EVT0010938_-_Amendment_One_-_QandA.pdf

Office of Procurement and Contracts 900 SW Jackson St., Room 1001 North Topeka, KS 66612

Phone: 785-296-2376 Fax: 785-296-7240 www.admin.ks.gov/offices/procurement-contracts

Adam Proffitt, Secretary Laura Kelly, Governor

Amendment

Request for Proposal

Questions and Answers

Date: September 25, 2026

Amendment Number: One (1)

Event Number: EVT0010938

Closing Date: October 13, 2026

Procurement Officer: Nicki Mears Telephone: 785-296-6924 E-Mail Address: nicole.mears@ks.gov

Agency: Kansas Department of Health and Environment

Item: NGS 2nd Tier Analysis, dried blood spots for Lysosomal Disorders

Conditions: 1) Answers to submitted questions follow on page two (2) of this document.

A signed copy of this Addendum must be submitted with your bid. If your bid response has been returned, submit this Addendum by the closing date indicated above.

I (We) have read and understand this addendum and agree it is a part of my (our) bid response.

NAME OF COMPANY OR FIRM:

SIGNED BY:

TITLE: DATE:

It shall be the vendor's responsibility to monitor this website on a regular basis for any changes/addenda.

http://admin.ks.gov/offices/procurement-contract mailto:nicole.mears@ks.gov http://admin.ks.gov/offices/procurement-contract

Event ID: EVT0010938

EVT0010938 – Amendment One (1)

NGS 2nd Tier Analysis, dried blood spots for Lysosomal Disorders

QUESTIONS

Number

Page

RFP Section

Question

Answer

1. General Question

We are able to do NGS for the requested conditions.

However, we also have Sanger sequencing available for these genes. Are we able to submit pricing for both methodologies of sequencing? Or is there only interest in NGS?

KHEL welcomes submission of pricing for both methodologies.

2. Prime contractor and laboratory partner Sections 2.3–

2.7 and 3.21– 3.22

I have worked with Garcia Family Medicine since 2009 and currently serve as Practice Manager. May this healthcare experience be considered together with a specialist laboratory partner’s experience and references when evaluating our proposal? May a non-laboratory prime contractor propose a named specialist laboratory to perform all sequencing and clinical reporting while the prime manages the contract? Which qualifications must belong to the prime itself? May the performing laboratory’s experience and three similar-service customer references satisfy sections 2.5–2.7? We understand five years of experience is preferred under section 2.6;

please confirm.

Any experience the Vendor believes relevant to this contract is welcomed for evaluation. A non-laboratory prime contractor may manage the contract and outsource testing to a third-party laboratory. The prime contractor would be expected to hold the third-party laboratory to the specifications outlined in this bid document as it pertains to test offerings, result turn-around-times, and reports. The prime contractor would be responsible for billing/invoicing related to this contract.

Determination of if currently submitted experience/references satisfy sections 2.5-2.7 will be determined at the time of bid evaluations.

3.

Laboratory credentials and validation

Sections 2.5 and 4.3–4.4

What laboratory certifications, accreditations, licenses, personnel qualifications and evidence of dried-blood-spot assay validation must be submitted? Please identify any requirements specific to the prime, performing laboratory or additional referral laboratories, including any CLIA or CAP requirements.

Evidence of CLIA and/or CAP certification will suffice, as these certifications imply that personnel qualifications and assay validations meet the necessary standards.

4.

Required sequencing and report content Sections 4.3– 4.4

For IDUA, IDS, GAA, GALC, ARSA and DMD, what coverage, variant types, confirmation methods and interpretation standards are required? Please identify required report elements, handling of uncertain findings, amended reports and any clinical consultation or urgent notification obligations.

There are no minimum requirements set for coverage, variant types, confirmation methods, and interpretation standards for this contract. Vendors should submit their full capabilities for evaluation by KHEL. Reports must contain Patient Name, Patient DOB, KHEL’s accession number, Date of Specimen Receipt, and Sample Type (DBS). Reports must also contain the Name and Address of the Laboratory performing testing.

