether a backup analyzer is required or desired at any site.

Answer: Size the analyzer appropriately based on the volumes given. Pine Ridge is the only facility that will need a backup instrument.

9) Do any locations have a space or installation area restriction? If yes, what are the installation space limitations?

Answer: Yes, the following are the space restriction measurements. All measurements are in inches.

Eagle Butte, Fort Yates, Belcourt maximum of 22.5" (W) x 19.5" (D) x 19.5" (H).

Pine Ridge main instrument 32" (W) x 33" (D) x 29.0" (H), Pine Ridge backup is maximum of 22.5" (W) x 19.5" (D) x 19.5" (H).

Rosebud maximum 30.5" (W) x 35.2" (D) x 27.0" (H).

10) Non manufacturer Rule (Small Business Set-Aside, NAICS 334516)

• The solicitation is a 100% total small business set-aside under NAICS 334516.

• Our market research has not identified a small business manufacturer of fully automated coagulation analyzers that meets the PWS Section

3.1–3.2 requirements.

• Has the Government requested, or does it intend to request, an individual waiver of the Non manufacturer Rule from SBA for this requirement?

• If not, please confirm how non manufacturer offerors are expected to comply.

• Please also confirm whether FAR 52.219-6 and FAR 52.219-14 apply, as they do not appear in the clause list.

Answer: The government wants the offeror to be a part of the manufacturing process.

11) Pricing Structure

• The solicitation describes a firm-fixed CPRR model (Section 4), a fixed monthly price per facility (PWS Section 13), and a price per year by period (SF1449 continuation, CLINs 1–5). Please clarify:

• Should offerors price a unit cost per reportable result, a fixed monthly price per facility, or both?

• Is a separate price schedule sheet provided? Section 6 refers to a "Price Schedule Sheet," which we could not locate in the solicitation package.

• How will the Total Proposed Price be calculated for evaluation?

Answer: The government would prefer a fixed monthly price per facility

12) Definition of Reportable Result

• Is INR considered a separately billable reportable result, or is it included in the PT result?

• Please confirm that repeats, dilutions, QC, calibration, and validation testing are excluded from billable reportable results.

Answer: INR would be included in the PT as it is a calculated result based off the PT result. You will need to account for all repeats, dilutions, QC, calibration, and validation testing into your billable results as they are needed to do business.

13) Test Menu

• PWS Section 3.1 lists precision thresholds for fibrinogen and Heparin anti-Xa, but Attachment A lists only PT, INR, aPTT, and D-dimer.

• Are fibrinogen and/or Heparin anti-Xa required at any facility? If so, please provide estimated annual volumes.

Answer: No they are not required, but maybe potential add-ons at a later date.

14) Workload Basis

• Attachment A shows 2024 volumes with a 5% increase, while the 2025 data shows higher volumes at several facilities.

• Which data set should offerors use as the basis for pricing?

Answer: Use volumes provided in the table on question 7 as the baseline volumes.

15) Period of Performance and Implementation

• The SF1449 continuation shows a base period beginning 11/01/2026, which precedes the quote due date of 11/09/2026. PWS Section 3.4 allows 90 days for installation, validation, and training. Please confirm:

• The anticipated award date and the effective start of the base period.

• Whether the incumbent equipment will remain in service during transition to allow parallel testing and correlation studies.

Answer: The base would be for 1 year from the start date of the contract and the option years would start each year at the anniversary of the start date. See answer provided above to the same question.

16) Current Equipment and LIS

• Please identify the current coagulation analyzer make and model at each facility.

• Please identify the IHS laboratory information system (vendor and version) to be interfaced.

• Will the Government or its LIS vendor charge any fees for building or maintaining the instrument interface? If so, is the contractor responsible for those fees?

Answer: Belcourt, Eagle Butte, and Fort Yates all have the Sysmex 600 series, Rosebud has the CS-2500, Pine Ridge has an ACL TOP 350.