Uncertain findings should be accompanied by a comment on the report stating as much. The presence or absence of clinical consultation or urgent notification obligations is up to the Vendor.

5.

Partial bids and awards Sections 4.2–

4.3 and 5

May a vendor bid selected conditions or genes only? If so, how should unoffered items be marked, how will partial bids be evaluated, and how will work be allocated if more than one contract is awarded?

Yes, a vendor may bid selected conditions or genes only. If a condition/gene is not offered by the Vendor, please mark “not offered” in the cost sheet. Partial bids will be evaluated with the same criteria as full bids. If more than one contract is awarded, the specimens would be allocated to those vendors based on the conditions for which they provide service. If both Vendors could provide services for the same condition, KHEL would then evaluate the cost of service to determine which Vendor would receive specimens.

6.

Corrected cost sheet Section 5 page 27

The item descriptions in the cost sheet appear garbled when we view the supplied PDF. Please provide a corrected editable form or confirm the exact item-to-row mapping. Are Part Number and Product Catalog Number required for testing services, and may a laboratory’s test code or N/A be used where appropriate?

Bid Documents have been updated with revisions of the cost sheet and the cost sheet has been attached to the bid event.

7.

Expected test volume and mix Sections 3.36 and 4.1–4.3

Does the estimate of approximately 250 specimens annually cover all listed conditions combined? Please provide the expected annual mix by condition, anticipated ordering frequency and any startup ramp.

Can more than one condition be ordered for the same specimen, and how should those tests be priced? We understand volume is not guaranteed.

Yes, the estimated 250 specimens annually is all the conditions combined.

The estimated annual number of specimens by condition is as follows:

- Pompe: 135

- MPS I: 30

- MPS II: 10

- Krabbe: 75

- MLD: Not yet screening at

KHEL

- DMD: Not yet screening at

KHEL

Ordering frequency can be anywhere from 2-10 specimens per week, with an average of 5-6 specimens.

It is very unlikely that more than one condition would be ordered for analysis on the same specimen. Were this to occur, KHEL would expect each condition to be billed separately.

8.

Individual and bulk prices Sections 4.3–

4.5 and 5

Should pricing be per condition, per gene analysis or per specimen when multiple tests are ordered? Are bulk discounts based on a shipment, monthly orders, annual cumulative volume or another threshold?

Please clarify how repeat tests, confirmatory testing, failed specimens, recollections and cancelled orders should be priced.

Pricing should be per test ordered. If a specimen were submitted for analysis of multiple conditions/genes (aka tests), KHEL would expect the invoice line items to correspond with the number of conditions/genes (tests) analyzed.

As the Vendor would be performing analysis on the shipped specimens, KHEL would look to the Vendor to establish the amount of specimens that would constitute as “bulk” for the Vendor’s workflows and therefore qualify for the Vendor’s “bulk pricing.”

If the Vendor has to repeat testing based on a failed assay, or some error by the Vendor, KHEL would not expect to be charged for the repeated test. If the Vendor’s testing algorithm requires positive specimens to be confirmed, it is up to the Vendor to determine if that confirmation testing should be billed. If the confirmation testing will be billed in addition to the initial test, this confirmation testing should be listed as a separate line item on the Cost Sheet for KHEL’s evaluation. Any subsequent charges to the initial charge for ordering a test should be included as a separate line item on the Cost Sheet with the associated price.

9.

Price adjustment terms Sections 3.37 and 4.5

Section 3.37 permits annual documented adjustment requests with increases capped at 5%, while section

4.5 states prices remain fixed during the contract period and refers to yearly-end changes. Which schedule controls during the initial term and renewals?

Please confirm the notice deadline, required support and whether an adjustment requires written State approval before taking effect.

Prices are fixed for the initial term of the contract which is DOA through December 31, 2029. Actual contract start date shall not begin until contract is fully executed, signed and dated by the Director of Purchases.

At the end of the initial term, you have an option to renew twice and at each of those renewal times you may request for up to 5% increase.

10.

Specimen shipping and handling Section 4.2 and Event Details Appendix A

Please confirm the actual specimen origin, destination, shipping frequency and required transit time. Section 4.2 lists 1115 SW Harrison Street, while Appendix A lists 1000 SW Jackson Street, Room 570.

Which address applies to each part of the workflow?

Please specify responsibility for packaging, labels, shipping accounts, specimen tracking, rejected samples and any return or disposal of residual specimens. We understand the selected vendor pays shipping, handling and insurance.

The specimen will originate (be shipped from) 1115 SW Harrison Street.

KHEL is responsible for the cost and logistics of shipping specimens to the vendor’s laboratory. Section 4.2 notes that the Vendor is responsible for all shipping and handling; this statement is directed towards goods/delivery, which is not relevant to this service contract.

KHEL would not expect the return of any specimens. Specimen disposal would be the responsibility of the Vendor.

Regarding rejected specimens: The Vendor would be expected to inform KHEL of the defined specimen acceptance/quality criteria that must be met when submitting specimens to the Vendor. Were a specimen to not meet these criteria, KHEL would expect a report from the Vendor stating why testing could not be performed. KHEL would then ship another specimen for the patient.

11.

Turnaround and result delivery Section 4.4

Please confirm when the 14-business-day clock begins, the applicable holiday calendar and whether any exceptions apply to inadequate specimens or required repeat testing. Is a secure portal, secure email or fax sufficient without a separate system interface? Please identify access, encryption, patient-data protection, retention and any data-use or business associate agreement requirements.

The 14-business-day clock begins the day the specimen is shipped to the Vendor. KHEL ships specimens overnight, for next day arrival at the Vendor’s location. The applicable holiday calendar is that of Fed-Ex, as those are the days when shipping is available to KHEL. Were inadequate specimens to be received by the Vendor, KHEL would expect a report for that patient stating the reason the specimen did not meet testing criteria. KHEL would then ship a second specimen for that patient and the 14-business-day clock would restart on the day the second specimen was shipped.

12.

Start date and contract term Cover page section 4.1 and Event

Appendix A

The cover sets the initial term from award through December 31, 2029; section 4.1 also describes three years from award. Please confirm the controlling term and expected service start. Appendix A lists October 18, 2026: is this an actual performance deadline or an administrative date? Is implementation or validation required before routine testing begins?

The contract term is from DOA through December 31, 2029. Actual contract start date shall not begin until contract is fully executed, signed and dated by the Director of Purchases.

Service would be expected to start January 1, 2027. KHEL would expect that the Vendor’s assays were validated and live prior to start of service on January 1, 2027.

13.

Invoices and payment arrangement s Section 3.38

What billing frequency and invoice documentation will KHEL require? Please confirm how service acceptance and receipt of a proper invoice determine the Net 30 payment date. Would the State consider separately identified setup charges, milestone payments or direct payment to the performing laboratory under an approved arrangement, or must all payment be made to the prime after completed services?

Invoices should be issued monthly.

Invoices should contain the KHEL accession number of any specimens analyzed, the condition/gene analyzed, and cost of analysis. Each specimen should be a unique line item, with a total amount due calculated on a separate line. KHEL would only process invoices once service was completed.

14.

Closing time and current amendments Cover page section 1.2 and Event

Please confirm the October 13, 2026, closing time: the cover uses 2:00 p.m. CST and Event Details uses 2:00 p.m. CDT. Please also identify any amendments issued to date and where the complete current package and written answers can be obtained.

Bid event closes on October 13, 2026, 2:00PM CST

It shall be the bidder's responsibility to monitor this website on a regular basis for any changes/amendments.

15.

Invitation and registration Cover notes and Event Details invitation requirement

Please confirm the process for GEG Ventures LLC dba Heartland Trade Services to receive the official event invitation and amendment notices, and whether any invitation acceptance step remains necessary.

Please identify any event-specific bidder or subcontractor registration documentation beyond the stated Kansas vendor registration and tax-clearance requirements.