LIS is Resource Patient Management System (RPMS) via Data Innovations(middleware)

The vendor needs to be available during the interface setup and for any trouble shooting that needs to be done with the interface as a representative of their instrument. Outside of that, there are no additional charges.

17) Backup Instrumentation

• Given the 24/7 laboratory operations, the 24-hour on-site repair requirement, and the ≥90% uptime standard, does the Government expect a backup analyzer at any facility?

Answer: Pine Ridge requires a backup instrument; the rest of the locations do not require a backup instrument. See answer to question #8 above.

18) Scope Description

• Section 2 of the synopsis refers to "hematology analyzers." Please confirm this is a typographical error and that the requirement is for coagulation instrumentation only.

Answer: this was a typographical error.

19) Order Limitations

• The Task Order Procedures attachment states task orders may range from $2,500 to $2,500,000, while the contract maximum is $900,000 and the CLIN order minimum is $500.

• Please confirm which limits govern.

Answer: The task order total amount may range from $2,500 - $150,000 and CLIN order minimum $500

20) Required Submittals

• Please confirm whether a Section 508 VPAT/ACR is required with the quote for the analyzer software, or only after award.

• Please confirm that the implementation plan required under PWS Section 3.4 should be included in the Management volume.

• Are there page limits or formatting requirements for the Management volume?

Answer: Section 508 clearance is required at the time of submission.

1. Implementation plan: PWS Section 3.4 requires the contractor to submit an implementation plan with its proposal covering installation, validation, and training within 90 days of award. However, this section does not specify the proposal volume in which the plan must appear.

Placement in the Management volume would be an appropriate place to include the implementation plan.

2. Page limits and formatting: The provided section does not establish page limits or formatting requirements for the Management volume.

21) Small Business Set-Aside / Nonmanufacturer Rule. The solicitation is issued as a 100% Total Small Business set-aside under NAICS 334516 (Analytical Laboratory Instrument Manufacturing), a manufacturing NAICS code. To our knowledge, no small business manufactures FDA-cleared automated coagulation instrumentation of the type described in the Performance Work Statement. Under the nonmanufacturer rule (13 CFR 121.406; FAR 19.505), a small business offeror that does not manufacture the item must supply the product of a small U.S.

manufacturer unless the Small Business Administration has granted a waiver. Please confirm whether an SBA class waiver or individual waiver of the nonmanufacturer rule applies to this procurement. If no waiver applies, please advise how the Government intends for small business offerors to comply.

Answer: The offeror must be the manufacturer

22) Absence of FAR 52.219-6. The provisions and clauses incorporated in Section 7 and the attached clause list do not include FAR 52.219-6, Notice of Total Small Business Set-Aside, or FAR 52.219-14, Limitations on Subcontracting, which are ordinarily included in total small business set-asides. Please clarify whether these clauses will be incorporated by amendment and, more generally, which set-aside compliance terms will govern the resulting contract.

Answer: if there are not small businesses qualified, then this will go out as open to all.

23) Eligible Offeror Structure. Please confirm whether a small business offeror proposing to furnish instrumentation and reagents manufactured by a large business OEM, under an authorized distribution arrangement with full OEM warranty as required by Section 3 of the solicitation, would be considered eligible for award under this set-aside.

Answer: No, the small business needs to be a part of the manufacturing process

24)

pg. 14, 3.1 Instrument Performance

≤10% CV (PT, aPTT, fibrinogen, Heparin Xa)

Finbrinogen and Heparin Xa are not listed on Attachment A, are there plans to add these assays? If yes, to which facilities and expected timing? COAG

Answer: At this time there are no anticipated expectations that fibrinogen and/or Heparin Xa will be added. It is preferred that any instrument proposed would have the capability for these assays as scope of practice change. It is a possibility that fibrinogen and/or heparin Xa might be added at any one of all the 5 hospitals.

25)

pg. 15, 3.2, System Functionality

Provide automated QC, calibration, and data management.