For an official invitation email nicole.mears@ks.gov with your company information. Be sure to include your FEIN to be able to cross reference your registration.

An official invitation is required.

No additional Sub-Contractor information is required.

mailto:nicole.mears@ks.gov

16.

Comparable purchasing history Cover page Replaces Contract New and section 4.1

We understand this is listed as a new contract. Are there prior comparable KHEL purchases, pilot services, publicly available unit prices or bid tabulations that bidders may review? Is an estimated budget available for this requirement?

No.

17. 25 Section 4.2 General Instructions

Who is responsible for the cost and logistics of shipping specimens from KHEL to the vendor’s laboratory? (Section 4.2 notes that the Vendor is responsible for all shipping and handling, but this appears directed towards goods delivery contracts).

KHEL is responsible for the cost and logistics of shipping specimens to the vendor’s laboratory.

18. 25 Section 4.2 General Instructions

In the event that multiple vendors are awarded contracts, how will the ~250 annual specimens be allocated?

Contracts would be awarded in the event vendors could provide all the technical specifications required for all or some of the conditions outlined.

If Vendor A could only provide services for 2 conditions and Vendor B could only provide services for 2 conditions different from that of A, the specimens would be allocated to those vendors based on the conditions for which they provide service. If both Vendors could provide services for the same condition, KHEL would then evaluate the cost of service to determine which Vendor would receive specimens.

19. 25 Section 4.3 Services

In the event that additional conditions are added to the KHEL Newborn Screening program during the contract term, will such additions be accomplished through amendment to the awarded vendor contract(s), with applicable pricing to be negotiated at that time?

Yes.

20. 25 Section 4.3 Services

What is the approximate breakdown by service for the 250 total annual samples?

KHEL Response:

Pompe: 135

MPS I: 30

MPS II: 10

Krabbe: 75 MLD: Not yet screening at KHEL DMD: Not yet screening at KHEL

21. 26 Section 4.3 Services

Does the requested service of NGS analysis limit the scope to single nucleotide variants (SNV) or should it also include copy number variation (deletion/duplication)?

The scope for NGS analysis was not defined so the Vendor should include both single nucleotide variants and copy number variation analysis if those are both offered by the Vendor.

22. 26 Section 4.4 Detailed Specifications

What procedures would be followed in the event of specimen quality (or similar) issues, and would the presence of such issues cause the reporting for the relevant specimen to fall outside the expected fourteen (14) business day turnaround time?

The Vendor would be expected to inform KHEL of the defined specimen acceptance/quality criteria that must be met when submitting specimens to the Vendor. Were a specimen to not meet these criteria, KHEL would expect a report from the Vendor stating why testing could not be performed. KHEL would then ship another specimen for the patient. In this instance, the expected 14 business day turnaround time would reset when the second specimen was shipped.

23. 26 Section 4.5 Pricing

What constitutes “bulk” for purposes of bulk pricing, and what are the expected bulk levels (if any)?

As the Vendor would be performing analysis on the shipped specimens, KHEL would look to the Vendor to establish the amount of specimens that would constitute as “bulk” for the Vendor’s workflows and therefore qualify for the Vendor’s “bulk pricing.”

24. 26 Section 4.5 Pricing

Is pricing fixed for the full initial 3-year term, or is pricing during that period subject to requests for adjustment at each yearly anniversary date pursuant to Section 3.37?

Prices are fixed for the initial term of the contract which is DOA through December 31, 2029. Actual contract start date shall not begin until contract is fully executed, signed and dated by the Director of Purchases.

At the end of the initial term, you have an option to renew twice and at each of those renewal times you may request for up to 5% increase.

Contractor shall furnish documentation at least 30 days prior to end of the term date.

25. 27 Section 5 Cost Sheet What are the specific Item Descriptions required for the 6 lines items since they are not legible?

Bid Documents have been updated with revisions of the cost sheet and the cost sheet has been attached to the bid event.

END OF AMENDMENT ONE – EVT0010938