Would you like the instrument to run QC at a prescribed time? If yes, does this apply to all sites? COAG

Answer: Automated QC testing and statistical tracking is necessary but an operator can load the controls and start the run.

26)

pg. 15, 3.2, System Functionality

Maintain reagent stability and onboard refrigeration

Does each site require on board refrigeration? Can you list the sites who do or don't require? COAG

Answer: All sites require refrigeration on board.

27)

pg. 16, Maintenance and Support

Respond to service calls within: 1 hour (callback) 24 hours (on-site repair)

Does the government request on-site repair within 24 hrs. and if an event occurs on a Friday the next business day (Monday) is acceptable for on-site response? COAG

Answer: No, facilities will use alternate testing sites as their back-up with the exception of Pine Ridge which required a backup analyzer. Next business day is acceptable.

28)

No Reference Pages

Not Identified by the

GOVT

Do you want pre-analytical sample integrity checks that evaluate sample tube over and under fill as well as Hemolysis, Icterus and Lipemia (HIL) levels standard for each facility? COAG

Answer: No, not required

29)

Reference Pages

Not Identified by the

GOVT

Would you like each facility to be standardized with the same analyzer and workflow? COAG

Answer: No, vendor should size the analyzer to the workload volumes of each facility.

30)

No Reference Pages

Not Identified by the

GOVT

What is the size of the space, by facility, that is available for a coagulation instrument? COAG

Answer: See response to question #9

31)

Not Identified by the GOVT Do you prefer a floor model or benchtop analyzer? COAG

Answer: Bench top for all locations

32)

Answer: No

Pages

Not Identified by the

GOVT

Is there a need to load more than 24 patient samples at one time? If so, which facilities? COAG

33)

Answer: No need for middleware…all instruments provided must have the capability with interfacing with Data Innovations.

34)

Answer: Answer to Question #33 is NO, is not applicable.

35)

Reference Pages

Not Identified by the

GOVT

Do you require middleware as part of the proposed solution? Does middleware need to be agnostic and be able to connect to 3rd party instruments? If so, can you identify the instruments and how many? COAG

No Reference Pages

Not Identified by the

GOVT

If yes to previous question can you provide the following information identified below.

1) How would each lab store their data if “middleware” is used, for example, on-premises, cloud, or a hybrid method?

More details provided, the better, from an architecture perspective.

2) In the event of a natural disaster (tornadoes, etc.) what expectations do you have to get your instruments/results back up and run, to start sending output results into your

LIS?

3) Do you require COAG rules to be set up & configured to run complete testing? How often do you change your COAG rules configuration(s)?

4) What rules do you currently have at each location over the last 3 years of history? COAG

Not Identified by the

GOVT

Would the government complete the table below to ensure that we gain the best understanding to your requirements at each site? COAG

SITE

Laboratory

Hours

Does Sites Require Primary and Alternate device? If yes, should they be mirroring image?

Device can be Stand-alone, benchtop, or either?

Measurement of space available?

Does site request Middleware?

Does site require maintenance engineering on a weekend or is the next business day acceptable, Monday?

Is there a need to run more than 24 patient samples at one time?

Site require onboard refrigeration?

Fibrinogen and Heparin Xa are not listed on Attachment A, are there plans to add these assays? If yes, to which facilities and expected timing?

Cheyenne 24/7 N Benchtop

See response to Question #9 for size requirements

See previous question

Next business day N Y

See response to question #24

Pine Ridge 24/7

Yes/ can be smaller, but same methodology and similar test comparison

Benchtop

See response to Question #9 for size requirements

See previous question

Next business day N Y

See response to question #24

Rosebud 24/7 N Benchtop

See response to Question #9 for size requirements

See previous question

Next business day N Y

See response to question #24

Standing Rock

M/F 8-4:30;

On-Call after

N Benchtop

See response to Question #9 for size requirements

See previous question

Next business day N Y

See response to question #24

Turtle Mountain 24/7 N Benchtop

See response to Question #9 for size requirements

See previous question

Next business day N Y

See response to question #24